rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
The Role Of Laserpuncture For Prevention Of Nausea And Vomiting Post Strabismus Surgery With General Anesthesia In Adult Patients
Status: Recruiting

This study to determine the effectiveness of a combination of pre-surgical laserpuncture with standard anti-emetic therapy for PONV symptoms in adult patients after strabismus surgery under general anesthesia compared to a combination of pre-surgical placebo laserpuncture with standard anti-emetic therapy. Research design using a double blinded randomized controlled trial (RCT) where research subjects and data takers who will be disguised. The research will be carried out in the Operation and Inpatient Room, Kirana Building, RSUPN Dr. Cipto Mangunkusumo (RSCM) with research subjects as adult patients undergoing strabismus surgery under general anesthesia. Assessment of nausea and vomiting using AVS ( Analog Visual Scale) consists of scoring using a score from 1-5 which indicates the severity of nausea and vomiting.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult patients aged 18-59 years. Patients undergoing simple strabismus surgery involving no more than two muscles without transposition under general anesthesia. Meets the ASA (American Society of Anesthesiologists) score of 1-2. Complete the surgical preparations according to the presedation sheet. Sign the informed consent sheet. Patients who can communicate with the research team. Patients undergoing surgery <3 hours.  Exclusion Criteria:  The patient is pregnant. Patients who have a history of drug or drug abuse. Patients with hypersensitivity to laser light. There are wounds or skin disorders at the radiation site (skin TB, SLE(Systemic Lupus Erythematosus) skin Patients who have gastrointestinal diseases (intestinal obstruction, peristaltic disorders gastrointestinal tract, gastroenteritis, irritable bowel syndrome, dyspepsia,gastroesophageal reflux disease/GERD, appendicitis, hepatitis, cholecystitis, inflammatory bowel synchrome, pancreatitis, peptic ulcer, peritonitis, food poisoning). Patients with metabolic diseases (acid-base imbalance, metabolic diseases calcium, glucose metabolism disease, hyperlactemia, mitochondrial disease, phenylketonuria) Patients with conditions of high intracranial pressure, head trauma, migraines, disease with symptoms of seizures, vestibular diseases, malignancies, mental and psychogenic diseases, diseases arising from consumption of drugs, nephrolithiasis, other kidney diseases, myocardial infarction, as well as the occurrence of nausea and vomiting before surgery. Infection accompanied by high fever (temperature >38°C) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 59 Years - StdAgeList: Adult
Profiling Microbiome Associated Metabolic Pathways in oesophageaL cancEr Survivors
Status: Recruiting

The goal of this observational study is to learn about long term symptoms in oesophageal cancer survivors. The main question it aims to answer is are:

Study the changes in gut bacteria by examining saliva, stool and blood.
Investigate the products of bacteria in breath to develop a non-invasive breath test to detect the changes in gut bacteria.
Develop new strategies to treat this change and trial new treatments to improve quality- of-life in oesophageal cancer survivors.

Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of breath, saliva, blood, urine, stool and complete validated healthy-related quality-of-life questionnaires.

Researchers will compare symptomatic and asymptomatic participants to detect the changes stated above.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male and female patients aged 18-90 years Patients who underwent oesophagectomy for oesophageal adenocarcinoma with curative intent Disease free patients (CT with no evidence of recurrence within last 6 months or more than 5 years post oesophageal resection) Patients more than 1 year post oesophageal resection  Exclusion Criteria:  Patients with Siewert III gastro-oesophageal junctional tumours Patients with evidence of disease recurrence Patients who are unable or unwilling to provide informed written consent Patients who have received antibiotic therapy within the last 4 weeks - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Disease free survivors who underwent curative treatment for oesophageal adenocarcinoma - SamplingMethod: Non-Probability Sample
STUDY TO EVALUATE THE WILLINGNESS OF HEALTHY VOLUNTEERS, PATIENTS, DOCTORS AND PHARMACEUTICAL/BIOTECHNOLOGY INDUSTRY TO USE A PLATFORM (WEB OR APP) TO FACILITATE RECRUITMENT AND ENGAGEMENT IN EARLY PHASE CLINICAL TRIALS . A SURVEY STUDY.
Status: Not yet recruiting

Study objective:

To assess whether the different stakeholders (volunteers, patients, doctors and industry) involved in early phase trials would be interested in using a platform to facilitate recruitment and engagement in this type of trials. In addition, we will also evaluate the degree of awareness existing in society about clinical trials.

Study subjects: General population, patient, physicians, pharmaceutical-biotechnological industry.

Keywords: healthy volunteer, patient, pharma industry, patient associaiton, questionnaire, clinical trial, platform, recruitment, engagement.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participant will be over 18 years old. Male, female or do not want to specify. Participants will be capable to understand spanish language. Subjects able to communicate with the investigator and able to read and write and follow all study instructions.  Exclusion Criteria:  Individuals not willing to complete the eraly phase clinical trial platform Study survey Individuals who do not meet eligibility criteria - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult
Cardio-Oncology Rehabilitation Care Process
Status: Recruiting

The objective of this observational study is to assess the outcomes of a hospital-based Cardio-Oncology Rehabilitation (CORe) program focused on exercise in cancer patients undergoing cardiotoxic treatment. This evaluation will be conducted by analyzing disease-related health indicators, functional capacity, and quality of life. Patients at risk of cardiotoxicity attending the Cardio-Onco-Hematology Unit will be offered the exercise program, which includes two modalities: in-person (center-based) and remote (home-based) options. The assignment to either modality is non randomized, based on the functional assessment conducted in the Rehabilitation Unit and the agreement between healthcare professional and patient. All participants will perform a 3-month supervised exercise intervention. There are 3 time points for assessment: at baseline (T0), 3-month after the exercise program (T1) and follow-up at 9 months from baseline (T2).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  High risk of cancer treatment-related cardiotoxicity Possibility of completing a cardio-onco rehabilitation program (centre-based or home-based) and programmed visits. Providing written informed consent.  Exclusion Criteria:  Patients with physical or mental limitation to carry out an exercise program. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Women with breast cancer at high risk of developing cardiotoxicity - SamplingMethod: Non-Probability Sample
MRI Guided Prostate Biopsy
Status: Recruiting

This study aims to assess the feasibility of magnetic resonance (MR) guided prostate biopsy using a needle holder frame. This frame is used to help position the needle used for the biopsy. The feasibility in this study is defined as whether the needle holder frame enables accurate tissue sampling from a suspicious region in the prostate found on an MR image. If it does, a biopsy can be carried out with the needle holder frame safely in a clinical routine. The study will be conducted during a routine MR-guided prostate biopsy procedure with an investigational needle holder frame instead of a conventional needle-guiding template.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Either an abnormal serum prostate-specific antigen (PSA) level (> 4ng/Ml) or a palpable nodule in the prostate on digital rectal examination or prostate MRI suspicious lesion.. Diagnostic MRI of the prostate gland. Age > 30 years Signed informed consent. No contra-indications to MRI, i.e. no cardiac pacemaker. No recent or ongoing active ischemic heart disease.  Exclusion Criteria:  Inability to give informed consent. Contra-indications to MRI- cardiac pacemaker, inner ear implants, non-MR compatible intracranial aneurysm clips. Recent or ongoing active ischemic heart disease such as recent or ongoing angina. - HealthyVolunteers: No - Gender: Male - MinimumAge: 30 Years - StdAgeList: Adult, Older Adult
Platelet Rich Plasma Combined With Human Umbilical Cord Mesenchymal Stem Cells for Stage 3 and 4 Stress Injury
Status: Recruiting

This study is an open-label, single-center trial which aim to evaluate of efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) combined with platelet-rich plasma (PRP) in stage 3 and 4 stress injury.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18-80 years old, regardless of gender; Patients with stage 3 and stage 4 pressure injuries (According to National Pressure Ulcer Advisory Panel (NPUAP)/European Pressure Ulcer Advisory Panel (EPUAP) classification system for pressure ulcers); There were no complications affecting the wound healing; After through debridement for the first time, the wound volume meets the requirement of "10-100cm3"; Platelet count before treatment 100~300×109/L; The patient voluntarily participates and signs an informed consent form.  Exclusion Criteria:  Individuals with coagulation dysfunction or hemorrhagic diseases; People with skin diseases, diabetes and immune diseases; Individuals with mental or psychological disorders; Individuals with allergies to multiple drugs; Pregnant or lactating women; Those who need to take medication that affects platelet and coagulation function for a long time or in the near future, but have not stopped taking medication within the past week. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
The Role of Immune Checkpoints in Lung Transplant (ILTRA)
Status: Not yet recruiting

The goal of this observational study is to learn about rejection in lung transplantation.

The main question it aims to answer is:

• what is the role of immune checkpoints in lung transplantation? Participants will describe pathways of rejection in lung transplantation analyzing the immune checkpoints on explanted lungs as well as trans-bronchial biopsies.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Lung transplant patients  Exclusion Criteria:  Hyperimmunized patients History of auto-immune disorders - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Cohort 1: Participants who received lung re-transplantation for chronic lung allograft dysfunction.  Cohort 2 and 3: Participants who received first lung transplantation for end stage respiratory insufficiency. - SamplingMethod: Non-Probability Sample
Treatment of Premature Ovarian Insufficiency Using Bone Marrow Cells
Status: Recruiting

investigator is doing single armed clinical interventional study to treat premature ovarian insufficiency with autologous bone marrow derived mononuclear cells to be given systematically and locally to the ovaries under ultrasound guidance with experienced gynecologist and to look for the results including: laboratory evidence through hormonal study ultrasound proof of ovarian follicle development. premature ovarian insufficiency is characterized by early loss of ovarian function (less than 40 years of age) manifested by menstrual irregularity or amenorrhea with elevated levels of gonadotropin hormones and low estrogen and anti-Mullerian hormone.

Autologous use of stem cells from bone marrow are alternative safe minimal manipulative products that can provide a solution to this clinical problem without the need for oocyte donation program.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  clinical diagnosis of premature Ovarian insufficiency. ineffective hormonal therapy. biochemical evidence of high gonadotropins.  Exclusion criteria:  solid or hematological malignancies. bleeding disorders. rejection of the procedure. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: mainly related to females - MinimumAge: 30 Years - MaximumAge: 60 Years - StdAgeList: Adult
"Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex"
Status: Not yet recruiting

This research project compares the effectiveness of different surgical techniques for lengthening the gastrocnemius-soleus system in patients with equinus deformity. The study will compare 2 techniques: gastrocnemius tendon recession (Strayer) and plantaris resection. Increased ankle range of motion, complications, operative time, recovery time, pain scales and function will be measured. The results will help determine which technique is most effective and safe for correcting equinus deformity.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Clinical and radiological diagnosis of clubfoot. Limitation of passive dorsiflexion of the ankle (<10°). Associated pain and functional limitation Absence of previous ankle/foot surgeries  Exclusion criteria:  Neurologic or congenital disease. Advanced ankle joint osteoarthritis Peripheral vascular insufficiency Uncontrolled diabetes mellitus Severe hepatic or renal disease Coagulopathies or anticoagulant therapy - HealthyVolunteers: No - Gender: All - MinimumAge: 10 Years - MaximumAge: 90 Years - StdAgeList: Child, Adult, Older Adult
Nature-based Mindfulness Intervention Program for Family Carers
Status: Recruiting

The program integrates ordinary mindfulness exercise with nature environment. Participants will be able to practice mindfulness in a natural environment in some of the program sessions. The study will study the effects of nature-based mindfulness program in reducing caregiving stress. The program will last for 4 session, 8 hours in total.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  parents with children experiencing divorce or separation parents of children with special needs family caregivers who are the primary caregivers of an older adult with dementia  Exclusion Criteria:  parents or caregivers who cannot understand Cantonese version of Chinese parents or caregivers who have psychosis or developmental disabilities who are not able to comprehend the program - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
5E Program for Preventing Venous Thromboembolism in Patients With Spinal Cord Disorders
Status: Not yet recruiting

The goal of this quasi-experimental study is to examine the effects of a venous thromboembolism prevention program, or "5E" program, on the rates of venous thromboembolism in patients with spinal cord disorders. The main questions it aims to answer are:

Will participants receiving the 5E program have lower rates of venous thromboembolism compared to those receiving the usual care?
Will participants receiving the 5E program have lower scores of venous thromboembolism signs and symptoms compared to those receiving the usual care?
Will the average thigh and calf circumferences of participants before and after receiving the 5E program be different?

Participants in the intervention group will receive the 5E program, including

Education: health education regarding venous thromboembolism prevention
Elevation: leg elevation of 10-20 degrees
Exercise: ankle exercises
Enough fluid: adequate fluid uptake
Early application of intermittent pneumatic compression (IPC): IPC use within 48 hours after admission

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Caprini scores of 5-8 and >8 Able to communicate in the Thai language Willing to participate in this study  Exclusion Criteria:  Alteration of consciousness Experiencing complications, including neurogenic shock and autonomic dysreflexia Being pregnant Having fluid restriction - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Adult Trauma Centers RE-AIM at Gun Safety (ACTFAST) Prevention
Status: Not yet recruiting

The goal of this interventional study is to evaluate the implementation and effectiveness of a comprehensive a universal firearm injury prevention program, ACTFAST (Adopting Comprehensive Training for FireArm Safety in Trauma centers), in level 1 trauma centers. The main aims of the study are:

(Primary Aim 1) Increase the adoption, implementation, and maintenance of a universal firearm injury prevention intervention at three participating trauma centers in the mid-Atlantic states;
(Primary Aim 2) Assess firearm injury prevention knowledge, attitudes, and safe storage practices among trauma patients treated within participating trauma centers.

Eligibility:
- EligibilityCriteria: Electronic Medical Record (EMR) Participants:  Inclusion Criteria:  trauma patients admitted to adult trauma inpatient services at participating institutions  Exclusion Criteria:  none  Patient participants  Inclusion Criteria:  at least 18 years of age; admitted to a participating trauma service for an injury; fluent in English or Spanish; able to provide written consent.  Exclusion Criteria:  prisoner or in police custody; admitted due to suicide attempt any acute conditions that would preclude provision of informed consent or assent (i.e., acute psychosis, altered mental status, cognitive impairment).  Staff participants  Inclusion Criteria:  trauma service physician, physician assistant, nurse practitioner, nurse or social worker at participating pediatric trauma center  Exclusion Criteria:  none - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Trial of INI-4001 in Patients With Advanced Solid Tumours
Status: Not yet recruiting

Phase 1 open-label, dose-escalation and dose-expansion study of INI-4001 as a single agent and in combination with approved checkpoint inhibitors in subjects with advanced solid tumors.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient has locally advanced or metastatic cancer (all solid tumours allowed except primary brain/CNS tumour or untreated spinal cord compression) Patient has at least one extracranial measurable disease lesion per RECIST 1.1/ iRECIST criteria.  Patients with known brain metastases are eligible if they meet all the following criteria:  Patient has received definitive treatment of brain metastases with stereotactic body radiation therapy (SBRT) or surgery provided that the brain lesions are stable (without evidence of progression by imaging for at least 4 weeks before the first dose of study treatment) Patient is neurologically stable and has had no persistent side effects / complications from prior treatment. Patient has no evidence of new or enlarging brain metastases (confirmed by repeat imaging) and has not required steroids for at least 14 days prior to first dose administration on Day 1. Female patients must be of non-child-bearing potential i.e., surgically sterilised at least 6 weeks before the screening visit or postmenopausal  Exclusion Criteria:  Prior therapy with a TLR7 and/or TLR8 agonist, unless first approved by the medical monitor. Has primary brain/CNS tumour or untreated spinal cord compression. Has known active, uncontrolled brain or CNS metastases and/or carcinomatous meningitis. Evidence of abnormal cardiac function Clinically significant active infection within 2 weeks prior to commencement of treatment, or unexplained fever (temperature > 38.1°C) within 7 days prior to first dose administration on Cycle 1 Day 1. Known active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit. History of other malignancy not meeting inclusion criterion #1 within the past 2 years Major surgery within 28 days of Cycle 1, Day 1, or minor surgical procedures within 7 days of Cycle 1, Day 1. Received cancer-directed therapy A history of autoimmune diseases that has caused terminal organ damage or required systemic immunosuppression / systemic disease modulating drugs within the past 2 years. Chronic use of immune-suppressive drugs (i.e., systemic corticosteroids used in the management of cancer or non-cancer related illnesses, (e.g., COPD) in dosing exceeding 10 mg daily of prednisone equivalent). Inhaled steroids are allowed. History of prior organ allograft. Known hypersensitivity to the study drug or its inactive ingredients. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Enhancing Prospective Thinking in Early Recovery
Status: Recruiting

The goal of this clinical trial is to use a novel virtual reality intervention to test for efficacy in reducing alcohol use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering alcohol use disorder (AUD) persons. The main question[s] this trial aims to answer are:

Will the Virtual Reality (VR) intervention decrease the number of stimulant use days? Will the VR intervention produce longer abstinence periods during follow-up visits? Will the VR intervention increase alcohol abstinence rates? Will the VR intervention increase future self-identification? Will the VR intervention increase self-reported future time perspective? Will the VR intervention increase preference for delayed rewards in a laboratory delay discounting task on the study day? Will the VR intervention produce gains in the behavioral effects of future self-identification, future time perspective, and delayed rewards at the 30-day and 6-month follow-ups? Researchers will compare the experimental and control groups to see if there are differences in the results for the questions outlined above.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Abstinence between ≥14 days and ≤1 year Verbal endorsement of commitment to recovery Outpatient Psychotropic drugs for SUD-comorbidity Drug/alcohol abstinence ≥ 24 hours at the time of the study day visit English comprehension  Exclusion Criteria:  Unstable medical disorders Habitual drug use Mu-opioid drugs Smell/taste disorders Unstable psychiatric conditions Extravagant/elaborate face tattoos - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult