cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of Combined Design Nance/Transpalatal Arch Appliance in Maintaining Arch Dimensions After Premature Extraction of Primary Molars

This study will evaluate the effectiveness of N-TPA appliance compared to Nance SM in maintaining the arch dimensions after bilateral premature extraction of primary molars in children.

In this randomized controlled clinical trial, 30 healthy children, 8-9 years of age with premature extraction of bilateral maxillary primary molars will be selected. Children will be randomly allocated into two equal groups of 15 children each according to the type of the appliance that will be used. Group I will receive a a Nance SM, and Group II a combined N-TPA appliance . Panoramic X-rays and study casts will be made, and baseline measurements will be recorded including arch circumference, intermolar width and arch depth. The appliances will be fabricated and cemented intra-orally.

The patients will be followed up at 3, 6 and 9 months for re-evaluation of arch circumference, intermolar width, arch depth, and patient acceptance.

Eligibility Criteria:
Inclusion Criteria:

* Fully erupted maxillary permanent first molars.
* Angle's class I occlusion.(31)
* Adequate space for premolar eruption according to Moyer's arch length analysis.(31)
* Fair to good oral hygiene according to Silness and Loe plaque index.(32)
* No history of allergy to polymethyl methacrylate.

Exclusion Criteria:

* Children with congenitally absent permanent successors.
* Children with successors not covered by bone with 2/3 of the root formed.(33)
Clinical Research on Acute Intermittent Porphyria and the Use of Carbohydrate-Rich Diet as a Treatment

The main aim of this clinical trial is to learn about the effect of carbohydrate-rich diet as a treatment for AIP (acute intermittent porphyria).

Aim: Investigate the diet's impact on tissue and serum glucose, plasma insulin, cytokine levels, amino acids, and gut microbiota in AIP, and their correlation with PBG (Porphobilinogen).

Aim: Assess the diet's effect on AIP symptoms and health status in AIP. Aim: Measure the effect of a high-carbohydrate diet on mitochondrial activity in AIP Aim: Map and detect potential mutations in mitochondrial genomic DNA in AIP Aim: Discover new markers in AIP through RNA sequencing and machine learning.

Participants will follow two diet plans, a 4-week intervention with 60-65 E% carbohydrates and a 4 week intervention with 40-45 E% carbohydrates.

Acute intermittent porphyria (AIP) is an inherited disease that leads to the accumulation of porphobilinogen (PBG), resulting in severe abdominal pain, paralysis, fatigue, low-grade inflammation, and an increased risk of kidney failure and liver cancer. Studies at the cellular level and in mice have shown that elevated levels of glucose and insulin can affect heme synthesis, potentially reducing PBG levels. The investigators have previously demonstrated that individuals with AIP consume less carbohydrate (E% 40) than recommended. The investigators aim to conduct a crossover study involving 50 participants with AIP, where 50% will be subjected to a 4-week intervention with 60-65 E% carbohydrates, while the other half will consume 40-45 E% carbohydrates for 4 weeks. After a 4-week intervention-free period, the two groups will switch to the respective carbohydrate percentages. Symptoms, PBG levels, continuous tissue glucose, plasma/serum insulin, glucose, cytokines, amino acid levels, microbiota in the gut, body composition, and physical activity measured using accelerometers will be assessed before and after each intervention and compared. Mitochondrial activity will be assessed at the cellular level as oxidative activity. Mutations in mitochondrial DNA and RNA will also be examined since defects in oxidative energy metabolism are known to be associated with inflammation and cancer. The work will be carried out at Nordland Hospital and at the University of Oslo. The study will be coordinated and conducted by the Postdoc and partners at Nordland Hospital, the University of Oslo, the Arctic University of Tromsø, and Nord University. Clinical nutritionists will create dietary plans, and bioengineers will perform analyses. Stay abroad for postdoc, and research cooperation, with porphyria researchers at UTMB, Texas and MGH, Boston, US.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AIP

Exclusion Criteria:

* Not having diagnosis of AIP
* Undergoing treatment as part of other clinical research on AIP
* Pregnancy
* Diabetes
* Below 18 years of age
Kinesio Tape Application in the Treatment of Plantar Fasciitis

This study is a prospective randomized clinical trial. Radial extracorporeal shock wave therapy (r-ESWT) is accepted as one of the most effective treatment modalities for plantar fasciitis (PF). Kinesio taping (KT) applied to the plantar fascia can provide patients with PF some benefits, but there no enough evidence about this topic. This study analysed the acute effect of adding KT to r-ESWT, on pain, foot function and flexibility when treating PF.

The study was performed on 42 patients with unilateral PF, that were randomly assigned into wo groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises. Patients' pain levels were evaluated via the Visual Analogue Scale (VAS), and foot function via the Foot Function Index (FFI). Flexibility was assessed through gastro-soleus and plantar fascia flexibility tests. The evaluations were done before and one week after the final treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of unilateral plantar fasciitis,
* The presence of a heel spur on a lateral radiograph

Exclusion Criteria:

* Lower extremity surgeries or traumas,
* Systemic inflammatory disease,
* Steroid injections administered within the past six months,
* Pacemaker usage,
* Coagulation disorders,
* Use of anticoagulants.
VIRtual Versus UsuAL In-office Care for Multiple Sclerosis (VIRTUAL-MS)

The current standard of outpatient MS care depends on in-clinic visits, but MS patients face many barriers to accessing this care. These barriers include those resulting from the disease itself, such as physical limitations, driving restrictions and financial limitations, and they are further compounded by an overall shortage of neurologists. Furthermore, MS care has a significant economic impact, with the estimated indirect and direct costs for treating MS in the US estimated to be \> $85.4 billion. Therefore, there is a need to improve access to and reduce cost of MS care, and telehealth is a potential solution. The VIRTUAL-MS study has been designed to evaluate the impact of telehealth care on MS clinical outcomes, costs, and satisfaction compared to in-person care. Additionally, the study aims to evaluate facilitators and barriers to telehealth use to inform widespread implementation.

The VIRTUAL-MS study aims to evaluate the impact of telehealth on MS care. The study will conduct a 24 month randomized controlled clinical trial at two Centers (Cleveland Clinic and University of California San Francisco) and will enroll 60 adult people with MS per Center with a recent diagnosis of MS. Participants will be randomized 1:1 to receive follow-up MS care via scheduled telehealth, or standard in-clinic, visits. All participants will have in-person visits at baseline and 24 months with in-person study visit including clinical assessments, patient reported outcomes, and medical history review. All participants will have clinical visits with their neurology clinician every 6 months (months 6, 12, and 18) via in-person or telehealth per randomized arm.

The primary objective of this study is to determine if MS care delivered via telehealth is non-inferior compared to in-clinic MS care as measured by worsening in one of the Multiple Sclerosis Functional Composite (MSFC) components at Month 24.

The secondary objectives of this study include the following:

* To determine if MS care delivered via telehealth has superior patient satisfaction compared to in-person MS care as measured by baseline to 24 month change in PSQ-18.
* To determine if MS care delivered via telehealth is more cost-effective than MS care delivered via in-person visits as measured by total non-medication costs over 24 months.

The researchers will also explore other clinical outcomes, treatment adherence, digital outcomes, patient experience, and clinician experience.

Eligibility Criteria:
Inclusion Criteria:

1. Ages ≥18
2. MS diagnosis within 24 months of randomization by 2017 McDonald Criteria.
3. Confirmatory MRI within 12 months prior to randomization.
4. Access to either mobile device, laptop or PC with internet connection to be able to conduct virtual visits
5. Participant's neurologist and/or advanced practice provider are participating in the study

Exclusion Criteria:

1. Clinically relevant condition that, in the opinion of the PI, could preclude participation in the study (e.g. neutropenia or wound care requiring frequent monitoring)
2. Inability to provide informed consent
Is Bronchoscopy Necessary in the Preoperative Workup of GGO Lung Cancer?(ECTOP-1005)

This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1005). It aims to evaluate the role of flexible bronchoscopy in the pre-operative workup of ground glass opacity featured lung cancer. All enrolled patients receive the flexible bronchoscopy examination before surgery. Investigators observe the intra-bronchial findings of bronchoscopy and the impact of these findings on established surgical plan.

The appropriateness of routine use of bronchoscopy in the operative workup of a solitary pulmonary nodule（SPN） is debatable. Options expressed in the literature vary from routine preoperative bronchoscopy having no role in obtaining tissue diagnosis in small SPNs to it begin very useful in determining underlying etiology and surgical strategy. The American College of Chest Physicians（ACCP）guidelines recommend bronchoscopy only if air-bronchogram is present or if operator has expertise with newer guided techniques. Previous study showed that bronchoscopy is not indicated in SPNs that present with ground-glass opacity on CT. The purpose of this analysis is to define that role by examining in GGO patients （1）intra-bronchial findings （2）impact of these findings on established surgical plan.

Eligibility Criteria:
Inclusion Criteria:

* Ground glass opacity pulmonary nodule diagnosed by thoracic CT
* karnofsky performance status ≥60
* No surgical contraindication
* Patients who sign the informed consent
* Pre-operation clinical stage :T1abcN0M0
* Age:18-80 years old

Exclusion Criteria:

* Central lung tumor diagnosed by CT
* Tracheal or bronchus deformity diagnosed by CT
* Tracheal or bronchus disease history
* Severe smoking history （smoking index ≥400/year）
Change in Brain Metabolism and Cognitive Function by Aripiprazole

Dopamine receptor occupancy and brain metabolism were measured using positron emission tomography after the administration of aripiprazole. Working memory performance was also measured using N-back task.

The investigators explored the relationship between changes in brain metabolism and working memory performance.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* right-handed

Exclusion Criteria:

* any significant abnormality on routine lab
* any psychiatric disease
Get ActivE Study for At-risk Youth

The study will adapt and deploy a digital Behavioral Activation app with mobile sensing, supported by health coaches, that encourages youth to engage in positive activities. The study has the potential to offer a low-cost and scalable behavioral intervention that may decrease risk of suicide among at-risk youth. This research will examine specifically whether an intervention involving an app called Vira, combined with health coaching (GET ActivE) can improve enjoyment for teens coping with depression. Research participants will be randomly assigned to one of two study intervention. One study intervention involves a) downloading an app called Vira and engaging by responding to a daily question, and b) participating in a conversation via text, phone, or messages through an appt with a health coach. The health coach will use the Vira app and principles from evidence-based therapy and behavior change to provide users with insights to sustain well-being and better manage risk factors for suicidal thoughts and behaviors such as depressed mood and behavioral withdrawal. The second study intervention involves downloading an app called EARS and responding to a daily question.

Aim 3 (Randomized Pilot): To examine implementation outcomes, initial effectiveness, and equity across outcomes in a pilot randomized trial (n=75, 2:1 randomization, 35% Black, 10% Hispanic) of GET ActivE vs. Activity Monitoring Alone. H3a. The study will observe high GET ActivE feasibility (50% of eligible youth approached will enroll; completion \>50%; attrition \<20%; response to health coach contacts \>80%); acceptability (\>80%); and appropriateness (\>80%). H3b. Youth who receive GET ActivE will show greater improvement in anhedonia (primary outcome) and H3c. depression severity and suicidal risk (secondary outcomes). H3d. Outcomes will be equitable by race. H3e. Exploratory (mechanistic): GET ActivE will lead to decreased depression and suicidal risk through increased activity and reward responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents age 12-18
* Current moderate to severe depression (PHQ-9-M \> 11)
* Current clinically significant anhedonia, operationalized as PHQ-9-M anhedonia item score \> 1
* English language fluency and literacy level sufficient to engage in study protocol
* Willing to download the app on their smart phones

Exclusion Criteria:

* Evidence of mania, psychosis, or developmental disability precluding comprehension of study procedures per electronic health record review and phone screen.
POHCA Resuscitation: Evaluation of IM Epinephrine

This is a pragmatic, two-arm, open-label, prospective stepped-wedge cluster quasi randomized control trial (SW-CRCT) looking to evaluate early intramuscular (IM) epinephrine in the management of pediatric out-of-hospital cardiac arrest (POHCA).

IM epinephrine may provide a more efficient means of administering the initial epinephrine dose (versus IV/IO administration) to a child experiencing pediatric out of hospital cardiac arrest (POHCA) with no greater risk of harm. In so doing, this may improve the short- and long-term outcomes of these patients. There is an abundance of literature detailing the risk/benefit profile of IM epinephrine use in anaphylaxis; however, there is no human data on this topic as it relates to cardiac arrest. Important knowledge gaps include whether the use of IM epinephrine via autoinjector and/or pre-filled syringe leads to faster administration of the initial doses of epinephrine without delaying time to definitive epinephrine (via IV/IO) and the impact on time to initial and sustained return of spontaneous circulation (ROSC). This trial will be the first to examine the role of IM epinephrine via autoinjector/pre-filled syringe in POHCA.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 day to and including 17 years experiencing an out-of-hospital cardiac arrest (OHCA)
* Must be receiving at least 1 minute of CPR by trained first responders (police, fire, or paramedic services)

Exclusion Criteria:

- Children who experience OHCA due to an obvious traumatic event.
"The Effect of Humor and Laughter on C Reactive Protein: A Pilot Study"

The study is to see if watching humor and laughing can affect CRP levels in healthy individuals. This is a randomized controlled trial.

Subjects will be...males and females: students, employees, and members of the community.

5. "Subjects will be between ___18_ and ___99_ years of age."

6. "In total, subject participation will last approximately ___1 day for 90 minutes_

7. "Subjects will be recruited _by word of mouth at the Loma Linda University Campus and surrounding communities___."

8. "Consent will take place _by investigators in Nichol Hall Room A620/A640___."

9. If Multi-center:

10. If Single center or investigator-initiated:

"_60__ subjects will participate in the study."

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-99 yrs , healthy individuals

Exclusion Criteria:

* Under 18 years old, or over 99 years old, non healthy individuals
ADVANCE Direct Aortic Study

This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected.

This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected. As part of the study analysis, resource utilization together with the Quality of Life questionnaires data will provide an important input into cost effectiveness analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Severe symptomatic aortic valve stenosis requiring treatment
2. Acceptable candidate for elective treatment with the Medtronic CoreValve® System according to the most recent version of the Medtronic CoreValve® Instructions For Use
3. 21 years of age or older
4. Patient is willing and able to comply with all protocol-specified follow-up evaluations
5. The patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form")
6. Patient will receive the CoreValve® device via direct aortic approach TAVI -

Exclusion Criteria:

1. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated
2. Sepsis, including active endocarditis
3. Recent myocardial infarction (\<30 days)
4. Left ventricular or atrial thrombus by echocardiography
5. Uncontrolled atrial fibrillation
6. Mitral or tricuspid valvular insufficiency (\>grade II)
7. Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)
8. Evolutive or recent (within 6 months of implant procedure) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
9. Patients with:

   1. Vascular conditions that make insertion and endovascular access to the aortic valve impossible, or
   2. Symptomatic carotid or vertebral arterial narrowing (\>70%) disease, or
   3. Thoracic aortic aneurysm in the path of delivery system
10. Bleeding diathesis or coagulopathy
11. Patient refuses blood transfusion
12. Estimated life expectancy of less than 12 months unless TAVI is performed
13. Creatine clearance \<20 mL/min
14. Active gastritis or peptic ulcer disease
15. Pregnancy or intent to become pregnant during study follow up
16. Patient is participating in another trial that may influence the results of this study

    -
Shade Matching of Universal Versus Conventional Nanohybrid Resin Composites in Class IV Restorations After Bleaching

The aim of the current study is to assess the shade matching potential of single shade universal resin composite versus conventional nanohybrid resin composite in class IV restorations after bleaching

The use of a dental material that can blend into the surrounding tooth structure is increasing in popularity . A new technology , smart chromatic technology , has been introduced as the shade matching composite called omnichroma . Omnichroma has the ability to match the new lighter shade of the bleached teeth unlike the conventional composite . In this study , an investigation will be done to evaluate if this new technology will help to preserve the tooth structure and be more conservative , by avoiding the removal of the old anterior restorations after bleaching

Eligibility Criteria:
Inclusion Criteria:

* Candidates must have one or more existing class IV restoration.
* Cases indicated for bleaching.
* Cooperative patient approving to participate in the trial.

Exclusion Criteria:

* Patients with severe medical conditions that might interfere with the study.
* Patients with rampant caries or xerostomia.
* Smoking.
* Patients with history of hydrogen peroxide sensitivity , periodontal inflammation.
* Lack of compliance.
* Tempromandibular joint disorders.
* Disabilities.
Evaluation of the POSOS Device for Iatrogenesis Detection in Clinical History? A Vignettes Study

This study is a multicenter evaluation of diagnostic performance using simulated clinical vignettes. It aims to test the effectiveness of the POSOS app in detecting drug-induced iatrogenesis in urgent medical situations, an issue of public health importance. Participating physicians, who are randomly assigned to either use or not use POSOS, are categorized based on their years of experience. Vignettes, including a mixture of complex, simple, and non-iatrogenesis cases, are assigned to these doctors. During the simulation, physicians respond to their respective vignettes on the YgheniVi platform, with responses recorded at two intervals (5 min and 15 min). The supervising physicians subsequently fill out an e-CRF, providing further data on the time spent, the number of medical research applications used, and the overall user experience of POSOS. A doctor/pharmacist pair then corrects the answers to the vignettes.


Eligibility Criteria:
Inclusion Criteria:

* Not applicable as the study population is made up of clinical vignettes, there is no inclusion of patients.
* The physicians included are emergency physicians, selected by convenience so as to have as many physicians (seniority of practice 3 years after thesis) as (seniority of practice less).

Exclusion Criteria:

* Not applicable.
* Simulations with technical faults will be excluded: (absence of the test doctor, internet access not working, PC malfunction, serious disruptions during the simulation).
A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia

The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia


Eligibility Criteria:
Inclusion Criteria:

* Subject has a serum sodium value between 115 and 133 mEq/L
* Subject is euvolemic or hypervolemic

Exclusion Criteria:

* Clinical evidence of volume depletion or dehydration
* Uncontrolled brady- or tachyarrhythmias requiring emergent pacemaker placement or treatment