rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Spatial Profile of Tumors
Status: Not yet recruiting

The research project focuses on analyzing the spatial organization of cells within various solid tumors, utilizing advanced technologies enabling in-depth multi-parametric analysis of tumor and immune cells. The primary objective is to understand the spatial distribution of cellular subpopulations within each type of tumor, while secondary objectives include correlating these data with clinical aspects and identifying potential therapeutic targets. The study involves 1000 patients with primary or metastatic tumors and spans a duration of 5 years, from 2024 to 2028. No experimental treatments are planned; rather, only spatial imaging analyses with multiple markers will be conducted. Data analysis involves descriptive statistical methods and hypothesis testing to generate hypotheses for subsequent studies. The analyses will be performed using SPSS® version 21.0 software for Windows®.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  male or female subjects aged 18 years primary or metastatic tumors Diagnosed by histology and/or radiological evidence, RNM, or endoscopic signature of informed consent substitute declaration to the consent form where applicable  Exclusion Criteria:  previous unrelated tumour disease significant acute or chronic infections (HIV, HCV and HBV infections) and/or ongoing bacterial and viral infections active autoimmune disease pregnant or breastfeeding patients who do not sign informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will be 1000 adult male and female patients with primary or metastatic neoplastic pathology of the following types of cancer: lung cancer, colon cancer, salivary gland cancer, hepatocarcinoma, sarcomas, osteosarcomas, breast cancer, glioblastoma, kidney cancer, pancreatic cancer, neck cancer.  The patient samples that will be examined in the study are derived from biopsies that patients have been subjected to according to their treatment plan. - SamplingMethod: Probability Sample
Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes
Status: Not yet recruiting

This study is a randomized controlled trial to assess whether the implementation of a TKA Personalized Outcome Prediction Tool to set expectation, in addition to targeted interventions to address patients with poor baseline mental health and poor physical function, improves satisfaction at 1-year (when compared to standard of care).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult subject (Age >18 and < 80 years of age) The subject is proficient in the English language The patient is voluntarily prepared to sign the 'Informed Consent Form' The patient is scheduled for a unilateral primary TKA TKA PROMs Phenotypes with higher risk of dissatisfaction Patient is willing and able to complete the protocol required follow-up  Exclusion Criteria:  Patient requires simultaneous or staged bilateral knee replacements, staged <90 days apart Patients undergoing revision TKA Inflammatory arthritis History of infection in the joint undergoing TKA Patient is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Immunogenicity and Safety of Inactivated and Live-attenuated HAV Vaccine Among Thai Healthy Children and Adolescents
Status: Not yet recruiting

Hepatitis A virus (HAV) vaccine is an effective strategy to prevent natural HAV infection. In Thailand, there are 2 types of HAV vaccine available, including inactivated HAV vaccine and live-attenuated HAV vaccine. This study aims to compare the immunogenicity and safety of inactivated and lived-attenuated HAV vaccine among Thai healthy children and adolescents age 18 months to 18 years.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age between 18 months and 18 years Has healthy status Has no history of hepatitis A infection or previous hepatitis A disease Has never received hepatitis A vaccine (from vaccine booklet or parental history) Participants and/or caregivers gives written inform consent/assent form  Exclusion Criteria:  Has acute illness within 4 weeks before enrollment Has fever with jaundice within 4 weeks before enrollment Has underlying disease of thrombocytopenia, coagulopathy, hemophilia A or B, neurologic disease, immunocompromised condition, chronic liver disease, chronic hepatitis B or C infection Has received immunosuppressive agents or immunomodulatory agents, corticosteroid >2 mg/kg/day or 20 mg/day within 6 months before enrollment Has received blood or blood component, or intravenous immunoglobulin within 6 months before enrollment Has received any lived-attenuated vaccine within 30 days before enrollment Has history of severe allergy to vaccine or vaccine component, including aluminum hydroxide, 2-phenoxyethanol, neomycin, formaldehyde, gentamicin sulfate, or has history of anaphylaxis or severe allergic reactions following vaccination Women planning for pregnancy, pregnant women or lactating women Women in childbearing age who cannot use contraceptive methods during study participation Is concurrently involved in other clinical trials in which receiving an investigational vaccine or study drug as part of study participation Have any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Months - MaximumAge: 18 Years - StdAgeList: Child, Adult
Schema Therapy for Treatment-resistant Anxiety Disorders
Status: Not yet recruiting

The aim of this study is to assess the cost-effectiveness of schema therapy compared to treatment as usual (TAU) in patients with treatment-resistant anxiety disorders. In a multicenter randomized controlled trial, patients will be assigned to receive individual schema therapy (maximum of 40 sessions) or treatment as usual (control group) within one year. The primary outcome is the difference between ST and TAU conditions in anxiety symptoms as measured with the Beck Anxiety Inventroy (BAI) at post treatment. Secondary outcomes include quality of life, societal costs, general mental health, remission from the anxiety disorders and/or comorbid affective disorders, positive and negative effects of psychotherapy, schemas and schema modes, and satisfaction. Measurements take place at baseline and after 1, 3, 6, 12, 24 and 36 months (follow-up of two years).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Primary diagnosis of an anxiety disorder (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder, separation anxiety disorder and specific phobia) based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Fulfilling the criteria of treatment-resistance based on a systematic literature search by Bokma and collegues: i) at least one unsuccessful CBT treatment of ≥ 8 weeks; and ii) at least one unsuccessful pharmacological treatment with a serotonergic antidepressant of ≥ 8 weeks, and iii) moderate to severe anxiety symptoms (BAI > 11). The adequacy of previous treatment will be checked.  Exclusion Criteria:  Substance use dependence Acute suicidality Has received schema therapy in the past Has insufficient language skills in Dutch and/or English - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Characterization of Exosomes Platelets-released
Status: Recruiting

Extracellular vesicles (EVs) play a key role in cell-to-cell communication. They are small vesicles that contain rich molecular cargo. Recently, they have been proposed as biomarkers for clinical diagnostics. EVs include three classes: small EVs (exosomes), large EVs (microparticles), and apoptotic bodies. Platelet-derived EVs (PEVs) are the most abundant class in human blood and can actively participate in numerous physiological and pathological processes. The information about the role of platelet exosomes in cardiovascular disease and the effect of antiplatelet agents on their release and content is very limited.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  subjects without known pathologies  Exclusion Criteria:  individuals with gastrointestinal diseases, individuals with history of hepatic diseases, individuals with history of urogenital diseases, individuals with history of hematological diseases, individuals with history of immunological diseases, individuals with history of renal diseases, individuals with history of metabolic diseases individuals with history of respiratory diseases individuals with history of cancer individuals with history of cardiovascular disease individuals having permanent organ damage individuals with major trauma in the last 6 months prior to enrollment individuals with surgery in the last 6 months prior to enrollment individuals taking medication in the 15 days prior to enrolment. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: subjects without known pathologies - SamplingMethod: Probability Sample
Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients
Status: Not yet recruiting

Clinically significant portal hypertension (CSPH) is defined as HVPG >10 mmHg. Patients with CSPH are at risk of developing esophageal varices and clinical decompensation (variceal bleeding, ascites, jaundice, encephalopathy), which mark the transition from compensated stage to a stage of the disease (decompensated) associated with higher mortality (1). HVPG is calculated by subtracting the free hepatic venous pressure (FHVP), a measure of systemic pressure, from the wedged hepatic venous pressure (WHVP), a measure of hepatic sinusoidal pressure. HVPG is surrogate marker in many clinical applications such as gold standard test to evaluate presence and severity of portal hypertension (PHT) diagnosis, risk stratification, monitoring of the patients on beta blockers (2). Non selective beta-blockers like propranolol and carvedilol are indicated in adults for primary and secondary prophylaxis of variceal hemorrhage. Acute hemodynamic response to intravenous propranolol with HVPG values coming down to <12 mm Hg or reduction to >20% from baseline have been shown to be associated with reduced long term risk of variceal bleed. Hence we are planning the current work to study the Acute hemodynamiC response To Carvedilol predicts survival in ACLF patients - "ACT - C ACLF study

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 18-70 yrs ACLF diagnosis (AARC criteria)  Exclusion Criteria:  Contraindications to NSBB (Heart rate < 65 /min, BP < 110/65 mm Hg, Asthma, Heart failure, AKI, Large ascites, SBP, S. Na < 125meq/l) PVT HCC BCS HE grades 2-4 NSBB therapy within 5 days Pregnancy Lactation Planned for LT in the next 12 weeks No consent. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients of age 18 to 70 years with ACLF fulfilling the conditions as per inclusion and exclusion criteria - SamplingMethod: Non-Probability Sample
Long-term Follow-up Study of BRL-101 for TDT
Status: Not yet recruiting

Observe long-term safety risk and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Provision of written informed consent for this study by subjects, or as applicable, subject's parent(s)/legal guardian(s) Treated with BRL-101 for therapy of transfusion-dependent β-thalassemia.  Exclusion Criteria:  - There are no exclusion criteria for this study - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 35 Years - StdAgeList: Child, Adult - StudyPopulation: Subjects with transfusion-dependent β-thalassemia who have been treated with BRL-101. - SamplingMethod: Non-Probability Sample
Motorized Fine Needle Biopsy vs Standard Needles
Status: Recruiting

Recent improvements in punctures techniques and needles now allow for the collection of high-quality specimens comparable to core needle biopsy. A newly developed motorized fine needle biopsy (mFNB), the Precision-GI (Limaca, Israel) promises intact tissue acquisition without sample damage, relying on controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition.

Given the advancement mentioned, the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of endoscopic ultrasound (EUS)-guided pancreatic and liver specimens through a prospective, interventional, single-center trial. The study will consist of two groups of patients: one assigned to the standard fine needle biopsy (FNB) and the other to the mFNB. The primary study outcomes will include sample quality (core integrity), and diagnostic accuracy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients between 18 and 99 years Patients referred to our center who require EUS-guided liver or pancreas biopsy. Male or female patients. Patients able to give consent  Exclusion Criteria:  Pregnancy or nursing Patients with coagulation disorders (platelets <50.000/mm3, international normalised ratio (INR) >2) Any underlying medical condition that contraindicates EUS-guided fine needle biopsy such as anatomical alterations, significant gastric outlet obstruction, collateral intervening vessels. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult
The Efficacy of Combination Therapy in Atrophic Scars
Status: Not yet recruiting

There are more than 100 million patients who develop scar formation caused by various factors, such as post-inflammatory acne and trauma (1). They often have physical, aesthetic, psychological, and social barriers. Scar tissue is naturally a stage of wound healing. Abnormal wound healing produces a spectrum of scar tissue types such as atrophic, hypertrophic, and keloid scars (2).

Atrophic scars are dermal depressions, which are commonly caused by the destruction of collagen following inflammatory process. This permanent disfiguring sequelae correlates with the duration of pathology, severity of lesion, and delay in therapy (3).

Treatment of atrophic acne scars remains a therapeutic challenge, yet there is no standard option as the most effective treatment (4). A range of possible options has been investigated including surgical techniques (subcision, non-ablative laser treatment, resurfacing techniques (ablative laser treatment, dermabrasion), and injection or dermal fillers or fat, and a combination of two or more modalities (5).

Ultrasound is a unique non-invasive and non-radiating medical imaging tool in the investigation of dermatological diseases by providing detailed anatomic and physiologic data of skin lesions and deeper soft tissue changes. Lesion size in three dimensions-lengths, width, and depth, morphology, the detailed anatomic information provided by sonography is useful to assessment of effect of different types of treatment modality to improve atrophic scar and avoid invasive assessment tools as punch biopsy for histopathological examination (6)

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - Patients aged from 12 to 60 years with  post inflammatory atrophic scar. post traumatic atrophic scar. post operative atrophic scar  Exclusion Criteria:  post acne scar. active skin infection. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 12 Years - MaximumAge: 70 Years - StdAgeList: Child, Adult, Older Adult
The Utility of Mobile Based Application for Patient Reported Outcome Measures In Patients With Acetabular Fractures : A Randomized Clinical Trial
Status: Not yet recruiting

The primary objective of this study is to validate the feasibility of a remote patient monitoring (RPM) system using Mobile App in terms of the frequency of data interruptions and patient acceptance.

The secondary objective is to Improve quality of life and early prediction of the complications.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All patients aged more than 18 years who will have a surgery for an acetabular fracture at assiut university hospital.  Exclusion Criteria:  Patients younger than 18years old - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All patients aged more than 18 years who will have a surgery for an acetabular fracture at assiut university hospital. - SamplingMethod: Probability Sample
A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
Status: Not yet recruiting

This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed with gMG who are expected to start commercial efgartigimod at enrolment or who are within their first cycle of efgartigimod at enrolment or Patients diagnosed with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment Have provided appropriate written informed consent  Exclusion Criteria:  None - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients diagnosed with gMG - SamplingMethod: Non-Probability Sample
Autonomic and Metabolic Response to Cardiac Rehabilitation After Acute MI
Status: Recruiting

Ischemic heart disease remains the leading cause of death in the western world. The beneficial effects of cardiac rehabilitation on the evolution of ischemic heart disease are known, but the effects of rehabilitation on the metabolic processes of the patients are so far poorly understood. Metabolomics is the qualitative/quantitative analysis of the body's metabolic responses to pathophysiological stimuli or genetic alterations. Metabolic changes caused by physical activity have been demonstrated in obese and diabetic patients and in athletes. Aim of the study is to evaluate whether cardiac rehabilitation after a first myocardial infarction induces changes in the metabolic state of patients, and whether these changes may be related with changes in the usual risk factors (i.e. glyco-lipidic profile, natriuretic peptides, homocysteine).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  recent first acute myocardial infarction  Exclusion Criteria:  severe diabetes - HealthyVolunteers: No - Gender: Male - MinimumAge: 25 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All consecutive patients meeting the eligibility criteria will be proposed to participate in the study - SamplingMethod: Non-Probability Sample
Clinical Performance of HISTOACRYL® LAPFIX - CANNULA for Laparoscopic Inguinal Hernia Repair
Status: Not yet recruiting

The goal of this retrospective study is to identify the incidence of hernia recurrence following the application of Histoacryl® Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery. All adult patients who underwent laparoscopic inguinal hernia repair with Histoacryl® Lapfix - Cannula in the period June 2018 - March 2021 at Hospital San Juan de Dios will be analysed. The investigator team will access electronical medical records for the cohort of patients identified.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult patients (≥18 years old) treated between June 2018 and March 2021 at the Hospital San Juan de Dios for laparoscopic mesh fixation with Histoacryl Lapfix - Cannula after inguinal hernia repair surgery.  Exclusion Criteria:  No exclusion criteria has been set. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients (≥18 years old) treated in the period June 2018 to March 2021 at the Hospital San Juan de Dios for laparoscopic mesh fixation with Histoacryl Lapfix - Cannula after inguinal hernia repair surgery. - SamplingMethod: Non-Probability Sample
Evaluation of the Impact of Therapeutic Education Workshops for COPD Patients in the North-West Val d'Oise Area
Status: Not yet recruiting

The aim of this study is to assess the impact of the Patient Therapeutic Education (PTE) workshops offered by the Maison de Prévention de la Santé et d'Accompagnement Thérapeutique (MPSAT) on the follow-up and feelings of the COPD patients who take part. These workshops are organised outside the hospital environment and supervised by hospital and town professionals in the NOVO zone.

Eligibility:
- EligibilityCriteria: Inclusion Criteria :  Patient aged 18 or over Patient living in the NOVO hospital area and the border towns of Yvelines, Oise and Eure Patient with a diagnosis of COPD confirmed by EFR, whatever the stage  For PTE group :  - Patient who has already attended at least 3 PTE workshops offered by MPSAT  For Control group :  - Patient on waiting list for PTE workshops offered by MPSAT  Exclusion Criteria :  Patient refusing to take part in study Patient under legal protection Patient with cognitive disorders, unstable clinical conditions, language barriers or other conditions that prevent them from understanding the study and answering the questionnaires - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease.
Status: Not yet recruiting

The purpose of this study is to compare how effective and how tolerable two different bowel preparation laxatives are for colonoscopy. The aim is to compare oral sulfate solution (OSS) to another laxative called 2L polyethylene glycol (PEG) solution to see which is more effective and more tolerable by individuals with IBD (Crohn's disease or Ulcerative colitis).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Crohn's disease or ulcerative colitis patients scheduled or about to be scheduled for colonoscopy. Age > 18 years Out-patients  Exclusion Criteria:  Prior subtotal or total colorectal resection Contraindications to use of 2L polyethylene glycol (2L-PEG) or Oral Sulfate Solution (OSS): Known renal insufficiency, congestive heart failure, cirrhosis, severe electrolyte imbalance. Colonoscopy being repeated because of poor preparation in the preceding six months. Allergies to the employed bowel preparations Toxic megacolon, ileus, suspected or diagnosed bowel obstruction. IBD patients thought to be too sick to undergo a full colonoscopy preparation in the opinion of the investigator/treating physician; hospitalized crohn's disease or ulcerative colitis patients. Pregnancy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult