cyrilzakka/clinical-trials huggingface dataset:
Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults

This randomized trial compares the efficacy of switching to a fixed-dose combination of B/F/TAF versus continuing a boosted protease inhibitor (bPI) regimen in HIV-1 infected participants who are virologically suppressed (HIV-1 RNA \<200 copies) on a second-line bPI regimen. Half of participants will receive B/F/TAF and half will continue a bPI regimen. The hypothesize is that B/F/TAF will have efficacy that is non-inferior to the boosted PI regimen.

The second generation integrase strand transfer inhibitors (INSTIs) dolutegravir (DTG) and bictegravir (BIC) are widely prescribed for the treatment of HIV, due to their favorable tolerability and toxicity profile, durable efficacy, and high barrier to resistance. However, there are limited data to guide the management of patients who are already virally suppressed on a second-line bPI regimen.

Though bPIs have a high barrier to resistance and durable virologic efficacy, they have several important drug-drug interactions, are associated with unfavorable long-term metabolic effects, and may be poorly tolerated. For these reasons, a second-generation INSTI would be preferable to a boosted PI regimen, as long INSTIs are demonstrated to have non-inferior efficacy for patients who are already suppressed on a second-line bPI regimen.

In the proposed study, the efficacy of continuing the bPI regimen will be compared to switching to B/F/TAF.

Eligibility Criteria:
Inclusion Criteria:

* The ability and willingness to give informed consent.
* Age ≥18 years
* History of meeting WHO criteria for immunologic or virologic failure after receipt of a first-line treatment regimen for ≥6 months
* Currently receiving a second-line ART regimen including either ATVr or LPVr + 2 NRTIs for ≥6 months
* At least one HIV-1 RNA \<200 copies/mL within 12 months prior to enrollment, and no HIV-1 RNA of at least 200 copies/mL during this period.
* Plasma HIV-1 RNA \<200 copies/mL at Screening Visit.
* eGFR ≥ 50 mL/min according to the MDRD study equation for creatinine clearance
* Hepatic transaminases (AST and ALT) \</=5X upper limit of normal (ULN)
* No active TB
* Women of childbearing age must agree to take reliable contraception

Exclusion Criteria:

* Active World Health Organization Stage 3 or 4 condition
* Treatment with an INSTI in the past
* Gap in care of at least one month in the prior six months
* Current alcohol or substance use judged by investigator to potentially interfere with participant study compliance
* History of poor adherence, that in the opinion of the investigator, would potentially interfere with study compliance
* Pregnant or breastfeeding at screening visit
* Planning to transfer care
Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants

The purpose of this study is to evaluate the immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers following the 0, 1, 6 months schedule

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 40 years old.
* Written informed consent will have been obtained from the subjects.
* Good physical condition as established by physical examination and history taking at the time of entry.
* Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry

Exclusion Criteria:

* Pregnancy or lactation.
* Serological signs of HBV infection
* Elevated serum liver enzymes
* Any vaccination against hepatitis B in the past.
* Any previous administration of MPL.
* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
* Axillary temperature \> 37.5°C at the time of injection.
* Any acute disease at the moment of entry.
* Chronic alcohol consumption.
* Any treatment with immunosuppressive or immunostimulant therapy.
* Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
* History of allergic disease likely to be stimulated by any component of the vaccine.
* Administration of any other vaccine(s) or any immunoglobulin during the study period.
* Simultaneous participation in any other clinical trial.
Arch Size Study for Anatomical Variations

The aortic arch with a common origin of the innominate and left carotid artery (CILCA) prevalence in the general population is 13.6%. Its reputation as a benign anatomical variant has been ultimately shattered by further studies that identified the CILCA arch as a potential marker for thoracic aortic disease (TAD) The aim of this work is to report the CT anatomical characteristics of the aortic arch in subjects with or without aneurysms requiring treatment, in 5 major European cardiovascular centers.


Eligibility Criteria:
Inclusion Criteria:

all patients with aortic arch CT scan at investigating centers

Exclusion Criteria:

none
Capsaicinoid Ingestion, Human Metabolism and Exercise

Capsaicinoids (the active ingredient in hot peppers) have been shown to cause a moderate increase in energy expenditure (50 kcal/day) as well as reductions in appetite, energy intake, and (visceral) adiposity. As such, there is considerable interest in capsaicinoid for weight loss supplements. Of particular interest are the recent findings that free-fatty acids in the blood are elevated 2-2.5hrs post ingestion, yet changes in typical cardiovascular or sympathetic nervous tone indicators (heart rate, blood pressure) were unaffected, suggesting some of the negative consequences of other stimulants may be avoided. At present, however, more in depth investigations of the effects on endothelial function, vascular autonomic tone and inflammation are lacking.

