cyrilzakka/clinical-trials huggingface dataset:
Genetic Counseling in African American Women

The objectives of this study are to develop a Culturally Tailored Genetic (CTGC) protocol for African American women and evaluate its impact on decision making and satisfaction about BRCA1/2 testing, quality of life, and cancer control practices compared to Standard Genetic Counseling (SGC). A secondary objective of this study is to identify African American women who are most and least likely to benefit from CTGC vs. SGC.

Five to 10% of all breast cancer cases have been attributed to two breast ovarian cancer susceptibility genes called BRCA1 and BRCA2 (BRCA1/2). Genetic counseling and testing for BRCA1/2 mutations is now available through clinical research programs using standard counseling protocols. The goal of pre test counseling is to facilitate informed decision making about whether to be tested and to prepare participants for possible outcomes. The goal of post test counseling is to provide information about risk status, recommendations for surveillance, and options for prevention. However, previous research suggests that African American and Caucasian women differ in their attitudes about and responses to pre test education and counseling. Increasingly, cultural beliefs and values are being recognized as important factors in genetic counseling. Despite recommendations to increase the cultural sensitivity of breast cancer risk counseling, such programs have not been developed or evaluated. Therefore, the purpose of this study is to develop a Culturally Tailored Genetic Counseling (CTGC) protocol for African American women and evaluate its impact on psychological functioning and health behaviors compared with Standard Genetic Counseling (SGC) in a randomized clinical trial.

1. To evaluate the relative impact of CTGC vs. SGC on decision making and satisfaction about BRCA1/2 testing. Compared to SGC, CTGC will lead to higher rates of test acceptance and satisfaction with testing decisions. These effects will be mediated by increases in perceived benefits and decreases in perceived limitations and risks of genetic testing.
2. To evaluate the impact of CTGC vs. SGC on quality of life and health behaviors following BRCA1/2 testing. Compared to SGC, CTGC will lead to larger decreases in general and cancer specific distress, greater increases in adherence to cancer screening guidelines, and lower rates of prophylactic surgery. Reductions in psychological distress will be mediated by increased use of spiritual coping strategies.

Secondary Aim

To identify African American women who are most and least likely to benefit from CTGC vs. SGC. We predict that the relative benefits of CTGC will be greatest for women with greater endorsement of African American cultural values and those identified as BRCA1/2 carriers.

Eligibility Criteria:
Inclusion Criteria:

* Female
* African American or Black
* 5% to 10% prior probability of having a BRCA1 or BRCA2 mutation

Exclusion Criteria:

* Men
* Individuals who are not African American or Black
Amotosalen and Platelet Transfusion in Adult Heart Surgery

Blood safety is ensured by the rigorous selection of donors and biological tests. However, infectious agents can escape this detection and be transmitted to recipients during transfusion. Amotosalen is a derivative of psoralens that intercalates with nucleic acids and inactivates them after UV exposure; it therefore makes it possible to inhibit any replication of an infectious agent present. Preliminary studies have shown its safety and efficacy in preventing the transmission of infectious agents during the administration of labile blood products (fresh frozen plasma and platelet concentrates) as well as the absence of loss of efficacy (absence of loss of pro-aggregating and procoagulant properties) of the transfused products. In addition, there is a significant reduction in side effects for platelet concentrates, especially compared to irradiated concentrates.

Treatment of platelet concentrates with Amotosalen may be responsible for a reduction in the platelet concentration in each concentrate with an overall decrease in efficiency and transfusion yield compared to untreated concentrates.


Eligibility Criteria:
Inclusion criteria:

* Major subjects ≥18 years old
* Cardiac surgery or ascending aorta
* Platelet transfusion for any reason
* Subject not having expressed their opposition, after information, to the reuse of their data for the purposes of this research

Exclusion criteria

* Subject having expressed opposition to participating in the study
* Presence or - installation of transient circulatory assistance (outside of the CEC) or definitive
* Heart or cardiopulmonary transplantation
* Subject under guardianship or guardianship
* Subject under safeguard of justice
Evaluation the Possible Influence of Transcatheter Arterial Chemoembolization on Hepatitis B Viral Replication

Transcatheter arterial chemoembolization (TACE) is the traditional method for the palliative management of patients with hepatocellular carcinoma (HCC). Few previous studies had demonstrated that the serum level of anticancer drug from patients treated by TACE was similar to those treated by systemic chemotherapy. Since systemic chemotherapy may have the possibility to influence patient's general defense ability, hepatitis B virus may reactivate after chemotherapy.This study is to investigate the possibility of TACE in the reactivation of hepatitis B virus.

Hepatocellular carcinoma (HCC) is the most common malignant tumor of the liver. Chronic hepatitis B infection is the common etiology for the development of HCC. Transcatheter arterial chemoembolization (TACE) is the traditional method for the palliative management of patients with HCC. Few previous studies had demonstrated that the serum level of anticancer drug from patients treated by TACE was similar to those treated by systemic chemotherapy. Since systemic chemotherapy may have the possibility to influence patient's general defense ability, hepatitis B virus may reactivate after chemotherapy. There is no study to investigate the possibility of TACE in the reactivation of hepatitis B virus. This project will collect 20 patients with HCC caused by hepatitis B who are planned to be treated by TACE. Quantitative determination of viral load in blood will be performed before TACE, the first and the third month after TACE to investigate the influence of TACE on hepatitis B virus replication. This study will not influence the doctor's decision in the management of HCC and the procedure of TACE. The serum used for HBV DNA examination is concomitantly obtained during regular blood sampling for TACE preparation and follow-up of patient. The amount of blood needed for each time HBV DNA examination is less than 10 ml.

Eligibility Criteria:
Inclusion Criteria:

* patients with hepatocellular carcinoma caused by hepatitis B virus without antiviral drug treatment and patients will be treated by transcatheter arterial chemoembolization

Exclusion Criteria:

* patients already received antiviral drug management
Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)

The overall goal of this study will be to assess and monitor the adherence to and effectiveness of the new prescribing guidelines for cabergoline.

Specific objectives will be to assess: 1. The indication for use of cabergoline (Parkinson, hyperprolactinemia, other) 2. Prior treatment strategies in patients who start cabergoline treatment for Parkinson's Disease 3. The percentage of cabergoline users who are prescribed doses above 3 mg per day 4. Whether cabergoline users are monitored by echocardiography prior and during treatment. 5. The incidence and prevalence of valvular fibrosis

does not involve random selection

Eligibility Criteria:
Inclusion Criteria:

* Treated with cabergoline during the study period (January 1st, 2006 and will end on July 1st 2012) and identified in one of 6 databases: The Health Information Network, Health Search Database, Integrated Primary Care Information database, PHARMO, Aarhus hospital databases, and the Universitaet Bremen - Bremen Institute for Prevention

Exclusion Criteria:

* Patients with eligibility dates that start after July 1st 2007 (meaning that they would have less than one year of valid data before publication of the results of the EMEA review), will be excluded as well as patients whose eligibility ends before July 1st 2008 (date of SmPC changes).
Cardiovascular Medication Use Before First Myocardial Infarction

Large randomised trials have shown that cardiovascular medications prescribed to patients at high cardiovascular risk are effective in reducing the incidence of cardiovascular events. Their use is recommended in the United Kingdom and international guidelines (e.g. the National Institute of Clinical Excellence). However, these medications do not prevent cardiovascular events in all patients and there is now a body of research investigating the effects of cardiovascular medications on outcomes in myocardial infarction (MI), including clinical presentation, infarct size and post-MI mortality. However, the independent effects of cardiovascular drugs on post-MI all cause mortality are unclear, and there are limitations to many of the published studies in terms of their cardiovascular drug exposure data. This project utilizes prospectively collected data on cardiovascular drug use, and links to MI data from hospital and mortality records.


Eligibility Criteria:
Inclusion Criteria:

Patients in GPRD practices which are deemed "up to standard" by GPRD criteria will be included if their practice agreed to be linked to the Myocardial Ischaemic National Audit Project (MINAP), Hospital Episode Statistics (HES) and Office for National Statistics (ONS) datasets.

Patients must have at least one year of GPRD "up to standard" registration before the date of first myocardial infarction.

Age over 18. First myocardial infarction occurring between 1st January 2003 and 31st December 2008, as recorded in the HES data or MINAP.

Exclusion Criteria:

Patients will be excluded if they do not fulfil one of the inclusion criteria.
Hypercapnia: Cognitive Effects and Monitoring

The investigators will simulate the conditions of a working, helmeted diver by using exercising, "head out" immersed subjects to test the following hypotheses:

1. An algorithm can be developed which predicts cognitive performance in immersed exercising divers, based on the exhaled carbon dioxide (PETCO2) and the diver's inspired partial pressures of oxygen and nitrogen (PIO2 and PIN2).
2. PETCO2 using mass spectrometry is an accurate estimate of arterial carbon dioxide (PaCO2) at rest and during immersed exercise and can be used as a PaCO2 surrogate at levels exceeding 50 mmHg and depths up to 158 fsw (gas density 6.4 g/l, similar to 165 fsw density of 6.8 g/l).


Eligibility Criteria:
Inclusion Criteria:

* healthy,
* male,
* age greater than 18,
* age less than 50

Exclusion Criteria:

* smoker,
* asthma,
* cardiac disease,
* inability to pedal a bicycle ergometer,
* inability to perform vigorous exercise
Study of AT-752 in Patients With Dengue Infection

The Phase 2 study will be conducted in adult patients with confirmed Dengue infection and will investigate safety, PK, and pharmacodynamics (PD) in this population. The study will be conducted in several dosing cohorts to enable dose selection for subsequent trials


Eligibility Criteria:
Key Inclusion Criteria:

* 18-55 years of age at time of screening
* Fever ≥38°C (or feeling feverish) with onset during the previous 48 hours
* Live/work in or recent travel to dengue endemic area
* Positive test confirming Dengue (DENV) on a NS1 antigen test or reverse transcription-polymerase chain reaction (RT-PCR) assay
* Negative rapid diagnostic test result for Coronavirus (SARS-CoV-2) and Influenza A and B

Key Exclusion Criteria:

* Pregnant, plans to become pregnant within 90 days of screening, or breast feeding.
* Has previously received any investigational or approved vaccine for dengue
* Previous history of HIV, chronic hepatitis B infection, or current hepatitis C infection (from medical history)
* Use of any antiviral drug within 30 days or within 5 half-lives of the active drug or metabolite (for long-acting antivirals)
* Current use of anticoagulant or antiplatelet drugs or documented medical history of bleeding disorders
* Current use of medications for treatment of inflammatory bowel disease or documented medical history of chronic gastrointestinal disease including inflammatory bowel disease
* Immunocompromised due to use of immunosuppressive drugs including systemic corticosteroids (inhaled or topical corticosteroids are allowed) or any current disease or condition
* Evidence of severe dengue disease
* Confirmed or suspected Coronavirus (SARS-CoV-2) infection or contact with patients with confirmed SARS-CoV2 infection within 7 days prior to screening
* Other clinically significant medical conditions or laboratory abnormalities, as described in the protocol.
Biomarkers in Tissue Samples From Young Patients With Liver Cancer

This research trial is studying biomarkers in tissue samples from young patients with liver cancer. Studying samples of 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.

PRIMARY OBJECTIVES:

I. To identify biomarker signatures associated with hepatoblastoma subtypes (by microRNA array profiling), and their potential correlation with liver developmental stages as well as outcome.

II. To correlate expression array data with copy number array data.

SECONDARY OBJECTIVES:

I. To carry out a focused sequencing interrogation of amplified or deleted genomic regions as well as genes in key cell pathways involved in embryonic development and/or stem cell signaling pathways for which preliminary data suggests involvement in the pathogenesis of hepatoblastoma.

II. To perform whole exome sequencing in a subset of tumors.

OUTLINE: This is a multicenter study.

Archived tumor tissue samples are analyzed for hepatoblastoma and other liver tumor biomarkers by microRNA array profiling and exome sequencing. Results are then compared with patients' clinical data.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hepatoblastoma or other liver cancer including the following subtypes:

  * Pure fetal histology
  * Transitional histology
  * Small cell undifferentiated histology
* Participated on the Children's Oncology Group (COG) clinical trials
* Available data and tumor samples
VRES Study in Two Phases to Monitor Cardiac Surgical Patients Following Discharge From ICU

Failure to recognise deterioration early is a major cause of preventable deaths amongst hospital patients. The investigators wish to study whether continuous monitoring of 'vital signs' (pulse rate, breathing rate, and blood oxygen saturations) with computer modeled alerting to detect patient deteriorations can reduce cardiac arrest rate and critical care readmissions from the wards by alerting staff to clinical deteriorations more effectively than current paperbased systems.

Continuous monitoring of 'vital signs' can be achieved in two ways. Continuous monitoring of 'vital signs' has traditionally been restricted to the bedside because of the need for the patient to be connected by wires to the monitor.

More recently, advances in telemetry (wireless technology) have allowed the development of wearable devices which allow patients to mobilise freely, whilst constantly monitoring these 'vital signs'.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the Papworth Hospital NHS Foundation Trust for routine cardiovascular surgery and who are discharged from ICU into the study ward (Mallard).

Exclusion Criteria:

* transplant surgery patients,
* VAD patients,
* children (less than 18 years old),
* prisoners (due to constant observation/security may bias normal level of care),
* patients who are subject to additional protections: this includes pregnant women, and persons with mental illness and learning disabilities,
* patients whose anatomy precludes the use of the required monitoring,
* patients who cannot understand written English (and where no translator is available),
* patients who are unable to give consent themselves,
* patients with learning difficulties who cannot understand the information to consent for themselves.
Studying Biomarkers in Samples From Younger Patients With Wilms Tumor

RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors to learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.

OBJECTIVES:

* To analyze 250 favorable-histology Wilms tumor (FHWT) samples from patients registered on NWTS4 for gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q by subtelomeric multiplex ligation-dependent probe amplification (MLPA), and to determine their association with relapse-free and overall survival.
* To develop a robust multiplex MLPA test using multiple synthesized probes to those targets identified as significantly associated with relapse in Aim 1.
* To validate the multiplex MLPA test designed and tested in Aim 2 on an independent set of 1727 FHWT and 250 anaplastic WT registered on NWTS-5.

OUTLINE: Archived DNA samples are analyzed for gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q by MLPA. Assay results are then researched for accuracy, clinical validity, sensitivity, precision, and potential analytical interferences.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* DNA samples from FHWT patients registered on:

  * NWTS-4
  * NWTS-5 with focal and diffuse anaplasia tumors

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
The Prognostic Role and Diagnostic Efficacy of Exercise Right Heart Catheterization With a Simultaneous Echocardiography in Patients With Dyspnea on Exertion

To evaluate the role of exercise hemodynamic testing in the diagnostic workup for patients with dyspnea on exertion referred to the catheterization lab.

Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. However, in practice, it's difficult to recognize early stage of HFpEF by resting hemodynamic study and echocardiography because the patients mainly complaint of dyspnea only during exercise but not resting condition. Accordingly, exercise stress test will be helpful to provide more information on pathophysiology, diagnosis, and severity in various cardiovascular diseases such as HFpEF, valvular heart disease, and chronic thromboembolic pulmonary hypertension. Thus, the broad objective of this proposal is to characterize the dynamic changes in cardiopulmonary mechanics during stress in patients with exertional dyspnea, establishing a comprehensive multimodality diagnostic approach to the evaluation of exercise intolerance. Specifically, this study will compare established and novel parameters derived from echocardiography and CPX with simultaneous, gold standard invasive measures of cardiovascular hemodynamics at rest and with exercise stress to define the role of noninvasive testing in the diagnostic workup for patients with dyspnea on exertion referred to the catheterization lab.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be at least 19 years of age.
* Patients with dyspnea on exertion
* Written informed consent of participating subjects after being fully briefed (for prospective analysis)

Exclusion Criteria:

* Patients with incomplete hemodynamic data at rest or exercise
* Advanced tumor disease or other diseases with a short life expectancy
* Uncontrolled systemic arterial hypertension ( \> 160/100 mmHg at rest)
* FEV1\<50% predicted
* TLC\<60% predicted
Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder

Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. This study will assess how safe and effective ABBV-932 is in treating participants with bipolar I or II disorder.

ABBV-932 is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder. Study doctors put participants in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 adult participants with bipolar I or II disorder will be enrolled in approximately 40 sites worldwide.

Participants will receive oral capsules of ABBV-932 or matching placebo once daily for 6 weeks. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International Neuropsychiatric Interview (MINI), with a current depressive episode of at least 4 weeks and not exceeding 12 months.
* Have a minimum score of 20 on the 17-item Hamilton Depression Rating Scale (HAMD-17).
* Have a minimum score of 2 on Item 1 of the HAMD-17 at screening.

Exclusion Criteria:

* Positive urine drug screen (UDS) result at screening.
* Treated with any investigational drug within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug, is currently enrolled in another clinical study, or was previously enrolled in this study.
* Current use of any antipsychotic, antidepressant, anticonvulsant, mood stabilizer, herb, or over-the-counter medication with psychoactive potential within 1 week or 5 half-lives of the medication (whichever is longer).
* Prior exposure to ABBV-932 within 90 days prior to baseline.
Molecular Variants Associated With Schizophrenia: Differential Analysis of Monozygotic Twins With Variable Phenotypic 22q11

The 22q11.2 microdeletion syndrome (22q11.2DS) is a rare disease with a psychiatric phenotype. Indeed, the diagnosis of schizophrenia is made in 5 to 10% of adolescents and 25 to 40% of adults carrying the 22q11DS. Thus, although this pathology has been able to provide a genetically homogeneous model for the study psychosis etiology, it is not currently possible to establish a link between genomic rearrangement and psychotic symptoms. However, this robust model of genetic vulnerability could provide us a lot of translational informations about schizophrenia genetics. To go furthermore, twin studies have provided us precious data for the study of hereditary diseases. Combining this two approaches, the translational 22q11.2 project proposes a molecular study of two monozygotic 22q11.2DS twins discordant for the psychiatric phenotype -one carrying schizophrenia and the other having no psychiatric symptoms-.

The main objective of the study is to propose a whole exome sequencing (WES), pan-genomic in whole genome sequencing (WGS), transcriptomic, epigenomic and intestinal microbiome approaches in order to determine specific molecular basis of psychotic symptoms in 22q11.2DS.

Eligibility Criteria:
Inclusion Criteria:

* • Sisterhood of monozygotic twins diagnosed with de novo 22q11.2DS is confirmed by CGH array and discordant for the psychiatric phenotype

Exclusion Criteria:

* • Refusal to use data for research purposes