rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Sleep Profile of Patients With Septo-optic Dysplasia
Status: Recruiting

The aim of this study is to evaluate sleep of patients with septo-optic dysplasia compared to patients with an isolated disorder of peripheral visual system and patients with corpus callosum agenesis since both visus defict and agenesis of corpus callosum might be present SOD but associated to other features / structural and functional anomalies.

Included patients and their caregivers will be asked to compile standardize sleep questionnaires and a sleep screening through an interview will be scheduled. Patients will be asked to wear an actigraph on their non-dominant hand wrist for 7 days.

Eligibility:
- EligibilityCriteria: Inclusion criteria group A:  diagnosis of SOD or SOD plus syndrome with or without a defined genetic diagnosis age 3-18 years availability of at least 2 serial sleep EEGs performed during clinical follow-up stable drug therapy in the last three months  Inclusion criteria group B:  diagnosis of congenital or early acquired isolated peripheral visual deficit with or without a known genetic diagnosis (e.g., congenital cataract, inherited retinal dystrophies, isolated eye maldevelopment). age 3-18 years grating or visual acuity < 3/10 availability of serial sleep EEGs performed during clinical follow-up stable drug therapy in the last three months  Inclusion criteria group C  isolated corpus callosum agenesis at brain MRI age 3-18 years availability of at least 2 serial sleep EEGs performed during clinical follow-up stable drug therapy in the last three months  Exclusion criteria group A:  absence of informed consent severe Intellectual disability and/or severe motor impairment melatonin assumption  Exclusion criteria group B:  absence of informed consent CNS involvement ( malformations/ lesions) severe Intellectual disability and/or severe motor impairment melatonin assumption  Exclusion criteria group C  absence of informed consent severe Intellectual disability and/or severe motor impairment melatonin assumption - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: Three groups of patients will be included:  Group A: 15 patients with septo-optic dysplasia Group B: 15 patients with disorder of peripheral visual system Group C: 15 patients with Corpus Callosum agenesis - SamplingMethod: Non-Probability Sample
Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients
Status: Not yet recruiting

This phase 1b open label, dose-escalating investigation study is to evaluate the dose dependent initial efficacy of the use of MT218 injection for biomarker targeted MR molecular imaging (MRMI) of prostate cancer in patients scheduled for radical prostatectomy.

Eligibility:
- EligibilityCriteria: Inclusion criteria  Male subjects aged >18 years. Patients with confirmed Gleason score of 8 - 10 prostate cancer, had at least one prostate mpMRI and one prostate biopsy. Ability to lie still for MRI scanning. Patients must be able to provide written informed consent. Glomerular filtration rate (GFR) > 60 mL/min within a 30 days of the research MRI.  Key exclusion criteria  Any diagnosis of active acute, chronic, or sub-chronic kidney or liver disease. Documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH) or urinary tract infections. Patients with uncontrolled diabetes or hypertension. Patients with active non-prostate malignancy. Patients with contraindications for MRI including implantable pace makers, cochlear implants. Patients with uni- or bilateral hip prosthesis. Subjects with other significant medical conditions that would create unacceptable operative risk, compromise retention on study or compromise study related assessments. Major surgery within 4 weeks prior to entry on this study or patients who have not recovered from side effects of such therapy. Prostate biopsy within 4 weeks prior to entry on this study in which inflammation might affect MRI result. Subjects who received or will receive any other MRI contrast agent within 48 hours prior to MT218 injection or up to 24 hours after MT218 injection. Is determined by the investigator that the patient is clinically unsuitable for the study. Is incapable of understanding the language in which the information for the patient is given. Participation in a concurrent clinical trial or in another trial within the past 30 days. - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
A Feasibility Study of Virtual Reality for the Treatment of Non-cardiac Chest Pain
Status: Not yet recruiting

The purpose of this study is to determine if virtual reality (VR) will improve symptoms in non-cardiac chest pain (NCCP).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Symptoms of non-cardiac chest pain (recurrent anginal-like or atypical chest pain) Negative prior cardiac evaluation (at a minimum, including electrocardiogram) Prior esophagogastroduodenoscopy and/or barium esophagram to rule out severe esophagitis, stricture, or motility abnormality  Exclusion Criteria:  Initiation of a proton pump inhibitor (PPI) within 8 weeks Major concomitant illness Current drug or alcohol use that that would interfere with adherence to study requirements Symptoms of vertigo or dizziness that would limit tolerability of the VR headset - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1
Status: Not yet recruiting

The goal of this fully decentralized, randomized controlled trial is to compare the efficacy of two educational interventions for individuals with Neurofibromatosis 1 (NF1). The primary objective of the study is to determine which intervention leads to higher rates of evidenced-based health screenings for NF1 patients in primary care settings.