The investigators seek to understand the effect of 3 months capsaicinoid ingestion on alterations in body composition, traditional cardiovascular risk factors and cardiovascular function

Hypotheses:

1) Continued use of capsaicinoids will alter resting metabolism substrate use, which will result in moderate (but clinically meaningful) alterations in body composition manifested as a decrease in adiposity. 2) Blood lipids will be unaffected by capsaicinoid use, as will brachial blood pressure. 3) Levels of systemic inflammation may increase slightly, and this could have an effect on vascular reactivity to hyperemic flow or baseline vascular tone. However, previous research suggests that these alterations will not be manifested in autonomic nervous tone assessed by changes in heart rate variability.

Project abandoned

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be male or female
* 18 yr -45yr and free from any known or suspected chronic conditions.
* General health and suitability to participate in an exercise/health research study will be confirmed through use of the PAR-Q+ screening questionnaire

Exclusion Criteria:

* Any participant who has a positive answer to a screening question will be required to seek physician approval prior to any physical exercise.
* Baseline arrhythmia (tachycardia (\>100pbm) and systolic or diastolic hypertension (\>140/90 mmHg) will also be reason for exclusion.
* During baseline anthropometric assessment we will confirm that participants all fall within a typical BMI range (20-30 kg/m2) of either "normal" weight or "overweight", but not "underweight" or "obese".
* Persons who take cardiovascular medications, metabolic medications, smoke cigarettes, excessively consume alcohol, are prone to heartburn, or have a previous diagnosis of hyperlipidemia or hyperinsulemia will also be excluded
Bupivacaine Epiphora Trial

The objective of this study is to investigate quantitative improvement in excessive tearing after administration of Bupivacaine, a local anesthetic, into the affected eyelids.


Eligibility Criteria:
Inclusion Criteria:

Patients age 18 and above, patients with unilateral or bilateral excessive tearing.

Exclusion Criteria:

Pregnant females, vulnerable populations, patients with severe hepatic disease, or patients using monoamine oxidase inhibitors or tricyclic antidepressants, which are contraindicated with bupivacaine and norepinephrine combinations.
Preventive Application of GnRH Antagonist on Early OHSS

Ovarian hyperstimulation syndrome is an iatrogenic complication of controlled ovarian stimulation. Ovarian hyperstimulation syndrome prevention is a multistage process and more important than treatment.Preventive administration of GnRH antagonist for high risk OHSS patients from the day of oocyte retrieval is not investigated. Besides, the relevant mechanism is not clear yet. Here we designed a prospective randomized study to investigate whether GnRH anatagonist treatment after oocyte retrieval is more effective in preventing early ovarian hyperstimulation syndrome development than traditional aspirin preventive administration in women at high risk for OHSS.

Ovarian hyperstimulation syndrome is an iatrogenic complication of controlled ovarian stimulation. Early ovarian hyperstimulation syndrome (OHSS) occurs during luteal phase of controlled ovarian stimulation within 9 days after human chorionic gonadotropin trigger and reflects an acute consequence of this hormone on the ovaries.Ovarian hyperstimulation syndrome prevention is a multistage process and more important than treatment.Recently the administration of GnRH antagonists during the luteal phase of in vitro fertilization cycles offers another therapeutic modality for patients with severe early OHSS.However, preventive administration of GnRH antagonist for high risk OHSS patients from the day of oocyte retrieval is not investigated. Besides, the relevant mechanism is not clear yet. Here we designed a prospective randomized study to investigate whether GnRH anatagonist treatment after oocyte retrieval is more effective in preventing early ovarian hyperstimulation syndrome development than traditional aspirin preventive administration in women at high risk for OHSS.

Eligibility Criteria:
Inclusion Criteria:

* number of oocyte retrieval more than 25;
* estradiol level higher than 5000pg/mL on the day of human chorionic gonadotropin administration;
* clinical or ultrasonography proven ovarian hyperstimulation syndrome on the day of oocyte retrieval.

Exclusion Criteria:

* contraindications to GnRH antagonist;
* coasting or other preventive measures for managing ovarian hyperstimulation syndrome had been applied;
* GnRH agonist for trigger.
Arachidonic Acid Supplementation in Very Preterm Infants

Long-chain polyunsaturated fatty acids (LCPUFAs), arachidonic acid (AA omega-6; 20:4ω-6), and docosahexaenoic acid (DHA omega-3; 22:6ω-3), are required for the formation of non-myelinated cell membranes in the central nervous system, including in the retina, hence the great importance of them for appropriate visual and cognitive development.

In this study, the investigators assessed anthropometric, visual, auditory, and psychomotor development in very preterm infants who had diets supplemented with different LCPUFA amount of AA to support the importance of sufficient AA values in formula.

the investigators carried out a prospective randomized controlled double blinded trial in order to study nutritional supplements for preterm infants \<1500 grams and/or \<32 weeks gestational age (GA) who were born in clinical University Hospital of Santiago de Compostela (CHUS). They were enrolled for a period of 14 months (from July 2011 to August 2012) and followed up from birth until 2 years of age. Milk formulas were provided either as adjunct to insufficient amount of breast milk, or as full formula feeding. Breastfeeding was actively encouraged. Patients were randomized into one of the two formula groups, depending on the type of formula they were to receive. Group A's formula was supplemented with DHA (0.3% of all fatty acids) and AA (0.6%) with an ω-6/ω-3 ratio of 2/1. Group B's formula was supplemented with DHA (0.3%) and AA (0.3%) with an ω-6/ω-3 ratio of 1/1.

Primary outcome:

Assessment of psychomotor development with the Brunet Lézine scale at 2 years of age (Early Care Unit CHUS)

Secondary outcomes:

Physical examination and anthropometric measurements (weight, length, and head circumference) at birth and at 3, 6, 9, 12, 18, and 24 months of age (Neonatology Unit CHUS) Blood levels of fatty acids in the first week of life and at 3 months, 6 months, and 12 months. (Metabolic Unit. Hospital de Cruces, Bilbao) Visual- and auditory-evoked potentials at 6 and 12 months of age (Neurophysiology Unit CHUS)

Eligibility Criteria:
Inclusion Criteria:

* Living infants who were less than 1500 grams and/or less than 32 weeks gestational age, and whose parents accepted and subscribed the informed consent

Exclusion Criteria:

* Preterm infants with any severe malformation.
* Extremely preterm infants with a gestational age of less than 25 weeks.
* Infants whose parents could not complete the follow-up process in our study center.
* Preterm infants with severe intraventricular hemorrhage or periventricular leukomalacia (more than grade 2).
* Neonates who did not need supplementary milk nutrition, i.e. breastfed-only children.
A Study of Oral CFG920 in Patients With Castration Resistant Prostate Cancer

This study was supposed to have assessed the safety and preliminary antitumor activity of CFG920, a new CYP17 inhibitor in castration resistant prostate cancer patients who are abiraterone naive or abiraterone resistant.

The study was terminated after Phase I (dose escalation phase) and Phase II part of the study was not initiated. Novartis voluntarily terminated this study and hence stopped further enrollment of patients into this study. As the decision to terminate the study was not due to any safety issues, the patients enrolled in the study by the time of this decision were allowed to continue with treatment per the protocol.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of castration resistant prostate cancer
* Documented metastases
* ECOG performance status 0 or 1
* Documented progression following the Prostate Cancer Working Group 2 guidelines
* Fresh or archived tumor sample

Exclusion Criteria:

* Impaired cardiac function
* Uncontrolled hypertension despire appropriate medical therapy
* History of pituitary or adrendal dysfunction
* Chronic steriod therapy other than daily use of 10mg prednisone
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of oral CFG920
* Brain metastases that have not been adequately treated
* Malignant disease other than that being treated in this study
* Laboratory abnormalities as specified in the protocol Other protocol-defined inclusion/exclusion criteria may apply
Serum Biomarker HE4 During IVF Treatment

Human epididymal secretory protein 4 (HE4) is a new biomarker for ovarian cancer. The effect of IVF stimulation will be evaluated in order to see whether severe hormonal changes in the gonadotrophin and steroid status affect the serum levels of this marker. Findings will be compared to serum concentrations of CA-125, which is currently the most often used marker for ovarian cancer.

The intention is to determine the serum concentration of HE4 and CA-125 in serial samples in 20 women undergoing IVF stimulation. Samples will be taken following GnRH agonist suppression, 2-3 times during FSH stimulation, at ovum pick up and two weeks following embryo transfer at the time of the hCG-test. The ovarian follicle count and the serum estradiol concentrations are recorded throughout the treatment. The serum biomarker HE4 is expected to ba a stable marker, which does not respond significantly to hormonal stimulation.


Eligibility Criteria:
Inclusion Criteria:

* infertility treated by IVF

Exclusion Criteria:

* pelvic tumor
* overweight (BMI over 35)
Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetics Failing on OADs

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the effectiveness of biphasic insulin aspart 30 in type 2 diabetics not achieving blood sugar levels when treated with oral anti-diabetics drugs (OADs) with or without basal insulin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus for at least 12 months
* HbA1c: 7.5-10.0%
* An antidiabetic regimen that has been stable for at least 3 months
* Able and willing to perform SMBG testing as per protocol

Exclusion Criteria:

* Use of any insulin preparations other than NPH or glargine within the past 6 months
* Pregnancy, breastfeeding, intention to become pregnant within the next 12 months, or judged to be using inadequate contraceptive measures (adequate contraceptive measures includes: sterilization, intrauterine devices, oral contraceptives, or consistent use of barrier methods)
* Known or suspected allergy to trial product or agents related to trial product
Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events

The regulatory effects of the autonomic nervous system (ANS) concern almost all organs which permanently feed information back to this global biological vigilance system controlling allostasis. Heart rate fluctuations are highly dependent on ANS control, making the heart one of the best indicators of ANS activity.

