cyrilzakka/clinical-trials huggingface dataset:
Retention Rate and Caries Preventive Effect of Self Etch Giomer Based Fissure Sealant

With limited evidence-based information in literature about using giomer based pit and fissure sealant(BeautiSealant) in non-cavitated pits and fissures in permanent molars, it is beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that this new pit and fissure sealant (BeautiSealant, Shoufu, USA). will have the same effect as resin based pit and fissure sealant (UltraSeal XT™ plus, Ultradent, USA) regarding retention rate and caries preventive effect.

Giomer is an adhesive material in dentistry made from resin that contains a Pre-Reacted Glass- ionomer (PRG) filler. The advantages of Giomer include the release and recharge of fluoride, resistance to acid, anti-plaque effect, remineralization of dentin, and acid buffering capacity. The surface pre-reacted glass-ionomer filler containing sealant (BeautiSealant) demonstrated superior fluoride recharging properties. BeautiSealant is filled with Shofu's proprietary S-PRG (Surface Pre-Reacted Glass) with cariostatic properties, acid neutralization, and plaque inhibition decreasing the risk for secondary caries. Beautisealant unlike traditional sealants which require phosphoric acid etching, demineralizing and dehydrating healthy teeth, shoufu's self etching primer is significantly less acidic helping to preserve healthy tooth structure and still maintaining equal or better shear bond strength. The clinical use of self-etching agents could be recommended before pit and fissure sealants application in new dental protocols. No clinical trials have been published uptill now evaluating caries incidence around giomer based fissure sealant by VistaCam iX proof. The aim of this study is to Evaluate the retention rate of self etch giomer based fissure sealant and also caries incidence using VistaCamiX.

Eligibility Criteria:
Inclusion Criteria:

* Young adults (16-22 y).
* Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
* Permanent molars teeth without any caries and cavitation.
* Permanent molar teeth that have deep pit and fissure morphology, with "sticky" fissures. •Permanent molar teeth with stained grooves.
* Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2).

Exclusion Criteria:

* Uncooperative behavior, limits the use of sealants due to hampering of adequate field or isolation techniques throughout the procedure.
* Patients allergic to sealant material.
* Patient with history of medical disease, drug therapies or any other serious relevant problem.
* An individual with no previous caries experience and well coalesced pits and fissures
* Partially erupted teeth.
* Teeth with cavitation or caries of the dentin.
* A large restoration is present on occlusal Surface.
* If pits and fissures are self-cleansable.
* Teeth with dental fluorosis, hypocalcification or hyper calcification.
Clinical Trial Designed to Determine the Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy

The study consists of two periods, the Screening Period (\~3 weeks) and Treatment Period (12 weeks).

Eligibility for the study will be determined by Screening tests, physical examination/medical history, and fulfilment of eligibility criteria including assessment of pain completed during the Screening Period. Potential participants will be required to provide written informed consent prior to any study-specific Screening procedures being performed.

Following Screening assessments, patients will be randomized to receive either EMA401 300 mg BID or placebo.

Patient study visits during the Treatment Period are at the end of baseline/randomization visit, and end of Weeks 3, 6, 9, and 12, for assessments.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type I or Type II diabetes mellitus with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least six months duration.
* Be assessed as suffering from moderate to severe pain across the Screening Period. The assessment of moderate and severe pain will be made using an algorithm proprietary to Spinifex. The investigator/site staff will be informed immediately as to whether the patient is eligible or ineligible on the ePRO website based on the patient entering all relevant pain scores in the eDiary device.
* Women of child bearing potential (WOCBP), must have a negative urine pregnancy test at the Screening visit (Visit 1) and within 72 hours prior to administration of IP.

Exclusion Criteria:

* Patients taking any topical treatment for their PDN at the time of Screening Visit 2 will be excluded, including lidocaine plaster, capsaicin patch, and any other topical preparations of these or any other topical medications (e.g., aspirin, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) for their PDN.
* Have a blood pressure reading, after resting for at least five minutes, outside a systolic blood pressure range of 84 - 151 mmHg or a diastolic blood pressure \> 95 mmHg. If the blood pressure is outside of the range, a repeat measurement can be taken after the patient has rested. The repeat measurement should be used as the screening value.
* Have serum aspartate transaminase (AST), or alanine transaminase (ALT) levels \> 1.5 x the upper limit of normal or have total bilirubin concentrations \> 1.5 x the upper limit of normal at Screening (Visit 1).
* Have hemoglobin A1c \> 11 %.
* Known history of, or positive laboratory results for hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection as defined by being seropositive for hepatitis B surface antigen (HBsAg), HCV antibodies or HIV antibodies respectively.
* Have undergone neurolytic or neurosurgical therapy or use a neurostimulating device for PDN.
Task-specific Training for Patients With Acute Exacerbation of COPD

Patients with Chronic Obstructive Pulmonary Disease (COPD) experience a progressive deterioration in their quality of life. Task-specific training is a type of approach focused on chronic patients that allows the acquisition of new skills or improvement of lost skills. The overall objective of this project is to evaluate the effectiveness of a task-specific training program during hospitalization of patients with acute exacerbation of COPD. A randomized clinical trial will be conducted in patients hospitalized for COPD. Participants after signing informed consent will be randomized between the control group (standard treatment) and the intervention group (task-specific training program in addition to standard treatment). The task-specific training program is a multidisciplinary program divided into three blocks where specific tasks will be performed on symptom education, education of activities of daily living and improvement of physical capacity with the aim of reinforcing skills necessary for the self-management of COPD patients in the short, medium and long term.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized for acute exacerbation of COPD.
* Over 18 years of age.
* Who wish to participate in the study.
* Who sign the informed consent form.

Exclusion Criteria:

* Patients with inability to provide informed consent.
* Presence of psychiatric or cognitive disorders, organ failure, cancer and/or inability to cooperate.
* Patients who had experienced exacerbation of COPD in the previous month were also excluded.
Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery

Excitement during the emergence from general anesthesia is a great post-operative problem. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters, and it can necessitate physically or chemically restraining the patient. It has been reported that the incidence of postoperative emergence excitement in adults after general anesthesia is 21.3% occurrence.

Many things are mentioned as risk factors for emergence excitement. Among them, excitement after orthognathic surgery (two-jaw) was more common than after other types of surgery. The patients undergoing emergence with nasotracheal intubation after orthognathic surgery may have a sense of suffocation during emergence from anesthesia, which may increase the incidence of emergence excitement.

Pain is also a main cause of postoperative excitement. Dexmedetomidine, which is an S-enantiomer of medetomidine with high specificity for α2-adrenoceptor (α2 : α1, 1620 : 1) compared to clonidine (a2 : a1, 220 : 1), is approved as a sedative and co-analgesic drug.

To the best of the investigators knowledge, effect of dexmedetomidine on emergence excitement was investigated only in children.

The investigators hypothesized that single dose of dexmedetomidine would reduce the incidence and the severity of the emergence excitement in adults with nasotracheal intubation after orthognathic surgery (two-jaw).


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1 or 2 patients
* patients scheduled for orthognathic surgery (two-jaw)

Exclusion Criteria:

* severe cardiovascular disease
* allergy to dexmedetomidine
* psychological disease
* patients who cannot understand Korean
A Study Using the LMC Diabetes Registry to Learn More About Chronic Kidney Disease (CKD) in Canadian Patients With Type 2 Diabetes (T2D)

In people with type 2 diabetes (T2D), the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels.

People with T2D are at a higher risk of having a condition called chronic kidney disease (CKD). In people with CKD, the kidneys become damaged and do not work as they should. People with CKD can have trouble breathing and often have swelling in their arms and legs, and high blood pressure.

People who have CKD and T2D are more likely to have other medical problems, such as heart disease.

There are many treatments available to patients who have CKD and T2D. But, researchers need more information about how doctors in Canada are deciding which treatment to give these patients.

In this study, the researchers will review health information from men and women with T2D who visited a doctor in 2019 and had check-ups for at least 6 months. The health information will be taken from a Canadian registry (or database) owned by LMC Diabetes \& Endocrinology. The registry contains information from people that went to an LMC clinic. In this study, the researchers will learn how many of these people had T2D and CKD. They will learn the treatments these people received, and if they had other related medical problems. The researchers will also use surveys to ask the doctors about why they chose certain treatments.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of T2D as captured in the LMC EMR system
* Assessed by an LMC endocrinologist between January 1, 2019 and December 31, 2019
* Followed by an LMC endocrinologist for ≥ 6 months prior to inclusion in the cohort
* Informed consent to use patient medical record data for research purposes was provided

Among patients who meet the inclusion criteria, estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73 m\^2 and/or urine albumin-to-creatinine ratio (uACR) ≥ 2 mg/mmol will be used to identify the cohort of patients with T2D and CKD

Exclusion Criteria:

- Any patients with documented non-diabetic etiology for renal disease will be excluded from the numerator (number of patients with CKD and T2D) when determining the primary endpoint
Therapeutic Diets in Alzheimer's Disease

By doing this study, researchers hope to learn how the ketogenic and Therapeutic Lifestyles Changes diets affect cognition in patients with Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AD by current McKhann et al. criteria
* CDR global score of 0.5 or 1
* Agreed cooperation from an appropriate study partner
* Speaks English as primary language
* Age 50 to 90
* No medication changes within the past 30 days

Exclusion Criteria:

* Resides in a nursing home or dementia special care unit, or cannot control diet
* A potentially confounding serious medical risk including insulin-requiring diabetes, cancer requiring chemotherapy or radiation within the past 5 years, or a recent cardiac event (i.e. heart attack, angioplasty, etc.)
* Participating in another clinical trial or using an investigational drug or therapy within 30 days of the Screening Visit
* A history of renal stones
Post-Licensure Safety Study of ISENTRESS™ (Raltegravir) in a United States Managed Care Network (MK-0518-268)

The objective of this study is to monitor Health Outcomes of Interest (HOI) in participants with human immunodeficiency virus-1 (HIV-1) infection following treatment with Raltegravir.

Study participants contributed data to one or more of 3 cohorts: 1) Historical Cohort: HIV-infected participants treated with antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of Kaiser Permanente (KP) between 1 January 2000 and 12 October 2007 (date of market authorization for raltegravir in USA), 2) Concurrent Cohort: HIV-infected participant treated with a new non-raltegravir antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007, and 3) Raltegravir Cohort: HIV-infected participant treated with raltegravir in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007. Participants could contribute data to more than one cohort, but no overlap in follow-up time was allowed.

Eligibility Criteria:
Inclusion Criteria:

* Historical Cohort: HIV-infected participant treated with antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of Kaiser Permanente (KP) between 1 January 2000 and 12 October 2007 (date of market authorization for raltegravir in USA)
* Raltegravir Cohort: HIV-infected participant treated with raltegravir in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007
* Concurrent Cohort: HIV-infected participant treated with a new non-raltegravir antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007
* All participants must have at least one year of continuous membership with KP prior to date when the participant received the first dispensed prescription for study drug (index date) to allow for the assessment of medical and treatment history

Exclusion Criteria:

* Less than 18 years of age
* Do not receive their medications through the KP pharmacy system
* Do not receive their laboratory examinations through the KP system
* Participating in the raltegravir phase III or expanded access program
Sesame Street Growing Together Evaluation

This study aims to evaluate the appeal and effectiveness of Sesame Workshop's Growing Together online professional development course.


Eligibility Criteria:
Inclusion Criteria:

Teachers:

* Work in an eligible center with a director who has agreed for the center to participate in the study
* Serve as the lead teacher in a classroom with at least 3 four year olds (can be a co-teacher and can teach a mixed age class)
* Have access to reliable, high-speed internet
* Have an email address that can be shared with researchers
* Read English enough to understand course materials and/or surveys
* Not have previously accessed the Growing Together course
* Be available during the timeframe of the study

Parents:

* Have a child who is 4 years old or about to be 4 years old during the weeks of the course enrolled in a classroom at least 3 days in a typical week with a teacher interested in participating in the study
* Have access to reliable, high-speed internet
* Have an email address that can be shared with researchers
* Read English enough to understand course materials and/or surveys
* Be available during the timeframe of the study

Exclusion Criteria:

Teachers:

* Working in an ineligible center
* Working in a center with a director who has not agreed for the center to participate in the study
* Not being a lead teacher
* Not teaching at least 3 four year olds
* Not having access to reliable, high-speed internet
* Not willing to share an email address with researchers
* Being unable to read English enough to understand course materials and/or surveys
* Having previously accessed the Growing Together course
* Not being available during the timeframe of the study

Parents:

* Not having a child who is 4 years old or about to be 4 years old during the weeks of the course
* Not having a child enrolled in a classroom at least 3 days in a typical week
* Not having a child enrolled in a classroom with a teacher interested in participating in the study
* Not having access to reliable, high-speed internet
* Not willing to share an email address with researchers
* Being unable to read English enough to understand course materials and/or surveys
* Not being available during the timeframe of the study
Treating Chronic Knee Pain with Noninvasive Peripheral Nerve Stimulation Using Novel Interferential RadioFrequencies

First, the subject will undergo screening and provide informed consent. Baseline measurements are then taken. The subject remains seated with back support throughout the session. The technician verifies and marks the knee for treatment and wraps an antenna applicator strap around the lower leg near the knee. The device is turned on in test mode to confirm the therapy location, with the subject identifying when they feel a sensation over their pain area. The power threshold for this sensation is recorded. The therapy, which lasts 15 minutes, is delivered at 90% of this threshold to ensure the subject does not feel it. After therapy, post-treatment measurements are taken.

1. Subject will perform screening and informed consent
2. Baseline measurements will be taken
3. Subject will sit in chair with back support throughout duration of the session
4. Knee for treatment will be verified and marked
5. Technician will wrap antenna applicator strap around the lower leg, at the knee
6. Device is turned on and set to test mode to verify therapy location. Subject will verify when they feel a sensation covering their existing chronic knee pain. The power threshold for sensation is recorded.
7. Therapy begins and lasts for 15 minutes, power threshold is set to 90% so that the subject does not feel the therapy
8. At the end of 15 minutes, post-therapy measurements are recorded

Eligibility Criteria:
Inclusion Criteria:

* Pain greater than mid-range using standardized pain inventory (SPI).
* No medication for pain both over-the-counter and by prescription for 24 hours prior to treatment.
* Body mass index (BMI) to be calculated for all participants with limitation for any BMI that is lower than normal. (Target is normal, overweight or obese).
* Age greater than 18.

Exclusion Criteria:

* Existing Peripheral Nerve Stimulator Implant in the lower extremities
Informational App Development for mHealth for Patient Self-Management of Opioid Use Disorder

This study will evaluate the feasibility of an app that provides drug information to people in recovery from opioid use disorder. This study is designed to test the prototype app, not to determine health outcomes. The study will confirm the design and operating specifications prior to being evaluated in a larger clinical trial.

The overall study is designed in two steps: 1) a one-week proof-of-concept study; and 2) a one-month pilot study.

Step 1: A one-week proof-of-concept study will be performed in a small population (n=5) of individuals in opioid use disorder recovery as an indicator of the app's suitability. Study participants will use the sham app for one week and will then complete a usability and user satisfaction survey. If the app is found to be exhibit acceptable usability and satisfaction, a one month study will be completed in a larger sample (see Step 2, below). If not, modifications to the app will be made and the one-week study will be repeated in a new group of participants.

Step 2: After completion of the proof-of-concept study, 20 new participants will be enrolled in a 4-week trial. Study participants will complete baseline assessments and then be asked to use the app at least three times per week, for four weeks. At the end of four weeks, participants will complete usability and user satisfaction surveys.

Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients 18 years of age or older
* Currently enrolled in an opioid treatment program and receiving medication assisted treatment for opioid use disorder
* Currently stable in opioid use disorder outpatient treatment for 4 weeks or longer
* Ability to access the app via smart phone, or tablet.

Exclusion Criteria:

* Unwilling or unable to comply with study requirements
* Have a psychiatric or medical disorder interfering with ability to use the app
* Incarcerated
* Pregnant
Comparative Effects of Hold Relax Technique and Mulligan Mobilization in Post Operative Knee Joint

The aim of this study is to investigate the comparative effects of hold relax technique and mulligan mobilization on pain, ROM and function in post operative knee joint.

Stiffness or restricted ROM of the knee joint is a term used commonly to describe any traumatic condition occurring within or around the knee joint. It can result from direct and indirect below and is experienced as pain with activity, local tenderness to palpation, and decreased ability to tolerate tension, which results in decreased movement and functional strength. Post-traumatic knee stiffness and loss of range of motion is a common complication of injuries to the knee area. Immobilization of human knees for several weeks or more can result in stiffness and loss of range of motion in the joints. After knee arthroplasties, cruciate ligament repairs and trauma may lead to contracture of muscles and knee instability. Limitations of joint movements both flexion and extension suggests intraarticular pathology.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female of age 20 to 40 years

  * Knee pain 3 or more on VAS
  * Patients with grade 3 or more than 3 power of knee muscle
  * Subjects with post traumatic stiffness of knee joint having a minimum of 70 degree of knee flexion

Exclusion Criteria:

* Hypermobile and unstable joint

  * Soft tissue injuries
  * Joint infection and loosening
  * Other complication of post fracture/ TK
COVID-19 RELATED KIDNEY DAMAGE

In this study, we investigate whether the early detection of risk factors in Covid-19 associated acute kidney injury contributes to us in the early initiation of treatment. We predict that if acute kidney damage is detected early in patients with early risk factors, permanent kidney damage will be seen less. In addition, we think that covid-19 patients may have positive contributions to shortening treatment time and reducing treatment costs. In addition, we are investigating whether it has a positive effect on patients' survival. In other words, we are investigating the contribution of risk factors to early diagnosis and treatment, the effect on health expenditures and mortality in patients with COVID-19 with acute kidney damage.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 aged
* patients in ICU

Exclusion Criteria:

* Patients with known Chronic Renal Failure
* who have received dialysis treatment before
* who are under 18 years of age