cyrilzakka/clinical-trials huggingface dataset:
Retention Rate of Giomer Pit and Fissure Sealant Applied With or Without Etching

The aim of this study is to evaluate the retention rate of Giomer S-PRG filler containing pit and fissure sealant applied with or without etching by using split mouth technique.with null hypothesis that Giomer S-PRG filler containing pit and fissure sealant applied either with or without etching will have the same retention rate.

Study Settings:

The study will be carried out at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University in Egypt. Ethical approval is taken from the Research Ethics Committee of the faculty of Dentistry, Cairo University. Signed informed consent is signed by each participant.

Recruitment:

Participants are recruited from the patients' flow at the clinics of the Conservative Dentistry Department of Faculty of Dentistry, Cairo university.

Eligibility Criteria:

Inclusion Criteria:

1. ICDAS score 0 or 1
2. Satisfactory oral hygiene
3. Normal salivary characteristics (consistency, pH, flow rate, buffering capacity)
4. Satisfactory cooperative behavior
5. Age between 15- 30 years old
6. Males or females
7. Subjects who signed informed consent

Exclusion Criteria:

1. ICDAS score \> 1
2. Poor oral hygiene
3. Evidence of tempromandibular joint disorders or malocclusion

Materials used in this trial are the Giomer S-PRG filler containing pit and fissure sealant (Beautisealant) and its self etching primer (Beauisealant primer).

Control group:

In the control group, an adequate amount of primer will be applied onto the enamel surface with a microbrush, left undisturbed for 5 s and then air-dried gently to avoid blowing it away. Beautisealant will be applied directly from the syringe into pits and fissures and light-cured for 10 s, according to the manufacturer's instructions.

Intervention Group:

In the intervention group, the same steps will be done except for an additional initial etching step with phosphoric acid etching for 30 s (for the uncut enamel) before primer and sealant application.

Outcome Assessment:

The results of sealant retention were assessed according to the following criteria (Simonsen):

A complete retention B partial loss (B1, without caries; B2, with caries) C complete loss (C1, without caries; C2, with caries)

Eligibility Criteria:
Inclusion Criteria:

1. ICDAS score 0 or 1
2. Satisfactory oral hygiene
3. Normal salivary characteristics (consistency, pH, flow rate, buffering capacity)
4. Satisfactory cooperative behavior
5. Age between 15- 30 years old
6. Males or females
7. Subjects who signed informed consent

Exclusion Criteria:

1. ICDAS score \> 1
2. Poor oral hygiene
3. Evidence of tempromandibular joint disorders or malocclusion
Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery

The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the postoperative ambulation.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Patients undergoing replacement of hip arthroplasty
* Be legally competent
* Read and understand Danish

Exclusion Criteria:

* Present malignant disease
* Known heart disease with functionality equivalent to NYHA II or CCS II or worse
Low Cost OCT for Point of Care

The purpose of this study is to compare the performance of a prototype optical coherence tomography (OCT) machine with currently available high resolution OCT machines.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to receive standard OCT testing as part of their clinical visit

Exclusion Criteria:

* none
Study of the Relationship Between Blood Vessels and Insulin Response in Adolescents

This study is designed to determine whether there is a relationship between the way insulin and blood vessels work. The difference in the interaction between Caucasian and African American adolescents will also be examined. This may play a role in the differing rates of heart disease and diabetes between the two groups.

Purpose: The purpose of the research is to learn more about how the lining of arteries in the body (called the endothelium) and insulin work in adolescents. Abnormalities in how the blood vessels and insulin work in adolescents may cause high blood pressure, type 2 diabetes, stroke and heart disease.

Healthy adolescents between 8 and 18 years of age are being studied in the Ohio State University General Clinical Research Center. Two visits will be necessary. One will be a screening visit to determine the child's stage of puberty and obtain a medical history. The second will be the study visit. During the latter, blood vessel function will be determined by studying the change in forearm blood flow before and after blood flow to the forearm is stopped. Insulin sensitivity will be determined using glucose water given into a vein.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian or African American adolescent
* Between 8 and 18 years of age

Exclusion Criteria:

* Pregnancy
* Chronic Disease
* Acute Disease
* Medication Requirement
The Effect of the Covid-19 Pandemic Among Operated Patients

This project covers several research aims. In a cohort study, the investigators aim to compare confirmed COVID-19 patients with non-COVID-19 patients who undergo surgical treatment and study factors associated with good or bad outcomes.

Background A novel Coronavirus (SARS-CoV-2) was first detected in the Hubei Province in China in December, 2019. The virus causes a severe respiratory disease (Coronavirus disease 2019, COVID-19) that has rapidly spread worldwide. The COVID-19 pandemic is prognosed to affect a majority of the world's population before the end of 2020. Throughout the course of the pandemic, patients will continuously need essential healthcare, such as for acute surgical conditions. How the clinical course and management of surgical conditions is influenced by concomitant COVID-19 is largely unknown. There is an acute need for an improved evidence base to inform treatment strategies and guide the management of this patient group.

Objectives of initial analyses

1. To compare confirmed COVID-19 patients with non-COVID-19 patients who undergo surgical treatment and study factors associated with good or bad outcomes.

Methods The study will enroll consecutive patients that undergo surgical treatment in the Stockholm Region. Data will be extracted from a series of linked electronic systems, such as electronic healthcare records systems, and regional data systems. Collected data will include routine clinical data, such as baseline characteristics, previous medical history, details on care given at the hospital and data from follow-up visits. Endpoints include death, length of hospital stay and complications, such as readmission, reoperation, sepsis, respiratory failure, and number of days in the intensive care unit. Outcome data of patients with confirmed COVID-19 will be compared to those of patients without COVID-19.

Dissemination and relevance To the best of the investigators knowledge, there has been no previous comprehensive comparative research on patients with and without confirmed COVID-19 that undergo surgical treatment. The results will be disseminated through peer-reviewed publications, aiming for journals with a rapid editorial process, preferably open access journals. The findings are expected to increase the knowledge to establish best-treatment strategies and improve outcomes, both for patients affected by COVID-19 and by future epidemics.

Eligibility Criteria:
Inclusion Criteria:

* Patients that undergo surgical treatment in the Stockholm Region during the study period

Exclusion Criteria:

-
eUltra 10k - Biofreedom Ultra

This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post Market Clinical Follow up (PMCF) as part of the Post-Market Surveillance.

Prospective, observational multi-center registry to be conducted at up to 150 interventional cardiology centers in up to 15 countries. Patients will be followed by telephone for 1 year after PCI for data collection. This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post-Market Surveillance.

This registry will enroll up to 10000 patients in up to 150 investigative centers in Europe, South America, Middle East, Asia over a period of 5 years. Each patient be followed with phone (or clinic) visit at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* According to the current version of Instructions of Use (IFU)
* Patient is at least 18 years old
* Patient provides a signed informed consent

Exclusion Criteria:

* According to current version of IFU
* Patients will be excluded as per Medical Device Regulation (MDR) (Article 65: "Clinical investigations on minors" and article 66: "Clinical investigations on pregnant or breastfeeding women"
* Patients will be excluded if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision
GP_Posit Intervention for Mothers of Preterm Infants for Maternal Sensitivity : Randomized Pilot Trial

The aim of this study is to evaluate the acceptability, feasibility and preliminary effects a GP_Posit intervention. GP_Posit is an intervention where mothers will learn how to participated in their preterm infant's care and positioning while being guided by a nurse. Preliminary effects will be estimated on maternal sensitivity, stress and anxiety as well as preterm infant's neurodevelopment.


Eligibility Criteria:
This study will recruit mother-infant dyads.

Inclusion Criteria for mothers:

* Understand, write and read French and/or English
* Are 18 years or older

Exclusion Criteria for mothers:

* Use drugs
* Have an instable mental health
* Give their newborn infant for adoption

Inclusion Criteria for preterm infants:

* Are born at 27 0/7 et 31 6/7 weeks of gestation
* Are hospitalized in the NICU for at least 4 weeks

Exclusion Criteria for preterm infants:

* Require surgery
* Have intraventricular haemorrhage (IVH) \> grade 2
* Have congenital malformations
CHOlesterol Lowering and Residual Risk in Type 2 Diabetes

The purpose of this study is to investigate why individuals with type 2 diabetes are at increased risk for heart disease and stroke. This study will investigate risk factors for heart disease and stroke, including platelet (involved in clotting) activity, inflammation, blood vessel wall function, and genetic information (blueprints of your cells), in participants with type 2 diabetes and elevated cholesterol. This study will also include a control group - subjects with elevated cholesterol who do not have diabetes. All participants will be given cholesterol-lowering medicines (PCSK9 inhibitor and statin or ezetimibe) for 1 month with the same risk factors being measured following cholesterol reduction. This study will help understand why individuals with type 2 diabetes are at higher risk for heart disease and stroke before and even after cholesterol reduction.

As part of this SFRN investigating REPAIR (non-progression of clinical events or regression of atherosclerosis) in T2D, this project will reveal mechanisms behind the platelet mediated increased cardiovascular risk in patients with T2D by focusing on the platelet transcriptome in those with clinical progression and subsequent cardiovascular events versus those without clinical progression. A prospective clinical study will investigate platelet activity and transcriptome before and after significant cholesterol reduction to better understand mechanisms of increased residual risk observed in patients with T2D, even when cholesterol is not elevated. By combining prospective studies on the platelet phenotype in humans with T2D, mechanistic mouse models of diabetes-accelerated atherosclerosis in the Fisher, Basic Project, and the human plaque and genomic data available data from the Giannarelli, Population Project, the investigators believe the research will fill an important and clinically significant gap in the understanding of how diabetes attenuates cardiovascular repair and to identify new treatment and prevention strategies.

Eligibility Criteria:
Inclusion Criteria:

Subjects with type 2 diabetes:

* Age ≥ 18 \& \< 90
* LDL-C \>100mg/dl
* Able and willing to provide written informed consent for the study

Control subjects without known diabetes:

* Age ≥ 18 \& \< 90
* LDL-C \>100mg/dl or lp(a) \>50 mg/dl
* Able and willing to provide written informed consent for the study

Exclusion Criteria:

Subjects with type 2 diabetes:

* Established cardiovascular disease on antithrombotic therapy
* Triglycerides \>250mg/dl
* Use of a PCSK9 inhibitor
* HbA1c \>10%
* Recent infection in the past 30 days
* Any hospitalization in the past 30 days
* Use of Immunosuppressive therapy
* Use of any antithrombotic therapy
* Use of aspirin
* Use of NSAID within the past 72 hours
* Pregnancy
* Anemia (hemoglobin \< 9 g/dl) or thrombocytopenia (Platelet count \<75), or thrombocytosis (Platelet count \>600)
* A history of severe bleeding or bleeding disorders
* Chronic kidney disease (CrCl \< 30ml/min)

Control subjects without known diabetes:

* Diabetes (type 1 or type 2)
* All other exclusions are identical to the type 2 diabetes group.
Efficacy and Safety of HRS9531 Injections in Overweight or Obese Subjects

To assess the efficacy of HRS9531 injection compared with placebo in weight reduction in overweight or obese subjects after 36 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent.
2. Male or female subjects, 18-65 years of age at the time of signing informed consent.
3. 28.0 ≤BMI≤ 40.0 kg/m2 or 24 ≤BMI\< 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit.
4. Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.

Exclusion Criteria:

1. Presence of - clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit.
2. poor-controlled hypertension.
3. PHQ-9 score ≥15.
4. Medical history of illness that affects weight.
5. History of diabetes.
6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening.
7. History of acute cardiovascular and cerebrovascular diseases.
8. Any organ-system malignancies developed within 5 years except cured local basal cell carcinoma of skin and cervical carcinoma in situ.
9. Confirmed or suspected depression, bipolar disorder, suicidal tendency, schizophrenia, or other serious mental illness.
10. History of alcohol , medication or drug abuse within 1 year prior to screening.
11. Use of any medication or treatment that may cause significant weight change within 3 months.
12. History of bariatric surgery.
13. Subjects participating in QT/QTc studies need to comply with relevant examinations.
14. Known or suspected hypersensitivity to trial product(s) or related products.
15. Participation in other clinical trials within 3 month prior to screening.
16. History of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening
17. Surgery is planned during the trial.
18. Mentally incapacitated or speech-impaired.
19. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method.
20. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.
21. In the judgment of the investigator, there are circumstances that affect the safety of the subject or any other interference with the evaluation of the test results.
Perturbation Based Training And Bobath-Based Trunk Exercises On Gait , Postural Control And Mobility

This study compares two approaches for rehabilitating stroke patients: Perturbation-Based Training and Bobath-Based Trunk Exercises. The perturbation based training focuses on challenging patients with unexpected movements to improve their balance and stability. While the Bobath method, concentrating on facilitating normal movement patterns. The study aims to determine which approach yields better outcomes in terms of trunk control, balance, and functional recovery for stroke patients. This study will also enable the individual to be more independent and minimize their falls.

Cerebrovascular is a leading cause of physical impairment and long-term disability in the globe. The complication of stroke is mobility impairment like balance, gait, and posture disorders. This impairment leads to a higher risk of falls, reduced ability in daily activities, and difficulty restoring the overall health and quality of life. Cerebrovascular accident is the second cause of fatality. Hence, one of the primary objectives in stroke rehabilitation is to restore postural stability and functional balance, which is a combination of dynamic, static and reactive balance. For improving postural stability and balance one such technique is the utilization of a rocker board, where a platform positioned on an unstable surface is used to challenge balance. Whilst rocker boards have been used effectively for, postural stability, injury prevention, rehabilitation and balance enhancement. Improvements in rocker board performance may be attributable to one or more of the following: muscle strengthening, enhanced intersegmental coordination, increase in brain activity in the supplementary motor area and/or enhanced feed-forward and feed-backward postural control mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Able to walk with or without ambulatory aids
* Able to follow commands.
* Patients in the subacute and chronic stages associated with stroke hemiparesis (time since
* stroke onset 6 months- 1 year)
* Scoring \> 21 on MMSE

Exclusion Criteria:

* Patients who have severe limitations in passive range of motion at lower extremities
* Visual and sensory deficits
* Patient who has contracture
* Orthopedic or any other neurological disorder which impair balance.
* Patients undergoing any other balance training protocol.
* Patients with recurrent strokes
* Participants who are currently participating in another clinical trial or research study
Study of INV-102 Ophthalmic Solution in Adults With Moderate Symptomatic Dry Eye Disease

Phase 1/2, first-in-human, 2-part study to assess topically administered eyedrops of INV-102 during 2-week repeat dosing in subjects with moderate symptomatic dry eye disease. Part 1 will be a Dose Escalation phase across 4 cohorts of subjects to assess safety and tolerability of INV-102, and Part 2 will be an Optional Dose Expansion phase in a fifth cohort of subjects, pending the outcome of Part 1, to assess efficacy of INV-102 in the treatment of moderate symptomatic dry eye disease.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male or female subject ≥18 years of age
* Presence of moderate DED in at least one eye

Key Exclusion Criteria:

* Presently using prescription eyedrops, except those used for DED, which must be discontinued 2 weeks prior
* Use of OTC eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing
* External eye disease except primary DED
* Systemic disease associated with DED
* History or evidence of ocular infection within the previous 30 days
* History or evidence of ocular herpes simplex or ocular herpes zoster
* Blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months
Finnish Imaging of Shoulder Trauma

The FIMAGE-Trauma study is an extension of the FIMAGE study and aims to answer the question if rotator cuff tears found on shoulder imaging after a shoulder injury are caused by the index trauma or are rather incidental findings. Eligible participants of the FIMAGE study will be invited to a follow up visit in the case of a shoulder injury or a sudden onset of significant shoulder symptoms (within a 2-year time frame). These findings will then be compared to the baseline data collected in the FIMAGE study (including the comparison of pre-injury and post-injury MRI:s)


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory
* Participated in the FIMAGE
* Baseline MRI from FIMAGE study available

Exclusion Criteria:

* Contraindications to MRI
* Previous shoulder joint replacement
* Previous rotator cuff surgery
Noxipoint Therapy Versus Standard Physical Therapy Using Electrical Stimulation for Chronic Pain

The purpose of this study is to validate the efficacy of Noxipoint(TM) therapy on chronic pain, and compare it with standard physical therapy using electrical stimulation on patients with chronic pain.

Invented by Dr. Charlie Koo at Stanford University, Noxipoint Therapy is a specific procedure with precise location, duration and intensity of TENS stimulation within the general FDA guidelines. The therapy substantially relieves general muscular/tendon pain and persistently restores the muscle and tendon function. The surface locations of nociceptors at the free nerve ending (i.e., "Noxipoints") are focused on in the stimulation therapy. Multiple clinical uses of Noxipoint Therapy confirmed the consistent efficacy of such stimulation at Noxipoints. An observational study of Noxipoint therapy within the FDA-approved use of TENS demonstrated an encouraging 93% success rate in eliminating the chronic pain, such as frozen shoulder pain, within 2-3 sessions. It is an order-of-magnitude improvement over the non-specific application of TENS and any other modalities in pain treatment. A unique neuro-immuno-signaling pathway that implicates the activation of adult stem cells, such as satellite cells in muscles, is implicated based on such a high success rate.

View http://paincurecenter.com/Clinical_Outcome.html for the observational study mentioned in the Brief Summary above. For more detailed cases, please view http://paincurecenter.com/uploads/Nocipoint_therapy_clinical_study_w_o_ID_2011-2012.pdf

Eligibility Criteria:
Inclusion Criteria:

* 18-64 years old male or female
* Having chronic pain (ICD-9: 338.21, 338.29) in the neck/upper back (ICD-9: 723.1), or the shoulder (ICD-9: 719.41)
* Pain duration over 6 months, with at least one month of history of other therapy treatments (Physical therapy, steroid injection, acupuncture, analgesic medicine, and/or massage therapy)

Exclusion Criteria:

* Patients with BPI Severity at its Worst below 5
* Traumatic injury from external impact force
* Pain caused by traumatic bone fractures
* History of traumatic cervical injury
* History of osteoporosis
* Pain related to systemic inflammatory conditions including polymyalgia rheumatic, systemic lupus erythematosis
* Signs of psychosomatic illness
* Severe rheumatoid arthritis undergoing active treatment including DMARD biologics
* Steroid injection on pain site within 4 weeks
* Language and/or cognitive inability to complete the assessment questionnaires
* Previous TENS for pain relief
* For safety reasons, patients wearing cardiac pace makers, implanted defibrillator, or pregnant women