rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Elamrousy Novel Approach of Socket Shield Technique
Status: Recruiting

The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous whole tooth graft (AWTG) with socket shield approach (SSA) and compared this approach to socket shield technique with xenograft.

The present study included 63 patients, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation using socket shield protocol, while group II patients underwent the same procedure, but the shield/fixture jumping gap was grafted by xenograft. finally group III was grafted by AWTG that was created using the decoronated crown and the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  above the age of 18years presence of non-restorable maxillary anterior tooth had intact socket walls following tooth extraction the gingival biotype was thick.  Exclusion Criteria:  history of systemic condition history of using bisphosphonates or other drugs that might impact bone turnover a history of smoking during the previous five years, a history of any acute infections at the surgical site, teeth having root resorptions massive periodontal destruction buccally fractured root either vertically or horizontally beneath the alveolar crest. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 25 Years - MaximumAge: 40 Years - StdAgeList: Adult
HCV Tappt Adherence Study
Status: Not yet recruiting

The goal of this non-inferiority clinical trial is to evaluate the efficacy of Tappt, a novel digital medication companion solution, among individuals with hepatitis C virus (HCV) who are starting a daily oral medication regimen following standard of care in a clinical pharmacy setting.

The primary aim is to assess the non-inferiority of Tappt with medication adherence, treatment completion, sustained virologic response (SVR) assessment, and SVR achievement rates.
The secondary aim is to assess the efficacy of Tappt at enabling pharmacists to personalize treatment and management decision based on participants' reported barriers to adherence, care, and SVR achievement.

Participants will download and utilize the Tappt app to record adherence to oral medication. For the purposes of this study, adherence for participants in the intervention arm will be measured using a modified medication possession ratio (MPR) measure called medication tag scan ratio (MTSR). MTSR is defined as a percentage of the number of times participants scanned their passive tags versus the total of expected tag scans based on that participant's medication regimen and treatment period.

Upon study completion, a retrospective matched control will be established for the intervention group. Historic data for the matched control's adherence, treatment completion, SVR assessment, and SVR rates will be compared to the intervention arm.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years of age or older Hepatitis C virus (HCV) infection (denoted by positive HCV antibody and detectable HCV RNA) Initiating oral HCV therapy with glecaprevir/pibrentasvir or sofosbuvir/velpatasvir HCV treatment provided and managed by the clinical pharmacist at UI Health Access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and/or Wi-Fi access Ability to verbalize understanding of the study protocol in English Able and willing to provide informed consent in English  Exclusion Criteria:  Inability to speak and read English Inability or unwillingness to adhere to the study protocol Pregnant individuals Decompensated cirrhosis (Child Turcotte Pugh Class B and C); hepatocellular carcinoma; prior liver or kidney transplant  No patient will be excluded because of gender, race or ethnic origin.  The following populations will be excluded from the study:  Adults 18 years of age and older who are unable or unwilling to consent Individuals less than 18 years old Pregnant individuals Prisoners - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Effect of Listening to Music on Chronic Low Back Pain
Status: Recruiting

The effects of passive music listening on pain, anxiety and quality of life in patients with chronic low back pain in addition to physical therapy will be examined.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  patients with LBP for more than 3 months with pain severity of 5 or greater according to the visual analogue scale (VAS)  Exclusion Criteria:  individuals who regularly take painkillers or anti-depressant and cortisone; pregnant individuals; and individuals having severe chronic illness and spine surgery were excluded from the study - HealthyVolunteers: No - Gender: All - MinimumAge: 30 Years - MaximumAge: 50 Years - StdAgeList: Adult
Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial
Status: Not yet recruiting

The study aims to compare the success and time of intubation through an intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.

