cyrilzakka/clinical-trials huggingface dataset:
Pancreatic Adenocarcinoma Neoadjuvant Chemotherapy Before Surgery

This is a single-arm, single-center feasibility trial of patients with borderline resectable pancreatic adenocarcinoma receiving chemotherapy with mFOLFIRINOX or gemcitabine / nab-paclitaxel followed by pancreatectomy.

Borderline resectable pancreatic adenocarcinoma infiltrates into adjacent vascular structures to an extent such that complete macroscopic resection is technically feasible, but an R0 resection poses a challenge when surgery is the primary therapy. Therefore, a different management strategy may be beneficial.

The primary outcome of the PANCREAS trial is defined as the proportion of eligible patients enrolled in the study over an 18-month period and the proportion of patients who complete the protocol (neoadjuvant therapy and pancreatectomy). Certain modifications of the neoadjuvant therapy protocol are expected and allowed, and the primary feasibility outcome will be one of the following: stop, main study non-feasible; continue with protocol modifications; or continue without modification. A safety analysis will be performed after first 15 patients are enrolled and complete neoadjuvant therapy and surgery. Patients enrolled in this trial will undergo interventions in the following order: neoadjuvant chemotherapy, re-staging CT scan, pancreatectomy and adjuvant chemotherapy. Postoperative mortality will be recorded up to 90 days after surgery. Patients will be followed every four months with a CT scan of the chest/abdomen for two years after resection or until evidence of disease recurrence. Patients who do not undergo surgical resection will be followed for two years after accrual (duration of study period) or until evidence of disease progression or death.

Eligibility Criteria:
Inclusion Criteria:

* 1. Men and women 18 years of age or older who present with biopsy proven borderline resectable pancreatic adenocarcinoma who are medically fit for surgery as per assessment by treating surgeon.

  2. Age ≤ 79 years 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 4. Normal bone marrow and organ function
  1. Absolute neutrophil count (ANC) = or \> 1500, platelets \> 100K
  2. Total bilirubin \<1.5x upper limit of normal (ULN)
  3. Alanine transaminase (ALT), Aspartate aminotransferase (AST) \< 3 x ULN
  4. Creatinine \<150umol/L
  5. Normal prothrombin time and international normalized ratio (INR) 5. Able to provide written informed consent

Exclusion Criteria:

1. Proven metastatic disease (e.g. on imaging modality such as CT scan of the chest, abdomen and pelvis or MRI)
2. Locally advanced pancreatic cancer (see definition section 3.3)
3. Prior treatment with radiation therapy to the pancreas or associated field.
4. Contraindications to receive chemotherapy
5. History of cardiac disease including congestive heart failure (New York Heart Association class 2), active coronary artery disease or uncontrolled hypertension
6. Concurrent ongoing systemic infections
7. Illegal substance abuse, or social conditions that may interfere with patient's participation in the trial
8. Pre-existing neuropathy
9. Pregnant patients
Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients

This study was designed to compare the pharmacokinetics of Prograf and Advagraf in stable pediatric kidney transplant recipients.

Enrolled patients on prograf will have pharmacokinetic study of tacrolimus for 24 hours and after that, the same dose of advagraf will be prescribed. The patients will have another pharmacokinetic study of tacrolimus after conversion to advagraf.


Eligibility Criteria:
Inclusion Criteria:

* ABO-compatible kidney-only transplantation
* more than 1 year after kidney transplantation
* 5 to 15 years old
* patients maintained on Prograf
* tacrolimus level of determined previously: 4 to 20 ng/ml
* eGFR by Schwartz equation \> 50mL/min

Exclusion Criteria:

* patients with acute rejection within 90 days
* patients with acute rejection requiring antibody therapy within 6 months
* patients with more than 2 times of acute rejection within 1 year
* AST/ALT 2 times more than upper normal limit
* ABO-incompatible or crossmatch-positive transplantation
* multiorgan transplantation
Quality Control of Home Mechanical Ventilators

A multicentre quality control survey of home mechanical ventilation in patients. The prescribed ventilation settings, the settings of the ventilator control panel and the actual performance of the ventilator will be tested.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Home mechanically ventilated
* \>18 years

Exclusion Criteria:

* Pacients with servoventilation
Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects

A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of PT003 in healthy Chinese adult subjects

A Phase I, Randomized, Double-Blind, Parallel Group, Study to Assess the Pharmacokinetics and Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects Following a Single Administration and After Chronic Administration for 7 Days

Eligibility Criteria:
Inclusion Criteria:

* Male and female Chinese subjects 18-45 years of age
* Females of childbearing potential must agree to be abstinent or else use one of the medically acceptable forms of contraception A female whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception.

A male subject with female partner of child bearing potential must agree to use one additional form of medically acceptable contraception

-Be in good general health as assessed at Screening and have no clinically significant abnormal labs at Screening.

Exclusion Criteria:

* Pregnant or nursing female subjects or subjects who are trying to conceive
* Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
* Subjects with a history of ECG abnormalities
* Subjects who have cancer that has not been in complete remission for at least 5 years
* Male subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator
* Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
* Males with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator
* Subjects with a diagnosis of glaucoma that in the opinion of the Investigator has not been adequately treated
* History of substance-related disorders within 1 year of Screening
* History of smoking or the use of nicotine containing products or electronic cigarettes within 3 months of Screening by self-reporting
* A positive alcohol breathalyzer or urine drug screen for drugs of abuse at the Screening Visit or at the beginning of each inpatient period
* Treatment with any prescription or non-prescription drugs (including vitamins, herbal, and dietary supplements) within 30 days
* Positivity for human immunodeficiency virus (HIV) or Hepatitis B surface antigen (HbsAg) or positive hepatitis C antibody at Screening
* Positive for Syphilis Antibody
* Subjects with any flu-like syndrome or other respiratory infections
* Recently vaccinated with an attenuated live virus
Evaluation of the Effect of Liposomal L-Arg and Vit C Integration on Mitochondrial Function in Patients With Heart Failure

Pilot study to assess the effect of L-Arg and Vit C liposomal supplementation on mitochondrial function in patients with heart failure, through analysis of the viability of mitochondria isolated from peripheral blood of mononucleate cells (PBMC).

Pilot, monocentric, national, non-pharmacological, prospective, double-blind randomized trial.

The primary objective of this study is to assess the effect of liposomal L-Arg and Vit C supplementation on mitochondrial function in patients with heart failure, by analysis of the viability of mitochondria isolated from peripheral blood of mononucleate cells (PBMC). Mitochondrial respiratory function of PBMC (in extensive lymphocytes and monocytes) is readily available. These cells are involved in many inflammatory diseases, including those driven by episodes of ischemia-reperfusion, which play a key role in cardiovascular alterations. In particular, the recruitment of T cells and myocardial infiltration are well described during ischemic and non-sischemic heart failure, so the mitochondrial function of PBMC could play a significant role in this immune disorderrelated during heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Diagnosis of heart failure with preserved EF 45%.

Exclusion Criteria:

* Age \<18 years
* Left ventricular ejection fraction \<45%
* Valvular heart disease
* Previous myocardial infarction or coronary heart disease
* Hypertension
* Diabetes mellitus
* Intolerance to L-arginine and liposomal vitamin C
* Pregnancy
* Lactation.
Young Adults' Reactions to Low Nicotine Cigarette Advertising

Reducing the nicotine content in combustible cigarettes to non-addictive levels has demonstrated promise as a safe and effective public health strategy for decreasing tobacco-caused morbidity and mortality. Little data are available, however, assessing how the marketing of low nicotine content (LNC) cigarettes could dampen their potential population health benefit. This study will examine LNC cigarette advertising content effects on message recall, viewing patterns, product perceptions, and use behaviors. Young adults (N = 340; 170 smokers, 170 non-smokers) will complete a single-session laboratory study using a 2 x 2 between-subject design to manipulate advertisement messaging accuracy (true vs. false/misleading) and content (implicit vs. explicit). Findings may be used to guide public health policy decisions related to regulating cigarette nicotine content and marketing.


Eligibility Criteria:
Inclusion Criteria:

* Aged 21-29
* Able to use a computer or related technology (such as a smartphone or tablet) with reliable internet access and willing to use the device to participate in the research study.
* Have a valid email address and willing to use email to participate in the research study. Participants without an existing email account who are willing to create one for study purposes are eligible to participate.

Additional inclusion criteria vary by smoking status.

Exclusion Criteria:

* Currently enrolled in a cessation program
* Report consuming ≥ 25 alcohol-containing drinks per week
* Report a history or current psychiatric diagnosis or severe medical condition
* Are color-blind or have another visual impairment (e.g., partial blindness, uncorrected cataract)
* Self-report being pregnant and/or lactating
* Are diagnosed with or test positive for COVID-19. Participants who report having traveled to a high-risk area in the past 2 weeks or who have been in close contact with someone confirmed or being evaluated for COVID-19 will be placed on a waitlist. Waitlisted participants will be asked to self-isolate for 14 days after exposure (even without symptoms) and will be re-screened for eligibility post self-isolation.

