rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Accuracy of an AI-clinical Knowledge-based Hybrid System for Detecting Periodontitis in OPG Images
Status: Not yet recruiting

Periodontitis is highly prevalent and rarely detected and treated in the earlier stages of the disease. Orthopantomography (OPG) is the most frequently taken dental radiograph around the world, and its systematic screening may contribute to early detection of periodontitis and access to the needed level of care. The investigators' recent study initially developed an AI-clinical knowledge-based system for automatic periodontitis diagnosis and indicated good performance for differentiating stage II-IV periodontitis. This cross-sectional diagnostic study aims to compare the diagnostic accuracy of this AI-clinical knowledge-based hybrid system (Index test) with human experts (reference test) for differentiating stage II-IV periodontitis using the OPG images obtained from different 4 centers around the world.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged 18 and above Having taken the OPG image  Exclusion Criteria:  Edentulous mouth - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients seeking care at Shanghai Ninth People's Hospital Pudong Clinics; Patients seeking care at Shanghai Ninth People's Hospital South Clinics; Patients seeking care at Prince Philip Dental Hospital in Hong Kong; Patients seeking care at The University of Rome La Sapienza in Italy; - SamplingMethod: Non-Probability Sample
High Flow Nasal Cannula and Conventional Oxygen Therapy in the Postoperative Management of Patients With Mild to Moderate Obstructive Sleep Apnea
Status: Not yet recruiting

This study aims to compare the effectiveness of conventional oxygen therapy oxygen and high-flow nasal cannula therapy on oxygen saturation (SpO2), measuring number of SpO2 drop >4% of base line oxygen saturation (o2 desaturation index), length of the ICU stay, and the need of use supplemental continuous positive airway pressure (CPAP) support in any of the study groups in the postoperative ICU setting.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age group from 21 - 40 years old. Both sexes. Mild to moderate obstructive sleep apnea (OSA) patients with STOP-BANG score less than 5. OSA patients undergoing non cardiac surgeries. Patients who will undergo scheduled elective surgeries under general anesthesia.  Exclusion Criteria:  Patient refusal of procedure or participation in the study. Patients with severe OSA, STOP-BANG score more than or equal 5. Patients dependent on home ventilation CPAP or bilevel devices. Pregnant females. Post cardiac or thoracic surgery patients. More than American Society of Anesthesiologists (ASA) II patients. Head and face trauma patients. - HealthyVolunteers: No - Gender: All - MinimumAge: 21 Years - MaximumAge: 40 Years - StdAgeList: Adult
REmote COnditioning in Out-of-Hospital Cardiac Arrest
Status: Not yet recruiting

Out-of-Hospital Cardiac Arrest remains a major public health problem, resulting in high mortality largely related to multiple organ failure and poor neurological outcomes due to brain anoxia. The pathophysiology of organ dysfunction after resuscitated out-of-hospital cardiac arrest involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic strategy used to protect organs against the detrimental effects of ischemia-reperfusion injury.

The objective of the present trial is to determine whether remote ischemic conditioning performed early after out-of-hospital cardiac arrest can decrease mortality, or multiple organ failure and/or severe neurological failure.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age between 18 and 80 years old Out-of-hospital cardiac arrest, whatever the initial cardiac rhythm (shockable or non-shockable) or the duration of no-flow and low-flow, Presence of a witness who may or may not have started cardiopulmonary resuscitation, or patient seen alive in the 30 minutes prior to the cardiac arrest, Hospitalisation in critical care (intensive care unit or cardiac intensive care unit) for less than 3 hours, Informed consent obtained from a close relative (exceptionally from the patient himself if his condition permits) or, failing this, use of the emergency procedure by the investigator.  Exclusion Criteria:  Traumatic cardiac arrest Patient on extracorporeal circulatory assistance Cardiac arrest for which continuation of resuscitation does not appear justified (unavoidable death, terminal stage of an irreversible disease, etc.) Contraindication of the use of brachial cuff on both arms (arteriovenous fistula, lymphoedema or severe peripheral vascular pathology, unstable humeral fracture, continuous infusion into an upper limb vein of an essential drug such as a catecholamine, radial arterial catheter for continuous invasive measurement of blood pressure) Pregnant, parturient, or breast-feeding women Patients deprived of their liberty by a judicial or administrative decision, Patients under legal protection (guardianship, curatorship), Patient not affiliated to a social security scheme or beneficiary of a similar scheme, Previous inclusion in the study, Subject participating in another interventional study with an exclusion period still in progress at pre-inclusion. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
A Digital Treatment for Adolescents With Eating Disorders
Status: Not yet recruiting

The goal of this feasibility study is to evaluate the feasibility and preliminary clinical outcomes of a personalized digital treatment for adolescents with eating disorders. The main objectives are to:

i) Evaluate whether a personalized digital treatment for adolescents with eating disorders are feasible in a child and adolescent psychiatric outpatient clinic.

ii) Evaluate who benefits from a personalized digital treatment for adolescents with eating disorders (what works for whom?) iii) Evaluate the cost-benefit of a personalized digital treatment for adolescents with eating disorders.

Participants will be enrolled in a 10-week digital treatment including weekly therapist contact. They will be asked to complete self-report questionnaires at pre-, during, post- and 3- and 6-months follow-up.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  A. Diagnosed with F50.1 Atypical anorexia nervosa, F50.3 Atypical bulimia nervosa, F50.8 Other eating disorders, F50.9 Eating disorder, unspecified  B. Age between 16 and 18 years.  C. Stable dose of medication for a co-morbid psychiatric treatment for six weeks and who continue to meet study entry criteria.  D. Internet access.  E. Speaks and write Norwegian.  Exclusion Criteria:  A. Diagnosed with F50.0 Anorexia nervosa or F50.2 Bulimia nervosa  B. Disorders of psychological development (F80-F89).  C. Patients with avoidant restrictive food intake disorders (F50.82)  D. Participants with a co-morbid medical condition or disorder known to influence eating or weight (i.e., pregnancy, cancer), psychotic disorders, acute suicidality, or substance abuse and/or substance dependence and severe depressive episode.  E. Receiving inpatient- or face to face psychological treatment. - HealthyVolunteers: No - Gender: All - MinimumAge: 16 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
A Study of Adebrelimab Combined With Famitinib and Chemotherapy in the Treatment of ES-SCLC.
Status: Not yet recruiting

This is a single arm, multi-center, phase II trial to evaluate the efficacy, and safety of adebrelimab combined with famitinib and chemotherapy for the treatment of first-line extensive stage small cell lung cancer.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age: 18-80 years old, male or female Patients with pathologically confirmed extensive stage small cell lung cancer (according to the Veterans Administration Lung Study Group, VALG staging) Never received prior systemic therapy for extensive stage small cell lung cancer Have a measurable tumour target lesion (meeting RECIST 1.1 criteria) Expected survival > 3 months ECOG PS: 0-1 points Normal function of major organs Women of childbearing potential must undergo a negative pregnancy test (βHCG) prior to initiation of treatment, and women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 6 months after the administration of the last therapeutic dose Patients voluntarily enrolled in this study by signing an informed consent form  Exclusion Criteria:  Previous or concurrent other malignant tumours within 5 years, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial or non-invasive bladder cancer Active tuberculosis infection, or a history of previous tuberculosis infection Uncontrolled, symptomatic brain metastases that are not effectively controlled or a history of psychiatric illness that cannot be easily controlled or severe intellectual or cognitive dysfunction Subjects with active, known or suspected autoimmune disease, hypothyroidism requiring only hormone replacement therapy, skin disorders not requiring systemic therapy (e.g., vitiligo, psoriasis, or alopecia areata) may be eligible for enrolment Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage Subjects with the presence of any severe and/or uncontrolled disease Imaging showing tumour invasion of large vessels or poor demarcation from large vessels Susceptibility to bleeding, risk of hemoptysis, and history of significant coagulation disorders History of psychotropic substance abuse, alcoholism or drug addiction Active hepatitis (Hepatitis B reference: HBsAg positive with HBV DNA test value exceeding the upper limit of normal value Hepatitis C reference HCV antibody positive with HCV viral titre test value exceeding the upper limit of normal value) Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive Patients who are unable to comply with the trial protocol or who are unable to cooperate with follow-up visits Patients who, in the opinion of the investigator, should not be enrolled in the trial - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Clinical Study Cohort of Idiopathic Inflammatory Myositis
Status: Not yet recruiting

Idiopathic inflammatory myositis (IIM), also known as myositis, are a heterogeneous group of diseases characterized by chronic inflammation of striated muscles and skin, with different clinical manifestations, treatment responses, and prognosis. This project will build a clinical follow-up cohort for idiopathic inflammatory myositis (IIM) centered on Renji Hospital, Shanghai Jiao Tong University School of Medicine, to promote the clinical and pathogenesis of this group of diseases.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:Subjects must meet the following criteria for inclusion in this study: meet the 2017 EULAR/ACR classification criteria for inflammatory myopathy (IIM) or the 2018 ENMC-DM classification criteria (see above), plus:  Age≥ 18 years old and ≤ 75 years old Meet the 2017 EULAR/ACR classification criteria for inflammatory myopathy (IIM), the above score ≥ 5.5 points if there is no muscle biopsy, and 6.7 points ≥ if there is muscle biopsy  Cooperate with follow-up, examination and treatment and voluntarily sign the informed consent form.  -  Exclusion Criteria:Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria:  a. IIM with other connective tissue diseases; b. Negative myositis antibody test; c. Those who are in the period of acute infection, or have a history of active tuberculosis in the past; d. People with allergies or allergies to multiple drugs; e. Those who have mental illness or other reasons and cannot cooperate with examination, follow-up or treatment; f. Women who are pregnant, or are trying to become pregnant; g. Those who are participating in or have participated in clinical trials within the specified time.  - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Aged 18-75 years and eligible for the 2017 European League Against Rheumatism/American College of Rheumatology. - SamplingMethod: Probability Sample
Auditory Intranerve Stimulation Study
Status: Recruiting

