cyrilzakka/clinical-trials huggingface dataset:
StandUPTV: Reducing Sedentary Screen Time in Adults

The goal of this study is to develop an optimized intervention for reducing leisure sedentary screen time (SST) in middle-aged adults with overweight or obesity. Investigators will use the multiphase optimization (MOST) framework to conduct a highly efficient full-factorial experimental study to simultaneously test the main effects for each of three intervention components (LOCKOUT, TEXT, EARN) and their interactions (e.g., TEXT+EARN; LOCKOUT+EARN+TEXT) over 16 weeks.

Primary Aim: To identify which component(s) from three components under consideration for inclusion in StandUPTV reduce SST by \>60 min per day per day at 16 weeks. The three components tested will be: (a) LOCKOUT (no vs. yes); (b) TEXT (no vs. yes); and (c) EARN (no vs. yes). The investigators will use a highly efficient experimental strategy to detect effects of individual components as well as all two- and three-way interactions.

The secondary aim of this study is to examine how reductions in SST displace time into other active behaviors, i.e., light-intensity physical activity (LPA), moderate-to vigorous physical activity (MVPA) and activity type (e.g., housework, walking, exercise behaviors). The investigators will use both device-based (activPAL3c) and self-report (ACT24) measures to understand whether SST displacement can increase active behaviors, particularly MVPA.

Eligibility Criteria:
Inclusion Criteria:

* 23-64.90 years of age
* BMI≥25 kg/m2
* 3+ h/day of SST
* Insufficiently active
* Own an Apple or Android smartphone/tablet
* Access to internet at home or unlimited data plan
* Willing to download StandUPTV
* Able to read/understand English
* Willing to be randomized

Exclusion Criteria:

* Current smoker (more than once per week)
* Major life event (e.g., move out of study area, pregnant)
* MVPA contraindicated
* Occupation requires media use or high amounts of physical activity
* Drug abuse, major illness and/or psychological disorder
MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Ca

Phase II non-inferiority randomized trial of annual systematic biopsies versus mpMRI and targeted biopsies for men with low risk prostate cancer on active surveillance with any volume Gleason's Score 6, but no prior MRI imaging of the prostate.

This is an unblinded, randomized trial of TRUS biopsy-based active surveillance versus mpMRI-based active surveillance. Patients on the TRUS biopsy-based arm will undergo annual systematic biopsies without any MRI staging or guidance. Patients on the mpMRI- based arm will undergo annual mpMRI surveillance imaging, with image-guided targeted biopsies only as indicated by radiographic findings.

Eligibility Criteria:
Inclusion Criteria:

* Prostate adenocarcinoma diagnosed by biopsy within 12 months prior to study registration.
* Gleason score ≤ 6
* PSA \< 10 ng/mL
* Completed and documented history and physical addressing all inclusion/exclusion criteria.

Exclusion Criteria:

* A diagnosis of prostate adenocarcinoma on more than one set of prostate biopsies, on separate calendar dates.
* Previous MRI imaging of the prostate.
* Prior history of pelvic radiotherapy.
* Prior history of prostatectomy.
* Contraindication to prostate mpMRI (renal failure, hip prosthesis, pacemaker, etc).
* Contraindication to prostate biopsy via transrectal or transperineal approaches (including coagulopathy).
* Patients on testosterone replacement therapy who are unwilling to discontinue.
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements.
* Unable to understand, or unwilling to complete the informed consent process.
Surgical Stabilization for Rib Fractures

The purpose of this study is to compare the usual care alone to usual care plus early surgical stabilization in adult trauma patients who have been admitted with rib fractures, to evaluate for heterogeneity of treatment effect in high risk subgroups and to determine the the impact of multiple rib fractures on post-discharge health status and time to return to work or usual physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Blunt trauma mechanism
* Severe chest wall injury (defined by one of the 3 below):

Radiographic flail segment (defined as greater than 2 fractures in greater than 3 consecutive ribs) or greater than 5 consecutive rib fractures or greater than 1 rib fractures with bicortical displacement

* At least one true rib (1-7) fractured and accessible for stabilization

Exclusion Criteria:

* Severe traumatic brain injury (best resuscitated GCS less than 8 as measured at 24 hours)
* Spinal cord injury
* Pre-existing congestive heart failure or oxygen-dependent pulmonary disease
* Any reason for which SSRF could not occur within 72 hours of admission
Reproducibility of Plasma Nucleosomes and Free DNA as Markers for Venous Thromboembolism

The main objective of this study is to evaluate, for 15 healthy volunteers and for 15 patients with a history of venous thromboembolism (VTE), the monthly variation (over 6 months) of plasma nucleosome and free DNA concentrations.

The secondary objectives of this study are:

A. To describe, for 15 healthy volunteers with no history of venous thromboembolism (VTE), plasma nucleosome and DNA concentrations.

B. To describe, for 100 patients with a history of VTE currently consulting for chronic disease or thrombophilia work-up, plasma nucleosome and DNA concentrations.

C. To compare plasma nucleosome and DNA concentrations between healthy volunteers and VTE patients

D. To describe, for 100 patients with a history of VTE currently consulting for chronic disease or thrombophilia work-up, the relationships between classification of VTE and plasma nucleosome concentrations:

* anatomical classification of VTE: (i)superficial, deep ((ii)distal or (iii)proximal), or (iv)pulmonary embolism
* circumstantial classification of VTE: (i) triggered, no chronic risk factor; (ii) untriggered, with chronic risk factor; (iii)triggered, with chronic risk factor; (iv) untriggered, no chronic risk factor (idiopathic)

E. To describe, for 100 patients with a history of VTE, the variation in plasma nucleosome concentrations 6 months after the first evaluation

* according to the above anatomical classification
* according to the above circumstantial classification
* according to intercurrent events and treatments

F. To compare the plasma concentrations of nucleosomes and free DNA

G. To evaluate the relationship between plasma nucleosome and free DNA concentrations and:

* circulating leukocyte populations: total leukocyte count, absolute number of neutrophils, monocytes, lymphocytes
* markers of coagulation activation: d-dimers, circulating fibrin monomers
* platelet count
* patients on antivitamin K: INR, patients receiving heparin: antiXa activity

H. Creation of a biological collection

Eligibility Criteria:
Inclusion Criteria:

* The patient or volunteer must have given his/her informed and signed consent
* The patient or volunteer must be insured or beneficiary of a health insurance plan
* The patient or volunteer is available for 6 months of follow-up

For group "P":

* patient with a history of VTE

For group "T":

* healthy volunteer
* no history of VTE
* no history of chronic disease
* no history of neoplastic disease
* no history of chronic infection
* not taking anticoagulants, antiplatelet medications
* no acute disease or infection during the last 2 weeks

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient gave birth in the past three months
The BRIDGE Rehabilitation Trial

The main aim of this multi-centre stepped wedge randomized controlled trial is to improve the quality, professional practice and cost-effective utilization of health care resources by evaluating if a new rehabilitation program aimed at bridging gaps in rehabilitation across levels of care may increase and/or prolong the effect of rehabilitation.

The goal of rehabilitation is to help people to reach and maintain their optimal functioning and coping capabilities, and to promote independence and participation in society. According to current political documents, there are large variation in the content and quality of rehabilitation in Norway, and systems to improve coordination and communication are needed.

This trial is a collaborative project between eight centres across Norway, investigating whether a new program aimed at bridging gaps in rehabilitation across levels of care increase and/or prolong the effect of rehabilitation for people with rheumatic and musculoskeletal diseases. Additionally, we will use a newly developed set of quality indicators to monitor and compare the quality of rehabilitation across different centres, and explore relationships between adherence to structure and process indicators and the outcomes of rehabilitation.

The effects will be evaluated in a multi-centre stepped wedge randomized controlled trial, where participating centres switch from control (current rehabilitation program) to intervention phase (adding the BRIDGE program to the current program) in a randomized order. Primary outcome is goal attainment after seven months, and secondary outcomes are health related quality of life and function.

The results will give insight in the content and organisation of current rehabilitation programs, what follow-up people want and receive in primary care, their planned and completed efforts to implement and maintain life style changes, and predictors for improvement following rehabilitation in specialist health care. Results will also have consequences on how rehabilitation is to be organized in the future regarding follow-up and coordination across levels of care.

The study has been developed in close collaboration with patient research partners, clinicians and international experts, who will also contribute in the process of integrating study results in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* inflammatory rheumatic disease or osteoarthritis or fibromyalgia or low back pain or wide spread pain or osteoporosis. Having a good understanding of Norwegian and having a bank-ID

Exclusion Criteria:

* Cognitive impairment or severe psychiatric disorder
Two-week Course Versus Conventionally Fractionated Chemoradiotherapy in Rectal Cancer

The investigators compare two-week course of chemoradiation (33 Gy in 10 fractions with oral capecitabine) and conventional chemoradiation (50.4 Gy in 28 fractions with 5-FU and leucovorin) in this randomized trial.

1.1 experimental arm Two-week course concurrent chemoradiotherapy

* Radiotherapy, 33 Gy/10 fractions for 2 weeks

  ↓↓↓↓↓ ↓↓↓↓↓ Radical surgery 6 weeks after completion of chemoradiotherapy D1----------------------D12
* Capecitabine 825 mg/m2, twice daily

1.2 control arm

Standard concurrent chemoradiotherapy (CRT)

* Radiotherapy, 50.4 Gy/28 fractions for 6 weeks

  ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓ Radical surgery D1--------------------------------------------------------------------------D38
* Bolus 5-FU, 400 mg/ m2 and leucovorin, 20 mg/ m2 during week 1 and 5
* Capecitabine, 825 mg/ m2, bid

Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed adenocarcinoma;
2. distal margin of the tumor located \< 10 cm from the anal verge;
3. cT3-4N0-2 classification as determined by magnetic resonance imaging (MRI) and/or endorectal ultrasonography (EUS);
4. no evidence of distant metastasis;
5. Karnofsky performance score over 70;
6. adequate bone marrow, liver, and renal function (leucocytes \>4000/mm3, hemoglobin \>10 g/dL, platelets \>100,000/mm3; serum bilirubin \<1.5 mg/dL, serum transaminase \<2.5 times the upper normal limit; serum creatinine \<1.5 mg/dL).

Exclusion Criteria:

1. Metastatic disease
2. No complete resection of tumor (R2)
Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

This trial will compare the effectiveness of two common surgical practices for Type C esophageal atresia repair: esophageal atresia (EA) with distal tracheoesophageal fistula (TEF). Infants with EA/TEF requiring surgical intervention will be recruited. Subjects will be randomized to either repair with or without transanstomotic tube (TT) during esophageal anastomosis creation. Primary outcome is symptomatic anastomotic stricture development requiring dilation within 12 months.

Esophageal atresia is a congenital condition requiring surgical intervention. The most common configuration is Gross type C, proximal EA with distal TEF (EA/TEF). The operation for type C includes tracheoesophageal fistula closure and esophageal anastomosis creation. Although mortality has markedly decreased since the operation was first described, overall complication rate remains at 62%, with the most common complication being anastomotic stricture, 43%.

During the creation of esophageal anastomosis, two common practices are to either use or not use a transanastomtic tube (TT) across the anastomosis. However the utility and benefits of TT have not been validated. A recent retrospective analysis by the Midwestern Pediatric Surgical Research Consortium identified anastomotic stricture to be the most common postoperative complications (43%). On univariate analysis, only utilization of a TT was significantly associated with strictures (p=0.013). On multivariate analysis after adjusting for both pre and perioperative variables, TT use remained significant with an odd ratio (OR) of 1.91 (p=0.04).

Given the inherent limitations and biases of retrospective analysis, there is a critical need for a prospective multi-institutional study to validate this finding. The Western Pediatric Surgical Research Consortium (WPSRC) consists of 10 children's hospitals including Phoenix Children's Hospital, Doernbecher Children's Hospital, Primary Children's Hospital, Lucile Packard Children's Hospital, Seattle Children's Hospital, Colorado Children's Hospital, Children's Hospital of Los Angeles, Rady Children's Hospital, Benioff Children's Hospital, and Children's Medical Center Dallas. The WPSRC will conduct a prospective randomized control trial comparing the effects of TT use. Target enrollment is 150. One group of patients will receive TTs and another group of patients will not receive TTs. We hypothesize that the use of TT will result in increased anastomotic stricture formation. Primary outcome is symptomatic anastomotic stricture requiring dilation within 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Infants diagnosed with type C esophageal atresia: proximal esophageal atresia and distal tracheoesophageal fistula
* Primary repair of the esophageal atresia within the first six months of life
* Minimum follow up of 1 year (12 months)

Exclusion Criteria:

* Other types of esophageal atresia without esophageal anastomosis creation
* Major anomaly that influences likelihood of developing primary outcome or affects surgical treatment considerations
Vitamin A Absorption From Cassava in Women

The purpose of this study is to determine the vitamin A equivalents in high-carotenoid varieties of cassava.

We plan to conduct a single site intervention phase II intervention study in healthy adult women. Women will serve as their own controls, and will be fed three treatments in random order: a single meal of low-carotenoid cassava porridge with fat, a similar meal of bio-fortified cassava (that is high in vitamin A-forming carotenoids) with fat, and a similar meal of bio-fortified cassava without fat. Carotenoids and vitamin A will be measured in the triacylglycerol-rich lipoprotein (TRL) fraction of plasma by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase HPLC using electrochemical detection. We plan to collect sufficient data to identify the times of the first appearance and peak concentrations in retinol, retinyl esters, alpha-carotene (AC), beta-carotene (BC), beta-carotene isomers (BCI), and cryptoxanthin (CX) in TRL: when a single meal containing moderately high amounts of carotenoids from bio-fortified cassava is fed to healthy adult women. We will use this data to determine the vitamin A equivalency of bio-fortified cassava in adult women, and the effect of fat on vitamin A equivalency of bio-fortified cassava.

Eligibility Criteria:
Inclusion Criteria:

* non-smoking
* BMI between 18-30
* total cholesterol concentrations between 90 and 225 mg/dL
* blood pressure under 140/90 mm Hg
* hemoglobin above 11.5 g/dL
* blood chemistries within the normal range

Exclusion Criteria:

* must not be pregnant or trying to get pregnant
* must not be taking fat, triacylglycerol, or cholesterol lowering medications) such as orlistat, gemfibrozil, niacin, lovastatin, simvastatin, colestipol, and ezetimibe)
* must not taking medicines containing high doses of retinoids such as Accutane or high vitamin A or carotenoid supplements
* must not have blood chemistry or health history results consistent with acute cancer or heart disease
* no obvious psychological or sociological problems such as alcoholism, drug abuse, or severe and acute mental illness that would influence their ability to sign an informed consent agreement or to participate in study duties and activities
* must not be allergic to cassava, peanuts, or peanut oil
Validation of HyperDetector for SARS-CoV-2

To evaluate the HyperDetector as a method to rapidly screen SARS-CoV-2

To determine the sensitivity and specificity of the screening assay performed on oral swab and saliva specimens, compared to a validated RT-PCR COVID-19 method using nasal or nasopharyngeal swabs and to separately collected nasal swabs, oral swabs, oral rinse and saliva samples.

To determine the best workflow for using such an assay to reflex suspicious/positive samples to a validated RT-PCR COVID-19 assay.


Eligibility Criteria:
Inclusion Criteria:

* Subjects at COVID-19 testing site for Rt-PCR test.

Exclusion Criteria:

* Minors under the age of 5
Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age

To compare the reactogenicity of ADACEL® vaccine given at intervals of 2 to 9 years with the reactogenicity of ADACEL® vaccine given at an interval of 10 or more years following the last previous administration of vaccine containing Diphtheria and Tetanus Toxoids (referred to as TD/Td).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 7 years and \< 20 years.
* Signed and dated IRB-approved informed consent form obtained from the participant, parent or legal guardian prior to the first study intervention.
* Judged to be in good health on the basis of reported medical history.
* Available for planned length of the study.
* Participant or parent or legal guardian (as applicable) can read and write English and can understand the informed consent documents and the study instructions.

A participant eleven years of age or older who meets an exclusion criterion may not be enrolled in the study but nonetheless may participate in the vaccination program, at the discretion of the Prince Edward Island public health authorities).

A participant younger than eleven years of age who meets an exclusion criterion may not be enrolled in the study and may not participate in the vaccination program.

Exclusion Criteria:

* Known or suspected allergy to ADACEL®, any of the vaccine's components, or prior allergic reaction to Diphtheria or Tetanus Toxoids or Acellular Pertussis Vaccine.
* Planned receipt of any other vaccine within the 14 days following administration of ADACEL® vaccine in this study.
* Any other medical condition that in the opinion of the investigator would cause an unexpected hazard or interfere with the study objective.
* Receipt of TD/Td within the preceding 12 months.
* Known or suspected to be pregnant.

A participant eleven years of age or older who meets an exclusion criterion may not be enrolled in the study but nonetheless may participate in the vaccination program, at the discretion of the Prince Edward Island public health authorities).

A participant younger than eleven years of age who meets an exclusion criterion may not be enrolled in the study and may not participate in the vaccination program.
Correlation Between Pre-transplant ICI Exposure and Post-transplant Graft Rejection

Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of advanced HCC. The combination of the ICI and other treatment regimens (Anti-VEGF, locoregional therapies et al) produced superior results in patients with advanced-stage HCC compared to those treated with traditional therapeutic regimens. Liver transplantation (LT) offers excellent long-term outcomes for certain patients with HCC. However, the immune-stimulating property of ICIs may lead to rejection and even graft loss, damping their use in treating HCC before liver transplantation. Therefore, it is worthwhile to explore the relationship between exposure to ICIs before LT and the incidence of graft rejection and rejection-related death or graft loss after LT.

This will be a retrospective and observational study, which will analyze the correlation between the use of ICIs and incidences of graft rejection and rejection-related death or graft loss after LT in consecutive recipients with LT for HCC at the Organ Transplantation Center of Sun Yat-sen Memorial Hospital of Sun Yat-sen University.

The primary aim of this study is to analyze the correlation between pretransplant exposure to ICIs and incidences of graft rejection and rejection-related death or graft loss within 1 year after liver transplantation.

The secondary aim is to analyze the risk factors for graft rejection and to explore the correlation between ICI exposure and posttransplantation complication, such as incidences of early allograft dysfunction (EAD), bleeding, infection, biliary and vascular complications et al.

The exploratory aim is to identify potential biomarkers in predicting graft rejection, such as subsets of lymphocytes and cytokines et al.

Eligibility Criteria:
Inclusion Criteria

1. Written informed consent must be obtained prior to any data collection.
2. Patients must have pathologically or cytologically or by radiological criteria proven hepatocellular carcinoma based on the AASLD practice guidelines.
3. All patients receiving liver transplantation for HCC.

Exclusion Criteria

1. Cholangiocellular carcinoma, combined hepatocellular and cholangiocarcinoma, and other rare types of liver cancer that are confirmed by histology/cytology.
2. Patients with incomplete follow-up data