Additional, general reasons for exclusion include:

* Significant non-compliance with protocol and/or study design as determined by the Principal Investigator (PI) at any point throughout the study.
* Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact study data as determined by the PI.
* Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the PI. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen.
Pancreatic Fistula After Minimally Invasive Enucleation

Patients suffering from postoperative pancreatic fistula (POPF) after minimally invasive enucleation (MIEN) show a characteristic pattern of longer duration and milder symptoms, which is different from pancreatic fistula after standard pancreatectomy. This study aimed to analyze the factors influencing clinically-relevant POPF (CR-POPF) after MIEN, investigate and develop a personalized predictive model for accurate prediction of CR-POPF.

Minimally invasive enucleation (MIEN) has been widely used in managing benign and low-grade malignant pancreatic tumors, showing better protection of pancreatic function and better long-term outcomes compared to standard pancreatectomy.

However, the incidence of postoperative pancreatic fistula (POPF) after MIEN is higher compared to standard resection, mainly since a large part of the pancreatic wound is exposed, and the main pancreatic duct may be exposed or injured, etc. POPF is the most important postoperative complication, and it has become a major constraint to the conduct of pancreatic MIEN.

Although risk factors and predictive models for POPF in standard pancreatic surgery have been reported in the past, no predictive models have been reported specifically for MEN. With the increasing adoption of MIEN, there is an urgent need for a predictive model to guide the treatment and prognosis of POPF. Therefore, this study aims to conduct a cohort study, with data prospectively collected and retrospectively analyzed. The result of this study will provide a valuable reference for the development and application of MIEN.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 70 years, regardless of gender.
2. Benign or low-grade malignant tumor of the pancreas.
3. Patients evaluated according to guidelines that indicate a need for surgery or a strong request for surgery.
4. Feasibility of performing minimally invasive pancreatic tumor enucleation based on preoperative imaging evaluation.
5. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Willingness to comply with the follow-up programme of the study and other protocol requirements.
7. Voluntary participation and signed informed consent.

Exclusion Criteria:

1. Concurrent presence of other malignant tumors.
2. Intraoperative frozen pathology or postoperative pathology indicating the tumor to be malignant, requiring oncological resection instead.
3. Severe impairment of cardiac, hepatic, or renal function (e.g., NYHA class 3-4 heart failure, ALT and/or AST levels exceeding three times the upper limit of normal, creatinine levels exceeding the upper limit of normal).
4. Missing data due to patient loss of followup, etc.
The SERENITY Study: Online Mindfulness-Based Cancer Recovery for Patients With Gynecological Cancer

The overall objective of this project is to explore the feasibility, acceptability and potential effects of the online MBCR program in gynecological cancer settings. This will provide preliminary efficacy data in prevision of a larger, confirmatory, randomized controlled trial. As this study will be one of the first led in a French speaking country and the first conducted in a university hospital environment in Switzerland, the investigators would like to investigate the early implementation of this program among professionals and patients. Furthermore, they will investigate if in the online MBCR group, participants will show improvement in psychosocial outcomes, consumption of psychotropic and opioid medication, spirituality and meaning in life and in different biological processes.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* Being a woman
* Being diagnosed with breast or any gynecological cancer (either ovarian, cervical, vulvar, womb or vaginal cancer), stages I to IV.
* For women with localized cancers: having completed all adjuvant treatments, such as surgery, chemotherapy and/or radiotherapy, at least 3 months previously, with the exception of hormonal, immune and targeted therapy,
* For women with metastatic cancers: having a performance status \< 3, not undergoing IV chemotherapy and having a life expectancy more than 9 months as estimated by their treating oncologist.
* Free from acute infection for 2 weeks before biochemical assessment.
* Speaking and reading French fluently
* Be able to follow the online course via a computer/tablet

Exclusion Criteria:

* Inability to follow the procedures of the study due to:

  * Significant deafness
  * Physical impairment that prevents attending the sessions
  * Mental retardation (ICD-10)
  * Dementia (ICD-10)
  * Depression (ICD-10) \*
  * Spectrum disorder of schizophrenia (ICD-10) \*\*
  * Alcohol or other substance dependence (ICD-10) \*\*
  * Emotionally labile personality disorder that is incompatible with group participation (ICD-10) \*\*
  * A post-traumatic stress disorder (PTSD) (ICD-10)\*\*
* Currently engages in meditation one or more times per week
* Previous participation in an MBI program
* Serious physiological illnesses that would interfere with the interpretation of biochemical data (e.g., anemia, diabetes, cardiovascular diseases, blood cancers, inflammatory bowel diseases, autoimmune diseases, asthma being treated with steroids, immunodeficiency)
3D Modeling to Improve Hip Arthroscopy Outcomes

This study will pilot the use of 3D printed models of the hip, for use in pre-operative planning and patient communication to improve clinical outcomes and patient engagement. This method will be implemented in the setting of femoroacetabular impingement (FAI), with the goal of identifying and measuring specific anatomical pathologies and impingement (range of motion) risks, to communicate a pre-operative plan to both the surgical team, and the patient.

Following a standard of care pre-operative CT scan, a 3D rendering of the CT scan will be completed. The de-identified CT Scan data will be transferred to the Clemson University Bioengineering Department, and a 3D modeling software will convert it to a computer model that will then be 3D printed. During the doctor-patient pre-operative consultation, the 3D Printed model will be used to assist the doctor in describing the patient's pathology and upcoming surgical procedure. In this pilot study, the surgeon will make measurements and estimates of resection for the femoroplasty and acetabuloplasty off of 2D CT scan, MRI, and x-rays. This will then be compared quantitatively to the results of the 3D model/3D printing measurements. Surgeon debriefings will occur postoperatively to determine the benefit of the model and how well it matched up to what the surgeon experienced during the surgery.

FAI involves complex anatomic morphology which can be unique to each patient. A thorough understanding of the type and specifically location of impingement is paramount to successful results if surgery is required. 2D imaging has limitations when analyzing a 3D anatomic lesion. 3D printed hip models have the potential to provide superior preoperative planning and subsequent surgical results. In addition, 3D models can potentially improve patient understanding, expectations, and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Surgical candidate for a hip arthroscopy for the treatment of femoroacetabular impingement
* Subject is willing to sign the informed consent.
* Subject is at least 18 years of age.

Exclusion Criteria (n/a)
Comparison of Helicobacter Pylori Eradication Effect Before and After Training of Gastroenterologists

The researchers recruited gastroenterologists. Physician subjects recruited Helicobacter pylori-positive patients before and after receiving standardized training on Helicobacter pylori eradication. There are no restrictions on treatment options and drugs during the trial. Compare the eradication rate, adverse reaction rate, and patient compliance before and after physician training.

The researchers recruited no less than 20 gastroenterologists to participate in the study, and gastroenterologists recruited 25 patients who were over 18 years of age and were positive for Helicobacter pylori for the first time. In this process, the patient population is not restricted, and the eradication program is not restricted. Gastroenterologists followed up their diagnosis and treatment. Researchers track and record patients' medications and adverse reactions during medication via phone or WeChat to assess patient compliance. Record the eradication rate. The researchers will provide standardized Helicobacter pylori eradication training for the Department of Gastroenterology after all patients treated by gastroenterologists have been eradicated and reviewed. After the training, the gastroenterologist recruited 25 patients who were over 18 years old and were newly treated with Helicobacter pylori positive. In this process, the patient population is not restricted, and the eradication program is not restricted. Gastroenterologists followed up their diagnosis and treatment. Researchers track and record patients' medications and adverse reactions during medication via phone or WeChat to assess patient compliance. Record the eradication rate. Compare the eradication rate, adverse reaction rate and compliance of patients before and after the training of gastroenterologists.

Eligibility Criteria:
Inclusion Criteria:

* 1.Physician specialized in gastroenterology.
* 2.Diagnosis and treatment conditions for H. pylori exist in the hospital where the gastroenterology doctor is located.

(C13 urea breath test, C14 urea breath test, rapid urease test, stool H. pylori antigen test, histopathological test, H. pylori culture, any of the above)

Exclusion Criteria:

* 1.Those who are unable or unwilling to provide informed consent.
* 2.Patients with H. pylori have never been diagnosed and treated.
Pin Size Influence the Incidence of Knee Pain

It has been the investigators observation that large diameter traction pins cause more postoperative knee pain than smaller traction pins. To the investigators knowledge, no study to date has identified knee pain as a consequence of traction pin placement. Furthermore, no study has identified whether pin size has an effect on the incidence of postoperative knee pain. The goal of the present study is to establish whether use of temporary skeletal traction is associated with subsequent knee pain and to determine whether traction pin size influences the incidence and/or magnitude of knee pain.

Objective #1:

Determine whether pin size influences the incidence and/or severity of postoperative knee pain in patients who undergo temporary skeletal traction.

Hypothesis:

Larger traction pins are associated with an increase in both the incidence and severity of postoperative knee pain.

Objective#2:

Determine whether pin size affects musculoskeletal function in the postoperative period.

Hypothesis:

There is no difference between small and large traction pins in postoperative musculoskeletal function.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults
* At least 18 years old
* Injury (Pelvic, acetabular, or femoral fracture) requiring temporary skeletal traction.

Exclusion Criteria:

* Neurovascular compromise.
* Ipsilateral fractures presenting contraindication to skeletal traction
* Patients who are non-ambulatory.
* Patients less than 18 years of age.
* Patients who do not speak English.
* Ipsilateral ligamentous knee injury