rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
The LINFU® U.S. Registry in Patients With Clinical Signs and/or Symptoms of Disease
Status: Not yet recruiting

Evaluate LINFU® in patients who exhibit signs or symptoms (i.e. jaundice, abdominal pain, weight loss, nausea and vomiting etc.) suggestive of pancreatic cancer (PDAC) or have evidence of imaging studies suggestive of PDAC.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Both males and females will be enrolled and must be at least 18 years of age and under age of 90 Patients, who in the opinion of the Investigator, require biopsy to rule out PDAC because they display at least one of the following or both: a) clinical symptoms of PDAC including jaundice, nausea and vomiting, weight loss, abdominal pain, bloating or the feeling of fullness, itchy skin, lower back pain, light-colored, greasy stools, sudden onset type 2 diabetes, etc. b) one or more imaging studies suggestive of PDAC All patients must undergo contemporaneous imaging, either within 90 days before the LINFU® procedure or within 30 days after the procedure, with one or more of the following: EUS± FNA, MRI/MRCP, ERCP, CT or CEUS. Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.  Exclusion Criteria:  Patient under the age of 18 and over the age 90 Contraindications to LINFU®/EUS/ERCP as determined by study investigators: Patient with uncorrectable coagulopathy; Patient that cannot undergo anesthesia due to cardiopulmonary contraindication as deemed by the anesthesiologist; Unstable medically (cardiopulmonary, neurologic, or cardiovascular status) Patients undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium Patients who are already known to have PDAC by cytologic or histologic evidence Patients with intraductal papillary mucinous neoplasm of the pancreas (IPMN) identified either before the study or during the study through imaging evaluation will be excluded Pregnant females will be excluded Patient that is unable to provide informed consent Patient with known allergy to the microbubble contrast agent or secretin - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: High risk patients with either clinical symptoms or imaging abnormalities or both, being evaluated for PDAC. - SamplingMethod: Non-Probability Sample
Writing Wrongs: Expressive Writing for Microaggressions
Status: Not yet recruiting

Racial and ethnic based stressors, such as microaggressions, are pervasive, distressing, and result in lasting negative repercussions for minoritized students at predominantly white institutions (PWIs). These racial and ethnic based stressors are experienced in addition to the universally experienced stressors of higher education. Negative repercussions of microaggressions include increased drop out or transfer rates, distress, fatigue resulting in decreased academic performance, and depression and posttraumatic stress symptoms. Expressive writing (EW) may be a scalable intervention for addressing the negative repercussions resulting from microaggressions experienced by minoritized students at PWIs. Previous research suggests that EW for stressful life events results in benefits such as reduced depression and posttraumatic stress symptoms, improved coping strategies, and reduced activity restriction. Despite such benefits, EW was not designed to specifically address microaggressions in a minoritized student population. Informed by the ADAPT-ITT model, our research group conducted a pilot study with similar procedures. This pilot study demonstrated the acceptability of an adapted version of the EW intervention titled Writing Wrongs (WW), as well as recommended future modifications for WW. In the current study we aim to conduct a randomized-controlled trial to establish the efficacy of WW in alleviating clinical symptoms. We hypothesize that WW will improve symptoms of racial and discriminatory trauma and symptoms of depression, anxiety, and posttraumatic stress over time and compared to an assessment-only condition. We will conduct exploratory analyses to examine short-term changes in affect within and across sessions and across conditions. We will recruit minoritized students enrolled at a PWI. Participants will complete a pre-intervention assessment prior to being randomized into the two conditions. Participants in the intervention condition will engage in three sessions of WW and complete measures of clinical symptoms across multiple time points (i.e., pre-intervention, immediately after the final writing session, one week after the final session). Participants in the assessment-only condition will be administered the same measures at the same timepoints and given access to the WW after completing the study. If found to be efficacious, WW has the potential to be widely disseminated to minoritized college students who experience microaggressions.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Auburn University Full-time Student Identifies with a Racial/Ethnic Minoritized Group  Exclusion Criteria:  Under age 18 - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
RCT Comparing KS Versus TS for Ovedenture
Status: Not yet recruiting

To evaluate the clinical and radiographic outcomes of KS implants used to rehabilitate edentulous mandible with dental-retained overdentures, and to compare it with same treatment on TS implants

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Any edentulous patient (post-extractive sites must to be healed from at least 3 months), with sufficient bone height and width in the anterior mandible (between canines) to allow the placement of two implants of 3.5 mm diameter of at least 8.5 mm of length. 18 years or older, and able to sign an informed consent. Smokers will be included and categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day). In case of post-extractive sites, they must have been healing for at least 3 months before being treated in the study.  Exclusion Criteria:  Exclusion criteria  General contraindications to implant surgery. Patients irradiated in the head and neck area. Immunosuppressed or immunocompromised patients. Patients treated or under treatment with intravenous amino-bisphosphonates. Patients with untreated periodontitis. Patients with poor oral hygiene and motivation. Previous guided bone reconstruction at the intended implant sites. Uncontrolled diabetes. Pregnancy or nursing. Substance abuser. Psychiatric problems or unrealistic expectations. Lack of opposite occluding dentition in the area intended for implant placement. Patients with infection and or inflammation in the area intended for implant placement. Patients participating in other studies, if the present protocol cannot be properly adhered to. Patients referred only for implant placement and cannot be followed ant the treating centre. Patients unable to be followed for 5 years. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Efficacy of a Combination of Conservative Treatments Compared to Isometric Exercise on Clinical Outcomes in Patients With Cervical Radiculopathy
Status: Not yet recruiting

This intervention study is to evaluate the efficacy of a combination of conservative treatments compared to isometric exercise on clinical outcomes in patients with cervical radiculopathy. It is a randomized, parallel, 2-arm superiority trial study. The study will be conducted at the District General Hospital in Trincomalee, where patients with cervical radiculopathy seek medical care. Patients who refer to the Department of Physical Medicine (DPM) from the Out Patients Department (OPD), orthopedic clinic and surgical clinic with a diagnosis of cervical radiculopathy or neck and arm pain (symptoms extending distal to the shoulder) will be eligible for recruitment. The study details will be explained to the subjects in the language that they best understand. Written informed consent will be obtained from the individuals who express their willingness to participate in the study, and they will sign the informed consent document accordingly.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  35-60 years Neck pain > 3 months Clinical Prediction Rules - Positive Spurling's test (+) Distraction test (+) Upper limb tension test A (+) Cervical rotation on affected side < 60  Exclusion Criteria:  Presence of any signs or symptoms of medical red flags  Less than 3(positive) items for the CPR Bilateral arm radiating pain Osteoporosis Tumor Whiplash injury Pregnancy woman Rheumatoid arthritis Post-surgery to cervical/thoracic spine - HealthyVolunteers: No - Gender: All - MinimumAge: 35 Years - MaximumAge: 60 Years - StdAgeList: Adult
Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer
Status: Not yet recruiting

This is a single arm feasibility study of exercise for improving long- course neoadjuvant chemoradiotherapy (NACRT) efficacy in people diagnosed with locally advanced rectal cancer. The study aims to recruit up to 30 patients from the Queen's Centre for Oncology and Haematology of Castle Hill Hospital, Cottingham, diagnosed with locally advanced rectal cancer. Consenting patients will be provided with an 11-week course of structured aerobic exercises and resistance training in the periods before, during and after their chemoradiotherapy treatment. The patients will be followed up for 6 months post long course neoadjuvant chemoradiotherapy (NACRT), with a total of 3 assessment periods.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years or older Have been diagnosed with locally advanced rectal cancer using MRI (Magnetic Resonance Imaging) and histological finding Have been offered long-course neoadjuvant chemoradiotherapy in the Queens Centre, Castle Hill Hospital Willing and able to comply with all study requirements Able and willing to voluntarily give informed consent to take part.  Exclusion Criteria:  Inability to understand basic written and spoken English, as research materials will all be written in English. Any movement deficiencies limiting ability to engage in exercise. Impaired cognition and/or capacity limiting ability to provide informed consent. Cardiovascular and/or cardiopulmonary conditions that will impede ability to safely perform exercise. Severe psychiatric disorders. With any other health condition which oncologists and research team agrees will impede ability to safely perform exercises. Presence of metastatic cancer. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Post-Concussion Differences Between Buffalo Concussion Treadmill Test (BCTT) and Modified Dynamic Exertion (mEXiT) Test
Status: Recruiting

This study aims to compare symptom provocation, physiologic response, and rate of perceived (RPE) between the Buffalo Concussion Treadmill Test (BCTT) and a Modified Dynamic Exertion (mEXiT) test after sport related concussion in adolescents aged 14-17. Participants will be enrolled at their initial concussion clinical visit within 14 days of their injury, and randomly assigned to either the BCTT or mEXiT group. Participants will complete a single visit.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed with a sport related concussion within 14 days of injury Participants referred to exertion therapy after a trained clinician from University of Pittsburgh Medical Center (UPMC) Sports Medicine Concussion Program has interpreted neurocognitive, vestibular, and clinical interview outcomes and determined the participant is capable of completing structured exercise.  Exclusion Criteria:  Medically cleared from a previous concussion within the past 6 months More than 2 previous concussions (excluding current injury) History of brain surgery or traumatic brain injury (TBI) (based on Glasgow Coma Scale of <13) History of neurological disorder (seizure disorder, epilepsy, brain tumors or malformations) Current history of pre-existing vestibular disorder or oculomotor condition Currently taking antidepressant, anticoagulant, beta-blocker, or anticonvulsant prescription medications Incapable of treadmill running up to 5.5 miles per hour (mph) and 4.5 mph for males and females respectively (self-reported). Diagnosed with a cardiac, peripheral, or cerebrovascular disease (type 1 or 2 diabetes, or renal disease. Experienced chest pain or shortness of breath while at rest or with mild exertion. Lose balance because of dizziness or have lost consciousness (aside from concussion) from exertion Currently have (or have had within the past 12 months) a bone, joint, or soft tissue (muscle, ligament, or tendon) problem that could be made worse by physical activity Been told by a doctor to only conduct physical activity under medical supervision. - HealthyVolunteers: No - Gender: All - MinimumAge: 14 Years - MaximumAge: 17 Years - StdAgeList: Child
Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk
Status: Recruiting

The goal of this educational clinical trial is to identify Black women most at risk for poor outcomes following delivery, the problems they experience, and to create a system to improve quality of postpartum care for high-risk women. The main question[s] it aims to answer are:

How can the investigators help postpartum Black people who have poor outcomes by decreasing the number of ED visits/readmissions for postpartum people within the first 30 days postpartum?
How can the investigators increase the ability of participants to "obtain needed services" and ability for patients to see their provider when they need to, in the 30-day post discharge period as one of the main pathways of unnecessary ED visits?

Participants will be put into the study group or control group. The study group will receive a pamphlet postpartum with helpful information as well as a patient navigator who the participants will be able to reach out to their first 30 days postpartum.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Postpartum patients who have delivered a baby at the Hospital of University of Pennsylvania Ages 18 or older Self-identify as Black (listed on chart) Speak English Able to read Other characteristics defined by our risk prediction model (algorithm)  Exclusion Criteria:  Unable to provide informed consent Speaks a language other than English - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
Intermittent Hypoxia in Persons With Multiple Sclerosis
Status: Not yet recruiting

This study aims to understand the mechanisms of a novel intervention involving breathing short durations of low levels of oxygen for persons with multiple sclerosis (MS). This intervention with low levels of oxygen is called Acute Intermittent Hypoxia (AIH), the levels of oxygen experienced are similar to breathing the air on a tall mountain, for less than 1 minute at a time. Previous studies have shown that AIH is a safe and effective way to increase strength in persons with MS. Here we aim to look at brain activation and ankle strength before and after AIH so we can gain a better understanding of how the AIH may improve strength in those persons with MS.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnoses of relapsing form of MS (including relapsing-remitting MS and secondary-progressive MS) Expanded Disability Status Scale (EDSS) score of at least 3 and no more than 6.5 Motor Functional System Scale (FSS) between 2-4 Relapse free for at least 1 year Age ≥ 18 years and ≤ 75 years Safe to be scanned based on MRI questionnaire Participants using dalfampridine will be eligible if taking the same daily dose for at least 2 months prior to screening  Exclusion Criteria:  Active contrast-enhancing MS lesions, or diffusion positive lesions suggestive of acute cerebrovascular disease on baseline MRI scan Uncontrolled hypertension (Systolic between 85 and 140, diastolic between 90 and 55) History of epilepsy Chronic obstructive pulmonary disease Uncontrolled Sleep apnea Pregnancy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Iron Deficiency in Pediatric Heart Surgery
Status: Recruiting

The prevalence of iron deficiency in pediatric cardiac surgery patients is not very well known. Iron deficiency can lead to anemia, higher transfusion rates and possibly higher complication rates. In this retrospective study, the iron status of all patients undergoing pediatric cardiac surgery at our institution between January 2019 and december 2023 will be analyzed. Together with iron status, transfusion requirements as well as complications will be recorded. Iron status will be reported with descriptive statistics, patients with or without iron deficiency will be compared using non-parametric tests.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All patients who underwent pediatric cardiac surgery at our institution between January 1, 2019 and December 31, 2023  Exclusion Criteria:  Incomplete medical charts Patients who did not consent to the use of their medical data - Gender: All - MaximumAge: 16 Years - StdAgeList: Child - StudyPopulation: All patients who underwent pediatric cardiac surgery at our institution between January 1, 2019 and December 31, 2023 - SamplingMethod: Non-Probability Sample
Screening for Neonatal Jaundice With a Mobile Health Device: a Validation Study in Oaxaca, Mexico.
Status: Recruiting

The performance and accuracy of the smartphone application (app) Picterus Jaundice Pro (PicterusJP) will be validated by a cross-sectional study conducted in low resource settings in Mexico. Physics-based and machine learning-based models will be used to analyze the images obtained with the app and its performance will be compared.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  gestational age of 37 weeks or more birth weight of 2500 g and above newborns in whom a blood test had been ordered for any reason, irrespective of the study  Exclusion Criteria:  newborns with congenital diseases newborns transferred to pediatric wards for reasons unrelated to neonatal jaundice newborns who had undergone phototherapy - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Day - MaximumAge: 14 Days - StdAgeList: Child
Efficacy and Safety of Sivelestat in Preventing Postoperative Acute Respiratory Distress Syndrome After Cardiac Surgery :a Single Centre Random Control Trial.
Status: Not yet recruiting

The aim of this study is to assess the effectiveness and safety of sivelestat sodium in preventing acute respiratory distress syndrome (ARDS) following cardiac surgery, with the objective of providing evidence-based support for its clinical application.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients aged between 50 and 80 years old. Both sexes. Patients undergoing elective cardiac surgery;informed consent.  Exclusion Criteria:  Patients undergoing emergency surgery. Patients undergoing deep hypothermic circulatory arrest surgery;. Patients with liver and kidney dysfunction (Child-Pugh class B or C, estimated glomerular filtration rate <35 mL/min/1.73 m2). Patients with abnormal baseline inflammatory markers [interleukin-6 (IL6) >10 pg/mL, procalcitonin (PCT) >0.5 ng/mL, C-reactive protein (CRP) >10 mg/L]. Patients diagnosed with inflammatory immune disease, infectious disease, or oncological disease; patients receiving other medications that inhibit neutrophil elastase (e.g., ulinastatin, alpha 1-antiprotease). Patients allergic to or intolerant to sodium sivelestat. Pregnant. Patients with prognostic mortality on the European System for Cardiac Surgery Risk Evaluation II (EuroSCORE II) >3% were randomly assigned to either the treatment group or the control group based on the inclusion and exclusion criteria. - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Bactiseal Catheter Safety Registry Study
Status: Not yet recruiting

Research Purpose:

This study aims to continuously evaluate the safety of subjects implanted with a catheter (trade name: Bactiseal) produced by Integra LifeSciences Production Corporation. Device safety will be assessed based on all the adverse events that occurred within 2 years after implanted the catheter.

Research Design:

This study is designed to be single arm, multi-center, and retrospective. A total of 200 subjects will be retrospectively enrolled. Information will be collected on adverse events, including bacterial culture and drug resistance testing when infection (if done), of subjects enrolled within 2 years after the implantation of the Bactiseal Catheter between January 01, 2019 and June 30, 2022.

The following information will be collected from subjects' medical records or hospitals' databases (if any):

General condition of the subjects (including previous shunting and external drainage operation)
Intraoperative condition and catheter implantation
Information on the shunt catheters
Adverse events of subjects within 2 years after the operation and classification of the adverse events (except anticipated adverse events listed in section 8.1.2)
Relevant examinations in case of postoperative infection, including bacterial culture and drug resistance testing (if done)

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The informed consent is exempted by the Ethics Committee of a research center. Or a subject or his/her legal representative signed the informed consent form (ICF) prior to the enrollment. A subject had an indication suitable to use Bactiseal Catheter. A subject implanted hydrocephalus shunt catheter for at least 2 years at the time of enrollment.  Exclusion Criteria:  A subject didn't have an indication suitable to use the catheter. A subject was known to be allergic to a component or ingredient of the catheter to be implanted, including silicone catheter, rifampicin, and clindamycin. According to the comprehensive judgment of an investigator, a subject had an infection of the implant site when the shunt is implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection. A subject was simultaneously implanted with another shunt catheter different from Bactiseal Catheter. A subject had a contraindication of the shunt operation. A subject had uncorrected coagulopathy or any bleeding disorder. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: A total of 200 hydrocephalus patients will be enrolled and adverse events will be collected for those enrolled subjects within two years after the implantation of the Bactiseal catheter from January 01, 2019 to June 30, 2022, through reviewing subject record or hospital database. - SamplingMethod: Non-Probability Sample
Impact of Surgical Approach on Adaptation of Posture-respiratory Coupling
Status: Not yet recruiting

This study aims to identify physiopathologic mechanisms related to surgical approaches during lobectomies for non-small cell lung cancer which can explain the better quality of life and the decrease of of post-operative complications in minimally invasive techniques (video-assisted thoracic surgery and robotic-assisted thoracic surgery) compared to conventional thoracotomy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients admitted for major lung resection Surgical approach by conventional postern-lateral thoracotomy Surgical approach by minimally invasive RATS  Exclusion Criteria:  - Extended lung resection - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult