rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
ViSiGi LUX Bariatric Sizing and Calibration System
Status: Recruiting

This study investigates the new ViSiGi LUX.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years or older able to consent candidate for robotic bariatric surgery  Exclusion Criteria:  esophageal stricture that does not allow passage of the device conditions that would preclude gastric or bariatric surgical procedures pregnant patients - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients undergoing gastric or bariatric procedures. - SamplingMethod: Non-Probability Sample
Serum Neurofilament Light in Multiple Sclerosis
Status: Not yet recruiting

This prospective cohort study is designed to characterize the utility of sNfL as a biomarker in clinical practice. This study also aims to understand how access to sNfL measures affects patient and clinician knowledge of their disease status and capture how this may have the potential to influence clinical decision-making. Level of disability, cognitive changes, fatigue, depression, and quality of life to detect clinical and subclinical worsening will be measured. While there is strong evidence in support of sNfL as a potential biomarker, literature regarding the application of sNfL in a real-world clinical practice setting is lacking. Understanding the utility of this test to clinicians and patients as a biomarker of MS disease activity is essential. Additionally, the optimum sampling frequency in clinical practice should be investigated to further elucidate its practicality. Given recent advances in the treatment of MS, there is increasing need for convenient and accessible measures of treatment efficacy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed with RRMS Adults aged 18+ at time of screening Patients who are able to consent Patients who agree to be reasonably compliant with study protocol for the duration of the study Any subject who is currently being treated with an MS DMT or any subject initiating a new MS DMT throughout the duration of their participation in the study will be initiated and/or treated according to local label  Exclusion Criteria:  Patients with current diagnosis of a neurodegenerative or autoimmune disease other than MS that may impact sNfL levels, in the opinion of the investigator (including but not limited to: Alzheimer's disease, Huntington's disease, Amyotrophic Lateral Sclerosis, or Parkinson's disease, systemic lupus erythematosus, rheumatoid arthritis) Inability to complete blood draws Pregnant or breastfeeding, or planning to become pregnant or breastfeed for the duration of the study Patients who have taken an investigational medication within five half-lives prior to screening or who plan to take an investigational medication during the study Patients with a medical condition or taking a medication that may interfere with study endpoints in the opinion of the investigator - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients diagnosed with relapsing remitting multiple sclerosis. - SamplingMethod: Non-Probability Sample
Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes
Status: Not yet recruiting

Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements (insulin pump or smart pen data), glucose variability (CGM data), nutritional information, and menstrual cycle information (cycle tracking app, LH tests, and premenstrual symptoms)) to identify categories of cycle trajectories.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Living with Type 1 Diabetes Perimenopausal people with menstrual cycle Using a hybrid closed-loop system Signed digital informed consent  Exclusion Criteria:  Using hormonal therapy or contraception - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult - StudyPopulation: People with menstrual cycles living with Type 1 Diabetes who are using a hybrid closed-loop system. - SamplingMethod: Non-Probability Sample
Early Transcatheter Mitral Valve Repair After Myocardial Infarction
Status: Not yet recruiting

To explore the impact of early transcatheter edge-to-edge repair of acute functional mitral regurgitation after myocardial infarction on the combined incidence of death and heart-failure associated hospitalisations at one-year follow-up, and quality of life and LV remodelling at two-year follow-up.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with symptomatic moderate to severe or severe MR after acute MI Age > 18 years Based on the following classification recently published in "Transcatheter Mitral Edge-to-Edge Repair for Treatment of Acute Mitral Regurgitation" by M. Shuvy et al. (Can J Cardiol. 2023) patients will be included if categorized in Type 2, 3 or 4:  Exclusion Criteria:  Primary MR (e.g. papillary muscle rupture) EF ≤ 25% Accepted for CABG Presence of cardiogenic shock (AMR type 1) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult
ACT-group for Stroke Survivors (Pilot Study)
Status: Recruiting

The goal of this clinical pilot trial is to test the feasibility, acceptance and preliminary efficacy of an adapted group psychotherapy manual in stroke survivors with psychological stress. The main questions it aims to answer are:

Is the group therapy feasible?
Is the group therapy accepted by stroke survivors and therapists?
Are there first indications on the efficacy of the group therapy to improve mental health?

Participants will take part in 8 weekly group therapy sessions of 90 minutes each.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Time since stroke > 3 months and < 2 years. Value above a cut-off on one of the DASS-21 subscales (depression > 10, anxiety > 6, and stress > 10) Sufficient cognition and language ability (clinical rating) Sufficient therapy motivation (clinical rating)  Exclusion Criteria:  Behavioral disorders (e.g., high irritability or apathy in clinical rating) Other severe mental disorder (dementia, psychosis, personality disorders, intellectual disability) Parallel psychotherapy or neuropsychological therapy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Risk Factors for Neuroendocrine Neoplasms
Status: Not yet recruiting

Recent studies show an increase in neuroendocrine neoplasms, especially for the digestive tract. Previous studies suggest various risk factors that were observed for various tumor sites, e.g. a family history of cancer, tobacco and alcohol consumption as well as metabolic disorders including diabetes and obesity. A risk factor that has been little studied to date is depressive disorders, which could increase the risk of neuroendocrine neoplasms either independently or through associated risk behaviors and/or antidepressant medication. The aim of this study is to identify risk factors for neuroendocrine neoplasms based on a case-control study in order to better understand the increase of neuroendocrine neoplasms in recent decades. The study is based on a record linkage of data from the Bavarian Cancer Registry and data from the Bavarian Association of Statutory Health Insurance Accredited Physicians. While the data from the Bavarian Cancer Registry enables the identification of neuroendocrine neoplasms on the basis of histopathological findings and thus is the basis for selecting cases, the claims data from the Bavarian Association of Statutory Health Insurance Accredited Physicians provides the source population as well data on diagnoses and thus enables the investigation of risk factors.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Resident in Bavaria for the years 2020 and 2021  Exclusion Criteria:  None - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: The study population comprises all patients within the claims data of the Bavarian Association of Statutory Health Insurance Accredited Physicians in the years 2020 and 2021 - SamplingMethod: Probability Sample
Protective Anesthesiological Management Procedure Imposes Control on Respiratory Comlications
Status: Recruiting

Anesthetic effects, surgery, and invasive mechanical intubation can impair respiratory function during general anesthesia. The risk factors for postoperative pulmonary complications (PPCs) include the type of surgery and duration, ventilation-perfusion discrepancy, and the presence of pain. Mitigating PPCs under anesthesia is a goal, but effective strategies are yet to be defined. Conventional ventilation (CV) procedure uses more inspired oxygen during pre-oxygenation and anesthesia maintenance. The protective lung ventilation (PV) procedure, on the other hand, includes high positive end-expiratory pressure, lung recruitment maneuver, oxygen saturation levels above 94%, lower inspired oxygen levels, and continuous positive airway pressure before the tube is removed. In this study, 56 consecutive patients undergoing abdominal surgery were randomly assigned, with 30 in the CV and 23 in the PV group, while 3 were lost during the follow-up. We concluded that the implementation of protective lung ventilation strategies has the potential to reduce the occurrence of PPCs, recommending these strategies be adopted as the standard practice in general anesthesia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  the inclusion criteria were as follows: subject status according to the American Society of Anesthesiologists Association classification ASA 1 (normal healthy patients, i.e. patients without associated comorbidities) or ASA 2 (patients with mild systemic disease, such as well-controlled hypertension), normal heart and lung function, both sexes, non-smokers, normal X-ray findings for heart and lungs, age 18-65 years, planned operation of medial laparotomy for colorectal cancer with a minimum duration of anesthesia of at least one hour, signed informed consent. In the case of hypertension in ASA 2 patients enrolled in the study, by examining the self-monitoring diary for the past three months (as described in Gropper et al., 2019), there was no increase in systolic pressure more than 20 mmHg from the average daily value and no increase in diastolic arterial pressure more than 10 mmHg from the average daily value. In the case of diabetes type II in ASA 2 patients enrolled in the study, the HbA1c values were not higher than 7% while taking oral hypoglycemic drugs and having a regulated diet. The patients enrolled also had no complications or episodes of hypoglycemia in the past three months, as described by Gropper et al., 2019. In the case of thyroid disease in ASA 2 patients enrolled in the study, values of TSH, fT3, and fT4 in the period up to 6 months since the last examination were normal.  Exclusion Criteria:  ASA 4 status terminal renal illness cardiac status NYHA III i NYHA IV at home oxygenotherapy during 16 hours - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm
Status: Not yet recruiting

The objective of this study is to determine if there is a meaningful benefit to using the sedative medication dexmedetomidine in the acute treatment of patients with recurrent ventricular arrhythmias, known as electrical storm. This will be a multi-centre, double-blinded, placebo-controlled, randomized trial. Patients with electrical storm will be randomized to receive 48 to 72 hours of dexmedetomidine or placebo as part of their initial treatment in an intensive care unit.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - All patients admitted to an intensive care unit with electrical storm over the age of 18 years will be approached for enrollment.  Exclusion Criteria:  Refractory shock lasting for more than 30 minutes unrelated to ventricular arrhythmias (VAs), defined as requiring two or more vasopressors SCAI class D or E cardiogenic shock Cardiac arrest(s) with a no-flow and low-flow total time of greater than 10 minutes prior to recruitment. ST-segment elevation myocardial infarction (STEMI)-induced VA with signs of active ischemia. Bradycardia with heart rate less than 40 beats per minute, bradycardia-induced ventricular tachyarrhythmia, second degree Mobitz type 2 or greater atrioventricular block in the absence of a pacemaker. Pregnancy Known dexmedetomidine allergy or intolerance Inability to obtain consent from patient or substitute decision maker. Patients who have received dexmedetomidine or clonidine during the 24 hours prior to randomization - HealthyVolunteers: No - Gender: All - GenderBased: Yes - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Machine Learning and 3D Image-based Modeling for Body Weight Estimation.
Status: Not yet recruiting

The goal of this randomized controlled clinical trial is to [learn about, test, compare etc.] in critically ill or injured cohorts of patients presenting to the Emergency Department. The main question[s] it aims to answer are:

Are weight estimates from a 3D camera system more accurate than standard methods of weight estimation?
Do patients who receive weight estimates with a 3D camera system have fewer drug dosing errors than patients receiving standard care?

Participants will either receive a weight estimate using a 3D camera system, or standard methods of care.

Researchers will compare the 3D camera group to those with standard care to see if the weight estimates are more accurate, to see if drug dosing is more accurate, and to compare the incidence of adverse events related to medications in each group.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - Any patient presenting to the Emergency Department of the study site, who will require any form of weight-based intravenous drug therapy, and who will be admitted to the hospital.  Exclusion Criteria:  Patients who are unable to provide consent. Patients whose medical treatment could be negatively impacted by participation in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Cryotherapy & Oxaliplatin
Status: Not yet recruiting

The primary objective of this study is to determine if cryotherapy is beneficial to patients with colon cancer who are receiving oxaliplatin in the prevention of developing chemotherapy induced peripheral neuropathy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Over the age of 18 years Willingness to participate in research Diagnosed with stage III colon cancer Chemotherapy naïve Planning to initiate Capecitabine + Oxaliplatin (CAPOX) chemotherapy regimen as part of standard of care.  Exclusion Criteria:  Pre-existing peripheral neuropathy Pre-existing diabetes Raynaud's disease Metabolic syndrome, including: Hypertension; Hypercholesterolemia; and Obesity (BSA > 2) Upper extremity amputees Specific autoimmune diseases: Guillain-Barre; Lupus; Rheumatoid arthritis; and Sjogren's syndrome - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Impact of Anti PD-1 Therapy in Children, Adolescents and Young Adults (CAYA) Melanoma Patients
Status: Not yet recruiting

This is a retrospective observational cohort study, the primary objective is investigate the activity and efficacy of anti PD-1 antibodies in children, adolescents and young adult melanoma patients, with radically resected or metastatic disease

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients of either sex aged ≥ 12 years; Histologically confirmed melanoma; Anti PD-1 Immunotherapy (Ipilimumab plus Nivolumab); Previous and subsequent treatments will be collected; Clinical and follow-up data available  Exclusion Criteria:  No immunotherapy received; No melanoma; Age > 30 yrs - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 30 Years - StdAgeList: Child, Adult - StudyPopulation: Adolescent, childhood and young adult with early and advanced melanomas treated with anti PD-1 therapy - SamplingMethod: Probability Sample
Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus
Status: Recruiting

This is a prospective multicenter randomized controlled trial with a total duration of 36 months aiming to evaluate the effectiveness and the safety of low protein diet on top of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and renin-angiotensin-aldosterone inhibitors (RAASi) in reducing the progression of chronic kidney disease in patients with type 2 Diabetes Mellitus

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age>18 years old confirmed chronic kidney disease (with eGFR between 60 and 20 ml/min/1.73 m2 and/or proteinuria >500 mg/g urinary creatinine) and confirmed type 2 Diabetes Mellitus stable kidney function for at least 12 weeks before enrollment (defined as decrease in eGFR < 5 ml/min/1.73 m2/year according to KDIGO 2012 guideline) treatment with ACE/ARBs and/or MRAs for at least 3 months no previous treatment with SGLT2i good nutritional status declared and anticipated good compliance with the prescribed diet signed informed consent  Exclusion Criteria:  eGFR < 25 ml/min/1.73 m2 poorly controlled arterial blood pressure (mean BP≥145/85 mm Hg) class IV NYHA heart failure, recent MACE (less than 6 months) relevant comorbid conditions (active infections (HBV, HCV, HIV), active neoplasia, digestive diseases with malabsorption, active autoimmune diseases/ immunosuppressive therapy) ADPKD kidney transplantation with functional graft malnutrition: BMI<18 kg/me, eight loss >10% during the last 6 months, serum albumin <3 g/dL feeding inability (anorexia, nausea) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
Status: Not yet recruiting

Tuberculosis (TB) is the leading cause of death among children living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children. Short-course TB prevention/latent TB infection (LTBI) treatment regimens increase completion rates but have not been adequately studied among children living with HIV. Our prospective, open-label PK study will examine and extend use of weekly rifapentine and isoniazid (3HP) among children receiving dolutegravir. This will address gaps in knowledge by examining two-way PK of short-course LTBI treatment in a vulnerable pediatric population.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  (1) ART-naïve or ART-experienced HIV-infected children 4 weeks to <12 years of age; (2) no evidence of active TB based on an appropriate clinical evaluation; (3) negative TB diagnostic test if performed (other than tuberculin skin testing); (4) weight of at least 4 kilograms; and (5) consent of the parent or legal guardian and assent of the child (if ≥7 years of age).  Exclusion Criteria:  (1) Baseline labs with evidence of ≥grade 3 abnormalities: alanine aminotransferase (ALT), total bilirubin, absolute neutrophil count (ANC), platelets, creatinine; (2) presenting with acute respiratory distress or decompensation, or any clinical syndrome which could suggest undiagnosed TB or other opportunistic infection; or (3) receipt of a medication that has drug-drug interactions with DTG or RPT. - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Weeks - MaximumAge: 11 Years - StdAgeList: Child
Mobile App-based Approach for Reducing Pain and Hazardous Drinking: a Pilot Study
Status: Recruiting

Chronic pain and heavy drinking are common co-occurring conditions among patients presenting to primary care settings. Given their impact on functioning and medical outcomes, there would be considerable benefit to developing an accessible, easily utilized, integrative approach to reduce alcohol use and pain that can be readily incorporated into the health care settings. The objective of this study is to test a modified version of a smartphone-based intervention for reducing pain and alcohol use among individuals experiencing chronic pain who engage in heavy drinking. The primary goal is to test the feasibility and acceptability of implementing this intervention in a sample that includes participants from rural areas and providing initial data on the utility of the intervention.

Eligibility:
- EligibilityCriteria: Inclusion Criteria  1 Heavy drinking by NIAAA guidelines (weekly limits [> 7 standard drinks for women or men age 65+, > 14 for men younger than 65], and/or a heavy drinking episode in the past month [>3 for women or men age 65+, > 4 for men younger than 65]) or by a positive USAUDIT-C score 2 Chronic pain [at least 3 months in duration] of at least moderate severity (4 or greater on the Numerical Pain Rating Scale from 0-10)  Exclusion Criteria:  1 If on medication for pain or alcohol, not on same dose for at least 2 months [Note: Participants who are on psychoactive medications for pain management may be included if they have a stable (at least 2 months) medication dose and state a willingness to continue use of medication as prescribed by their physician through the intervention phase] 2 Patients with bipolar disorder, schizophrenia, other psychotic disorder, or current suicidal intent. 3 Prior history of withdrawal-related seizures or delirium tremens 4 Current non-pharmacological treatment for alcohol use disorder or chronic pain. 5 Any acute life-threatening illness that requires treatment or intend to have surgery for a pain-related condition in the next 6-months 6 Pain that is related to a current cancer diagnosis 7 Patients who are unable to provide one or more individuals who will likely know where they are at follow up 8 Individuals who do not have a smartphone with which they can use to complete the remote study procedures. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Photon Counting Detector CT Image Quality
Status: Not yet recruiting

This study aims to compare subjective image quality and diagnostic accuracy of a photon counting detector computed tomography (PCD-CT) scanner compared with an energy integrating detector (EID)-CT scanner as the reference standard.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient admitted for non-contrast enhanced CT scan of the upper or lower extremity at the radiology department of Balgrist University Hospital Signed general consent ("Information zur Weiterverwendung gesundheitsbezogener Daten und Proben zu Forschungszwecken") >18 years of age Written consent to participate in this study  Exclusion Criteria:  Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) Women: pregnancy Age below 18 years Known or suspected non-compliance, drug or alcohol abuse Inability to consent and/or follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject Enrolment of the PI, his/her family members, employees and other dependent persons Body mass above 200 kg. Body mass below 31 kg. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult