cyrilzakka/clinical-trials huggingface dataset:
Prostate Cancer Antigen 3 (PCA-3) Gene Project

Nowadays, prostate cancer screening is largely widespread although it is not recommended yet. This screening includes primarily digital rectal examination and PSA.

Recently, a new specific genetic marker of prostate cancer has been discovered. It is PCA-3 gene.

The main objective is to evaluate prospectively this new marker in patients treated for prostatic pathology (benign or malign) in the department.

Nowadays, prostate cancer screening is largely widespread although it is not recommended yet. This screening includes primarily digital rectal examination and PSA.

The main drawback is the poor PSA specificity. Prostate cancer diagnosis is only histologic diagnosis (mainly by prostate biopsies). However, prostate needle biopsies have a poor rentability and are negative in 60 to 80%. Recently, a new specific genetic marker of prostate cancer has been discovered. It is PCA-3 gene. This gene encodes for RNAm noncoding. So, RNA expression must be assayed by RT-PCR. The main objective is to evaluate prospectively this new marker in patients treated for prostatic pathology (benign or malign) in the department.

PCA-3 assay will be made from urine specimens collected by vesical catheterism just before surgery. Moreover, the investigators will analyse expression of several prostatic markers (genes coding for androgen receptor and steroid alpha-reductase type 1 and 2). The main objective is to improve the prostate cancer diagnosis specificity. Gene expression will be assayed by RT-PCR.

Prostatic cells in urine specimens will be confirmed by assay of PSA gene expression. Normalization of data will be performed using 3 housekeeping genes expression (ß-actin, K-a-1 tubulin and Glyceraldehyde-3-phosphate).

The originality of this clinical study compared to previous reports, consists to two elements. Firstly, all patients included in our study will be operated for a prostate cancer or a BPH. So, the risk to ignore a prostate cancer will be low unlike prostate biopsies made for a prostate cancer screening. Secondly, PCA-3 assay will be coupled with others prostatic specific markers.

Eligibility Criteria:
Inclusion Criteria:

* Patients operated for a prostate cancer or a benign prostatic hypertrophy
* Patients not in state of emergency

Exclusion Criteria:

* Patients with an urinary infection proved bacteriologically
* Patients with a vesical malign disease
* Patients in state of emergency
Ocular Manifestations in Rheumatic Diseases

This is a search strategy for determining the prevalence of ocular complications in inflammatory rheumatic diseases for the purposes of a meta analysis.

For the purposes of determining the prevalence of ocular complications in inflammatory rheumatic diseases, the following search terms were used: conjunctivitis, keratoconjunctivitis sicca, xerophthalmia, uveitis, eye hemorrhage, optic neuritis, papilledema, orbital disease, retinal artery/vein occlusion, macular edema, retinitis, chorioretinitis, scleritis, iridocyclitis, choroid hemorrhage, blindness and amaurosis fugax.

These terms were searched in the context of a corresponding inflammatory disease on Medline, Cochrane and Web of Science from their inception (1966, 1991 and 1990 respectively) until the point of study completion.

Studies were included if they provided numerical data of the prevalence or incidence of ocular manifestations in an inflammatory rheumatic disease. Studies were excluded if they were review articles, case reports where all patients experienced the same ocular comorbidity, if different comorbidities were not grouped independently, and if the study reported on fewer than 20 patients. When the same study cohort was used in more than one analysis, the most recent or largest sample-size study was included. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist was used to assess the quality of cohort, case-control, and cross-sectional studies.

Eligibility Criteria:
Inclusion Criteria:

* Studies were included if they provided numerical data of the prevalence or incidence of ocular manifestations in inflammatory rheumatic disease

Exclusion Criteria:

* review articles,
* case reports where all patients experienced the same ocular comorbidity
* if different comorbidities were not grouped independently
* if the study reported on fewer than 20 patients
The Effect of Mobile Lymphedema Self-Care Support Program on Self-Care in Women With Breast Cancer-related Lymphedema

The aim of this randomized controlled study is to evaluate the effect of the mobile lymphedema self-care support program on self-care, quality of life and symptoms related to lymphedema in women with breast cancer-related lymphedema.

H1: There is a difference between the Lymphedema Self-Care Scale mean score in women who develop lymphedema due to breast cancer, according to the use of the mobile lymphedema self-care support program.

H2: There is a difference between the Lymphedema Quality of Life Scale average score in women who develop lymphedema due to breast cancer according to the status of using the mobile lymphedema self-care support program.

H4: There is a difference between lymphedema arm circumference measurements according to the use of the mobile lymphedema self-care support program in women who develop lymphedema due to breast cancer.

H5: In women who develop lymphedema due to breast cancer, there is a difference in the situation of experiencing symptoms related to lymphedema according to the use of the mobile lymphedema self-care support program.

The content of the mobile program was developed by the researchers. The mobile lymphedema self-care support program content was reviewed by an expert group consisting of doctors, physiotherapists and nurses working with patients with lymphedema. Patients will be contacted via telephone and will be informed about the study, and the experimental and control groups will be selected through the randomization program among the patients who agree to participate in the study and meet the sampling inclusion criteria. Patients were blinded, and blindness will be achieved in the data analysing stage. All measurements will be made to the experimental and control groups at the same time. The standard lymphedema self-care training will be given to the experimental and the control group. And the experimental group will be educated on how to use the mobile program. When the study is completed, the control group will also be allowed to use the mobile program.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as breast cancer-related lymphedema
* literate,
* having a smart phone,
* completed breast cancer treatment at least six months ago
* volunteering to participate in the study

Exclusion Criteria:

* having morbid obesity
* having metastazis
* having dementia
* having other psychiatric conditions
* another health problem that could prevent to exercise
* not using smart phone
TabCAT Brain Health Assessment in Primary Care

Efficient and user-friendly paradigms to detect cognitive impairment, including dementia are needed in primary care. The TabCAT Brain Health Assessment accurately detects cognitive impairment via an appealing tablet interface with automated scoring and EMR integration. This study will evaluate the effectiveness of the paradigm on detection rates and other brain health outcomes via a pragmatic cluster randomized trial in 26 Kaiser Southern California primary care clinics.

Twenty-six Kaiser Permanente Southern California (KPSC) primary care clinics will be randomized in two waves to receive either the TabCAT-BHA paradigm or usual care. Clinics have been matched in pairs by number of providers, median panel size, the racial/ethnic makeup of the patient panel, baseline rates of cognitive impairment diagnosis, rates of telehealth encounters, and percentage of members who are 65+ in the practice. The trial will be conducted over two 18-month waves, with six intervention practices in the first wave and seven intervention practices starting in the second wave. All patients seen at least once across these 26 practices will be included in the trial and the primary analyses will use data extracted from the EMR. Patients in the intervention practices will receive care in accordance with the TabCAT-BHA paradigm whereas patients in the control practices will continue with usual care workflows. The intervention will include a 6-month startup period during which the research team will partner with the physician leads to adapt the paradigm workflows to each practice and onboard the PCPs, and then a 12-month steady state period when effectiveness on the primary and secondary outcomes will be measured. During the TabCAT-BHA paradigm intervention, pragmatically, primary care providers concerned that their patients are exhibiting signs of cognitive decline will refer them to clinical research associates located in the primary care clinics who will then perform the TabCAT-BHA tablet-based test either on the spot or as a scheduled procedure visit. The tablet-based test provides an automated scoring report that includes guidance for providers to identify reversible causes of cognitive impairment, involving a care partner, diagnostic disclosure, community and educational resources, and specialty referral including the option to refer the patient for a "Brain Health Consultation" telephone call with a study nurse or social worker.

Eligibility Criteria:
Inclusion Criteria:

* Patient with at least one encounter at an intervention clinic during the intervention period
* Age 18+ (limited to 65+ for primary analyses)

Exclusion Criteria:

* Patients under the age of 18.
Interoception in Anorexia Nervosa

Anorexia nervosa is a serious psychiatric illness whose causes remain poorly understood, and which remains difficult to treat to this day. Many clinical manifestations of this disease can have their origin in abnormalities in the perception of signals coming from inside the body, but this remains to be demonstrated. In recent years, research in healthy subjects has shown how the brain constantly perceives the viscera (heart, lungs, stomach). The examiners will use these new, objective and validated methods to explore how the brain processes information from the viscera (interoception) in anorexic patients. In practice, they will quantify the coupling between the cardiac cycle and involuntary eye movements, as well as between the respiratory cycle and voluntary actions such as pressing a button. Finally, by simultaneously recording the electrical activity of the brain, and that of the stomach, the examiners will measure the coupling between the brain and the stomach. All these measurements, which will be compared between a population of patients and healthy subjects, will make it possible to determine whether anorexic patients have an alteration in the perception of their internal body signals and whether this damage affects several organs.


Eligibility Criteria:
Inclusion Criteria - AN groups:

* Females
* 6 to 25 years old
* Diagnostic of AN according to DSM-5 criteria
* No past or current psychotic disorders
* No current substance abuse or dependence (excluding tobacco).
* No current psychiatric medication

Inclusion Criteria - control groups:

* Females
* Age : matched for the AN group
* No present or past eating disorders
* No past or current psychotic disorders
* No current substance abuse or dependence.
* No current psychiatric medication

Exclusion Criteria for both groups:

* age below 16 years and above 25 years,
* Past or current psychotic disorders,
* Current substance abuse or dependence (excluding tobacco)
* Opposition to participation has been expressed.

In addition, for the control group,

* Subjects with present or past eating disorders or current mental disorders will be excluded.
The Unhide™ Project: Economic Impact Study of IVIG Treatment for PANS

The Economic Impact Study of IVIG treatment for PANS is a part of the Unhide™ Project, which is a research initiative developed by the Brain Inflammation Collaborative. Specifically, the Unhide™ project is a collection of investigations with the overall goal of better understanding the problems with thinking and mood that can sometimes be symptoms of conditions like autoimmune disease, infection-associated chronic conditions like Long COVID, ME/CFS, PANDAS, PANS, and other illnesses. Your contribution to this research will allow us to better describe these symptoms and understand what causes them, how they develop, and how they can best be treated and prevented.

This study seeks to assess how PANDAS/PANS affects the financial well-being of families who pursue IVIG treatment, as well as the overall health and quality of life of children with the condition. By gathering data through this survey, we aim to gain important insights into the economic consequences of treating - or not treating - PANS with IVIG, including how it impacts parents' ability to work and children's ability to attend school.

Key Eligibility Criteria

* Aged 2-89, U.S. resident, fluent in English, and have access to computer and/or smartphone
* Suspected or confirmed diagnosis of PANS/PANDAS
* Have received IVIG OR have sought and/or been prescribed IVIG but have not received it


Eligibility Criteria:
Inclusion Criteria:

* Individuals who who have, or have had, a healthcare provider-diagnosed or suspected diagnosis of PANDAS and/or PANS
* Have received IVIG OR have sought and/or been prescribed IVIG but have not received it
* Fluent in English, sufficient to communicate status via the ePRO instrument as required by the protocol
* Is a U.S. resident
* Access to a computer and/or smartphone and the internet, and possessing the ability to operate those devices without assistance from another person (except that children can be assisted by their parents/guardians).

Exclusion Criteria:

* Ward of state
* Failure to meet inclusion criteria
Clopidogrel Vs. Aspirin in Patients with S. Aureus Bacteremia

This is an open-label randomized controlled trial which will enroll patients with S. aureus bacteremia who are already taking aspirin for secondary prevention of cardiovascular events. We will randomize patients to continue their aspirin or change clopidogrel which is also approved for secondary prevention.

Unlike aspirin, clopidogrel may have activity against S. aureus. We wish to determine if changing to clopidogrel will improve outcomes in S. aureus bacteremia in people who otherwise would have a reason to be taking it.

This study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119).

If positive, this study will support a second RCT in people who do not currently have an indication for clopidogrel.


Eligibility Criteria:
The participant must meet all inclusion and exclusion criteria for the SNAP

Platform (NCT05137119) and also the following inclusion and exclusion criteria:

Inclusion Criteria:

* Patient is taking aspirin for secondary prevention of cardiovascular disease (coronary, cerebrovascular, or peripheral vascular disease)

Exclusion Criteria:

* Active bleeding (allowing up to 3 days from platform entry to randomize in the event anti-thrombotic therapy is resumed)
* Anticipated major cardiac surgery, neurosurgery, or spine surgery within the next 3 days
* Pregnancy
* Known receipt of clopidogrel, prasugrel, or ticagrelor within the last month
* Allergy to clopidogrel
* Concomitant receipt of oral Xa inhibitor
Erector Spinae Plane Block Analgesia for Lumbar Spine Fusion Surgery

The purpose of this study was to investigate the effect of a bilateral ultrasound guided erector spinae plane block on the pain scores and opoid utiliziation in fusion surgery of the lumbar spine.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists class I-III adult patients
* BMI less than or equal 35 kg/m2

Exclusion Criteria:

* Patient refusal
* unable to give consent
* age \< 18 or \> 65
* BMI more than 35 kg/m2
* known allergy to the study medication
* coagulopathies or on anticoagulant medications
* hepatic insufficiency
* renal insufficiency
* chronic opioid use
Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps

Cross-over study of 20 pediatric patients (age 7-19) randomized to the group receiving universal fixed meal boluses coefficients (300/TDD for breakfast and 400/TDD other meal) or to the group with individualized coefficients for the period of 14 days with consecutive analysis of the results from Carelink Raport.


Eligibility Criteria:
Inclusion Criteria:

* age 7-19
* type 1 diabetes diagnosed at least 1 year ago
* insulin in the dose 0,5-1,0 units/day/kg
* MiniMed 780G pump usage at least 1 month.

Exclusion Criteria:

* Active coeliac disease
* Chronic disease possible to influence diabetes treatment
* Acute disease at the moment of recruitment
Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver Transplantation

Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver Transplantation

This Study Aims to Evaluate:-

1. Quality of life after LDLT In Egyptian patients using short form 36 (SF - 36) score.
2. Impact of post transplant medical and psychiatric complications on quality of life

Eligibility Criteria:
Inclusion Criteria:

* Adult Egyptian patients
* 18-60 years old
* Patients transplanted for HCV related disease and /or HCC
* Informed consent

Exclusion Criteria:

* Other etiologies for end stage liver disease (such as HBV and cholestatic liver disease and autoimmune hepatitis).
Treatment of Depression With Quetiapine

The purpose of this study is to examine the mood stabilizing and antipsychotic properties of quetiapine in the treatment of depression by comparing subjects who were randomly assigned to either quetiapine monotherapy, quetiapine and citalopram; or haloperidol and citalopram. We hypothesize that quetiapine monotherapy would have similar effects to the combination of a first generation antipsychotic plus an antidepressant for the treatment of a major depressive episode with psychosis.

Thus, current practice for treating psychotic depression is to combine an antidepressant with an antipsychotic. However, there are limitations to this approach. The rate of response is still lower than in other forms of major depression (Janicak et al., 2001). The rate of noncompliance is higher in this group; and the incidence of adverse effects related to the antipsychotic is increased (Janicak et al., 2001). As a result, studies have examined alternative treatments. The present study proposes to examine quetiapine's antipsychotic and mood stabilizing properties for the treatment of a major depressive disorder with psychotic features Subjects will be randomized to either quetipine monotherapy, quetiapine and citalopram; or haloperidol and citalopram.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between the ages of 18 to 75 years.
* A Structured Clinical Interview for the DSM-IV (SCID) derived diagnosis of major depression with psychosis, single or recurrent episode (unipolar or bipolar).
* Subjects may have an anxiety disorder or an additional mood disorder such as dysthymia.
* Baseline 24-item Hamilton Depression Rating Scale (HDRS) score of greater than or equal to 21.
* A baseline Positive and Negative Syndrome Scale (PANSS) score of greater than or equal to 4 on at least one of the 4 psychosis items.
* Women of childbearing potential must agree to practice a medically accepted means of contraception.
* Length of current episode no longer than 3 months.

Exclusion Criteria:

* Pregnant or lactating women
* Women of child-bearing age who refuse a pregnancy test or who refuse to use a contraceptive technique when sexually active.
* Persons with other psychotic disorders; a mood disorder due to a general medical condition or substance-induced; substance dependence disorder in the last 6 months; substance abuse in the last 6 months or a dementing disorder are excluded.
* Persons with serious, unstable medical illnesses.
* Subjects who have been intolerant or nonresponsive to adequate trials of quetiapine, haloperidol and/or citalopram.
* Subjects who have received an injectable decanoate medication within 1 half life of the medication (i.e, 4 weeks for haloperidol or 2 weeks for fluphenazine).
* Subjects who have received fluoxetine within 4 weeks prior to randomization.
* Subjects who have received aripiprazole within 2 weeks prior to randomization.
* Subjects who have been treated with ECT within the last 6 months.
Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis

Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) of the colon. Complaints such as abdominal pain, cramps and bloody diarrhoea usually start in early adulthood and lead to life-long substantial morbidity. There is no medical treatment available that meets the desired criteria of high efficacy versus low adverse effects. The current prevailing hypothesis regarding the cause of UC states that the pathogenesis involves an inappropriate and ongoing activation of the mucosal immune system driven by the intestinal microbiota in a genetically predisposed individual. Systematic investigation into the effect of correcting the dysbiosis in ulcerative colitis patients has never been performed. The most radical way to restore the presumably disturbed natural homeostasis in UC is to perform faecal transplantation from a healthy donor. In this trial the potential beneficial effects of restoring microbial homeostasis by faecal transplantation through a duodenal tube will be studied in a phase II randomised placebo controlled design.

Endpoints are clinical remission and reduction of endoscopic inflammation after 12 weeks (primary), as well as time to recurrence, intra individual changes in faecal samples and mucosal biopsies. Follow up is 12 months.

treatment with faecal transplantation from a healthy donor in active ulcerative colitis patients. In this trial the potential beneficial effects of restoring microbial homeostasis by faecal transplantation through a duodenal tube will be studied in a phase II randomised placebo controlled design.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Ability to give informed consent
* Established ulcerative colitis with known involvement of the left colon according to the Lennard-Jones criteria
* SCCAI of 4 \> \< 11
* Endoscopic Mayo score of \> 1
* Stable dose of thiopurines in preceding 8 weeks
* Stable dose of corticosteroids and 5-ASA in preceding 2 weeks

Exclusion Criteria:

* Condition leading to profound immunosuppression
* Anti-TNF treatment in preceding 2 months
* Cyclosporine treatment in preceding 4 weeks
* Use of Methotrexate in preceding 2 months
* Prednisolone dose \> 10 mg
* Life expectancy \< 12 months
* Use of systemic antibiotics in preceding 6 weeks
* Use of probiotic treatment in preceding 6 weeks
* Positive stool cultures for common enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic e coli)
* Positive faecal PCR-test (positive PCR means: \> 1 of the following viruses is present) for: Rotavirus, Norovirus, Enterovirus, Parechovirus Sapovirus, Adenovirus 40/41/52. Astrovirus.
* Pregnancy or women who give breastfeeding
* Vasopressive medication, icu stay