Kornimate/medical-research-clean huggingface dataset:
quantifying drug adherence and drug exposure to antiretroviral therapy

Conditions: HIV/AIDS

Summary: the purpose of this study is to evaluate cumulative exposure to tenofovir diphosphate (tfv-dp) using dried blood spots (dbs) in treated hiv-infected patients who are receiving a tfv-based regimen. using dbs will allow the investigators to assess this simple method to measure drug exposure in the clinical setting. the investigators hypothesize that tfv-dp levels will be lowest in individuals with a detectable viral load and highest in those with viral suppression.

antiretroviral drug exposure is directly linked to individual host factors which include age, weight, diet, and genetics. however, the main factor impacting long-term drug exposure is drug adherence. adherence is a strong predictor of hiv treatment outcomes, but measuring adherence is difficult due to the inaccuracy of self-reporting and other commonly used monitoring methods. to date, no gold standard measure to monitor antiretroviral exposure and adherence has been applied in clinical practice. tenofovir (tfv) and its active metabolite, tenofovir diphosphate (tfv-dp), have distinctive pharmacological characteristics that make them ideal candidates for drug adherence and exposure monitoring. the long half life (\~14-17 days) of tfv-dp in red blood cells (rbc) are properties well suited for monitoring average dose exposure over time. based on these, the investigators propose that rbc levels of tfv-dp are an accurate and precise measure of long-term drug exposure in hiv-infected individuals. in addition, the investigators aim to quantify tfv-dp in dried blood spots (dbs) as a simple method to measure drug exposure. this is an observational, 48-week prospective study of hiv-infected individuals treated with tfv in which the investigators will compare dbs tfv-dp levels in virologically suppressed vs. non-suppressed individuals and evaluate the utility of tfv-dp in dbs to predict virologic failure and also drug toxicity. to accomplish this, the investigators will approach hiv-infected patients currently taking tfv (which is being prescribed by a primary care physician) and who present to the clinic for regular hiv care. after informed consent is obtained, the investigators will collect extra blood samples for dbs tfv-dp and obtain information on drug adherence. the investigators will also collect extra blood samples for dbs tfv-dp at each subject's subsequent visit for approximately 3 visits in a 48 week period of time.

Eligibility criteria:
inclusion criteria: * hiv-infected individual. * 18 years and older. * taking tenofovir. * blood drawn during regular clinic visit. exclusion criteria: * refusal to participate. * pregnancy. * inability to provide informed consent.

Keywords: hiv/aids adherence tenofovir dried blood spots
tqb2223 injection in combination with penpulimab in patients with advanced cancers

Conditions: Advanced Cancer

Summary: tqb2223 is a recombinant, fully humanized antibody that binds lymphocyte activation gene-3 (lag-3) and blocks the lag-3/ major histocompatibility complex class ii (mhc-ii) interaction, thus allowing for increased t-cell proliferation and cytokine production. this is a phase i study to evaluate the safety, tolerability, pharmacokinetics (pk) and effectiveness of tqb2223 injection in combination with penpulimab in subjects with advanced cancers.


Eligibility criteria:
inclusion criteria: * evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study; * male or female patient 18 to 75 years of age, an eastern cooperative oncology group (ecog) performance status of 0 to 1, and life expectancy ≥3 months; * histologically or cytologically confirmed malignancies; * subjects with advanced malignant tumors who failed standard treatment or lacked effective treatment; * patient has at least one evaluable lesion assessed by recist 1.1; * the main organs function is well; * male or female patient had no plans to become pregnant and voluntarily take effective contraceptive measures during study period until at least 6 months after the last dose of study drug. exclusion criteria: * concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 5 years; * history of uncontrolled intercurrent illness; * major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose; * prior treatment targeting lag-3; * unstable or serious concurrent medical conditions, as assessed by the investigators, that would substantially increase the risk-benefit ratio of participating in the study.
diurnal triglyceridemia in relation to alcohol intake

Conditions: Healthy Subjects; Hyperlipidemias; Type 2 Diabetes Mellitus; Cardiovascular Diseases

Summary: the purpose of this study is to determine the impact of alcohol consumption in diurnal triglyceridemia in a free living situation.


Eligibility criteria:
inclusion criteria: * healthy volunteers patients with: * hyperlipidemia * type 2 diabetes mellitus * cardiovascular diseases exclusion criteria: * renal disease * liver disease * thyroid disease

Keywords: ethanol lipemia postprandial triglyceride
acute responses to arm-crank exercise on cardiovascular function of patients with peripheral artery disease

Conditions: Intermittent Claudication; Cardiovascular Diseases; Blood Pressure; Endothelial Dysfunction; Peripheral Arterial Disease

Summary: the aim of this study is to analyze acute responses of arm-cranking exercise on cardiovascular function of peripheral arterial disease patients and compare it to the main exercise recommendation, walking exercise.

twenty patients with peripheral arterial disease and claudication symptoms will be recruited. the patients will perform three experimental conditions, in randomized order (walking, arm-cranking and control). the exercise conditions will be composed of 15 bouts of 2 minutes exercise with an intensity equivalent to 13-15 on borg's subjective perceived exertion scale. during the experimental conditions (walking, arm-cranking and control) blood pressure, heart rate and cerebral blood velocity will be evaluated, along with perceived exertion and affective responses. before and after experimental conditions, vascular function, blood pressure, heart rate variability, cerebral blood velocity, subjective perceived exertion and affective responses will be evaluated.

Eligibility criteria:
inclusion criteria: * peripheral arterial disease diagnosis; * age ≥ 40 years old; * if a woman, be in menopause without the use of hormone replacement therapy; * do not be an active smoker; * be apt to perform exercise. exclusion criteria: * any change in medication; * any health impairment that contraindicates the practice of physical exercise.
intracoronary injection of autologous bone marrow cells in patients with chronic heart failure: five years follow up

Conditions: Chronic Ischemic Symptomatic Heart Failure

Summary: the study aim is to evaluate the long term outcome of intra-coronary autologous bone marrow (bm) transplantation in patients with severe ischemic cardiomyopathy without the option for revascularization.

several studies have demonstrated the short term safety, feasibility and efficacy of cell transplantation in patients with advanced heart failure. there are no data about the long term outcome.

Eligibility criteria:
inclusion criteria: * patients with evidence of hibernation and/or ischemia in at least 2 different myocardial segments underwent coronary angiography exclusion criteria: * idiopathic or non-ischemic cardiomyopathy * other etiology for heart failure, history of past or current disease involving the bone marrow * patients on dialysis * positive serologic test for hiv, hepatitis b or c or any neoplastic or terminal disease
icbt for gd and comorbidities - a pilot

Conditions: Gambling Disorder; Comorbidities and Coexisting Conditions

Summary: the study is a pilot study (total n=30), with at pre, weekly during treatment, post and at three-month follow-up.

recruitment will be done through online advertisement via social media and gambling-related websites. participants will self-referred to the study via a study dedicated website (www.spelstudien.se). login to a treatment platform will be verified using double authentication (detailed description of the online platform is provided in the application to the swedish ethical review authority). written information about the study will be provided on the web page. consent will be done online, with the possibility for participants to download study information and consent. consenting participants will start a screening procedure. after screening, participants will be contacted for a telephone assessment with a clinical psychologist. during this interview, participants will be assessed for gd with a diagnostic interview, as well as the inclusion criteria for utilization of "spelpaus". if meeting criteria for the study, participants will be referred to the baseline/ pre-measures - which will start with an additional informed consent for the treatment phase and the icbt. inclusion will be done after the completion of the informed consent and baseline/pre-measures. after that, participant will get access to the icbt.

Eligibility criteria:
inclusion criteria: * screen positive for gd, as measured with the gambling disorder identification test (total score ≥20 gdit). * fulfilling gd, assessed according to the structured clinical interview for gambling disorder (sci-gd). * utilization of "spelpaus" (3 months from treatment start). * ≥18 years of age. * able to provide digital informed consent. * classified within pathways 2 or 3, as measured with the gambling pathways questionnaire (gpq). * screen positive for at least one common mental diagnosis in addition to gd, assessed according to the web screening questionnaire (wsq). exclusion criteria: * other ongoing psychological treatment for gd. * severe depression, screened according to the montgomery åsberg depression rating scale (total score \>34 madrs-s). * suicidality, screening of ≥4 points on item 9 of the madrs-s
a study to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects

Conditions: Obesity

Summary: this is a study to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.


Eligibility criteria:
inclusion criteria: * is obese with a body mass index (bmi) \>=30 kg/m\^2 to \<=50 kg/m\^2, and has been obese for at least one year before screening. * usually consumes at least three major meals (morning, midday, and evening) each day. exclusion criteria: * is currently enrolled in a formal weight-loss program. * has had liposuction within 1 year before screening or is planning to have liposuction during the study. * has received any investigational drug within 3 months before screening. * has previously participated in a study using pramlintide.

Keywords: obesity weight loss amylin pramlintide symlin
mark 1a series: percutaneous microwave ablation for patients with lung tumor(s)

Conditions: Lung Neoplasms; Cancer of Lung; Cancer of the Lung; Lung Cancer; Neoplasms, Lung; Neoplasms, Pulmonary; Pulmonary Cancer; Pulmonary Neoplasms; Metastatic Cancer to the Lung

Summary: does lung ablation improve clinical outcomes for patients deemed to be surgically high-risk?

surgical resection is the gold standard treatment for localized non-small cell lung cancer (nsclc). however, surgery is invasive and not all patients are surgical candidates, thus providing an opportunity for percutaneous microwave ablation, for both primary and metastatic disease. patients that are deemed inoperable are typically treated with other targeted therapies such as radiofrequency ablation (rfa), cryoablation and stereotactic body radiation therapy (sbrt), or systemic therapies. percutaneous microwave ablation (mwa) is an alternative option for targeted treatment of cancer. microwave tumor ablation is a procedure that uses heat made by an electric current to destroy a tumor (ablation). with imaging equipment, such as ultrasound or ct (computed tomography), and a small incision made in the skin, the tumor is located and treated with radiofrequency energy. the cells that are killed by the microwave ablation are typically not removed but are eventually replaced by fibrosis and scar tissue. patients will be followed for 1 year by contrast enhanced chest ct, chest pet/ct and chest pet/mri to evaluate lesion outcomes.

Eligibility criteria:
inclusion criteria: * subject must be at least 18 years old. * subject is able to understand the study procedures and provide informed consent. * subject is willing and able to complete the entire study as specified in the protocol, including the follow-up visits. * subject has lung lesion that is biopsy-proven cancer (of any type) or suspicious, with confirmation at the time of the procedure. * lung lesion(s) are reachable/treatable per clinician opinion. * subject can have other location of disease if it is controlled, or there are plans for control. * subject has 1 or more lung nodules (not more than 10), that have a mean diameter \<3 cm on axial ct scan. * life expectancy ≥6 months exclusion criteria: * subject is pregnant or breast feeding. * subject has a significant clinical disease or condition, e.g. cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematological, psychiatric or neurologic that would preclude enrollment, as determined by the primary investigator. * subject has another location of disease that is not controlled, and there are no plans for control. * subject has more than 10 lung nodules.
postoperative effects of chewing gum, ibuprofen and acetaminophen on pain after initial archwire placement

Conditions: Pain

Summary: the purpose of this study is to compare the efficacy of ibuprofen, acetaminophen, chewing gum in reducing orthodontic pain. this study include 81 patients to be classified into 4 groups of 19 each: ibuprofen (400 mg), acetaminophen (500 mg), chewing gum and control. the patients in each group will receive 1 method immediately after placement of the initial archwire and every 6 hours for a week if they experiences pain. pain perception will be recorded by the patients while jaw rest position and fitting back teeth at 2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement, using a visual analog scale.


Eligibility criteria:
inclusion criteria: * moderate teeth crowding * no need for tooth extraction to orthodontic reasons exclusion criteria: * presence of autoimmune diseases * history of orthodontic treatment with fixed appliances

Keywords: pain orthodontics
safety and efficacy study of epinastine nasal spray in subjects with seasonal allergic rhinitis (p08648)

Conditions: Seasonal Allergic Rhinitis

Summary: the purpose of this study is to determine the safety and efficacy of epinastine nasal spray compared to placebo for the treatment of subjects with seasonal allergic rhinitis


Eligibility criteria:
inclusion criteria: * a documented history of seasonal allergic rhinitis to mountain cedar or other spring pollen exclusion criteria: * significant medical condition * significant nasal abnormality * significant cardiac condition * recent infection * use of other allergy medication during the study * use of asthma medication other than as-needed albuterol
non-invasive prediction of fluid and noradrenaline responsiveness using the carotid wave intensity.

Conditions: Shock; Aortic Valve Disease; Coronary Artery Disease; Mitral Valve Disease

Summary: the goal of this observational study is to study a new method to compute ventricular-arterial coupling (vac) in adult intensive care patients after cardiac surgery. vac is a metric that describes the interaction between the heart and the arterial system. the new method of measuring vac uses carotid ultrasound measurements. the main questions this study aims to answer are: * can vac measured using carotid ultrasound predict the hemodynamic response to drugs? * what is the concordance of vac measurements obtained via carotid ultrasound with vac measurements obtained via the standard, single-beat method? measurements will be performed in the operating room and at the icu.

the goal of this prospective observational study is to study ventricular-arterial coupling (vac) measured using carotid ultrasound in adult intensive care patients after cardiac surgery. the objectives of this study are: * to determine if vac measured using carotid ultrasound can predict the hemodynamic response to drugs. * to assess and quantify the concordance of vac measurements obtained using carotid ultrasound with vac measurements obtained using the single-beat method. measurements will be performed in the operating room and at the icu.