Adults with NF1 and parents/guardians of children with NF1 from across the U.S. who do not go to a specialized NF clinic and who have an upcoming annual wellness visits scheduled with a primary care provider (PCP) are eligible to enroll in the study.

Eligibility:
- EligibilityCriteria: Adult Inclusion Criteria:  Currently lives in the United States (including Puerto Rico and other United States territories) Has a clinical diagnosis of neurofibromatosis 1 Does not attend an NF clinic within the Children's Tumor Foundation NF Clinic Network Has an in-person, well-person visit with a primary care provider scheduled within 3 months of their consent Speaks English or Spanish  Parent/Guardian of a Child with NF1 Inclusion Criteria:  Currently lives in the United States (including Puerto Rico and other United States territories) Cares for a child (age <18 years) with a clinical diagnosis of neurofibromatosis 1 Does not attend an NF clinic within the Children's Tumor Foundation NF Clinic Network Their child has an in-person, well-person visit with a primary care provider scheduled within 3 months of their consent Speaks English or Spanish  Exclusion Criteria:  Only one person per household may participate in the study Unwilling or unable to give informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Combined FIFA 11+ and Change of Direction Training
Status: Recruiting

The study has investigated the effects of adding change of direction (COD) training to the FIFA 11+ on lower extremity performance in soccer players. The investigators are interested in knee valgus angle during cutting which is typically suggested as a critical risk of anterior cruciate ligament injury. Peak knee valgus angle during cutting is expected to reduce immediately after adding COD training to the FIFA 11+.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Soccer players  Exclusion Criteria:  Having experience of serious injury such as, ACL injury and chronic ankle instability Having experience of lower limb surgery such as, bone fracture, tendon rupture, or ligament rupture Having current musculoskeletal injuries such as, muscle sprain Attending other prevention program or similar study especially on lower extremity Soccer player who are unable to perform level 3 of part 2 of the FIFA 11+ prevention program - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult
Effect of Structured Training Program in Diabetic Patients
Status: Recruiting

Diabetic neuropathy, a challenging condition resulting from poorly managed type-1 or type-2 diabetes mellitus, often proves resistant to conventional medications when it comes to alleviating the associated symptoms. In such cases, implementing a well-organized exercise regimen has proven beneficial in mitigating diverse symptoms associated with the condition and enhancing the overall quality of life for affected individuals.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diabetes mellitus with moderate to severe DPN Subjects of both gender Age from 40 to 70 years Independent walking MNSI score more than 2 out of 13  Exclusion Criteria:  Presence of an active planter ulcer History of surgery during intervention period Neurological diseases other than DPN - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 40 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial
Status: Not yet recruiting

The objectives of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and improving other clinical outcomes in people undergoing pulmonary surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria ( 2 or more of the following risk factors):  Male Sex Age greater than or equal to 40 years History of Diabetes Mellitus Prior pelvic irradiation Use of indwelling Thoracic Epidural analgesia Prior history of urinary retention  AND  International Prostate Specific Score greater than or equal to 1.  Exclusion Criteria:  Active treatment of Benign Prostatic Hyperplasia (BPH) Hypersensitivity or allergy to tamsulosin HCL Active treatment with tamsulosin or other alpha-blocker or uses of tamsulosin/ other alpha-blocker within 3 weeks of enrollment date Active urinary tract infection History of urological disorder specified as urethral stricture, BPH, bladder or prostate malignancy. History of urological surgery (Transurethral resection of the Prostate, Transurethral resection of the Bladder, Bladder suspension, prostatectomy) Underlying neurological disorders resulting in impaired bladder function Any known contraindication to the use of tamsulosin HCL - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - StdAgeList: Adult, Older Adult
Transcriptome, Proteome and Microbiome Profile in Periodontal and Peri-implant Diseases
Status: Not yet recruiting

To investigate the transcriptomic profile of periodontitis and peri-implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included to investigate the gene expression profile in tissue affected by periodontitis and peri-implantitis. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and the number of teeth. During surgical intervention, tissue biopsies (two specimens per site) will be collected by a periodontist from site with ongoing periodontitis and site from ongoing peri-implantitis.
To study the microbiome and biomarker profile associated with periodontitis and peri- implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included in this study to determine the bacteria composition, cytokine profile and inflammatory biomarkers profile. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and number of teeth. Peri-implant crevicular fluid (PICF), gingival crevicular fluid (GCF), saliva and submucosal/subgingival plaque will be collected.The presence and composition of periodontal and peri-implant plaque samples are investigated.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ≥18 years of age Defined periodontitis at two non-adjacent teeth Defined peri-implantitis at ≥1 implant Signed informed consent  Exclusion Criteria:  Surgical intervention of periodontitis and/or peri-implantitis during last 6 months.  Local or systemic use of antibiotics during last 6 months. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients diagnosed with periodontitis and peri-implantitis, referred from a general clinic in Stockholm County to a periodontist. - SamplingMethod: Non-Probability Sample
The Effect of Cold Application on Pain Level, Edema and Drainage Amount
Status: Recruiting

In this study, we aimed to investigate the effect of cold application applied for 20 minutes every hour for 8 hours on the first day, second and third days after total hip arthroplasty with gel pads, on the pain level, edema and drainage amount of total hip arthroplasty patients. The main question[s]it aims to answer are:

Is there a difference between the pain levels of patients in the control and cold application arms?
Is there a difference between the knee edema of patients in the control and cold application arms?
Is there a difference between the amount of drainage of patients in the control and cold application arms? This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years and above, Able to communicate verbally and in writing, Turkish speaking, TKA applied for the first time, Unilateral total knee arthroplasty applied, Spinal anesthesia applied, Having a hemovac drainage catheter, Without peripheral vascular disease,  Exclusion Criteria:  Revision total knee arthroplasty applied, Bilateraltotal knee arthroplasty applied, Those who use alcohol and substances, TKA was performed for a reason other than knee osteoarthritis, General anesthesia applied, - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Dynamics of AMR Spread, Persistence and Evolution Between Humans, Animals and Their Environment
Status: Not yet recruiting

Humans in contact with animals such as dog owners, may be at risk of antimicrobial resistance (AMR) acquisition. This is the central issue to be investigated in DYASPEO

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult or child planning to live in the same household as his/her dog during the three months following inclusion. Planning to live in the same habitat in the next three months following inclusion (except for holidays). Written consent of all adults and of at least one of the two parents for minors under parental authority. A different information note will be elaborated for each age category (6-10 yr-old, 10-15 yr-old and 16-18 yr-old). Owning a dog recorded for a surgery at the National Veterinary School  Exclusion Criteria:  Lack of signed informed consent Subject in alternating custody Subject under legal protection (guardianship) Subject deprived of liberty under judicial constraint Subject undergoing psychiatric care Lack of affiliation to a social security scheme Volunteers who do not speak/write French - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: The healthy volunteers (dog owners) will be recruited at a single recruitment centre, which is the National Veterinary School (Maisons-Alfort). - SamplingMethod: Non-Probability Sample
Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation.
Status: Not yet recruiting

The goal of this clinical trial is to compare the safety and efficacy of fospropofol and propofol during sedation in invasively mechanically ventilated patients in the Anesthesia Intensive Care Unit (AICU). Specific objectives include the following:

Evaluate the sedative effects of fospropofol and propofol in invasively mechanically ventilated patients. Compare the sedative effects of the two medications using relevant clinical indicators and scoring tools, such as the Richmond Agitation-Sedation Scale (RASS).
Compare the safety of fospropofol and propofol during sedation. Monitor medication-related adverse reactions, such as respiratory depression, hypotension, arrhythmias, headache, injection site pain, and assess the differences in adverse reaction incidence between the two medications.
Compare the characteristics of recovery from sedation between PPD and propofol. Focus on the time from sedation to emergence from sedation and compare the differences in recovery time between the two medications.

Participants will be sedated with fospropofol or propofol during invasive mechanical ventilation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged 18-65 years old Intubation and mechanical ventilation <12h before enrollment Expected to require continuous invasive ventilation and sedation less than 6h after admission to anesthesia intensive care unit (AICU). Signed informed consent  Exclusion Criteria:  parturient, childbirth or lactating mothers acute severe neurological disease or coma chronic renal failure previous mechanical ventilation >12h severe liver dysfunction (Child-Pugh score C) BMI >30kg/m2 (>90kg) dying - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Magnetic Localization of Sentinel Nodes in Squamous Cell Oral Carcinoma.
Status: Recruiting

Sentinel node biopsy has been shown to be a viable alternative to elective neck dissection in the early stages of squamous cell oral carcinoma. The aim of this study was to describe the magnetic localization of sentinel nodes (SN) after peritumoral injection of superparamagnetic iron oxide (SPIO) for treating this type of tumor and to analyze the technique's diagnostic performance in 23 patients. The technique located SNs (with minimal complication) in 95.6 % (22/23) of the patients. Three relapses occurred, one in a patient who had shown negative in magnetic SN location and elective neck dissection. The diagnostic performance of magnetic localization achieved a sensitivity and negative predictive value of 0.80 y 0.94, respectively. Magnetic localization of SNs has been shown to be a reproducible technique that may offer a viable alternative to the conventional technique.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Oral squamous cell carcinoma T1-T2, cN0. Absence of alterations to iron metabolism.  Exclusion Criteria:  Previous neck surgery. Treatment with iron chelators. Pregnant - HealthyVolunteers: No - Gender: All - MinimumAge: 29 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients recruited consecutively when diagnosed with oral squamous cell carcinoma at clinical stages I-II by biopsy and magnetic resonance. All patients were intervened by the same surgeon at the Department of Maxillofacial Surgery at Donostia University Hospital. - SamplingMethod: Non-Probability Sample
A Pivotal Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With Unknown Diabetes Status and Performance Evaluation of the Glyconics SW Package
Status: Not yet recruiting

The main clinical study objective is to confirm the accuracy of the Glyconics-DS spectrometer when used in its intended medical purpose population, i.e., in individuals with unknown diabetes risk. Additionally, this investigation will serve as a pivotal performance evaluation for the associated software for correct delivery of the algorithm-based analysis of the individual diabetes risk. The study will be considered positive if the backend delivery of the chemometrics output is performed correctly as per the cloud-based analysis and its delivery represents the essential medical software to be evaluated in this investigation. The 'true' diabetes risk will be contrasted against values of an internal biomarker indicative of glycaemia, HbA1c, as measured based on standardised, certified methodology.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Apparently healthy adults (≥18 years of age) with unknown diabetes status willing to participate in and provide a written consent for the study Willingness to undertake assisted assessment of glycaemia: by both the NIR spectral measurements in a chosen middle fingernail, and HbA1c (blood sample) Individuals with at least one visually assessed undamaged, intact (preferably middle) fingernail.  Exclusion Criteria:  Individuals with any known medical conditions impacting either of the assessment methodology for glycaemia, such as:  Severe forms of anaemia (diagnosed iron deficiency, sickle cell anaemia or similar). Haemoglobinopathies or atypical haemoglobin subtypes not detectable by regular (local) laboratory assays for HbA1c. Severe renal impairment (CKD stage III-IV) or decompensated hepatic disease. Severe Vitamin D deficiency (diagnosed or measured 25(OH)D3 < 25 nmol/ml). Known severe immunodeficiency such as HIV, malignancy or other chronic condition significantly impacting assessment of glycaemia. Eating disorders (as per clinical assessment) Recent (within 28 days) blood donation Any other type of known diabetes than T2DM, if diagnosed (T1DM, GDM, MODY, etc.)  Any structural, deviating and visually detectable deviations in the appearance of the (only/ to be assessed) middle fingernail potentially impacting the spectra measurement, including:  nail dystrophy or deformity severe nail infections (onychomycosis causing visual changes in the appearance of the nail). rare hereditable conditions impacting the structure of keratin. mechanical damage or marks on the surface of the nail after removal of nail polish. use of acrylic or gel nail decoration and polish, which cannot be removed with acetone (use of acetone necessitates a 15 min post-removal wash-out time) Any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of HbA1c value. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult