rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Effectiveness of a Self-management Program After Traumatic Injury
Status: Recruiting

Traumatic injuries, defined as a physical injury with sudden onset, are a leading cause to disability and impaired health. Persons who sustain a traumatic injury often report problems in daily life activities and reduced quality of life, which may limit participation in work/studies, leisure activities and family life. Consequently, complex rehabilitation and support is recommended in National Trauma guidelines due to the often long-lasting physical and psychological sequela of the injury.

The main goal of this study is to determine the effectiveness of a self-management support program delivered to persons with a moderate or severe traumatic injury in the sub-acute phase of recovery (i.e. 3-4 months after injury). The self-management program aims to enhance patients' self-efficacy by building skills and self-management strategies to cope with injury-related consequences. The program has a group-based format and consists of eight sessions comprising psychoeducation, skill mastery and sharing of experiences. The participants who will be included in the study must be between 18 and 70 years, be residing in the southeast region of Norway, be admitted to Oslo University hospital or transferred from local hospital within 72 hours after injury, have at least a two-day hospital stay, and be able to read and understand Norwegian language. Participants will be randomly assigned to either intervention or control group. A group of patients will also be able to self-select if they want to receive the self-management support program or be in the control group. The latter is an explorative part of the study to evaluate the influence of patients' treatment-preferences on the study outcomes. Participants in the control group will receive treatment as usual.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults residing in the southeast region of Norway who are aged between 18 and 72 years. Admitted to OUH directly or after transfer from local hospitals within 72 hours of injury. At least a two-day hospital stay. Traumatic injury corresponding to a New Injury Severity Scale score (NISS) >9. Patients reporting injury-related symptoms, functional impairments, and/or difficulties with daily activities at the discharge from OUH.  Exclusion Criteria:  Cognitive function corresponding to a Mini Mental Status score (MMS) < 20 points. Psychiatric diseases that require treatment. Drug/alcohol dependence that require treatment. Complete spinal cord injury and isolated thoracic or abdominal injury Insufficient command of Norwegian - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 72 Years - StdAgeList: Adult, Older Adult
RECOVER-AUTONOMIC: Platform Protocol, Appendix B (Ivabradine)
Status: Not yet recruiting

This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.

This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  See NCT######## for RECOVER-AUTO: Platform Protocol level inclusion criteria which applies to this appendix (or sub-study)  Additional Appendix B (Ivabradine Sub-study) Level Inclusion Criteria:  Abnormal active standing test defined as presence of orthostatic tachycardia (an increase of 30 beats per minute (bpm) or more in HR within 10 minutes upon standing without orthostatic hypotension) and experiencing orthostatic symptoms COMPASS-31 Score > 25 and not enrolled in the IVIG appendix  Exclusions Criteria:  See NCT######## for RECOVER-AUTO: Platform Protocol level inclusion criteria which applies to this appendix (or sub-study)  Additional Appendix B (Ivabradine Sub-study) Level Exclusion Criteria:  A person of child-bearing potential who is not taking effective contraception Use of the following medications: clonidine, tizanidine, amphetamines, and serotonin and norepinephrine reuptake inhibitors (SNRIs) with the exception of modafinil Use of beta-blockers (any formulation), calcium channel blockers, midodrine, pyridostigmine, fludrocortisone, and guanfacine will be excluded unless participant is on a stable dose (>4 weeks). Participants on stable doses will be allowed to continue the medication throughout the study. Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties Lactating and breast-feeding women Severe hepatic impairment Use of drugs known to prolong the QT-interval (e.g., quinidine, disopyramide, bepridil, sotalol, amiodarone, pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine Concomitant use of digoxin Participants who are pacemaker dependent Patients with hypokalemia (serum K+<3.5 mEq/L) Patients taking potassium-depleting diuretics A history of congenital or acquired long QT syndrome, with or without torsade de pointes Patients with high degree AV block such as Mobitz II - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG)
Status: Not yet recruiting

This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.

This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in Post-Acute Sequelae of SARS-CoV-2 infection (PASC) participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  See NCT######## for RECOVER-AUTO: Platform Protocol level inclusion criteria which applies to this appendix (or sub-study)  Additional Appendix A (IVIG Sub-study) Level Inclusion Criteria:  Abnormal active standing test defined as presence of orthostatic tachycardia (an increase of 30 beats per minute (bpm) or more in HR within 10 minutes upon standing without orthostatic hypotension) and experiencing orthostatic symptoms COMPASS-31 Score > 40  Exclusion Criteria:  See NCT######## for RECOVER-AUTO: Platform Protocol level exclusion criteria which applies to this appendix (or sub-study)  Additional Appendix A (IVIG Sub-study) Level Exclusion Criteria:  Current or previous IVIG treatment Contraindication to intravenous immunoglobulin. Known allergic reactions to blood products including IVIG and/or subcutaneous immunoglobulin (SCIG), such as history of clinically relevant hemolysis after IVIG infusion, aseptic meningitis, recurrent severe headache, hypersensitivity, severe generalized or severe local skin reactions Selective IgA deficiency Current and recent (within 5 half-lives) use of high-dose corticosteroids (for example for prior solid organ transplant), omalizumab, anti-TNF-alpha inhibitors Use of immunosuppressants such as Plaquenil, or low-dose steroid (prednisone, no more than 10mg a day) will be excluded unless the participant is on stable (>4 weeks) dose Significant thrombotic events after the acute phase of COVID-19 and/or within 6 months of enrollment Veins that are not viable for infusions Not willing to adhere to dosing schedule for IVIG infusions for 9 months - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005)
Status: Not yet recruiting

The purpose of this study is to assess the safety and efficacy of V940 in combination with pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection. The primary study hypothesis is that V940 in combination with pembrolizumab results in a superior disease-free survival (DFS) as assessed by the investigator compared to pembrolizumab alone in participants with high-risk MIUC after radical resection.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Has muscle-invasive urothelial carcinoma (MIUC) Has dominant histology of UC Has high-risk pathologic disease after radical resection Must provide formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for next generation sequencing (NGS) Must provide blood samples per protocol, to enable V940 production, and circulating tumor Deoxyribonucleic acid (ctDNA) testing Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization  Exclusion Criteria:  Has received prior systemic anticancer therapy Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention Has known additional malignancy that is progressing or has required active treatment <3 years prior to study randomization Has severe hypersensitivity to either V940 or pembrolizumab and/or any of their excipients Has current pneumonitis/interstitial lung disease Has active infection requiring systemic therapy Has active hepatitis B and hepatitis C virus infection - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Study of Early Cancer Detection in People at High Risk of Developing Pancreatic Ductal Adenocarcinoma (PDAC)
Status: Recruiting

The purpose of this study is for researchers to find ways of detecting pancreatic ductal adenocarcinoma/PDAC early to avoid the invasive procedure of surgery. The study researchers think a combination of imaging and a series of blood tests may be an effective way to detect PDAC early. In this study, researchers will look at whether a combination of the following types of imaging with blood tests can detect PDAC in pancreatic cysts:

The ImmunoPET scan (immune-positron emission tomography scan) with the imaging agent 89Zr-DFO-HuMab-5B1
The HP MRI scan (hyperpolarized pyruvate magnetic resonance imaging scan)

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Men and women aged >18 years Pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection Able to provide informed consent  Exclusion Criteria:  Pathologic evidence of pancreatic cancer Pregnant or breast-feeding patients Refusal or inability to tolerate scan (eg anxiety or claustrophobia) Inability to lay flat or meet the standard requirements of traditional MRI  Hepatic function from assays obtained within 6 weeks prior to the study enrollment. For each patient, the upper limit of normal (ULN) value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay  Bilirubin > 1.5 x ULN AST/ALT > 2.5 x ULN Albumin < 3 g/dL GGT > 2.5 x ULN if Alkaline Phosphatase > 2.5 x ULN Renal function with Creatinine > 1.5 x ULN or creatinine clearance < 60 mL/min, from assays obtained within 6 weeks prior to study enrollment Cardiac: congestive heart failure with New York Heart Association (NYHA) status ≥2, poorly controlled hypertension, a history of clinically significant EKG abnormalities, or myocardial infarction within 6 months of study enrollment. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering (MSK). - SamplingMethod: Non-Probability Sample
Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X)
Status: Not yet recruiting

This prospective, two-part, single-arm, phase II trial is designed to evaluate whether the use of definitive radiation to the primary lung lesion prolongs progression-free survival (PFS) in treatment-naïve, metastatic, driver-mutated non-small cell lung cancers (NSCLC) patients who are subsequently placed on a tyrosine kinase inhibitor (TKI).

Eligibility:
- EligibilityCriteria: Inclusion Criteria Part 1  Age ≥18 years. Patient must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC). An identifiable primary lung lesion must be present based on the consensus opinion of the medical oncology and radiation oncology investigators. Patient did not previously receive radiation therapy to the primary lung lesion. Previous or concurrent palliative radiation to symptomatic metastatic lesions and definitive radiation to central nervous system metastases are allowable. Patient must have advanced disease, either stage IV or stage IIIB/C that is not amenable to definitive multi-modality therapy. Patient must not have received prior targeted therapy for NSCLC. A subject may receive up to 2 cycles of standard cytotoxic chemotherapy for NSCLC prior to trial enrollment. For example, a cycle of carboplatin and pemetrexed is given once every 3 weeks. Patient must have measurable disease as defined by RECIST v1.1. Patient must have Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2. Ability to understand a written informed consent document, and the willingness to sign it.  Inclusion Criteria Part 2  1. Must have an actionable driver mutation for which an Food and Drug Administration (FDA) -approved and/or National Comprehensive Cancer Network (NCCN) -recommended front-line TKI is available.  Exclusion Criteria:  Anticipated prognosis < 3 months. Inability to swallow oral medications or history of GI abnormality that would impair absorption of oral medications. Patients with prior or concurrent malignancy are eligible provided the investigator assesses this malignancy does not have potential to interfere with evaluation of the safety or efficacy of the study treatments. Patient must not have any unresolved toxicities from prior cancer therapy greater than CTCAE grade 2 at time of study enrollment. Any grade alopecia is allowable. Patient must not have medical contraindications, as determined by treating radiation oncologist, that would preclude safe delivery of radiation therapy. Women must not be pregnant or breast-feeding. All females of childbearing potential must have negative blood or urine pregnancy testing within 14 days of study enrollment. Women of childbearing potential and sexually active males must use effective methods of contraception for 14 days prior to study enrollment, while on study treatment, and for 4 months after the last targeted therapy treatment. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking*
Status: Recruiting

To compare and contrast the clinical, gait and parent-reported outcomes following either non-operative (casting) or operative treatment for children with idiopathic toe walking (ITW) and determine whether there are specific genes associated with ITW.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of Idiopathic Toe Walking Persistent (ITWp) Between the ages of 6-18 years Passive dorsiflexion dorsiflexion with knee extension between -10 plantar flexion - + 5 degrees of dorsiflexion, DiGiovanni defined an isolated gastrocnemius contracture as maximum passive ankle dorsiflexion as < 5 degrees with the knee in full extension  Exclusion Criteria:  Diagnosis of Autism or autism spectrum disorder Presence of any indicators of trauma, neuromuscular influence or neurogenic influence as identified by using the Toe Walking Tool - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)
Status: Recruiting

Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Cases:  Aged at least 18 years Newly diagnosed primary tumor, histologically confirmed squamous cell carcinoma of the oropharynx (stages I-IV) Has not received treatment (surgery, chemotherapy, radiation, or immunotherapy) within the previous four weeks Provided written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is identified and enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center Aged at least 35 years Have no previous diagnosis of HNC or HPV-related cancer Fully understands study procedures Voluntarily agrees to participate by giving written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center  Exclusion Criteria:  Not meeting all of the above inclusion criteria for either the case or control group - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will consist of 100 early and 100 late disease pre-treatment Oropharyngeal Cancer cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh). - SamplingMethod: Non-Probability Sample
Probiotic Influence on Obesity-Related Lipidemia
Status: Not yet recruiting

This study aims to investigate the effects of Bifidobacterium breve BBr60 on key health indicators in overweight and obese adults. Specifically, it will assess the probiotic's impact on body composition metrics such as BMI, body fat percentage, WHR, and BMR. The inclusion criteria for participants are a BMI of ≥28 kg/m^2, targeting individuals who stand to benefit significantly from metabolic and body composition improvements.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Body mass index (BMI) ≥ 28 kg/m2; Voluntarily, in writing, and signing the informed consent form, agreeing to participate in this study; Those who agree to abide by the protocol and study restrictions and are able to comply with a low-carbohydrate, energy-restricted diet plan. Subjects (including male subjects) have no plans to have children from 14 days before screening to 6 months after the end of the trial and voluntarily take effective contraceptive measures;  Exclusion Criteria:  Taking items with similar functions to those tested in a short period of time will affect the judgment of the results; Patients with severe allergies and immune deficiency; Women who are pregnant, breastfeeding or planning to become pregnant; Severe diseases of cardiovascular, lungs, liver, kidneys and other important organs, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, and severe immune system diseases; People who have used antibiotics in the past two weeks; Those who failed to consume the test samples as required or failed to follow up on time, resulting in uncertainty in determining the efficacy; Have used laxatives or fiber supplements in the past 6 weeks; Subjects judged by other researchers to be unfit to participate. Those who meet any of the above conditions will not be selected. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 19 Years - MaximumAge: 45 Years - StdAgeList: Adult
Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease
Status: Not yet recruiting

This protocol describes a randomized controlled trial testing the effectiveness and implementability of the CHESS Health Connections smartphone application among patients with alcohol-associated liver disease (ALD) at two medical centers in Michigan and Wisconsin, in two types of clinics: general hepatology and multidisciplinary that offers care for advanced ALD alongside co-located, integrated mental health and substance abuse treatment. The long-term goal of this and future work is to prevent disease progression and promote healthy behaviors by improving the rate of abstinence among patients with ALD earlier in the course of their disease. 298 participants will be enrolled and can expect to be on study for up to 6 months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of ALD (any stage) Alcohol use within the last 6 months  Receiving care at UW or UM  Either the general hepatology clinic or the multidisciplinary ALD clinic Able to read and write proficiently in English Willing and able to use a smartphone app  Exclusion Criteria:  Actively listed for liver transplant or history of liver transplant In hospice care Has severe cognitive impairment (as described in electronic health record including dementia, delirium, and/or unable to maintain cognitive alertness during screening--as determined by study staff.) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
European and North Indian Cohort of KaWasaki dIsease
Status: Recruiting

Kawasaki disease (KD) is currently the leading cause of acquired heart diseases in children in developed countries. Cardiac involvement is the main determinant of the long-term prognosis of these patients, as coronary aneurisms (CAAs) may lead to ischemic heart disease and even sudden death. The current standard of care for KD has consistently reduced CAAs frequency from 25-30% to about 5%. Unfortunately, 10-20% of KD patients results resistant to standard treatment leading to a major risk of cardiac complications. Thus, scoring systems have been constructed in order to identify patients likely to be resistant to IVIG and who may benefit from more aggressive initial therapy. Different scoring scales developed by Kobayashi, Egami et Sano had shown a good sensitivity (77-86%) and specificity (67-86%) in predicting IVIG unresponsiveness in Japanese populations. However, their predictive value was not confirmed by subsequent studies in different ethnic populations. Recently, the French Kawanet group have proposed a IVIG unresponsiveness score that provided good sensitivity and acceptable specificity in a non-Asian KD population even if it was not subsequent validated by an external study. In our study population, the achievement of specificity and sensitivity values for both scores consistent with those reported by the original studies (sensitivity 70% and specificity 80% for Kobayashi and sensitivity 77% and specificity 60% for Kawanet), will be considered a success.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients aged less than 18 years at diagnosis Diagnosis of KD according to the AHA criteria  Exclusion Criteria:  Patients who do not meet the criteria for KD Patients for which an alternative infectious diagnosis was not investigated and/or excluded. - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Year - MaximumAge: 17 Years - StdAgeList: Child - StudyPopulation: The setting is represented by 1 Asian and 4 European pediatric rheumatology centres which with internationally recognized expertise in the treatment and follow-up of a large number of Kawasaki disease patients - SamplingMethod: Non-Probability Sample