rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants
Status: Recruiting

The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants. The secondary objective of the study is to evaluate PK over time, clinical safety, pharmacodynamic (PD) profiles and immunogenicity of BIIB800 and Actemra.

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria:  Have a body mass index between 18.5 and 29.9 kilograms per meter square (kg/m^2), inclusive. Total body weight between 60.0 and 90.0 kg, inclusive. Systolic blood pressure <135 millimeters of mercury (mmHg) or >85 mmHg at Screening, after being supine for at least 5 minutes. No clinically significant (as determined by the Investigator) 12-lead electrocardiogram (ECG) abnormalities, no cardiac pacemaker.  Key Exclusion Criteria:  History or positive test result at Screening for human immunodeficiency virus (HIV). History of hepatitis C infection or positive test result at Screening for hepatitis C virus antibody. Current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and total hepatitis B core antibody [anti-HBc]). Serious infection (as determined by the Investigator) within the 6 months prior to Screening. History of systemic hypersensitivity reaction to the active drug substance, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study. History of immunodeficiency or other clinically significant immunological disorders, or autoimmune disorders. History of clinically significant (in the opinion of the Investigator) atopic allergy (e.g., asthma, urticaria, eczematous dermatitis, allergic rhinitis), hypersensitivity, or allergic reactions. History of angioedema. A positive diagnostic tuberculosis test result within 35 days prior to Day -1, defined as a positive QuantiFERON® test result or 2 successive indeterminate QuantiFERON test results. Any prior exposure to tocilizumab or to any other agent directly acting on IL-6 or on its receptors including investigational products (e.g., siltuximab, sarilumab etc.). Administration of immunoglobulins for anti-tetanus and anti-rabies post-exposure prophylaxis within 3 weeks prior to administration of study drug. Any live or attenuated immunization or vaccination given within 30 days prior to Day -1 or planned to be given during the study period.  NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
OCD Prevention: a Randomized Clinical Trial
Status: Not yet recruiting

The main purpose of this randomised clinical trial is to test the efficacy of a prevention program for adult who are at risk of developing OCD, thus constituting a form of tertiary prevention.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - age over 18  Exclusion Criteria:  clinically diagnosed OCD current psychiatric/psychotherapeutic treatment personality disorder diagnosis suicidal ideation - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Fecal Microbiota Transplant National Registry
Status: Recruiting

A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness. Neonates will not be enrolled at any site for this study. The study data will derive from patient and donors past and present medical records, research records, and records about phone calls made as part of this research. The patient data will also be used from the records on visits.

Eligibility:
- EligibilityCriteria: Recipient Inclusion Criteria :  Ability to give informed consent Receiving FMT or other gut-related microbiota product within 90 days after providing consent Access to internet and/or telephone  Donor Inclusion Criteria:  Ability to give informed consent Providing stool sample for FMT  Exclusion Criteria:  Incarceration - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Participants will be eligible for participation regardless of age, race, ethnicity, or gender. Pediatric patients may participate if consent is given by a guardian. - SamplingMethod: Probability Sample
rTMS Over S1 Enhance Motor Learning in Healthy People
Status: Recruiting

The purpose of this study is to compare the effectiveness of different repetitive Transcranial Magnetic Stimulation protocols for enhancing motor learning in healthy peolple.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Older than 18 years old and younger than 65  Exclusion Criteria:  Presenting any neurological pathology Pain during the study Any contraindications to rTMS, such as metal implants, history of epileptic seizures or taking medication that lowers the seizure threshold - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002
Status: Not yet recruiting

This is a follow-up study of subjects who received NTLA-2002 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  A subject has completed or discontinued from an Intellia-sponsored or -supported treatment protocol in which a complete or partial dose of NTLA-2002 was received. A subject has provided informed consent for the LTFU study. A subject is willing to attend study visits, complete protocol-required follow-up schedule, and comply with the study requirements.  Exclusion Criteria:  None - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Participating sites in an Intellia-sponsored clinical study of NTLA-2002. - SamplingMethod: Non-Probability Sample
Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial
Status: Recruiting

For patients with lung cancer who have undergone tumor resection, early relapse significantly impacts survival. However, there are currently no reliable screening or imaging tools available to identify patients at risk of early relapse. To address this clinical challenge, many studies have focused on understanding the clinicopathologic characteristics associated with an increased risk of early relapse. Despite these efforts, we can identify patients at risk but cannot pinpoint which individuals will actually experience early relapse. Studies on adjuvant therapy have shown improved survival in cases of more advanced disease but have not demonstrated a reduction in early relapse rates.

In our preliminary analysis of previous study data, we observed that patients with a smaller reduction in circulating tumor cells (CTCs) within the first three days after surgery, followed by an increase on the third-day post-operation, are more likely to experience early relapse during regular monitoring. This pattern may be indicative of minimal residual disease. By combining trends in circulating tumor cell variations with pathologic characteristics, we aim to select patients for adjuvant therapy who are at high risk of developing early relapse.

The objective of our study is to employ screening based on circulating tumor cell dynamics and pathologic features to identify patients likely to experience early relapse and to assess the effectiveness of adjuvant therapy in these cases.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients who presented with resectable disease ( Clinical stage 1a to 3a) Patients who received tumor resection  Exclusion Criteria:  Pathologic stage greater than stage 3b or 4 Pathologic stage less than stage 1a1 Could not complete treatment course Could not receive blood sampling for CTC (circulating tumor cell) or regular surveillance - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD
Status: Not yet recruiting

The primary objective of this study is to evaluate the ability of TOME to increase Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and postpartum persons.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Potential participants must be:  18 years of age or older; Pregnant or be within 12 months postpartum; Enrolled in MOUD (either buprenorphine or methadone) at the study site or affiliated clinic where enrollment can be confirmed; Able to understand the study, and having understood, provide written informed consent in English  Exclusion Criteria:  Potential participants must not:  1. have suicidal or homicidal ideation requiring immediate attention. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Evaluating the Fade to Fitness Program: A Barbershop-based Program for Black Men
Status: Not yet recruiting

The Fade to Fitness Program is a targeted intervention designed to improve the holistic health and quality of life among Black men. This comprehensive initiative focuses on four key health behaviors: Physical Activity, Healthy Eating, Stress Management, and Depression Management.

It is grounded in psychological and social theories like Self-Determination Theory, Motivational Interviewing, and Social Cognitive Theory. The program emphasizes the importance of making informed choices, feeling competent and connected, and learning through observation and modeling. Facilitators play a pivotal role, leading group discussions, providing support, and fostering an inclusive atmosphere.

The program is structured into weekly sessions that tackle each health behavior, interspersed with off weeks; for community engagement, especially in barbershops, to discuss health topics and promote a healthier lifestyle.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Self-identify as African American or Black American male - 18 - 90 years of age Able to speak and understand English  Exclusion Criteria:  Currently participating in another health promotion intervention On a special diet for a serious health condition Intending to move within 6 months of participating in the intervention - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - GenderBased: Yes - GenderDescription: Individuals must identify as male regardless of biological sex. - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
Emotional Support for Women Experiencing PPROM
Status: Not yet recruiting

Preterm Prelabour Rupture of the Membranes is a pregnancy complication affecting 3% of all pregnancies. Outcomes for both the mother and baby are variable including: preterm delivery, fetal infection, cord prolapse, abruption as well as maternal sepsis and even maternal death. The outcomes are not only variable but the stress and uncertainty can be over a protracted period of time. This is a pilot study that aims to provide personalised psychological intervention at the time of PPROM based on Cognitive Behavioural Principles to see whether this improves psychological outcomes for women.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Woman (or birthing person) aged 16 years or over; Is experiencing PPROM Has been admitted to the ward Has capacity to give informed consent to take part in the research Speaks and writes English  Exclusion Criteria:  • Unable or unwilling to give informed consent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Pregnant women or individuals who are pregnant - MinimumAge: 16 Years - StdAgeList: Child, Adult, Older Adult
National, Observational Registry for Comprehensive Follow-up of All Implementations of the AVEIR VR LP Device in France (France LEADLESS)
Status: Not yet recruiting

Although the idea of a leadless pacemaker was first proposed in the 1970s to eliminate the probes, pockets and connectors required by conventional cardiac procedures and the associated complications, the first devices were not developed until the late 2010s. Leadless pacemakers can also improve patient comfort by replacing surgery with a percutaneous procedure, eliminating the mass and scar visible at the implantation site of a conventional pacemaker, and eliminating the need for activity restrictions to prevent dislodgement after implantation of a conventional lead.

The AVEIR VR LP leadless pacemaker was CE marked in July 2023 and will be implanted in patients in Europe.

The objective of this national registry is to evaluate the safety and performance of the AVEIR VR LP system in a population of patients indicated for implantation of a VVI(R) pacemaker in France. This registry will also allow the collection of patient characteristics and indications under normal conditions of use.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient implanted with an AVEIR VR LP device Patient over 18 years old Patient informed of the nature of the study, agrees to participate in the study  Exclusion Criteria:  Patient under 18 years of age Patient refusing to participate in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients will be included in cardiology departments participating in the study. The study may be offered to any patient undergoing an implantation of leadless pacemaker using AVEIR VR LP device in France. - SamplingMethod: Non-Probability Sample
The Effect of Heating With Electrical Blanket After Cesarean Section on the Postpartum
Status: Recruiting

It is known that maintaining and maintaining normal body temperature in women after cesarean section facilitates the mother's adaptation to the postpartum period. One of the important problems after cesarean section is hypothermia. Therefore, various methods are used to maintain normal body temperature. One of these methods is the use of electric blankets. This study will investigate the effect of using electric blankets after cesarean section on postpartum comfort, pain, milk quantity and breastfeeding success.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years and over, At least primary school graduate The one who is married Primiparous women who gave birth at term, Having the baby with her after birth Those who agreed to participate in the study  Exclusion Criteria:  Those who gave birth at less than 37 weeks of gestation Mothers with babies weighing less than 2500 grams The newborn has a congenital anomaly, Those with a history of high-risk pregnancy Those who received any food, including water, other than breast milk until the 10th day of follow-up Those with cardiovascular disease problems, those with a history of neurological diseases Mothers with nipple problems Diabetes Mellitus, those diagnosed with gestational diabetes mellitus, Mothers who gave birth with general anesthesia - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Mobile MRI for Immediate Radiological Acute Cerebral Lesion Evaluation in Stroke
Status: Recruiting

This prospective observational study will evaluate the potential value of mobile MRI in patients with suspected or proven acute stroke and Transient Ischemic Attack (TIA), undertaking additional imaging in the emergency department, acute stroke unit, or outpatient settings, and comparing diagnostic accuracy, Diffusion-weighted imaging (DWI) lesion volume and detection of complications (brain swelling or haemorrhagic transformation). Information on ease of use, tolerability and image quality will also be gathered.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or non-pregnant female > or = 18 years of age Clinically suspected stroke or transient ischaemic attack, or confirmed clinical diagnosis of stroke or TIA Consent of patient or legal representative  Exclusion Criteria:  Contraindications to MRI brain scan as per standard MRI checklist for NHS Greater Glasgow & Clyde - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Clinically suspected stroke or transient ischaemic attack, or confirmed clinical diagnosis of stroke or TIA - SamplingMethod: Non-Probability Sample
Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw (Shark Screw).
Status: Not yet recruiting

The goal of this clinical trial is to compare the treatment of Hallux Valgus using the conventional method (metal screw) with the new method (human allogeneic cortical bone screw (Shark Screw®) in adult patients with confirmed Hallux Valgus.

The main questions it aims to answer are:

Can the new method obtain similar results as the conventional method in regard to union rate and time to union? Are the number of complications lower with the new method? Participants will be operated either with the metal screw or with the Shark Screw®. The assignment to the groups is randomized.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  between 18 and 85 confirmed Hallux Valgus  Exclusion Criteria:  <18 years and >85 years Known underlying oncological disease Pregnant women or breastfeeding mothers Alcohol and drug abuse Foreseeable compliance problems Foreseeable loss of responsibility as a study doctor Neoplastic diseases Active osteomyelitis Ulcerations in the area of the skin of the surgical site Immunosuppressive medication that cannot be discontinued - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy
Status: Recruiting

This study seeks to determine how an adjustable stiffness ankle braces affects walking performance and biomechanics in cerebral palsy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age between 8-35 years old, inclusive Diagnosis of cerebral palsy (CP) Gross motor functional classification score level I, II, or III Physician-prescribed AFOs of common design (i.e., rigid molded thermoplastic) Ability to walk for 6 minutes on a treadmill At least 20° of passive plantar-flexion range of motion No concurrent treatment other than those assigned during the study No condition other than CP that would affect safe participation No surgery within 6 months of participation.  Exclusion Criteria:  -Excessive knee flexion during walking caused by CP - HealthyVolunteers: No - Gender: All - MinimumAge: 8 Years - MaximumAge: 35 Years - StdAgeList: Child, Adult
Parenting STAIR: Adapting a Trauma-Focused Parenting Intervention for Military-Connected Mothers and Their Children
Status: Not yet recruiting

The purpose of this study, which includes a clinical trial, is to adapt and assess the efficacy of Parenting-STAIR (PSTAIR), an intervention which combines existing evidence-based treatments Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Care (PC-Care) to reduce symptoms of Post-traumatic Stress Disorder (PTSD) and improve parenting among military-connected mothers. Participants in the clinical trial will receive PSTAIR or trauma-focused treatment as usual (either prolonged exposure or cognitive processing therapy).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  military connected mother, defined as mothers who are either a female service member or veteran or female spouse of a service member or veteran; with a child aged 2-10 (if more than one child in this age range, the mother will indicate child with most behavioral difficulties); lifetime trauma exposure; screen positive for PTSD defined by scores ≥ 32 on PTSD Checklist-5 (PCL-5) with and without depression (scores ≥ 10 on Patient Health Questionnaire-9 (PHQ-9); able to speak and understand English or Spanish. being the legal guardian for the child with physical and legal custody  Exclusion Criteria:  high risk for suicide, defined by VA as having intent, means, and a plan; current psychotic symptoms (SCID); communication disability (e.g., deafness); child with diagnosed severe developmental disability Meeting a diagnosis of severe substance or alcohol use disorder (≥ 6 symptoms on SCID) AND not in early remission (≥3 months without meeting any substance or alcohol use disorder criteria (except craving) - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Evaluation of Liver Damage in Patients With Anorexia Nervosa by Blood Biomarker Analysis
Status: Not yet recruiting

The main goal of the BIocoLlection in Anorexia Nervosa-liver damage evaluation BILAN study the blood biomarkers associated with liver cytolysis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria :  Patient over 15 years old Diagnosis of Restricted Eating Disorders including Anorexia Nervosa according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Admission to Nantes University Hospital.  Exclusion Criteria :  Chronic active viral hepatitis Hemochromatosis Other genetic, autoimmune. Treatment with a drug known to induce fatty liver disease (amiodarone, carbamazepine, tamoxifen, valproate, clozapine, anti-retrovirals) unless the dose has been stable for ≥ 3 months Excessive alcohol consumption (≥ 30 grams per day in men, ≥ 20 grams per day in women) Pregnant, parturient or breast-feeding women, persons deprived of liberty, adults under legal protection or unable to express their consent, persons not affiliated or not beneficiaries of a social security scheme, persons under guardianship or curators - HealthyVolunteers: No - Gender: All - MinimumAge: 15 Years - MaximumAge: 99 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Consecutive inclusion of patients hospitalized in the endocrinology department for anorexia nervosa with malnutrition criteria. - SamplingMethod: Probability Sample