cyrilzakka/clinical-trials huggingface dataset:
Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery

This pilot clinical trial studies the side effects of ascorbic acid and combination chemotherapy in treating patients with pancreatic cancer that has spread to other places in the body, has come back, or cannot be removed by surgery. Nutrients found in food and dietary supplements, such as ascorbic acid, may improve the tolerability of chemotherapy regimens. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ascorbic acid and combination chemotherapy may work better in treating patients with pancreatic cancer.

PRIMARY OBJECTIVES:

I. To determine safety of intravenous ascorbic acid in combination with fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (FOLFIRINOX) as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 in patients with advanced pancreatic cancer.

SECONDARY OBJECTIVES:

I. To test feasibility of collecting quality of life (QOL), patient reported outcomes (PRO) data and correlative studies on patients with advanced pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving informed consent
* Histological diagnosis of adenocarcinoma of the pancreas
* Stage IV or recurrent pancreatic cancer by imaging
* Locally advanced unresectable pancreatic cancer by National Comprehensive Cancer Network (NCCN) criteria
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
* No prior treatment for metastatic disease (prior neo-adjuvant or adjuvant chemotherapy, except FOLFIRINOX, chemoradiation or radiation allowed)
* White blood count \>= 3000
* Platelets \>= 100,000
* Total bilirubin =\< 1.5 mg/dl
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 5 X upper limit of normal (ULN)
* Creatinine \< 1.5 mg/dL
* Glucose-6-phosphatase deficiency (G6PD) level of 5-14 units/g hemoglobin (Hgb) or within institutional standard parameters
* All subjects of child producing potential must agree to use contraception or avoidance of pregnancy measures while enrolled on study

Exclusion Criteria:

* Other pancreatic cancer histology (islet cell, acinar, neuroendocrine tumors)
* Resectable pancreatic cancer
* Prior neoadjuvant FOLFIRINOX
* Pregnant or lactating females
* No clinical ascites (mild ascites on scans permissible)
* Central nervous system (CNS) metastasis
* Known congestive heart failure, significant ventricular arrhythmias, cirrhosis, grade 4/5 chronic kidney disease, uncontrolled diabetes
* Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
* Peripheral neuropathy grade 2 or greater
* Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc.)
Effectiveness of a Digital Treatment for Adolescents with Chronic Pain

Research has shown that the prevalence of chronic pain in adolescents is high and increasing. These young people report significant changes in both their physical and psychological functioning. Currently, psychosocial treatments enjoy strong empirical support and are crucial to maintaining and improving the quality of life of adolescents suffering from chronic pain. However, the availability of these evidence-based interventions is insufficient to meet the high demand, especially outside of large cities. The aim of this project is to develop a digital treatment that helps improve the quality of life of adolescents with chronic pain and complementary websites for their parents and teachers.


Eligibility Criteria:
Inclusion Criteria:

* 12-18 years old,
* Having a non-oncology secondary chronic pain problem,
* Having internet access,
* A parent willing to participate in the study,
* Providing informed consent/assent.

Exclusion Criteria:

* Cognitive or language problems
Esophageal pH-MII Duration: 12 or 24 Hours?

To check whether the first 12 hours of MII-pH recording are sufficient to diagnose gastroesophageal reflux disease (GERD) among newborns/infants, with a diagnostic accuracy similar to 24 hours of recording as currently advised.

The results of the 24 hour MII-pH recording will be compared to those from the first 12 hour of the same study. To this end the study investigators will select the first 12 hour of the recording using the manufacturer's software (Diversatek Zvu Advanced GI Diagnostic Software). Published normal reference values will be used to confirm gastroesophageal reflux (GER). Appropriate statistical methods will be used to perform calculations. Subgroup analyses based on preterm birth, presence of bronchopulmonary dysplasia and type of prevalent GER symptom (respiratory or gastrointestinal) will be performed.

Eligibility Criteria:
Inclusion Criteria:

* 24 hours MII-pH performed for suspected GER

Exclusion Criteria:

* major malformations
* previous thoraco-abdominal surgery, gastrostomy, anti-GERD therapy (thickeners, alginates, H2 blockers, proton pump inhibitor - PPIs, etc.) in the 7 days preceding the MII-pH,
* ventilatory support (invasive or non-invasive) at the time of the MII-pH
Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older ICU Survivors

Older ICU survivors with ICU acquired weakness (ICUAW) are malnourished, sarcopenic, and functionally debilitated as a consequence of the high burden of comorbidities common in the elderly. To address the sequalae of critical illnesses, the investigators will perform a trial incorporating an intervention that combines mobility-based physical rehabilitation (MRP), high protein supplementation (HPRO), and neuromuscular electric stimulation (NMES). The investigators will then assess both clinical and functional outcomes and determine the relationship of disability with systemic inflammation.

Annually, nearly 3 million patients ≥ 65 years old are admitted to intensive care units (ICUs) nationwide, 20% of whom experience a long, protracted ICU stay resulting in muscle deconditioning, atrophy, inflammation, and functional disability necessitating transfer from the ICU to a long term acute care hospitals (LTACH). In the LTACH exacerbations of chronic comorbidities and the cycle of prolonged bed rest, ongoing inflammation and malnutrition often leads to continued functional disability, immobility, prolonged mechanical ventilation and increased one-year mortality of up to 25%. After a patient has survived critical illness and is transferred to an LTACH facility, one of the major challenges of their continued care is how to address - and ameliorate - their profound physical and functional deficits.

To address these sequalae of chronic critical illness, the investigators will perform a trial incorporating an intervention that combines mobility-based physical rehabilitation (MRP), high protein supplementation (HPRO) and neuromuscular electric stimulation (NMES) to assess both clinical and functional outcomes and to determine the relationship of disability with systemic inflammation. The investigators will prospectively randomize patient to receive our multicomponent intervention or usual care and assess the outcomes of functional mobility, change in muscle mass and discharge disposition. Additionally, the investigators will determine the effects of our intervention on inflammatory cytokine profiles to determine to what degree systemic inflammation mediates clinical recovery.

Eligibility Criteria:
Inclusion Criteria:

1. LTACH admission within 72 hours
2. Age ≥ 60 years old
3. Prior ICU stay ≥ 2 weeks
4. Able to follow commands in English
5. Pre-ICU Barthel Index ≥ 70
6. Able to give consent
7. Able to perform physical therapy
8. All four limbs intact and mobile prior to LTACH admission

Exclusion Criteria:

1. Acute kidney injury with a glomerular filtration rate \<15 ml/min
2. Diagnosis of severe organ dysfunction including end stage liver disease or cirrhosis
3. Diagnosis of active cancer
4. Severe functional impairment or physical impairment to rehabilitation
5. Liver function tests \>2.5x normal limits
6. Chronic dementia or cognitive impairment
Efficacy and Safety of Ethanol Lock Solution in Prevention of Catheter Related Bloodstream Infection for Patients Suffering Acute Renal Failure, and Hospitalized in Intensive Care Unit. A Multi-Center, Randomized, Versus Placebo, Double Blinded Clinical Trial

The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing major catheter related infections in critically ill patients.

The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing major catheter related infections in critically ill patients

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders, over 18 years,
* Patients admitted in ICU
* Dialysis catheter insertion for renal replacement therapy
* At least two renal replacement therapy sessions
* Written informed consent
* Social security

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient requiring dialysis on arteriovenous fistula or permanent catheter
* Known allergy to ethanol
* Dialysis catheter covered or impregnated with antimicrobial agent
* Dialysis catheter insertion before ICU admission
* Single-lumen dialysis catheters
* Patient whose death is likely to occur within hours after admission to ICU
Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors - a Pilot Study

A metaverse-based multidimensional rehabilitation program will be implemented for colorectal cancer survivors who have undergone curative surgery and adjuvant therapy. The intervention is based on the behavior change wheel and includes dietary intervention, exercise intervention, psychological support, and behavior management. Through various methods such as training, education, and motivation, the program aims to enhance the patients' functional ability, opportunities, and motivation, thereby promoting healthy behavior. Outcome measures include quality of life, fear of recurrence, and adoption of a healthy lifestyle. The intervention period is 4 weeks, with evaluations conducted at baseline and week 4 of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing adjuvant therapy after curative surgery for colorectal cancer.;
* Age 18 years old and under 65 years old, estimated survival period ≥ 6 months;
* PG-SGA (Patient-Generated Subjective Global Assessment) score less than 4.
* be able to walk without assistance;
* Conscious and intellectually normal;
* Voluntarily participate in the research of this topic and provide the consent form for medical record review;
* Mobile phones can be used.

Exclusion Criteria:

* Patients with multiple cancers.
* Tumors not completely resected.
* Patients with severe psychological disorders, severe visual or hearing impairments, or other conditions that hinder intervention.
* Patients with severe complications such as short bowel syndrome, Crohn's disease, ulcerative colitis, diverticulitis, previous stroke, congestive heart failure or edema, liver or kidney failure, or other conditions that affect patient compliance.
* In addition to colorectal cancer or any other diseases deemed unsuitable for participation by the researchers, patients with severe heart, liver, lung, or kidney diseases.
* Patients with special dietary requirements.
Gender Solutions Natural Knee Post-Market Study

This is a prospective multicenter study of the Gender Solutions Natural Knee Flex System when used in primary total knee arthroplasty. The purpose of the study is to obtain short-, Mid-, and long-term clinical outcomes and implant survivorship data for the Gender Solutions Natural Knee Flex System.

Survival and outcome data on the Gender Solutions Natural Knee Flex System will be done by an analysis of standard scoring system, radiographs and adverse event records. Survivorship will be evaluated by monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated adverse device effects. Outcomes will be measured by comparing the overall pain and function performances (based on the Knee Society Scoring System), survivorship, subject quality of life and radiographic parameters of study subjects receiving the Gender Solutions Natural Knee Flex System.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18-75 years of age, inclusive;
* Patient qualifies for a total knee arthroplasty based on physical exam and medical history including at least one of the following: osteoarthritis, inflammatory arthritis, post-traumatic arthritis, rheumatoid arthritis, or valgus, varus, or flexion deformities;
* Patient has undergone a study related informed consent process;
* Patient is willing and able to provide written consent;
* Patient is willing and able to cooperate in the required post-operative therapy;
* Patient is willing and able to complete scheduled follow-up evaluations.

Exclusion Criteria:

* Patient has previous history of infection in the affected joint and/or a local or systemic infection that could affect the prosthetic joint;
* Insufficient bone stock on femoral or tibial surfaces;
* Skeletal immaturity
* Neuropathic arthropathy
* Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb;
* Stable, painless arthrodesis in a satisfactory functional position;
* Severe instability secondary to the absence of collateral ligament integrity;
* Patient has rheumatoid arthritis and an ulcer of the skin or a history of recurrent breakdown of the skin because of their risk of postoperative infection is greater;
* Patient has known sensitivity or allergy to one or more of the implanted materials;
* Patients pregnant or considered a member of a protected population (e.g., prisoner, mental incompetence, unable to understand what clinical trial participation entails, etc.)
PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

This is a multi-center, non-randomized, open label study. Subjects will be enrolled if they are deemed eligible given the inclusion criteria. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Subjects will be exposed to non-radioactive 13C-Urea with citric acid, and may submit a stool sample or undergo endoscopy for Rapid Urease Test and Histology samples.

Center(s) will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus UBT System.

Treating physician will either prescribe a H. pylori Stool Antigen Test through P4 Diagnostics, along with another Urea Breath Test using Breath ID, or patient will undergo Endoscopy to provide a composite reference method consisting of Rapid Urease Test and Histology. These will act as the comparators to the PyloPlus Urea Breath Test System.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female at least 18 years of age
* Patients who have been diagnosed with H. pylori and have been treated within the past 6 months
* Naive to H. pylori treatment in the past 4 weeks (including PPIs)

Exclusion Criteria:

* Pregnant and/or lactating women.
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Participation in other interventional trials.
* Allergy to test substrates.
* Antibiotics taken within 4 weeks of the testing.
* Study subjects shall not consume the following items at least 1 hour prior to the PPUBT test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to simulate the effect of ketone production that may result from some diets), Alcohol, Food
Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds

To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler with lidocaine

To assess pain immediately after nasolabial fold treatment with Radiesse® Injectable Dermal Filler with lidocaine in one nasolabial fold compared to Radiesse® Injectable Dermal Filler without lidocaine in the contralateral nasolabial fold

Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age
* Is a candidate for nasolabial fold treatment using Radiesse
* Has approximately symmetrical nasolabial folds
* Understands and accepts the obligation not to receive any other facial procedures in the lower half of the face for 1 month

Exclusion Criteria:

* Has received any type of treatment or procedures including surgery in the nasolabial folds
* Has received neurotoxin, hyaluronic acid, calcium hydroxylapatite (CaHA) or collagen injections in the lower half of the face within past 6 months
* Has received polylactic acid, polymethyl methacrylate (PMMA), silicone or any other permanent filler in the lower half of the face
* Has nasolabial folds that are too severe to be corrected in one treatment session
* Has any history of hypersensitivity to lidocaine or anesthetics of the amide type
Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation

The aim of the study is to assess the real-world effectiveness of managing participants within the first year post-activation (between 3 and 12 months) using Cochlear's Remote Care (Remote Check and Remote Assist), as compared with standard in-clinic management. The study captures also the time and costs associated with both models of care to quantify the potential costs savings and efficiency gains possible with delivering Cochlear Implant (CI) aftercare remotely.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older (no upper age limit)
* Post-lingually deafened
* Unilaterally implanted with the CI600 Series (CI612, CI622, CI632),CI500 Series (CI512, CI522, CI532) or Freedom Series (CI24RE(CA),CI24RE(ST), CI422)
* Currently using a Nucleus 7 (CP1000) or Kanso 2 (CP1050) Sound Processor (or latest compatible Sound Processor)
* 3 months, +/- 2 weeks, experience with a cochlear implant (post-activation) at the time of baseline measurements
* Owner of a compatible Smart Phone
* Fluent in the languages used for the study, as determined by the investigator
* Willing to participate in and comply with all requirements of the protocol, including willingness to be randomised to either arm
* Willing and able to provide written informed consent

Exclusion Criteria:

* Patient has a MAP incompatible with Master Volume, Bass and Treble (MVBT) programming:

  * Non-monopolar MAPs (bipolar, common ground, variable mode)
  * Dynamic range of \<10 Comfortable Level (CL)
  * Hybrid mode enabled
  * Pulse widths \>100 µs
  * 10 or more electrodes turned off
* Patient has on-going fluctuations in MAP Threshold levels (Ts) and Comfort levels (Cs) and/or impedances
* Patient requires frequent individual channel measurements and/or measurements without the use of live-stimulation
* Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire (MDPQ)
* Abnormal cochlea anatomy and/or facial nerve stimulation
* Additional disabilities that would prevent participation in evaluations, including significant visual impairment and/or dexterity issues
* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling
* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
* Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
A Prospective Validation Cohort Study of a Prediction System on nSLN Metastasis in Early Breast Cancer

In the previous study, the investigator established a predictive model for non-sentinel lymph node involvement in early breast cancer (cT1-2cN0, 1-2 SLNs involvement). To validation the clinical value of the model, the investigator design a prospectively research using the model guiding for further axillary lymph node dissection in SLN-positve early breast cancer.

In the previous study, a predictive model for non-sentinel lymph node involvement in early breast cancer (cT1-2cN0, 1-2 SLNs involvement) was established. This model was designed for predicting the status of non-sentinel lymph node in cT1-2cN0 with 1-2 SLNs involvement breast cancer based on peripheral blood CK19 and contrast-enhanced ultrasound. The investigator previously tested this model comparing with MSKCC model in a same population and confirmed a result of satisfactory low false-negative rate and high AUC. This model had a potential practise value in clinic applying. For further validation, the research group design the CK19B trial to prospectively using this model in decision strategy of whether receiving ALND in 1-2SLNs+ patients. If the model predictive result is negative, the risk of nSLNs involvement is estimated very low and the patients should be avoid ALND, even radiotherapy no matter the surgery is mastectomy or conserving. If the model result is positive, then further ALND or radiotherapy should be accepted by patients to decrease the risk of local and regional recurrent. A prospectively and conditional grouping method is planned for this cohort study. The primary endpoint is disease-free survival (DFS) in two groups, the second primary endpoint is local recurrent rate (LRR) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

the test group should be in accordance with the pathological diagnosis of breast cancer, the clinical stage of breast cancer (stage cTis, cI, cII and cT3N1M0), the initial treatment to receive surgical treatment. Complete preoperative clinical diagnosis data, including the ipsilateral axillary lymph node CEUS data and peripheral blood sample; The negative-control group should comply with the pathological diagnosis, breast adenosis, fibrocystic lesions, breast cysts and other benign lesions, with complete preoperative clinical data, also including ipsilateral axillary lymph node CEUS data and peripheral blood sample

Exclusion Criteria:

1. metastatic breast cancer, inflammatory breast disease, surgery without lymph node staging
2. pregnancy or lactation
3. patients with hematopoietic system disease or cancer, autoimmune diseases
4. preservation of substandard peripheral blood samples.