rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery
Status: Recruiting

Robotic surgical systems have become a promising surgical assistance system, with unique advantages such as 3D high-definition visual system, highly flexible wrist-jointed instruments, and automatic fitering of hand tremors. Robotic surgical systems is applied in various fields including urology, general surgery, cardiothoracic surgery, head and neck surgery, and gynecology. Currently, the Da Vinci surgical robot system is the most widely used robot system globally. However, the Da Vinci robot system for single-port laparoscopic surgery has not yet been launched in China. Therefore, the investigators conduct a prespective, single-center study to evaluate the efficacy and safety of single-port surgical robot system in thoracic surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age between 18 and 75 years, regardless of gender. Patients who require endoscopic surgical treatment and have indications for lung segment/lobe resection; for pre-trial subjects, there is no restriction on the type of procedure, and inclusion is based on the investigator's judgment of having indications for thoracic surgery. Preoperative ASA classification of I-III. Voluntary participation in the clinical trial and willingness to provide informed.  consent, either by the subject or their guardian.  Willingness to cooperate and complete trial follow-up and related examinations.  Exclusion Criteria:  Patients with a history of thoracic surgery or previous history of other malignant tumors deemed unsuitable for inclusion by the investigator. Patients with severe comorbidities (cardiac, pulmonary, hepatic, cerebral, renal diseases) or physical weakness who cannot tolerate general anesthesia or surgery. Patients with severe bleeding tendencies or coagulation disorders. Patients in the active phase of infectious diseases or with other severe non-communicable infections. Patients positive for Human Immunodeficiency Virus (HIV) antibodies or syphilis seropositive patients. Patients with a suspected or confirmed alcohol, drug, or substance addiction. Patients with a history of epilepsy, mental illness, or cognitive impairment. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period. Participation in other interventional clinical trials within 3 months prior to signing the informed consent form. Other situations in which the investigator deems inappropriate for participation in this clinical trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Duration of Music Interventions and Pain Tolerance (DOMINANT)
Status: Not yet recruiting

This study will investigate the effect of different durations of music interventions (1, 5 and 20 minutes of music) on pain tolerance.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Between 18 and 64 years of age Sufficient knowledge of the Dutch language to understand the study documents (in the judgement of the attending physician or researcher) Provision of written informed consent by subject  Exclusion Criteria:  Significant hearing impairment Current complaints of tinnitus Current use of analgesic medication Presence of acute or chronic pain History of cardiac disease or arrhythmias Current treatment by a medical specialist or general practitioner Professional musician or singer (practicing in average >1 hour each day) Pregnancy - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 64 Years - StdAgeList: Adult
Midline Restoration After HYbriD Hernia RepAir Surgery (HYDRA)
Status: Not yet recruiting

The goal of this observational study is to learn about the functioning of the abdominal wall in patients who underwent hybrid (open- and laparoscopic) incisional hernia repair. The main objective is to assess the anatomical restoration and function of the linea alba one year after surgery by ultrasonography and mean peak torque during trunk flexion using a BioDex machine.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years or older Scheduled for elective HYDRA-surgery Midline incisional hernia larger than 4 centimetres in mean width Sufficient knowledge of the Dutch language to be able to understand and fill in the questionnaires Signed informed consent form by patient  Exclusion Criteria:  Pregnant at inclusion Inclusion in other trials with interference of the primary and secondary endpoints American Society of Anesthesiologists Classification (ASA Classification) > 3 Hernia defect larger than 10 centimetres in mean width Incarcerated hernias or emergency procedure Unable to perform a trunk flexion Incapacitated patients - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients scheduled for Hybrid repair of their incisional hernia - SamplingMethod: Non-Probability Sample
Red Cell Distribution Width as a Predictor for Post Operative Atrial Fibrillation After Open Heart Surgries
Status: Not yet recruiting

In this study we investigate the correlation between RDW and POAF, as we use the RDW as a predictor for inflammation for prediction of POAF

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient aged 35-65 years of both sex Scheduled for open heart surgery with cardiopulmonary bypass machine used with preoperative Normal sinus rythm  Exclusion Criteria:  Echo showing left atrial diameter above 4 cm Patient on rythm control medications Patient undergoing emergency surgery History of cardiac tachyarrythemia - HealthyVolunteers: No - Gender: All - MinimumAge: 35 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patient undergoing open heart surgery with cardiopulmonary bypass used intraoperative, with no history of cardiac tachyarrythemia and not using rythm control drugs with normal cardiac dimensions - SamplingMethod: Non-Probability Sample
Alpha Lipoic Acid in Pediatrics on Hemodialysis
Status: Not yet recruiting

The goal of this clinical trial is to test alpha lipoic acid in children undergoing hemodialysis. The main questions it aims to answer are:

Will the use of alpha lipoic acid lower cardiovascular events in that population?
Is the incidence of those cardiovascular events linked to the oxidative stress and endothelial dysfunction in that population?
Will the drug cause side effects?

Participants will:

take either one dose daily of 600mg tablet Alpha lipoic acid orally or a look-alike tablet containing no drug.
be monitored for the occurrence of cardiovascular events (stroke, angina, etc.)
be monitored for the occurrence of side effects
give blood samples for testing serum levels of E-selectin biomarker and superoxide dismutase enzyme
undergo clinical examinations (Echocardiogram, Duplex ultrasonography, Intima-Media-Thickness) Researchers will compare between the group taking alpha lipoic acid and the group taking the look-alike tablet.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Pediatric participants admitted to Pediatric Hemodialysis Unit for regular hemodialysis. The ability to swallow capsules will be enrolled in the study.  Exclusion Criteria:  Participants who suffered from any previous cardiovascular event. Participants suffering from inflammatory diseases or other diseases that may increase oxidative stress. Participants taking supplements that decrease oxidative stress or inflammatory markers Participants with hypersensitivity to alpha lipoic acid Participants who are non-compliant. - HealthyVolunteers: No - Gender: All - MinimumAge: 8 Years - MaximumAge: 16 Years - StdAgeList: Child
A Comparison of Diagnostic Testing Modalities in the Assessment of Asthma
Status: Not yet recruiting

This study aims to assess the concordance of international asthma guidelines in the diagnosis of asthma and explore the presence of airways disease using additional non-guideline physiologic criteria, such as IOS, not included in the guidelines, but available in the Portsmouth lung function service.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The patient will meet all the following criteria to be considered eligible for the study:  Aged 18 years or over. All patients who have attended full asthma workups from November 2021 till date Willing and able to consent to use their data in this study (opt-out form or e-consent). Patients referred to the Portsmouth asthma service for diagnosis and further management of presumed asthma. Comorbidities are common in asthma, thus patients with co-existing conditions such as obesity, bronchiectasis or COPD will be included.  Exclusion Criteria:  The participant may not enter the study if either of the following apply:  Unable to comprehend the study and provide informed consent, e.g., insufficient command of English in the absence of someone who can adequately interpret. Patients with other primary respiratory conditions, such as ILD. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: The study population will consist of patients referred for specialist review from primary care and needing specialist review after emergency admission. This research will utilise historical and contemporary data from pulmonary function tests performed during the asthma workup at the Queen Alexandra Hospital, Portsmouth. The tests will include FeNO, Skin prick tests, Impulse Oscillometry, Spirometry, Gas transfer, lung volumes and Bronchodilator reversibility. - SamplingMethod: Non-Probability Sample
The Effect of Education and Reminder Messages on the Fatigue Level of Individuals With COPD
Status: Recruiting

COPD is an important respiratory system disease that progresses with damage to the airways.Increased mucus secretion and thickening in the airways causes obstruction.This obstruction causes symptoms such as shortness of breath, cough, phlegm and wheezing.The most obvious problem that the emerging symptoms will cause for the patient is fatigue.Coping with fatigue is an important problem in COPD.

The main questions it aims to answer are:

Does the training given in COPD affect the level of fatigue?
Do the education given and text messages sent regarding COPD affect the level of fatigue?

In this study, patients were given informative education about COPD and ways to cope with fatigue were explained. Then, in order to increase the permanence of the training, motivational messages and short briefings were continued for 8 weeks.2 messages were sent per week. Three groups were created to reveal the effectiveness of the trainings and messages.

Group 1 was trained and messages were sent for 8 weeks. Group 2 was trained and no message was sent. Group 3 is the control group. No training has been provided other than routine maintenance.

The initial information of all groups was taken again at the end of the 8th week.

Main outcomes:

Dyspnea severity,
COPD general conditions and
Fatigue level. The results obtained will be interpreted by comparing between 3 groups.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed with COPD for the last 1 year Hospitalized for at least 3 days, Voluntary patients  Exclusion Criteria:  Under 18 years old Over 85 years old Those with chronic fatigue syndrome Those with severe heart failure Those who had surgery in the last 6 months - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
Efficacy of Phentolamine in Prevention of Contrast-Associated Acute Kidney Injury After Complex PCI
Status: Not yet recruiting

To evaluate the efficacy and safety of phentolamine in prevention of CA-AKI following complex PCI in patients at high risk of CA-AKI.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients admitted to CCU with CAD. Patients underwent successful complex PCI defined as multivessel disease, more than two lesions, high coronary lesion complexity, chronic total occlusion, lesion length >30 mm, or bifurcation. Patients at high or very high risk for CA-AKI based on Mehran-2 CA-AKI Risk Score (Model 2).  Exclusion Criteria:  Patients with end stage renal disease on regular dialysis. Patients with failed PCI revascularization. Patients presented with STEMI and underwent primary PCI. Patients presented with high risk NSTEMI defined as elevated cardiac enzymes with chest pain refractory to medications and/or dynamic ST changes. Patients presented with cardiogenic shock. Patients presented with any degree of heart block. Patients with of history of asthma or hypersensitive for phentolamine. Patients on α-blockers, barbiturates or antipsychotic treatment. Patients intolerant to phentolamin with significant hemodynamic changes defined as >20% drop of systolic blood pressure (SBP) or >20% increase of heart rate (HR) after loading dose of phentolamine. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome
Status: Recruiting

The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:

the efficacy of Virtual Reality Therapy in the rehabilitation of patients with dysphagia in Wallenberg syndrome.

Participants received conventional dysphagia treatment and Virtual Reality Therapy once a day for 14 days. Researchers compared the control group to see the effect and mechanism of Virtual Reality Therapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age ranged from 18-85 years and right-handed; first onset, vital signs stable and conscious; the dysphagia confirmed by videofluoroscopic swallowing study; no cognitive impairment, the mini-mental state examination score: >17 for those with an illiterate education, >20 for those with an elementary education, and >24 for those with a secondary education and above; cranial integrity without craniotomy and/or craniectomy; patient and/or his/her relative agrees and signs written informed consent.  Exclusion Criteria:  combined ischemic foci at other sites; presence of organic swallowing dysfunction or pre-existing dysphagia due to Parkinson's disease, dementia, and others; severe cardiac, pulmonary, hepatic, and renal insufficiency and vital organ failure; infected or broken skin on the head; poorly controlled epilepsy; poor patient compliance. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control
Status: Recruiting

The main objective is to estimate the annual symptomatic incidence of Bordetella pertussis and RSV infections in patients aged 18 years and over with asthma, which will be identified by PCR, for Bordetella pertussis and by PCR for RSV performed at a specific timepoint from onset of symptoms for each symptomatic Acute Respiratory Infection (ARI).

A multicentre prospective cohort study will be undertaken in Spain. Thirty-five centres from different autonomous communities in Spain will participate in the study.

Participants will be asked to report to the investigator if they experience an asthma exacerbation or symptoms of acute respiratory infection with 2 years follow up

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult patient (age 18 years and over) Diagnosed with asthma at least one year prior to the date of enrolment. Patients who, in the opinion of the investigator, can and will comply with the requirements of the study protocol for the duration of the follow-up period (e.g. agree to provide samples for testing, able to attend for testing upon asthma exacerbation and/or ARI symptoms occurring) Patients who are able to provide written informed consent.  Exclusion Criteria:  Patients with a prior history of pertussis in the last 12 months Patients with ARI within the 2 weeks prior to enrolment Patients who have another respiratory disease other than asthma, alcohol or drug abuse at the time of being included in the study, or an active oncological disease (patients in treatment or follow-up for oncological disease) or pregnant women. Patients treated with immunosuppressive or immunomodulating agents not related to asthma diagnosis. will be excluded. Patients vaccinated for RSV will be also excluded (NOTE: -Patients that have received an RSV (investigational) vaccine or medicine for any of the above, should be excluded from the study from the beginning. Patients that might be vaccinated in the upcoming years, while the study is still ongoing, can enrol. However, from the moment they receive a vaccine, they should be excluded and no additional data will be collected. Data collected during the study up until the time of vaccination will still be included in the analysis). Patients vaccinated for B. Pertussis during the previous 12 months will be also excluded. Patients who plan to move during the study period will be excluded. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Consecutive adult patients (18 years and over) with asthma diagnosed at least one year before will be enrolled from the asthma clinics of selected hospitals.  Every group (at each participating site) should include 35% of patients over 60 years old considering that this age-group has higher risk of infection and worse prognosis than the younger one. - SamplingMethod: Non-Probability Sample
Complications of High Frequency Jet Ventilation
Status: Not yet recruiting

High frequency jet ventilation (HFJV) has been introduced in 1967 as technique allowing ventilation with simultaneous access to the airway for bronchoscopy. Continuous improvement in the technique has led to a large use during interventional bronchoscopy, especially in large centers. However, complications occuring during the use of HFJV are poorly known. In this retrospective cohort study, the charts of all patients who had a bronchoscopy with the use of HFJV between 2019 and 2023 in our hospital will be analyzed. Primary outcome will the description of all complications during HFJV. Complications are defined as:

Hypoxia: SpO2 < 90% for 1 min
Severe hypoxia: SpO2 < 85% for 1 min
Hemodynamic instability, defined as Arterial pressure < 90/60
Cardiac arrhythmia
Laryngospasm or bronchospasm
Barotrauma or volutrauma
Need for ICU admission

A model predicting the risk for developing any complication will be developped using 2 mathematical methods:

a multivariate analysis
a data mining approach

For both approaches, the following variables will be included in the model:

Age
Gender
Weight
Height
BMI
Smoking
Alcohol consumption
Consumption of Other drugs
ASA class
Obstructive pulmonary disease
Restrictive lung disease
COPD status (1, 2, 3, 4)
Interstitial lung disease

Lung tumor

Trachea location
Carina location
Bronchial location
Pulmonary or tracheal stenosis
Presence of stridor
Severe stenosis (< 6 mm)
Baseline SpO2 (pre-intervention)
Pre-intervention oxygen requirement Procedure
Duration (min)
Stent placement
Dilation
Laser treatment
Length of hospital stay Lung function tests
FEV1 (forced expiratory volume)
VC (Vital Capacity)
FEV1/VC (Tiffeneau ratio)
CPT (total lung capacity)
DLCO (carbon monoxide diffusion)

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All patients who underwent a bronchoscopy with the use of high frequency jet ventilation between January 1st, 2019 and December 31st, 2023 at Erasme University Hospital, Brussels  Exclusion Criteria:  Incomplete medical chart Patient who expressed their opposition to the use of their medical data - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All patients who underwent a bronchoscopy with the use of high frequency jet ventilation - SamplingMethod: Non-Probability Sample
Retrospective Study Chimaera Long Nail in Adult Patient
Status: Recruiting

The CHIMERA study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The patient expressed his willingness to participate in the Study by signing and dating informed consent. Patients who had a regular indication for surgical intervention with the long variant of CHIMAERATM according to the manufacturer's IFU. Patients equal or older than 18 years at the time of surgery. Patients who underwent surgery performed with CHIMAERATM. Patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study.  Exclusion Criteria:  Patient who had/has a medical condition that is a contraindication according to the manufacturer's IFU leaflet. Patient has been diagnosed with bilateral proximal femur fractures. Patient who needed the application of, or ha already in-situ a concomitant not permitted device which cannot be safely removed. Patient with other concurrent medical or non-medical condition that in the opinion of the participating investigator may prevent participation or otherwise render the patient ineligible for the study. The patient is participating in other clinical studies, or he/she has participated in other clinical studies in the 3 months prior signing the informed consent . - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adults suffering from pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur, where the usage of Orthofix® Chimaera Hip Fracture SystemTM (from now on CHIMAERATM) was part of the normal clinical practice. - SamplingMethod: Non-Probability Sample
The DREAM Study: A Multidimensional Sleep Health Intervention for Reducing Cardiometabolic Health Inequities
Status: Recruiting

The purpose of this randomized controlled trial is to evaluate the impact of a multidimensional sleep health promotion intervention on blood pressure, glycemic control indicators, anthropometric markers of adiposity, and lifestyle factors in Hispanic/Latina/o/x adults. Participants will be randomized into an intervention or a control group. The control arm will receive standard Life's Essential 8 cardiovascular health educational materials. The intervention arm will additionally receive a multi-component intervention aimed at improving sleep health based on evidence-based sleep hygiene education and established behavior change techniques that include personalized sleep health feedback, goal setting and establishing a sleep health plan, coaching, self-monitoring, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation determinants, processes, and outcomes, ensuring the successful completion and future expansion of this intervention.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults aged 30-65 years Hispanic/Latina/o/x ethnicity English or Spanish speaking Systolic blood pressure greater than or equal to 120 mmHg Sub-optimal sleep health No history of overt cardiovascular disease No history of cancer  Exclusion Criteria:  Optimal sleep health History of cardiovascular disease or cancer Non-English or non-Spanish speaking Not cognitively able to complete study requirements Severe psychiatric disorders Inability to provide informed consent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 30 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult