rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Soi TS3 Surface in Patients With and Without Type 2 Diabetes
Status: Not yet recruiting

The aim of this prospective cohort study is to compare clinical and radiographic data of Osstem implants with SOI surface placed in patients with or without diabetes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients of at least 18 years old able to sign an informed consent. Patients with at least a single tooth loss in the maxilla or mandible. Patient will provide only one site for the research. Implant sites must allow the placement of implants of at least 3.5 mm (upper laterals and lower incisors); 4 mm (central incisors, canines, and premolars) or 4.5 (molars) mm of diameter and at least 7 mm of length. Smokers will be included and categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day). Patients with a plaque index (PI) of less than, or equal to 25% at the time of surgery. In case of post-extractive sites, they must have been healing for at least 3 months before being treated in the study. Only in the test group, patients with controlled type 2 diabetes mellitus with at least 2 years of disease evaluation of HbA1C values between 6% and 10 % at the time of implant placement will be included. Only in the control group, healthy patients without any sign of type 2 diabetes mellitus will be included  Exclusion Criteria:  General contraindications to implant surgery (except for type two diabetes in test group). Patients irradiated in the head and neck area. Immunosuppressed or immunocompromised patients (except for type two diabetes in test group). Patients treated or under treatment with intravenous amino-bisphosphonates. Patients with untreated periodontitis. Patients with poor oral hygiene and motivation. Previous guided bone reconstruction at the intended implant sites. Uncontrolled diabetes (except for type two diabetes in test group). Pregnancy or nursing. Substance abuser. Psychiatric problems or unrealistic expectations. Lack of opposite occluding dentition in the area intended for implant placement. Patients with infection and or inflammation in the area intended for implant placement. Patients participating in other studies, if the present protocol cannot be properly adhered to. Patients referred only for implant placement and cannot be followed ant the treating centre. Patients unable to be followed for 5 years. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Single-center, Double-blind, Randomized, Placebo-controlled Trial to Explore the Efficacy and Safety of Lymphoblock for Prevention of Lymphorrhea in Patients With Thoracoabdominal Aorta Repair.
Status: Recruiting

Randomized, double-blind, placebo-controlled study will determine the clinical efficacy and safety of Lymphoblock in the prevention of postoperative retroperitoneal chylo-/lymphorrhoea in patients with open surgical treatment of the thoracoabdominal aorta. It is planned to recruit 138 clinical observations. Efficacy will be evaluated based on clinical and laboratory data.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  patient in thoracoabdominal or abdominal aorta repair underwent retroperitoneal aortic access  Exclusion Criteria:  refusal to participate in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Quality of Sexual Life of PrEP Users
Status: Not yet recruiting

The study will recruit participants on the occasion of their visit in a sexual health center or another HIV pre-exposure prophylaxis (PrEP) facility in France.

PrEP users will be proposed to fill a self-administered, online, anonymous questionnaire regarding how they perceive different fields of their sexual life, and how they perceive that PrEP has an impact on the quality of sexual life.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  current PrEP use adult  Exclusion Criteria:  unwilling to participate - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: current PrEP users in sexual health centers or other PrEP facilities - SamplingMethod: Probability Sample
Food at Home Study
Status: Not yet recruiting

The study objective is to develop an accessible home food environment assessment toolkit that includes valid and reliable paper and electronic tools targeting foods known to impact diet-related health that can be user-administered across literacy levels in English and Spanish.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Speak Spanish or English at home 18 or older primary grocery shopper or meal preparer  Exclusion Criteria:  Any person younger than 18 lacks the capacity to consent does not purchase the majority of the groceries for the home - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adults over 18 who speak either English or Spanish at home and who are responsible for the majority of the cooking or grocery shopping for their family. There will be 150 participants in the paper validation phase (75 who speak English at home and 75 who speak Spanish at home) and 200 participants in the validation of the electronic Home Food Inventory (eHFI) (100 who speak Spanish at home and 100 who speak English at home) - SamplingMethod: Non-Probability Sample
Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases
Status: Not yet recruiting

The aim of the study is to identify adolescent patients that are at risk of developing oral diseases, and to assess if targeted preventive oral treatment with antibacterial dual-light therapy as an adjunctive treatment method can have a positive impact in preventing oral diseases from emerging.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  14-16 years old, and a junior high school 8th-grade pupil from the area of the Wellbeing Services of County Pirkanmaa Agreement to participate in the study and to sign a written consent form, including either consent from caregiver(s) with pupils under 14 years, or information to caregiver(s) with pupils from 15 to 16 years old Able to cooperate with the treatment  Exclusion Criteria:  Presence of any physical limitation or restriction that might restrict Lumoral use Unwilling to participate in the study Periodontal treatment within 3 months prior to study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 14 Years - MaximumAge: 16 Years - StdAgeList: Child
A Study of VRG50635 in Healthy Volunteers
Status: Not yet recruiting

The primary objectives of this study are to investigate the safety and tolerability of VRG50635 and to determine how VRG50635 is absorbed by the body.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Must have a body mass index ≥ 18.5 and ≤ 32 kilogram per square meter (kg/m2) and weigh ≥ 50 kg. Participants of childbearing potential are eligible to participate if they are not pregnant or breastfeeding and agree to use 1 highly effective and 1 barrier method of contraception, if sexually active, for the duration of the study through 90 days after the last study drug administration. Participants must not donate eggs for the duration of study through 90 days after the last dose of study drug. Participants capable of producing sperm must agree that they will use 1 barrier method of contraception and that their partners of childbearing potential will use 1 highly effective method of contraception for the duration of the study through 90 days after the last study drug administration. Participants must not donate sperm for the duration of study through 90 days after the last dose of study drug.  Exclusion Criteria:  Have a history of clinically significant hematologic, renal, neurologic, pancreatic, gastrointestinal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, immunological, allergic disease, or other major disorders, as determined by the principal investigator (PI). Have any surgical or medical condition that could possibly affect drug absorption (including inflammatory bowel disease, history of gastrectomy, cholecystectomy, or other gastrointestinal tract surgery except appendectomy). Have a current significant medical or psychiatric condition, as determined by the PI.  Other protocol-defined criteria apply. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 19 Years - MaximumAge: 55 Years - StdAgeList: Adult
Evaluation of the Cancer Tracking System (CATSystem)
Status: Recruiting

Cervical cancer contributes to significant preventable mortality in Kenya where less than 20% of women are screened. The Cancer Tracking System (CATSystem) is a web-based, algorithm generated tool to promote guideline adherent cervical cancer screening and retention through treatment. The goal of this project is to rigorously evaluate the efficacy, implementation, and cost-effectiveness of the CATSystem to improve rates of screening, treatment, referral, and follow-up care in a matched, cluster randomized controlled trial in 10 Kenyan government hospitals (5 intervention, 5 standard of care).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  women above 16 years of age access to a cell phone, presenting for cervical cancer screening at a study hospital.  Exclusion Criteria:  greater than 20 weeks gestation, incarcerated patients, women who study staff feel are unable to provide written informed consent due to impaired capacity. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: female - MinimumAge: 16 Years - StdAgeList: Child, Adult, Older Adult
Effect of Dual-task Training on the Number of EEG Band in Stroke Patients
Status: Not yet recruiting

Stroke is a prevalent global health concern, causing widespread disability as it disrupts blood supply to the brain, leading to functional impairments. Upper limb dysfunction affects over 80% of stroke survivors acutely and becomes permanent in approximately 60%, hindering daily activities and autonomy. Dual-task training (DTT), involving simultaneous cognitive and motor tasks resembling daily activities, is proposed as an effective intervention.

The study suggests using electroencephalogram (EEG) analysis, particularly the Fast Fourier Transform (FFT), to assess changes in brain signals pre- and post-DTT intervention. EEG provides real-time insights into brain function, and FFT analyzes signal frequencies. The intervention involves three tasks performed concurrently with mental calculations, such as sorting blocks and manipulating objects. This 12-session, four-week intervention aims to improve upper limb function. The study explores EEG's role in evaluating DTT effects on stroke patients, particularly using FFT to analyze brain signal frequencies.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Unilateral stroke proven by imaging evidence Women between 35 and 75 years old At least six months have passed since the onset of the stroke  Exclusion Criteria:  Suffering from another neurological or orthopedic disease Score greater than 3 on the modified modified Ashworth scale in the upper limb Having received a botulinum toxin injection before or during the course of the study History of brain surgery Be using medication that may alter cortical activity or brain plasticity or aimed at reducing the level of spasticity. - HealthyVolunteers: No - Gender: Female - MinimumAge: 35 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Topical Anti-Androgens in Pilonidal Sinus Disease
Status: Not yet recruiting

The goal of this randomized clinical trial is to test the topical drug clascoterone in patients with pilonidal disease, which is a common, benign skin condition of the gluteal cleft. The main questions it aims to answer are:

Does clascoterone improve the severity of pilonidal disease as scored by a physician?
Does clascoterone improve patient symptoms due to pilonidal disease?
Does clascoterone improve the inflammation seen under the microscope in pilonidal disease removed at surgery Participants will apply clascoterone or a placebo cream to the diseased area for 3 months. They will be assessed every 4 weeks for disease severity assessed by a physician viewing patient photos and a symptom-based survey.

Researchers will compare participants who received clascoterone treatment to those who received placebo.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 18 and above Diagnosis of Pilonidal Disease Willingness to comply with study procedures and availability for duration of study Ability to apply topical medications and willing to adhere to regimen  Exclusion Criteria:  Current use of any topical medication to natal cleft Presence of pilonidal-associated abscess Pregnancy or lactation Allergic reaction to components of 1% clascoterone cream Febrile illness within 7 days Treatment with another investigational drug within three months - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Evaluating the Long-term Effects of Microfocused Ultrasound on Facial Tightening Using Quantitative Instruments
Status: Recruiting

By utilizing standardized photographs in conjunction with quantification detection instruments, data analysis before and after treatment is conducted, along with long-term efficacy observations. This approach aims to provide more comprehensive scientific evidence for the clinical application of ultrasound treatment in anti-aging therapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Ages between 25 and 60 years old. Clear manifested skin issues such as sagging and wrinkles: Merz Facial Aesthetics Score of 2 or above. Absence of significant systemic diseases, cardiovascular disorders, impaired liver or kidney function, malignant tumors, etc. Willing to participate in this study and sign an informed consent form.  Exclusion Criteria:  Pregnant or lactating women. Individuals with a scar-prone constitution, allergic or abnormally healing skin. Treatment areas with damaged skin, acute inflammation, active infection, rosacea, vitiligo in the progressive stage, or severe acne. Patients with skin conditions such as urticaria, itching, or other dermatological diseases. Those with psychological disorders or drug allergies. Individuals harboring unrealistic expectations about treatment outcomes. Treatment areas containing metal foreign bodies or fillers deemed unsuitable for treatment by the physician. Recent facial laser treatments or injections within the past month, including but not limited to filler treatments such as hyaluronic acid, botulinum toxin, and PRP injection therapy. Any skin-tightening cosmetic treatments on the face or neck within the last three months. Any minimally invasive cosmetic treatments on the face within the last three months. Thread embedding treatments on the face within the last year, excluding thread blepharoplasty. Patients with severe insomnia or those requiring intense sun exposure within the next three months. Patients deemed unsuitable for participation by the investigator. Those unable to cooperate with the treatment and complete all required visits. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 25 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: Healthy women who age naturally - SamplingMethod: Non-Probability Sample
Pelvic Neuro-Angiogenesis in Deep Endometriosis
Status: Recruiting

Endometriosis is observed in one out of every ten women in society, causing endometrial cells to be found outside their normal location in the body and proliferate in other locations, leading to fibrosis in the tissue due to the secretion of various factors from the cells. Additionally, the substances secreted by the cells can cause various other changes in the tissue besides fibrosis. Increased neurogenesis and neovascularization are among the primary changes, which occur as a result of the secretion of substances from the cells. Increased neovascularization, neurogenesis, and fibrosis in the tissue lead to the formation of nodular structures in the pelvic region, resulting in pain development in women.

Nodular formations in the pelvic region due to endometriosis are especially observed in the rectovaginal space. Despite being small in size, they can induce increased neovascularization and neurogenesis even in healthy peritoneal tissue due to the microenvironment they create, leading to different clinical symptoms clinically. However, it is not known how far these changes occur around the endometriotic nodule in the presence of endometriosis.

In this project, in patients operated on due to endometriosis, the density of nerve and vascular structures in the surgical margins of the peritoneal tissue excised along with the nodule, and the synthesis and release of chemical mediators causing pain (e.g., Bradykinin, Substance-P) are evaluated. The aim is to determine the minimum surgical margin where excision should be applied in surgery and to demonstrate any endometriotic changes that may exist in the tissues, even though they may appear macroscopically healthy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with suspicion of deep endometriosis (Physical Examination and MRI) Patients with ineffective response to medical therapy Patients who undergo laparoscopic conservative endometriosis surgery (douglasectomy)  Exclusion Criteria:  Patients with malignity suspicion Patients with extensive surgery (hysterectomy, ovariectomy) Patients with previous endometriosis or another pelvic surgery Patients with oocyte pick up procedure history Patients with pelvic inflammatory disease history - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult
Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK)
Status: Recruiting

Kinocardiography (KCG) is a portable measurement technique developed to estimate cardiac mechanical performance by studying the vibrations produced by myocardial contraction during each heartbeat and transmitted to the body surface.

The goal of this observational study is to learn about kinocardiography in patients with aortic valve disease (AVD) or thoracic aortic aneurysm (TAA). The investigators believe that this technology will enable us to diagnose aortic valve disease and aortic aneurysm.

In patients with AVD of different severities or TAA, the investigators will collect informations from echocardiography and/or cardiac magnetic resonance imaging and KCG recordings. Researchers will also compare subjects without any AVD nor TAA to better understand these effects on KCG.

Eligibility:
- EligibilityCriteria: Inclusion Criteria  "Interventional treatment" group  Adults (>18 y) Interventional treatment indication for severe AVD and/or severe TAA, as decided by the Heart Team  "Aortic valve disease of different severities" group  Adults (>18y) Aortic stenosis and/or aortic regurgitation and/or bicuspidy of different severities confirmed by echocardiography and/or cardiac MRI "Control" group : - Adults (>18 y) appariated with the participants of other groups according to their age, sex, body surface area and LVEF  Exclusion Criteria:  Any severe rhythm disorder such as frequent ventricular extrasystoles, atrial tachyarrhythmias Subject's disabilty to give consent Subjects suffering from aortic valve disease or thoracic aortic aneurysm will be excluded from the "control" group. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Both inpatients and outpatients may be included in "interventional treatment" group and "aortic valve disease of different severities" group.  "Control" group may include inpatients, outpatients and healthy subjects. - SamplingMethod: Non-Probability Sample
Lifestyle InterVEntion Study in General Practice: LIVES - GP
Status: Recruiting

Patients with depression are at a substantially increased risk of chronic physical disease including cardiovascular disease. This may be attributed primarily to an unhealthy lifestyle related to their disorder. Interestingly, the unhealthy lifestyle feeds back to decreased quality of life and increased depressive symptoms, thus creating a hazardous vicious circle. Consequently, there is a great potential for 'Lifestyle Medicine' for depression. Yet, it is known that patients with depression often have motivational and self-management problems. Therefore an 18 session multimodal lifestyle intervention (MLI) specifically tailored to the needs of depressed patients was developed and piloted in mental health care, with promising results. This research aims to investigate using a process evaluation the feasibility of this MLI in general practice because this is the setting where the majority of patients with depression are treated and results from mental health care are unlikely to apply.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of depressive symptoms or depressive disorder in the past year as registered in the general practice electronic health record and coded according to the International Classification of Primary Care (ICPC) as P03 and P76, respectively, or currently treated for depressive symptoms or depressive disorder in general practice. At least mild depressive symptom level according to the Quick Inventory Depressive Symptomatology-Self-Report (QIDS-SR) (score ≥6) Body mass index ≥ 25 kg/m2 or increased waist circumference (>88 cm (women) of >102 cm (men)).  Exclusion Criteria:  Current treatment in mental health care (GGZ in Dutch) Severe somatic / neurological disease at the discretion of the GP Currently participating in another lifestyle intervention Insufficient proficiency in Dutch Inability to read and write - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Music Therapy in Acute Leukemia Patients With Fatigue
Status: Not yet recruiting

The objective of this study is to assess the efficacy of employing music therapy in alleviating fatigue and medical laboratory values among patients with acute myeloid leukemia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed with acute myeloid leukemia by a clinical specialist. Patients undergoing chemotherapy for the first time. Aged 18 years or older, capable of communicating in Mandarin or Taiwanese. Normal hearing ability. No history of psychiatric disorders and clear consciousness. Participants with no prior involvement in any intervention studies related to fatigue management. Demonstrates understanding of the research objectives, willingly participates in the study, and completes the informed consent form. Willing to cooperate with study procedures throughout the research period.  Exclusion Criteria:  Severe hearing impairment. Individuals with unstable vital signs or altered consciousness. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Cold Oxygen Lung Preservation and Ventilation With the "Angel Cooler"
Status: Not yet recruiting

The objective of this feasibility study is to evaluate continuous temperature monitoring, oxygen (O2) concentration and ventilation with positive end expiratory pressure (PEEP) to keep lungs cooled at 4-8 degrees Celsius, with continuous O2 concentration of 100% and inflated with a PEEP of 8-10 during the entire cold ischemic period.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age at least 18 years Subjects who have signed Universal Consent are eligible for participation. Subjects willing to sign the Universal Consent for the use of their lungs in this study.  Exclusion Criteria:  • Explanted lungs of those who have not signed the Universal Consent (UC) or who have declined participation in the UC will be excluded. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult