cyrilzakka/clinical-trials huggingface dataset:
Impact of Microneedling on Coverage of RT1 Gingival Recession in Thin Phenotype.

Gingival Recession (GR) is a common finding in among adults, regardless of the oral hygiene levels. When it is associated with esthetic impairment, dentin hypersensitivity, root caries, surgical treatment is indicated. Mid-buccal Gingival Recessions are an extremely prevalent condition and have root coverage potential through periodontal plastic surgery procedures.

A flap thickness of \> 0.8 mm results in a covered root surface of 100%, whereas a flap thickness of \< 0.8 mm results in partial root coverage in Coronally Advanced Flap (CAF)procedure.

The present study aims to increase the gingival thickness by microneedling procedures to enhance root coverage by CAF procedures in thin gingival phenotype.

Gingival recession is defined as the migration of the marginal tissue toward the apical of the cementoenamel junction. It is one of the most common mucogingival deformities requiring surgical correction. The rationale for treating buccal recessions are mainly aesthetic concerns, and clinical situations where unfavourable contour of the gingival margin might be an obstacle for proper plaque control. Cairo et al in 2018 categorised GRs into 3 types with reference to interdental clinical attachment loss as RT1, RT2 and RT3. Mid-buccal GRs have root coverage potential through periodontal plastic surgery procedures. Coronally positioned flap is a simple and predictable treatment of gingival recession defects. It has been observed that a flap thickness of \> 0.8 mm results in a covered root surface of 100%, whereas a flap thickness of \< 0.8 mm results in partial root coverage in CAF procedure. Microneedling (MN), creates microinjuries that result in minimal superficial bleedings and create a wound-healing cascade from which various growth factors are released. MN as opposed to Connective Tissue Grafts is a non-surgical approach to increase gingival thickness, that results in significant changes in the Gingival Thickness of individuals with thin gingival phenotype.

Eligibility Criteria:
INCLUSION CRITERIA:

* Presence of isolated (RT1) by Cairo et al 2011 buccal maxillary gingival recessions in esthetic zone including maxillary central incisors, lateral incisors and canines associated with esthetic complaints and/or dental sensitivity and otherwise systemically healthy.
* Gingival Recession ≥2mm and clinically identifiable CEJ
* Age 20years-50 years
* Patient demonstrating compliance for maintaining good oral hygiene after Phase 1 thearpy Plaque index (PI) \<1, Gingival Index (GI) \<1
* Providing a written and verbal informed consent.

EXCLUSION CRITERIA

* Patient with systemic disease that can influence the outcome of therapy.
* Pregnant females or on oral contraceptive pills or hormone replacement therapy.
* Smokers and patients undergoing orthodontic therapy
* Physically and mentally impaired patients.
* Non vital, malpositioned tooth
* Presence of cervical abrasions or restorations in the area
* Previous history of periodontal surgery on the involved sites.
Multimodal GA for Lumbar Spine Surgery

To evaluate the effects of multimodal general anesthesia on the recovery profile of elder patients undergoing lumbar spine fusion surgery.

Multimodal general anesthesia has been proposed in recent years. By administration of multiple agents acting on a different component of the nociceptive pathways, the multimodal general anesthesia may elicit maximal anesthetic effects with minimal anesthetic dose. These may be beneficial to improve postoperative recovery and reduce adverse effects such as postoperative delirium and perioperative neurocognitive impairment. It is not uncommon that elder patients undergoing lumbar spine fusion surgery suffer from postoperative poor recovery, postoperative delirium as well as the postoperative neurocognitive disorder. Therefore, this study aims to explore the potential effects of multimodal general anesthesia, which comprised with electroencephalography density spectrum array guided co-administration of sevoflurane, ketamine and dexmedetomidine, on the postoperative recovery profiles for elder patients undergoing lumbar spine fusion surgery.

Eligibility Criteria:
Inclusion criteria:

1. patients with ages at least 60-year undergoing elective lumbar spine surgery

Exclusion:

1. A history of dementia
2. Impaired liver function, eg. AST or ALT \>100; liver cirrhosis \> Child B class
3. Impaired renal function, cGFR\< 60 ml/min/1.73 m2
4. Cardiac dysfunction, such as heart failure \> NYHA class II
The Effects of Transcranial Direct Current Stimulation on Executive Function in People With Mild to Moderate Dementia

To study the effects of transcranial direct current stimulation on executive function in people with mild to moderate dementia

Extensive research had shown executive dysfunction in people with dementia (PWD) is associated with functional abnormalities in prefrontal regions such as the right inferior frontal gyrus (Right IFG) or the left dorsal lateral pre-frontal cortex (Left DLPFC) . Clinical studies suggest that tDCS may be a useful therapeutic tool. Post-tDCS improvements have also been shown in visuo-motor coordination of healthy controls and performance in working memory. The aim of this study is to investigate the effect of tDCS stimulation over left DLPFC or right IFG on attention, inhibition and working memory and their neural correlates in people with dementia (PWD) and healthy controls (HC).This study is planned as a double-blinded, randomized case-control interventional study with a duration of 30 months.

Eligibility Criteria:
Inclusion Criteria:

* PWD must be aged at least 65 years or above when informed consent is obtained in the presence of his / her first degree relatives.
* PWD must meet criteria of DSM-V for dementia as well as for historical diagnosis of dementia.
* PWD must have a Chinese MoCA score \> 19 (mild to moderate cognitive deficits) at screening.
* Subjects (both PWD and HC) must be physically healthy, and must be able to understand and be willing to sign the informed consent document

Exclusion Criteria:

* Subject with major neurological illness.
* Subject with other diagnosed psychiatric disorders
* Subjects reported with history of substance abuse, which including alcohol, drugs or any medication which is indicative of chronic abuse.
* Failures to comply with the study protocol or to follow the instructions.
* Self-reported with known skin diseases or skin allergy history.
* Self-reported with metallic implants, dentures
* Self-reported with history of claustrophobia. (This is excluded because subject needs to stay in a quiet room with the head-mounted fNIRS and tDCS, which may elicit their feeling of anxiety)
Effect of Spirulina on Periodontitis

The purpose of this study is to assess the clinical and immunological effect of spirulina in treatment of stage II periodontitis.

In this study, the investigators tested the effect of spirulina gel as adjunctive of scaling and root planing in treatment of stage II, grade B periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, and level of interleukin 6.

Eligibility Criteria:
Inclusion Criteria:

* All the patients suffer from stage II, grade B periodonitis with attachment loss 3-4 mm and probing pocket depth ≤ 5mm.

Exclusion Criteria:

* Any systemic disease that affects the periodontium. ·
* Pregnant, postmenopausal women. ·
* People who take anti-inflammatory drugs, antibiotics, or vitamins within the previous 3 month.
* People who use mouth washes regularly ·
* Participation in other clinical trials.
Assessment of the Role of Incisura Biopsy in the Staging of Chronic Gastritis

This prospective multicenter study investigates the added benefit of incisura biopsy to correct identification of patients with high-risk chronic gastritis (OLGA stages III-IV). It compares a biopsy protocol with and without a single incisura biopsy in a non-inferiority design.


Eligibility Criteria:
Inclusion Criteria:

* indication to perform upper GI endoscopy for diagnosis or surveillance

Exclusion Criteria:

* lack of informed consent, previously diagnosed advanced gastric cancer, incomplete endoscopy, surgically altered stomach
CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation

The aim of the study is to compare the acute procedure and safety outcomes as well as long term clinical outcomes of 2 groups of patients treated with the HeartLight® Endoscopically Guided Laser Ablation (EGLA) or a commercially available Contact Force Sensing Irrigated Radiofrequency (RF) Ablation Catheter plus, at the operator's discretion, 3D Electroanatomical Mapping (EAM) for the treatment of Paroxysmal Atrial Fibrillation (PAF).


Eligibility Criteria:
Inclusion Criteria:

* Patient must not have undergone a previous ablation for the treatment of PAF
* AF Type - Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) where PAF is defined as recurrent (two or more) episodes of AF that terminate spontaneously in less than seven days, usually less than 48 hours

Exclusion Criteria:

* Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
* Diagnosed with persistent atrial fibrillation defined as recurrent episodes lasting more than 7 and less than 365 days
* More than 4 electrical cardioversions in the year prior to enrollment but not including cardioversions performed within 48 hours of arrhythmia onset
* Documented left atrial thrombus on imaging
* Cannot be removed from anti-arrhythmic drugs for other reasons than atrial fibrillation
* New York Heart Association (NYHA) functional Class III or Class IV heart failure
* Left ventricular ejection fraction \< 30%
* Left atrial size \> 55 mm as measured in the parasternal antero-posterior view
* Myocardial infarction within 60 days prior to enrolment
* Woman of childbearing potential who is pregnant, lactating or not using adequate birth control
Diabetic Patients Needs in Therapeutic Education About Work. TE-DIW (Therapeutic Education of DIabetic Working People)

Diabetes mellitus is an important disease around the world and the number of diabetic people increase every day. The type 1 diabetes often occurred in the youth and people have to learn to work with it and its complication. Conversely, diabetic people sometimes have trouble to manage their diabetes with working obligation. Actually, French therapeutic education don't teach how to reconcile diabetes and work. The study hypothesis is that type 1 diabetic people can be helped by therapeutic education in order to reconcile the management of their diabetes and their work. This study is a qualitative study. Interviews will help to find the needs of the type 1 diabetic patients to reconcile diabetes and work.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years old
* To be diagnosed with type 1 diabetes according to the criteria of the French High Authority of Health and confirmed by an endocrinologist
* To have paid employment with an employment contract during the study
* to be informed and having no opposition to the study

Exclusion Criteria:

* self-employed person
* to be unemployed
* To be diagnosed with an other disease wich could damage cognition or motricity and could interfere with work (cancer, neurodegenerative disorder, etc)
* To have legal guardian.
An Open Study of Tipepidine Hibenzate in Adolescent Patients With Depression

Accumulating evidence suggests a role of G protein-coupled inwardly-rectifying potassium (GIRK) channel in the pathology of excitement of nerve, and the medicine with the action (like the Tipepidine Hibenzate) is expected as a new curative medicine of adolescent depression.

The purpose of this research is to confirm the effect by carrying out the additional dosage of the Tipepidine Hibenzate to the adolescent patients with depression.

If suggestion is obtained by this research about the effect on adolescent patients with depression of Tipepidine Hibenzate, it can contribute to development of the medical treatment of adolescent patients with depression.


Eligibility Criteria:
\[Inclusion Criteria\]

1. Depressive Episode for ICD-10 criteria.
2. Patients are treated with antidepressants (SSRI ; Fluvoxamine, Paroxetine, Sertraline, Escitalopram, SNRI ; Milnacipran, Duloxetine, NaSSa; Mirtazapine), mood stabilizers (Lithium, Sodium Valproate, Carbamazepine, Lamotrigine), atypical antipsychotics (Risperidone, Olanzapine, Quetiapine, Perospirone, Aripiprazole, Blonanserin, Paliperidone) or not treated.
3. Patients are stable for 4-weeks for medication.

\[Exclusion Criteria\]

1. Patients with a previous hypersensitivity to Tipepidine Hibenzate.
2. Patients treated with typical antipsychotics and antidepressants except inclusion criteria 2. and mood stabilizers except inclusion criteria 2.
3. Pregnant or breast-feeding women
Prognostic Value of Early Postoperative Right Ventricular Systolic Function in Patients With Isolated Severe Tricuspid Regurgitation

Preoperative right ventricular end-systolic area (RV-ESA) and hemoglobin level were suggested as independent prognosticator for predicting long-term prognosis in patients with isolated severe TR undergoing corrective surgery We attempted to explore whether early postoperative echocardiography provides additional prognostic information on top of preoperative clinical and echocardiographic variables.

We prospectively recruited patients with isolated severe TR undergoing corrective surgery. Comprehensive preoperative echocardiography was performed in all patients, with the performance of early postoperative echocardiography in all patients. During follow-up, clinical events, defined as operative mortality (death within 30 days after surgery or before discharge), cardiovascular death, repeated open heart surgery, and readmission due to cardiovascular problems were investigated.

Eligibility Criteria:
Inclusion Criteria:

* severe tricuspid regurgitation

Exclusion Criteria:

* concomitant left-sided valve surgery
* significant coronary artery disease
Damages From Macular Grasping During Vitrectomy Comparing Traditional and 3D Microscope

Randomized, prospective, descriptive and comparative clinical study. The comparison is between a group of patients affected by macular pucker or macular hole, whose macular peeling is performed using a traditional optical microscope (Leica F40) - control arm, and a group of patients affected by macular pucker or macular hole whose macular peeling is performed by 3D heads-up microscopy system (NGenuity 3D, Alcon) - experimental arm.

It is a blind study for both the operator that collects data and for the statistician.


Eligibility Criteria:
Inclusion Criteria:

* Patients affected by macular pucker or macular hole, whose internal limiting membrane peeling need to be performed
* Willing and able to understand and sign an informed consent
* Willing and able to undergo postoperative examinations of the protocol program:
* ≥ 21 years of age, of both sexes and any race

Exclusion Criteria:

* History of ocular trauma or amblyopia.
* Other ocular pathologies (glaucoma, uveitis, diabetic retinopathy, diabetic macular edema, macular degeneration, Irvine Gass Syndrome, degenerative myopia, malformation of the optic disc, i.e.: tilted disc, optic disc pit, posterior staphyloma)
* Multiple procedures programmed during the surgery
* Pregnancy, lactation or programmed pregnancy during the course of the study.
GliflOzin in eLderly Diabetic patiENts: A praGmatic Intraclass Evaluation Trial

Three SGLT2i were commercially available in Italy at the time the trial was designed: canagliflozin, dapagliflozin, and empagliflozin. Preliminary evidence suggests that the higher dose canagliflozin (300 mg/day) might exert a stronger glucose-lowering effect than dapagliflozin or empagliflozin. The clinical relevance of this putative difference is however unknown. On the other side, the use of canagliflozin, but not empagliflozin and dapagliflozin, has been associated with an increased risk of some adverse events, namely bone fractures and lower limb amputations. Currently, the available information on the efficacy and safety of SGLT2i in elderly (70+ years) patients with type 2 diabetes are is very scant. Thus, a compelling need now exists of comparing efficacy and safety of the commercially available SGLT2i in a population of frail patients at high risk of cardiovascular and renal diseases.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Age 70+ years
* Male or female
* Prevalent cardiovascular disease (symptomatic or asymptomatic) or eGFR \<90 ml/min/1.73 m2 and above the lower limit for initiation of SGLT2i according to label (currently eGFR \<60 ml/min/1.73 m2)
* HbA1c above individualized target
* Indication to add SGLT2i

Exclusion Criteria:

* Age \>90 years
* Estimated life expectancy \<1 year
* Very high risk of genitourinary tract infections (\>2 events in the last 6 months)
* Recent weight loss (\>5% in \<6 months)
* Inability to provide informed consent
Effect of Electroacupuncture on Refractory Pain in Juvenile Rheumatoid Arthritis: Randomized Controlled Trial

the purpose of the study is to investigate the effect of Electrical Acupuncture Versus naproxen phonophoresis on Refractory pain in Juvenile Rheumatoid arthritis

Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in children and adolescents, affecting approximately one in 1000 children in North America. It is diagnosed in children younger than 16 years of age with arthritis in one or more joints for at least six weeks after other causes have been excluded. Arthritis in JIA is characterized by stiffness, pain and swelling of affected joints. The disease course of JIA may involve flares of increased disease activity or chronic persistent joint inflammation, even into adulthood. Various complications may arise secondary to ongoing disease activity or treatment, including joint damage and deformity, growth abnormalities and osteoporosis with fragility fractures The prevalence of refractory pain in children with arthritis is of particular concern because it often contributes to poor physical and psychosocial outcomes. Increased daily symptoms of pain predict considerable functional disability, including significantly reduced participation in school, social and physical activities, and augmented mood disturbance

Eligibility Criteria:
Inclusion Criteria:

* • Age ranges from 14 to 16 years.

  * All children will be assigned to the study are suffering from persistent oligoarthritis.
  * All children have regional knee pain complaint more than 6 weeks.
  * Pain and stiffness especially in the morning, and a joint that feels warm to the touch
  * Low grade fever at the onset of disease

Exclusion Criteria:

* • Neurological disorders.

  * Dermatological disorders.
  * Acute trauma prior to the study.
  * Other co- morbidities like diabetes and conditions associated with inflammation such as malegnancies.
  * Analgesic drugs or NSAIDs during the treatment period.
Biological Phosphocalcic Metabolism and Coronary Artery Calcifications

Study a sample of patients in primary prevention, moderate cardiovascular risk (n = 83 patients), with normal, non-diabetic renal function. The investigators quantify the phophocalcic intake and excretion, realizing a food examination and a urine collection of 24 particular. The investigators will measure plasma levels of FGF23 serum calcium, phosphatemia, the investigators will calculate the tubular reabsorption of phosphate. The investigators will conduct a quantitative assessment of coronary calcification by a non-injected CT scan, measuring semi automated way Agatston calcium score. There will be an analysis of collinearity. An adjustment will be made for confounding variables in a generalized linear regression model.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalization for a cardiovascular check in the Detection Centre and the Atherosclerosis Prevention (CHU Rangueil Toulouse)
* In primary prevention of coronary heart disease
* Introducing an intermediate cardiovascular risk according to the European SCORE equation, that is to say, a risk of cardiovascular death at 10 years greater than or equal to 1% and less than 5%
* signed the informed consent,

Exclusion Criteria:

* Chronic renal failure patients with an estimated GFR less than 60 mL / min / 1.73m2, due to alterations in phosphate metabolism,
* Patients receiving glucose-lowering therapy,
* Patients with a fasting blood glucose greater capillary or equal to 1.10 g / l, confirmed by a plasma glucose greater than or equal to 1.10g / l.
* The diuretic therapy patients (due to a change in urinary electrolytes)
* HIV-positive patients for HIV, antiretroviral (due to a change in urinary electrolytes)
* Pregnant women,
* Patients under judicial protection, guardianship or trusteeship.
Efficacy and Safety of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH)

The purpose of this study is to investigate the efficacy, safety, tolerability and pharmacokinetics of multiple oral administration of MT-3995 in patients with NASH.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with NASH before randomization
* Subjects who conducts diet or exercise therapy at the beginning of run in period.
* Subjects who has given full and adequate information of the protocol and with written informed consent

Exclusion Criteria:

* Subjects with hepatic failure or previously diagnosed with hepatic cirrhosis
* Subjects with alcohol dependence or previously diagnosed with alcohol dependence
* Subjects with other chronic liver disease (e.g., primary sclerosing cholangitis, alcoholic liver damage, hemochromatosis, Wilson's disease)
* Presence, history, or family history of long QT syndrome or Torsades de Pointes
* Subjects with heart failure (New York Heart Association Class III-IV)
Tobacco Use Intervention Among Radiation Oncology Patients

Tobacco prevention and intervention strategies in the general population are ongoing and evolving. However, strategies to help cancer patients overcome tobacco dependence have been limited. Radiation oncology patients who continue to smoke despite their cancer diagnosis have a lower quality of life (QOL), increased frequency and severity of side effects during their cancer treatment, higher risks of developing a smoking-related primary cancer, and may have a poorer survival rate than their non-smoking counterparts. These are all compelling reasons to be more pro-active in helping cancer patients stop smoking. The overall objective of this project is to adapt a model of an effective tobacco use intervention that can be delivered by any trained radiation oncologist and their staff.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age;
* current cigarette smoker (smoked any cigarettes within the previous 7 days prior to their first visit) or recent ex-smoker (last cigarette smoked was \>7 but ≤ 30 days);
* planning to undergo radiation therapy (RT) that is to be delivered by the members of the Department of Radiation Oncology in Rochester, MN;
* be receiving a minimum of 5 weeks of RT and/or be willing to return for all 5 sessions.

Exclusion Criteria:

* patient is currently (in previous 30 days) using other formal behavioral tobacco cessation program \[i.e., behavioral therapy (Nicotine Dependence Consultation and treatment) or telephone quitline\];
* daily use of tobacco products other than cigarettes;
* hospitalized patients;
* Karnofsky Performance Status (KPS) score of \< 60 (KPS = 60 corresponds to a person who requires occasional assistance but is able to care for most of their own needs;
* presence of an unstable or untreated psychiatric disorder.