cyrilzakka/clinical-trials huggingface dataset:
Breast Cancer, Omics, and Precision Medicine

The standard tissue biopsy strategy for cancer detection is not comprehensive enough to profile the whole epi-genomic signatures of breast cancer (BC) and ensure an accurate prognosis and prediction of drug response. Liquid-based assays have the potential to reduce the molecular heterogeneity of BC and a possible utility for improving disease management. In particular, genomic DNA (gDNA) and circulating tumor (ctDNA) can be sequenced for genetic and epigenetic (DNA methylation) profiling of the BC patients to enhance personalized prognosis and prediction of drug therapy. We describe a study protocol for evaluating the clinical utility of the early use of the network-oriented BR(E)2ASTOME algorithm which combine the power of liquid-based assays, advanced epi-genomics platform, and network analysis to identify improve precision medicine and personalized therapy of BC.

The BR(E)2ASTOME study will be performed at the U.O.C. Patologia Molecolare e Clinica, University of Campania "L. Vanvitelli", Naples (Italy) with a long-standing experience in diagnosis and treatment of BC (Refs.). From each study participant, total of 10 mL of pheripheral blood in EDTA tubes will be collected at time of BC diagnosis. Blood-based assays will be performed to obtain genetic and/or epigenetic big data from ct-DNA and gDNA, respectively. A network-oriented algorithm combined with patient-level clinical information will be applied to big data in order to identify clusters of genes (BC-modules) harboring novel genetic mutations, in the NGS-ctDNA BC-group, and differentially methylated regions (DMRs), in the RRBS-gDNA group, with a potential predictive and prognostic role in BC management. In the NGS-ctDNA-RRBS-gDNA group, we will evaluate whether the multi-omics approach is more informative as compared to the single-omic paradigm.

BC patients (males and females) will be randomized to the 2 study arms: ctDNA-NGS + gDNA-RRBS, and standard of care alone. No modifications of intervention assignment will be possible after randomization process of patients. The BR(E)2ASTOME study will provide evidence about the potential clinical utility of early use liquid-based assays and network-oriented biomarkers in prognosis and prediction of drug response in BC management.

Thus, results from BR(E)2ASTOME study will bring to identify not only new molecular mechanisms associated with BC, but also non-invasive biomarkers that can direct towards an early diagnosis, contribute to monitor the cancer progression and the response to therapeutic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Sporadic BC
* Inherited BC
* 18 years old
* Males and Females

Exclusion Criteria:

* Inflammatory diseases
* Cardiovascular diseases
Malaria Survey in Mbarara District, Uganda 2010

Malaria is one of the major public health problems in Sub-Saharan Africa. In response to this threat, Roll Back Malaria (RBM) has rolled back a strategy using ACT as first line therapy for malaria episode, a wide distribution of Insecticide Treated Bednet (ITN), intermittent presumptive treatment of pregnant women and indoor residual spraying. Recent epidemiological observations suggested a decline in malaria prevalence in some countries but further evidences are still needed to confirm this evolution. The RBM strategy requires the use of reliable rapid diagnostic test (RDT) for which an operational assessment is necessary. Lastly, home-based management of malaria is also an important compound of this strategy. However, a better understanding of the actual use of antimalarial drugs, of the use of bednet and of the barrier to the use of health care is important to implement good quality strategies for malaria control.

This study is a cross-sectional community based survey made of two rounds (one in January 2010 and the second in June 2010). The general objective is to measure the prevalence of infection with Plasmodium falciparum at two periods of the year (at the moment of lowest and highest transmission based on the seasonal rainfalls) and to compare it with the prevalence estimated in 2004 after the rainy season for the same area. Specific objective are the estimation of the prevalence by age stratum, the analysis of the geographical distribution of the infection, the description of the parasitological characteristics, the assessment of three RDT, the description and the analysis of the prevention and care seek behaviours related to malaria.

The study area is the great Mbarara district located in south-west of Uganda. A three-stage cluster sampling method will be used. Spatial information will be collected with global positioning system and imported to Geographical Information System. Behaviour information will be collected through face to face interview.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Ages 1 month to 59 months

Exclusion Criteria:

* None
Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain

This is a prospective, multi-center, post market study to evaluate Intrathecal (IT) preservative-free morphine sulfate (PFMS) using the SynchroMed™ II infusion system as an alternative to systemic opioids for the treatment of chronic, intractable, non-malignant primary back pain with or without leg pain.

Subjects will be assessed for pain control and opioid-related side effects following a route of delivery change from systemic opioids to IT morphine therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide a signed and dated (Medtronic and Institutional Review Board (IRB) approved) Informed Consent Form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form prior to any study procedures being performed
2. A candidate per labeling for the Intrathecal Drug Delivery System (IDDS)
3. A diagnosis of chronic, intractable, non-malignant primary back pain with or without leg pain, treatable with the IDDS
4. Current daily systemic opioid dose of \>0 and ≤ 120 Morphine Milligram Equivalents (MME)
5. A Visual Analogue Scale (VAS) of ≥50 mm for pain intensity at the Baseline Visit and/or a Numerical Opioid Side Effect (NOSE) Assessment Tool ≥40 for intolerable side effects at the Baseline Visit
6. Psychological evaluation or investigator assessment of patient psychological suitability for study participation
7. Has an MRI or CT prior to enrollment verifying patent spinal canal and no clinical change in status since last imaging
8. At least 18 years old at time of enrollment
9. Willing and able to attend visits and comply with the study protocol
10. Male or non-pregnant, non-lactating female. Females must be post-menopausal or surgically sterile; or be utilizing a medically acceptable form of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide) for the duration of the study

Exclusion Criteria:

1. Previously trialed or implanted with an IDDS
2. Concomitant stimulation device implanted for the treatment of pain
3. Any ongoing health condition that would be expected to interfere with pain and/or quality of life ratings (i.e. active malignancy, other painful conditions not treatable with IT therapy, etc.)
4. Psychological or other health conditions, financial and/or legal concerns that would interfere with the subject's ability to fulfill the requirements of the protocol as per the investigator's discretion
5. Substance Use Disorder (SUD) within the last 2 years or current Medication Assisted Treatment (MAT) for substance use disorder
6. Currently using cannabinoids or illicit drugs
7. History of allergy or significant adverse reaction to morphine per investigator discretion
8. Currently participating or plans to participate in another investigational study unless written approval is provided by Medtronic Study Team
Cardiopulmonary Stress Testing (CPET) AlloSure Study

1. Cell-free DNA does not vary significantly as a function of the activity of immunologically quiescent cardiac transplant recipients, despite the metabolic demands of the transplanted organ. (The implication of the null result would be that no restrictions to patient activity, nor modification of cardiac rehabilitation prescription, would be necessary to maintain proper test characteristics of AlloSure testing).
2. In immunologically active cardiac transplant allografts, exercise prior to assay of donor-derived cell-free DNA can be used to increase the sensitivity of the AlloSure test. (The implication of this would be that the optimal time-frame for drawing an Allosure may actually be post-exercise, and that window will be characterized).

The specific research questioned aimed to be addressed with this proposed study are:

i. Are dd-cfDNA levels in heart transplant recipients independent of recent cardiopulmonary exercise? More specifically, does the metabolic demand of maximal cardiopulmonary exercise in recent heart transplant recipients trigger a release of dd-cfDNA (if so, then what is the time course for resolution back to baseline?) ii. If dd-cfDNA does not release to any significant degree with cardiac allografts with short donor-ischemic time, does this test characteristic continue to hold for cardiac allografts transplanted after longer donor ischemic times? iii. In cardiac transplant recipients with medically stabilized, treated antibody-mediated rejection (AMR) and persistent dd-cfDNA elevation, does a discrete episode of maximal cardiometabolic activity trigger any additional elevation of dd-cfDNA, and again, with what time course?

Eligibility Criteria:
Inclusion Criteria:

Post-orthotopic heart transplant patients

Exclusion Criteria:

1. orthopedic, neurologic and/or any other limitations that do not allow for exercise testing on a treadmill or cycle ergometer;
2. individuals who require supplemental oxygen or have current permanent tracheostomies will be excluded from this study;
3. individuals who are discharged to a long-term acute care facility;
4. skilled nursing facility or with palliative care or hospice care will be excluded; (e) inmates and pregnant women;

(f) patients with antibody-mediate rejection that are not felt to be safe for cardiopulmonary stress testing.
A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung

This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung
* Positive for translocation or inversion events involving the ALK gene locus
* No prior systemic treatment for locally advanced or metastatic disease; Patients with brain metastases only if treated and neurologically stable with no ongoing requirement for corticosteroids
* Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome \[PRO\] measures.
* 18 years of age or older with the exception of India which has an upper age limit of 65 years old

Exclusion Criteria:

* Current treatment on another therapeutic clinical trial.
* Prior therapy directly targeting ALK.
* Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. - - Appropriate treatment with anticoagulants is permitted.
* Ongoing cardiac dysrhythmias of NCI CTCAE Grade \>=2, uncontrolled atrial fibrillation of any grade, or QTc interval \>470 msec.
* Pregnancy or breastfeeding.
* Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
* Known HIV infection
* Known interstitial lung disease or interstitial fibrosis
* Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study
Exploring the Risk Factors of Otomycosis: A Case-Control Study

The goal of this observational study is to explore the risk factors of fungal otitis externa in the fungal otitis externa patients The main question it aims to answer is:

What behaviors lead to the occurrence of fungal otitis externa? Participants will complete a detailed questionnaire survey. If there is a comparison group: Researchers will compare the healthy group and the disease group to see if there are any differences.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms in the case group include tinnitus, ear fullness or blockage, itching, ear pain, discharge, and hearing loss. Physical examination reveals the presence of hyphae, scabs, secretions, masses, pus, red skin, erosion, swelling, or granulation in the ear canal. Laboratory fungal cultures must be positive. The control group does not have the aforementioned ear symptoms and has not sought medical attention for ear-related symptoms.

Exclusion Criteria:

* Patients with otitis media, tympanic membrane perforation, or post-radiotherapy.
Comparing Risk of Heat Illness Based on Peak Core Temps During Preseason Football Camp Across 3 Different Age Levels

To collect field data in professional, collegiate, and high school football players to determine how they respond physiologically to the rigors of preseason training environment. Investigators will compare core temperature, hydration status, practice guidelines regarding rest and hydration, and baseline knowledge of heat illness and hydration among the three levels. The hypothesis is higher peak temperatures will be observed in the younger less experienced football players.

Observations will occur over a 4-5 day period at the start of pre-season training camp. Researchers will meet with the high school volunteers and their parents to discuss the study and obtain informed consent prior to participating. Participants will swallow the HQInc CorTemp pill at least three hours (or late the night before) before practice. Temperature readings will be scanned every 15-30 minutes throughout practice. Pre and post practice weights will be recorded as well as urine specific gravity to help assess hydration status. Participants will also fill out a short 1 page questionnaire regarding their prior heat acclimatization, sleep habits, and baseline knowledge of hydration and heat illness. Protocol will be the same at all three age/competition levels.

Eligibility Criteria:
Inclusion Criteria:

* Football player on one of the teams from the pre-selected teams. Male.

Exclusion Criteria: based on being able to swallow HQInc CorTemp Pill

1. Any athlete weighing less than eighty (80) pounds.
2. Any athlete with any known or suspected diseases of the gastrointestinal tract.
3. Any athlete with impairment of the gag reflex.
4. Any athlete with previous gastrointestinal surgery.
5. Any athlete with history of problems with their esophagus.
6. Any athlete who might undergo an MRI scan before the temperature sensor has been eliminated from the body.
7. Any athlete with problems moving food through their gastrointestinal tract.
8. Any athlete having a cardiac pacemaker or other implanted electro medical device.
The Third Survey of Prescription Pattern of Psychotropic Drugs in China

The investigators aimed to examine the psychotropic prescription pattern in China.


Eligibility Criteria:
Inclusion Criteria: aged 18-65, inpatient or outpatient, Patient must be willing and able to give written informed consent,the patient suffers from schizophrenia or depression or bipolar disorder -

Exclusion Criteria:aged\<18or aged\>65

-
Analgesic Efficiency of Pudendal Nerve Block Versus Penil Block for Circumsion in Children

The aim of this prospective randomized study is to assess the analgesic efficacy of Pudendal block compared with penil block for pediatric patients undergoing circumsion concerning postoperative analgesic consumption within 24 hours.

In this prospective study, patients will be randomized into 2 groups, either receiving penil Block( PNL) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will be assessed during the first 24 hours postoperatively. The "CHEOPS pain scale" will use to assess postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

ASA I-II patients, aged 1-12 years old patient undergoing circumcision,

Exclusion Criteria:

history of local anesthetics's allergy, infection at the injection side, anatomical abnormalities, coagulopaty, bleeding disease, liver disease
Prospective Use of Philips iSuite for Interventional Procedures

This research study is being done to look at new MRI imaging guidance software, Philips Interventional iSuite software, to see if using will improve the physician's ability to quickly place and guide needle tip position for biopsies and ablations.

The purpose of this study is to evaluate Philips Interventional iSuite software used for MRI guided procedures in the MRI suite. The real-time MRI Imaging software will be used during an MRI procedure to take continuous pictures.

The Philips Interventional iSuite software package has not received FDA 510(k) clearance. The Investigator will be evaluating and publishing on the use of this software as a clinical aid in performing interventional procedures within the MR suite. The primary evaluation will be weighted toward enhanced facilitation of ablation procedures. However, the software will not replace standard MR imaging for final confirmation of needle tip position and ablation margins.

Eligibility Criteria:
Inclusion criteria:

* Patients already scheduled for a percutaneous MR guided procedure

Exclusion criteria:

* Pregnant Women
Effectiveness of Alcohol Swabs for Preventing Infections During Vaccination

Alcohol is used to disinfect the skin prior to injections in order to prevent infections caused by bacteria on the skin being injected within tissue. At present, however, clinical trials do not demonstrate a clinical impact of using or not using alcohol swabs on infections and infection symptoms calling into question the practice of using it prior to all injections. These studies are methodologically flawed, and do not specifically examine vaccine injections. The present study is being undertaken to provide some preliminary data for the risk of infection and infection symptoms when alcohol swabs are not used to perform vaccine injections.

Alcohol is used to disinfect the skin prior to injections in order to prevent infections caused by bacteria on the skin being injected within tissue. Alcohol has been shown to be a good disinfectant, reducing the number of bacteria on skin by 47-91%. However, in previous clinical trials, there has been no clinical impact of using or not using alcohol swabs on infections and infection symptoms calling into question the practice of using it prior to all injections. These studies, however, are generally of low scientific rigor (e.g., not randomized, not blinded, did not use standard case definitions of the adverse reactions being measured). Moreover, it is important to note that none of them specifically evaluated vaccine injections, the most common type of injection worldwide.

At present, based on the available evidence base, the World Health Organization (WHO) and the Centre for Disease Control (CDC) do not recommend the use of alcohol swabs before vaccine injections. As a result, immunizers in many countries around the world currently do not cleanse the skin with alcohol prior to vaccination. Despite these recommendations, clinicians in our community and across Canada commonly use alcohol swabs prior to all vaccine injections. In this application, investigators will undertake a pilot randomized study to evaluate the incidence of infection symptoms and infections in children undergoing vaccination with and without skin cleansing with alcohol swabs.

Eligibility Criteria:
Inclusion Criteria:

* healthy pediatric patients undergoing routine vaccinations

Exclusion Criteria:

* no contra-indications to vaccination or alcohol swab,
* ability to understand English and consent to the study
A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy

The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy.

The purpose of the study is to compare the safety and efficacy of Prograf versus placebo in the prevention of erectile dysfunction in men after a bilateral nerve-sparing radical prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

* Male scheduled to undergo bilateral nerve sparing radical prostatectomy for prostate cancer.

Exclusion Criteria:

* Patient is \> 65 years of age
* Patient has been diagnosed with Type 1 or Type 2 diabetes
* Patient is actively smoking on a daily basis
Transitional Treatment of Adolescents in Family Therapy

The purpose of this study is to test different treatments to reduce relapse for drug-abusing adolescents who have completed family therapy. Adolescents receive 12 weeks of family therapy, designed to strengthen family relationships and develop skills for helping the adolescent avoid drug use. Then they are randomly assigned to receive one of three eight-week follow-up treatments: phone calls from a project therapist, group therapy, or a customized schedule of therapist visits with the adolescent, the adolescent's family and teachers, coaches, probation officers and others who can help the adolescent reach or maintain abstinence. Families are assessed using questionnaires and interviews before, during and after treatment, to provide information about family functioning, the adolescent's drug use, the adolescent's peers and other factors that may contribute to treatment success or failure. Adolescents also provide urine specimens for drug screening at assessment visits. Study investigators expect the study will show that a functional family environment and insulating adolescents from the influence of peers who use drugs will help prevent relapse for adolescents who have received family therapy.


Eligibility Criteria:
Inclusion Criteria:

1. At least one parent, step-parent, or surrogate parent willing to participate in the study
2. 13 to 18 years if age
3. meets DSM-IV (APA, 1994) diagnostic criteria for substance abuse or dependence
4. Lives in the Albuquerque metropolitan area or surrounding communities with a parent, step-parent, or surrogate parent; AND
5. Sufficient residential stability to permit probable contact at follow-up (e.g., not homeless at time of intake).

Exclusion Criteria:

1. Evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures
2. Adolescent deemed dangerous to self or others during evaluation
3. Services other than outpatient treatment required for the adolescent (e.g., inpatient, detoxification)
4. Adolescent already has participated in treatment project at CFAR; AND
5. A sibling is already participating in project.