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) * admitted to the icu after cardiac surgery exclusion criteria: * no informed consent for study participation * within the first 3 hours of icu admission noradrenaline infusion is not increased or started, and/or a fluid bolus is not given; both on indication of the attending physician * patient with chronic obstructive pulmonary disease (copd) gold stage 3 or 4 * pregnancy * moderate to severe aortic valve disease * atrial fibrillation * carotid artery stenosis \>50% * history of cerebrovascular accident or transient ischemic attack * history of cerebral trauma * morbid obesity (bmi \>40 kg/m2) * emergency surgery

Keywords: ventriculo-arterial coupling carotid ultrasound
frailty in vascular patients undergoing surgery

Conditions: Vascular Diseases; Carotid Artery Diseases; Aneurysmal Disease; Peripheral Artery Disease

Summary: an observational cohort study of the frailty of vascular surgery patients undergoing intervention and their outcomes.

vascular surgical operations are major procedures with significant associated morbidity and mortality. frailty is a major factor influencing surgical outcome, but the effect on morbidity/mortality and quality of life is poorly understood in vascular surgery. activity levels play a significant role in frailty and in pre-intervention preparation. it is anticipated that as frailty levels increase, activity levels decrease. it is hypothesised that vascular surgery patients suffer from a high prevalence of frailty and that increasing frailty will lead to increased morbidity and mortality and decreased quality of life. this initial study will provide the foundations to identify targets for improvement in degree of frailty, appropriateness for surgery and outcome. this project aims to: assess and quantify the prevalence of frailty as well as recording activity levels in the vascular surgery patient cohort explore the impact of frailty and pre-op activity on surgical outcomes in the vascular surgical patient cohort to guide surgical treatments as well as future studies aimed at improving frailty and activity and thereby quality of life. identification of an appropriate metric of frailty for this population group to include activity, is a secondary aim of this proposal.

Eligibility criteria:
inclusion criteria: 1. all patients attending for aortic aneurysm repair, carotid artery surgery and lower limb revascularisation under the care of the vascular surgery team 2. willing and able to give informed written consent exclusion criteria: 1. those unable to give informed written consent 2. those \<18 years of age 3. in the opinion of the investigator unable or unwilling to comply with the requirements of the study

Keywords: vascular diseases peripheral artery disease
conventional photodynamic therapy vs. painless photodynamic therapy for small genital warts

Conditions: Genital Warts

Summary: this study is being done to compare a new, continuous illumination and short incubation time regimen of aminolevulinic acid photodynamic therapy（ala-pdt) to a conventional regimen for treatment of small genital warts. the hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosed with genital warts; 2. aged \> 18 years; 3. all patients are unfit and reluctant to undergo surgery for any reasons, and volunteered to participate in the study and ability to understand and the willingness to sign a written informed consent. patents agreed to take a picture of the skin lesions. 4. the maximum diameter of a single carcass does not exceed 0.5cm; the skin lesions are at least 6 or more or substantially symmetric exclusion criteria: 1. those who did not complete the informed consent; 2. the lesions belongs to any of the following conditions: there is damage and inflammation, which may lead to the drug entering the open wound; the individual corpus callosum is more than 0.5cm in diameter; the corpus callosum is located in the vagina, the anal canal, the cervix; 3. patients with skin photoallergic diseases, porphyria; 4. known to have a history of allergies to test drugs (porphyrins) and their chemically similar drugs; 5. patients with other obvious diseases that may affect the evaluation of efficacy; (6)scars or patients with a tendency to form scars; (7)known to have severe immune dysfunction, or long-term use of glucocorticoids and immunosuppressants; (8)severe heart, liver, kidney disease; with hereditary or acquired people with sexual coagulopathy; (9)those with severe neurological, psychiatric or endocrine diseases; (10)women who are pregnant, breast-feeding or using inappropriate contraceptives; those with a history of drug abuse; those who have participated in other drug clinical trials within 4 weeks before treatment.

Keywords: photodynamic therapy，pdt conventional painless genital warts
rct of cesip for children with emotional and stress problems

Conditions: Emotional Stress

Summary: to explore the effect of child-adolescent emotion and stress intervention program for children with emotional and stress problems, providing early social psychological intervention for aiming the core impairments of emotional and stress problems.

80 children with emotional and stress problems will be randomly divided into the intervention group and the waiting group. the waiting group received regular clinical intervention, while the intervention group received 12-week training. the intervention program includes emotional regulation and stress intervention training for children by two therapists, which were carried out in one meeting rooms in xinhua hospital. therapists are psychotherapists with a background in child psychotherapy training. after 12 weeks, the improvement of emotional symptoms was compared.

Eligibility criteria:
inclusion criteria: * the results were positive on the scared scale; age 6 years 0 to 12 years 11 months; total iq is above 80 assessed by wppsi. exclusion criteria: * attention deficit disorders resulting from organic neurological diseases, extensive developmental disorders, mental retardation, childhood schizophrenia, mood disorders, epilepsy, and other organic diseases or other primary mental disorders; parent or guardian with a serious mental illness, such as schizophrenia, mood disorder (onset), etc., and educational level is lower than junior middle school; participants who failed to attend more than 80% of the intervention sessions (at least 9 sessions).

Keywords: emotional stress intervention rct