cyrilzakka/clinical-trials huggingface dataset:
Detection of Prostate Cancer Using Voided Urine

This study collects urine from male patients seen at the urology clinic to detect prostate cancer cells, shed in voided urine, using the optical imaging method developed in the laboratory, which targets certain biomarkers expressed on prostate cancer cells. The information learned from this study may allow researchers develop a simple diagnostic test for the management of those patients who have elevated prostate specific antigen (PSA) and are suspected to have prostate cancer. It may also help researchers understand the genetic risk factors associated with prostate cancer.

PRIMARY OBJECTIVE:

I. To detect prostate cancer cells, shed in voided urine, using the optical imaging method developed in our laboratory, which targets vasoactive intestinal polypeptide receptor 1 (VPAC1) receptors expressed on prostate cancer cells and validates the results with prevailing condition of the patients/volunteers and evaluate diagnostic accuracy.

SECONDARY OBJECTIVES:

I. To establish if the malignant cells as a percent of total cell shed in the urine.

II. To establish the fluorescence intensity around malignant cells. III. To establish if the VPAC protein quantity in shed malignant cells correlate with the aggressiveness of the disease.

OUTLINE:

Patients undergo collection of urine samples at baseline during standard of care office/clinic visit.

Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent form
* Male
* Patients must be 50-70 years of age
* Willing to comply with all study procedures
* Prior to digital rectal exam (DRE)
* Patients with the diagnosis of prostate cancer (Cohort 1 N=150)

  * Prior to radical prostatectomy/radiotherapy (XRT) or systemic therapy
  * May be on active surveillance
* Patients with elevated PSA level but no know prostate cancer (Cohort 2 N=150)

  * Diagnosis of BPH/lower urinary tract symptoms (LUTS)
  * No prior diagnosis of prostate cancer
  * Prior negative biopsy with PSA \> 1.5
  * Without biopsy PSA \< 1.5
* Patients with normal PSA levels (Cohort 3 N=200)

  * No documented history of BPH (no medical management or prior surgical treatment for BPH)
  * PSA \< 1.5
  * No documented history of prostate cancer
  * No documented history of urothelial carcinoma
* Patients Pre DRE and Post DRE (Cohort 4 N=200)\*\*
* Patients on with a known Gleason Score (Cohort 5= 150)

Exclusion Criteria:

• Patients under the age of 50
Indirect Endovenous Systemic Ozone for New Coronavirus Disease (COVID19) in Non-intubated Patients

Systemic medical ozone has proved to help in several viral diseases, chronic obstructive pulmonary disease and chronic inflammation process. The investigators are sure that its application to COVID-19 patients, as an adjuvant therapy, will improve the health status of these individuals.

Due to the extreme world situation caused by COVID19 pandemic, the investigators consider unethical not to try any treatment option with a justified rationale.

The investigators have explained that medical ozone therapy has a clear scientific basement thanks to all preclinical and clinical investigation already published. It can be classified as chemical stressor that produces a modulation in the redox balance and immunity. Moreover, it is easy and safe to administer with insignificant side effects.

The efficacy in viral diseases has been proved in publications together the modulation of interleukin 6 and other proinflammatory cytokines that could potentially help in COVID19 patients. The improve of exchange of gases and microcirculation will surely contribute to enhance this patients' health status.

As explained above, the investigators propose to carry out a randomized control trial to evaluate the safety and efficacy of systemic ozone (indirect endovenous) in these patients.

Eligibility Criteria:
Inclusion Criteria:

* COVID19 virus detected in oro/nasopharynx
* mild ill according WHO numeric scale
* mild ill according Berlin criteria
* non intubated patients
* signed informed consent

Exclusion Criteria:

* patients treated with systemic ozone in the last 6 months
* patients treated before with systemic ozone and referring any side effect
* glucose-6-phosphate-dehydrogenase deficit
* other severe concomitant disease apart from COVID19
* psychiatric disease specified in axis I of l Diagnostic and Statistical Manual of Mental Disorders, 5 edition, but major depression
* patients not capable of understanding the study methods and targets
* pregnant woman
Influence of Operator Factors on Succes and Survival of Indirect Restorations

Background: Nowadays, tissue preserving, aesthetically high-quality and sustainable dentistry is more and more becoming the standard way of treatment. To reach those standards, one of the treatment options is applying a partial indirect restoration made by glass ceramics using immediate dental sealing (IDS). Using IDS, a protocol is followed to applicate a dentin bonding agent to freshly cut dentin when it is exposed during tooth preparation for indirect restorations (inlays/onlays, crowns). The preparation made for partial restorations is minimal invasive. Glass ceramic restorations have very high survival rates (90 to 100% after five years) (Morimoto et al., 2016) and glass ceramic mimics the color and structure of the tooth very well.

This kind of treatment is gaining interest and increasingly applied however little information is available on the long-term effects when multiple general practitioners apply these restorations.

Objectives: The main goal of this study is to evaluate partial posterior ceramic restorations with the application of an immediate dentin sealing (IDS) performed by various practitioners.

Study design and population:

Twenty dental practitioners, who followed a course on making ceramic partial restorations using IDS, will be asked to include patients for this study. The dental practitioners are being asked to share their data (occlusal light photo's, impression and x-rays) of twenty-five restorations they make after having the course. Restorations of individuals with a minimum age of 18 will be included. The information from pictures and impressions will be evaluated.

Items to evaluate

The practitioners will be interviewed to get to know in what circumstances they do their treatment. Items that are discussed are:

* using rubber dam;
* using magnification by means of loupes/microscope;
* scheduled time for the treatment;
* number of restorations after following the course.

Initial data (gathered directly after treatment) will be evaluated looking at:

* surface of preparation after IDS;
* size of the prepared surface;
* color.

Follow up data will be evaluated looking at:

* tooth extraction
* fracture restoration
* fracture tooth
* secondairy caries
* de-bonding
* endodontic problems

Outcome: Failures (fracture, de-bonding, secondairy cariës, endodontic problems) are the main outcome measurements.

Description and estimation of the load and risk for the subjects:

No extra intervention is performed. The dental practitioners will provide their data (i.e. impressions, occlusal light photo's) and these will be evaluated by the researchers. Follow up data will be gathered from X-rays already made for periodical oral examination (taking the caries risk into account). Summarizing, there is no extra load or risk for the patients.

Studie design Prospective practice-based research, multicenter.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Adults

Exclusion Criteria:

* Periodontal unstable situation
* Endodontic unstable situation
* Allergies for one or more of the used products
Comparing SBRT to CRT in Patients With Spinal Metastases

This is a single institutional registry-based, prospective, observational study to describe radiation oncologists' decision making during evaluation of patients and to compare real-world outcomes of SBRT vs CRT.

A registry-based trial involves observing the effect of something without manipulating it.

The purpose of this study is to study the differences between CRT and SBRT. The investigator's are assessing radiation oncologists' decision-making during the evaluation of patients with spinal metastases by requesting radiation oncologists complete a questionnaire. Additionally, the investigator's will compare outcomes, including local progression, pain response and overall survival between SBRT and CRT. By collecting this information, the investigator's will develop an evidence-based algorithm that may be used to support medical decision-making for others with spinal metastases in the future.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older.
* Patients seen at the Princess Margaret Cancer Centre with painful spinal metastases amenable to radiation treatment.
* Confirmation of diagnosis: a) Known/documented prior histological cancer diagnosis
* Able to provide written consent
* ECOG performance status 0-3

Exclusion Criteria:

* Prior radiotherapy, with fields overlapping, resulting in excessive doses to organs at risk
* Lymphoma, myeloma or germ cell malignancies
Telemedicine in the Management of Pain in Patients With Advanced or Metastatic Pancreatic Cancer

Adenocarcinoma of the pancreas is a major public health issue because of its disastrous prognosis. The symptomatology of locally advanced or metastatic forms, particularly painful, is often major and difficult to balance, impacting both the quality of life of patients (and those around them) and the course of treatment (chemotherapy).

The objective of this study is to evaluate the interest and feasibility of telemedicine in the management of pain in patients undergoing treatment for advanced or metastatic pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old ;
* Patient with histologically or cytologically proven locally advanced and/or metastatic adenocarcinoma of the pancreas;
* Patient undergoing or failing medical treatment and comfort care only;
* Patient with EVA ≥ 4 and/or requiring analgesics level 3;
* Performans Status (ECOG) \< 3 ;
* Informing the patient and obtaining free, informed and written consent signed by the patient and the investigator;
* Patient affiliated or beneficiary of the social security system

Exclusion Criteria:

* Patient does not have a smartphone, tablet or computer;
* Patient with no personal internet access at home (WIFI, wired), or via his smartphone;
* Patient does not feel able to fill out an electronic questionnaire;
* Patient cannot read or write French;
* Patient does not speak and understand French;
* Persons deprived of liberty or under guardianship or trusteeship ;
* Dementia, mental alteration or psychiatric pathology that could compromise the patient's informed consent and/or compliance with the protocol and follow-up of the trial ;
* Inability to submit to trial protocol follow-up for geographical, social, or other reasons ;
* Patient participating in another interventional study evaluating treatment and pain management.
MSCs For Treatment of Azoospermic Patients

In this study, we performed autologous BMDMSC transplantation to the testis of Azoospermic patients in a trial to enhance and activate the spermatogonial stem cells of the testis and aiming to produce motile sperm.

Bone marrow aspirated and stem cells were isolated, cultured and characterized using flow cytometer. Stem cells prepared according to GMP regulations then injected into rete testis using special syringe. Patients follow up will carried out for a year , three month interval. FSH, testosterone, testicular size as well as sexual potency will assessed every three months.

Eligibility Criteria:
Inclusion Criteria:

* All Non obstructive Azoospermic Patients.
* Azoospermic Patients due to Administration of Chemo/Radiotherapy.

Exclusion Criteria:

* Patients with Testicular Cancer.
* Patients with Complete Deletion of Chromosome Y AZF (a,b,c) Regions.
Electromyographic Activity of Masseter Muscle During Deglutition in Total Laryngectomized Subjects

The objective of this study is to evaluate the electromyographic activity of masseter muscle during deglutition in laryngectomized subjects.


Eligibility Criteria:
Inclusion Criteria:

* laryngectomy

Exclusion Criteria:

* neurological diseases
* no oral feeding
Pharmacokinetic, Safety and Tolerability Study of SPARC1028

Evaluation of pharmacokinetic profile of SPARC1028

This is a phase I study of SPARC1028 and recommend phase II dose of SPARC1028 administered once a week for 3 weeks, followed by 1 week of rest.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage which taxane-based therapy is a rational treatment option.
* Age ≥18 years
* ECOG Performance Status ≤ 1.
* Estimated life expectancy of at least 12-weeks;

Exclusion Criteria:

* Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer
* Known hypersensitivity to the study drugs
* Treatment with any anti-cancer agents within 28 days of study entry
* Presence of clinically evident active CNS metastases, including leptomeningeal involvement, requiring steroid or radiation therapy
Health Information Technology System ("Roadmap 2.0") in the Context of Hematopoietic Cell Transplantation

The purpose of this research study is to measure the effects of using a mobile phone app (Roadmap 2.0) on the health-related quality of life of caregivers and patients undergoing allogeneic/autologous hematopoietic cell transplantation (HCT).

Health information technology tools may enable caregivers and patients to become more active participants in their healthcare.This study is not to provide any treatment, but rather to investigate the use of this mobile health technology-mediated intervention (Roadmap 2.0). Roadmap 2.0 is a web-based application that integrates patient-specific information and includes several domains: laboratory results, medications, clinical trial details, photos of the healthcare team, trajectory of transplant process, and discharge checklist.

This trial is anticipated to enroll 664 participants, but only caregivers (332 total) will be evaluated for the primary and secondary outcome measures. Thus, the sample size is 332. The total enrollment includes 166 caregiver-patient dyads of adult patients (age \>/=18 years) undergoing HCT ("adult dyads" = 332 total) and 166 caregiver-patient dyads of pediatric patients (age 5-17 years) undergoing HCT ("pediatric dyads" = 332 total).

Eligibility Criteria:
Inclusion Criteria

* The caregiver must have an eligible patient (see below)
* The caregiver must be of age ≥18 years.
* The caregiver should be comfortable in reading and speaking English and signing informed consents.
* The caregiver should provide at least 50% of care needs.
* An eligible patient is one who identifies the eligible caregiver as their primary caregiver (i.e., provides at least 50% of care needs).
* An eligible patient is age ≥5 years.
* An eligible patient is scheduled to undergo HCT.
* An eligible patient is able to sign informed consent/assent forms.
* Patients and caregivers agree to provide informed consent that is in regulatory compliance and IRBMED-approved and also in accordance to institutional guidelines. A patient is able to undergo HCT at the U-M only if a designated family caregiver (e.g., parents, adult children, spouses, family members, neighbors, friends) accepts the roles, in accordance to the Clinical Practice Guidelines of the U-M BMT Program.
* The caregiver and patient must have his/her own smartphone to participate.

Exclusion Criteria

- Patient does not meet eligibility criteria to undergo HCT at the U-M BMT Program or Oregon Health \& Sciences University.
F18PET/CT Versus TC-MDP Scanning to Detect Bone Mets

The primary objective is to compare the diagnostic performance of 18F- Fluoride PET/CT scanning to that of conventional bone scanning for detecting cancer that has spread to the bone (bone metastasis). The intent of the study is to determine whether 18F-Fluoride PET/CT will lead to improved treatment and patient outcomes.

The trial will accrue four hundred-eighty eight (488) evaluable patients with breast cancer, prostate cancer or lung cancer (approximately 163 of each cancer type) referred for routine bone scanning by their respective physicians. The specific stages of cancer required for eligibility are described in the eligibility criteria.

Approximately eleven to fifteen qualified clinical centers will participate in the trial, with target enrollment for each site set at roughly 40-50 patients per site.

The images of the patients will be transmitted to ACR Image Metrix, an imaging contract research organization (iCRO), for quality assurance and archival. iCRO will conduct blinded core lab interpretations by 3 radiologists who have not been involved in the design of the trial nor the clinical image interpretation. The data from the core lab readings will be compared with the deliberations of a multidisciplinary panel of oncology experts who will be blinded to the initial scan results and will determine the standard of evidence (truth) for each patient. The analysis will be based on this comparison.

Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years old at the time of the drug administration (Patient may be male or female of any race / ethnicity.)
* Patient or patient's legally acceptable representative cognitively provides written informed consent
* Patients without known bone metastases who are newly diagnosed with ≥ stage 3 breast cancer, ≥ stage 3 lung cancer, or ≥ stage 2 prostate cancer (and/or PSA \>10 micrograms/L), including patient with recurrent breast, lung or prostate cancer
* Patient is scheduled to undergo a conventional bone scan
* Patient is capable of complying with study procedures
* Patient is able to remain still for duration of imaging procedure (about one hour)
* Patient may have had a prior PET or PET/CT scan for staging/restaging.

Exclusion Criteria:

* Patient is \< 18 years old at the time of the drug administration
* Patient is pregnant or nursing;

  * testing on site at the institution (urine or serum ßHCG) within 24 hours prior to the start of investigational product administration
  * obtaining surgical history (e.g., tubal ligation or hysterectomy)
  * confirming the subject is post menopausal, with a minimum 1 year without menses
* Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data
* Patient has known bone metastases
* Patient has previously received \[18F\]NaF in the last thirty days
Neuropathic Pain After Breast Surgery

To understand pain pathophysiology in terms of risk factors and protective mechanisms ranging from molecular pathways to societal impacts.

Pain and loss of function are intimately associated with the reaction of the nervous system to neural damage. A lesion to the somatosensory nervous system caused by mechanical trauma, metabolic disease, neurotoxic chemicals, infection or tumor invasion may give rise to neuropathic pain. Neuropathic pain affects around 8% of the population and may negatively impact the individual's quality of life; moreover, the condition leads to significant costs to the healthcare system and society. Not all subjects with such a lesion develop neuropathic pain, and those who do develop neuropathic pain have varying degrees of symptom severity, impact and outcomes and may respond unpredictably to treatment.

The interaction between genetics and environmental and clinical factors in a susceptible individual most likely contribute to the variation in pain prevalence and severity. A better understanding of the exact nature of these risk factors and their interactions will ultimately improve the patients' health, both in terms of recognizing patients at risk and identifying new treatment modalities.

Genetic, neurophysiological and psychological factors all influence the risk of developing persistent pain. It is therefore possible to describe a genetic, neurophysiological and psychological profile, in particular in patients experiencing neuropathic pain after surgery and/or neurotoxic chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for breast cancer resection performed via lumpectomy (partial or segmental mastectomy) or mastectomy with or without sentinel lymph node biopsy and axillary lymph node dissection, and any combinations hereof.
* Willingness and ability to comply with study procedures as judged by the site investigator/manager.
* Expected availability for follow-up throughout the study, i.e., \~12 months.
* Willingness to voluntarily sign and date the study-specific informed consent form.

Exclusion Criteria:

* Mental incapacity or language barriers precluding adequate understanding of study procedures.
* Current alcohol or substance abuse according to the site investigator's medical judgement.
* Unsuitability for participation in the study for any other reason, e.g. due to a significant serious underlying condition (e.g. other cancer or AIDS), as determined by the site investigator/manager.
Adherence to Palivizumab Prophylaxis

The goal of this clinical trial is to analyze implications of two alternative nudge-interventions to increase adherence to palivizumab prophylaxis in children with congenital heart disease. The main questions investigators aim to answer are:

* Are well-established cognitive biases effective in increasing patient families' adherence to the palivizumab prophylaxis program?
* What are the factors that affect families' adherence to the prophylaxis program and whether and how the effects of interventions depend on these factors?

To study these questions investigators planned to utilize four well-established cognitive biases in designing two alternative nudge-interventions and investigators measured the effectiveness of each nudge-intervention against a control group.

Patients were randomly allocated to one control and two treatment groups. In the control group, investigators informed participants about the prophylaxis program and provided a schedule. Patients in the first treatment group were additionally called two days before appointments (status quo bias), and were asked to plan the appointment day (implementation intention). Patients in the second treatment group received biweekly messages informing them about the benefits of the program as well as the current adherence rate (availability bias and social norm).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of congenital heart disease which are hemodynamically unstable, congestive heart failure, diagnosis of congenital heart disease with hemodynamically significant residual defects after corrective heart surgery, cardiomyopathy, pulmonary hypertension
* Being between 0-2 years of age

Exclusion Criteria:

* Diagnosis of congenital heart disease in which palivizumab prophylaxis is not needed (the diagnosis of congenital heart diseases which are hemodinamically stable.)
* Becoming exitus during prophylaxis program
* Not being between 0-2 years of age