rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
FibriCheck Data Registry
Status: Recruiting

The goal of this interventional clinical trial is to establish a comprehensive, structured database that includes photoplethysmography (PPG) measurements with simultaneously recorded electrocardiography (ECG) data to evaluate the FibriCheck Algorithm in patients with heart rhythm disorders.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  At least 18 years old Access to a smartphone to perform daily measurements Ability to understand Dutch  Atrial Fibrillation diagnosis OR one of the following:  CHA2DS2-VASc score ≥2 (male) or ≥3 (female) Underwent elective cardiac surgery  Known with:  Chronic obstructive pulmonary disease Obstructive sleep apnea Heart Failure Hypertension Previous stroke or transient ischaemic attack Having palpitations and/or racing heart as symptoms Other arrhythmia such as atrial flutter, premature atrial contractions (PAC), premature ventricular contractions (PVC)  Exclusion Criteria:  Individuals which are currently in follow-up with their physician, using the FibriCheck application Individuals with unnaturally coloured fingers (i.e. tattoos, ink); this may weaken the signal and may interfere with the effectiveness of the device Persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. Parkinson or dementia) as, in this case, the device may not be able to accurately process a measurement Persons with reduced blood flow in the fingertips (e.g. perniosis or severe callus formation) as the device may not be able to detect the intensity variations induced by the blood flow Persons that have a disability to perform the measurements according to the instructions for use Persons with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can control the natural heart rhythm - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Fibricheck Detection cApabilities for Atrial Fibrillation
Status: Not yet recruiting

Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  At least 22 years old; Capable of independently performing FibriCheck recordings (researcher-observed); Cardiology patients, hospitalized/in-clinic or consulting the cardiac outpatient clinic, with or without a diagnosis of atrial fibrillation.  Exclusion Criteria:  Individuals with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can influence the natural heart rhythm; Individuals enrolled in another clinical trial; Individuals with physical or medical characteristics that prevent them from successfully taking a measurement e.g. extreme callus (i.e., rough or thickened area of skin fingertip), tremor, cognitive impairment, Parkinson's disease; Pregnant and/or nursing women. - HealthyVolunteers: No - Gender: All - MinimumAge: 22 Years - StdAgeList: Adult, Older Adult
Telemedicine for Postoperative Follow-up After Oncological Surgeries
Status: Not yet recruiting

The study will be a prospective, randomized, non-inferiority, open-label study, to be carried out at the Cancer Institute of the State of São Paulo for 6 months and will include patients agreeing to voluntary participation upon signing an informed consent form.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All patients with urological neoplasms who have undergone low and medium complexity surgical procedures (e.g. prostate TUR, Bladder TURP, double-J passage, partial or total nephrectomy videolaparoscopic and open) at ICESP  Exclusion Criteria:  All patients undergoing emergency operations, outpatient procedures, major procedures, patients with probes or drains or no support for home telemedicine - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Oncologic patients from the ICESP - SamplingMethod: Non-Probability Sample
Fatigue and Recovery: a Comparison Between Trail and Marathon
Status: Recruiting

Road marathon is a famous running race known for hundreds of years. Trail running is an emerging running discipline which count new runners every year. Trail running and road marathon are two running endurance disciplines which differed by variation of elevation and nature of the terrain. While marathon is essentially run on flat roads, trail races are realized on steep paths (mountain, desert…) with an important variation of elevation. Neuromuscular, biomechanical and physiological consequences are different depending on the discipline, especially with a greater eccentric contribution in trail running. In spite of this characteristic, trail runners take part in several races longer than 40 km per year, while road runners participate in one to two marathons per year.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Common for MARASIM, TRAILSIM and TRAILNAT:  Male or female 18-55 years old Endurance runners who run at least one running session of 20 km per week Being able to run a marathon under 5 h or finishing a trail of 30 km during the last 3 years Refrain from participating to a competition one month before the first visit and during the duration of the study To have a medical certificate of no contraindication of running practise in competition Registered with a social security scheme Having given the written consent freely  Specific for the 3 groups :  Specialist of trail running (TRAILSIM and TRAILNAT) Specialist of road running (MARASIM)  Exclusion Criteria:  Subjects who present cardiac or articular chronic pathologies (example: repeated sprain, patellar or joint problems) Subjects who present chronic or central neurological pathologies Subjects deprived of liberty or who should be legally deprived Subjects who report to take forbidden products by the World Anti-Doping Agency pregnant or breastfeeding woman - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness
Status: Not yet recruiting

An open-label, randomized by school, two-arm pragmatic trial, will be conducted involving two study sites in Sub-Saharan-Africa (SSA), Ghana and Kenya, to evaluate safety and effectiveness of the newly developed fixed dose combination (FDC) of albendazole (ALB) and ivermectin (IVM) as a single dose to treat Soil-Transmitted Helminths (STH), compared to the standard dose ALB single dose for the treatment and control of STH (REALISE study: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness). The general objectives are to validate the benefits of FDC through this pragmatic trial in a context of mass drug administration (MDA) programme to evaluate the safety as a primary endpoint and effectiveness profile as a secondary endpoint, in a large population of school-aged children.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Individuals of both sexes that attend the selected schools in the trial areas in Ghana and Kenya that meet the following criteria:  Age: 5 to 17 years old (included). Height: over 90cm. Parental acceptance to participate in the study by obtaining written informed consent approved by the Ethics Committee. Written assent will also be obtained from children according to the local national legislation. (In Kenya written assent will be obtained from children 12-17 years old and in Ghana for children 15-17 years old.)  Exclusion Criteria:  Epidemiological risk of being infected by Loa loa. Serious medical illness, per investigator's criteria. Any condition prevents the appropriate evaluation and follow-up of the participant, per the investigator's criteria. Known hypersensitivity to any component of either study treatment. Pregnant or first week post-partum, reported by the participant during interview. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 5 Years - MaximumAge: 17 Years - StdAgeList: Child
Effect of Isometric and Aerobic Physical Exercise on Blood Pressure Levels in Hypertensive Elderly People
Status: Recruiting

Introduction: Adequate blood pressure control is necessary to reduce the risk of mortality from cardiovascular events. The effects of aerobic exercise on systemic arterial hypertension are already well known, however, to date, there is little evidence regarding the effect of an isometric exercise session for the lower limbs on blood pressure levels, especially when performed in elderly hypertensive individuals. Objective: To verify the effect of an isometric or aerobic exercise protocol for the lower limbs on 24-hour ambulatory blood pressure in elderly hypertensive individuals.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Hypertensive elderly; Both genders; Aged ≥ 60 years; Hypertensive patients on continuous use of antihypertensive medication; Hypertensive who did not practice physical exercise regularly (≥ 2 sessions per week).  Exclusion Criteria:  Those who presented one of the following issues will be excluded: Diabetes mellitus; Chronic renal failure; Body mass index (BMI) ≥ 35 kg/m2; Coronary artery disease; Heart failure; Any injury to the lower limbs; Smokers. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants
Status: Not yet recruiting

The goal of this study is to investigate the preferential responses of speech neural systems in infants.

The main question it aims to answer is to determine whether the oscillatory synchronization capacity is associated with children's language level (i.e. vocabulary).

Participants will be presented with synthetically modulated stimuli at three frequency scales: 4 Hz, 5 Hz and 30 Hz.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  be 6 or 10 months old (+/- 2 weeks) have received age-appropriate information on the experiment their legal guardians have received appropriate information and given their oral consent.  Exclusion Criteria:  A neurological disorder (visual, auditory, motor, executive) Developmental delay - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 6 Months - MaximumAge: 10 Months - StdAgeList: Child
Seeing the Light: Early Intervention in People at Risk for Bipolar Disorder
Status: Not yet recruiting

In the current study, the feasibility, acceptability and effectivity of a new add-on early intervention program for individuals at risk for the development of bipolar disorder is evaluated. This intervention program entails psycho-education, light and lifestyle therapy in combination with Imagery focused Cognitive Therapy (ImCT). The program aims to contribute to early intervention by focusing on subclinical mood swings, anxiety symptoms, circadian rhythm and lifestyle factors such as activity level. We hypothesize a relationship between this early intervention and a significant improvement in mood symptoms, anxiety, subjective and objective sleep factors and lifestyle variables. Also, the feasibility, acceptability and associations with clinical improvement of symptoms will be studied.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Must be bound to start the early intervention treatment being evaluated Aged 16-35, or > 35 by indication of the patients' treating clinician Found to be at risk for SMI, as determined by the Early Detection and Intervention Team of GGzE Sufficient knowledge of Dutch or English language Ability to give informed consent Willing to complete daily monitoring throughout the duration of the study  Exclusion Criteria:  Learningdifficulties,organicbraindiseaseorsevereneurologicalimpairment. Previously received BLT (less than 3 weeks prior to study entry Current severe substance or alcohol misuse (clinicians' assessment) In case of BLT: eye problems contraindicating BLT and/or being unable to visit the GGzE - HealthyVolunteers: No - Gender: All - MinimumAge: 16 Years - MaximumAge: 35 Years - StdAgeList: Child, Adult
Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study
Status: Recruiting

The main aim of the study is evaluate quality of life and motor performance of patients with soft tissue sarcomas undergoing surgical treatment and post-operative rehabilitation treatment.

Primary objectives:

Identification of clinical characteristics and motor damage after surgery for soft tissue sarcomas;
Impact of perioperative treatments and surgery on the quality of life of patients with soft tissue sarcomas;
Impact of post-operative rehabilitation treatment on quality of life and recovery of motor activity The primary endpoint will be the improvement in the Toronto Extremity Salvage Score (TESS) between T1 (post-surgery) and T3 (at the end of rehabilitation treatment).

Secondary endpoints will be:

1. the evolution over the various timepoints of the selected rating scales (Toronto Extremity Salvage Score, Musculoskeletal Tumor Society Rating Scale, Numerical Rating Scale, Brief Pain Questionnaire, Douleur Neuropathique en 4 Questions, Leeds Assessment of Neuropathic Symptoms and Signs Scale, European Organization for Research and Treatment of Cancer, Quality-of-Life Questionnaire (QLQ)-C30, Short Form Health Survey 36);

• The change in walking performance before and after the rehabilitation treatment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - Adult patients affected by primary localized soft tissue sarcoma, candidate to limb/trunk surgery with wide excision or retroperitoneal resection (including resection of the iliopsoas muscle with possible damage to the femoral nerve) with curative intent.  Exclusion Criteria:  Patients with recurrent tumors; patients with metastatic disease; patients with palliative surgery; patients with amputations. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Patients candidates for surgery for soft tissue sarcoma and undergoing post-operative rehabilitation treatment. - SamplingMethod: Non-Probability Sample
Application of Augmented Reality Neuronavigation in Transnasal Endoscopic Skull Base Surgery
Status: Not yet recruiting

"For lesions in the skull base, including meningiomas, chordomas and pituitary tumors, endoscopic surgery has replaced traditional microscopes as the mainstream procedure. Although neurosurgeons can enlarge the surgical area using a neuroendoscope, it does not provide any information on the morphology and location of anatomical structures beneath visible surfaces. Due to the complex anatomical relationships of adjacent structures in the skull base, lesions occurring here are often located deep within anatomy that is difficult to fully expose and remove with endoscopic surgery alone. Especially when dealing with larger tumors that surround major arteries and nerves, limited visibility at surface level can easily damage blood vessels or nerves causing complications such as bleeding during or after surgery, deformities or functional impairments. The purpose of this study is to explore how augmented reality (AR) technology can highlight important anatomical structures in a neuroendoscope's field of view to optimize surgical visibility beyond what is possible with just an endoscope alone. This will make it easier for surgeons to distinguish deeper anatomical structures and reduce intraoperative and postoperative complications associated with endoscopic surgery."

Eligibility:
- EligibilityCriteria: Inclusion Criteria：  Patients who are suitable for Transnasal endoscopic surgery 。 Patients who have performed thin-layer head MRI and CTA scans before surgery.  Exclusion Criteria：  Patients without clear preoperative imaging data. Patients who do not agree to receive the assistance of AR fusion neuroendoscopy. Patients with incomplete medical records. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult
the Efficacy and Safety of Ondansetron Oral Soluble Pellicles
Status: Recruiting

The name of this prospective study is a multicenter, open-label, randomized controlled clinical study of the efficacy and safety of Ondansetron Oral Soluble Pellicles for the prevention of delayed nausea and vomiting induced by highly emetogenic chemotherapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥18 years, gender is not limited; Histologically or cytologically confirmed diagnosis of malignant solid tumor; Initial highly emetogenic one-day chemotherapy regimen (cisplatin dose 60-75 mg/m2; anthracycline compound adriamycin ≥ 60 mg/m2 or epothilone ≥ 90 mg/m2 ); and Nausea and vomiting prophylaxis with a triple regimen of fosaprepitant + ondansetron orally dissolved membrane + dexamethasone started before chemotherapy; Expected survival ≥ 3 months; Eastern Cooperative Oncology Group (ECOG) physical status score ≤2; Patients were able to read, understand, and complete study questionnaires; Patients understood the study procedures and signed a written informed consent form  Exclusion Criteria:  Patients scheduled to receive multiple days of highly emetogenic chemotherapy within one week; Patients using an antiemetic drug other than the study drug or a drug with an antiemetic active ingredient within 48 h prior to initiation of randomization and/or within one week of enrollment; Symptoms such as vomiting prior to randomization; Patients on opioid therapy (except stable dose administration); Patients treated with a chemotherapy regimen containing generic paclitaxel (using castor oil as a solvent); Patients who have received, or are expected to receive, radiotherapy to the abdomen (including the diaphragmatic plane and below) or pelvis within 1 week before randomization or one week after enrollment; Patients with active infection (e.g., pneumonia) or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) other than malignancy; The patient has participated in another clinical trial within the past 4 weeks; Any condition that, in the judgment of the investigator, is unstable or may jeopardize the safety of the subject and his or her compliance with the study; Pregnant or lactating females; Presence of allergic conditions or prior serious adverse reactions to the study drug and excipients; Suffering from psychological, familial, social, or geographic conditions that may prevent compliance with the study protocol and follow-up schedule; - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Consequences on the Gait Pattern of Patients With Distal Femur Megaprostheses
Status: Recruiting

The primary aim of this study is to compare spatiotemporal gait parameters between participants with distal femur tumor prostheses and healthy individuals without prostheses.

Eligibility:
- EligibilityCriteria: Inclusion Criteria (cases group):  Megaprosthesis of unilateral distal femur Tumor cause Ambulation capacity  Exclusion Criteria (cases group):  Neurological alterations prior to the inervention than affect the lower limbs or general movement Patient incapable of ambulation due to progression of his/her pathology Patient with palliative treatment for advanced tumor diseas More than one ipsilateral or contralateral prosthesis Infection, traumatic or sequel to revision surgery cause - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 16 Years - MaximumAge: 99 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Cases: Patients with megaprosthesis of the distal femur due to tumor treated at Hospital Universitario la Fe.  Controls: Healthy volunteers - SamplingMethod: Non-Probability Sample
SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy
Status: Not yet recruiting

The goal of this single blind placebo-controlled intervention study is to examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care. The main question[s] it aims to answer are:

What is the impact of exercise on quality of life
What is the impact of exercise on physical fitness

Participants will have an individual training program with supervised training by physiotherapists.

Researchers will compare with usual care to see if advice about exercise has significant less effect than an supervised training program.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Signed informed consent Age > 18 years old Able to read and complete questionnaires in Dutch Proven histologically and /or radiologically metastatic prostate cancer (TxNxM1)  Exclusion Criteria:  Other cancers Clinicians' judgement Age >80 years old or not able to walk 400m Structural exercise (moderate-intensity exercise more than 150 minutes a week) during the past 3 months Musculoskeletal, cardiovascular, or neurological disorders that could inhibit them from exercising Spinal cord compression, history of pathological fractures - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)
Status: Not yet recruiting

The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Must have given written informed consent before any study-related activities are carried out. Adult males and females, 18 to 75 years of age (inclusive) at Screening. Weight range between 40-120 kg at Screening.  Diagnosis of gMG by the following tests:  Acetylcholine receptor antibody (AChR Ab) positive, and  One of the following:  i. History of abnormal neuromuscular transmission test; ii. History of positive anticholinesterase test; iii. Clinical response to acetylcholinesterase inhibitors.  Myasthenia Gravis Foundation of America (MGFA) Class II-Iva Myasthenia Gravis Activities of Daily Living (MG-ADL) score of 6 or more Vaccination against N. meningitidis with the quadrivalent meningococcal vaccine, and where available, meningococcal serotype B vaccine within 3 years prior to, or at the time of, initiating study drug.  Female participants must:  Be of nonchildbearing potential, or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.  Male participants must be surgically sterile for at least 90 days prior to screening or agree not to donate sperm  Exclusion Criteria:  History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant Prior history (at any time) of N. meningitidis infection. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies during Screening. Any thymic surgery/biopsy within 1 year of Screening. Any known or untreated thymoma. Any history of thymic carcinoma or thymic malignancy.  Concurrent or previous use of the following medication within the time periods specified below.  Rituximab within 6 months (180 days) prior to randomization (Day 1); Intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28 days) prior to randomization (Day 1). Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult