cyrilzakka/clinical-trials huggingface dataset:
CT Perfusion Images in Assessing Treatment Response in Patients With Pancreatic Cancer

This pilot clinical trial studies how well computed tomography (CT) perfusion images work in assessing treatment response in patients with pancreatic cancer. Analyzing specific measurements on the CT perfusion images may help doctors better determine how a tumor responds to chemotherapy and/or radiation therapy and may help guide treatment for patients with pancreatic cancer.

OUTLINE:

Patients undergo CT perfusion sequence during the first 40 seconds of the baseline standard of care CT scan and during follow-up CT scans at 2 and possibly 4 months after chemotherapy, at 4-6 weeks after radiation therapy, or prior to definitive surgery.

After completion of the study, patients are followed up periodically for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* A diagnosis of pancreatic ductal adenocarcinoma

Exclusion Criteria:

* Patients unable to provide informed consent
* Women who are pregnant or intending to become pregnant during the study
* Patients with body mass index greater than 40 kg/m\^2
* History of severe allergic-like reaction to iodinated contrast media
Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia

The purpose of this study is to evaluate the efficacy and safety of parsaclisib compared with placebo in participants with Primary Warm Autoimmune Hemolytic Anemia (wAIHA),

Prospective participants must have primary wAIHA as well as other protocol-defined criteria. After participants have been determined to be eligible for the study, they will be randomized to 2:1, with stratification factor of corticosteroid dose and hemoglobin (Hgb \<9 g/dL or ≥ 9 g/dL). Once a participant has completed the week 24 assessments in the double-blind period, the participant will have the opportunity to receive parsaclisib in the open-label treatment which will last up to another 24 weeks. Participants may then continue to receive parsaclisib in a long-term extension period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary warm AIHA.
* Participants who have at least 1 unsuccessful prior therapy for warm AIHA or unable to receive or tolerate other therapies.
* Hemoglobin ≥ 6.5 to \< 10 g/dL with symptoms of anemia at screening.
* FACIT-F score ≤ 43 at screening.
* Willingness to avoid pregnancy or fathering children.
* Willingness to receive PJP prophylaxis.
* Further inclusion criteria apply.

Exclusion Criteria:

* Women who are pregnant, breastfeeding or who are planning a pregnancy.
* Diagnosis of other types of AIHA (CAD, cold agglutinin syndrome, mixed-type AIHA or paroxysmal cold hemoglobinuria).
* Secondary warm AIHA from any cause or diagnosis of Evans syndrome.
* Splenectomy less than 3 months before randomization.
* Participants with a history or ongoing significant illness as assessed by the investigator.
* Participants with a current of medical history of a malignancy within the past 5 years except basal or squamous cell skin cancer that has been removed and considered cured, or superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.
* Participants know to be infected with HIV, Hepatitis B, or hepatitis C.
* Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment or exposure to a live vaccine.
* Participants with laboratory values outside of the protocol defined ranges.
* Further exclusion criteria apply.
BioFreedom French Registry

Prospective, observational multi-center registry to be conducted at up to 25 French interventional cardiology centers. Patients will be eligible once they have received at least one BioFreedomTM DCS as per standard clinical practice and will be followed for up to 2 years post PCI for data collection.

The purpose of the registry is to explore the safety and effectiveness of the BioFreedomTM DCS in standard clinical practice in France and to serve as part of Post Market Surveillance.

Prospective, observational multi-center registry to be conducted at up to 25 French interventional cardiology centers. Patients will be eligible once they have received at least one BioFreedomTM DCS as per standard clinical practice and will be followed for up to 2 years post PCI for data collection.

The registry will be purely observational and will not interfere with physician's decisions relating to stent selection or indication for treatment.

The purpose of the registry is to explore the safety and effectiveness of the BioFreedomTM DCS in standard clinical practice in France and to serve as part of Post Market Surveillance.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with one or more BioFreedom™ DCS .Patients who agree to comply with the follow up requirements. .Patients with a life expectancy of \> 1 year at time of consent. .Patients eligible to receive dual anti platelet therapy (DAPT).
* Patients who have signed an Informed Consent

Exclusion Criteria:

* Patients unable or unwilling to give documented informed consent
* Patients taking part in another interventional trial which has not completed follow-up for the primary endpoint .Patient has received an additional stent different from a BioFreedom™ DCS stent during the index procedure.
* Pregnant or breastfeeding women
* Planned surgery within 6 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri surgical period for non HBR patients
* Planned surgery within 1 month of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri surgical period for HBR patients
* Patients under judicial protection, tutorship or curatorship
Promoting Increases in Living Donation Via Tele-navigation (PILOT)

We hypothesize that expansion of the Living Donor Navigator (LDN) program to include tele-health delivery will overcome geographic disparities in access and facilitate sustained increases in living donation. We will utilize an individually randomized group trial (IRGT) design with delayed intervention initiation to compare the effectiveness of tele-health LDN model to standard of care.

Transplant candidate-related and potential living donor-related factors, including difficulty asking family/friends to donate on one's behalf and lack of knowledge about the donation process, respectively, have been implicated in lower donation rates. The investigators will conduct an individually randomized group trial (IRGT) with delayed intervention initiation allowing for: (1) scalability/ implementation in a less resource-intensive fashion compared to traditional randomized trials; (2) Avoid self-selection bias as all participants ultimately participate in the intervention. The LDN Program combines advocacy-training to overcome barriers in initiating conversations with and identification of potential living donors with the use of non-clinical navigators to guide donors through the evaluation process. Participants will be randomized to one of two arms; Arm 1 includes the LDN program via in-person modality, and Arm 2 includes the LDN program via tele-health modality. The investigators primary objective is to demonstrate the effectiveness of these interventions in increasing living donation.

Eligibility Criteria:
Inclusion Criteria:

* End-stage kidney disease (ESKD) patients who are ≥ 18 years old and have initiated evaluation for kidney transplantation.
* If there is an individual willing to donate, but the candidate is unwilling to consider this option or this particular individual, the candidate is eligible for the study and may still benefit from identification of new donors or increased comfort accepting donation from others.
* Candidates must be English-speaking or deaf with an interpreter.

Exclusion Criteria:

* Individuals under the age of 18 will be excluded from the study.
* Individuals who are not English speaking will be excluded from the study.
Factors Associated With Pain During Unsedated Colonoscopy

Colonoscopy is the gold standard in the diagnosis and treatment colorectal disease, but due to the uncomfortable or even painful procedure, a part of people unwilling to undergoing the examination and giving analgesic agents were recommended in several guidelines. However, use of analgesic agents have their own drawbacks, and nearly 70% patients felt no pain or only mild discomfort with the unsedated colonoscopy, routine administration of sedative or analgesic agents to all patients was considered as unnecessary. However, unsedated colonoscopy was thought to be an option for some but not for all, therefore a method to identify which patients at high risk for painful colonoscopy in preoperational stage is necessary.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-80 years
* underwent unsedated colonoscopy

Exclusion Criteria:

* no bowel preparation or colon cleansing by enema only
* no need to reach cecum
* prior finding of severe colon stenosis or obstructing tumor
* history of colectomy
* unstable hemodynamics
* pregnant
* unable to give informed consent.
Percutaneous Dilatation Tracheostomy, Broncoscopy, Pro-seal Laryngeal Mask

In this study, our primary goal is to compare whether there is any difference in the complication of using pro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure. Our secondary goal is to compare in terms of processing time.

Following the approval of Muğla Sıtkı Koçman University Clinical Research Ethics Committee, 61 cases over the age of 18 who were scheduled for elective percutaneous dilatation tracheostomy in intensive care units were included in the study.

Elective percutaneous dilatation tracheostomy cases were randomly divided into two groups. Group 1 was determined as endotracheal tube and group 2 as pro-seal laryngeal mask group.

In the endotracheal tube group, which is a conventional method, after entering the trachea with percutaneous technique, the intubation tube was removed before dilatation and percutaneous dilatation tracheostomy was performed with the Seldinger method.

In the pro-seal laryngeal mask group, the fiberoptic bronchoscope was advanced with a pro-seal laryngeal mask, and after the correct position was achieved, percutaneous dilatation tracheostomy was performed using the Seldinger Method.

Arterial blood pressure, oxygen saturation, heart rate, arterial blood gas, mechanical ventilation mode, positive end expiratory pressure and mean airway pressure values were recorded before and 30 minutes after the procedure.

The time until the end of the procedure and complications were determined.

Eligibility Criteria:
Inclusion Criteria:hospitalized in intensive care units of our hospital and planned for elective percutaneous dilatation tracheostomy were included in the study.

-

Exclusion Criteria:

* history of cervical trauma,
* high-pressure mechanical ventilation (inspiratory pressure above 40 cmH2O),
* pulmonary edema,
* acute respiratory distress
Bacterial Contamination of Healthcare Worker Uniforms

Healthcare worker uniforms are frequently contaminated with bacteria known to cause infections in humans. These bacteria are acquired during the workday. A new technology of antimicrobial textiles have been developed and incorporated into the fabric of health care worker uniforms, reportedly with effectiveness rates of \> 99% but there is little literature describing the effectiveness of Healthcare worker (HCW) uniforms with antimicrobial properties in the clinical setting. Because of the potential benefit that such uniforms could offer HCWs and patients alike, further investigation into whether these fabrics are effective is warranted.

Up to 140 physicians, nurses, and midlevel providers who work at Denver Health on the general internal medicine wards will be invited to participate in this study. Participants will be randomized to wear either uniforms (scrubs) that have antimicrobial properties or standard scrubs provided by the hospital. At the end of an 8-hour workday, three areas on each uniform and each subject's wrist area will be cultured to assess for total bacterial colonization as well as for various resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and resistant gram-negative rods.

Primary Hypothesis: HCW uniforms with antimicrobial properties will have less bacterial contamination than standard uniforms (scrubs) at the end of an 8-hour workday.

Specific aim 1a. Demonstrate that antimicrobial uniforms will have less total bacterial contamination of sites swabbed compared to standard uniform after an 8-hour workday.

Specific aim 1b. Demonstrate that antimicrobial uniforms will have less antimicrobial-resistant bacterial contamination (specifically looking for MRSA, VRE, and resistant gram negatives) of sites swabbed compared to standard uniform after an 8-hour workday.


Eligibility Criteria:
Inclusion Criteria:

* Physicians, nurses, and midlevel providers who work at Denver Health on the general internal medicine wards;
* Provider must be available for cultures at the end of the day, provider must be on service at Denver
* Health for the duration of the study, provider must be willing to avoid wearing white coats

Exclusion Criteria:

* Refusal to participate
* Known to be pregnant
Peers for Promoting Adolescent Transplant Health

Adolescents with solid organ transplants have poorer outcomes than adults, and do not respond as well to post-rejection treatment. In addition to well-recognized declines in individual health-related quality of life, premature graft loss creates considerable health and economic burdens. High nonadherence rates among adolescents are believed to contribute majorly to rejection, premature allograft dysfunction and failure. Studies suggest that a telephone-based peer mentoring approach, with texting and e-communication, is a promising, practical means to promote medication adherence in adolescent solid organ transplant recipients. The study's main objectives are 1) to determine the efficacy of peer mentoring to improve medication adherence and health-related quality of life vs. usual care in adolescents and young adults with solid organ transplants, and 2) to determine the mechanisms through which peer mentoring impacts medication adherence and health-related quality of life.

The investigators will conduct a single-center Phase II randomized clinical trial in which adolescents ages 14-23 and greater 3 months post solid organ transplant will receive either a peer mentor or usual care. The investigators will assess changes in quality of life from baseline to one year post-study entry. The investigators will also examine adherence changes over the same time frame using pharmacy refill data and a questionnaire. Peer mentors will provide social support and promote subject self-efficacy primarily via e-communication. Changes in social support and self-efficacy will be measured over a one-year period.

Eligibility Criteria:
Inclusion Criteria:

* Males or females age 14 to 23 years
* Greater than one year post kidney, heart or liver transplant
* Able to speak and read in English
* Willing and able to provide informed consent or assent
* Parental guardian permission (informed consent) if appropriate

Exclusion Criteria:

* Unwilling to participate
* Unable to speak or read in English
* Unable to provide informed assent or consent
* Estimated glomerular filtration rate (eGFR) less than 20 ml/min/1.73m\^2
* On dialysis
* Less than three months post transplant
* Post-transplant lymphoproliferative disease
External Oblique Intercostal Plane Block Versus Subcostal Transversus Abdominis Plane Block in Supra-umbilical Surgical Incisions

Various newer techniques have been proposed to enhance analgesia in upper abdominal region. The subcostal transverse abdominis plane (SCTAP) block is the deposition of local anesthetic in the transverse abdominis plane inferior and parallel to the costal margin. There is a growing consensus that the SCTAP block provides better analgesia for upper abdominal incisions than the traditional transverse abdominis plane block.

The External oblique intercostal plane (EOIP) block is a novel technique reported by Hamilton et al. performed EOPB by administering LA superior or deep of the external oblique muscle from the sixth intercostal space leading to the blockage of thoracoabdominal nerves at T6-T10. It has several attractive aspects such as easy sono-anatomy ribs one strip of muscle so easy to demonstrate even in obese patients, there is a bony backstop, easy expandable fascial plane that can accommodate a catheter and it is shallow block with no big vessels nearby.


Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status grade I -II,
2. Scheduled to undergo elective supra-umbilical surgeries under GA (epigastric herniotomy- gastrectomy- open cholecystectomy- nephrectomy).

Exclusion Criteria:

1. Allergy to local anesthetics,
2. Infection at the site of injection,
3. Coagulopathy,
4. Chronic pain syndromes,
5. Prolonged opioid medication,
6. Patients who received any analgesic 24 h before surgery.
7. Chronic liver disease, chronic renal disease, and cognitive impairment.
Vitamin D Supplementation in Patients With COVID-19

Coronavirus disease 2019 (COVID-19) was declared an emergency public health problem by the World Health Organization (WHO) in March 2020. Since then, several initiatives by the medical and scientific community have sought alternatives to treat infected individuals, as well as identifying risk or protective factors for the contamination and prognosis of patients. In this perspective, vitamin D supplementation can improve some important outcomes in critically ill patients, being considered a potent immunomodulatory agent. Vitamin D deficiency is a common outcome in critically ill patients, thus making it a modifiable risk factor with great potential for reducing hospital stay and intensive care and mortality. The investigators speculate that vitamin D supplementation could have therapeutic effects in patients with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of flu syndrome with hospitalization criteria;
* Respiratory rate ≥ 24irpm and / or saturation \<93% in room air, or belonging to the risk group for complications: 1. Chronic diseases: heart disease, diabetes mellitus, systemic arterial hypertension and neoplasms, 2. Immunosuppression, 3. Pulmonary tuberculosis; 4. Obesity;
* Tomographic findings compatible with coronavirus disease.

Exclusion Criteria:

* Patient admitted already under invasive mechanical ventilation;
* Patient admitted with severe acute respiratory syndrome and diagnosed with an etiologic agent other than SARS-CoV-2;
* Prior vitamin D supplementation (above 1000 IU/day);
* Renal failure requiring dialysis or creatinine ≥ 2.0mg/dl;
* Admitted patients with expected hospital discharge in less than 24 hours;
* Patient unable to sign the consent form.
Is Ejaculation Preservation TURis the Natural Evolution of the "Gold Standard".

evaluation of the impact of apical urethral mucosa sparring with the urethra around the verumontanum on the ejaculatory function and early postoperative urinary incontinence

Benign Prostatic Hyperplasia (BPH) is a common disease in elderly men and transurethral resection of the prostate (TURP) is still the gold standard for the treatment of BPH However, postoperative urinary incontinence (UI) and retrograde ejaculation are of the common complications and its incidence is nearly 2% of UI UI brings great suffering to patients and its unpredictability and uncertainty in the recovery period cause significant pressure to surgeons. External urethral sphincter damage is the main reason for UI after prostatectomy. The treatment of postoperative UI and post operative retrograde ejaculation has also become an important issue for many years. Along with the progress of technology, there have been various methods of transurethral resection of the prostate but no method has been found to adequately avoid the occurrence of UI and retrograde ejaculation

Eligibility Criteria:
Our inclusion criteria were preidentified to those who complained of voiding lower urinary tract symptoms (LUTS) and scheduled for TURP with prostate size less than 100 gm. This included patients with refractory retention, recurrent gross hematuria of prostatic origin, non-compliance to medical treatment, recurrent infection, and patients with bladder calculi secondary to obstruction. Exclusion criteria were: patients with neurogenic bladder, detrusor hypo-contractility, Diabetes more than 10 years, urethral stricture, or previous prostatic surgeries.
Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

This is a randomized, controlled clinical trial at three sites to determine the safety and preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8). It is hypothesized that the drug may lower pressure in the brain, reduce mortality and the patient may have improved neurological function following treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis TBI
* GCS 4-8
* Age 16-70

Exclusion Criteria:

* Multiple trauma resulting in shock
* Bilateral absent pupil response
* Time from injury \> 6 hours
* Brain tumor or mass effect secondary to hemorrhage or brain surgery
* Pregnancy
* Confounding condition or injury
* Spinal cord injury
* Sustained high blood pressure or arterial oxygen saturation
Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride

This study will evaluate and compare the effect of the amount of toothpaste used and brushing time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel fluoride uptake (EFU).


Eligibility Criteria:
Inclusion Criteria:

General and Dental Health

* Good general and dental health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination
* Have no current active caries or periodontal disease that may compromise the study or the health of the subjects
* Residency: Currently living in the Indianapolis, Indiana area

Dentures:

* Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 mm x 7 mm)
* Willing to have their denture modified to accommodate enamel test specimens and willing and capable of wearing their removable mandibular partial dentures 24 hours per day during the experimental periods
* All restorations in a good state of repair
* Salivary Flow: Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/minute; gum base stimulated whole saliva flow rate ≥ 0.8 mL/minute)

Exclusion Criteria:

* Antibiotics: Use of antibiotics two weeks prior to a treatment visit or anticipated use during the study treatment periods
* Study Scale Use: Subjects unable to measure product weights accurately using the assigned study scale as determined by the study staff (as demonstrated on or before Visit 4)
* A member of the site study staff who is directly working on the project or living in that staff's household
* Any employee of any toothpaste manufacturer or their spouse or family member