Low ANS activity level is associated with severe cardiac and cerebral events, as well as to death from any cause in the general population.

This PROOF study was hence designed to evaluate ANS activity levels among a healthy retired population, but should these levels decline overtime, to use this as a predictor of cardiovascular and cerebrovascular events, taking into account established cardiovascular risk factors.

The main goal of this PROOF study is to evaluate, on a selected prospective cohort of subjects aged 65 years upon study entry, the prognostic values of ANS activity levels measured at preset times, and more specifically, of its decline over the follow-up period, for fatal and non-fatal cardiovascular and cerebrovascular events.

Eligibility Criteria:
Inclusion Criteria:

* 65 years old
* informed consent signed

Exclusion Criteria:

* prior myocardiac infarction
* prior stroke
* hearth failure
* atrial fibrillation
* insulin-treated diabetes mellitus
* cardiac pacemaker
* disease limiting life expectancy to \< 5 years
* contraindication to brain MRI
* living in an institution
Diabetes Telemedicine Consultation: A Systems Improvement Intervention

This study seeks to evaluate and document the processes of outreach consultation through joint-clinics via teleconferencing as an intervention for system improvement in care delivery and management of diabetes mellitus (DM) at a Community Based Outpatient Center (CBOCs).

Background:

Diabetes is a national problem that has reached epidemic proportions, according to the U.S. Centers for Disease Control and Prevention. Diabetes has particular importance for the Department of Veterans Affairs (VA) because the prevalence among VA patients -- one in six, or 16 percent -- is substantially higher than in the general population.

Objectives:

The objective of this study was to evaluate and document the processes of outreach consultation through the use of joint-clinics via teleconferencing as an intervention for system improvement in care delivery and management of diabetes at CBOCs. The intervention consisted of a teleconferenced joint-clinic consultation session involving the patient, Diabetes Specialist Team, the Primary Care Provider (PCP) and other relevant care team members. The impact of the 16-month intervention was assessed based on patients who were involved in the telemedicine clinic and those who were referred to a specialist to be seen on-site at the Cleveland VAMC.

Methods:

Study settings include the CBOCs affiliated with the Cleveland Veterans Affairs Medical Center (VAMC) and involve primary care referrals to see diabetes specialists at the Cleveland VAMC. Inclusion criteria patients(N 282)=included: (i) current prescription of insulin or an oral hypoglycemic agent; (ii) A1c \> 7.0%; or (iii) fasting glucose levels\> 130 mg/dl; and (iv) referred to see a consultant (beginning three months prior to the active intervention phase and continuing through enrollment for the last month of the active intervention phase). Patients with either Type l or Type II diabetes will be included. Patients referred will be contacted and asked to participate.

Eligibility Criteria:
Inclusion Criteria:

* 1) Current prescription of insulin or an oral hypoglycemic agent
* 2) A1c \> 7.0%
* 3) fasting glucose levels \> 130 mg/dl
* 4) referred to see a consultant and are seen during the active intervention phase. Patients with either Type I or Type II DM will be included

A Primary Care Provider for a Cleveland CBOC

Exclusion Criteria:

* 1) primary care obtained at more than one site (based on stop codes with evidence of more than 1 CBOC involved in care during the last 6 months)
* 2) documented dementia, aphasia, and psychosis
Impact of Preoperative Frailty and Cognitive Impairment on Postoperative Outcomes in Elderly Cardiac Surgery Patients

This is a retrospective study of patients aged 65 years and older who underwent cardiac and aortic surgery between March 5, 2021 and October 12, 2022 in the operating room of Severance Cardiovascular Hospital to determine the impact of physical frailty as well as nutritional status, emotional dysregulation, and cognitive dysfunction on postoperative outcomes. Physical frailty will be determined by the Clinical Frailty Scale, handgrip strength, and nutritional status, cognitive dysfunction will be determined by the K-MMSE and K-MoCA administered at the preoperative interview, and emotional dysregulation will be determined using the SGDS-K. These were measured during the pre-anesthesia evaluation and only results from patients who agreed to be tested will be used. Nutritional status will be analyzed based on blood test values measured within one month of surgery.


Eligibility Criteria:
Inclusion Criteria:

* 65-year-old patients undergoing surgery for heart and aortic disease, who completed physical (Clinical Frailty scale, Handgrip strength), cognitive(K-MoCA, K-MMSE), and emotional (SGDS-K) functioning tests at the preoperative interview

Exclusion Criteria:

* Failed to complete two or more of assessments shown above