This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Level III NICU consultants and residents will be eligible to participate in the study  Exclusion Criteria:  None - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 25 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
The Effect of Listening to Qur'an Recital on Quality of Life in Systemic Lupus Erythematosus Patients
Status: Recruiting

The goal of this quasi-experimental study is to evaluate the effect of listening to the Qur'an recital on quality of life among systemic lupus erythematosus patients. There will be intervention and control groups. Before the intervention, the quality of life of participants will be assessed using the Lupus-QoL questionnaire. After the baseline assessment, participants in the intervention group will be asked to listen to a Qur'an recital by Surah Ar-Rahman using an MP3 player twice a day for a minimum of 15 minutes each for 40 days. The control group will not receive any specific intervention and will continue with their usual routine. After the 40-day intervention period, the quality of life of participants in both groups will be assessed using the Lupus-QoL questionnaire. The results will be analyzed to determine if there is a significant improvement in quality of life. Besides, potential confounding factors such as SLE clinical manifestations, disease activity, pharmacologic treatment regimen, anxiety/depression, comorbidities, age, and economic status will also be collected before and after intervention to evaluate its effect on the quality of life.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Systemic Lupus Erythematosus Patients based on EULAR/ACR 2019 diagnostic criteria, Female aged ≥ 18 years old, Muslim (follower of the religion of Islam), Have no auditory problems, Received a steroid dose ≤ 20 mg/day equivalent to prednisone,  Exclusion Criteria:  Cannot read or write, Using drugs that affect the work of the central nervous system, Not willing to take part in research. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Female - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Comparing the Effectiveness of Two Produce Prescription Approaches On Fruit and Vegetable Intake and Food Security, While Exploring Implementation Outcomes Such as Reach, Implementation, Sustainability, and Cost
Status: Not yet recruiting

The produce prescription program is one type of food is medicine (FIM) programs, where healthcare providers "prescribe" fruits and vegetables (F&V) to patients with low household incomes, experience food insecurity, and one or more diet-related diseases. NutriConnect seeks to compare the effectiveness of two produce prescription approaches on F&V intake and food security: credit to Rewards account (NutriConnect Credit) vs. produce box delivery (NutriConnect Delivery), while exploring implementation outcomes such as reach, sustainability, implementation, and cost.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults (>= 18 years) Received care at either medical floors or observation unit at the Bares Jewish Hospital (BJH), and discharged to home. Being screened positive for food or financial insecurity. Have elevated cardiovascular risk, i.e., self-reported diabetes, hypertension, hyperglycemia, or calculated BMI meeting obesity.  Exclusion Criteria:  Does not have competence to provide informed consent. Is under suicide watch. Is in police custody. In hospice or palliative care. Not have a stable home. Is pregnant. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult
Cold and Heat Investigation to Lower Levels of Depression
Status: Not yet recruiting

This study will recruit 112 medically healthy adults (aged 18-65) currently experiencing depressive symptoms to be randomized to receive either a single Whole Body Hyperthermia (heat therapy) treatment or a Whole Body Hyperthermia treatment followed by a cold water plunge. Participants will complete a baseline assessment of their depressive symptoms as well as 1-week and 2-week post-treatment followup assessments.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Meets DSM 5 criteria for major depressive disorder (MDD) with a depressive episode of ≥ 60 days duration. Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 28 at screening English or Spanish speaking (able to provide informed consent and complete questionnaires in one of these languages) Able and willing to adhere to trial requirements, including attending all trial visits, preparatory and follow-up sessions, and completing all trial evaluations.  Exclusion Criteria:  Previous adverse reaction to hypothermia, hyperthermia and/or infrared exposure Use of any medication that may impact thermoregulatory capacity. Pregnancy, active lactation, or intention to become pregnant during the study period. Endorses current active suicidal ideation with a plan or made a suicide attempt in the prior 6 months. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy Attempted Suicide Short Intervention Program (ASSIP) on Neuropsychological Correlates and Psychological Process Factors - Project 2
Status: Not yet recruiting

The present study consists of 3 projects in total and aims to investigate the (neuro-) psychological patterns from suicidal ideation to suicidal behavior as well as the effects and feasibility of ASSIP Home Treatment.

The overall aim of project 2 is to investigate how the (neuro-) psychological patterns are modulated by the Attempted Suicide Short Intervention Program (ASSIP). Therefore, suicide attempters participating in this project 2 will be randomly assigned to either the intervention group ASSIP or a standard care plus resource interview (STAR) group. The ASSIP and STAR interventions take place at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland).

At the end of the assessment in project 1 participants who reported a history of past suicide attempt (SUAT) will be informed about project 2.

Only if participants agreed to take part in project 2 and have signed the informed consent, they are randomized into two conditions: The ASSIP intervention (ASSIP) versus standard of care plus resource interview (STAR). Participants of both groups will be assessed again 4 weeks and 12 months after their first baseline assessment of project 1.

Eligibility:
- EligibilityCriteria: Inclusion Criteria for Project 2:  Subjects fulfilling the following inclusion criteria are eligible for the study:  Informed consent as documented by signature Age ≥ 18 years At least one previous suicide attempt Willingness to attend the ASSIP brief therapy Owns a smartphone  Exclusion Criteria for Project 2:  The presence of any one of the following exclusion criteria will lead to exclusion of the subject:  Serious cognitive impairment Any psychotic disorder Any current medication, which substantially impairs the attention span, reaction, rate or any other relevant cognitive functions Inability to follow the procedures of the study (e.g., insufficient mastery of the German language, previous enrolment into the current study) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Goniometry and Goniometric Measurement on Standardised Images in Dupuytren's Disease
Status: Recruiting

Measuring range of motion (ROM) is essential in detecting musculoskeletal deficits, monitoring the effects of treatment and progression of the disease. In Dupuytren's disease the active and passive extension deficits (AED, PED) of digits 4 and 5 are usually clinically measured using a universal, short arm goniometer which is considered the standard of care. Using the goniometer can be time consuming. Measuring the extension deficit on a standardised picture could improve follow up, since it is a faster and easier process to take a picture and upload it to the patients files. Though this gives rise to the question whether this kind of measurement would be equally accurate and reliable in comparison to regular clinical measurement using a goniometer.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Older than 18 years of age Current AED in digit 4 or 5, in the MCP or PIP joint  Exclusion Criteria:  Abnormalities to the fingers other than Dupuytren's disease which make goniometry impossible (e.g. amputation, arthrodesis of finger joints, deformations due to rheumatoid arthritis etc.) Patient's unable to give a written participating consent. Younger than 18 years of age. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with diagnosed Dupuytren's disease - SamplingMethod: Non-Probability Sample
Anti-Diabetic Medications to Fight PD and LBD
Status: Not yet recruiting

The purpose of this study is to test the hypothesis that DPP4 inhibitors and SGLT2 inhibitors are well tolerated and have beneficial neurological effects, specifically for Parkinson's disease and Lewy body dementia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Parkinson's disease or Lewy Body Dementia (diagnosis confirmed by neurologist at Mayo Clinic) with stable neurological treatment in the past approximately three months. Glucose intolerance or mild diabetes: The American Diabetes Association criteria for pre-diabetes/ glucose intolerance includes fasting glucose 100-125, random glucose 140-199, or hemoglobin A1C 5.7-6.4% and diabetes is > 125 mg/dL, > 200 mg/dL, and 6.5% or greater, respectively (40). It has been previously reported that 50-80% of individuals with Parkinson's disease have abnormal glucose tolerance (17), so this should not limit recruitment.  Exclusion Criteria:  Use of insulin or other anti-diabetes medications other than metformin. Contraindication to taking a DPP4 inhibitor or SGLT2 inhibitor including: allergy, history of angioedema, pancreatitis, active gallbladder disease, renal impairment with EGFR < 45). Bleeding disorder, use of anticoagulants, thrombocytopenia, or severe anemia. Use of high dose steroids. Current systemic chemotherapy. Pregnancy or breastfeeding. Recent (within 30 days) or recurrent (defined as more than one in the past 12 months) urinary tract infection or yeast infection. Other contraindication that would make study participation unsafe or make study related data unable to be interpreted. - HealthyVolunteers: No - Gender: All - MinimumAge: 45 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Incorporation of a Health Equity Approach to Hospital Violence Intervention Programs: The Integration of a Community and Hospital Based Initiatives to Reduce Gun Violence in a Large Metropolitan Area
Status: Not yet recruiting

The purpose of this study is to evaluate the effectiveness of Houston-Hospital Violence Intervention Programs (HVIP) in reducing the occurrence of repeat violent events among adults receiving care at Memorial Hermann Hospital in Houston, to determine the impact of the community-engaged Houston-HVIP program on violent re-injury and mental and behavioral health, assess the impact of the Houston-HVIP program on racial and ethnic disparities in those impacted by firearm violence injury and to identify the predictors of implementation success, including dosage, reach, fidelity, and acceptability from the perspective of gun violence victims, health care providers, and community violence intervention specialists

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  presented for a gunshot injury stemming from community violence at Memorial Hermann Hospital English or Spanish-speaking provide informed voluntary consent to participate in the study  Exclusion Criteria:  presenting for a firearm injury arising from a self-inflicted gunshot, accidental firearm injury, unintentional gun violence, or domestic violence - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult
Hand Exercises in Psoriatic Arthritis
Status: Recruiting

This study is a randomized controlled study examining the effects of 8-week hand home exercises on grip strength, functionality, disease activity and quality of life in patients with PsA. Individuals participating in the study will be randomly divided into 2 groups. Individuals in the intervention group will perform home exercises consisting of stretching, mobility and strengthening, 4 days a week for 8 weeks, and the patients' compliance with the exercise will be monitored by phone call once a week. Individuals in the control group are on the waiting list and the same home exercise program will be taught to the patients at the end of the study.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being diagnosed with PsA by a physician according to CASPAR criteria Being 18 years or older Involvement in hand joints (pain, swelling, tenderness) Being on stable drug treatment for the last 6 months Having sufficient cooperation to participate in the study Volunteering to participate in the study  Exclusion Criteria:  Having difficulty cooperating at work Having additional orthopedic and/or neurological disease that will affect hand functions - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation
Status: Recruiting

The main goal of this prospective pre-post implementation study is to investigate how a structured testing and treatment program for obstructive sleep apnea using the NOX T3s device and a Fitbit smartwatch with the FibriCheck algorithm impacts the proportion of atrial fibrillation (AF) in an AF population.

Participants will wear the NOX T3s respiratory polygraphy device for one night at home. In case of a positive obstructive sleep apnea diagnosis, patients will be referred to the sleep clinic for a polysomnography examination. Patients positively diagnosed with polygraph will be monitored semi-continuously with the Fitbit smartwatch for three months. After the polysomnography examination, the positively diagnosed patients will be monitored semi-continuously for another three months after initiation of treatment (mostly continuous positive airway pressure (CPAP) treatment). Additionally, patients will be administered satisfaction and symptom burden questionnaires twice: right after the polysomnography examination and after the 3-month treatment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients in whom AF (paroxysmal or persistent) is diagnosed with a 12-lead ECG Patients who experience symptoms of their AF (mEHRA ≥ 2a) Older than 18 years Owning a smartphone compatible with Fitbit and FibriCheck applications (i.e. recent versions of Apple iOS or Android drivers) Ability to sign the informed consent  Exclusion Criteria:  Patients diagnosed with permanent AF or only atrial flutter Prior/recent polysomnography evaluation Prior/active CPAP/BiPAP/ASV treatment Cognitive impairment Inability to speak or fully understand Dutch Pacemaker-dependent heart rhythm - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Semaglutide and Preoperative Residual Gastric Volumes
Status: Not yet recruiting

Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by recent case reports of patients who either retained or regurgitated stomach contents despite being adequately fasted.

To address this gap, we plan to measure preoperative residual gastric volumes with point-of-care ultrasound (POCUS) in patients taking this medication. The priority is to first gather data to identify which patient populations need risk stratification and to then use this data to support the development of specific guidelines that reduce anesthetic complications, such as aspiration pneumonia.

Our primary objective is to use POCUS preoperatively to assess gastric volumes of fasted patients to demonstrate if there is a clinically significant increase in residual gastric volumes in patients on semaglutide.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  all elective surgical patients (> 18 years of age) followed institutional fasting protocol for surgery patients taking GLP-1 receptor agonist (subcutaneous for weight management and/or blood glucose control in type II diabetes mellitus, N = 45) patients not taking GLP-1 receptor agonist (N =45)  Exclusion Criteria:  confounding delayed gastric emptying due to pregnancy previous esophageal or gastric operation etiologies at increased risk for delayed gastric emptying (hiatal hernia, Parkinson's disease, scleroderma, multiple sclerosis, and amyloidosis) on medication that could potentially cause gastroparesis or delayed gastric or intestinal emptying (opioids, proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, antipsychotic medications, loperamide, diphenoxylate, oxybutynin, hyoscine butylbromide, scopolamine, promethazine, glycopyrrolate, atropine, chlordiazepoxide, and lithium) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Elective surgical patients meeting inclusion/exclusion criteria at the South Health Campus (Calgary, AB, Canada) - SamplingMethod: Non-Probability Sample