cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Novel Microfluidic Device to Purify Metastatic Lung Cancer Patients CTC (Circulating Tumoral Cells)

Currents strategies for cancer diagnosis consist of the extraction of a solid tissue from the affected area. This sample enables the study of specific biomarkers and the genetic nature of the tumor.

However, the tissue extraction is risky and painful for the patient and in some cases is unavailable in inaccessible tumors.

In addition, cancer is a dynamic disease and during the course of disease, cancers generally become more heterogeneous. As a result of this heterogeneity, the bulk tumour might include a diverse collection of cells harbouring distinct molecular signatures with differential levels of sensitivity to treatment. This heterogeneity might result in a non-uniform distribution of genetically distinct tumour-cell subpopulations across and within disease sites (spatial heterogeneity) or temporal variations in the molecular makeup of cancer cells (temporal heterogeneity).

To overcome these drawbacks, new alternatives are rising up, such as liquid biopsy.

A liquid biopsy is the analysis of biomarkers in a non-solid biological tissue, mainly blood, which has remarkable advantages over the traditional method; it has no risk, it is non-invasive and painless, it does not require surgery and reduces cost and diagnosis time.

Of the various circulating biomarkers, circulating tumor cells (CTCs) have particularly opened new windows. Circulating tumor cells (CTCs) are released into the bloodstream from primary cancer, metastasis, and even from a disseminated tumor cell reservoir.

CTCs may ideally replace tissue biopsies in the prediction and monitoring of therapeutic responses and tumor recurrence. CTCs can be used to guide therapeutic cancer management and serve as drug targets.

There are a wide range of instruments and methods for capturing, enriching, and enumerating CTCs. However, none of them is considered optimal.

To improve the purity of CTCs, the study consortium has developed a cutting-edge microfluidic device (LUTON) to reduce leukocytes contamination while preserving CTCs viability.

The added-value of the study innovation has been validated on clinical cell lines. The aim of this study is now to determine the performance of the device using patients' blood samples.

For this purpose, CTCs from non-small cell lung metastatic cancer patients will be isolated using ClearCellFX1 before injection into the LUTON workflow.

Collected cells will then be either growth in vitro or in ovo and the added value of this extra step of purification determined.


Eligibility Criteria:
Inclusion Criteria:

* Adult Patient (\>18 years)
* Stage IV non-small cell lung cancer (depending on classification)
* First line treatment approved by Multidisciplinary Team Meeting (MDTM) and referent physician
* Able to provide non-objection to participation

Exclusion Criteria:

* Patient weight below 50kg at inclusion
* Suspected Pregnancy
The Effectiveness of Combined Virtual and Clinical Simulation in Midwifery Students

Objective:

To evaluate the effectiveness of a combined virtual and clinical simulation strategy compared to virtual simulation alone and clinical simulation alone in the development of theoretical knowledge and clinical judgment among midwifery students, specifically in the management of preeclampsia.

Study Population:

75 undergraduate midwifery students in the second cycle of their studies at the Universidad de Los Andes, Chile.

Interventions:

Group 1: Virtual and Clinical Simulation combined (VSim® case on preeclampsia followed by hands-on clinical simulation with a manikin).

Group 2: Virtual Simulation only (VSim® case on preeclampsia).

Primary Outcomes:

Development of theoretical knowledge (measured by a test) on preeclampsia. Improvement in clinical judgment skills (assessed using the Lasater Clinical Judgment Rubric).

Secondary Outcomes:

Student satisfaction with the training. Perceived self-efficacy in managing preeclampsia. Usability of simulation platform

Duration:

The intervention lasts for 4 days. Pre- and post-tests will assess knowledge, clinical judgment, satisfaction, and self-efficacy.

Methodology:

A randomized controlled trial (RCT) with 35 participants divided equally into two groups. Each group will undergo either virtual simulation, or both. Data analysis will involve repeated measures ANOVA to assess the differences in learning outcomes between the groups.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment Status: Students in the second cycle of the midwifery program at the University of Los Andes.
* Educational Background: Participants must have completed the foundational courses in obstetrics and gynecology, as well as their initial clinical rotations.
* Consent: Participants must provide written informed consent to participate in the study.

Exclusion Criteria:

* Previous Clinical Experience: Students who have had prior clinical experience in high-risk obstetric units, or in preeclampsia management, will be excluded.
* Other Professional Backgrounds: Individuals with a degree or professional certification in obstetric or gynecological nursing (e.g., technicians with a title in obstetric nursing) will not be eligible.
* Exchange Students: Midwifery students participating in exchange programs will not be permitted to participate in the study.
Lifestyle vs.Surgery for Morbid Obesity Treatment

The purpose of the current study is to determine whether an intensive lifestyle intervention was as effective as surgery to treat morbid obesity nine years post-intervention.

Behavioral/lifestyle interventions produce acceptable success in treating moderately obese subjects. However, their effectiveness on weight loss and maintenance in morbidly obese subjects remains elusive.

Twenty-nine morbidly obese females participated in this non-randomized study. Fifteen subjects were assigned to the lifestyle group and 14 underwent vertical banded gastroplasty. Subjects in the lifestyle group attended 30 behavioral modification sessions over three years, whereas the surgery group received the standard of care nutrition. Body weight, resting metabolic rate, physical activity, body composition measurements and dietary intake data were assessed at standard time points during the first 3 years post-intervention. Follow-up data on body weight and physical activity were also collected 9 years later.

Eligibility Criteria:
Inclusion Criteria:

* female sex
* Age ≥ 18 years
* BMI ≥ 40 kg/m2
* Absence of mental illness as determined by evaluation by an experienced psychiatrist
* Additional inclusion criteria for vertical banded gastroplasty were history of multiple, non-successful, previous attempts for weight loss
Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

The purpose of this trial is to assess whether the new endovascular repair technique of the abdominal aortic aneurysm (AAA) is an adequate substitute of the conventional AAA repair.

After the introduction of endovascular repair of abdominal aortic aneurysms (AAA), both benefits and drawbacks of this new technique have been reported. To assess whether the new technique is an adequate substitute of conventional AAA repair, a randomised study is required. The DREAM trial is a randomised multicenter trial enrolling patients eligible for elective treatment of infrarenal AAAs. The primary endpoint is combined operative mortality and morbidity. Secondary endpoints and additional assessments include event-free survival, quality of life,and costs.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic, infrarenal AAA that requires surgery
* Adequate infrarenal neck
* Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the device to be used
* Patient having a life expectation of at least 2 years and cleared for transabdominal intervention
* Signed informed consent

Exclusion Criteria:

* ruptured AAA or symptomatic AAA, which requires emergency surgery
* maximum aneurysm diameter\< 5.0 cm
* suprarenal AAA
* Inflammatory AAA (more than minimal wall thickening)
* infrarenal neck unsuitable for endovascular fixation or aortic-iliac anatomic configuration otherwise unsuitable for EVAR according to criteria of the device to be used
* bilateral retroperitoneal incision required for EVAR
* sacrifice of both hypogastric arteries required
* anatomical variations, i.e. horseshoe-kidney, arteries requiring reimplantation
* patient unsuitable for laparotomy
* administration of contrast agent not possible: proved, severe systemic reaction to contrast agent
* active infection present
* transplantation-patients
* limited life expectation due to other illness (\< 2 year)
* non-iatrogenic bleeding diathesis
* connective tissue disease
Evaluation of MicroRNAs and Vitamin B12 Expression in Subjects with Neurologic Symptoms of Depression, Anxiety and Fatigue in Long COVID-19

At the moment, the number of people with long COVID is unkown because there is still no effective diagnosis. This is why is very important to analyze the most common symptoms, which are: depression, anxiety and fatigue. This project seeks to analyze some blood components of people with long COVID, such as microRNAs and vitamin B12, in order to identify the body processes that changed after COVID-19 and thereby design better therapies and diagnostic methods focused on each of them.

The hypothesis is that the expression of miR-21, -146a and -155 will be overexpressed as well as there will be a deficiency of vitamin B12 in serum in subjects suffering from long COVID with neurological symptoms of depression, anxiety and fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with confirmed diagnosis of COVID-19 by SARS-CoV-2 infection by PCR or antigen testing.
* With presence of neurological symptoms of depression, anxiety and fatigue associated with COVID-19 after three months from the first day of acute infection symptoms.

Exclusion Criteria:

* Subjects who have presented symptoms of acute infection in the last twelve weeks.
* Subjects who present diagnostic premorbid neurological alterations.
* Subjects who do not have at least 2 doses of COVID-19 vaccine, with last application date equal or older than 3 months.
Interdisciplinary and Family Intervention to Prevent Type 2 Diabetes

The purpose of the study is to evaluate the effect of a family and interdisciplinary approach on individual and family insulin resistance and insulin secretion in patients with prediabetes.

This a randomized clinical trial designed to evaluate the efficacy of the following treatments:

1. Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months
2. Individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months

To improve individual and family insulin resistance and insulin secretion in patients with prediabetes.

Patients will have a follow-up visit every month in the Metabolic Research Laboratory at the University of Guanajuato, Mexico, and will have a fasting measurement of lipids, glucose and insulin every 3 months, as well as 2h oral glucose tolerance test (OGTT) at basal, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with prediabetes (Fasting glucose 100-125mg/dl and/or 2h post OGTT glucose 140-199mg/dl)
* Family of patients with prediabetes (in case of the patients that are randomized to FAMILY APPROACH)
* Signing of the inform consent

Exclusion Criteria:

* Type 2 diabetes
* Pregnancy
* Liver disease
* Renal disease
Effect of the Use of Protective Masks on the Ability to Perform Daily Activities in Patients with Heart Failure or Obstructive Pulmonary Disease

Scientific Rationale: In late 2019 and early 2020, researchers at the Wuhan Institute of Virology identified a potential new etiologic agent, called new coronavirus 2019 (nCoV-2019). Subsequently, the epidemic unleashed by this virus involved the whole world and radically changed the habits of the entire global population. Since that time, in fact, the need to contain the spread of infection through specific social distancing procedures and through the use of personal protective equipment has become compelling. The main tool was the requirement for all citizens to wear masks for airway protection. This measure has thus become in daily use for the majority of the population.

Therefore, it has become increasingly important to evaluate the impact of mask wearing on activities of daily living (ADls), both in healthy subjects, for which several evidences have already been brought, and in patients with different diseases, for which data are still insufficient to fully describe the effects.

Oxygen consumption and dyspnea during simple activities of daily living (ADLs) have already been studied in patients with heart failure (HF) and chronic obstructive pulmonary disease (COPD), and there is evidence that these subjects compared with healthy subjects perform ADLs at a higher percentage of their peak VO2 with more dyspnea. However, there are still no studies highlighting, however, the consequences of performing such activities while wearing a protective filtering facepiece particles class 2 (FFP2) mask, to date considered the most suitable to preserve the most fragile subjects from infection.

In this study, therefore, the investigators aim to asess the effects of these devices on the ability to perform ADLs by evaluating the exchanges of respiratory gases in the body during the performance of normal activities or during sleep in patients with HF or COPD compared with healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

Healthy subjects:

* Age: 18-80 years
* Not taking cardiovascular medications
* No history of cardiovascular disease
* Normal physical examination
* Normal ECG

Inclusion criteria for subjects with HF:

* Age: 18-80 years
* New York Heart Association Class (NYHA) II to III in stable clinical condition
* Left ventricular ejection fraction (LVEF) \<40%
* Ability to perform a maximal CPET

Patients with COPD:

* Age: 18-80 years
* Diagnosis of COPD stage GOLD II-III in stable clinical condition
* Absent concomitant heart disease
* Ability to perform a maximal CPET

Exclusion Criteria:

* Healthy subjects:
* Presence of concomitant diseases

Patients:

* Oxygen therapy
* Inability or contraindication to perform a maximal CPET
A Study to Assess the Relative Bioavailability of 4 Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Volunteers

The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of 4 new formulations of fentanyl transdermal patch in healthy participants after a single application for 72 hours.

This is an open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), 4-way crossover (participants will receive different interventions sequentially during the trial) study. The study will assess the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) and relative bioavailability (the extent to which a drug or other substance becomes available to the body) of 4 new formulations of fentanyl transdermal patch, TDS-Concept 1 50 µg/h, TDS-Concept 2 50 µg/h, TDS-Concept 3 50 µg/h and TDS-Concept 4 100 µg/h compared with DUROGESIC fentanyl 50 µg/h in healthy participants after a single application. All participants will be randomly assigned to 1 of 8 possible treatment sequences. During the 4 single-application treatment periods, each transdermal patch will be worn, on a different application site on the lateral side of the upper arm, continuously for 72 hours. The treatment periods will be separated by a washout period (period when receiving no treatment) of at least 8 and no more than 14 days. The total study length is from 64 days to a maximum of 82 days.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI; weight \[kg\]/height2 \[m\]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
* Participants must utilize a medically acceptable method of contraception throughout the entire study period including the washout period and for 3 months (men) or 1 week (women) after the study is completed
* Men must not donate sperm from the first drug administration until 3 months after completion of the study
* Each participant will receive a test for opioid dependency. Only those participants that pass this challenge test will be allowed to continue in this study
* Non-smoker

Exclusion Criteria:

* History of or current clinically significant medical illness, disease or condition that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
* Clinically significant abnormal laboratorial values
* Clinically significant abnormal physical examination, vital signs or electrocardiogram (ECG)
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, oral contraceptives and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled
* History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years
Effectivity and Safety of Endoscopic Ultrasonography-guided Laser Ablation for Refractory Neoplasms

The purpose of this study is to evaluate the safety and efficacy of endoscopic ultrasonography (EUS) guided laser ablation liver, pancreas, and retroperitoneal tumors, the investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with refractory neoplasms including small hepatocellular carcinoma adjacent to the gastrointestinal tract, pancreatic neuroendocrine tumor, retroperitoneal tumor with less than 3 cm in diameter;
* Patients with Child-Pugh A/B;
* Patients with PLT ≥ 50\*10E9/L and PT ≤ 20s.

Exclusion Criteria:

* Patients with severe cardiopulmonary disease, intolerant endoscopy and anesthesia, upper gastrointestinal bleeding in shock, corrosive esophagitis and acute gastritis.
ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus (T2DM)

This is a Phase 1, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of ALT-801 and its effects on glucose control in overweight and obese subjects with type 2 diabetes mellitus (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed prior to the performance of any study procedures
* Male or female volunteers, age 18 to 65 years, inclusive
* Overweight to obese (BMI 28.0 - 40.0 kg/m2)
* Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening, of any combination of (1) diet and exercise, (2) metformin with absent or mild gastrointestinal symptoms (nausea, vomiting or diarrhea), and/or (3) sodium glucose cotransporter-2 (SGLT-2) therapy
* Female subjects of childbearing potential who are not pregnant or breastfeeding, do not plan to become pregnant during the study, and agree to use effective birth control

Exclusion Criteria:

* Type 1 diabetes mellitus (DM) and/or insulin-dependent T2DM, or uncontrolled T2DM defined as hemoglobin A1c (HbA1c) ≥ 9.5% or C-peptide ≤ 8 ng/mL
* History of acute or chronic pancreatitis or hypersensitivity reaction to GLP-1 analogues
Alternative Support for Rural and Isolated Women in an HMO

Evaluate the effects of a workbook/journal for helping isolated women to cope with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* 1) is a woman; and 2) has been diagnosed with primary breast cancer

Exclusion Criteria:

* 1) is under 18; or 2) can not speak and read in English
Association Between Body Composition and Pain in Spinal Cord Injury

The purposes of the study are to quantify and compare relationships among acute changes in inflammatory markers and evoked pain sensitivity after a high-fat meal (HFM) challenge, compared to a moderate-fat meal challenge, and explore the influence of body composition on these responses, in individuals with chronic spinal cord injury


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* SCI occurring at least 2 years prior to study entry
* Neurological level of injury (LOI) between C4 and L2
* American Spinal Injury Association Impairment Scale (AIS) A-D
* English-speaking.

Exclusion Criteria:

* Cognitive dysfunction that limits ability to adequately understand the risks of the study or are otherwise unable to consent
* Health conditions associated with chronic systemic inflammation unrelated to weight or adiposity (e.g., systemic autoimmune diseases, recurrent or active urinary tract infection, pressure injury \> Stage 2)
* Conditions that preclude measurement of body composition by dual-energy x-ray absorptiometry (DXA; e.g., lower limb contracture \> 15 degrees)
* Inability to obtain free-flowing blood from a superficial forearm or hand vein
* Pregnant women
* Prisoners
Effect of Sperm Selection Techniques on Human Neonatal Gender Ratio in Patients Undergoing ICSI

babies of known gender born out of 388 ICSI cycles were investigated for the gender ratio and then divided into three groups according to the sperm selection technique used before performing sperm injection. Statistical analysis were made to compare ratios and compare results of three arms

A total of 529 babies of known gender born out of 388 ICSI cycles between August 2016 and May 2018 at Ganin Fertility Center, Cairo, Egypt, were investigated for the gender ratio and then divided into three groups according to the sperm selection technique used before performing sperm injection; DGC (237 neonates out of 173 ICSI cycles), PICSI (147 neonates out of 109 ICSI cycles) , and MACS (145 neonates out of 106 ICSI cycles). In PICSI and MACS groups. Power analysis was done by comparing the sex ratio of the neonates between DGC, PICSI and MACS. The chi-squared test for independent samples was chosen to perform the power analysis with α-error level at 0.05. P values less than 0.05 were considered statistically significant. All statistical calculations were done using IBM SPSS (Statistical Package for the Social Science; IBM Corp, Armonk, NY, USA) release 22 for Microsoft Windows.

Eligibility Criteria:
Inclusion Criteria:

* Full Term Delivery
* ICSI cases using DGC for sperm selection
* ICSI cases using MACS for sperm selection
* ICSI cases using PICSI dishes for sperm selection
* Fresh blastocyst stage embryo transfer at
* Fresh ejaculate

Exclusion Criteria:

* Frozen sperm
* Frozen Embryo transfer
* Fresh cleavage stage embryo transfer
* Vanishing Twin Syndrome
* Fetal Reduction
* Preimlantation genetically screened embryo transfer
Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus

The main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE).


Eligibility Criteria:
Inclusion Criteria:

* Completion of SLE Study (NCT03252587) through the protocol-required treatment period, and currently receiving blinded study drug. Note: If a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product \[IP\] due to COVID-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the BMS Clinical Trial Physician or designee.

Exclusion Criteria:

* Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason
* Evidence of active tuberculosis (TB)

Other protocol-defined inclusion/exclusion criteria apply