cyrilzakka/clinical-trials huggingface dataset:
18F-PSMA-1007 PET Imaging to Detect Primary Prostate Cancer

To study the added value of 18F-PSMA-1007 PET to mpMRI in the detection of local prostate cancer lesions.

Prostate cancer (PCa) is the second most common diagnosed malignancy in males worldwide, with over 1.2 million new patients diagnosed every year. Since the introduction of prostate-specific antigen (PSA) the primary diagnosis consisted of histologic confirmation by transrectal ultrasound (TRUS) systematic biopsies. However, in recent years this has changed into performing multi-parametric MR imaging (mpMRI) prior to prostate biopsy.

MpMRI has proven to be a valuable tool to avoid unnecessary prostate biopsies and prevent over-treatment of low-grade PCa, while maintaining equal or higher detection rates of high-grade PCa. Prostate MRI is evaluated using the Prostate Imaging-Reporting and Data System (PIRADS). Lesions are given a category score, from 1 (high-grade PCa is unlikely to be present) to 5 (presence of high-grade PCa is highly likely). A PIRADS 3 is an equivocal scan. Nonetheless, mpMRI has room for improvement as its specificity for high-grade tumors is only 73% and local staging is limited with mpMRI. Also, the mpMRI is frequently unclear as 4-39% of detected lesions are classified as PIRADS 3.

Prostate-specific membrane antigen receptor (PSMA) is highly overexpressed by 95% of the prostate cancer cells and seem to positively correlate to aggressiveness of the tumor. PSMA-positron emission tomography (PET) uses this feature by visualizing PSMA expressing prostate tumors. Currently, the PSMA-PET is generally used to detect recurrences or metastases. However, there is an increasing interest for PSMA-PET scans in patients with a primary diagnosis of PCa for staging purposes. Yet, there is no published data on the role of PSMA-PET on PCa prior to biopsy in comparison to the detection rate of mpMRI and histopathology.

This study aims to investigate the added value of a 18F-PSMA-PET to mpMRI in the detection of local prostate cancer lesions.

75 patients with the suspicion on prostate cancer (e.g. elevated PSA and/or abnormal digital rectal exam) will receive a 18F-PSMA-1007 PET following mpMRI. 25 patients with PIRADS 1-2 (probably benign disease), 25 patients with PIRADS 3 (equivocal disease) and 25 patients with PIRADS 4-5 (highly suspicious for malignancy) will be included in this study.

If either the mpMRI or 18F-PSMA-1007 PET shows a potential malignant lesion, a (target) biopsy will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Suspicion for PCa (e.g. elevated PSA, suspicious rectal examination)
* Males ≥ 18 years
* ECOG 0-1
* Signed informed consent

Exclusion Criteria:

* Prostate biopsy in the last 6 months
* History of prostate cancer
* Second active malignancy
* Any prior surgery in the pelvic area that might interfere with the scans (e.g. hip replacement surgery)
* Any medical condition that in the opinion of the investigator will affect patients' clinical status when participating in this trial.
* Contra-indications for mpMRI or PET: claustrophobia or inability to lay still for the duration of the exam.
Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3

The primary objective of this study is to evaluate the safety and tolerability of GS-4997 (selonsertib \[SEL\]) alone or in combination with simtuzumab (SIM) in adults with nonalcoholic steatohepatitis (NASH) and fibrosis stages F2-F3. Participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 study treatment arms.


Eligibility Criteria:
Key Inclusion Criteria:

* Males and non-pregnant, non-lactating females
* Evidence of NASH with fibrosis on biopsy

Key Exclusion Criteria:

* Cirrhosis of the liver (e.g. Brunt/Kleiner score of F4)
* Other causes of liver disease including viral hepatitis and alcoholic liver disease
* Any history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
* History of liver transplantation
* Alcohol consumption greater than 21 oz/week for males or 14 oz/week for females (1 oz/30 mL of alcohol is present in 1 12 oz/360 mL beer, 1 4 oz/120 mL glass of wine, and a 1 oz/30 mL measure of 40% proof alcohol)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Role of Epoxyeicosatrienoic Acids in Chronic Allograft Nephropathy - The TRANSPLANT-EETs Study

Endothelial lesions within the transplanted kidney are a major determinant of chronic allograft nephropathy. Epoxyeicosatrienoic acids (EETs) are endothelium-derived hyperpolarizing factors with anti-inflammatory, antiproliferative and vasodilator properties.

The main goal of the investigators' study is to evaluate whether genetic polymorphisms of specific enzymes responsible for the bioavailability of EETs are associated with post-transplant kidney function.

To this end, 80 kidney transplant recipients will be included. Prespecified genetic polymorphisms of CYP 2J2, CYP 2C8, CYP 2C9, CYP 2C9, CYP 2C19 and EPHX2 will be determined. Kidney function will be recorded 3, 6, 12 and 36 months after transplantation. Flow-mediated dilatation, EETs and circulating biomarkers of endothelial function will be measured in the radial artery.

The expected results of this study to provide preliminary evidence supporting a beneficial role of an increase in the bioavailability of EETs in kidney transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 to 75 yo
* Caucasian (because of different CYP epoxygenase polymorphisms)
* First kidney transplantation performed in Rouen University Hospital after 2000, and at least 12 months before inclusion
* Patient having read, understood and approved the informed consent
* Efficient contraception in child-bearing aged women
* Regular health insurance

Exclusion Criteria:

* Primary non-function, or allograft loss before 1 year
* Previous kidney transplantation
* History of psychiatric, psychologic or sensorial disorder preventing the patient from correctly understanding the protocol
* History of bilateral arm or forearm arteriovenous fistula
* Counter-indication to trinitrin
* Insufficient understanding of written or spoken French language
* Liberty-deprived patient
* Pregnancy or absence of contraception in child-bearing aged women
* Patient enrolled in another research protocol within 2 weeks before inclusion
Implantable Loop Recorder in Hemodialysis Patients

The purpose of this study is to use implantable loop recorder (ILR) in patients under chronic hemodialysis to record arrhythmias and conduction disorders and correlate them with hemodialysis parameters.

Primary cause of death in patients under chronic hemodialysis is Sudden Cardiac Death (SCD) (25% of all cause mortality). SCD is mainly due to cardiac arrhythmias (conduction disturbances or ventricular arrhythmias). These cardiac arrhythmias are highly sensitive to hydro-electrolytic disorders which are extremely frequent in patients under hemodialysis. In addition, other conditions leading to cardiac arrhythmias are frequent in this population such as ischemic myocardiopathy or dilated myocardiopathy. However, so far, little is known about the occurrence of arrhythmias because of studies using only standard Holter monitoring (24 to 48 hours monitoring at best).

The investigators sought to evaluate the incidence of cardiac arrhythmias by using an implantable loop recorder (ILR)(Reveal XT, Medtronic) that allows continuous rhythm monitoring for 24 months. This ILR will be implanted under local anesthesia.

Clinical follow-up will be performed during hemodialysis and rhythm management will be performed automatically using a remote-monitoring system (Carelink, Medtronic). Pre-programmed alerts (conduction disturbances, supra-ventricular arrhythmias or ventricular arrhythmias) recorded by the ILR will be sent automatically on a daily basis in our center. These data will be analyzed during week days from 9AM to 5PM. They will be reviewed by an electrophysiologists and depending on the potential lethality, the patients will be called and ask to come to the emergency room in case of high risk or the nephrologist will be contacted and he will see the patients during the next hemodialysis in case of on vital event.

Eligibility Criteria:
Inclusion Criteria:

* Patients under chronic hemodialysis
* Age between 45 and 80 yo
* written informed consent
* affiliated to the French Social Security system

Exclusion Criteria:

* Pace-maker or Implantable Cardioverter Defibrillator
* Active infection
* Neoplasia or any pathology with a life expectancy \<12 months
* Cachexia
* Patient with restricted civic rights by law
A Study to Identify and Characterise Bacteria Causing Chronic Cough Among Children in United Kingdom

The purpose of this study is to investigate the role of Haemophilus influenzae and other bacteria in causing chronic cough, through a direct comparison of chronic cough cases and healthy controls recruited from paediatric respiratory clinics in the United Kingdom.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that parent(s)/ legally acceptable representative can and will comply with the requirements of the protocol.
* A male or female child between, and including, six to 72 months of age at the time of enrolment.
* Written informed consent obtained from the parent(s)/ legally acceptable representative of the subject.
* No antibiotic therapy within four weeks prior to the visit.
* No cystic fibrosis or known major immunodeficiency such as agammaglobulinaemia, T cell deficiency or Human Immunodeficiency Virus / Acquired Immune Deficiency Syndrome.
* No documented evidence or suspicion of gastroesophageal reflux disease.
* No evidence of an upper viral respiratory infection four weeks prior to the visit.

In addition, all subjects regarded as 'cases' must satisfy all the following criteria at study entry:

* Persistent cough greater than eight weeks.
* No response to five-day prednisolone treatment.
* Chest X-ray showing no evidence of a lobar pneumonia or gross structural abnormality.

In addition, all subjects regarded as 'controls' must satisfy the following criteria at study entry:

* No respiratory symptoms four weeks prior to the visit.
* No documented evidence or suspicion of lung disease upon physical examination.

Exclusion Criteria:

* Concurrently participating in another study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Use of any investigational or non-registered product within 30 days prior to study procedures, or planned use during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Child in care.
Pharmacologic Study of Oseltamivir in Healthy Volunteers

"Pharmacologic Study of Oseltamivir in Healthy Volunteers" is a Phase I study in which 8 to 32 adult healthy Thai volunteers will be randomized to one of four drug doses and regimens within each of 4 visits. The study is being conducted at the Bangkok Hospital of Tropical Diseases Research Unit, Faculty of Tropical Medicine, and commenced enrolling healthy volunteers on 23 November 2006. The duration of the study is expected to be approximately four months. The goals of this study are to assess the use of loading dose oseltamivir and the concomitant use of probenecid and to characterize the pharmacokinetic properties of oseltamivir in Thai subjects.


Eligibility Criteria:
Inclusion Criteria:

* healthy with no underlying chronic disease
* normal baseline laboratory screening
* no regular prescribed medication used in the past 30 days and no over-the-counter medication in the past week
* agree to abstain from self-medication during the study
* negative urine pregnancy test for females and agreement that they will not try to become pregnant until 1 month after the study is completed
* only use non-hormonal methods of contraception for females
* non-smoker for the last 30 days and for duration of the study
* no consumption of alcohol for the last 30 days and for duration of the study
* no use of recreational drugs for the last 30 days and for duration of the study

Exclusion Criteria:

* known hypersensitivity to oseltamivir and/or probenecid
* Hepatitis B virus surface antigen positive
* presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study
A Clinical Study on the Effectiveness of a Lacticaseibacillus Strain on Blood Cholesterol Levels

This is a 12-week prospective, multicentre, randomised Phase 4 study to evaluate the effect of a wild type strain of Lacticaseibacillus in cholesterol of blood levels.

The goal of this study is to evaluate the effect of a wild type strain of Lacticaseibacillus as an incorporated ingredient of oat powder in the improvement of low density lipoprotein levels. In the study will participate two groups of subjects, one group with receive the strain with oats for 2.5 months and the other a group of subjects will receive plain oats. During the study, the subjects will receive only the product of the study and no other intervention will be performed except the standard clinical practice. The subjects will perform 4 visits and their eligibility will be evaluated at the baseline visit by performing routine clinical and laboratory examinations. The subjects who will consent to participate in the study will be randomised 1:1 into one of the study arms (Lacticaseibacillus and oats vs. oats). At each follow-up visit, the standard clinical and laboratory tests for dyslipidemia will be performed at the hospital.

Following a treatment period of 10 weeks, a 2-week washout observational period will take place where subjects will not receive any product.

Eligibility Criteria:
Inclusion Criteria:

1. Adult participants of either sex with ages between 18 and 70 years (limits included).
2. Participants with serum LDL-C ≥116 mg/dl.
3. Body Mass Index (BMI) between 18.5 and 35 kg/m2 (limits excluded).

Exclusion Criteria:

1. Subjects who systematically receive any other lipid-lowering non-medicinal product, supplement or functional food such as ACTIMEL, ACTIVIA, oat beta-glucan, pharmaceutical garlic, or stopped less than 1 month prior to study inclusion.
2. Participants that have been under lipid-lowering drug treatment (e.g. statins, fibrates, etc.) or any other medication that has a significant effect on LDL-c within the last 2 months prior to study inclusion.
3. Lactating females or those that are planning pregnancy within 6 months from the start of the study.
4. Participants with a history of ischemic cardiovascular events, alcohol abuse, or suffering from a severe chronic disease (e.g. cancer, diabetes, chronic advanced kidney disease, thyroid disorders, hepatic disorders, cancer, familial hypercholesterolemia or immunosuppression) that would potentially affect the outcomes of the study.
5. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
6. Subjects with a known intolerance or allergy to any ingredient of the administered products.
7. Participants who are planning on making significant changes in their diet, lifestyle, and physical activity during the duration of the study, i.e. participants that are currently on weight-reducing diets.
8. Participants who are receiving any interventional procedure or are currently included in a clinical study.
Gene Analysis of Parkinson's Disease

The purposes of this study are to identify the gene or genes responsible for an inherited form of Parkinson's disease and learn more about how the disease develops.

In Parkinson's disease, a deficiency of a brain chemical called dopamine impairs the function of the part of the brain that controls movement. As a result, patients may have difficulty moving or they may have uncontrolled movements of their hands and fingers. Parkinson's disease usually occurs sporadically, with no known cause. In a few families, however, the disease seems to be inherited through a gene mutation (change). There is a 50-50 chance that a parent with the mutated gene will pass it on to a child. Children who do inherit the abnormal gene may or may not go on to actually develop Parkinson's disease-the relative chance of this happening is not known.

Individuals 18 years of age and older from families in which Parkinson's disease appears to be inherited may be eligible for this study. Participants will have their medical records reviewed, provide a personal and family medical history (by telephone or in person), and have a small blood sample (2 tablespoons) taken for genetic studies. The total time required for the study is about 1 to 2 hours.

Participants are encouraged to meet with a NIH investigator or with a genetics specialist in their local area before testing to talk about the possible implications for themselves and their families of the test results....

Mutational analysis in patients with Parkinson's disease and a positive family history will be undertaken in an effort to identify and better understand the function of defective genes that cause Parkinson's disease in these individuals. DNA from these individuals is an important resource for screening candidate genes for mutations, for confirming that genes identified by other approaches are altered in patients, and for defining the mutational spectrum in these genes (genotype/phenotype correlation).

Unrelated, anonymous normal individuals will serve as controls for sequence comparisons. Information about genotypes will not be communicated back to the individuals as part of this study. While mutational analysis will continue, no further participants will be recruited to this study.

Eligibility Criteria:
* INCLUSION CRITERIA:

Individuals over the age of 18 from families in which there are three or more individuals affected with Parkinson's disease (within three generations) and the proband was the only affected person available or willing to participate in the study

The diagnosis must be supported by accepted clinical criteria: tremor, bradykinesia, and responsiveness to L-DOPA.

PD may be associated with dementia. The study will lose power if individuals with mental impairment and PD are excluded. For this reason, decisionally-impaired individuals will be enrolled.

EXCLUSION CRITERIA:

No one under 18 will be enrolled because, with the exception of the rare autosomal recessive PD due to parkin mutations, PD does not affect minors. Study design does not involve testing fetuses.
Disease Management and Educational Intervention Outcomes in High-Risk Diabetics

Social, medical and economic burdens of diabetes care result from microvascular, macrovascular and neurological complications. Sustained reduction in hyperglycemia can reduce the incidence of these complications by as much as 50 percent. Studies have demonstrated improved glycemic control with nurse case-management or educational care models. However, none have controlled for their independent contributions, intervened with advanced practice nurses (APN), or targeted highest risk individuals.

Background:

Social, medical and economic burdens of diabetes care result from microvascular, macrovascular and neurological complications. Sustained reduction in hyperglycemia can reduce the incidence of these complications by as much as 50 percent. Studies have demonstrated improved glycemic control with nurse case-management or educational care models. However, none have controlled for their independent contributions, intervened with advanced practice nurses (APN), or targeted highest risk individuals.

Objectives:

The objective of this project is to examine whether interventions of diabetes self-management education programs with or without APN case managers improve outcomes and are cost effective.

Methods:

Patients were randomly assigned to one of four groups: 1) Disease-management and diabetes education; 2) Disease-management alone; 3) Diabetes education alone; and 4) Routine Care. Veterans receiving primary care in VISN-5 and meeting high-risk criteria (HbA1c � 9.0%) were screened for inclusion. Patient outcome measures were collected at baseline, three months and twelve months. These included: Quality of Life (QOL), HgbAlc levels, and incidence of diabetes-related hospitalizations/ER visits. In addition, patient-level intervention costs, health care use and costs were examined. ANOVA comparisons were used to test hypotheses.

Status:

Recruitment is over and final analyses are underway.

Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetes HbA1C. 9.0%, consistent diabetes tx over last 3 months.

Exclusion Criteria:

Homelessness-not able to be consistently contacted; Dementia, Planned Movement from area; Unstable angina, Myocardial Infarction in past 3 months; Stroke; Two or more seizures in last 3 months; document alcoholism or drug abuse; Pregnant or planning to become pregnant in next 12 months; Severe immunodeficiency or cirrhosis of the liver; Type 1 diabetes; blind individuals; psychosis; pancreatitis with secondary diabetes; Renal disease.
EEG Brain Activity At Various Cycling Intensities

The aim of this study is to investigate brain activity with EEG during incremental cycling at various cycling intensities.

Increases in EEG power spectra have been found during graded cycling to fatigue linking brain activity to exercise intensity. Additionally, to the activation of the classical motor control regions (e.g.: motor, somatosensory, premotor and supplementary motor cortices and cerebellum), the activation of the regions associated with autonomic regulation (i.e.: insular cortex) during exercise, as well as reduced activation of cognitive-related areas (i.e.: prefrontal cortex), an effect that increased at higher perceived intensities of cycling has been observed.

Furthermore, the precentral gyrus and cerebellar vermis, as well as brain areas (e.g.: posterior cingulate cortex (PCC) and precuneus) have been associated with higher levels of perceived exertion as well. Although the results were assessed sing a specially designed compatible fMRI cycling ergometer (Fontes et al., 2020), due to which the brain imaging techniques were limited to static (and horizontal) measurement conditions during cycling, we believe that the present study clearly distinguishes between claims proposed by different theoretical frameworks on brain responses during exercise.

Therefore, the aim of this study is to examine the brain activity with EEG during the same incremental protocol, which will allow us to investigate the functioning of surface electrocortical activation patterns during progressive cycling exercise. Furthermore, using the advanced brain image analysis (machine learning techniques and standardized low-resolution electromagnetic tomography - sLORETA) helped us determine the frequency spectrum of brain activity in the same brain areas.

Eligibility Criteria:
Inclusion Criteria:

* Heathy and recreationaly active men
* No significant muscular, skeleton or nervous system damage
* Cycloergometry test (positive)

Exclusion Criteria:

* Nervous system disorders
* Cardiovascular disorders (e.g.: high blood pressure, arrhythmia...)
* Asthma