cyrilzakka/clinical-trials huggingface dataset:
Modified-FOLFIRINOX Regimen Based Neoadjuvant Therapy in Chinese Patients With Locally Advanced Pancreatic Cancer

FOLFIRINOX regimen is first-line neoadjuvant chemotherapies for patients with locally advanced pancreatic cancer (LAPC) worldwide. However, FOLFIRINOX is not well accepted in China because of the high prevalence of adverse events and poor tolerance. To evaluate the safety and efficacy of modified-FOLFIRINOX (mFOLFIRINOX) in Chinese LAPC patients and compare survival between LAPC patients with mFOLFIRINOX-based preoperative therapy and LAPC patients who underwent surgery alone.

At this institution, a mFOLFIRINOX regimen has been adopted for metastatic pancreatic cancer (MPC) patients and promising results obtained. The modification resulted in a significantly reduced prevalence of severe adverse events in MPC patients, whereas the OS and PFS were extended to 10.3m and 7.0m, respectively, which is similar to that for patients on a full-dose regimen. Therefore, the investigators further evaluated the efficacy of mFOLFIRINOX in LAPC patients. Here, investigators want to prospectively enroll LAPC patients who underwent preoperative therapy with mFOLFIRINOX from April 2014 and compared the surgical resectability and surgical morbidity/surgical mortality among patients with surgically resectable pancreatic cancer (RPC) or LAPC who underwent surgery alone retrospectively. For patients with LAPC, mFOLFIRINOX was administrated for several cycles until the optimal response was obtained and then patients were evaluated for surgery. Moreover, survival data, including OS and PFS, were determined.

Eligibility Criteria:
Inclusion Criteria:

1. The patients are diagnosed by histology to have pancreatic adenocarcinoma
2. The patients are defined as locally advanced pancreatic cancer according to NCCN guideline
3. The patients prescribed mFOLFIRINOX-based neoadjuvant therapy

Exclusion Criteria:

1. ECOG performance score more than 2
2. Insufficient bone marrow, liver and renal function
3. Patients with other malignancies
4. Patients were older than 85 years or less than 18 years
Integrated Diagnosis and Treatment of CKD on Outcomes

Objective: To establish a study cohort and follow up of patients with CKD in our hospital, and evaluate the status of integrated CKD diagnosis and treatment according to guidelines in the real world, as well as the clinical prognosis of patients with different stratification.

Methods: By establishing a cohort of 1000 patients with CKD and conducting long-term follow-up, integrated diagnosis and treatment for CKD was performed, namely: Regular monitoring, control of blood pressure, blood glucose, blood lipid, correction of anemia, minerals - bone metabolic abnormalities, malnutrition, acid and alkali, and electrolyte disorder, diet and exercise, such as the guidance of integrated management, non intrusive, observational studies, prospective cohort were analyzed retrospectively, describe the implementation of the integration of diagnosis and treatment, chronic kidney disease (CKD) Stratified analysis and risk factor analysis were performed for cardiovascular disease and other main endpoint events, so as to objectively reflect the status of integrated treatment of CKD and provide data support for continuous quality improvement of CKD diagnosis and treatment and improvement of clinical prognosis of patients.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old;
* Voluntarily signed informed consent;
* Patients who are estimated to develop CKD.

Exclusion Criteria:

* Age \< 18 or ≥100 years;
* Unable to comply with the procedures stipulated in this study;
* Estimated follow-up time ≤6 months.
Immune Checkpoint Blockade Therapy Using 18F-FLT PET/CT

In the current study, advanced positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance (PET/MR) imaging methods will be used to validate the hypothesis that participants receiving immune checkpoint blockade (ICB) therapy, who ultimately achieve clinical benefit, will show an increase, or "FLARE", in tumor FLT and/or FDG uptake from baseline, as seen after cycle#1 of treatment, and that after 2 cycles of treatment responders will have a decline in FLT and FDG uptake, in comparison to the participants classified as "non-responders".


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically confirmed diagnosis of cancer.
* Patients who are planned to receive checkpoint blockade therapy, per referring oncologist.
* Life expectancy ≥ 6 months and \< 5 years.
* Disease that is measurable per RECIST 1.1.
* Age ≥18 years.
* Ability and willingness to provide informed consent
* Women of child-bearing potential must have a negative urinary or serum pregnancy test within 7 days of each imaging time point.

Exclusion Criteria:

* Patient receiving other investigational radiotracers within 14 days prior to FLT and FDG imaging time points.
* Patients receiving ICB in combination with chemotherapy.
* Immunosuppressive therapy including systemic corticosteroids except for maintenance dosing for adrenal insufficiency. Patients requiring immunosuppressive therapy during the study will no longer be eligible.
* Known additional malignancy that is progressing or requires active treatment with the exceptions of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune diseases, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients with a pacemaker, stainless steel aneurysm clip or any other magnetic resonance (MR) contraindicated implant or foreign body would warrant exclusion from this study. Pacemakers may be reprogrammed or turned off by the strong MRI magnetic field. Radio-frequency (RF) fields in MR can also cause severe heating of pacemaker lead tips. Steel aneurysm clips are prone to torque in the strong MR field which can displace the clips and may damage the vessel, resulting in hemorrhage, and/or death.
* Pregnant women are excluded from this study
TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer

To evaluate the clinical efficacy and safety of TAS-102 combined with bevacizumab and tislelizumab in third-line or above treatment in patients with advanced colorectal adenocarcinoma with liver metastasis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who provided informed consent and voluntarily enrolled
* Patients with liver metastasis of advanced colorectal adenocarcinoma with MSS confirmed by pathology;
* 18-75 years old;
* Measurable target lesions according to RECIST V1.1 assessment criteria;
* Progression after standard second-line treatment (irinotecan, oxaliplatin, or fluorouracil);
* 0 \~ 2 points according to ECOG quality of life score;
* Drugs can be taken orally
* Estimated survival ≥3 months;
* Women of childbearing age should comply with contraceptive measures if pregnancy test is negative;
* Ascites with no obvious symptoms and no clinical intervention;
* Adequate organ and bone marrow functions, ecg, blood, biochemical and other basic tests are not contraindications of chemotherapy;
* Adherence to scheduled visits, treatment plans, laboratory tests, and other study procedures Willingness and ability.

Exclusion Criteria:

* Previous application of TAS-102;
* Pregnant or lactating women;
* No contraception during the reproductive period;
* patients known to have a history of allergy to any study drug, similar drug or excipient;
* Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;
* Patients with a history of thromboembolism, except those caused by PICC;
* Patients with active infection;
* Patients with uncontrolled hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90) MmHg);
* Patients with brain metastases with clinical symptoms or imaging evidence;
* Contraindications for treatment of other chronic diseases;
* Previous immunotherapy-related myocarditis, pneumonia, colitis, hepatitis, kidney Inflammation and other conditions, the current AE is still ≥2;
* According to THE NCI CTCAE 5.0 assessment criteria, there are all types of existing cases due to previous treatment Patients with grade ≥2 toxic reactions;
* Other conditions that the investigator determines are not suitable for inclusion in the study.
* Received any anti-tumor therapy and participated in other clinical studies within 4 weeks prior to enrollment.
Resiliency Programming for Caregivers of Children with Learning and Attentional Difficulties

This is a randomized open pilot trial enrolling up to 40 co-primary caregivers of children with LAD. Participants will be randomized to receive either mind-body resiliency group (SMART-LAD, intervention) or an evidence-based group intervention Health Education Program (HEP, control) which is a multiple behavior change program that addresses sleep, exercise, nutrition, substance use, and working with one's healthcare team. Both the SMART-3RP and HEP programs have been modified based on adaptions from our previous qualitative study.

The primary objective of this protocol is to conduct an open pilot to elicit initial quantitative and qualitative feedback regarding feasibility and acceptability of the interventions (SMART-3RP and HEP) that we have refined. Both groups are designed to improve well-being for caregivers experiencing stress-related to caring for a child with LAD.

The investigators will ask participants to complete approximately 15-minute survey batteries via REDCap at baseline and after the 8-week program, including assessments of intervention feasibility and acceptability as well as psychosocial outcomes. To inform plans for ongoing program refinement, the investigators will also elicit specific feedback regarding study assessment tools, recruitment procedures, and group composition.

Results will be used to inform a larger randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Age 18 or older
* Ability to participate in group, virtual sessions including access to computer, tablet, or smartphone, and internet
* Parents or guardians of a child (\< age 18) with LAD.

Exclusion Criteria:

* Parents with significant psychiatric conditions (i.e., active suicidality or psychosis) or who are otherwise unable to participate, at the investigators' clinical discretion.
* Only one parent per family can participate.
* Unwilling or unable to participate in the study
* Considered medically or otherwise unable to participate by the study PI
A Surveillance Study of Susceptibility to Baloxavir Marboxil in Participants With Influenza

The purpose of this study is to evaluate the pre-treatment and single-dose post treatment susceptibility of baloxavir marboxil in participants aged 1 to \<12 years with influenza.


Eligibility Criteria:
Inclusion Criteria:

* Participants with symptoms suggestive of influenza with diagnosis confirmed by a positive local influenza test within 24 hours before full study screening.
* Participants with a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test within 48 hours before full study screening.
* Time interval between onset of influenza symptoms and the pre-dose examinations at screening is 48 hours or less

Exclusion Criteria:

* Participants with severe influenza virus infection requiring inpatient treatment.
* Severely immunocompromised participants \[including participants receiving immunosuppressant therapy, or those with cancer or human immunodeficiency virus (HIV) infection\] as defined by the investigator.
* Participants with concurrent (non-influenza) infections requiring systemic anti-microbial and/or anti-viral therapy at the pre-dose examinations.
* Treatment with baloxavir marboxil, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir or amantadine within 30 days prior to screening.
* Treatment with an investigational influenza-specific monoclonal antibody within 6 months or 5 half-lives, whichever is longer, prior to screening.
* Treatment with an investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening.
* Known hypersensitivity to baloxavir marboxil or the drug product excipients.
* Females who have commenced menarche (i.e., child-bearing potential).
Prospective Analysis of Spinal Epidural Abscess

This is a prospective study involving all patients treated at the University of Kentucky for spinal epidural abscess over a 2-year period. Based on ongoing referrals of patients with SEA, we expect that 200 patients will be enrolled during this time window. We propose to study all available clinical, pathological, radiological, and socioeconomic data of patients diagnosed with a spinal infection with or without a history of drug abuse over this study period. All patients' charts will be prospectively reviewed starting at the time of presentation for a period of 1 year.


Eligibility Criteria:
Inclusion Criteria:

* All patient with ICD codes for pyogenic vertebral osteomyelitis, discitis, and spinal epidural abscess will be reviewed for inclusion.

Exclusion Criteria:

* Patients unwilling or unable to attend follow up appointments.
Visual Outcome of Vitrectomy After Refractive Surgery

Results of retinal detachment surgery may be affected in cases with history of previous intraocular surgery.

Pars-plana vitrectomy for management of retinal detachment has favorable visual outcome with early intervention and development of small gauge instruments, cases with previous refractive surgery may be affected by other factors that may change the final visual outcome.

In this study, we aim to analyze the effect of refractive surgeries on the final visual outcome after vitrectomy for the management of retinal detachment.

Eligibility Criteria:
Inclusion Criteria:

* cases diagnosed with primary retinal detachment and prepared for pars-plana vitrectomy.
* cases with previous history for refractive surgery were enrolled in refractive surgery group.

Exclusion Criteria:

* cases with corneal diseases or trauma that may affect the final visual outcome.
* cases with other retinal diseases that may affect the final visual outcome as age related macular degenerations and diabetic eye disease.
Can we Improve Mortality Prediction in Patients With Sepsis in the Emergency Department

This study aims to identify the prognostic role of procalcitonin (PCT), soluble Triggering Receptor Expressed on Myeloid Cells-1 (sTREM-1), the soluble form of the urokinase plasminogen activator receptor (suPAR), highly sensitive C-reactive protein (hs-CRP), Interleukin-6 (IL-6), and azurocidin 1 (AZU1) in 28-day mortality for patients with sepsis in Emergency Department.

The levels of the specified biomarkers were measured upon patient arrival at the Emergency Department (ED) and analyzed their correlation with 28-day mortality. The values of these biomarkers were monitored over the initial three days following admission to the ED, aiming to explore their potential in guiding the de-escalation of antibiotic treatment. Considering their prognostic significance, the main goal is to develop a novel scoring system tailored for use in the emergency department setting.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis 3 Criteria

Exclusion Criteria:

* individuals aged under 18 or above 90
* pregnant women
* individuals in custody or deprived of their liberty
* patients with associated pathologies such as severe trauma
* other types of shocks
* acute stroke
* burns
* pancreatitis myocardial infarction, pulmonary edema, status asthmatics, convulsions, drug overdose, those requiring emergency surgery
* terminal stage of neoplastic disease
Lufwanyama Neonatal Survival Project

We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify sepsis and initiate antibiotics in the field.

This is a cluster randomized trial of the impact of providing additional training and supplies to traditional birth attendants in a rural setting in Zambia. 120 TBAs are randomized into intervention/control. Intervention TBAs receive NRP training, supplies for neonatal resuscitation, receiving blankets for thermoregulation, and amoxicillin tablets. Control TBAs continue according to prior standard of care. Primary outcome is mortality at 28 days life as a proportion of births attended by TBAs in each study arm.

Eligibility Criteria:
Inclusion Criteria:

* TBA trained in safe delivery;
* willing to sign informed consent; willing to be randomized; willing to adhere to study procedures

Exclusion Criteria:

* TBA living outside of Lufwanyama district
Exercise Training in Youth With Inflammatory Bowel Disease

Children and adolescents with inflammatory bowel disease (IBD) suffer from many extra-intestinal side effects, including impaired muscle strength, low aerobic fitness, low bone density, and chronic inflammation. While exercise training can help remedy these issues in adults with IBD, no studies have examined the physiological effects of a structured aerobic and resistance exercise training intervention for youth with IBD.

The aim of this pilot study is to to assess the feasibility, safety, and participant satisfaction of a structured 16-week training program for children with IBD. The secondary objectives of this study were to quantify the effects of a 16-week exercise training program on select physiological and behavioural outcomes in children with IBD.


Eligibility Criteria:
Inclusion Criteria:

* In remission (score of \>10) according to the pediatric Crohn's disease activity index (PCDAI) or the ulcerative colitis activity index (PUCAI)
* Confirmed IBD diagnosis

Exclusion Criteria:

* Children who exercise train 3 times a week of more
Ibuprofen Sodium Tension Headache Study

This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of tension-type headache


Eligibility Criteria:
Inclusion Criteria:

* Males and females at least 18 years to 65 years of age
* A diagnosis of an episodic tension-type headache, as defined by the International Headache Society

Exclusion Criteria:

* Pregnancy or breast-feeding
* Alcohol or substance abuse
* Any serious medical or psychiatric disorder
Effectiveness of Coordinated Care to Reduce the Prolonged Disability Risk Among Patients Suffering from Low Back Pain in Primary Care

Common low back pain affects about 23% of general population and can be associated with psychosocial difficulties and prolonged inability to work. Its management in France mainly depends on general practioners, and sometime on physiotherapists.

A coordinated care between general practioners, physiotherapists and occupational health services would help to improve the care pathway for patients and health professionals.

The main objective is to assess the impact of coordinated primary care and deployed at the territories' level, in subacute or acute recurrent low back pain patients in comparison with the standard care.


Eligibility Criteria:
Inclusion Criteria:

* Patient consulting an investigator GP for subacute low back pain or acute recurrent low back pain
* Patient with occupational activity (including sick leave)
* Patient depending of occupational health service
* Obtaining the signature of the consent to participate in this trial
* Patient Registered with social security scheme

Non-inclusion Criteria:

* Specific low back pain (fracture, infection, osteoporosis, inflammatory disease, tumor)
* Low back pain with sciatic, cruralgia
* Contraindication to active reeducation
* Impossibility to follow up during 12 months
* Patient planning to retire within the 12 months following the enrollment
* Disability to write or read french
* Adult patient protected under the law (guardianship),
* Pregnant, breastfeeding or parturient women
* Persons deprived of their liberty by judicial or administrative decision
* Persons subject to legal protection measures
* Persons unable to consent
* Persons on coercion psychiatric care
* Physiotherapy by a physiotherapist who don't participate in this trial
Association of Probable Bruxism With Periodontal Status

This cross-sectional study was conducted to assess i) the prevalence of probable bruxism ii) the association between probable bruxism and periodontal status.The age, gender, education level, tooth loss, presence of probable bruxism and periodontal status of patients were evaluated. Periodontal statuses of the participants were defined according to the American Association of Periodontology/European Federation of Periodontology, 2017 consensus and assessment of probable bruxism was performed according to the 2018 consensus report on the assessment of bruxism.

This cross-sectional study was conducted to assess i) the prevalence of probable bruxism ii) the association between probable bruxism and periodontal status dental examination, all participants completed a standardized questionnaire. Sociodemographic findings comprised age, gender and educational level. Periodontal statuses of the participants were defined according to the American Association of Periodontology/European Federation of Periodontology, 2017 consensus. Participants were diagnosed with periodontitis if interdental clinical attachment loss (AL) was detected at ≥2 non-adjacent teeth, or buccal or oral AL was ≥3 mm with probing depth \>3 mm was detected at ≥2 teeth. 12 In addition number of missing teeth is recorded.Assessment of probable bruxism was performed according to the 2018 consensus report on the assessment of bruxism.Presence of masticatory muscle hypertrophy, temporomandibular joint pain, indentations on the tongue or lip and/or a linea alba on the inner cheek, damage to the dental hard tissues (eg, cracked teeth), mechanical wear of the teeth (ie, attrition), repetive failures of restorative work/prosthodontics constructions were examined in clinical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with 18 years and older

Exclusion Criteria:

* age under 18 years,
* edentulous patients,
* not interested to participate in this study.