rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Family Intervention for Black Teens With Type 1 Diabetes
Status: Not yet recruiting

The purpose of this study is to conduct a multicenter, randomized effectiveness trial of The 3Ms 2.0 compared to an educational control condition for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with type 1 diabetes (T1D) and their primary caregivers. The proposed study would develop and test The 3Ms 2.0 adapted intervention when delivered using a mobile health approach (accessed via parents' cell phone). The intervention will also include new family intervention content (videoclips and text messages).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age: 10 years, 0 months - 14 years, 11 months Diagnosed with Type 1 diabetes Diagnosed for at least 6 months Black Primary caregiver willing to participate Residence within 30 miles of a recruitment site Caregiver ownership of an Internet-enabled device (cell phone, laptop or desktop computer, tablet, etc)  Exclusion Criteria:  Mental health conditions that might compromise data integrity (e.g., developmental delay, schizophrenia, psychosis, current suicidality, homicidality) Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis) Inability to speak or read English Child is in out-of-home placement - HealthyVolunteers: No - Gender: All - MinimumAge: 10 Years - MaximumAge: 14 Years - StdAgeList: Child
Comprehensive Assessment of Morphometric, Functional, Biomechanical and Biological Interactions Between Atherosclerotic Plaque and Platelets Within the Stenosed Coronary Artery
Status: Recruiting

The main objective of the present study is to verify, in vivo, whether shear forces computed solely based on coronary angiography and computational fluid dynamics (CFD) techniques are associated with the biomarkers indicating the prothrombotic tendency of circulating blood in situ - distally and proximally to the coronary stenosis. The study will prospectively assess the relationship between i) the value and distribution of shear rate and shear stress (SS) estimated using three-dimensional angiography and CFD techniques, and ii) atherosclerotic plaque characteristics as assessed by optical coherence tomography (OCT), iii) functional parameters of diseased vessels assessed by vessel fractional flow reserve (vFFR), and iv) in situ platelet activation, as expressed by platelet-derived microvesicles (pMVs) and small extracellular vesicles (sEVs), platelet aggregometry and other serum prothrombotic or inflammatory biomarkers sampled within the coronary artery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Chronic coronary syndrome Angiographically confirmed coronary stenosis (30% - 90%) Amenable to OCT imaging  Exclusion Criteria:  Cardiogenic shock ST-segment elevation or non-ST-segment elevation myocardial infarction Active bleeding Left main coronary artery disease Multivessel disease Lesions located at a distance ≤3 mm from the ostium of the vessel Thrombocytopenia Previous coronary artery bypass grafting Previous coronary intervention with stent implantation or balloon angioplasty Previous use of novel oral anticoagulants or vitamin K antagonists - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients will be enrolled presenting with chronic coronary syndrome and angiographically confirmed coronary stenosis (30% - 90%) amenable to OCT imaging (according to the operator's judgment). - SamplingMethod: Probability Sample
Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention
Status: Not yet recruiting

The IMAGINATION trial is an investigator-initiated, prospective, single-center study of symptomatic patients with a native chronic total occlusion (CTO) undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB). Post-PCI IVUS and fractional flow reserve (FFR) at baseline and at 6-months follow-up will be performed. In addition, patients included in the coronary computed tomography angiography (CCTA) substudy will undergo photon-counting CCTA at 12-months follow-up. The aim of this study is to evaluate the efficacy and safety of DCB-only approach in native coronary CTO.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  clinical indication for CTO PCI as determined by the local heart team (presence of angina or equivalent symptoms and/or documented ischemia or viability) native CTO lesion without severe calcification within the occlusion site as defined by invasive coronary angiography (according to Mintz et al. classification) informed consent for participation in the study  Exclusion Criteria:  <18 years of age myocardial infarction cardiogenic shock severe valvular disease estimated life expectancy <1 year contraindication to PCI positive pregnancy test or breast-feeding in-stent CTO severe calcification within the occlusion site as defined by invasive coronary angiography CTO recanalization using antegrade or retrograde dissection and re-entry techniques - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction
Status: Recruiting

This protocol studies the clinical outcome of patients with active thyroid disease with visually significant signs and symptoms of proptosis, pain, diplopiam lid/orbital edema, or lid/orbital erythema recommended for treatment with teprotumumab infusion (Tepezza®). Patients recommended for treatment will be evaluated by an oculoplastic surgeon (Dr. Eva Chou) and endocrinologist (Dr. Thanh Hoang).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  only DOD beneficiaries adult patients 18 years of age or older adult patients with proptosis, ocular/orbital pain, diplopia, lid/orbital edema, or lid/orbital erythema associated with autoimmune thyroid disease  Exclusion Criteria:  Patients with evidence of compressive optic neuropathy necessitating urgent orbital decompression or external beam radiation patients with a history of uncontrolled diabetes mellitus patients with a history/diagnosis of uncontrolled inflammatory bowel disease patients under age 18 years patients who are pregnant or trying to become pregnant. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study participants were 18-80 years old at the time of treatment with teprotumumab, diagnosed with autoimmune thyroid disease (positive stimulating thyroid receptor antibodies or elevated TSI), presenting with active eye disease (associated with at least one of the following: lid retraction of ≥2 mm, moderate or severe soft-tissue involvement, proptosis of ≥3 mm above the normal values for race and sex, and periodic or constant diplopia), and treated with at least one dose of teprotumumab. - SamplingMethod: Probability Sample
Repositioning Immunotherapy in VetArans With Lung Cancer
Status: Recruiting

This study is a multicenter Phase II single arm trial to assess the safety and efficacy of chemotherapy and immunotherapy followed by radiotherapy in patients with unresectable Stage III NSCLC.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants must be more than 18 years of age. Patient must have a performance status of 0-1 (ECOG Performance Scale). Patient must be a candidate for concurrent chemoradiation. Unresectable Stage III NSCLC as assessed by investigator or multidisciplinary tumor board assessment PD-L1 tumor expression greater than or equal to 1% Presence of measurable disease according to RECIST v1.1 Adequate organ function Available tissue (archival FFPE preferred) with adequate tumor content ( 20% tumor cellularity).  Exclusion Criteria:  Active autoimmune disease that has requires immunosuppressive therapy in the previous year. Uncontrolled primary or acquired immunodeficiency (including HIV) Baseline corticosteroid usage (>10 mg prednisone or equivalent daily) aside from supportive medication use. Tumor with known EGFR, ALK, ROS1, MET or RET mutations/fusions. Presence of significant comorbidities precluding participation in a clinical study as determined by investigator. Prior thoracic radiotherapy or prior systemic treatment for stage IIIB/IV NSCLC Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with informed consent through 180 days after the last dose of trial treatment. Has a known history of active TB (Bacillus Tuberculosis) Has known active Hepatitis B or Hepatitis C. Has received a live vaccine within 30 days of enrollment. Known diagnosis of Interstitial Lung Disease Inability to provide informed consent. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Dinutuximab Beta at the HUS and the Toulouse Oncopole
Status: Recruiting

In this study the investigators wish to describe the cohort of pediatric patients suffering from neuroblastoma and treated with Dinutuximab and to compare the costs and quality of life between the two French centers, the University Hospital of Strasbourg (HUS) and the Oncopole of Toulouse.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects aged 2 years to 25 years Male or female gender Subjects suffering from neuroblastoma and treated at the HUS or at the Oncopole center in Toulouse during the period from January 1, 1998 to December 31, 2023. Subject (and/or holders of parental authority) not opposing, after information, the reuse of the child's data for the purposes of this research and agreeing to respond to the quality of life survey.  Exclusion Criteria:  Patient or parents of the minor having expressed their opposition to participating in the study. specific clinical forms of the disease, interfering treatments and associated diseases. - Gender: All - MinimumAge: 2 Years - MaximumAge: 25 Years - StdAgeList: Child, Adult - StudyPopulation: Subjects aged 2 years to 25 years suffering from neuroblastoma and treated at the HUS or at the Oncopole center in Toulouse during the period from January 1, 1998 to December 31, 2023. - SamplingMethod: Probability Sample
Physical Exercise Benefits for Cancer Patients
Status: Recruiting

The purpose of the study was to analyze the effect of a synchronous-supervised online home-based group during a 6-month exercise program on physical fitness, body composition and adherence compared to an exercise recommendation group of patients undergoing breast cancer treatment without supervision.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years old or older Diagnosted with breast cancer Undergoing cancer treatment No medical contraindications  Exclusion Criteria:  Medical contraindications for sport practice Refusal to participate in the study Comorbilities - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Breast Cancer females undergoing cancer treatment - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Effect of Raised End-Tidal pCo2 on Choroidal Volume
Status: Recruiting

This study is to investigate the relationship between arterial carbon dioxide (CO2) concentration and vitreous pressure on the choroidal volume by integrated intraoperative OCT imaging under eye exams under anesthesia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  any child undergoing an eye exam under anesthesia for an ophthalmologic reason. children between the ages newborn to 8 years of age.  Exclusion Criteria:  children who are not having an eye exam under anesthesia. * children over the age of 8 years of age. * children with altered cerebral autoregulation, or increased intracranial pressure, or any other condition deemed appropriate by the anesthesiologist. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MaximumAge: 8 Years - StdAgeList: Child
A Retrospective Study of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis
Status: Not yet recruiting

The goal of this observational study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC） in progressive pulmonary fibrosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with PPF, ≥18 years of age, unclassified ILD, HRCT ≤3 months, forced vital capacity (FVC)≥50% predicted value, pulmonary carbon monoxide diffusion (DLCO)≥35% predicted value, echocardiography ≤12 months, estimated pulmonary systolic blood pressure ≤40 mmHg, Body mass index (BMI)≤35 kg/m2.  Exclusion Criteria:  Patients with platelet counts below 50,000e+9/L or International Normalized ratio of prothrombin time (INR) above 1.5 are not eligible for TBLC - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients receiving TBLC for progressive pulmonary fibrosis - SamplingMethod: Probability Sample
Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone to Treat Subglottic Stenosis
Status: Not yet recruiting

This study employs a multicenter, randomized controlled trial method, where patients meeting the inclusion criteria for subglottic stenosis are randomly divided into two groups. These groups are respectively undergoing translaryngeal endoscopic mucosal injection and ultrasound-guided injection of triamcinolone treatment. The comparison will focus on various indicators such as therapeutic effect, incidence of adverse reactions, treatment costs, and hospital resource utilization between the two groups. The safety and effectiveness will be compared to determine the relative merits of the two treatment methods.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  1: "Diagnosed with subglottic stenosis through laryngoscopic examination or imaging studies such as CT." 2: "Experiencing symptoms related to subglottic stenosis, such as breathing difficulties, hoarseness, etc."  Exclusion Criteria:  1: "Severe cardiopulmonary dysfunction, patients extremely debilitated and unable to tolerate the procedure." 2: "Patients allergic to lidocaine, midazolam, triamcinolone, or any of their components." 3: "Pregnant or lactating women." 4: "Unstable angina, congestive heart failure, severe bronchial asthma." 5: "Severe hypertension and arrhythmias, hemodynamically unstable, and severe respiratory failure (PaO2 <60mmHg after oxygen therapy or mechanical ventilation)." 6: "Known coagulation dysfunction, inability to stop anticoagulants, antiplatelet agents, aspirin, or nonsteroidal anti-inflammatory drugs before treatment." 7: "Patients do not agree to participate in this study." 8: "Participation in other studies within the last three months and not withdrawn or concluded, or having received triamcinolone treatment less than 1 month ago." 9: "Researchers believe there are any circumstances making the patient unsuitable for inclusion." - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Outcomes of MIST for BPH: A Single-Institution Prospective Study
Status: Not yet recruiting

The investigators wish to perform a prospective study at the Men's Health Clinic in Winnipeg, Manitoba to accomplish two goals: 1) Prospectively describe 1 year outcomes for MIST therapies performed at the clinic 2) perform a head to head comparison of Rezum water vapor therapy vs the iTind device in respect to symptom score improvement, uroflow parameters and side effect profile.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  patients > 18 years of age undergoing Rezum or iTind treatment  Exclusion Criteria:  ASA 3 or higher, active UTI within past week, age < 18 years of age, no informed consent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Establishment of Human Lung Stem Cell Proliferation System and Organoid Construction in COPD
Status: Not yet recruiting

The goal of this study is to proliferate human lung stem cell in vitro in order to establish a lung organoid derived from patients with COPD. The main question it aims to answer are:

Can human lung stem cell proliferate in vitro.
Can a lung organoid derived from patients with COPD be established. Participants will be sampled during pulmonary bronchoscope for organoid establishment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  1. Age under 55, regardless of gender 2. Patients with COPD lung disease who are going to undergo bronchoscopic biopsy 3. No genetic diseases and other respiratory diseases  Exclusion Criteria:  Other conditions determined by the investigators to be unsuitable for inclusion, such as difficult sampling, difficult follow-up, and complicated with other serious diseases - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult - StudyPopulation: COPD Patients with indications of bronchoscopic biopsy - SamplingMethod: Non-Probability Sample
Mindful Yoga for Postpartum Depression
Status: Recruiting

This is a parallel-group randomized controlled trial. A total of 198 postpartum women with depressive symptoms (EPDS scores≥8 at baseline) will be recruited and randomized into two groups: 10-week mindful yoga intervention and 10-week psychoeducation program. Clinical assessment of depression, self-report questionnaires and salivary cortisol tests will be performed at baseline, after 10-week intervention, and at 6-month and 12-month follow-ups. The investigators expected that the mindful yoga intervention will reduce depression after 10 weeks compared to psychoeducation. The mindful yoga intervention will further reduce anxiety, stress, improve quality of life and sleep, and steepen diurnal cortisol slopes. These effects will be maintained for at least six months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Postpartum women aged 18-60 years old. The scores of EPDS ≥ 10. At least 6 week and up to 1 year after childbirth. Giving birth to a single full-term healthy baby (gestation between 37-41 weeks, body weight > 2.5kg, APGAR score at 5 minutes > 7). Fewer than 10 hours of yoga/Qi gong/Tai Chi or mindfulness/meditation practice in the previous 3 months.  Exclusion Criteria:  Severe complications after delivery, or their infants are admitted to NICU. Regular psychiatric follow-up. Currently taking antipsychotic drugs. Known pragnancy, or other contraindications to physical exercise (e.g., wound healing situation) according to the body examination by O&G clinicians at 6 weeks after delivery. - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Postpartum women with depression. - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
H. Pylori Screen-and-treat Study in a Population of Young Adults
Status: Recruiting

Gastric cancer remains a major challenge to public health on a global scale. H. pylori related cancer burden contributes to the largest proportion of cancer cases attributable to infections in Europe. Considering its absolute burden and persisting disparities, in addition to the substantial prevalence of H. pylori infection worldwide that is treatable, gastric cancer is a logical target for urgent action for prevention. Population-based H. pylori test-and-treat has therefore been proposed as a strategy for gastric cancer prevention. To fill the gaps in knowledge about gastric cancer prevention through H. pylori screening and eradication in younger adults, a study of a population-based H. pylori test-and-treat strategy in Ireland, Croatia, Latvia, Poland, Romania and Slovenia.

Main goals of this study are to assess future program processes, feasibility, acceptability and effectiveness. In total of 6,800 adults aged 30-34 will be tested for H. pylori infection. They will be randomly selected to represent the chosen population and invited to participate in the study based on informed consent. Confirmed infections will be treated by available combined therapy in line with treatment guidelines and the success of eradication will be retested during a control check-up.

Patients who will provide their consent to participate will undertake an interview about the risk factors in early childhood and their habits regarding alcohol consumption and use of tobacco. Compliance to testing and treatment, treatment results, adverse effects and reasons for dropping out will be additionally monitored. Gathered data will be analysed in alignment with our research questions. The investigators will disseminate reports and present the results to both the general public and the scientific community in order to foster future developments in gastric cancer prevention.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Young adults (generally 30 - 34 years of age)  Exclusion Criteria:  Patients with mental or developmental limitations who cannot provide a fully-informed consent to participate (based on the assessment from research or patient's personal physician team) Previously treated H. pylori infection History of partial or total gastric resection due to benign or malign lesions - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 30 Years - MaximumAge: 34 Years - StdAgeList: Adult - StudyPopulation: Infected adult patients by Helicobacter pylori - SamplingMethod: Non-Probability Sample
Alternatives to Dental Opioid Prescribing After Tooth Extraction
Status: Not yet recruiting

The goal of this clinical trial is to test a three-item intervention in oral surgeons who remove teeth. The main questions it aims to answer are:

Can the intervention reduce opioid prescriptions to adolescents and young adults after tooth removal?
Do oral surgeons' beliefs about the intervention and opioid prescribing change?
Do patients that report using opioids after tooth removal have different experiences than patients that do not?

Oral surgeon participants will:

Attend a 1-hour education session with a trained pharmacist
Receive patient instructions and blister packs of pain medicine to give to patients
Complete 2 surveys about feasibility and appropriateness

Patient participants will complete a survey about pain and medication use after having a tooth removed.

Researchers will compare the intervention to usual care to see if it reduces opioid prescribing.

Eligibility:
- EligibilityCriteria: Inclusion Criteria (Provider):  Actively U.S. licensed dentist or oral surgeon practicing at a participating cluster. Participating clinics were finalized prior to the beginning of the study based on the following criteria: (1) perform tooth extractions on at least 70 AYA patients during a 5-month screening period from July 1, 2022 through November 30, 2022 and (2) electronically prescribe opioids to at least 30% of AYA patients who underwent extraction during the screening period. Additionally, each participating cluster signed a data use agreement (DUA) for sharing electronic health record data, can provide the necessary electronic health record data, and agreed to comply with study procedures and be available for the duration of the study. Provide a signed and dated informed consent form. Willing to comply with all study procedures and be available for the duration of the study.  Inclusion Criteria (Patient):  Undergoes any tooth extraction at a participating cluster during the study (intervention condition, transition period, or control condition) between 6-10 days earlier. Age 12-25 at the time of tooth extraction. Reads and acknowledges survey cover letter in lieu of a full consent/assent process. Can access the electronic survey using an internet-capable device.  Exclusion Criteria:  There are no other exclusion criteria for clusters or provider/patient participants that meet all inclusion criteria. - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 25 Years - StdAgeList: Child, Adult