cyrilzakka/clinical-trials huggingface dataset:
Duplex Ultrasonography Performed by Nurses

Catheter-related thrombosis (CRT) has been found as the major complication of the established central venous catheter in intensive care unit (ICU) patients. Its reported incidence varies from 5 to 66 %. Although most cases are asymptomatic, in up to 10 - 15 % of the patients pulmonary embolism occurs. In addition, CRT is associated with the risk of infection, post-thrombotic syndrome and with general disruption of the management of the underlying disease. The most accessible diagnostic method for CRT recognition is duplex ultrasonography. However, screening of CRT by duplex ultrasonography is not common approach in ICUs. Normally, duplex ultrasonography is performed by physicians. In this setting, implementation of the screening in ICU would be time consuming and practically unrealizable. Delegating this competence to ICU nurses can increase availability of this screening method.

Therefore, as a first step, investigators decided to perform a validation clinical study to verify the diagnostic accuracy of duplex ultrasonography of the venous system for CRT screening performed by a general nurse.

Approximately 150 patients with central venous catheter will be enrolled in this study.

Investigators:

1. General nurses - trained and able to perform duplex ultrasonography examination of venous circulation
2. Doctors - experienced specialists in intensive care or urgent medicine

Every patient with central venous catheter enrolled in clinical study is examined with duplex ultrasonography within 24 hours by both investigators, doctor and nurse. Each examination includes ultrasonography of a whole vena cava venous system with central venous catheter, bilaterally. Results of both examinations are blinded until the end of study, with one exception. In case of positive result - catheter related thrombosis is present, investigator ( nurse )informs patients attending physician.

Results of investigations are recorded in Investigation Form with some other routine medical data.

Timetable:

18.3.2019 - 30.6.2020: Enrolling, collection of data 1.7.2020 - 30.9.2020: Finalization od database, statistic analysis 1.10.2020 - 31.1.2021: Preparation of publications 1.2. 2021 - 31.12.2021: Result presentation

Eligibility Criteria:
Inclusion Criteria:

* central venous catheter more than 48 hours in situ
* consent of a patient

Exclusion Criteria:

* technical difficulties of ultrasound machine
* unfavorable local findings - inflammation of skin, excoriation etc.
Tesetaxel as Second-line Therapy for Patients With Advanced Melanoma and Normal Serum LDH

Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line therapy to patients with advanced melanoma and normal serum lactate dehydrogenase (LDH).


Eligibility Criteria:
Primary inclusion criteria:

* Histologically confirmed diagnosis of melanoma
* Progressive disease that is not surgically resectable, or metastatic Stage IV disease
* Measurable disease (revised RECIST; Version 1.1)
* Serum LDH not more than 1.1 times the upper limit of normal
* Eastern Cooperative Oncology Group performance status 0 or 1
* Treatment with 1 prior regimen (including cytotoxic chemotherapy, immunotherapy, radiation therapy, or cytokine, biologic, or vaccine therapy) as first-line treatment for metastatic disease (Administration of interleukin-2 or interferon as adjuvant therapy is allowed and is not to be considered in determining the 1 prior treatment regimen administered as first-line treatment for metastatic disease.)
* Adequate bone marrow, hepatic, and renal function, as specified in the protocol
* At least 3 weeks and recovery from effects of prior surgery or other therapy with an approved or investigational agent
* Ability to swallow an oral solid-dosage form of medication

Primary exclusion criteria:

* History or presence of brain metastasis or leptomeningeal disease
* Primary ocular or mucosal melanoma
* Significant medical disease other than cancer
* Organ allograft
* Presence of neuropathy \> Grade 1 (National Cancer Institute Common Toxicity Criteria \[NCI CTC\]; Version 4.0)
* Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid
* Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
Chemotherapy-induced Cognitive Alterations in Recruits With Ovarian and Breast Cancer

Neurotoxic phenomena are among the most common and difficult to treat side effects of chemotherapy. The development of chemotherapy induced peripheral neuropathy (CIPN) is a well-recognized adverse reaction in the peripheral nervous system. Side effects of chemotherapy in the central nervous system, however, particularly changes of cognitive function (in non-medical literature referred to as "chemobrain") are diffuse and difficult to attribute to individual cytostatic drugs. The primary purpose of this study is to assess cognitive function in patients with ovarian and breast cancer before and after systemic chemotherapy with paclitaxel with standardized neuropsychological tests and compare the outcome to patients with benign gynecological tumors and breast cancer without chemotherapy treatment, respectively. Secondary parameters include the assessment of olfactory function, total neuropathy score and cytokine profiles.

Primary outcome parameter:

compound score of standardized neuropsychological test

Secondary parameters:

* olfactory function (Sniffin Sticks)
* total neuropathy score (TNS), reduced version (clinical examination, neurography of sural and peroneal nerve)
* cytokine profiling from serum samples (ELISA)
* quality of life (questionnaire)
* depression screening (questionnaire)
* symptoms of polyneuropathy (questionnaire)
* symptoms of cognitive impairment (everyday memory test questionnaire)

Assessment time points:

* baseline (after surgical tumor resection and before chemotherapy)
* follow up 1 (3 weeks after last chemotherapy cycle or 21 weeks (control patients))
* follow up 2 (optional; 1 year after chemotherapy completion)

Eligibility Criteria:
Inclusion Criteria:

* age
* written informed consent
* Karnofsky index \>70% / ECOG \<1
* at least 8 years of education

Exclusion Criteria:

* post surgical delirium
* major depression
* alcohol or drug abuse
* anemia \< 8 g/dl
* mild cognitive impairment or dementia
* previous neurotoxic chemotherapy treatment
Tailoring Shared Decision Making for Lung Cancer Screening in Persons Living With HIV

This study tailors a shared decision making intervention for lung cancer screening in persons living with human immunodeficiency virus (HIV). Information collected in this study may help doctors better understand how to perform lung cancer screening in persons living with HIV, so as to enhance shared decision making in persons living with HIV.

OUTLINE:

AIM I: Participants attend a focus group over 1-1.5 hours providing feedback on refining potential methods of shared decision making (SDM).

AIM II: Participants receive the SDM intervention developed in Aim I and provide feedback. Participants may attend a telephone interview over 45 minutes 1 month later.

Eligibility Criteria:
Inclusion Criteria:

* AIM I: Patients with human immunodeficiency virus (PWH) enrolled in the local UW HIV cohort and primary providers at Madison Clinic and other Seattle-based clinics serving PWH
* AIM I: Using proposed United States Preventive Services Task Force (USPSTF) guidelines, participants enrolled in the registry who are current or former smokers, report \>= 20 pack-years smoking history, and \>= 50 years old (n=165) will be eligible for recruitment
* AIM I: Clinicians (medical doctors, physicians assistants and nurse practitioners) who provide primary care for PWH (n=48) will be eligible
* AIM II: PWH who are eligible for lung cancer screening (LCS) based on proposed USPSTF criteria

Exclusion Criteria:

* Those found to be ineligible for LCS on coordinator review
* Are non-English speaking or have cognitive dysfunction that would prevent participation in SDM
A Study of the Treatment of Disitamab Vedotin in Patients With Locally Advanced or Metastatic Pancreatic Cancer

This is a phase 2 clinical study,to explore the efficacy and safety of Disitamab Vedotin in patients with locally advanced or metastatic pancreatic cancer expressing HER2.

63 patients with locally advanced or metastatic pancreatic cancer will participate in this study. HER2 expression in locally advanced or metastatic pancreatic cancer patients is defined as the expression of HER2 in tumor tissues detected by immunohistochemistry (IHC) as IHC 1+, 2+, or 3+. The arm 1 recruits 43 patients and the arm 2 recruits 20 patients.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age: 18 (inclusive) or above, regardless of gender.
* 2. histologically or cytologically confirmed patients with locally advanced or metastatic pancreatic cancer who cannot undergo radical surgery
* 3. HER2 expressing(Immunohistochemical IHC 1+,2+ or 3+)
* 4. Number of treatment lines: Cohort 1: Prior first-line gemcitabine-free regimen or intolerant to gemcitabine-containing regimen; Cohort 2: Previous treatment with second-line standard or intolerance
* 5. Patients who have previously received neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy or chemoradiotherapy for the purpose of curing non-metastatic disease must have a disease-free interval of 6 months from the last chemotherapy and/or radiotherapy to the random date
* 6. There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline.
* 7. ECOG fitness status score: 0 or 1 point.
* 8. Estimated survival time ≥ 3 months.
* 9. Adequate organ function.
* 10. Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
* 11. Voluntary agreement to provide written informed consent.

Exclusion Criteria:

* 1. Central nervous system metastasis or meningeal metastasis with clinical symptoms.
* 2. Have a history of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
* 3. Active hepatitis B (hepatitis B virus titer\>1000 copies/ml or 200 IU/ml); Hepatitis C virus and syphilis infection.
* 4. Have undergone major organ surgery (excluding puncture biopsy) or have experienced significant trauma within 3 weeks before the first use of the study drug.
* 5. Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.
* 6. Strong inducers and inhibitors of P-gp, a strong or moderate inducer of CYP3A4, used within 14 days prior to the first use of the study drug
Feasibility of Positive Links for Youth Care Engagement Intervention

A small pilot study to assess feasibility and acceptability of the PL4Y intervention.

After completing enrollment and informed consent, participants will be randomly assigned to PL4Y in a 2:1 fashion (intervention:control) with a target enrollment of 40 receiving the intervention and 20 in the control arm for a total of 60 participants. There is no blinding in this study protocol.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV infection
* Recent diagnosis of HIV (within the past 6 months) OR be virologically unsuppressed (\>1000 copies/ml) OR disengaged from HIV care (\< 2 visits/last 12 months \> 90 days apart)

Exclusion Criteria:

* Cannot consent
* Unwilling to come to visits
* Unwilling to be in San Antonio for a year
Évaluation de l'Impact du Compressed Sensing Sur le Signal QSM

Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which a maximum of four additional 25-minute sequences will be added.

MRI of routine care includes at least the following sequences:

* 3D T1 TFE (2 minutes)
* T2 TSE (2 minutes)
* 3D FLAIR (3 minutes)

The sequences added by the research lasting 25 minutes are:

* SWI QSM 1.0iso 8 echoes (10 minutes)
* SWI QSM 1.0iso 8 echoes CS 6 (7 minutes)
* SWI QSM 1.0iso 8 echoes CS 9 (5 minutes)
* SWI QSM 1.0iso 8 echoes CS 12 (3 minutes)

Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which a maximum of four additional 25-minute sequences will be added.

MRI of routine care includes at least the following sequences:

* 3D T1 TFE (2 minutes)
* T2 TSE (2 minutes)
* 3D FLAIR (3 minutes)

The sequences added by the research lasting 25 minutes are:

* SWI QSM 1.0iso 8 echoes (10 minutes)
* SWI QSM 1.0iso 8 echoes CS 6 (7 minutes)
* SWI QSM 1.0iso 8 echoes CS 9 (5 minutes)
* SWI QSM 1.0iso 8 echoes CS 12 (3 minutes)

Eligibility Criteria:
Inclusion Criteria:

For patients with MS:

* Patient over 18 years old
* Presenting MS defined according to McDonald's revised criteria for spatial and temporal clinical or radiological dissemination \[16\],
* Should benefit as part of the care of an MRI examination with or without injection of gadolinium
* Express consent to participate in the study
* Affiliate or beneficiary of a social security scheme

For patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS disease:

* Patient over 18 years old
* Should benefit as part of the care of an MRI examination with or without injection of gadolinium
* Express consent to participate in the study
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* For patients with MS:
* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman

For patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS disease:

* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman
* Patient with inflammatory and / or demyelinating pathology of the CNS

Secondary exclusion criteria :

* Motion artefact not allowing interpretation of images
* Patient who did not perform one of the following sequences: 3D T1 TFE, 3D FLAIR (for MS patients), SWI QSM 1.0iso 8 echoes.

Secondarily excluded patients will be replaced.
Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum

A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.

This study will be performed at two sites and two-hundred and fifty (250) healthy male and female subjects will be included. Treatments comprise single doses of an experimental Nicotine Replacement Therapy (NRT) and Nicorette Freshfruit gum 4 mg, which are chewed during 30 minutes. All subjects will be given both treatments in a crossover setting. The length of the time interval separating treatment visits, and during which no NRT must be used, will be at least 36 hours.

The subjects will abstain from smoking from 8 pm the evening before until the end of each visit. The subjects will take the gums according to instructions from the study personnel. After chewing, used gums will be collected for nicotine analysis.

Electronic diaries will be used to collect data. Urges to smoke will be scored on a 100 mm visual analogue scale (VAS) before the start of treatment and during 5 hours thereafter. Subjects will also be monitored to capture any adverse events that may occur.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, smoking more than 20 cigarettes daily during at least one year preceding inclusion.
* Body Mass Index (BMI) between 17.5 and 32.0 kg/m2 and a total body weight of at least 55.0 kg.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product within one month preceding the first dose of study medication.
Interactive Program for Effective Playground Supervision

The goal of the Playground supervision clinical trial is to see if playground management skills are improved, after implementing the school-wide behavior management program.

The Center for Disease Control and Prevention (CDC) reports that over 200,000 children every year are admitted to emergency rooms due to playground related injuries sustained at school. The National Association for Playground Safety recommends not only improving surface materials and equipment, but also improving adult supervision of children while at play. Yet, there are limited empirical studies in the literature that have examined the impact of a comprehensive training program to improve playground safety by improving supervisor knowledge and attitudes. The purpose of this study was to evaluate the efficacy of a comprehensive, stand-alone interactive multimedia computer-based training program for elementary school faculty to implement a school-wide behavior management program for playground environments. To do this, a randomized control trial comparing the experiences of playground supervisors, students, and staff from schools of a large urban school district was carried out. School was both the unit of randomization and the unit of analysis. The comparisons were measured by pre, post and follow-up assessments conducted by the investigators. Results suggest significant positive differences due to treatment in knowledge, beliefs and attitudes for playground supervisors, students, and staff.

Eligibility Criteria:
Inclusion Criteria:

* school staff in elementary schools (grades K-5)
* must be in the included school district for Las Vegas, NV.

Exclusion Criteria:

* schools outside of the Las Vegas school district
* middle schools
* junior high schools
* high schools
TextFluenza: Using Technology To Promote Flu Vaccination In Underserved Maternal And Child Populations

The Advisory Committee on Immunization Practices (ACIP)recommends that the flu vaccine be administered annually to all children aged 6 months to 18 years as well as women who are pregnant during the influenza season. Nevertheless, targeting and mobilizing these populations has been difficult and influenza immunization rates nationwide remain low. Immunization reminder-recalls have been shown to be effective, but have had limited ability to rapidly identify and reach large target populations in a cost-effective manner. Evidence on how to optimally design these systems is not yet available and thus text message immunization alerts have not been widely implemented. The investigators propose to implement and evaluate tailored, targeted influenza text message reminders in urban pediatric and pregnant populations.


Eligibility Criteria:
Inclusion criteria Parents (2010-2011 and 2011-2012 influenza seasons)

* Children aged 6 months to 18 years at the beginning of current influenza season
* Children with one previous visit at participating pediatric community health center in last year
* Parent with cell phone number in registry

Pregnant women Pilot (2010-2011 influenza seasons)

* Pregnant women who will be in their 2nd or 3rd trimester during the influenza season
* Own a cell phone with text message capability

Randomized controlled Trial (2011-2012 influenza seasons)

* Pregnant and will be in their 2nd or 3rd trimester during the influenza season
* Cell phone number in registry
Feasibility of Holmium-166 Micro Brachytherapy in Head and Neck Tumors

The main objective is to establish the feasibility of 166-Holmium microspheres for intratumoral injections in oral squamous cell carcinoma (OSCC) of the tongue.

Participants will receive intratumoral injections with a low radioactive 166-Holmium microspheres followed by surgical resection

166-Holmium microspheres poly lactic acid microspheres are currently used in selective internal radiation therapy. These microspheres emits beta radiation. The majority of the radiation dose will be absorbed within 3.2 mm with a maximum penetration in tissue of 9 mm. Therefore this can result in a high local tumor ablative dose with minimal dose to healthy adjacent tissue.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have given written informed consent.
2. Aged 18 years and over.
3. Confirmed histological diagnosis of squamous cell carcinoma of the tongue.
4. primary tumor, regional nodes, metastasis (TNM) stage T1-2 Nx M0.
5. Eligible for local surgery with curative intent.
6. World Health Organization (WHO) Performance status 0-2.

Exclusion Criteria:

1. Previous oncologic surgery and/or external beam radiation therapy on the tongue and oral floor.
2. Major surgery (Oro-facial) within the past 4 weeks or incompletely healed surgical incisions before starting study therapy.
3. Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.03) grade 2 from previous anti-cancer therapy.
4. Pregnancy or nursing (women of child-bearing potential).
5. Patients suffering from psychic disorders that make a comprehensive judgment impossible, such as psychosis, hallucinations and/or depression.
6. Previous enrolment in the present study.
A Cosmetic Study to Measure the Change in Tooth Colour After Using Instant Whitening Prototypes Compared to a Negative Control

This will be a double blind, randomised, four-group crossover study. This study will involve 5 visits to the study site, with a wash-out period of 1 week between visits. Visit 1 will be for screening, participants who meet inclusion and exclusion criteria (including having Vita shade score of 2M2, 3R1.5, 2R2.5, 3L1.5, 2L2.5, 4M1, 2M3, 3M2, 4R1.5, 4L1.5, 3L2.5, 3R2.5, 5M1, 4M2, 3M3 from VITA 3D-MASTER Shade Guide) will be accepted onto the study. At each test visit (visit 2 - 5), participants will have images taken of their front upper incisors using a a Video-based Digital Imaging System (VDIS) pre- and post-brushing with randomly allocated test or control toothpaste \[1.5g for 90 seconds, followed by water rinse\]. The digital images will be analysed using the VDIS image analysis software and the mean CIELAB and WIO of the upper central incisors will be obtained.


Eligibility Criteria:
Inclusion Criteria:

* Two upper central incisors must be natural.
* The two upper central incisors must be within the colours of 2M2, 3R1.5, 2R2.5, 3L1.5, 2L2.5, 4M1, 2M3, 3M2, 4R1.5, 4L1.5, 3L2.5, 3R2.5, 5M1, 4M2, 3M3 from VITA 3D-MASTER Shade Guide.
* The two upper central incisors must be free of intrinsic stain e.g. caused by tetracycline, fluorosis etc.
* The two upper central incisors must be extrinsic stain free.
* Willing to sign an informed consent form and complete a medical history questionnaire.

Exclusion Criteria:

* Two upper central incisors have any caps, crowns, veneers or cracks in the teeth, have excessive gum recession, or have restorations on the distal, mesial, buccal, incisor edge in the opinion of the dentist and technician.
* Smoker (including e-cigarettes) or chews tobacco.
* Are diabetic
* Currently pregnant or breast feeding.
* Currently having orthodontics bands, partial removable dentures.
* Currently experiencing severe oral problems such as untreated caries, gingivitis or periodontal disease.
* Regular use of medication, which in the opinion of the study dentist, could interfere with study objectives.
* Known allergies to the toothpaste ingredients or to any dental materials.
* Use of tooth bleaching products in the past 6 months.
* Have been using whitening oral care products in the last 12 weeks or had a scale and polish in the last 3 months.
* Have or have had a medical condition that in the opinion of the study dentist would make them unsuitable for inclusion.