rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Acute and Long-term Effects of CPAP in OSA
Status: Recruiting

Two-phase interventional non-inferiority trial (phase 1: at least 8 weeks of CPAP; phase 2: 2 weeks of CPAP withdrawal) including 32 patients with moderate to severe OSA to compare the physiological consequences of a short-term CPAP withdrawal to the changes in previously untreated OSA. The trial has been designed as a validation of the CPAP-withdrawal model. Baseline in-laboratory sleep studies will be performed prior to CPAP initiation, after 6-8 weeks on CPAP (treatment effect) and following 2 weeks of CPAP therapy withdrawal (withdrawal effect, effect of OSA recurrence).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years Untreated moderate or severe OSA with an apnoea-hypopnoea-index (AHI) of ≥ 20/h and an oxygen desaturation index (>3%-dips) of ≥ 20/h in an in-laboratory sleep study Epworth Sleepiness Scale Score ≥7/24 points Indication for CPAP therapy Written informed consent  Exclusion Criteria:  Moderate or more severe obstructive or restrictive ventilatory disorder (FEV1 or FVC < 70%) Heart failure Other types of sleep-related breathing disorders, e.g. sleep-associated hypoventilation, central sleep apnoea, Cheyne Stoke's Breathing Hypoxic or hypercapnic respiratory failure (awake paO2 < 9 kPa or paCO2 > 6 kPa) Active treatment for OSA (CPAP, mandibular advancement device, hypoglossal nerve stimulation) Current professional driver or previous sleepiness-related accidents Pregnancy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Effects of Music on Acute Postoperative Pain Intensity and Mobility After Fragility Hip Fracture
Status: Recruiting

Music has been proven to be beneficial in postoperative care by reducing pain. The effects of music listening to reduce pain postoperatively are well studied among cases undergoing elective orthopaedic surgery. No study has been conducted focusing on pain control among cases with fragility hip fractures in an acute ward setting with non-schedule non-elective orthopaedic operation.

In Queen Elizabeth Hospital a standardized analgesic protocol is used for all fragility hip fracture cases unless contraindicated, a suboptimal post-operative pain control is not uncommonly seen. Stepping up analgesics is usually a concern in the elderly with a higher rate of side effects, a safe and simple non-pharmacological intervention for pain control is therefore needed.

The aim of this study is to study the effectiveness of incorporating music on pain intensity and mobility with the standard postoperative rehabilitation care of fragility hip fracture in Queen Elizabeth Hospital.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Emergency admitted to QEH/G9 due to fragility hip fracture (#NOF or # TOF) within the study period Plan for surgical intervention Able to provide written informed consent Able to communicate in Cantonese/ Putonghua/ English  Exclusion Criteria:  History of dementia Acute delirium upon admission Disorientated to time, person or place Concurrent fracture at other sites Utilization of other analgesics on top of pain protocol Appreciable deficits in hearing or vision Hemodynamically unstable Plan for neurolysis/ nerve block as definite treatment or opt for conservative treatment - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult
Curve Correction of Early Onset Scoliosis by Mehta Serial Casts
Status: Not yet recruiting

Assessment of the role of Mehta Serial Casts in Curve Correction of Early Onset Scoliosis

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All cases with Early Onset Scoliosis up to 10 years Age presenting to Assiut University Hospitals during 2 years period .  Exclusion Criteria:  Cases with previous spine surgery and those whose guardians refuse to participate in the study . - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 10 Years - StdAgeList: Child
nVNS for the Prevention and Treatment of Primary Headache
Status: Not yet recruiting

This study was a single-arm, single-center study. Children and adolescents (7-20 years old) with migraine who met the inclusion criteria were enrolled as subjects in the experimental group, and the changes in headache scores before and after the intervention were compared. The intervention method was as follows: ictal intervention, in which subjects were evaluated for headache improvement after a short intervention during an acute exacerbation. By wearing a vagus stimulator, the stimulating electrode was located in the concha region rich in vagus nerve fiber endings, and the appropriate stimulation intensity was adjusted for stimulation. Therefore, this study will verify the effect of nVNS on the acute attack and preventive treatment of primary headache in children and adolescents. Based on the electrocardiogram and electromyography indicators during the intervention process of nVNS, an objective evaluation system for the improvement of headache by nVNS is established, and the role of stimulation parameters on the effect is further explored to realize the optimization of parameters.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with migraine, cluster headache and tension-type headache were diagnosed according to Chinese Guidelines for the diagnosis and Treatment of Migraine (2022 edition) and Chinese Guidelines for the diagnosis and treatment of cluster headache (2022 edition). Age >=7 years old, <=20 years old; Patients have experienced headache on 3-15 days per month in the past; Maintain a stable dose and frequency of medication and do not take new drugs during the course of participating in the trial; They volunteered to participate in the trial and signed informed consent.  Exclusion Criteria:  History of secondary headache, aneurysm, intracranial hemorrhage, brain tumor, severe head trauma, drug abuse, addiction, syncope, or seizures; prior migraine-preventive surgery, cervical vagotomy, or implantation of an electronic or neurostimulator device; Simultaneous use of other devices (e.g., TENS devices, muscle stimulators); An implantable medical device in use, such as a pacemaker, hearing aid, or any implantable electronic device; underwent head and neck nerve block within the past 2 months; Opioid use (more than 2 days per month); Use of analgesics alone or non-steroidal anti-inflammatory drugs (more than 15 days per month); Or tamoxifen, ergots or combination analgesics (more than 10 days per month); Patients who underwent cervical vagotomy (cervical vagotomy); Pediatric patients (under 6 years old); Pregnant women; Patients with clinically significant hypertension, hypotension, bradycardia or tachycardia; Patients with congenital heart disease; Mental/cognitive disorders, etc. - HealthyVolunteers: No - Gender: All - MinimumAge: 7 Years - MaximumAge: 20 Years - StdAgeList: Child, Adult
Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)
Status: Not yet recruiting

This is a long term follow-up study for chronic hepatitis B (CHB) subjects who have received imdusiran treatment in a prior clinical trial, stopped NA therapy during that trial, and remain off therapy. Subjects may enroll after completing the end of study visit (baseline visit within 12 weeks ± 1 week from the end of study [EOS] visit) from their imdusiran clinical trial (the "parent study"). No interventions will be performed in this study other than blood sample collections, review of current medications, and reporting of any adverse events related to study procedures or NA therapy if restarted. Study participation will be for approximately 2 years (to complete a total of at least 3 years of follow-up while off NA therapy, inclusive of parent study participation).

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria:  Have participated in a prior imdusiran clinical trial, Have discontinued NA therapy in that trial and remain off NA therapy, Have completed less than 3 years of follow-up visits after NA discontinuation in the parent study. Have the ability to review and provide signed informed consent which includes compliance with all protocol-specified visit schedules and requirements.  Exclusion Criteria:  Not applicable - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: CHB subjects who have received imdusiran treatment in a prior clinical trial, stopped NA therapy during that trial, and remain off therapy at the end of study visit. - SamplingMethod: Non-Probability Sample
A Phase 3 Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis
Status: Recruiting

Brief Summary: This is a randomized, double-blind study comparing LNK01001 to placebo in Chinese participants with moderately to severely active rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response or Intolerance to biologic DMARDs(bDMARDs).

The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of LNK01001 12 mg twice daily (BID) versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.

The study objective of Period 2 (Week 24 to Week 76) is to evaluate the long-term safety, tolerability, and efficacy of LNK01001 12 mg BID in participants with RA who completed Period 1.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants aged 18 and above. Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months. ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and baseline visit. Erythrocyte sedimentation rate (ESR) ≥ 28mm/h or high-sensitivity C-Reactive Protein (hsCRP) ≥ ULN at Screening. Participants have been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. Have an inadequate response to ≥ 1 bDMARD.  Exclusion Criteria:  Subjects who were prior exposure to Janus Kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib) and have evidence showing an inadequate response or intolerance. Subjects who received intra-articular, intramuscular, intravenous, trigger point or tender point, intracapsular, or intra-tendon injections of glucocorticoids within 4 weeks before randomization. Current diagnosis of systemic inflammatory disease other than RA. History of malignancy or current diagnosis of malignancy within 5 years before screening visit. Uncontrolled diabetes, hypertension, kidney disease, liver disease, severe heart disease. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Effectiveness of iTero Element 5D NIRI System in Early Proximal Caries Detection in Permanent Teeth
Status: Recruiting

As a new emerging technology for the diagnosis of dental caries, near-infrared imaging requires further research and validation to determine its effectiveness. This study aims to compare near-infrared imaging with cone-beam computed tomography (CBCT) and validate the specificity and sensitivity of near-infrared imaging in diagnosing early proximal caries using large-scale clinical data through cross-sectional studies.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Permanent dentition Participants aged 12 and above Patients who have undergone iTero Element 5D oral scanning, as well as CBCT imaging, intraoral photography, and clinical oral examination within 1 week CBCT or iTero Element 5D oral scanning indicating proximal caries  Exclusion Criteria:  The following teeth were excluded:  Third molars Teeth with gross loss of tooth structure Teeth with amalgam fillings and their adjacent teeth Teeth with crown restorations and their adjacent teeth - Gender: All - MinimumAge: 12 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Patients who underwent orthodontic treatment at the West China School of Stomatology. - SamplingMethod: Non-Probability Sample
Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia
Status: Not yet recruiting

Radiation-induced xerostomia (dry mouth) is one of the most common and severe toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. New radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment.

This randomized Phase II study explores the contribution of magnetic resonance imaging (MRI) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. The severity of xerostomia will be measured by patient-reported (PRO) symptoms, saliva secretion, saliva pH, and buffering.

Eligibility:
- EligibilityCriteria: In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Eligibility must be maintained up for the subject to be considered eligible for treatment.  Inclusion Criteria  Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information. Subjects is willing and able to comply with study procedures based on the judgment of the investigator. Age ≥ 18 years at the time of consent. T0-4, N0-3, M0 disease American Joint Committee on Cancer (AJCC 7th or 8th edition) of the oropharynx (this includes patients with head and neck cancer of unknown primary origin, often categorized as T0 disease, who will be treated with radiotherapy to the oropharynx) planned for definitive radiotherapy +/- chemotherapy  5 No contraindications to receiving MRI such as implanted electrical devices, pregnancy, and significant quantities of metal in the head/neck  Exclusion Criteria  Patients with Sjogren's syndrome or baseline xerostomia (CTCAE > 0 for the question regarding dry mouth) Patients with lesions grossly involving the salivary glands Patients with an allergy to lemon juice Prior history of radiation therapy to the head and neck - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Evaluation of Joint Position Sense in Healthy Individuals
Status: Recruiting

It was aimed to measure the elbow joint position sense in healthy individuals in the case of a closed kinetic chain and to compare it with the measurement made in the case of an open kinetic chain.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being between the ages of 18-25 Being healthy Agreeing to participate in the study  Exclusion Criteria:  Those who have had upper extremity surgery within the last year Those with neurological, orthopedic, rheumatic or cardiovascular problems affecting the neck, shoulder, elbow, hand and wrist Those with central and peripheral nervous system involvement Having pain anywhere in the body - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 25 Years - StdAgeList: Adult - StudyPopulation: healthy individuals - SamplingMethod: Non-Probability Sample
An Open-label Randomized Controlled Trial Comparing the Role of Therapeutic Plasma-exchange in Ameliorating Secondary Organ Dysfunctions in Patients With ACLF and Develop Biomarkers of Treatment Response
Status: Not yet recruiting

Rationale: Current understanding of the pathophysiology of ACLF suggests that unresolved injury, poor infection control, and liver regeneration result in persistent systemic inflammation and cytokine storm, which subsequently lead to systemic inflammatory response syndrome (SIRS) resulting in multiple organ failures, septic shock and deaths in ACLF. Nearly 74% of ACLF patients initially diagnosed without SIRS, sepsis, or organ failure developed SIRS by day 7 which increases the onset of secondary organ failure and sepsis with high short-term mortality. The emerging use of plasma exchange has shown some potential benefits in terms of dampening systemic inflammation and improvement of outcomes in some ACLF patients. However, there is currently no randomized controlled trial exploring the potential role in ameliorating secondary organ dysfunctions in patients with ACLF is not known. Hence in the current objective, we want to study the role of plasma exchange in the management of sec. organ failure in ACLF patients in a randomized controlled trial and identify the biomarker to access the treatment response to therapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with ACLF with AARC grade 2 or more with or without single secondary organ failure.  Exclusion Criteria:  1. Patients with age less than 18 years or more than 65 years Patients with HVOTO or EHPVO Hepatocellular carcinoma (beyond Milan) or any extrahepatic malignancy Active bleed (mucosal or variceal) or severe coagulopathy (platelets <20,000 or INR>4) Patients with refractory shock requiring norepinephrine >0.5ug/kg/min Patients with retroviral infections Pregnancy or active breastfeeding Known severe cardiopulmonary diseases (structural or valvular heart disease, coronary artery disease, coronary pulmonary disease, chronic kidney disease) Lack of informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Functional Near-Infrared Spectroscopy (fNIRS) Assessing Neural Activity During Virtual Reality Walking Intervention
Status: Not yet recruiting

The purpose of this study is to evaluate the safety and feasibility of using a portable neuroimaging device called functional near-infrared spectroscopy (fNIRS) to successfully analyze fNIRS data in individuals with chronic TBI during treadmill training augmented with VR.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Moderate to severe TBI that required inpatient rehabilitation program; at least one-year post-injury at time of consent; weight less than 298 pounds and able to fit appropriately in the treadmill system; intact skin (no open lesions/bandages) in the area of treadmill harness contact; able to walk ten feet requiring the assistance of no more than one person (bracing and assistive devices allowed); self-reports ongoing balance deficits; ability to follow directions/standardized instructions; minimum 18 years of age at consent  Exclusion Criteria:  - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Cardiac Denervation Ablation Strategy for Severe Sinus Bradycardia
Status: Recruiting

This is a prospective clinical observation and registration study. The investigator aimed to evaluate the efficacy and safety of cardiac denervation ablation as a treatment strategy for severe sinus bradycardia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Sinus bradycardia and pacemaker implantation indication: long interval with mean heart rate <45 bpm or 3s recorded within 6 months before inclusion; Negative atropine test: sinus heart rate> 90bpm after atropine injection SSB related symptoms: dizziness, palpitations, fatigue, amaurosis, syncope, etc. Age ≥18 and <60 years old; The patient has agreed to participate in this trial and has signed the informed consent form.  Exclusion Criteria:  Previous history of atrial arrhythmia ablation or surgical procedure; Structural heart disease, chronic liver and kidney dysfunction, diabetes mellitus, neurological diseases.; Drug-related SSB; presence of left atrial thrombus; Pregnant women. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: SSB patients undergoing cardiac denervation ablation - SamplingMethod: Probability Sample
The Effect of Using Desensitizers Containing S-PRG In Treatment Of Dentin Hypersensitivity Over 6 Months: A Randomized Clinical Trial
Status: Not yet recruiting

The goal of this clinical trial is to compare the effect of desensitizer containing S-PRG have similar effect as sodium fluoride with functionalized tri-calcium phosphate containing desensitizer in relieving dentinal hypersensitivity in adult patients for six months follow-up. patients will be asked to report pain degree on the visual analogue scale (VAS) along the follow up periods on both groups.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Good oral hygiene. Cooperative patients who show interest to participate in the study and welling to sign the informed consent. Healthy patients with no history of previous systematic diseases that can affect their oral health. Normal and healthy gingival tissue. Teeth that have no cavitation or restorations. Patients with at least 20 natural permanent teeth and at least two teeth with a VAS score from 4 to 10. Anterior teeth.  Exclusion Criteria:  Allergic to the ingredients used in the study. Gastrointestinal disorders (They have repeated vomiting attacks). Medically compromised (They cannot tolerate the procedures). Taking desensitizing treatment in the last 6 months (It affects the outcome). Taking anti-inflammatory drugs (It affects the hypersensitivity perception). Pregnant females (They complain from nausea and repeated vomiting attacks) Smokers (Smoking will affect the oral hygiene and periodontal health). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult
The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)
Status: Not yet recruiting

In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia). The study will also help determine if LINFU® results in earlier intervention, treatment and improvement in patient outcomes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Both males and females will be enrolled and must be at least 18 years of age and under age of 90 Patients with a documented history of IPMN by any imaging method. All patients must undergo contemporaneous imaging (within 90 days before or after the LINFU® procedure) with one or more of the following: EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT Patients undergoing EUS-FNA may be enrolled but the FNA must be performed after the LINFU® procedure Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.  Exclusion Criteria:  Patient under the age of 18 and over the age 90  Contraindications to LINFU® as determined by study investigators:  Patient with uncorrectable coagulopathy Patient that cannot undergo anesthesia due to cardiopulmonary contraindication as deemed by the anesthesiologist Unstable medically (cardiopulmonary, neurologic, or cardiovascular status) Patients with IPMN that has been subjected to FNA or biopsy prior to the LINFU procedure Patients with pancreatic cystic neoplasms other than IPMN i.e. mucinous cystic neoplasms, serous cystic neoplasms and other rare cystic lesions Pregnant females will be excluded Patient that is unable to provide informed consent Patient with known allergy to the microbubble contrast agent or secretin  Study Design Overview: - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with a documented history of IPMN by any imaging method. - SamplingMethod: Non-Probability Sample