This feasibility clinical investigation is designed to answer the question of whether auditory brainstem responses can be safely elicited by acute electrical stimulation within the human auditory nerve.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Written informed consent Patients who will undergo an acoustic neuroma removal surgery and are functional deaf Age ≥ 18 years Women with childbearing potential: willingness to use a reliable contraceptive method (e.g. copper intrauterine devices or hormonal methods) after consulting their gyncecologists  Exclusion Criteria:  Disabilities in addition to hearing impairment which might interfere with the study procedure Pregnant and breast feeding woman or other vulnerable population - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
An Adaptive Clinical Trial of BeginNGS Newborn Screening for Hundreds of Genetic Diseases by Genome Sequencing
Status: Recruiting

The goal of this clinical trial is to test a new method for newborn screening using whole genome sequencing, called BeginNGS. Parents will be approached to provide informed consent to enroll their newborns in prenatal, postnatal, and outpatient settings. The main questions this study aims to answer are:

What is the utility of BeginNGS as compared to state newborn screening? What is the acceptability and feasibility of BeginNGS as compared to state newborn screening? What is the cost effectiveness of BeginNGS as compared to state newborn screening?

Enrolled newborns will have a blood sample taken and will receive the BeginNGS test. Newborns will have also had the state newborn screening test.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Neonates (<28 days old) at enrollment sites. Parents must have identified a primary care provider (or group).  Exclusion Criteria:  Neonates whose mother is less than 18 years of age. Neonates who are wards of the state. Neonates whose parent/legal guardian is unable to provide consent. Parents with a home address outside the US or jurisdiction of the enrollment sites. Neonates or fetuses who are ill and in whom enrollment or sampling is anticipated to interfere with healthcare provision at delivery. For example, fetuses or neonates who are likely to require transfer to a higher level of care, such as to a Level IV NICU upon delivery. Neonates who are under consideration for a rapid diagnostic genome sequence or other diagnostic genetic testing. Neonates who are not expected to survive the neonatal period. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 1 Day - MaximumAge: 28 Days - StdAgeList: Child
Effect of Parental Attitude on Functional and Physical Level of Children With Cystic Fibrosis
Status: Recruiting

Some parents may be more protective of children with CF due to concerns about worsening of the disease due to infection, which can affect their functional level. The goal of this observational study is to learn about the family's protective approach to the functioning and disease course of children with cystic fibrosis (CF) to determine whether there are possible negative effects. There will be an alternative viewpoint offered to clinicians regarding the management of CF with outputs of this study.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  For a child  To be between 7-17 years old, Living with family or caregiver.  For the parent  Being the mother, father or other caregiver of the child, Voluntarily agreeing to participate in the study on behalf of both the child and oneself.  Exclusion Criteria:  For the child  Having cognitive impairment that would prevent participation in the study or being able to cooperate with the measurements and not being able to adapt, History of previous lung or liver transplantation, History of hospitalization within the last 1 month, Having a neurological or orthopedic comorbidity that affects mobility.  For the parent  Having cognitive impairment at a level that prevents participation in the study Not living in the same household with the child. - HealthyVolunteers: No - Gender: All - MinimumAge: 7 Years - MaximumAge: 17 Years - StdAgeList: Child - StudyPopulation: Children with cystic fibrosis and their parents who visited a private hospital's Pediatric Chest Diseases Outpatient Clinic made up the study's population. 37 parents of children with cystic fibrosis and their 37 offspring who match the inclusion and exclusion criteria and willingly consent to take part in the study will make up the sample. - SamplingMethod: Non-Probability Sample
Determination of Posture in Patients With Restrictive and Obstructive Lung Disease
Status: Not yet recruiting

The aim of this study is to determine posture and posture related factors in patients with restrictive and obstructive lung disease.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Chronic Obstructive Pulmonary Disease Group Inclusion Criteria:  Over 55 years old, Stage 1-2-3-4 according to the GOLD, Being clinically stable for the last 4 weeks.  Chronic Obstructive Pulmonary Disease Group Exclusion Criteria:  Receiving long-term oxygen therapy, Having central and peripheral vestibular disease, Communication problems, known mental and cognitive problems, Having undergone any surgical intervention related to the spine within the last six months,  Inclusion Criteria for the Cystic Fibrosis Group:  Being diagnosed with CF as a result of two sweat tests, Being over 18 years old.  Cystic Fibrosis Group Exclusion Criteria:  Being in acute pulmonary exacerbation period, Receiving long-term oxygen therapy, Having undergone any surgical intervention related to the spine within the last six months,  Inclusion Criteria for the Asthma Group:  Diagnosed with asthma according to the Global Strategy for the Prevention and Treatment of Asthma (GINA), Clinically stable for the last 1 month Being over 18 years old.  Asthma Group Exclusion Criteria:  Change in medication for the last 1 month. Having undergone any surgical intervention related to the spine in the last six months,  Inclusion Criteria for Bronchiectasis Group:  Being over 18 years old, Being diagnosed with bronchiectasis other than cystic fibrosis, Being clinically stable for the last 1 month.  Bronchiectasis Group Exclusion Criteria:  Receiving long-term oxygen therapy, Having undergone any surgical intervention related to the spine in the last six months.  Diffuse Parenchymal Lung Diseases Inclusion Criteria:  Being diagnosed with diffuse parenchymal lung according to American Thoracic Society/European Respiratory Society (ATS/ERS) criteria, Being over 18 years old, Having volunteered to participate in the research, To be clinically stable and to have comorbid conditions (such as hypertension, diabetes) under control,  Diffuse Parenchymal Lung Diseases Exclusion Criteria:  Having undergone any surgical intervention related to the spine within the last six months, Having exacerbation in the last 3 months - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Obstructive and restrictive lung disease and healthy controls will be included in this study according to the inclusion and exclusion criteria. - SamplingMethod: Non-Probability Sample
Buprenorphine for Individuals in Jail
Status: Not yet recruiting

This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult male or female inmates at participating jail who are eligible for release within 120 days (sentenced and/or pretrial [note: individuals who might be sentenced to state/federal prison will be excluded]); Those individuals who are pre-trial and/or sentenced who are completing their sentence in the community (probation, parole, home detention, electronic monitoring, drug or other treatment court [or equivalent]) will be eligible to participate; History of opioid use disorder (meeting DSM-5 criteria of moderate or severe opioid use disorder at the time of incarceration; individuals not meeting the opioid-disorder criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration); Suitability for XR-B and/or SL-B treatment as determined by medical evaluation; Willingness to enroll in XR-B or SL-B treatment in jail and continue in the community; Planning to live in Baltimore City or the Baltimore Region;  Exclusion Criteria:  Liver function test levels greater than 5 times normal (if we are unable to obtain labs, a determination by the study physician will be made to allow inclusion); Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; moderate to severe renal impairment; adequately treated medical conditions are acceptable); Conditions or medications that may predispose to QTc prolongation (personal or family history of long QT syndrome, hypokalemia, medications that prolong QTc interval, e.g., macrolide antibiotics, azole antifungal compounds, anti-arrythmics, antipsychotics and antidepressant); Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, bipolar disorder with mania; adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed); History of allergic reaction to buprenorphine; Suicidal ideation (within the past 6 months); Inability to pass a study enrollment quiz; and Currently receiving non-buprenorphine MOUD in jail (methadone, naltrexone). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTMF TBLAMFIA and Its Impact on the Initial TB Diagnosis
Status: Not yet recruiting

Evaluation of the performance of an in vitro test, the STANDARDTM F TB LAM Ag FIA (SD BIOSENSOR, INC.) for the early diagnosis of tuberculosis (TB) infection. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection. The test will be used according to the instructions for use (IFU).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Inclusion criteria for PTB, PNTM and extraPTB:  Adult subjects with documented active pulmonary TB, pulmonary NTM or extrapulmonary TB Subjects who have signed informed consent Aged ≥18 years  Inclusion criteria for HC:  healthy donors who have signed informed consent aged ≥ 18 years no TB or NTM risk factors or exposure  Exclusion Criteria:  Exclusion criteria for PTB, PNTM and extraPTB:  Do not have active pulmonary TB, NTM or extrapulmonary TB Do not sign the informed consent Are aged < 18 years  Exclusion criteria for HC:  Have active pulmonary TB or NTM Do not sign the informed consent Are aged < 18 years - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Subjects attending the Infectious Diseases Ward of the participating centers with a pulmonary TB, pulmonary NTM or extrapulmonary TB. Healthy controls, - SamplingMethod: Probability Sample