cyrilzakka/clinical-trials huggingface dataset:
Cholesterol Metabolites Analysis in Human Thyroid and Iodine Resistance

The study team previously shown that a cholesterol metabolite, dendrogenin A (DDA) differentiates anaplastic thyroid cancer cell lines and that its mRNA expression is diminished in human radioiodine refractory thyroid cancer samples. The team aim to quantify via mass spectrometry and immunohistochemistry DDA and other cholesterol metabolites in thyroid cancer versus healthy thyroid tissue human samples.

Retrospective study to analyze tissue samples of patients after thyroid surgery at Claudius Regaud Institute Toulouse, France, for thyroid cancer or thyroid aggressive lymphoma or benign thyroid pathology or other head\&neck pathology necessitating total thyroidectomy despite normal thyroid.

Analysis focused on cholesterol metabolites quatification by mass spectrometry in liquid and gas phase.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone surgery at Institut Claudius Regaud for thyroid or laryngeal cancer confirmed by histology.
* Patients who have consented before surgery, for the use of participants samples for future researches.

Exclusion Criteria:

* None
Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation

To investigate the safety and efficacy of long-term use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation for preventing the occurrence of ischemic stroke or systemic embolism (SEE).


Eligibility Criteria:
Inclusion criteria:

- Patients with nonvalvular atrial fibrillation who have never received Prazaxa Capsules for preventing the occurrence of ischemic stroke and systemic embolism will be included.

Exclusion criteria:

- None
Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds

This is an IRB-approved multicenter study.This non-inferiority study aims to evaluate differential healing rates between Lavior Diabetic Wound Gel and other Hydrogels. Study therapy will be started in the outpatient setting and followed accordingly.


Eligibility Criteria:
Inclusion Criteria:

* Foot Wound in the setting of Diabetes Mellitus
* Written informed consent
* Minimum wound surface area of 0.7 x 0.7 cm (0.49 square cm)

Exclusion Criteria:

* Age \< 18 years
* Noncompliance with study procedures, visit schedule or follow up Gangrene and/or untreatable Peripheral Arterial Disease
* Malignancy of the wound
* Use of any other hydrogels not being studied in this investigation within 1 month of being enrolled
* Dry, uninfected, stable pressure ulcers of the heel
* Dry, stable eschar in arterial wounds
* Simultaneous participation in competing clinical trials
* Pregnancy or Nursing mothers
a Prospective Study of Surgical Results, Complications and Predictive Values in Chinese Women Breast Reconstruction

This study prospectively evaluates and compares the effectiveness of ICG fluorescence imaging and LSCI in predicting the risk of necrosis following direct-to-implant breast reconstruction.

This study prospectively evaluates and compares the effectiveness of Indocyanine Green (ICG) fluorescence imaging and Laser Speckle Contrast Imaging (LSCI) in predicting the risk of necrosis following direct-to-implant breast reconstruction. The investigation includes both intraoperative and postoperative assessments of flap perfusion, with a focus on identifying specific thresholds for necrosis prediction. By analyzing the sensitivity, specificity, and predictive accuracy of each technique, the study aims to establish their respective strengths and limitations. Additionally, the research aims to explore the feasibility of using these methods in different surgical stages, evaluating their consistency and reliability in monitoring the viability of the skin flap and nipple-areolar complex.

Eligibility Criteria:
Inclusion Criteria:

All patients presenting for implant-base reconstruction immediately after mastectomy

Exclusion Criteria:

delayed reconstruction, expander removal followed by prothesis implant, ICG allergy or intolerance, autologous reconstruction
Flourishing and Virtue in Cognitive-Behavioral Therapy for Anxiety and Depressive Disorders

This two phase study is testing an online version of a transdiagnostic, cognitive behavioral therapy, against a modified version of that therapy emphasizing positive affect. The first phase of the trial will focus on content development for the modified therapy and the second phase will be a randomized control trial comparing the two.

Research shows that positive emotions can buffer against the effects of stress as well as contribute to overall well-being and functioning. People with emotional disorders, such as anxiety and depression, often report lower levels of positive emotions. However, to date, most existing treatment approaches for emotional disorders focus on regulating negative emotions, without explicitly focusing on positive emotions.

The Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy that has been shown to be effective for treating emotional disorders. The UP targets negative emotions and helps people respond to their emotions in ways that are more helpful for them and in line with their goals. In its current form, the UP does not explicitly target positive emotions, but some research suggests that individuals treated with the UP and other cognitive-behavioral treatments experience some improvement in positive affect.

In the current study, the researchers will create a modified version of the UP (called the UP+) delivered entirely on an online platform that will include exercises specifically designed to enhance positive emotions. Then, the researchers will evaluate the UP+ in a small sample of participants to examine acceptability and feasibility and will then use this information to continue to refine the protocol. Finally, the researchers will conduct a randomized controlled trial to assess the efficacy of the UP+. Participants diagnosed with emotional disorders will be randomized to either receive the UP or the UP+ delivered on an online platform and will be assessed on a range of outcomes, including positive and negative affect, psychological symptoms, and functional outcomes.

Eligibility Criteria:
Inclusion Criteria:

Diagnosed with a DSM-5 anxiety, obsessive-compulsive, or depressive disorder

Exclusion Criteria:

Acute risk factors (suicidal or homicidal ideation or clinical condition requiring immediate treatment);

The individual is in treatment elsewhere for related issues; and/or

The individual is considering changing their treatment and and/or psychotropic medication during the time period in which they would be enrolled in the study and/or

The individual is unable or unwilling to commit to the study procedures.
A Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia

The purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of imatinib mesylate.


Eligibility Criteria:
Inclusion Criteria:

* Signed Written Informed Consent
* Subjects with chronic phase chronic myeloid leukemia (CML)
* Subjects resistant/intolerant to imatinib
* Subjects presenting:

  1. ECOG performance status (PS) score 0-2
  2. Adequate hepatic function
  3. Adequate renal function
  4. Adequate lung function

Exclusion Criteria:

* Concurrent malignancy other than CML
* Women who are pregnant or breastfeeding
* Concurrent pleural effusion
* Uncontrolled or significant cardiovascular disease
* A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy.
* Prior therapy with dasatinib
* Subjects with T315I and/or F317L BCR-ABL point mutations
Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes

GLP-1 is a hormone made by the body that promotes the production of insulin in response to GLP-1 is produced within the islets expressing prohormone convertase 1/3eating. However, there is increasing evidence that this hormone might help support the body's ability to produce insulin when diabetes develops. The purpose of this study is to determine the effect of endogenous GLP-1 secretion on insulin secretion in people with and without type 2 diabetes.

Accumulating evidence suggests that in rodents and humans GLP-1 is synthesized within islets and may act locally in a paracrine fashion. Indeed, mice with genetic loss of intra-islet GLP-1 exhibit decreased insulin secretion and impaired response to metabolic stressors. 'Pancreatic' GLP-1 may contribute to the effects of DPP-4 inhibitors in rodents and humans. Antagonism of GLP1R with exendin-9,39 during fasting impairs the islet cell response to an I.V. glucose challenge. Islet GLP-1 content is increased in T2DM and in islets from non-diabetic humans exposed to hyperglycemia and Free Fatty Acids. These observations imply that paracrine GLP-1 secretion supports islet function in the presence of glucolipotoxicity. In this experiment we will examine the role of endogenous GLP-1 secretion in people with and without T2DM and during β-cell stress induced by FFA elevation.

Eligibility Criteria:
Inclusion criteria - non-diabetic subjects:

* Weight-stable, non-diabetic subjects

Exclusion Criteria - non-diabetic subjects:

* Age \< 25 or \> 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
* HbA1c ≥ 6.5%
* Use of glucose-lowering agents.
* For female subjects: positive pregnancy test at the time of enrollment or study
* History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
* Active systemic illness or malignancy.
* Symptomatic macrovascular or microvascular disease.

Inclusion criteria - diabetic subjects:

* Weight-stable, diabetic subjects treated with diet and lifestyle alone or with metformin monotherapy

Exclusion Criteria - diabetic subjects:

* Age \< 25 or \> 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
* Use of any glucose-lowering agent other than metformin.
* 2 or more fasting glucose values \> 250mg/dl on medication or after medication withdrawal.
* Unwillingness or inability to withdraw medication for three weeks prior to, and for the duration of the study.
* For female subjects: positive pregnancy test at the time of enrollment or study
* History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
* Active systemic illness or malignancy.
* Symptomatic macrovascular or microvascular disease.
Assessment of the Bioavailability of Iron in Iron Fortified Bouillon Cubes in Healthy Nigerian Women

The prevalence of iron deficiency anemia is a wide spread problem in Africa and iron fortification can be an effective strategy to decrease this.

In the current study adding different levels of a stabilizer to iron fortified cubes and it's effect on iron bioavailability from these cubes will be studied in the context of a Nigerian meal in women.

24 Female subjects with low serum ferritin levels will be included in the study. The study will last 64 days and subjects will be asked to consume a breakfast and lunch prepared with a bouillon cube with isotope labeled iron during 3 periods of 5 consecutive days. The absorption of iron will be evaluated after every period and compared between the cubes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female Nigerian subjects;
* Age \> 18 and \<40 years at screening;
* Body weight \<65 kg;
* Apparently healthy: no medical conditions which might affect study measurements (judged by study physician);
* With iron deficiency judged by a serum ferritin concentration of \<15µg/L;
* Reported intense sporting activities ≤ 10h/w;
* Reported alcohol consumption ≤ 14 units/w;
* Willing and able to participate in the study;
* Having given a written informed consent.

Exclusion Criteria:

* Being an employee of Unilever or the Department of Family, Nutrition and Consumer Science of the Obafemi Alowolo University;
* Blood donation or significant blood loss over the past 6 months;
* Being severely anemic (hemoglobin \< 8.0 g/dL)
* Reported use of any medically- or self-prescribed diet;
* Use of vitamin or mineral supplements and unwillingness to discontinue their use one week prior the study and during the study;
* Smoking or consuming tobacco in any form, and/or was smoking or consuming tobacco in any form for 6 months preceding the study and/or will be smoking or consuming tobacco in any form, during the study;
* Is pregnant or will be planning pregnancy during the study period;
* Is lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period;
* Known gastrointestinal (including helminth infection) or metabolic disorders;
* Participation in another clinical trial during the last 30 days prior to the beginning of the study;
* Symptomatic malaria (no blood smear analyses on malaria required)
Nab-paclitaxel Plus S-1 in Patients With Advanced Pancreatic Cancer

The purpose of this study is to determine the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus S-1 as first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma (PDA).

Advanced PDA is a lethal disease with a approximately 6 months of median survival. Gemcitabine is always the only approved single agent. The recent results of the phase III trial MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) demonstrated an improvement in overall response rate (ORR), progression free survival (PFS) and overall survival (OS) for the combination of nab-paclitaxel plus gemcitabine compared to gemcitabine alone. Thus, the combination of nab-paclitaxel with gemcitabine became one of a standard treatment in metastatic PDA. S-1 is an oral fluoropyrimidine, and shown to be non-inferior to gemcitabine on OS for unresectable pancreatic cancer, and also demonstrated non-inferior, and even superior to gemcitabine as adjuvant chemotherapy. This single-arm study is to explore the efficacy and safety of nab-paclitaxel plus S-1 as first-line treatment in Chinese patients with local advanced or metastatic pancreatic ductal adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed-consent form.
2. Age no less than 18 years.
3. Histologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, with RECIST measurable lesions.
4. Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks.
5. Patients must have received no previous chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-fluorouracil or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
6. Adequate liver/bone marrow function.
7. Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end.
8. Compliant, and can be followed up regularly.

Exclusion Criteria:

1. Pregnant or breast-feeding female, or not willing to take contraception measures during study.
2. Serious infection requiring antibiotics intervention during recruitment.
3. Allergic to study drug.
4. More than grade 1 neuropathy.
5. Uncontrolled brain metastasis or mental illness.
6. Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
7. Other malignancy within 5 years.
8. Can't be followed up or obey protocol.
9. Ineligible by the discretion of the investigator.
BrighT STAR LIBRA: Leveraging Implementation Science for Blood Culture Reduction Approaches

This study will compare two strategies that target distinct determinants of blood culture overuse in an exploratory, hybrid, pilot trial in 8 PICUs. It aims to determine if there is any association between specific strategies used to reduce blood culture overuse on unit-wide blood culture rates, patient safety, and concurrently explore aspects of the implementation process (acceptability, feasibility, appropriateness).

Blood cultures are an important test to diagnose bacterial bloodstream infections, but can be ordered reflexively, excessively, and lead to downstream negative patient consequences such as unnecessary antibiotic exposure. Work to date has demonstrated safe and effective reduction in blood culture rates in the pediatric intensive care unit (PICU) setting, but optimal strategies to reduce culture use are currently unknown.

