rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Eye-tracking Investigation of Clinical Measures in Multiple Sclerosis
Status: Not yet recruiting

The overarching goal of this research protocol is to acquire eye-tracking, cognitive, and disease-severity metrics in MS patients to train machine learning algorithms that will support the development and performance assessment of a sensitive and non-invasive eye-tracking software application. The training of our machine learning classifying algorithms to identify which eye-tracking metrics-or combination thereof-can serve as reliable markers of MS disease severity and cognitive status.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Able to provide informed consent Aged 18 years or older at the time of enrollment Able to read in either French or English Able to read the oculomotor task on-screen instructions at the testing distance (45cm) with or without corrective lenses Confirmed diagnosis of MS as per the Macdonald criteria, irrespective of MS subtype (relapsing-remitting (RRMS), secondary-progressive (SPMS), primary-progressive (PPMS), and progressive-relapsing (PRMS)) Neurologist-determined EDSS score between 1.0-8.0  Exclusion Criteria:  Evidence or medical history of psychiatric issues, which are known to also affect movements and oculomotor control Presence of comorbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia) Diagnosis of macular edema or other pre-existing ocular conditions that would prevent a participant from performing the eye movement assessments Having started a new prescription medication or having changed the dose of a medication known to influence ocular motor visual function (e.g. benzodiazepines, antipsychotics and anticonvulsants) within the past three months Participants with non-disease related physical impairments to a leg, hand, or arm (e.g., broken bone or severe sprain) that would not allow completion of the assessments - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Our target sample size for the MS group is up to 100 patients. Eligible patients with MS will be selected and categorized based on their EDSS score. - SamplingMethod: Non-Probability Sample
Evaluation of the RESTART Survival Programme
Status: Not yet recruiting

The RESTART survivorship programme has been implemented in the care pathway for patients with localised breast cancer since 2022. In this project, investigators are going to evaluate the satisfaction of patients taking part in the RESTART programme, as well as measuring changes in quality of life and health literacy after participation in the RESTART programme.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age >= 18 at the time of signing the ICF Minimum understanding of French Signed study informed consent form obtained prior to any study-related procedure. Participation in the RESTART programme Patient with curative breast cancer (AJCC stage I-II-III)  Exclusion Criteria:  - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Refusal to participate in the RESTART programme Patients with AJCC stage IV breast cancer will be excluded. - SamplingMethod: Non-Probability Sample
Enhancing Prospective Thinking in Early Recovery (BEAM)
Status: Not yet recruiting

The goal of this clinical trial is to test the prosocial effects of personally-relevant, high-intensity episodic future-thinking (EFT) cues in alcohol use disorder persons and related brain mechanisms. The main question[s] this trial aims to answer are:

Will high-intensity EFT cues will produce greater delayed reward preference than low-intensity cues?
Will high-intensity EFT cues effect greater treatment-seeking interest?
Will high-intensity EFT cues elicit greater response in regions for prospective thinking during delay discounting (vs. low-intensity)
Will nucleus accumbens-precuneus resting connectivity correlate with behavioral SS?
Will the novel behavioral SS decision-making task activate the nucleus accumbens?

Researchers will compare the experimental (high-intensity group) and control (low-intensity) groups to see if there are differences in the results for the questions outlined above.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Individuals who meet current heavy drinking (≥2 heavy drinking days/month OR ≥7 drinks/week for biological females, and ≥14 drinks/week if biological male [NIAAA definition] and/or AUDIT scores ≥8) English comprehension  Exclusion Criteria:  Unstable medical disorders Outside the age range of 18-60 Smell/taste disorders Unstable psychiatric conditions - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
Enhancing Prospective Thinking in Early Recovery
Status: Recruiting

The goal of this clinical trial is to test the prosocial effects of personally-relevant, high-intensity episodic future-thinking (EFT) cues in alcohol use disorder persons and related brain mechanisms. The main question[s] this trial aims to answer are:

Will high-intensity EFT cues will produce greater delayed reward preference than low-intensity cues? Will high-intensity EFT cues effect greater treatment-seeking interest? Will high-intensity EFT cues elicit greater response in regions for prospective thinking during delay discounting (vs. low-intensity) Will nucleus accumbens-precuneus resting connectivity correlate with behavioral SS? Will the novel behavioral SS decision-making task activate the nucleus accumbens? Researchers will compare the experimental (high-intensity group) and control (low-intensity) groups to see if there are differences in the results for the questions outlined above.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Abstinence between 30 days ≤ 1 year Verbal endorsement of commitment to recovery English comprehension  Exclusion Criteria:  Unstable medical disorders Outside the age range of 18-60 Habitual substance or alcohol use Smell/taste disorders Unstable psychiatric conditions - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
A Dried Blood Spot Sampling Method for Vancomycin and Creatinine Monitoring for OPAT
Status: Recruiting

The Outpatient Parenteral Antibiotic Therapy (OPAT) service consists of providing antimicrobial therapy through parenteral infusion without hospitalization. This service is provided to stable patients otherwise ready for hospital discharge. Generally, the clinical monitoring for this patient population is minimal. However, clinical monitoring of vancomycin, an antibiotic widely used during OPAT, can be intensive primarily due to therapeutic drug monitoring. To ensure optimal treatment and minimize nephrotoxicity and microbial resistance, TDM and monitoring of serum creatinine levels are crucial during vancomycin therapy. TDM of vancomycin with OPAT presents a challenge for patients who must frequently travel to blood sampling facilities or the hospital for measurements. An alternative sampling method for TDM is the dried blood spot (DBS) method, which involves collecting a small drop of capillary blood from a finger prick onto filter paper. By implementing the DBS sampling method, the amount of outpatient visits regarding vancomycin treatment in OPAT can be reduced. Furthermore, the addition of measuring a biochemical parameter, such as renal function with serum creatinine, could lead to even less outpatient visits during OPAT. To date, studies investigating the effectiveness of DBS sampling of vancomycin and creatinine in terms of reducing outpatient visits have not yet been conducted in the OPAT population.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged 18 and over Able to understand written information and able to give informed consent Hospitalized Treated with intravenous vancomycin and to be discharged with vancomycin OPAT service with minimal 1 planned outpatient vancomycin TDM order Able and willing to perform finger pricks for dried blood spot sampling, or able and willing to undergo finger pricks performed by family members or other caregivers Able and willing to fill in questionnaires  Exclusion Criteria:  Former participation in this trial Cognitive dysfunction or other dysfunctionalities which makes the patient unable to draw blood by a finger prick or fill out questionnaires Unable to sample an adequate DBS after training in the hospital (this is also applicable for family members or other caregivers who are failing to perform adequate DBS sampling for the patient) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 120 Years - StdAgeList: Adult, Older Adult
ICF-based Comparison on Musculoskeletal Health in Poland and Spain
Status: Not yet recruiting

Musculoskeletal conditions are a major cause of disability worldwide. These conditions are often associated with chronicity, which is a challenge for healthcare systems to address. Health care must be person-centred and take into account the individual perspective from which the disease is experienced. The lived experience of health conditions depends to a large extent on contextual factors. Comparison between different contexts helps to identify which aspects are most relevant in the experience of the disease. The International Classification of Functioning, Disability and Health (ICF) provides a unified language that allows such comparisons to be made. The aim of this study is to identify differences in musculoskeletal health between the Polish and Spanish populations using the ICF as a frame of reference.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age between 18 and 65 years, diagnosed musculoskeletal disorder according to ICD-10, normal cognitive status to perform reliable study (The Abbreviated Mental Test Score >6), informed and voluntary consent to participate in the study, sufficient knowledge of the Spanish or Polish language.  Exclusion Criteria:  mental disorders - depression or personality disorders confirmed by a medical diagnosis, referral for a non-musculoskeletal problem, referral from hospital services. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: People with musculoskeletal conditions from the general population in Poland and Spain will be the potential participants in this study. - SamplingMethod: Probability Sample
AHA (American Heart Association) Food is Medicine Test of Choice Architecture and Salience of Incentives
Status: Not yet recruiting

The goal of this interventional study is to test ways to improve the effectiveness of a healthy foods prescription program in increasing the purchase of healthy foods for patients who have both obesity (BMI > 30) and diabetes (last A1C>8 in the last 90 days). The main questions it aims to answer are:

Aim 1: Examine feasibility and engagement among participants by assessing percent enrollment among those identified as eligible, rates of Instacart platform use, amount of the subsidy used each week, and amounts of healthy foods ordered.

Aim 2: Examine strategies to optimize the user experience of trial participation, including communication strategies and on-boarding, to increase uptake and engagement in this and subsequent studies.

Usual Care (Control): Participants in the usual care arm will not receive weekly subsidies on Instacart, and they will not receive any modifications to the virtual storefront on Instacart. They will have access to the standard Instacart platform and Instacart + memberships with $5 per week to cover service and delivery fees and delivery tips for 3 months.

Intervention Arms: The four treatment groups will also each receive a $160 subsidy per month for 3 months to be used on produce (fruits and vegetables).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Between the ages of 30 and 70 Patients in the Penn Medicine system who have obesity (BMI>30) and diabetes (last A1C>8 in the last 90 days) Have internet access and self-report using online shopping at least three times in the past year Have a backup payment option available to use in registering for Instacart  Exclusion Criteria:  Not fluent in English Participating in another food and nutrition study Opted out of research The patient does not have a Primary care provider assigned The patient is part of a Penn primary care practice engaged with the Healthy Heart Program - HealthyVolunteers: No - Gender: All - MinimumAge: 30 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty
Status: Recruiting

The study is a single center randomized, open-label, phase IV clinical trial. Obese patients who have indication to Endoscopic sleeve gastroplasty (ESG) for clinical reasons are included and ESG is performed as per clinical practice. After randomization, the patients are divided in two arms:

Arm A: patients will stop proton pump inhibitors (PPI) 24h after the procedure.
Arm B: patients will assume oral Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for 4 weeks (total 8 weeks of PPIs after ESG- standard current treatment).

The primary aim of the study is to evaluate the effect of PPI on the structural integrity of the ESG

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 20 to 65 years BMI between 30 to 45 kg/m2 Willingness to participate in the study and ability to comply and understand the study protocol.  Exclusion Criteria:  Active gastric gastro-duodenal during the last 6 months Helicobacter pylori infection. Organic or motility disorder of the stomach and / or esophagus Anticoagulant treatment Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum Ongoing or active malignancy during the last 5 years. Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification. Drug or alcohol abuse Bulimic or binge eating pattern Continuous glucocorticoid or anti-inflammatory treatment Uncontrolled thyroid disease. Pregnancy, breastfeeding Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study. Hiatal hernia ≥ 5 cm Known allergy or hypersensitivity to the active substance or any of the other excipients Liver cirrhosis of any Child-Phugh stage or MELD> 15 Chronic Severe Renal Insufficiency (eGFR < 30 ml/min/1.73 m2 based on CKD-EPI equation) Currently participating in other study, or previously participated in an experimental drugs trial within 30 days before or 5 half-life of the drug administered Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome
Status: Not yet recruiting

This study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the neonatal microbiome and increase the neonatal microbiome diversity.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Neonate:  Neonate has anticipated NICU length of stay > 7 days Neonate ≥25 weeks gestation At least one parent/adult provider not colonized with S. aureus (as determined by baseline screening) Neonate is not colonized with S. aureus on baseline screening  Parent/Adult provider:  1. Parent/Adult provider is able to provide informed consent  Exclusion Criteria:  Neonate:  Neonate has had a prior clinical or surveillance culture grow S. aureus Neonate is a ward of the State Neonate with antenatal suspicion for immunodeficiency (e.g. sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency) Neonate cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)  Parent/Adult provider:  Parent/adult provider had positive COVID-19 test in prior 21 days Parent/adult provider with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough) Parent/adult provider has been in close contact with someone in the last 7 days who had a respiratory viral infection, like the cold or the flu? Parent/adult provider tests positive on baseline screening test for S. aureus nasal colonization. Parent/adult provider tests positive on baseline screening test for a respiratory pathogen. Parent/adult provider is not able to provide written informed consent Parent/adult provider is not able to be present at the bedside at the time of intervention. Parent/adult provider has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism. Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 0 Years - MaximumAge: 60 Years - StdAgeList: Child, Adult
Systemic Treatments for Alopecia Areata Registry
Status: Recruiting

A multicenter prospective registry (STA2R) is conducted to assess systemic treatments for alopecia areata, focusing on effectiveness, safety, and long-term outcomes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed with alopecia areata; Starting/using a systemic treatment for alopecia areata; Informed consent for registry participation obtained from patient and/or caretaker.  Exclusion Criteria:  Not sufficiently capable of understanding the Dutch language; Not willing to participate. - HealthyVolunteers: No - Gender: All - MinimumAge: 16 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: All adult patients with alopecia areata starting/using systemic treatment, who are willing to provide voluntary informed consent prior to inclusion in the registry and comply with the requirements of the registry. All patients will be recruited in the dermatology outpatient clinics. - SamplingMethod: Non-Probability Sample
Fetal Clavicular Measurement to Predict Fetal Macrosomia
Status: Not yet recruiting

Macrosomia is associated with increased risks for both the mother and the baby, including complications during delivery, injuries, and even death. The accurate diagnosis of macrosomia is often difficult before birth. There are a number of factors that can increase the risk of macrosomia, such as maternal obesity, diabetes, and excessive weight gain during pregnancy. There are also a number of different techniques that can be used to try to predict macrosomia, but none of them are perfect.

The aim of this study is to evaluate sensitivity of measuring fetal clavicle length in third trimester compared with biacromial diameter and Hadlock formula IV for prediction of fetal macrosomia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Singleton pregnancy. Gestational age between 37-42 weeks. Accepting to be included in the study.  Exclusion Criteria:  Congenital fetal malformation affecting birth weight or affecting clavicle. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult - StudyPopulation: pregnant women with gestational age between 37 weeks and 42 weeks - SamplingMethod: Non-Probability Sample
Assessment of Coeliac Disease in Patients With Type 2 Diabetes
Status: Not yet recruiting

This study aims to screen and diagnose coeliac disease in patients with type 2 diabetes and monitor the effect of gluten-free diet on the metabolic status

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  adult patients ≥18 years old diagnosed with type 2 diabetes mellitus  Exclusion Criteria:  Patients already diagnosed with co-morbid autoimmune disorder patient diagnosed as systemic lupus diagnosed as rheumatoid arthritis already diagnosed with coeliac disease - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All Diabetic type 2 willing participants, after obtaining informed consent, will be subjected to full history taking, thorough clinical examination and total immunoglobulin A (IgA) and IgA tissue transglutaminase antibody (tTG-Ab). -Those with IgA deficiency or positive tTG-Ab are offered upper endoscopy for confirmation by duodenal biopsy. -Those with confirmed Coeliac Disease will be given detailed dietary advice and promoted to strictly adhere to gluten-free diet - SamplingMethod: Non-Probability Sample
PediRISE Feasibility
Status: Not yet recruiting

The goal of this research study is to learn whether investigators can successfully give the PediRISE program to families-in other words, whether most families are interested in participating in a study about the PediRISE program, including a 50-50 chance of receiving standard usual care, and a 50-50 chance of receiving the PediRISE support program.

The names of the study groups in this research study are:

PediRISE Program Group
Usual Care Group

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Child diagnosed with de novo cancer Child has established care at a study site and initiated cancer-directed therapy in the prior 2-months Child planned to receive at least 4-months of cancer-directed therapy at study site from time of diagnosis per initial cancer treatment plan Child is <18 years at time of enrollment Parent/guardian screened positive for self-reported low-income (<200% FPL). Family primary residence in MA, NY or NJ Provider approval for permission to approach  Exclusion Criteria:  Planned transfer of child to a non-DFCI or non-Columbia facility for cancer-directed therapy Foreign national family receiving care as an Embassy-pay patient Child is enrolled on embedded correlative health equity aims of open or upcoming clinical drug trials which are powered on descriptive parent-reported poverty data (e.g. AALL1731, AHOD2131, ANBL2131, DFCI 23-001). Child or household member receiving SSI. - HealthyVolunteers: No - Gender: All - MaximumAge: 17 Years - StdAgeList: Child
Pilot Study to Investigate the Effect of a Dysmenorrhoea App
Status: Not yet recruiting

The pilot study investigates the influence of a dysmenorrhoea app on the quality of life and symptoms of women with dysmenorrhoea. The intervention group can use the app over the study period of 12 weeks in addition to usual care, while the control group only receives the usual standard care. The aim is to evaluate the effectiveness of the app and to gain insights for the design of future studies. The study is expected to last seven months and include 100-200 participants.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Legal capacity Resident in Germany Female Age ≥18 years of age Known and medically confirmed dysmenorrhoea Ownership of an internet-enabled mobile phone and ability to use it Internet access for the app application and questionnaire Answering email address for registration Willingness to complete questionnaires online Motivation to use the app regularly Sufficient knowledge of the German language Absence of exclusion criteria  Exclusion Criteria:  Pregnancy existing at the time of interview Gynaecological abdominal surgery planned in the next 12 weeks or gynaecological abdominal surgery performed within the last 8 weeks before study start Previous or existing access to the Endo app or other comparable digital health applications or current active prescription Current participation in other clinical studies Non-compliance with inclusion criteria - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult