cyrilzakka/clinical-trials huggingface dataset:
Comparison of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty

Randomized controlled parallel designed clinical study aimed to compare vestibule depth gain and dimensional changes of wound area in individuals who underwent vestibule deepening surgery using diode laser and conventional technique

52 systemically healthy patients aged between 18 and 53 years (10 males and 42 females) with inadequate vestibular depth and insufficient attached gingiva in the anterior mandible were included in this randomized examiner- and patient-blinded, parallel design study. Following nonsurgical periodontal treatment, patients were divided into 4 groups as follows: a) diode laser (L); b) diode laser+Low level laser therapy (LLLT); c) conventional surgery and conventional surgery+LLLT, and vestibule deepening was applied to all subjects either with scalpel or laser assisted.

Scalpel surgery was performed as Clark's vestibuloplasty. A local anesthetic was administered bilaterally to the mental area. Then, a horizontal incision was prepared at the mucogingival junction with a scalpel blade 15c. All the muscle fibers over the periosteum were resected carefully. Following, the mucosal flap was sutured to the depth of the vestibule sulcus with 4-0 polypropylene suture material, once every 4 mm, from a total of 5 regions.

Laser assisted vestibuloplasty was performed using diode laser. Local anesthesia was achieved in the same manner as the control group (scalpel surgery). Laser irradiation was performed in continuous wave mode, using a 980 nm diode laser with a power of 1.5W, 600 μm optical fiber. After adequate local anesthesia, ablation was started from the mucogingival junction and performed with horizontal movements parallel to the bone. The muscle attachments were slowly released until the deepest point of the wound site was 5 mm. The mucosal flap was not stabilized with sutures and periodontal dressing was not used to cover the wound area.

Eligibility Criteria:
Inclusion Criteria:

* Patients were\> 18 years old and of both genders,
* Patients presenting inadequate vestibular depth and insufficient attached gingiva on incisors in the mandibular anterior region
* Full mouth plaque index (PI) and gingival index (GI) scores \< 1
* The patients had to be systemically healthy and nonsmokers

Exclusion Criteria:

* Patients who had Miller class II and more advanced gingival recession in the region of the lower anterior incisors and interproximal attachment loss
* Patients who were taking medications that would interfere with the wound-healing process, pregnant or lactating women,
* Patients who had previously undergone periodontal surgery in the study area, who had orthodontic therapy and using fixed/removable dentures involving lower anterior teeth were excluded from the study.
Transatrial Pericardial Separation to Enhance Safety of Subxiphoid Pericardial Access for Left Atrial Appendage Ligation

We use a tiny catheter through the heart to separate the pericardium with gas. We expect this to improve the safety of the Lariat procedure.

The Lariat suture device enables non-surgical exclusion of the left atrial appendage possibly to prevent thromboembolism and stroke in patients with atrial fibrillation. Subxiphoid needle access to the pericardium (a standard approach to enter the pericardial space surrounding the heart using a needle underneath the breastbone) during Lariat risks injury to the heart surface that requires surgical repair.

In this protocol the investigators propose test a new method to increase the safety of needle access to the pericardium. Before needle access, the investigators introduce a separate tiny catheter into the pericardium from inside the heart through a tiny hole. The investigators then inject gas to push the heart away from the pericardial needle. This reduces the risk of injuring the heart during the standard Lariat procedure.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing subxiphoid access to the "empty" pericardial space as part of a Lariat left atrial appendage exclusion procedure
* Age ≥ 21 years

Exclusion Criteria:

• Does not consent to participate
Analysis of the Effect oh the Carriere Motion 3D

Class II subdivision malocclusions are common and complex to treat due to their asymmetry. The range of orthodontic correction devices is expanding towards systems that are more comfortable for the patient but may not necessarily have scientific evidence to demonstrate their effectiveness. The aim of this study was therefore to evaluate, for the first time, the effect of a Class II correction device, namely the Carriere Motion 3D (CMA), on patients with a Class II subdivision malocclusion. Method:this retrospective observational study included all patients presenting with a Class II subdivision malocclusion and treated with CMA between July 2018 and November 2023. Before treatment (T0) and after treatment with CMA (T1), orthodontic data from dental molds and lateral cephalometric radiographs (Steiner analysis) were collected and statistically analyzed to assess dentoalveolar as well as skeletal effects of treatment using CMA."


Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed their growth and present with a Class II subdivision malocclusion.
* Patients who underwent orthodontic treatment with CMA between 07/11/2018 and 11/22/2023.
* Patients who have a complete orthodontic record allowing for pre- and post-treatment measurements with CMA.

Exclusion Criteria: None
Serum Magnesium Level Administration in Severe Pre-eclampsia Obese Pregnancy

Comparison of the magnesium level in difference continuous rate in women who were diagnosed severe pre-eclampsia obese

Magnesium sulfate is, generally, applied in order to alleviate or to avoid seizures. It can be administered according to many medical approaches. Nevertheless, at Rajavithi Hospital, the recommended administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2 grams for maintenance dose per hour (Zudpan regimen). The therapeutic index of magnesium is in the range of 4.8-8.4 mg/dL. After that, the level of magnesium sulfate will be evaluated every 4 or 6 hours.

At Rajavithi Hospital, there are a lot of patients having pre-eclampsia symptom and many patients, who were received magnesium sulfate in the treatment, having the level of magnesium sulfate lower than the therapuetic level and needed to increase the maintenance dose to 2.5 grams/hour. Therefore, this work aims to studying the amount of magnesium sulfate administered to pregnant woman with pre-eclampsia symptom who possess high body mass index (BMI), especially for BMI greater than or equal to 30 kg/m2.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy women who have MBI ≥ 31kg/m2
* Pregnancy women who were diagnosed severe pre-eclampsia at gestational age 24 weeks more.
* Pregnancy women who were diagnosed eclampsia at gestational age 24 weeks more.

Exclusion Criteria:

* Pregnancy women who were chronic kidney disease or have serum creatinine more than 1.1 mg/dl
* Pregnancy women who have contraindication to use magnesium sulfate
Improving Evidence-Based Care for Cancer Patients

The purpose of this study is to improve cancer care and the delivery of cancer care. Researchers are interested in studying patient reported information and examining how different factors may impact cancer care.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with head/neck, lung, breast, prostate, gastrointestinal or gynecologic cancer
* 21 years of age or older at time of study registration
* Must have been referred to MUSC radiation oncology for treatment with curative radiation therapy
* Must report current smoking defined as self-reporting smoking within the past 30 days using a structured intake questionnaire.

Exclusion Criteria:

* Patients with primary central nervous system malignancies will be excluded.
* Patients that have other cancer disease types will be excluded due to either significant differences in standard radiation therapy approaches or rarity of disease required radiation.
* Patients who are currently participating in the Medical University of South Carolina Hollings Cancer Center smoking cessation program
* Patients who are unable to provide informed consent
Botulinum Toxin for the Management of Chronic Orchialgia

The purpose of this research study is to determine if Botox injections will provide relief from chronic testicular pain. In the study, the spermatic cord of particpants will be injected with either Botox or a placebo of saline. Botox is currently used to treat other urological conditions like overactive bladder and lower urinary tract problems. For these conditions, Botox works by relaxing muscles in the affected areas. The investigators believe that Botox will act similarly in the treatment chronic testicular pain.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic testicular pain (orchialgia)

Exclusion Criteria:

* Active infection of urinary tract (UTI)
* Active infection of the scrotal skin of the affected side
* Bilateral orchiectomy
Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3)

This is a one-year pilot, interventional, prospective, single arm, non-randomized, multicentric (3 centers) controlled study that aims to evaluate the response of type 3 choroidal neovascularization to treatment by Aflibercept following a classic protocol.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged more than 50 years
* Patients with type 3 choroidal neovascularization assessed on FA, ICG and OCT
* Exudation on SD-OCT scans defined by intraretinal cysts or subretinal fluid.
* Best Corrected Visual Acuity at inclusion between 24 and 78 letters (ETDRS)
* Media clarity, pupillary dilation and patient cooperation sufficient to allow fundus photographs of adequate quality

Exclusion Criteria:

* Any contraindications as reported in the labelling of Aflibercept (Eylea®): Ocular or periocular infection, Active intraocular inflammation or Hypersensitivity.
* Any previous history of intravitreal injections in the study eye for exudative AMD
* Any secondary chorioretinal anastomosis due to retinal scar or fibrosis
* Any history of vitrectomy
* Media opacities preventing accurate imaging of the retina (cataract)
* Any other retinal disorder possibly associated with type 3 CNV (epiretinal membrane, macular hole)
* Confirmed intraocular pressure ≥25 mmHg or non-stable glaucoma.
Prescription of Valproate and Derivatives in Women of Childbearing Age: Qualitative Study

The prescription of valproate in women of childbearing age has decreased by 82% in France, for mood disorders. Exposure to valproate during pregnancy 60%. However, the ANSM sent an alert document in August 2022 because there are still patients on valproate. In addition, there were 32 births taking valproate to mothers with bipolar disorder in 2018. The risks of exposure during pregnancy which occur in 10% of exposure cases are: congenital malformations; neurodevelopmental disorders including autism spectrum disorders, attention deficit disorders more or less hyperactivity, language disorders, motor disorders, mental delays; reduction in social, attentional, motor and language abilities; a lower level of education.


Eligibility Criteria:
Inclusion Criteria:

* Subject (≥16 years old)
* Female gender
* Prescription of Valproate and/or derivatives (Sodium Divalproate, Valpromide, Valproic Acid, Sodium Valproate) in an indication of psychiatric disorder for the period from January 1, 2021 to December 31, 2022,
* Subject not opposing, after information, the reuse of their data for the purposes of this research
* Holders of parental authority who do not object, after information, to the reuse of their child's data for the purposes of this research

Exclusion criteria:

* Subject and/or holder of parental authority having expressed opposition to participating in the study
* Impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.)
Clinical Trial of the Effect of Different Categories of Adhesive System

This study aims to evaluate the clinical effectiveness of contemporary resin-based adhesive systems by retention rate of resin restorations placed in non carious cervical lesions with four different adhesive strategies: 3 and 2 steps etch-and-rinse adhesive system, 2 and 1 step self-etch adhesive systems.

The etch-and-rinse (3 and 2 steps) and self-etch (1 and 2 steps) adhesive systems allow the bond between the resins restorations with the dental substrates, but they have mechanism of action different.

The success of resin composite restorations is reliant upon adhesion to the underlying tooth via adhesive systems. The mechanism of adhesion to enamel and dentine could be involved for one hand, the etching the substrates with 30-40% phosphoric acid, followed by the application of a primer and subsequently an adhesive resin 3 steps etch-and- rinse approach or 2 steps when to combine the primer and adhesive into one bottle. For another hand, the self- etch systems with acid monomers in their primer, allow conditioning the surface without phosphoric acid step. So, they consist of either a self-etching primer accompanied by an adhesive resin applied as a subsequent step (2 steps) or a self-etch adhesive, which does not require a separate primer (1 step).

Eligibility Criteria:
Inclusion Criteria:

* Good general health,
* Patients with acceptable oral hygiene level,
* Patients with at least 20 teeth under occlusion.
* Patients with at least four non-carious cervical lesions in four different teeth
* Patients with maximum of eight lesions that needed to be restored.
* These lesions had to be non-carious, non-retentive, deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility.

Exclusion Criteria:

* Patients with extremely poor oral hygiene,
* Patients with severe or chronic periodontitis,
* Patients with heavy bruxism habits.
Effects of Robotic-Assisted Gait Training in Patients With Stroke (EoRAGTiPwS)

This study was conducted to examine effects of gait training with exoskeleton ExoAthlet and Lokomat Free-D on functional independence, functional capacity and quality of life in stroke patients.

The study included 32 patients who had stroke. Participants were randomized into two groups. Functional independence of patients was evaluated with Functional Independence Measure (FIM), physical function with 30-second chair stand test (30-CST), functional capacity with 6-Minute Walk Test (6MWT), and their quality of life with Short Form 36 (SF36). Conventional physiotherapy program was applied to groups for eight weeks, three days a week, each session 60 minutes. Then, one group received walking exercise training with exoskeleton ExoAthlet (ExoAtlet 1 model/2019, Russia), other group with Lokomat Free-D (Hocoma, Lokomat Pro Free-D model/2015, Switzerland). Participants were assessed at baseline and post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age between18-65 years old
* Patients who had a stroke at least three months ago
* Can independently ambulated

Exclusion Criteria:

* Heart failure and rhythm disorder,
* Visual and cognitive problems,
* Neglect phenomenon (Neglect Syndrome),
* Cerebellar pathology,
* Any lower extremity surgery
* An additional neurological pathology that could prevent receiving a training program
Deconstructing Post Stroke Hemiparesis

TRACTs (DeconsTructing Post StRoke HemipAresis for PreCision NeurorehabiliTation) is a single timepoint study that aims to deconstruct post-stroke deficits of the upper extremity into distinct components and relate these components to brain anatomy and physiology.

Veterans will be recruited through the Providence Veterans Affairs Medical Center and will have research visits at the Providence VA Center for Neurorestoration and Neurotechnology (CfNN, centerforneuro.org). The research visits will span two to three days. The study will involve motor outcome measures, magnetic resonance imaging of the brain, and transcranial magnetic stimulation. The goal of this study is to associate post-stroke deficits of the upper extremity with brain anatomy and physiology.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a unilateral ischemic stroke occurring \>6 months prior as documented in medical chart
* Upper extremity motor impairment as measured by Fugl-Meyer Upper Extremity Assessment ≤60
* Ability to follow simple instructions in English

Exclusion Criteria:

* Greater than moderate difficulty using the arm and hand pre-dating the stroke as assessed by the questions adapted from the QuickDASH outcome measure score on any question \>= 3, which measures physical function and symptoms in people with difficulty using the arm and hand.
* Visual or auditory disorders resulting in the inability to see or hear, respectively, the stimuli presented as part of research sessions
* Inability to maintain a seated position for at least one hour
* Standard MRI exclusion (e.g., significant claustrophobia or inability to tolerate loud noises, cardiac pacemaker (unless MRI-safe), implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord)
* Standard (single-pulse) TMS exclusion which include (in addition to those listed for MRI) pregnancy/lactation/planning to become pregnant during the study, seizure disorder, and primary or secondary CNS tumors
Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage

Study population: Subjects with long standing symptoms from calcific tendonitis, non-responsive to other forms of conservative treatment

Study method: A cohort of 50 patients with symptomatic calcific tendonitis will be treated by ultrasound-guided needle lavage. At baseline all study subjects will be assessed by clinical examination, imaging of the shoulder by x-ray and sonography and by the self-report section of the American Shoulder and Elbow Surgeons score (ASES). Follow-up will be performed after 1 and 4 weeks (score only), 3 (clinical, score, ultrasound, x-ray), 6 and 12 months (score only), and after 24 months (clinical, score, ultrasound, x-ray). Patients with insufficient treatment effect will be offered physiotherapy, re-lavage or surgical treatment by acromioplasty.

Purpose of the study: The investigators want to find out

* if shoulder function, measured by a shoulder score, will increase during follow-up
* how much of the calcific material can be aspirated (in ml)
* to which extend the calcific deposit disappears on x-rays and sonographic images
* how many patients will need surgical treatment


Eligibility Criteria:
Inclusion Criteria:

* Shoulder pain for at least 6 months, localised laterally on the upper humerus
* Painful arc
* Positive Hawkins test and/or Neers tegn for impingement
* Calcific deposit of \>= 5 mm on shoulder x-ray, verified on sonography with a localisation in the supraspinatus or infraspinatus tendon

Exclusion Criteria:

* The presence of other local or systemic diseases affecting shoulder function like arthritis, inflammatory arthropathy or instability
* Symptoms from a cervical root syndrome
* Sonographic or MRI findings for a rotator cuff tear
* Earlier surgery in the study shoulder
Adaptive Interventions for Prevention/Intervention for Youth Substance Abuse

The main aim of this formative study is to test and iteratively refine a new mobile phone app, which delivers assessments and tailored intervention content. The study will use social media advertisements to recruit a total of 40 youth between the ages of 16-24 years. Those screening positive for past-month binge drinking or marijuana use will be invited to complete a baseline survey, download and use the app for 30 days, and complete a follow-up survey about the app functionality, design and content, and preliminary outcomes (intentions and importance of reducing use).

Previously, the study team developed a prototype mobile application which utilized novel engagement strategies to enhance user adherence with daily and weekly survey assessments. The new app developed for this study extends the previous app by featuring the capability to also deliver tailored health intervention. As part of the app, users are prompted to complete brief daily and weekly assessments for 30 days. For each completed assessment, users earn small financial rewards and points to unlock new fish that populate a virtual aquarium in the app. The app also features push notifications with survey reminders and life insights (or graphs plotting data collected over time) to increase user engagement with the app. Additionally, each day, users are randomized to receive intervention content (see the "Interventions" section for more information) tailored on their recent assessment responses. After 30 days of using the app, participants will be asked to complete a follow-up survey; data collected will provide preliminary feedback regarding the feasibility and effectiveness of using the app to deliver substance use intervention content to affected youth.

Eligibility Criteria:
Inclusion Criteria:

1. Have an iPhone smartphone on which the app can be downloaded
2. Self-reported past-month binge drinking (4/5 or more drinks on one occasion, tailored by sex) OR any past-month marijuana use without a medical marijuana card
3. Meet study verification criteria (i.e., use of CAPTCHA, IP address checks, social media checks).

Exclusion Criteria:

1. Unable to understand English
Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)

The purpose of this study is to assess the long term safety and efficacy in subjects with Type 1 Diabetes Mellitus who completed the Protege Study (CP-MGA031-01).

The primary objective of the extension study is to assess long-term safety, with particular focus on the development of serious adverse events (SAEs), adverse events of special interest (AESIs) including opportunistic infections and lymphoproliferative disease, and other immediately reportable events (IREs), in subjects with recent-onset T1DM who complete CP-MGA031-01.

The secondary objectives of the extension study are to: 1) assess long-term efficacy; 2) evaluate immunological effects(North America only); 3) measure anti-teplizumab antibody levels;4) assess Health Related Quality of Life Questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1. Complete Protocol CP-MGA031-01 (i.e., all subjects who complete Study Day 728, regardless of how many doses of study drug are received).
2. Provide written informed consent.

Exclusion Criteria:

None