The primary study team will initially work with all enrolled sites in an identical fashion, facilitating a core series of steps for implementing a quality improvement blood culture diagnostic stewardship program which is identical to the steps used in the parent study, called BrighT STAR (Testing STewardship to reduce Antibiotic use and Resistance). In addition, the primary study team will randomize sites into two arms, in which different strategies are introduced that each target distinct determinants of blood culture overuse. The primary study team will examine the impact on blood culture rates, as well as evaluate aspects of the implementation process, in all sites pre- vs-post intervention.

Eligibility Criteria:
Inclusion Criteria:

* Males or females over 18 years old
* PICU clinicians with direct patient care roles

Exclusion Criteria:

* Non-English speaking
* PICU clinicians who report to the investigator
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery

This phase II trial studies the neurological function in patients with multiple brain metastases undergoing stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Assessment of neurocognitive function may help show that SRS preserves neurological function in patients with multiple brain metastases better than SBRT.

PRIMARY OBJECTIVES:

I. Assessment of neurocognitive function at months 4.

SECONDARY OBJECTIVES:

I. Assessment of neurocognitive function at months 4 and 12 as measured by neurocognitive decline on a battery of tests.

II. Assessment of symptom burden, as measured by the M.D. Anderson Symptom Inventory- Brain Tumor Module (MDASI-BT).

III. Assessment of quality adjusted survival and health outcomes using the European Quality of Life Five Dimension Five Level scale questionnaire (EQ-5D-5L).

IV. Assessment of local control, in brain control. V. Assessment of progression free survival (PFS), and overall survival (OS). VI. Assessment of side effects and toxicities.

OUTLINE:

Patients undergo SRS on day 1 or SBRT for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline, 4, and 12 months after undergoing SRS or SBRT.

After completion of study, patients are followed up at 2, 4, 6, 8, 10, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven solid tumor malignancy (except for small cell lung cancer \[SCLC\], germ cell tumor)
* Karnofsky performance status \>= 60
* 1 to 10 brain metastases (mets) (no more than two lesions and/or cavities \>= 3 cm in maximum diameter)
* Maximum diameter of brain metastasis or resection cavity is 6 cm
* Serum creatinine =\< 3 mg/dL and creatinine clearance \>= 30 ml/min
* Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up; patients must be willing to complete neurocognitive assessments at pre-specified time points outlined in the protocol
* Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 21 days prior to registration
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 4 months after last dose
* Patient able to provide his/her own written informed consent and speak English

Exclusion Criteria:

* Patient with diagnosis of glioma, or other World Health Organization (WHO) grade II - IV primary brain tumor
* Prior brain surgery =\< 14 days prior to enrollment
* Planned chemotherapy during radiosurgery
* Leptomeningeal metastases
* Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per week for the past 2 months
* Pregnant women
Microparticles in Peritoneal Carcinomatosis of Colorectal Origin

Peritoneal carcinomatosis (PC), a tumoral tumor of the peritoneum, is a frequent metastatic localization of colorectal cancer (CRC, 13%). Long regarded as a palliative situation, its management has progressed significantly with a curative treatment based on a complete cytoreduction surgery coupled with intraperitoneal hyperthermic chemotherapy. However current screening tools, tumor markers (ACE, CA19-9, CA125) and abdominopelvic CT scan are insufficient, to diagnose CP early. A non-invasive biomarker, more sensitive and more specific than currently available tumor markers, would be a major advance in oncology. Microparticles (MPs), vesicles from extracellular membrane budding in response to cell activation or apoptosis of different cell types, have been described as implicated in tumor progression, procoagulant activity associated with cancer, and initiation of metastatic niches. A specific microparticulate (microparticulosome) signature has been reported in patients with CRC, particularly in the presence of a thromboembolic event. However, there is currently no data on PMs and their involvement in CP. In addition, CP and surgery coupled with hyperthermic intraperitoneal chemotherapy are major risk factors for thromboembolic complications. The characterization of prothrombotic PMs is therefore essential to predict such event.

The main objective of this project is to characterize the microparticulate signature of CP of colorectal origin and to compare it with that of CP without CP. The secondary objectives are to compare the microparticulate signature obtained on peripheral venous samples and intraoperative tumor samples, evaluate the evolution of the microparticulate signature between the beginning and the end of the intervention, then correlate the peripheral signature to the oncological follow-up of the patients with CP and the occurrence of a thromboembolic event.


Eligibility Criteria:
Inclusion Criteria:

* patient presenting a peritoneal carcinomatosis from colorectal cancer origin

Exclusion Criteria:

* patient presenting a peritoneal carcinomatosis from other pathologies than colorectal cancer origin