rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Hidden Impairments During Subarachnoid Haemorrhage Recovery, Description and Evolution of a Newly Described Syndrom
Status: Not yet recruiting

Descriptive observational study in patients with spontaneous subarachnoid hemorrhage or following aneurysmal rupture to assess the presence of a post-HSA syndrome at 3 months, 6 months and 1 year, and its impact on functional outcome using the Rivermead questionnaire

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient aged 18 to 65  Patient hospitalized in intensive care unit at Hôpital Lariboisière between September 2022 and September 2023 for subarachnoid hemorrhage due to aneurysmal rupture. Patient affiliated to the French social security system Patient expressing no objection  Exclusion Criteria:  Motor deficits persisting 1 month after SAH Hospitalization > 1 month Patient does not speak French Patient with diagnosis of neurodegenerative disease. Traumatic meningeal hemorrhage Patients on AME - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients aged 18 to 65 who had presented with an episode of spontaneous subarachnoid haemorrhage or aneurysmal rupture, excluding meningeal haemorrhage due to trauma, - SamplingMethod: Non-Probability Sample
Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection
Status: Not yet recruiting

This study aims to assess the efficacy and safety of pembrolizumab in immunocompromised patients with progressive multifocal leukoencephalopathy (PML). This phase II, multicenter, single-arm study includes patients with an underlying cause of immunosuppression hardly reversible, i.e. not the patients with HIV nor those receiving biologics for chronic inflammatory diseases. Patients will receive intravenous pembrolizumab (2 mg/kg, maximum 200 mg) at month 0, 1 and 2 (total of three doses). The primary endpoint will be achieving at least one negative result of JCV viral load in cerebrospinal fluid (CSF) within the M0 to M3 period.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years old Diagnosis of definite PML since less than 2 months according to American Academy of Neurology Presence of JCV in the CSF in the last CSF sampling. Signed informed consent (from the patient, or if unable to consent, from a surrogate) For women of childbearing potential: negative serum or urine b-HCG test and agree to use a highly effective contraception methods during 8 months (i.e. until 6 months after end of experimental treatment)  Exclusion Criteria:  Patients in whom immune reconstitution is achievable (HIV infection - Multiple sclerosis - Auto-immune and inflammatory diseases) Patients who have received solid organ transplantation Hypersensitivity to the active substance or to any of the excipients Life expectancy less than 1 month Pregnancy or lactating women or planning birth during the study period Having previously been treated by anti-PD1mAb Patient receiving IL-2 or IL-7 for the treatment of PML at inclusion Patient whose weight is > 100kg  Participation in other interventional study [a patient already included in another interventional study for which the treatment can lead to an immunodepression can be included if:  the investigational treatment has been completed and there is no risk of drug interaction with the administration of Pembrolizumab as defined in PENALTY study if this does not alter the study's ability to evaluate the effect of Pembrolizumab in terms of safety and efficacy (from the investigator's point of view)] Patient without national health insurance, and patient on AME (state medical aid) Patient under guardianship or curatorship Patient deprived of their liberty by a judicial or administrative decision - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Phase 1, Safety and Tolerability Study of XmAb®541 in Advanced Solid Tumors
Status: Not yet recruiting

The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate effect of XmAb541 on tumor outcomes.

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria:  Age ≥ 18 years. For subjects with GCTs, age ≥15 years CLDN6+ tumor Histological evidence of locally advanced, recurrent, or metastatic solid malignancy Ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT Have documented progressive disease (PD) on standard-of-care therapies appropriate for the specific tumor type; have exhausted therapies with a survival benefit or the standard therapy has no survival benefit or proven to be ineffective, intolerable, or subject is not a candidate for such available therapy. Eastern Cooperative Oncology Group performance status of 0-2 Life expectancy ≥ 3 months Adequate liver, kidney, thyroid and bone marrow function  Key Exclusion Criteria:  Prior exposure to a CLDN6 targeting product Ovarian cancer that is platinum refractory, or has rapid progression on most recent prior ≥ second line systemic anticancer therapy Have known active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate, provided they are radiologically stable. Active known or suspected autoimmune disease Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug Clinically significant cardiovascular, pulmonary or gastrointestinal disease Known Human immunodeficiency virus (HIV) positivity Positive test for hepatitis C RNA Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb) - HealthyVolunteers: No - Gender: All - MinimumAge: 15 Years - StdAgeList: Child, Adult, Older Adult
Supporting Resilience Among Re-entered Seniors
Status: Not yet recruiting

The first goal (Aim 1) of this clinical trial is to learn about specific strengths, challenges, and desired areas of knowledge and skill-building among older adults who re-entered their communities from a period of incarceration and to then develop a new psychoeducational intervention tailored to these older adults. The second goal (Aim 2) of this clinical trial is to test if the intervention increases chronic disease management and whether the intervention is considered appropriate and acceptable by older adults who re-entered their communities from a period of incarceration.

Aim 1 participants will:

complete a baseline survey
participate in a focus group

Aim 2 participants will:

complete a baseline survey
participate in an 8-week once weekly intervention
complete three follow up surveys

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  at least 45 years old have re-entered the community from a period of incarceration from jail or prison have at least one chronic health condition able to speak and understand English  Exclusion Criteria:  aged 44 or younger have not re-entered the community from a period of incarceration from jail or prison does not have at least one chronic health condition unable to speak and understand English - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 45 Years - StdAgeList: Adult, Older Adult
Intraoperative Imaging of Lymph Nodes
Status: Recruiting

One-third of the global population battles cancer, with surgery being the primary treatment for localized forms. Successful treatment often hinges on the thorough removal of primary tumors and pinpointing cancerous sentinel lymph nodes (SLN). Although modern surgical imaging and fluorescent probes enhance the detection of sentinel lymph nodes using near-infrared (NIR) fluorescence, their inability to precisely determine the nodes' status can result in additional surgeries, lymphedema, and a reduced quality of life for patients. Our research direction aims to harness the potential of bioinspired imaging technologies with the goal of precisely identifying SLN status and ensuring only the cancerous lymph nodes are excised during the initial procedure. To realize this objective, we're drawing inspiration from the mantis shrimp's visual system to create a single-chip multispectral camera that spans the deep ultraviolet to the near-infrared spectrum. Our pioneering sensor seamlessly combines perovskite nanocrystals, optical filters, and vertically-aligned photodetectors on a single chip, enabling concurrent imaging of external NIR fluorophores and internal UV fluorescence from tumor-specific markers.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  early or progressive stage of breast cancer who needs to be treated with breast surgery  Exclusion Criteria:  pregnant women previous breast cancer surgery history of allergic reactions to iodide or seafood allergy. man - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The population we are studying has been diagnosed with early or progressive stage of breast cancer who need to be treated with breast surgery. The participants will undergo breast tumor removal per standard practices. - SamplingMethod: Non-Probability Sample
Plants Optimizing Development Study (PODS)
Status: Recruiting

This study aims to conduct a randomized clinical trial to measure the effects of a 3-month daily mixed-soy food intervention vs. a control group receiving isocaloric foods on reproductive hormones, body composition, metabolic risk, fecal microbiota, and cognition among 8-11-year-old children. Additionally, this study will assess soy food intake immediately following participation in the clinical trial to determine changes in soy food acceptance in children.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Child assent and parent/guardian consent Free of any food allergy 8-11 years of age Tanner scale score of ≤ 2 20/20 or corrected vision No antibiotic usage in the past 3 months ≤1 serving/d of soy food habitual consumption  Exclusion Criteria:  Non-assent or consent by child assent and/or parent/guardian Presence of any food allergy Younger than 8 years or older than 11 years Presence of specific neurological and genetic disorders (i.e., Autism, Cerebral Palsy, Multiple Sclerosis, Down syndrome) Presence of endocrine, metabolic, and gastrointestinal disease e.g., hypertension, diabetes, celiac disease Tanner scale score of > 2 Not 20/20 or uncorrected vision Antibiotic usage in the past 3 months >1 serving/d of soy food habitual consumption - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 8 Years - MaximumAge: 11 Years - StdAgeList: Child
REgistRy BRAnch goRE EndopRosthEsis
Status: Not yet recruiting

Multicenter registry on patients treated by the new Gore thoracic branched endoprosthesis

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  patients receving the Gore TAG thoracic branched endograft for thoracic aorta pathologies  Exclusion Criteria:  less than 18 years allergy to endograft components patients receiving other types of arch endografts - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All consecutive patients treated with the Gore TAG thoracic branched endograft in the participating centers - SamplingMethod: Non-Probability Sample
Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis
Status: Recruiting

This clinical trial will test a mindfulness program in individuals with rheumatoid arthritis (RA). The main goals of this pilot study are to:

Assess patient satisfaction with a mindfulness course
Identify barriers to participation in, or completion of, a mindfulness course
Gather initial information to understand how a mindfulness course impacts RA symptoms

Participants will:

Complete online questionnaires
Attend two in-person study visits, involving a brief joint exam and blood draw
Roughly half the participants will have the chance to participate in an 8-week online mindfulness course
Roughly half the participants will be invited to participate in an online focus group following completion of the mindfulness course

Researchers will compare those in the mindfulness course with those receiving standard care in preparation for a larger future study to see how mindfulness impacts stress and inflammation in individuals with RA.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Physician-confirmed diagnosis of rheumatoid arthritis (RA) Access to a web-enabled computer, smartphone, or tablet  Exclusion Criteria:  RA disease activity in remission Current regular mindfulness practice (> 20 minutes per week) Inability to participate in an intensive 8-week online mindfulness course Prior participation in a mindfulness-based stress reduction (MBSR) course - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients
Status: Not yet recruiting

To compare the safety of dual antiplatelet therapy with aspirin and clopidogrel and single antiplatelet therapy administered from 30 days to 12 months following carotid artery stenting on clinically significant bleeding and its prevention effects on net clinical events including combined cardiovascular and cerebrovascular accidents and major bleeding events in patients with carotid artery disease who are at high bleeding risk.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients ≥19 years Symptomatic patients with carotid artery stenosis* greater than 50% and asymptomatic patients with carotid artery stenosis* greater than 70% who are scheduled to undergo carotid artery stenting  High bleeding risk is defined as a Bleeding Academic Research Consortium type 3 or 5 bleeding risk of ≥4% at 1 year or a risk of an intracranial hemorrhage (ICH) of ≥1% at 1 year, Patients who meet at least one of the criteria for high bleeding risk** below  The degree of stenosis is determined using the method performed in the North American Symptomatic Carotid Endarterectomy Trial.  Criteria for high bleeding risk (≥ 1)  Incidence of non-access site bleeding within 12 months prior to stenting (gastrointestinal tract or hematuria) Presence of BARC type 3 or 5 bleeding regardless of the onset time, but the cause has not been completely cured. Adults aged ≥75 years Thrombocytopenia < 100,000/mm3 (based on the screening test) Blood clotting disorders that increase bleeding (Von Willebrand disease, factor VII, VIII, IX, and XI deficiency) Patients with anemia defined as hemoglobin <12g/dL in men and <11g/dL in women or patients who donated blood within 4 weeks (based on the screening test) Patients received steroids or NSAIDs for ≥4 weeks Patients with active malignancy (except for nonmelanoma skin cancer) Renal disease (dialysis, transplantation, Estimated Glomerular Filtration Rate < 60ml/min per 1.73m2) Liver disease (cirrhosis with portal hypertension) Cerebral microbleeds ≥ 5 Stroke or transient ischemic attacks within 6 months Incidence of nontraumatic intracerebral hemorrhage regardless of duration or incidence of traumatic intracerebral hemorrhage within 12 months  Exclusion Criteria:  Incidence of net clinical events, including cardiovascular and cerebrovascular accidents or major bleeding events, within 30 days following carotid artery stenting Coronary artery stenting or other vascular stenting or vascular recanalization within 1 year Aspirin or clopidogrel hypersensitivity Pregnant or breastfeeding women Patients requiring anticoagulation for ≥12 months Patients requiring administration of other antiplatelet therapies Patients who are participating in another intervention clinical trial - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult
Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia
Status: Recruiting

This is a single ascending dose phase 1 study to evaluate the pharmacokinetics (PK), safety, and tolerability of a single intramuscular (IM) injection of quarterly Risperidone (QUAR) for different formulations and dose strengths in participants with schizophrenia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Capable of providing informed consent. Male or female aged ≥ 18 years to < 65 years with BMI ≥17.0 to ≤35.0 kg/m2 Current diagnosis of schizophrenia, according to the Diagnostic and DSM-5 criteria. Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment currently taking oral risperidone as maintenance therapy Score of ≤ 4 (moderately ill at most) on the Clinical Global Impression - Severity of Illness (CGI-S) If a sexually active female of childbearing potential, using a medically accepted method of birth control.  Exclusion Criteria:  Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator could interfere with the interpretation of safety and PK evaluations If female, a positive serum pregnancy test, or planning to become pregnant between signing informed consent and 1 month after the last dose of study drug or is breastfeeding a child. History of neuroleptic malignant syndrome and current or past history of clinically significant tardive dyskinesia. The participant has a primary diagnosis other than schizophrenia diagnosis that is primarily responsible for current symptoms and functional impairment Positive test result for drugs of abuse or alcohol unless the positive finding can be accounted for by documented prescription use. In the investigator's opinion, at imminent risk of committing self-harm or harm to others. Unwilling to discontinue any of the prohibited medications prior to the baseline visit or unable to safely washout such medication without significant destabilization or increased risk of self-harm (suicide). Receipt study drug in another investigational study in the last 90 days. Current participation in any other clinical trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Assessment of All Spine Segments ın Individuals With Low Back Pain
Status: Recruiting

The aim of the study is to evaluate the kinematics of all spine segments in 3 planes and compare them with asymptomatic controls using wearable technology while performing functional tasks that patients with chronic low back pain often describe as painful in their daily lives.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  For the low back pain group:  Individuals aged 18-55 with non-specific chronic low back pain Individuals who have been experiencing pain for more than 3 months Individuals whose pain intensity is above 3 on the Visual Analog Scale  For the healthy group:  - Individuals aged 18-55 with no history of low back pain lasting more than 1 week for 6 months prior to the study  Exclusion Criteria:  Current rheumatological or neurological diseases Recent or current pregnancy History of tumors or spine fractures Known spinal defects or surgery history Body mass index over 30 kg/m² - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
Protein Molecular Characteristics and Prognosis of Cervical Neuroendocrine Tumors
Status: Recruiting

The clinical diagnosis and treatment data of 300 cases of cervical neuroendocrine tumors were collected, including age, preoperative biopsy pathology results, postoperative histopathological results, TCT results, and colposcopy biopsy pathology results. At the same time, paraffin tissue specimens (remaining specimens after pathological diagnosis) from 100 cases of cervical neuroendocrine tumors from multiple centers across the country were collected to establish a cervical neuroendocrine tumor data follow-up database. Protein concentration and omics analysis were performed on the data results, to evaluate the molecular characteristics and prognosis of cervical neuroendocrine tumor proteins, and to preliminarily explore its clinical application value.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed with cervical neuroendocrine carcinoma by histopathology Clinical data were complete  Exclusion Criteria:  Patients who are not being treated in our hospital Patients with lack of follow-up data, unable to obtain survival information Patients call to refuse to participate in this project The quality of paraffin specimens can not meet the requirements of proteome concentration determination - HealthyVolunteers: No - Gender: Female - StdAgeList: Child, Adult, Older Adult - StudyPopulation: All 300 patients were diagnosed with cervical neuroendocrine carcinoma by histopathology - SamplingMethod: Non-Probability Sample
Heart Rate Variability After Ablation
Status: Recruiting

Pulsed-field catheter ablation is a promising new treatment method for patients with atrial fibrillation. The mechanism of cell damage here is different from that of classic catheter ablation, in which the ganglion plexuses around the pulmonary veins are also damaged and thus changes in the autonomic nervous system occur. The aim of the work is to find out, using heart rate variability, whether the autonomic system is less affected during pulsed field ablation than in classic radiofrequency ablation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  paroxysmal atrial fibrillation indication for catheter ablation due to atrial fibrillation willingness to participate  Exclusion Criteria:  atrial fibrillation throughout Holter ECG recording significant valve disease left ventricular dysfunction, EF less than 35% - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with paroxysmal symptomatic atrial fibrillation fulfilling standard criteria for catheter ablation - SamplingMethod: Probability Sample
Multi-centre, Open-label, First-in-man Study With Mucopad HA
Status: Recruiting

The device´s intended use is to treat defects and/or lesions of the oral mucosa, e.g. oral mucositis.To prove safety of the device in terms of clinical results.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years Oral Mucositis after radiotherapy of grade I - IV according to WHO Patient willing and able to provide the written consent Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study  Exclusion Criteria:  Age < 18 years Pregnant or lactating women Patients in terminal stage of living Patients with known hypersensitivity or allergy to any of the substances contained in Medical Device Alcohol or drug abuse - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult