rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Pyrocardan® Implant Arthroplasty or LRTI for Trapeziometacarpal Osteoarthritis
Status: Recruiting

This is a randomized controlled trial comparing the Pyrocardan® implant (intervention group) with the standard ligament reconstruction and tendon interposition (LRTI) (control group). All Danish citizens with osteoarthritis of the thumb carpometacarpal joint referred to the orthopedic department at Copenhagen University Hospital in Herlev/Gentofte will be considered for participation in the trial. The following exclude from participation in the study: Below 40 years of age; cognitive or linguistic impairment; osteoarthritis of other carpal bones; previous surgery in the carpometacarpal joint; patients with rheumatoid arthritis. A total of 64 patients will be included. The primary outcome is the patient reported outcomes questionnaire; Quick-DASH. The secondary outcomes are patient-reported outcomes, functional outcomes, radiographic outcomes, readmission, complications, revisions. The patients are examined before surgery and 3, 6, 12 and 24 months after the operation. The patients are also contacted after 5 and 10 years.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Osteoarthritis of the trapeziometacarpal joint of the thumb. Insufficient effect of non-surgical treatment with symptoms severe enough to justify surgical treatment. ASA score 1-3, physically fit for surgery and rehabilitation  Exclusion Criteria:  Below 40 years of age Cognitive or linguistic impairment Osteoarthritis in other carpal bones (STT OA and others) Previous surgical treatment in the trapeziometacarpal joint. Patients with rheumatoid arthritis - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - StdAgeList: Adult, Older Adult
Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis
Status: Not yet recruiting

The goal of this study is to learn if GS-1427 is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo (Part 1), and participants treated with GS-1427 or ustekinumab alone with participants treated with GS-1427 in combination with ustekinumab (Part 2).

The primary objectives of this study are:

Part 1: To assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12

Part 2: To assess the efficacy of combination therapy with GS-1427 and ustekinumab, compared with GS-1427 and ustekinumab monotherapies, in achieving clinical response at Week 12

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria:  Individuals have Ulcerative Colitis (UC) of at least 90-days duration before randomization confirmed by endoscopy and histology at any time in the past. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents. Individuals have UC with minimum disease extent of 15 cm from the anal verge. Individuals have moderately to severely active UC as determined by endoscopy occurring during screening with a total modified Mayo Clinic Score (mMCS) of 5 to 9 points, including a centrally read endoscopic subscore of at least 2. Individuals have an inadequate response or loss of response or is intolerant to at least 1 of the following conventional UC treatments  Individuals have an inadequate response or loss of response or are intolerant to:  At least one of these conventional UC treatments: Corticosteroids, azathioprine or 6-mercaptopurine (6-MP)  OR  No more than two advanced therapies: Tumor necrosis factor-alpha inhibitors, interleukin (IL)-12/23 inhibitors (Part 1 only; no prior use in Part 2), sphingosine 1-phosphate receptor modulators, and Janus kinase inhibitors  Key Exclusion Criteria:  Have a current diagnosis of Crohn's Disease (CD) or clinical findings suggestive of CD, diagnosis of indeterminate colitis due to etiologies such as an enteric pathogen, or lymphocytic or collagenous colitis. Have a current diagnosis of toxic megacolon, symptomatic colonic stricture, acute severe colitis, fulminant colitis, or abdominal abscess at screening or randomization. Part 1 and 2; have any history of exposure to vedolizumab Part 2 only: have any history of exposure to interleukin - 12/23 or 23 inhibitor (eg ustekinumab) Requirement for ongoing therapy with or use of any prohibited medication as specified in the protocol  Note: Other protocol defined Inclusion/Exclusion criteria may apply - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Tobacco Education and Lung Health Study (TEAL)
Status: Recruiting

Primary Objective To compare two smoking cessation interventions among individuals undergoing lung cancer screening. Primary outcomes are: 3-month self-reported abstinence from cigarettes and 6-month self-reported and bioverified abstinence from cigarettes.

Secondary Objectives 1) To evaluate reach and engagement overall and by subgroup (e.g., race and ethnicity, underinsured, readiness to quit). 2) To conduct an economic analysis to evaluate intervention costs from the health system perspective.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  eligible for a screening or diagnostic scan, USPSTF eligibility criteria (50-80 years old and >20-pack years); currently smoking cigarettes (>1 in the past 30 days); English speaking; able to provide meaningful consent.  Exclusion Criteria:  prior lung cancer, hearing impairment, cognitive impairment, household member already enrolled. - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy
Status: Recruiting

Circulating tumor DNA assays are becoming relevant for routine diagnostics, but many related aspects are yet unresolved. With this project, the investigators aim to develop pragmatic molecular diagnostic pathways of liquid biopsies relevant in advanced gastrointestinal malignancies with focus on clinical utility and sensible use of resources. They want to evaluate the ctDNA assays on a fully automated "low-cost" multiplex platform which is already implemented in routine molecular diagnostics of solid biopsies. The project will evaluate to what extent these ctDNA assays are relevant for clinical decision-making.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Newly referred patients with advanced pancreatic cancer (~20/year), Cholangiocarcinoma (~20/year), metastatic colorectal cancer (mCRC) (~50/year) and anti-EGFR-treated mCRC patients (~10/year) to Oslo University Hospital are eligible for inclusion. - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Advanced malignancy - SamplingMethod: Probability Sample
Analysis of Body Balance Parameters in Children With Idiopathic Scoliosis
Status: Not yet recruiting

The aim of the study is to compare body balance parameters assessed using the AMTI dynamometric platform in children with idiopathic scoliosis (with and without Schroth therapy) compared to control group.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Idiopathic adolescent scoliosis aged 10-18 years, female, control group aged 10-18 years, female.  Exclusion Criteria:  congenital spine defects, spine surgeries, neurological diseases, cardiological diseases, genetic diseases, rheumatological diseases, immunological diseases, endocrine diseases back pain, lower limb pain, past injuries of lower limbs or spine - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - MinimumAge: 10 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: children aged 11-18 years diagnosed with adolescent idiopathic scoliosis - SamplingMethod: Non-Probability Sample
Abdominal Massage and Kegel Exercises on Constipation and Quality of Life in Female Students
Status: Not yet recruiting

In this prospective, randomized controlled study, n=140 female students with functional constipation studying at two universities Faculty of Health Sciences and meeting the Rome-IV Diagnostic Criteria for Constipation will be included in the study. Between 15.03.2024 and 31.05.2024, n=140 (35=control group, 35=kegel exercise group, 35=abdominal exercise group, 35=abdominal and kegel exercise group) volunteered to participate in the study. Female students with functional constipation will be randomly divided into four groups as intervention and control groups. Personal Information Form", "Bristol Stool Scale", "Constipation Severity Scale", and "Patient Assessment of Constipation Quality of Life Questionnaire" will be used in this study. The scales will be used in the research two times: pre and post-test (scales were reassessed at the end of the study after the exercise intervention). Descriptive statistics, Pearson, and Spearman's correlation analyses will be used in the analysis of research data.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Must include two or more of the following:  Straining during more than ¼ (25%) of defecations Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations Sensation of incomplete evacuation of more than ¼ (25%) of defecations Sensation of anorectal obstruction/blockage of more than ¼ (25%) of defecations Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) Less than 3 defecations per week Loose stools are rarely present without the use of laxatives Insufficient criteria for irritable bowel syndrome  Exclusion Criteria:  the study included patients with intra-abdominal infection advanced heart disease previous bowel surgery cancer diagnosis irritable bowel syndrome any intestinal problem, metabolic, endocrine, and neurological constipation, current or past smoker congenital megacolon, pseudo-obstruction, and anorectal disorder any mental, psychological, and physical disorder any medication, fecal and urinary incontinence, pregnant do not volunteer to participate in the research will not be included. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult
Orelabrutinib Combined With R-CDOP for DLBCL Patients With High-risk of CNS Relapse Defined by CNS-IPI
Status: Recruiting

This is a prospective, multicenter, single-arm clinical study on the treatment of newly diagnosed diffuse large B-cell lymphoma with high-risk of CNS relapse defined by CNS-IPI using Orelabrutinib in combination with R-CDOP regimen.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥18 years old; ECOG score 0-3; Histologically confirmed diffuse large B-cell lymphoma, including DLBCL and transformed DLBCL; CNS-IPI≥4 points Previously untreated participants with CD20-positive DLBCL,; Heart, liver, and kidney function: creatinine < 2 times the normal upper limit (ULN); ALT (alanine aminotransferase)/AST (Aspartate Aminotransferase) < 2.5ULN; Total bilirubin < 2ULN; Cardiac ejection fraction (EF) ≥50%. At least one measurable lesion. Have the sufficient understanding ability and voluntarily sign informed consent.  Exclusion Criteria:  Patients with evidence of CNS involvement ; Clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional scale, or a history of myocardial infarction within 6 months before screening; Human immunodeficiency virus (HIV) infection; Pregnant or lactating women; Other tumors that require treatment; Uncontrolled active infection; The HBV DNA copy number of active hepatitis after antiviral treatment can not be controlled within 2×103/ml. unable to understand and follow the research protocol or unable to sign the informed consent. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Peer Delivered, Emotion Regulation-Focused Mental Health Prevention Training for Fire Fighter Trainees
Status: Not yet recruiting

The goal of this clinical trial is to determine if a peer-delivered emotion regulation training (Brief-Unified Protocol) workshop is effective for preventing posttraumatic stress and other psychological health symptoms in firefighter trainees. The main questions it aims to answer are:

Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower PTSD symptom severity over time compared to those who receive psychoeducation?
Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower AUD, depression, anxiety, and functional impairment symptom severity over time compared to those who receive psychoeducation?
Do changes in neuroticism or emotion regulation mediate the effect of receiving the Brief-Unified Protocol on the treatment outcomes?

Participants will:

Participate in a Brief-Unified Protocol workshop or psychoeducation workshop during fire academy training.
Complete a questionnaire and clinical interview prior to the workshop.
Complete a questionnaire immediately following the workshop and follow up questionnaires at 6, 12, 18, and 24 months after completing the fire academy.

Researchers will compare firefighters who receive a peer-delivered Brief-Unified Protocol workshop to firefighters who receive peer-delivered psychoeducation to see if the Brief-Unified Protocol is effective for preventing posttraumatic stress and other psychological health symptoms.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  21 years of age or older English speaking Able to sign an informed consent form Able to complete the structured interview and self-report assessment Willing to be contacted to complete post and follow-up assessments  Exclusion Criteria:  Pregnant Have plans to relocate within two months of protocol initiation Report psychotic symptoms or suicidal behavior within the past 30 days Are currently dependent on substances other than tobacco or caffeine. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Low-Risk Polycythemia Vera
Status: Not yet recruiting

This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with low-risk PV. Approximately 110 patients with low-risk PV will be enrolled. The whole study period is 108 weeks, including a main treatment phase (56 weeks), an extension treatment phase (48 weeks), and a safety follow-up phase (four weeks).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients ≥18 and ˂60 years old; PV according WHO 2022 Criteria; Low-risk PV according to the NCCN guideline; Hct value lower than 45%; JAK2 V617F or exon 12 mutation AND a bone marrow biopsy performed with morphology consistent with PV and reticulin fibrosis grade of 0-1; Females of childbearing potential must agree to use an acceptable form of birth control; Written informed consent obtained from the patient or the patient's legal representative  Exclusion Criteria:  Previous well documented cardiovascular PV-related events; Prior use of cytoreductive agents in the past 4 weeks prior to randomization; Any contraindication to pegylated interferon or its excipients; Non-responder or resistance to interferon or any other cytoreductive therapies; Documented autoimmune disease at screening or in the medical history; Prior or current autoimmune thyroid disease; Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis at screening that, in the Investigator's opinion, would jeopardize the safety of the subject or their compliance with the protocol; Infections with systemic manifestations except hepatitis B (HBV) and/or hepatitis C (HCV), at screening; Any investigational drug less than 6 weeks prior to the first dose of study drug; History or presence of depression requiring treatment with antidepressant; Previous suicide attempts or at any risk of suicide at screening, in the judgement of the Investigator; Any significant morbidity or abnormality which may interfere with the study participation; Pregnant or lactating females; History of alcohol abuse or drug abuse within the last year; Evidence of severe retinopathy; Significant liver or renal disease; History of major organ transplantation; History or presence of clinically significant neurologic diseases; History of malignant disease, including solid tumours and hematological malignancies within the last 3 years. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 59 Years - StdAgeList: Adult
Determining the Learning Curve for Ultrasound-guided Caudal Epidural Block
Status: Recruiting

mastering ultrasound-guided sacral canal block entails traversing a multifaceted learning curve characterized by anatomical intricacies, technical challenges, and patient variability. Through systematic education, deliberate practice, and clinical experience, clinicians can ascend this learning curve and harness the full potential of this innovative technique in pain management. As the landscape of regional anesthesia continues to evolve, a commitment to ongoing learning and proficiency attainment is paramount for delivering safe, effective, and patient-centered care.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Residential training students in the first -third grade  Exclusion Criteria:  No-resident trainees - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Residential trainee - SamplingMethod: Non-Probability Sample
A Machine-learning Model to Predict Lymph Node Metastasis of Intrahepatic Cholangiocarcinoma
Status: Recruiting

The object of this study is to develop a model for prediction of lymph node metastasis among intrahepatic cholangiocarcinoma (ICC) patients. Intrahepatic cholangiocarcinoma is the second most common kind of primary liver cancer, accounting for approximately 10%-15%. There is a lack of agreement regarding the necessity of performing lymph node dissection (LND) in patients with ICC. Currently, the percentage of LND is below 50%, and the rate of sufficient LND (≥6) has plummeted to less than 20%. Consequently, a large proportion of patients are unable to acquire LN status, which hinders the following systematic treatment strategies after surgery:. Therefore, our objective is to construct a LN metastasis model utilizing machine learning techniques, including patients' clinical data and pathology information, with the goal of offering a reference for patients who have not undergone LND or have had inadequate LND.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  1.Patients who were confirmed with intrahepatic cholangiocarcinoma 2. curative-intent hepatectomy 3. Without concurrent extrahepatic disease  Exclusion Criteria:  1.Patients lacking complete pathology information, 2. Patients who didn't get curative resection 3.Patients with concurrent extrahepatic disease or had missing follow-up data - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The data was collected from patients who underwent curative-intent hepatectomy and were diagnosed with ICC pathologically. The data was collected from the hepato-biliary and pancreatic department of West China Hospital, SCU, between the periods of January 2010 to December 2016 and January 2019 to October 2023. - SamplingMethod: Probability Sample
Vasodilator and Exercise Study for DMD (VASO-REx)
Status: Not yet recruiting

Examining two strategies as potential adjuvant therapies for Duchenne muscular dystrophy (DMD); aerobic exercise training (to induce adaptations in skeletal muscle and improve cardiovascular health) and tadalafil, an FDA-approved vasodilator (to optimize blood flow and muscle perfusion which is impaired and often overlooked in DMD). Target: improved muscle function, vascular health, and DMD treatment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of DMD confirmed by genetic report Minimum entry age of 6.0 years old Ambulatory On stable glucocorticoid regimen (for > 3 months)  Exclusion Criteria:  Contraindication to a Magnetic resonance Imaging examination (e.g. severe claustrophobia, magnetic implants, unable/unwilling to perform test) Presence of unstable medical problems, including severe cardiomyopathy, left ventricular ejection fraction <45%, cardiac conduction abnormalities as evidenced on ECG, uncontrolled seizure disorder, uncontrolled hypo or hypertension Presence of a secondary condition that impacts muscle function or muscle metabolism (e.g., myasthenia gravis, endocrine disorder, mitochondrial disease) Presence of a secondary condition leading to developmental delay or impaired motor control (e.g., cerebral palsy) or previous history of unprovoked rhabdomyolysis Contraindications to phosphodiesterase 5 inhibitors (use of nitrates, alpha-adrenergic blockers, other phosphodiesterase 5 inhibitors) or other medications known to modulate blood flow or muscle metabolism Participation in currently approved FDA trials or other investigational clinical trials during the period of the study - HealthyVolunteers: No - Gender: Male - GenderBased: Yes - GenderDescription: Duchenne Muscular Dystrophy is an X-linked disorder, and therefore predominantly in males. As a result, we are limiting our children study participants to males. - MinimumAge: 6 Years - StdAgeList: Child, Adult, Older Adult