cyrilzakka/clinical-trials huggingface dataset:
TTV-based MAnagement of Long-term ImmunosuppreSsion in Kidney Transplantation

Long-term outcomes in kidney transplantation remain a significant challenge, as complications such as donor-specific antibodies (DSA), antibody-mediated rejection, infections, and cancer increasingly threaten graft and patient survival over time. The development of non-invasive biomarkers to guide the management of therapeutic immunosuppression beyond the first year post-transplantation is therefore a crucial unmet need.

Torque Teno Virus (TTV), a non-pathogenic virus with a high prevalence worldwide, has emerged as a promising biomarker in this context. Its replication inversely reflects immune control by T cells, correlating with the depth of therapeutic immunosuppression. Additionally, its slow replication kinetics make TTV DNAemia a useful marker for evaluating patient adherence to immunosuppressive treatments.

The TAOIST study tests whether longitudinal monitoring of TTV DNAemia every three months, starting from the second year after transplantation, can guide the personalization of immunosuppressive therapy. The primary endpoint is the time to the first occurrence of complications linked to inadequate immunosuppression, including dnDSA, biopsy-proven rejection, infection, cancer, or graft loss. Secondary objectives include evaluating the acceptability of TTV DNAemia among healthcare professionals and assessing its cost-effectiveness compared to standard care. An ancillary objective examines the link between TTV DNAemia and the immunosuppressant possession ratio (IPR) to explore its potential as a marker of treatment adherence.


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years-old
* Recipient of a kidney allograft (third graft at most)
* 12 to 48 months post-transplantation
* Stable graft function (defined as: delta creatininemia over the previous 6 months \< 20% and proteinuria \< 30mg/mmol)
* On maintenance immunosuppression, which includes CNI (cyclosporin or tacrolimus) and MMF (Cellcept or Myfortic) with or without corticosteroids
* Detectable TTV DNAemia at enrollment
* No circulating DSA in solid phase assay
* Undetectable BKV DNAemia at enrollment
* Written informed consent

Exclusion Criteria:

* Recipient of an HLA identical graft
* Mutiple organ transplantation or functional transplant other than kidney
* Maintenance immunosuppression that includes a mTOR inhibitor, belatacept or imurel
* Presence of histological sign of active rejection (i+t \> 2 and g+cpt \> 2) on graft biopsy performed within 3 months before enrollment
* Uncontrolled infection at inclusion
* Infection requiring hospitalization or vaccination within 3 months before inclusion
* Pregnant, unwillingness to practice adequate contraception or patient with a pregnancy plan during 3 years of study
* Person not affiliated to a social security scheme or beneficiary of a similar scheme
* Person subject to a legal protection measure (guardianship, curatorship) or deprived of liberty
Fiji Integrated Therapy (FIT) - Triple Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji

Lymphatic Filariasis (LF), scabies and soil transmitted helminths (STH) are common neglected tropical diseases affecting the people of Fiji. There is a dedicated LF eradication program supported by the World Health Organization (WHO), however scabies and STH are currently managed on an individual level with symptomatic treatment as required.

In an attempt to reduce the prevalence of LF globally, research is being undertaken into alternative, more effective treatment options. A recent study in Papua New Guinea demonstrated a new triple drug therapy (ivermectin, diethylcarbamazine and albendazole) is superior to the currently recommended two drug therapy (diethylcarbamazine and albendazole) used by WHO LF programs in the Pacific. However, adverse events were more frequent. Despite no serious adverse events being observed, it is necessary to conduct further studies to review the safety of this new triple therapy before it can be endorsed as an effective mass drug administration (MDA) regimen for LF in endemic countries. Fiji's burden of LF, that has been recalcitrant to previous MDA with diethylcarbamazine and albendazole, make it an ideal site to obtain further efficacy and safety data of the triple therapy.

Ivermectin given to communities as MDA has been proven to be effective in reducing the community prevalence of scabies. What is not known is the effects of one dose versus two doses of ivermectin as MDA. This question will be reviewed within the design of the community randomized study. The prevalence of impetigo in a community is linked to scabies and this will also be reviewed. Ivermectin and albendazole are both effective individually against STH. The effectiveness of this combination of treatment as MDA in Fiji for STH has not been studied. The effectiveness for the individual in the short-term and the community in the longer-term will be reviewed.

In addition, the acceptability and feasibility of the new therapy in communities at risk of these three diseases will be reviewed.


Eligibility Criteria:
Inclusion Criteria:

* All community members that have given written informed consent to participate

Exclusion Criteria:

* No informed consent
COVID-19 and SARS-CoV-2 Detection in Saliva

This study aims to validate the use of human saliva as a substrate for an assay to detect SARS-CoV-2 and define accuracy, analytical sensitivity and specificity of the TaqPath RT-PCR test.

Investigators will carry out validation of a laboratory assay to detect SARS-CoV-2 nucleic acids in human saliva samples. Data for the validation will include the test results from standard nasopharyngeal (NP) swabs (controls) AND matched saliva samples (experimental group) of individuals who are either known to be infected or at high risk of being infected. Investigators hypothesize that the performance of an assay designed specifically for saliva will not perform differently, as defined by a predetermined margin, from the standard assay performed on NP and other respiratory samples

Eligibility Criteria:
Inclusion Criteria:

* Reads and understands English or Spanish
* Willing and able to provide consent
* Diagnosed with COVID-19 or at high risk of disease based on objective criteria

Exclusion Criteria:

* Unwilling or unable to provide consent.
* Pregnant female
Preventing Suicide in African American Adolescents

The overarching aim of the Success Over Stress Prevention Project is to reduce African American youth suicide. This study examines the impact of a 15-session, group-delivered, culturally-grounded, cognitive-behavioral intervention (i.e., PI Robinson's Adapted-Coping with Stress Course \[A-CWS\]), on the outcomes of interest, when it is delivered by social workers who are indigenous to the school system. The main objectives of this project are to (a) determine whether the intervention is effective when facilitated by social workers who are indigenous to the school system and (b) enhance resilience, increase adaptive coping strategies, and reduce both intrapersonal and interpersonal violence among youth receiving the prevention intervention. It is expected that increases in adaptive coping will lead to an increased ability for youth to manage stressors, thereby decreasing the incidence of suicide and violence among the youth. In addition, it is expected that evidence of the intervention's effectiveness, when facilitated by social workers who are indigenous to the school system, will lead to greater dissemination and sustainability of the intervention, thus, providing access to effective intervention resources to greater numbers of African American youth.

This study will establish the effectiveness of Robinson's Adapted-Coping with Stress Course (A-CWS) and test hypotheses pertaining to the mechanism of change by which the A-CWS reduces suicide risk. Additionally, this study is expected to augment current theoretical models of adolescent suicidality. This effectiveness trial will inform procedures for scaling up efficacious, high quality, and culturally-grounded suicide prevention programs for low-resourced, urban African American youth; as such, this study is practice relevant and expected to inform best practices for the prevention of suicide among African American adolescents. The specific aims are:

1. To examine the effectiveness of the A-CWS intervention, as delivered by social workers who are indigenous to the school system, to reduce active suicidal ideation, within a sample of low-resourced, urban African American adolescents.
2. To understand the mechanism by which the A-CWS intervention reduces suicide risk for low-resourced, urban African American adolescents.
3. To establish the fidelity of an evidence-based, culturally-grounded coping with stress intervention (i.e., the A-CWS), developed for low-resourced, urban African American adolescents, delivered by social workers indigenous to the school system.
4. To understand the extent that thwarted belongingness, perceived burdensomeness, and socio-ecological factors influence the development of active suicidal ideation.

Eligibility Criteria:
Inclusion Criteria:

* Students: Enrolled 9th grade student at time of initial enrollment at participating high school
* Parents/guardians: Child enrolled in study
* Teachers: Student enrolled in study

Exclusion Criteria:

* Not a 9th grade student at time of initial enrollment
* No parent/legal guardian permission
* For parents and teachers: no students enrolled in study
Phase 2 Study of NGM282 in Patients With Primary Sclerosing Cholangitis

The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of PSC

Exclusion Criteria:

* Clinically significant acute or chronic liver disease of an etiology other than PSC
* Secondary or IgG4 related sclerosing cholangitis
An Intervention to Improve Prolapse Using Femmeze® (v1)

The main purpose of the feasibility study is to identify the patient experience of Femmeze® which is a device aimed at improving posterior vaginal compartment prolapse (rectocele) for women with obstructive defaecation. The investigators want to investigate implementation and preliminary effectiveness of the device. The method of investigation will be a pre-post intervention design, which involves asking 30 women to use Femmeze® over a period of 8 weeks. This is an academic study on a labelled indication (http://www.nres.nhs.uk/search/?q=medical+devices).

Aim Evaluate the feasibility of the Femmeze® device to improve management of posterior vaginal compartment prolapse addressing implementation of the intervention and preliminary effectiveness.

Objectives

* demonstrate effectiveness of the device (comfort, ease of use, empty the rectum of stool more easily than their current approach and quality of life)
* identify which stage of prolapse the device would be most suitable
* identify any changes to the device or instructions for use (needs adjustment to its design in terms of length/width)

The study will use a pre-post intervention design with the aim of evaluating the feasibility of the intervention (using the device); and identifying any implementation issues and preliminary effectiveness. The participants will be followed prospectively to compare the device against their own usual care. Usual care in this context will be using their fingers to help empty their rectum of stool.

Participants will be invited to complete a semi-structured interview to understand their lived experience. A Patient and Public Involvement Group has contributed to improving the study methods.

Eligibility Criteria:
Inclusion Criteria:

* Adult women (over 18 years of age) with symptoms of obstructive defaecation
* Not undergone posterior vaginal compartment prolapse surgery

Exclusion Criteria:

* Cognitive impairment
* Hand disability
* Refuse to give informed consent
* Pregnancy
* Less than 12 weeks post-partum
* Neurological disease
Stroke and CPAP Outcome Study 2

Obstructive sleep apnea (OSA) is associated with impaired stroke recovery. Treatment with continuous positive airway pressure (CPAP) may prevent this but is limited by poor adherence. In this study, the investigators enrolled eligible stroke patients undergoing inpatient rehabilitation (IPR) into an intensive CPAP adherence protocol (iCAP) with an aim to increase tolerance and adherence to auto-titrating CPAP (APAP).

The SCOUTS (Stroke and CPAP Outcome Study 2) was a single-arm, open-label study performed at 2 IPR units of the University of Washington. Eligible stroke patients undergoing IPR were provided an intensive CPAP adherence protocol (iCAP) to increase tolerance and adherence to auto-titrating CPAP (APAP). The iCAP included patient education and encouragement, device adjustments, close monitoring of adherence and a 3-night run-in period of APAP to identify those patients who 1. have OSA and 2. have APAP tolerance-- defined as participant willingness to continue APAP during IPR and over the 3-month treatment period. If both criteria were met, APAP treatment with iCAP continued during the rehabilitation stay and over a 3-month period. The goal of the intervention was to achieve 50% of subjects meeting APAP adherence (an average ≥ 4 hours per night) over the 3-month treatment period. The investigators evaluated if demographic, co-morbid or stroke-specific factors predicted APAP adherence and assessed the relationship between APAP adherence and neurological recovery from stroke.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted after acute ischemic or hemorrhagic stroke to one of two inpatient rehabilitation units

Exclusion Criteria:

* The investigators will exclude participants if: their stroke was a subarachnoid hemorrhage or due to a secondary cause (vascular malformation, vasculitis, brain tumor, head trauma, or predisposition to bleeding); they have active CPAP use, advanced chronic lung disease requiring supplemental oxygen, heart failure (NYHA class III or IV); or they needed a nasogastric feeding tube.
Relationship Between Delivery Route and Fetal Complications With Doppler Indices and CPR Parameters

Term pregnancies within their 37-41 gestational week, who were planned to undergo induction of labor, were included in the study. Prior to initiation of the induction of labor, all included pregnant women underwent an assessment of Doppler flow indices, which included fetal umblical artery PI (pulsatility index) and fetal middle cerebral artery (MCA:Middle cerebral arter) PI. Cerebroplacental Ratio (CPR) was calculated by dividing MCA PI value to umbilical artery PI (MCA PI/UA PI=CPR).Included pregnant women were categorized as Group 1 and Group 2, which comprised of those with CPR value below 1.0 and above 1.0, respectively. Route of delivery and fetal complications, described as umbilical cord pH\<7.20, APGAR score at 5 minutes \<7, meconium aspiration syndrome, newborn intensive care unit admission, neonatal sepsis and neonatal death.

Term pregnancies within their 37-41 gestational week, who were planned to undergo induction of labor, were included in the study. Prior to initiation of the induction of labor, all included pregnant women underwent an assessment of Doppler flow indices, which included fetal umblical artery PI (pulsatility index) and fetal middle cerebral artery (MCA:Middle cerebral arter) PI. Cerebroplacental Ratio (CPR) was calculated by dividing MCA PI value to umbilical artery PI (MCA PI/UA PI=CPR).Included pregnant women were categorized as Group 1 and Group 2, which comprised of those with CPR value below 1.0 and above 1.0, respectively. All women who were considered appropriate for induction of labor were performed an pelvic examination and their Bishop scores were calculated. Those with a Bishop score equal to or below 5 were included in the study. Vaginal misoprostol (prostoglandin E1, 25 mcg) and dinoproston (prostoglandin E2, 10 mg) were used for induction of labor. Repeat doses were implemented in case of insufficient cervical ripening. Oxytocin was not used at the initial stages of labour, while it was used at the latter stages when necessary.

Route of delivery and fetal complications, described as umbilical cord pH\<7.20, APGAR score at 5 minutes \<7, meconium aspiration syndrome, newborn intensive care unit admission, neonatal sepsis and neonatal death.

Eligibility Criteria:
Inclusion Criteria:

* Term pregnancies between 37 and 41 gestational weeks Pregnancies destined to induction of labor

Exclusion Criteria:

* history of uterine scar, nonverteks presentation, multiple pregnancies, use of vacuum of forceps at delivery, shoulder dystocia, confirmed fetal structural or chromosomal anomalies
Prognostic Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is studying prognostic biomarkers in cell samples from young patients with acute myeloid leukemia.

OBJECTIVES:

Primary

* To determine the percentage of primary acute myeloid leukemia (AML) samples with increased Stat3 signaling pathway activity.
* To evaluate the presence of constitutive Stat3 activation and the sensitivity of Stat3 activation to low- and high-doses of cytokines.
* To evaluate the expression levels of Stat3 protein and the upstream and downstream regulators of Stat3 activation.

Secondary

* To classify samples according to a Stat3 activation pattern and correlate this result with event-free survival (EFS) and overall survival (OS).

OUTLINE: Cryopreserved AML specimens are analyzed for pStat3 and pStat5 levels, response to cytokine levels, and expression level of proteins known to influence stat activity by flow cytometry and western blot assays. Results are also compared with prognostic variables determined in CCG-291 study, including age, race, WBC, and cytogenetic risks.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia (AML)
* Cryopreserved AML specimens

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Electronic Nose and Fetal Chromosomal Disorders

"electronic nose"- the tiny sensors, will smell and detect the changes in the sample of abnormal fetal karyotype, and fluid that will be confirmed by amniocentesis.

The biochemical engineering department had developed a device called "electronic nose" that can detect various diseases Including cancer and asthma on basis of evaporable substances. The device simulates the human nose ", which includes an array of tiny sensors connected to nanometric sizes electronic calculating unit.. Thanks to their small size, electrical, physical and chemical properties, the sensitive sensors smell and identified changes in composition of the materials that characterize various diseases including kidney disease and asthma.

The electronic nose was developed by Professor Haick from the Technion. The main concept of the device is testing and characterization a trace amounts of substances in the air with the help of nana-technology sensors the idea is revolutionary and would allow the diagnosis of different diseases, like cancer, by exhaling air into the device.

The test is simple and not complicated to perform ,the examiner inhale air into a bag which connected to the "electronic nose". The molecules of the patient's breath will be tied to sensors and transmit an electrical signal to computer chip.

After processing the data the "electronic nose "can distinguish between normal cells and pathological cells.

Hypothesis: the tiny sensors ("electronic nose") will smell and detect the changes in the sample of abnormal fetal karyotype, and fluid that will be confirmed by amniocentesis.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women candidates for amniocentesis
* 17-33 gestational weeks

Exclusion Criteria:

* women that refuse to participate in the research
* women older than 45 or less than 16
Pilot Phase I/II Study of Amino Acid Leucine in Treatment of Patients With Transfusion-Dependent Diamond Blackfan Anemia

This study will determine the safety and possibility of giving the amino acid, leucine, in patients with Diamond Blackfan anemia(DBA)who are on dependent on red blood cell transfusions.

The leucine is expected to produce a response in patients with DBA to the point where red blood cell production is increased. Red cell transfusions can then be less frequent or possibly discontinued.

The investigators will study the side effects, if any, of giving leucine to DBA patients. Leucine levels of leucine will be obtained at baseline and during the study.

The drug leucine will be provided in capsule form and taken 3 times a day for a total of 9 months.

Leucine will be provided to participants in the form of a capsule and will be taken three times daily.

Blood hemoglobin levels will be monitored every 3-4 weeks for 9 months.

The entire study will last 12-15 months in length.

Subjects must be two years of age or older and on transfusion for more than six months prior to enrollment.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with Diamond Blackfan anemia as published in British Journal of Hematology
* transfusion dependent
* age 2 years and older
* adequate renal function
* adequate liver function
* negative B-HCG if patient is a menstruating female and documentation of adequate contraception
* signed informed consent

Exclusion Criteria:

* Known hypersensitivity to branched chain amino acids
* Diagnosis of an inborn error of amino acid metabolism disorder
* Prior hematopoietic stem cell transplantation
* Pregnancy, or plans to become pregnant during duration of trial