cyrilzakka/clinical-trials huggingface dataset:
Impact of Essure Tubal Sterilization Devices on the Endometrium

The mobilization of natural killer cells (uNK) triggers and coordinates all stages of embryo implantation. They are at the origin of the local secretion of cytokines, growth factors, chemokines affecting vascular development and the local immunotrophisme for the conceptus. The main objective of this study is to evaluate the expression of endometrial uNK cells before and after tubal obstruction by Essure devices. Endoluminal and endometrial levels of various cytokines and growth factors will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 3 months of follow up
* The patient has had at least one child
* The patient desires definitive tubal sterilization via the ESSURE technique
* The legal delay of 4 months between request for sterilization and surgery has been respected
* Local contraception (condom or spermicide) must be used for three months before and after tubal sterilization

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient had a diagnosed pregnancy (this includes pregnancies lost or interruptions in the 2nd or 3rd trimester) within the 4 months before ESSURE implants
* The patient has a contraindication for a treatment used in this study
* The patient uses one of the following types of contraception: intrauterine device; oestroprogestatif (pill).
* Endometriosis
* Gynecological infection
* adenomyosis
* uterine polyp
* uterine surgery
Patient Preferences on Same-day Bilateral Intravitreal Dexamethasone Injections

Intravitreal injections with dexamethasone implant (Ozurdex®) provide a reasonable and long-lasting treatment option in the cases of diabetic macular edema, as well as macular edema resulting from retinal vein occlusion and noninfectious posterior uveitis. During the course of these diseases, both eyes may be affected and may need therapy. The treatment burden associated with frequent medical visits associated with treatments in both eyes and follow-ups can be significant for patients and caregivers alike. Same-session bilateral ophthalmic procedures have proven safe and cost-effective, with patients consistently expressing a strong preference for this approach, particularly in the cases of cataract surgery and anti-VEGF injections when given the choice. The safety profile of same-day bilateral dexamethasone injections aligns with those of unilateral injections.

This patient preference study will focus on addressing the practical aspects of same-day bilateral dexamethasone injections from the patients' perspective and aims to explore the impact of personal and socio-economic variables, and the overall perspective of patients on choosing same-day bilateral dexamethasone injections. Understanding and mitigating the challenges patients face can lead to a more patient-friendly and resource-saving approach. Based on the outcomes of this study, considerations may be made to introduce bilateral injections at our department, potentially optimizing patient experience and clinical resources.

The aim of the study is to establish patient preferences regarding the administration of intravitreal dexamethasone implant injections in both eyes on the same day, in the same session and to identify key motivating and limiting factors from the patients' perspective.


Eligibility Criteria:
Inclusion criteria

* Having received at least one intravitreal dexamethasone implant in either eye
* \>18 years of age
* Capacity to comprehend and answer questions in Danish language
* Signed informed consent

Exclusion criteria

• No intravitreal dexamethasone implant received within the last 12 months
Efficacy and Safety of Conbercept for Diabetic Macular Edema Combined With Severe Non-proliferative Diabetic Retinopathy

The goal of this prospective multicenter open label study is to evaluate the efficacy and safety of intravitreal injection Conbercept (IVC) for the treatment of diabetic macular edema (DME) combined with severe nonproliferative diabetes retinopathy (sNPDR).

The main questions it aims to answer are:

* mean changes in best corrected visual acuity (BCVA) and central macular thickness (CMT) in comparison with baseline at 12 months after initial treatment
* proportion of eyes with visual gain ≥15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) chart and ≥2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score after 12 months of the treatment
* proportion of eyes actually underwent PRP treatment after 3 and 12 months of the treatment
* mean changes in BCVA and CMT from baseline to monthly follow-up time point
* complications and adverse effects


Eligibility Criteria:
Inclusion Criteria:

* symptomatic patients aged 18 years or above with center involved diabetic macular edema in the involved eye and without clinically significant diabetic macular edema in the fellow eye defined on the basis of spectral-domain optical coherence tomography (OCT)
* central macular thickness (CMT) ≥300 μm measured by OCT
* the involved eyes diagnosed as severe non-proliferative diabetic retinopathy (sNPDR) confirmed by two independent experienced ophthalmologists based on the ETDRS standard seven field color fundus photographs

Exclusion Criteria:

* concomitant or previous macular diseases that may hinder visual improvement other than diabetic retinopathy (e.g., retinal vein occlusion, age-associated macular degeneration, uveitis, vitreomacular traction or epiretinal membrane)
* history of glaucoma or optic neuropathy of any kind
* previous vitreoretinal surgery or pan-retinal photocoagulation
* intravitreal injection anti-VEGF drugs within 6 months or intravitreal injection glucocorticoid within 3 months
* macular focal/grid laser photocoagulation within 3 months
Study of Oral cMET Inhibitor INC280 in Chinese Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (NSCLC)

A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult Chinese patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) who have received one or two prior lines of systemic therapy for advanced/metastatic disease as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.


Eligibility Criteria:
Inclusion Criteria:

* Stage IIIB or IV NSCLC (any histology) at the time of study entry
* Histologically or cytologically confirmed diagnosis of NSCLC that is:

  1. EGFR wt as per patient standard of care by a validated test
  2. AND ALK-negative rearrangement as part of the patient standard of care by a validated test
  3. AND (by central assessment) either:

     * Cohort 1: Pre-treated patients with cMET GCN ≥ 6 or
     * Cohort 2: Pre-treated patients with cMET GCN ≥4 and \< 6, or
     * Cohort 3: Pre-treated patients with cMET mutations regardless of cMET GCN, or
* Patients must have failed one or two prior lines of systemic therapy for advanced/metastatic disease
* At least one measurable lesion as defined by RECIST 1.1
* Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter the study.
* Patients must have adequate organ function
* ECOG performance status (PS) of 0 or 1

Details and other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Prior treatment with crizotinib, or any other cMET or HGF inhibitor
* Patients with characterized EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 mutations
* Patients with characterized ALK-positive rearrangement
* Clinically significant, uncontrolled heart diseases.
* Patients receiving treatment with medications that cannot be discontinued at least 1 week prior to first INC280 treatment and for the duration of the study:

  * Strong and moderate inhibitors of CYP3A4
  * Strong inducers of CYP3A4
* Impairment of GI function or GI disease that may significantly alter the absorption of INC280
* Patients receiving treatment with any enzyme-inducing anticonvulsant
* Previous anti-cancer and investigational agents within 4 weeks or ≤ 5 x half-life of the agent (whichever is longer) before first dose
* Pregnant or nursing women
* Women of child-bearing potential, unless they are using highly effective methods of contraception
* Sexually active males unless they use a condom during intercourse

Other protocol-defined exclusion criteria may apply
GO-ACTIWE Energy Metabolism

The aim of the present study is to investigate the changes in body composition and the degree of compensation to exercise induced energy expenditure after 1 year of physical activity with either moderate or vigorous intensity in overweight and class 1 obese men and women. The present study is a sub study to main study "Active Commuting To Improve Well-being and Health in Everyday Life" (NCT 01962259)


Eligibility Criteria:
Inclusion Criteria:

* Participation in main study (NCT 01962259)

Exclusion Criteria:

* No participation in main study
Signal Analysis for Neurocritical Patients

The project uses big data analysis techniques such as wavelet transform and deep learning to analyze physiological signals from neurocritical patients and build a model to evaluate intracranial condition and to predict neurological outcome. By identification of correlations among these parameters and their trends, we may achieve early detection of anomalies and enhance the ability in judgement of current neurological condition and prediction of prognosis. By continuous input of the past and contemporary data in the ICU, the model will be modified repeatedly and its accuracy improves as the model grows. The model can be used to recognize abnormalities earlier and provide a warning system. Clinicians taking care of neurocritical patients can adjust their treatment policy and evaluate the outcome according to such system.


Eligibility Criteria:
Inclusion Criteria:

* Age equal to or older than 20 years
* Neurocritical patients admitted to intensive care unit (ICU), including but not limited to traumatic brain injury, hemorrhagic stroke, ischemic stroke, brain infection, brain tumor and acute hydrocephalus.
* Patients who have undergone cranial surgery and had intracranial pressure monitor inserted or external ventricular drainage. The central monitor of ICU is able to collect the data continuously

Exclusion Criteria:

* Age younger than 20 years.
* Continuous monitoring of intracranial pressure is not feasible.
Lung Open Ventilation to Decrease Mortality in the Acute Respiratory Distress Syndrome

A multinational, randomized trial comparing two lung protecting strategies of respiratory life support among critically ill patients with severe lung injury.

To compare an innovative Lung Open Ventilation strategy with a proven low tidal volume strategy, hypothesizing that the Lung Open Ventilation strategy may reduce mortality, other organ dysfunction, and the duration of mechanical ventilation, intensive care, and hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Invasive mechanical ventilation
* Acute respiratory insufficiency (within past 28 days)
* Bilateral infiltrates on frontal chest radiograph
* Hypoxemia, defined as PaO2/FiO2\<=250

Exclusion Criteria:

* Primary cause of respiratory failure is cardiac
* Anticipated duration of mechanical ventilation \< 48 hours
* Inability to wean other experimental ventilation strategies
* Severe chronic respiratory disease
* Neuromuscular disease that will prolong mechanical ventilation
* Conditions where hypercapnia-induced intracranial hypertension should be avoided
* Morbid obesity (\> 1Kg per cm body weight)
* Pregnancy
* Very unlikely to survive and lack of commitment to life support Underlying irreversible condition with 6 month mortality \>= 50%
* Greater than 48 hours elapsed since first eligible
* Current participation in competing trial
* Lack of physician, patient or proxy consent
Post-operative Crohn's Endoscopic Recurrence Study

This randomised, controlled study aims to evaluate the impact of endoscopic assessment, and adjustment of therapy, after surgery in patients with Crohn's disease. The primary endpoint is the severity of endoscopic recurrence. In addition, tissue will be collected for microbiological and immunological analysis.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Crohn's and proven history of disease
* patient undergone surgical resection with creation of a primary anastomosis

Exclusion Criteria:

* endoscopically inaccessible anastomosis by standard colonoscopy
* presence of an end stoma
* pregnancy
* suspected perforation of the gastrointestinal tract
* presence of certain unsuitable comorbidities
Nthabi in Lesotho - Implementation

This project will determine how well the mobile health (mHealth) Nthabi application is introduced and used at district hospitals in Lesotho. This will help with measuring the effectiveness of an evidence-based mHealth application in a low-income country. Three factors will be studied when assessing the mHealth application's overall impact: 1) end-user content knowledge 2) pre and post stage of change and 3) system usage. This data will be collected by the mHealth application. End-users will use the mHealth application over a period of two months. Results will be shared with the clinical, health services research, information technology, and policy communities.

Lesotho has second-highest HIV and fifth-highest tuberculosis prevalence rates worldwide, and a maternal mortality rate (1024/100,000) that is among the highest in Africa. As there are only 6.2 nurses and 0.5 physicians per 10,000 people, both about one-third of the African average, there is an enormous need for eHealth systems to assist the clinical care system.

Preconception care is an effort to focus on engaging young women in their health before they become pregnant since many women enter pregnancy at risk for poor outcomes because of preexisting medical conditions or not following evidence-based preventive action. In 2013, the WHO prioritized research that focuses on developing, delivering, and scaling preconception women's health interventions in low and middle-income countries to optimize health and birth outcomes. The WHO emphasized implementation research as the key step in helping to maximize the coverage and uptake of preconception care to enhance the long-term health outcomes for women and their children.

The existing "Gabby" system is a patient-facing, user-friendly, evidence-based, scalable, culturally adaptive, health communication system designed to improve women's health. The investigator's team has developed and tested several Embodied Conversational Agents (ECAs), which are virtual characters designed using expertise from health communication, psychotherapy, social psychology, sociolinguistics, linguistics, and communication theory.

For this project, the investigators will first adapt the existing "Gabby" system to a culturally appropriate mHealth application, called "Nthabi", and second, study the impact of the Nthabi application into district hospitals in Lesotho in partnership with the Lesotho Boston Health Alliance (LeBoHA) using the existing educational infrastructure. The research team will assess the effectiveness of Nthabi based on the periodic stage of change assessments over the two-month implementation, end-user content knowledge, and system usage.

Eligibility Criteria:
Inclusion Criteria:

* Female Resident of Lesotho
* English Speaking
* Have access to an Android smartphone
* Not currently pregnant at time of enrollment

Exclusion Criteria:

-None
Primary Culture of Residual Specimens Obtained From Aspiration of Hepatic Tumor to Predict the Prognosis of the Patients

The aim of this project is to investigate whether the proliferative speeds of cultured cells using our method can be integrated into Barcelona Clinic Liver Cancer (BCLC) staging classification for the possibility of personalized treatment and prediction the outcomes in hepatocellular carcinoma (HCC) patients.

A total of at least 150 patients will be included and followed for at least one year. The proliferative speeds of cultured cells will be classified into (a) rapid proliferation of HCC cells with or without concomitant rapid proliferation of cancer-associated fibroblasts (CAFs), (b) rapid proliferation of CAFs alone, and (c) slow proliferation three groups. The definition for the rapid proliferation of cultured cells fits at least one of the following two items: (1) growth area of cultured cells at the 15th-28th day \> two times of the growth area measured at the 14th day, or (2) growth area of cultured cells at the 15th-28th day \> 70% growth area of the 25 cm flask. The GraphPad Prism software version 4.03 (GraphPad Software, Inc., La Jolla, CA, USA) is applied for statistical analysis. Influence of the proliferative speeds of cultured cells on survival and cancer progression will be calculated by the logrank test. The statistical significance is defined as P \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

1. Patients are proven to have HCC based on fine-needle aspiration of the tumor.
2. Patient have residual specimens obtained from fine-needle aspiration of the tumor.
3. Patients agree to participate this study after fully explanation.

Exclusion Criteria:

1. Patients are not proven to have HCC based on fine-needle aspiration of the tumor.
2. Patient do not have residual specimens obtained from fine-needle aspiration of the tumor.
3. Patients do not agree to participate this study after fully explanation.
To Compare Sweeping of Membranes Versus Expectant Management for Spontaneous Onset of Labor and Vaginal Delivery.

The study is planned to fill the gaps regarding the effectiveness of sweeping of membranes versus expectant management in terms of spontaneous onset of labor and vaginal delivery in post-date primigravida.

This study is important as it provides localized data on the effectiveness and practicality of membrane sweeping in a low-resource setting, which is underrepresented in current literature. Potential benefits of this research may include reduced need for formal labor induction, lower healthcare costs, and improved maternal and neonatal outcomes. The findings may enhance clinical practices by offering an evidence-based, patient-friendly approach to managing postdate pregnancies, particularly in resource-limited settings where induction facilities are constrained.

Eligibility Criteria:
Inclusion Criteria:

* Primigravid women
* Aged between 18 and 40 years
* Gestational age ≥40 weeks, confirmed by ultrasound or early dating scan
* Singleton pregnancies
* Cephalic presentation

Exclusion Criteria:

* Multiple gestations
* Fetal distress or anomalies detected on ultrasound
* Contraindications to vaginal delivery (e.g., placenta previa, previous uterine surgery)
* Previous uterine scar
Phase 3 Clinical Trial of CartiLife® in Korea

To evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) obtained by cultivating costal chondrocytes of the subject implanted into articular cartilage defects of the knee resulting from trauma or degeneration.

This open-label, phase 3 study is being conducted to evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) compared with microfracture surgery in adults with articular cartilage defects due to trauma or degeneration of the knee. It is hypothesized that CartiLife® treatment will demonstrate structural regeneration and improvement in function and pain at Week 48 compared to baseline.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following:

1. Patients over the age of 18.
2. Defect size: 2 to 10 cm\^2 on the unilateral knee cartilage (up to 4 ㎤ in volume).
3. Defect: isolated ICRS (International Cartilage Repair Society) grade III or IV single defect chondral lesion on articular cartilage with comparatively healthy cartilage present near the lesion site (ICRS Grade 1 \~ 2).
4. Patients with a KOOS total score below 55.
5. Patients able to walk without aid.
6. Patients who agree to abide by rehabilitation protocols and follow-up programs, including residential exercise routines.
7. Patients who provide written consent to the application of the clinical trial.

Exclusion Criteria:

Individuals who meet any of the following will be excluded from participation in this study:

1. Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis.
2. Patients scoring 3 or above on the Kellgren-Lawrence Grading Scale.
3. Patients with inflammatory articular diseases related to autoimmune diseases.
4. Patients hypersensitive to bovine derived proteins or any of the components in this product.
5. Patients hypersensitive to Gentamycin.
6. Patients with Haemophilia or markedly reduced immune function.
7. Patients with arterial bleeding and severe venous bleeding.
8. Patients with other diseases including tumors except for cartilaginous defects of joints.
9. Patients with a history of radiation treatment and chemotherapy within the past two years.
10. Patients who are pregnant, or nursing a baby.
11. Patients who participate in concurrent clinical trials or previous clinical trials within 30 days of administration.
12. Other cases where the investigator deems the patient ineligible for participation.