rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE)
Status: Not yet recruiting

Biliary stricture is mainly malignant in the adults and caused by several types of fatal malignancies such as pancreatic cancer, cholangiocarcinoma, and metastatic tumor, which have poor prognosis that the overall survival of unresectable lesions is no more than 15 months. The poor outcome often relates to a lack of reliable strategies for early diagnosis, which results in most patients with malignant biliary stricture being already advanced-stage disease at presentation. Therefore, it is critical to discover novel and effective strategies for the early diagnosis of malignant biliary strictures.

Brush cytology and biopsy during endoscopic retrograde cholangiopancreatography (ERCP) are the main methods for recognizing malignant diseases of the bile duct, but their sensitivity is relatively low, 45% and 48.1%, respectively. Even when combined with other biomarkers like carbohydrate antigen 19-9 (CA19-9), their sensitivity is still less than 80%.

In the previous study, the investigators found that bcf-eccDNA has excellent diagnostic value in predicting uncertain bile duct stricture, and the sensitivity and specificity of a related eccDNA in 40 samples are 80.8% and 100%. The sensitivity and specificity of another eccDNA were 92.3% and 92.9%, respectively. However, the sample size is still relatively small, and further prospective studies are needed to evaluate its diagnostic efficacy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients is suspected indetermined biliary strictures Patients have the indication for brush cytology during ERCP  Exclusion Criteria:  ERCP or brush cytology failed, or can not obtain bile Sever comorbidities Predicted overall survival less than 1 year because of other disease Patients who are unlikely to comply with the protocol, inability to return for subsequent visits - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients are suspected indetermined biliary strictures - SamplingMethod: Non-Probability Sample
Effect of Mutations in T2DM Susceptibility Genes on the Expression of Susceptibility Genes in Patients With T2DM and Controls
Status: Recruiting

In this study, investigators wanted to determine the effect of T2DM susceptibility gene mutations on self-expression.

Participants (T2DM patients and controls) were recruited to identify genotypes and detect the levels of T2DM susceptibility genes expression in the fresh peripheral plasma. The normal pancreatic tissues or adjacent tissues of pancreatic cancer were also collected to identify the expression differences of T2DM susceptibility genes under different genotypes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  no drug therapy; 25 to 70 years old; Hemoglobin A1c (HbA1c) 7%-12%; BMI 20-35 kg/m2; Stable body weight (≤10% change within 3 months)（For newly diagnosed patients with T2DM）. 25 to 60 years old; BMI 19-26 kg/m2; in good health, with no abnormalities of motor system, digestive system, respiratory system, urogenital system, blood system, circulatory system, nervous/mental system, endocrine system, etc（For healthy subjects）. 20-80 years old; surgical resection of part or all of the pancreas; pancreatic lesions confirmed by enhanced CT or magnetic resonance (MR) examination or confirmed by intraoperative and postoperative pathology（For the patients in general surgical）.  Exclusion Criteria:  had taken antidiabetic drugs; had a history of pancreatic surgery; Complicated with severe organ lesions; Long-term use of drugs that affect pancreatic function. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 25 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Cognitive Training for Attention Deficit Hyperactivity Disorder and Developmental Delays
Status: Not yet recruiting

To explore whether children with Attention Deficit Hyperactivity Disorder and developmental delays who receive cognitive training and conventional rehabilitation can improve executive function more than traditional rehabilitation alone. A magnetoencephalographic examination will be arranged to explore how brain network activation works.

Research method: 20 preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under regular rehabilitation programs intelligence quotient 70 or greater  Exclusion Criteria:  age less than 4 or greater than 6 metal in teeth intelligence quotient less than 70 - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 6 Years - StdAgeList: Child
a Prediction of Post-Endoscopic Retrograde Cholangiopancreatography Complication
Status: Recruiting

To develop effective preoperative and postoperative prediction models for postoperative complications of ERCP

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Routine ERCP patients  Exclusion Criteria:  Unwillingness or inability to consent for the study Pregnant women or breastfeeding current acute pancreatitis - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Routine ERCP patients - SamplingMethod: Probability Sample
Exercise in Patients With Hypermobile Joints and Knee Pain
Status: Not yet recruiting

Pain associated with knee joint hypermobility is common in the adult population, but evidence on treatment is sparse. This study investigates if high-load resistance training is superior to usual care in improving activity-related pain in young patients (18-45 years) with hypermobile joints and knee pain.

Eligibility:
- EligibilityCriteria: Inclusion criteria  Persistent knee pain for ≥ 3 months (self-reported) Knee pain ≥ 30mm during the last week using a 0-100 mm visual analogue scale (VAS; 0=no pain and 100=worst imaginable pain) (self-reported) Generalised joint hypermobility assessed with the Five-Part Hypermobility Questionnaire (positive ≥ 2/5) (self-reported) Local knee joint hypermobility using the passive hyperextension of the knee in standing (positive > 10 degrees of hyperextension) and confirmed in supine lying (heel resting on 20 cm high block on the bench surface), with passive knee hyperextension (positive > 10 degrees) (objectively measured)  Exclusion criteria  Diagnosed with patellar tendinopathy Pregnancy or childbirth within the past year (due to increased levels of relaxin that could affect joint stability) Knee surgery within the past year Participation in regular structured resistance training within the past six months Inability to speak and understand Danish. All types of Ehlers-Danlos syndrome Other heritable connective tissue disorders such as Marfan syndrome, osteogenesis imperfecta, Loeys-Dietz syndrome, Stickler syndrome, skeletal dysplasias Autoimmune rheumatic connective tissue disorders such as lupus, rheumatoid arthritis; Chromosomal conditions such as Fragile X syndrome, Kabuki syndrome, Down syndrome Neuromuscular disorders that can cause joints to become unstable, such as multiple sclerosis - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult
Evaluation of Impedance Cardiography for Assessing Hemodynamic Shifts in Patients With LA-NSCLC During Treatment.
Status: Recruiting

This study aimed to investigate the role of impedance cardiography (ICG) in evaluating hemodynamic changes during the 6-minute walk test (6MWT) in patients with locally advanced non-small cell lung cancer (LA-NSCLC) who underwent combined concurrent chemoradiotherapy (CCRT) and immunotherapy. Additionally, It sought to analyze the predictive significance of cardiac parameters to both treatment toxicity and survival prognosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  had untreated histologically or cytologically confirmed NSCLC be between the age of 18 and 75 had unresectable stage IIIA-IIIC disease, as defined by the AJCC 8th edition staging system had an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0~1 had adequate bone marrow function (neutrophil count ≥1.5x109/L, hemoglobin concentration ≥90 g/L, platelet ≥100x109/L), kidney function (serum creatinine clearance ≥50 ml/min) and liver function (serum bilirubin ≤1.5 times upper limit of normal (ULN), aspartate transaminase (AST) and alanine transferase (ALT) ≤2.5 ULN) had a forced expiratory volume in 1 second (FEV1) of ≥0.8L.  Exclusion Criteria:  mixed small cell and NSCLC histology life expectancy lower than 12 weeks history of another primary malignancy poorly controlled intercurrent illness female in pregnancy or breast-feeding and any situation not suitable for this study judged by researchers patients with contraindications to 6MWT, including unstable angina pectoris or myocardial infarction within the past month, systolic blood pressure (SBP) over 180mmHg, diastolic blood pressure (DBP) over 100mmHg, muscle strength below grade 3, and severe spasm. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Locally advanced non-small cell lung cancer patients treated by neoadjuvant chemotherapy plus immune checkpoint inhibitors following definitive concurrent chemoradiotherapy. - SamplingMethod: Non-Probability Sample
Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia
Status: Recruiting

The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice, in an unselected population of patients with "no-option" CLTI.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥18 years Patient has signed an approved informed consent form All patients, with non-revascularizable critical lower limb ischemia defined on the basis of 2 previous unsuccessful Percutaneous Transluminal Angioplasty (PTA) attempts or on severe Medial Artery Calcification (MAC)/Small Artery Disease (SAD) stage. Patient with Critical Limb Ischaemia, Rutherford category, 5 (minor tissue loss) or 6 (major tissue loss) with active trophic lesions Ejection Fraction > 30%  Exclusion Criteria:  Subject no able to perform the follow up or other factors making clinical follow-up difficult Patients with critical ischaemia of the lower limbs revascularizable by bypass or angioplasty, critical ischaemia characterised by rest pain (Rutherford class ≤ 4) Ejection Fraction < 30% - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Subjects presenting the most advanced stage of lower limb arterial disease, defined as patients with CLTI and no indication for revascularization. - SamplingMethod: Probability Sample
Prognotic Role of CMR in Takotsubo Syndrome
Status: Recruiting

The primary objective of this observational registry is to develop a comprehensive clinical and imaging score (incorporating echocardiography and cardiac magnetic resonance data) that enhances risk stratification for patients with Takotsubo syndrome.

The secondary objectives of this registry are as follows:

Investigate the diagnostic value of cardiac magnetic resonance parameters in predicting in-hospital and long-term outcomes in patients with Takotsubo syndrome.

Compare the proposed risk stratification score for patients with Takotsubo syndrome with previously existing scores.

Investigate the contribution of machine learning models in predicting in-hospital and long-term outcomes compared to standard clinical scores.

The design and rationale of this registry are available at 10.1097/RTI.0000000000000709

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Takotsubo syndrome diagnosis (according to Position Statement of the European Society of Cardiology Heart Failure Association) Adult patients ( > 18y old) Availability at baseline of clinical variables, standard transthoracic echocardiography, and cardiovascular magnetic resonance acquisition  Exclusion Criteria:  <18 y old Lack of transthoracic echocardiography and cardiovascular magnetic resonance examinations Preexisting cardiomyopathies Previous myocardial infarction Suspected or known prior irreversible myocardial damage Valvular heart disease - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Takotsubo syndrome patients - SamplingMethod: Probability Sample
E-cigarettes as a Harm Reduction Strategy
Status: Recruiting

E-cigarettes have emerged as an effective strategy for replacing cigarettes among smokers from the general population, but there is a dearth of studies investigating their utility in replacing cigarettes among smokers with opioid use disorder (OUD). This study aims to evaluate the feasibility and acceptability of implementing a cigarette harm reduction intervention involving e-cigarettes in office-based buprenorphine clinics.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult (age ≥21) Report smoking ≥ 5 cigarettes per day for ≥ one year Interested in switching to e-cigarettes (self-reported) OUD diagnosis (DSM-V)(chart review) Currently receiving buprenorphine or other medications for opioid use disorder (MOUD) (chart review) Plan to remain on buprenorphine for at least 3 months (duration of the study) (self-reported) Have a smartphone with internet access  Exclusion Criteria:  Use of other tobacco or nicotine products other than cigarettes (≥9 days in the past 30) Used nicotine replacement, bupropion or other pharmacotherapies as cessation aids in the past month (bupropion will be allowed for treatment of depression) (self-reported) (3) Having a severe medical condition, including decompensated cirrhosis, severe cardiovascular disease (myocardial infarction, percutaneous transluminal coronary angioplasty, unstable angina, coronary artery bypass graft, and/or serious arrhythmia in the prior 6 months) (chart review) Having severe asthma or chronic obstructive pulmonary disease requiring supplemental oxygen or hospitalization in the past 6 months (chart review) Being hospitalized for human immunodeficiency virus/acquired immunodeficiency syndromes-related illness in the past 6 months (chart review) Having a history of seizure disorder (chart review) Pregnancy (chart review) or breast-feeding (self-reported) for female participants Having current DSM-V criteria for mania, psychosis, or major depressive disorder (chart review) Current suicidal ideation or past year suicide attempt (PHQ-9; see protections against risk) Being hospitalized for psychiatric reasons in the past year (chart review) Being unable to independently read and/or comprehend the consent form or other study materials (unable to read study materials aloud) Being unable to read/speak English (inability to read and complete study materials) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 21 Years - StdAgeList: Adult, Older Adult
Patient Empowerment in the Management of Gestational Diabetes Mellitus
Status: Recruiting

This study is a clustered randomized controlled trial assessing the outcome of "Patient Empowerment" in the management of Gestational Diabetes Mellitus by applying the patient empowering model in the intervention group and the conventional method of treatment in the control group. It will be conducted in four centres in Dhaka city of Bangladesh. The primary outcome measures will be determining the frequency of good fetomaternal and neonatal outcome through glycemic control. Target of Glycemic Status: For Pregnant Mother, Fasting, 95 mg/dL (5.3 mmol/L), Two-hour postprandial,120 mg/dL (6.7 mmol/L), For Neonate glycemic status at or above 2.5 mmol/l. Maternal outcome during pregnancy - Decrease chance of antenatal infections that is Vulvovaginitis and recurrent UTI, Decrease pre-eclampsia, Decrease Antepartum Hemorrhage and Polyhydramnios. Maternal outcome in the form of mode of safe delivery- Increase frequency of vaginal delivery, Decrease chance of obstructed labour. Maternal outcome after delivery- Decrease chance of Postpartum Hemorrhage, Decrease chance of puerperal sepsis. Fetal Outcome- Less chance of Intra uterine death and prematurity. Neonatal Outcome- Less chance of Birth injury, Birth asphyxia, Perinatal death, Good Apgar score (≥ 7) in 1st and 5th minute, Less need for NICU care and Less chance of macrosomia (≥ 4 kg) at term. Fewer proportion of patients will require insulin to manage GDM. The secondary outcomes will be patient satisfaction and the patient will be a future resource person.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Screen positive GDM cases, who have not been managed for diabetes by any means Gestational age from18 weeks to 36 weeks  Exclusion Criteria:  Known history of diabetes before pregnancy Women with twin or multiple pregnancies - HealthyVolunteers: No - Gender: Female - MinimumAge: 20 Years - MaximumAge: 35 Years - StdAgeList: Adult
A Phase 3 Study of LNK01001 Capsule in Subjects With Moderate to Severe Atopic Dermatitis.
Status: Not yet recruiting

This is a randomized, double-blind study comparing LNK01001 to placebo in participants with moderately to severely atopic dermatitis who were candidates for systemic therapy (ie, patients with a history of inadequate response to topical treatments, those who were using a systemic treatment, or those for whom topical treatments are otherwise medically inadvisable).

The objective of this study is to evaluate the efficacy and safety of LNK01001 in adult patients with moderate to severe AD who are candidates for systemic therapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants must be at least ≥18 and ≤75 years of age. The subject has a diagnosis of atopic dermatitis for at least 1 year. Meets the following disease activity criteria: BSA ≥10% of AD involvement. EASI ≥16. IGA ≥3. WI-NRS ≥4. Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit.  Exclusion Criteria:  Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of investigational product unable or unwilling to discontinue current atopic dermatitis treatments before the study. Requirement of prohibited medications during the study. Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions. History of malignancy or current diagnosis of malignancy before screening visit.  In the opinion of the investigator or sponsor, any uncontrolled clinically significant laboratory abnormality that would affect the interpretation of study data or the subject's participation in the study uncontrolled diabetes, hypertension, kidney disease, liver disease, or severe heart disease. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Nutrition Care in Patients Living With Chronic Pain
Status: Not yet recruiting

The investigators' purpose is to develop and test the feasibility, usability, and satisfaction of the Diet4painrelief app as a platform for implementing nutrition care in a specialist pain rehabilitation clinic. The Diet4painrelief will consist of two components: a) a screening tool for nutrition status b) an individually tailored behavior change program aiming to improve the dietary habits and behaviors of patients living with chronic pain.

The study is planned to include 20 patients with complex chronic pain and non-optimal BMI (underweight or overweight/obesity) to examine the feasibility and outcomes of evidence-based Interdisciplinary Pain Rehabilitation Program (IPRP) integrated with nutrition care. The Diet4painrelief includes a screening tool to assess basic nutritional status as well as their intake of key unhealthy and healthy foods and drinks (through three 24hour-dietary recordings or food diary). Thereafter, the patients receive a personalized behavior change program for dietary optimization. The investigators will design and adapt 6 modules in the digital platform (Diet4painrelief app) based on the International Association for the Study of Pain (IASP) recommendations (6 aspects about 'nutrition and pain') and Sweden's food culture. Clinical outcomes using patient-reported data on socio-demographics, pain aspects, psychometric data, physical disability, and quality of life will be measured at three occasions: first appointment (Pre-IPRP), immediately after completing the rehabilitation program (Post-IPRP), and at a 12-month follow-up (FU-IPRP). Blood samples will be taken to identify biomarkers at the same occasions that provide objective information on metabolic and nutritional abnormalities and further to evaluate the effect of the dietary intervention on changing of pain rehabilitation outcomes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Self reported Body Mass Index (BMI)>=25; Written consent to participate and attend to the pain rehabilitation program due to disabling chronic pain (on sick leave or experiencing major interference in daily life due to chronic pain) Agreement not to participate in other parallel treatments for weight reduction Not currently using medications of weight reduction Available to get access to internet via own mobile/cellphone.  Exclusion Criteria:  Health conditions such as pregnancy, active metabolic disease, rheumatoid arthritis, and serious psychiatric disease (investigator's judgement, eg, psychosis or suicidal ideation); Coagulation disorders with predisposition to bleeding, medication with anticoagulants (low- dose aspirin is permitted); hypersensitivity to anaesthetic Difficulties in understanding the Swedish language. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
68Ga-TCR-FAPI PET/CT Guided Precision Surgery for MTC
Status: Recruiting

This is a phase II clinical trial to evaluate the capability of 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide the surgical treatment of medullary thyroid carcinoma (MTC). The surgical extent of MTC is determined based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, with the main endpoint being 1-month post-surgical calcitonin level.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age between 18 and 75 years； Diagnosed with MTC and have surgical indication based on preliminary evaluation; the tumor may be newly diagnosed or previously treated; Expected survival of at least 12 weeks; No major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection; Be willing and able to understand the research content and provide written informed consent/assent for the trial.  Exclusion Criteria:  Have a history of imaging agent allergies; Does not meet the PET-CT scan sedation requirements, or has contraindications for PET-CT examination; Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial; No surgical indication (i.e., no measurable disease, unresectable disease, or significant present of distant metastasis), refusing surgery or 68Ga-TCR-FAPI PET/CT-guided surgery. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult