rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Selected Immunological Indicators and Microbiota in Patients With Premature Birth and Preeclampsia
Status: Recruiting

The goal is to demonstrate the relationship of the circulating pool of T-regulatory lymphocytes in the mother's peripheral blood with populations in the placentas and to compare with controls, what is the difference in the expression of individual regulatory molecules of T-regulatory lymphocytes according to new paradigms. The proportional and functional characteristics of T-regulatory lymphocytes will be correlated with the composition of the intestinal and vaginal microbiota.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  singletone pregnancy gestational age 9+0 - 12+0 history of preeclampsia (PE) history of spontaneous preterm birth (PTL = preterm labour) history of pPROM (preterm premature rupture of membranes).  Exclusion Criteria:  uterine malformations gestational age out of 9+0 - 12+0 age out of 19-40 - Gender: Female - MinimumAge: 19 Years - MaximumAge: 40 Years - StdAgeList: Adult - StudyPopulation: Pregnant women - SamplingMethod: Probability Sample
Ultrasound Device Study
Status: Not yet recruiting

The aim of the study is to develop a device that can eliminate failed neuraxial placements in challenging patients.The study will attempt to improve safety and efficacy of neuraxial anesthesia with high precision real-time needle visualization through automated real-time needle guidance at the bedside with an experimental device (Accuro 3S). We will verify the clinical workflow for utilizing the Accuro 3S during epidural and spinal procedures and validation of needle visualization while using the device as well as anatomical guidance provided by the device during spinal imaging.The underlying bone imaging enhancement algorithms were introduced in the commercially available FDA approved Accuro. The Accuro 3S will be used to establish needle insertion point and trajectory, after which the clinician will use standard of care methods to advance the needle such as the loss of resistance method.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged 18 years or older The patient is eligible for placement of neuraxial anesthesia, and the patient has agreed to the procedure. Patient skin is intact in the area of placement of the epidural or spinal anesthesia.  Exclusion Criteria:  Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myeloopticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 70,000/μL, or evidence of infection at potential epidural site. Presence of orthopedic implants in the spine. Skin dyscrasias or allergies to the ultrasound procedure. Unable to assume sitting position. Body Mass Index (BMI) less than 20 kg/m2. Known allergies to ultrasound gel. Known history of allergic reactions to adhesives used in standard epidural placement - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR)
Status: Not yet recruiting

This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Written informed consent Diagnosis of PMR according to European League Against Rheumatism and American College of Rheumatology classification criteria confirmed by a rheumatologist Absence of PMR relapse based on symptoms and acute phase markers Daily oral prednisolone 10, 12.5, 15, 17.5, or 20 mg dose that will have been stable for at least 7 days prior to Day 1  Exclusion Criteria:  Any contraindication for prednisolone administration A diagnosis or any clinical features of giant cell arteritis Any autoimmune disease (e.g., late-onset rheumatoid arthritis) other than PMR Use of medications for treatment of PMR other than oral prednisolone within specified intervals prior to Day 1 and during the treatment period Use of other medications likely to interfere with trial assessments History or diagnosis of endogenous hypercortisolism Any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the trial or the evaluation of its results - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Study of Brain-spinal Cord Neural Connectivity in Spasticity
Status: Not yet recruiting

Little is known about the peripheral and central mechanisms of action of selective dorsal rhizotomy surgery for the treatment of spasticity. A better understanding of these mechanisms will enable us to improve the surgical procedure. This will require cortico-medullo-radiculo-muscular recordings never before performed and published in the literature, and the identification of variations in connectivity correlated with the clinic.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients aged 3 to 17 years included scheduled for selective rhizotomy surgery Having received informed consent to participate in the study (written consent from both parents) Affiliated or beneficiary of a social security scheme  Exclusion Criteria:  Contraindications to selective rhizotomy History of epilepsy Known neurological and/or psychiatric disorders with past and/or current medical treatment, or drug addiction Patient under legal protection Pregnant or breast-feeding women - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 17 Years - StdAgeList: Child - StudyPopulation: Patients with a diagnosis of spasticity requiring selective rhizotomy in neurosurgery. - SamplingMethod: Non-Probability Sample
Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery
Status: Recruiting

This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). The study design involves the histological confirmation of pCR using vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) guided by ultrasound. The primary objective is to demonstrate that the non-surgical, RT-only treatment and follow-up approach is not inferior to the traditional surgical approach in patients with pCR after NACT.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age> 18 years infiltrating breast carcinoma, non-special histotype, triple negative or HER2 +, T1-T2 N0 single lesion neo-adjuvant chemotherapy treatment for at least 12 weeks according to clinical practice conservative surgery proposal M0 tumour bed identified by breast markers placed in pre NACT by radiologist  Exclusion Criteria:  Bilateral or multicentric tumour Presence of microcalcifications visualised on mammography Presence of associated DCIS Positive history of previous breast cancer Positive history of medical or psychiatric conditions preventing adherence to the protocol High risk patient - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Post-trial Follow-up of MERINO Participants to Evaluate Long-term Effects of Methotrexate Treatment in Adults With Erosive Hand OA.
Status: Not yet recruiting

In response to the high prevalence of synovitis in hand osteoarthritis (OA) and its association with pain, there&amp;#39;s a compelling rationale for investigating the efficacy of MTX in managing inflammatory erosive hand OA. Recent guidelines highlight the need for large, well-designed trials to assess the effectiveness of MTX. A recent trial (METHODS study) showed promising pain reduction with MTX, but due to pandemic-related protocol changes, the duration of the study was limited to six months. The ongoing MERINO trial randomizes participants to MTX or placebo for one year. After completing the MERINO trial, several participants asked for MTX open label. In the subsequent MERINO:2 study, participants completing the trial will be invited to a structured follow-up after one year, including electronic questionnaires and hand radiographs, providing valuable long-term data on the effects of MTX in hand OA. Together, these trials aim to fill gaps in understanding the long-term impact of MTX in hand OA, particularly on structural progression.

Eligibility:
- EligibilityCriteria: Participants completing the MERINO trial, i.e. having erosive hand OA and being randomized to MTX or placebo for 12 months. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Eligible participants are those completing the MERINO-trial (EudraCT number 2019-004641-33, Clincaltrials.gov number NCT04579848, REK ID 2020/187524, CTIS number 2023-510523-30-00). - SamplingMethod: Non-Probability Sample
Evaluation of SkillTalk for Autistic Young Adults
Status: Recruiting

The goal of this clinical trial is to evaluate the effectiveness of using a Microskills video training library for young adults, aged 18-28, with autism spectrum disorder (ASD) to enhance their skills in developing and maintaining healthy relationships.

The main questions it aims to answer are:

Does using SkillTalk increase autistic young adults skills in the communications skills that are demonstrated in the video curriculum (skills: resolve conflict, compromise, give feedback)?
Does using SkillTalk increase reported confidence and satisfaction in communication and relationship skills?
Does using SkillTalk increase interpersonal competence?
Does using SkillTalk increase ability to cope with rejection?
Does using SkillTalk improve mental health and wellbeing?

Participants will be asked to:

Take a survey at the beginning of the study, after one month the end of the study, and at 3-month follow up
Participate in recorded video calls with projects staff, comprised of 2-3 brief roleplay scenarios of relationship skills at the beginning of the study, after one month the end of the study, and at 3-month follow up
Watch a minimum of 85% of the 60 minutes of video assigned

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants must be young adults, aged 18-28, have ASD, with reciprocal communication skills and receptive language skills. Eligibility will be determined by study staff with screener questions posed to the participants about their age, ASD status (self-report based on self-determination), and comfort with the study activities.  Exclusion Criteria:  There will be no exclusionary criteria based on gender or race/ethnicity, however during recruitment and enrollment staff will try to ensure that the race/ethnicity demographics reflect those of the U.S. more generally, with a 10% oversampling for Black and Latinx participants, and the gender ratio is balanced. Interested individuals participate in a consent screening call where they are asked to answer four simple questions about the information provided in the consent form. Participants who are unable to answer these questions correctly after prompting from study staff are excluded from the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 28 Years - StdAgeList: Adult
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants
Status: Recruiting

This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Males, aged between 18 to 65 years, inclusive Body mass index between 18.0 and 32.0 kg/m2 In good health When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception History of a minimum of 1 bowel movement per day  Exclusion Criteria:  History or clinical manifestation of any clinically significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder Have a history of malignancy, except fully resected basal cell carcinoma History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs Have previously completed or withdrawn from this study or any other study investigating DNL343 and have previously received DNL343 - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer
Status: Recruiting

The goal of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in 2 cohorts of patients. Cohort A will evaluate the effect of the addition of HRV BI in patients with breast cancer treated in the neoadjuvant setting (vs. standard of care alone, SOC) followed by local therapy (surgery +/-radiotherapy). Cohort B will evaluate the effect of the addition of HRV BI in patients with colon cancer after surgery in the adjuvant setting (vs. standard of care alone, SOC).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients older than 18 years. Pathologically confirmed breast cancer indicated for neoadjuvant systemic treatment or colon cancer after curative surgery indicated for adjuvant systemic treatment. Adequate renal functions: measured or calculated (by Cockcroft formula) creatinine clearance > 60 ml/min. Absolute granulocytes count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5x the upper limit of normal value. Adequate liver functions defined by AST (Aspartate aminotransferase) and ALT (Alanine transaminase) ≤ 3xUNL (upper normal of limit). Basic computer skills of patient or his family member. Signed informed consent.  Exclusion Criteria:  Previous chemotherapy. Previous malignancy, except for basal-cell carcinoma of the skin within last 5 years. Patients with know primary immunodeficiency and patients infected by the Human Immunodeficiency Virus (HIV). Patient receiving long term corticosteroid treatment, anti-arrhythmic drugs and opioids who can not withdraw the treatment for the period of application of the heart rate variability (HRV) biofeedback training. Patients with diabetes mellitus, cardiac arrhythmia, cardiac pacemaker implant. Patients who do not fit inclusion criteria. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
TYK2 Inhibition in Paradoxical Psoriasis
Status: Not yet recruiting

Paradoxical psoriasis is a side effect of a biological treatment (anti-tumor necrosis factor agent, short called anti-TNF) that is used to treat diseases of the skin, the intestine or the joints. If paradoxical psoriasis occurs, the anti-TNF-treatment often needs to be stopped and so far, no specific treatment for paradoxical psoriasis exists.

This research project aims to study whether the efficacy of the drug 'Deucravacitinib' 6mg, a tablet taken by mouth once a day is superior compared to taking a placebo in treating paradoxical psoriasis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Clinical diagnosis of Paradoxical Psoriasis caused by anti-TNF treatment, with with Investigator Global Assessment ≥ 2 and Body Surface Area ≥ 2% Females who are of child-bearing potential should be practicing highly-effective contraception methods throughout the study and for 28 days after the last dose of study drug; Male subjects with a mechanical contraceptive method; be in good health be willing to have skin biopsies taken  Exclusion Criteria:  Use of any other anti-psoriatic therapy. Certain washout periods of treatments needs to be respected Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the Baseline visit; A positive serology test for hepatitis B, hepatitis C, HIV; History of lymphoproliferative disease or of malignancy within the past 5 years. Chronic recurring bacterial infections or active tuberculosis; Positive pregnancy test at Screening and at the Baseline visit; Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study; History of clinically significant alcohol or drug abuse in the last 12 months Known hypersensitivity to Deucravacitinib or any of its excipients Current severe progressive or uncontrolled disease Live vaccine within 12 weeks before Baseline Visit. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System
Status: Recruiting

Previously, the investigators showed that preterm newborns are exposed chronically to very low radiofrequency levels in average while hospitalized in NICUs. Most of the infants were nevertheless frequently exposed to transient values above 1 V/m. The investigators also showed that an increase in RF exposure is likely to alter the activity of some neurophysiological functions and their regulatory systems in preterm newborns. The investigators hypothesize that above results are extremely specific to the location of the previous study and may be different in other NICU environments.

This study will aim at quantifying RF levels to which preterm newborns are exposed during their stay in several NICUs spread across the French territory, and assessing its impact on the central and peripheral nervous systems. The first step of this study will be to quantify the precise, continuous and individual levels of daily RF exposure to which each recruited neonate is subjected during his stay in the different NICUs from birth to 1 week postnatal life. Infants' clinical data (medical history, nutrition, morphology...) will also be continually monitored. At 1 week postnatal life, the investigators will investigate cerebral activity (EEG) and autonomic nervous system activity (ECG, heart rate variability). The impact of RF will be evaluated by analyses of the relationship between exposure levels and the various parameters extracted from the neurophysiological investigation phase.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  preterm newborns born between 26-34 weeks of gestational age  Exclusion Criteria:  infants infected, suffering from neurological disorders, serious heart, respiratory, digestive or metabolic diseases; infants born from mothers aged less than 18 years old or deprived of their parental rights - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Day - MaximumAge: 1 Month - StdAgeList: Child
First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours
Status: Not yet recruiting

This is a prospective, single-arm study to evaluate the feasibility and safety of performing transurethral en-bloc resection of bladder tumours using the Zenith robotic system.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age between 18 and 75 years Body mass index <35 kg/m2 Bladder tumour located <3 cm in size; clinically non-muscle invasive bladder tumour Clinically indicated for en-bloc resection. Willingness to participate as demonstrated by giving informed consent  Exclusion Criteria:  Presence of endoscopic or imaging signs of detrusor muscle invasion Contraindication to general anaesthesia / spinal anaesthesia ASA > 2 patients Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention Untreated active infection Un-corrected coagulopathy Presence of another malignancy or distant metastasis Emergency surgery Vulnerable population (e.g. mentally disabled, pregnant) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine
Status: Recruiting

The "RIALTO-PRO" study aims to optimize the diagnostic and therapeutic algorithm for myocardial bridge (MB) patients, testing the diagnostic value of a full invasive diagnostic procedure, and, consequently, the prognostic value of a tailored approach. the study objective is to determine the diagnostic and prognostic value of a full-physiology approach strategy versus a standard approach strategy in patients with a MB.

The "RIALTO PRO" study is a randomized, multicentre, prospective, open-label, superiority trial comparing a personalised versus standard management in patients with MB. Consenting and eligible patients will be randomised 1:1 to either a "full-physiology approach", consisting of a comprehensive diagnostic algorithm aimed at unmasking the main pathophysiological mechanism of myocardial ischemia and consequently a tailored treatment, or a "standard approach", consisting of angiographic evaluation of the tunnelled segment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Ability to give informed consent to the study. Age ≥ 18 years and ≤ 75 years. Diagnosis of MB during index coronary angiography*. Symptoms or signs of inducible ischemia (if signs, these should involve the territory of the index vessel).  Angiographic definition of MB *  Myocardial bridge is a congenital anomaly characterized by an intramural course of an epicardial coronary segment. This anatomical arrangement causes the artery to be squeezed during systole, with a relaxation in diastole. In this study, MB is defined as a visual ≥ 50% reduction in the minimal luminal diameter during systole and a complete or partial relaxation in diastole ("milking effect").  The use of intracoronary vasodilators (i.e., nitrates) can increase the systolic narrowing of the vessel, through a reflex rise of the adrenergic drive, and consequently the angiographic sensitivity in detecting MB.  Exclusion Criteria:  Moderate to severe CAD (≥ 50% stenosis in any vessel, including chronic total occlusion) at the time of enrolment/randomization. Previous CABG involving the index vessel. Severe valvular heart disease. Left ventricular systolic dysfunction [ejection fraction (EF) < 40%], regardless of the etiology. Clinically significant right ventricular dysfunction. Known severe renal impairment (eGFR < 30 ml/min/1.73 m2). Known severe hepatic impairment, or history of cirrhosis with evidence of portal hypertension. History of malignancy of any organ system with a life expectancy < 1 year. Any previous history of ischemic stroke, intracranial haemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm). Pregnant or breastfeeding women. Known hypersensitivity or contraindication to any of the drugs used for coronary physiology testing (nitrates, adenosine, dobutamine, acetylcholine). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult