cyrilzakka/clinical-trials huggingface dataset:
Treatment of Intraosseous Periodontal Defects With Amelogenins

The aim of the present investigation will be evaluate the healing of periodontal intraosseous defects following Minimally Invasive Non Surgical Debridement (MINSD) and application of amelogenins, compared to MINSD alone.

A total of 22 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: amelogenin (A) and no-amelogenin group (B).

The objective of the study will be compare the healing of periodontal intraosseous defects following treatment with Minimally Invasive Non Surgical Debridement (MINSD) and application of amelogenins compared to MINSD alone.

Twenty-two patients with intraosseous periodontal defects will be randomly assigned to treatment with MINSD and application of amelogenins (A Group) or MINSD alone (B Group).

Primary outcome will be "Clinical Attachment Level" (CAL) gain, while the secondary outcomes will be "Probing Depth" (PD), "Gingival Recession" (GR) and "Radiographic Defect Angle" (RDA).

After local anesthesia, in A group MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied in the intraosseous periodontal pockets using a sterile syringe with plasticized needle.

In the B group, only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.

Finally, a polishing paste will be applied to the supra-gingival level in both groups using a rubber cup. Patients of both groups will be recalled every month for professional oral hygiene and, after 6 months, all measurements will be repeated and the final evaluation will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with periodontitis;
* Age ≥ 18 years old;
* Presence of at least 10 teeth per arch;
* Presence of at least two teeth with Probing Depth (PD) ≥ 5 mm per quadrant;
* Presence of at least one intraosseous pocket;
* Single-rooted and multi-rooted teeth.

Exclusion Criteria:

* Patients with systemic diseases;
* Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to periodontal therapy;
* Pregnant or lactating;
* Tobacco smokers (≥ 10 cigarettes per day);
* Multi-rooted teeth with furcation involvement;
* Third molars.
Swimming and Water Walking on Spirometry Values

To study the effects of swimming with water walking in children aged between 6 and 12 years in terms of spirometric values.

The present research aims to verify if there are differences in body composition and spirometric values in children aged between 6 and 12 years who practice swimming complemented with water walking at the end of each session and those who only practice swimming. The sample consisted of 28 individuals aged 6 to 12 years and was divided into two groups: swimming group (SG) with 9 children and swimming complemented with water walking group (SWWG) of 19 children. In this study, the investigators wanted to know which were the benefits in body composition and for that purpose used a bio-impedance scale Targa Silvercrest Z29777A (Germany), and an anthropometric tape to measure the waist circumference. To calculate the spirometric values, namely forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and even peak expiratory flow (PEF) a Cosmed Microquark spirometer was used. In terms of statistical procedures, the investigators used the program Statistical Package for the Social Sciences version number 20 (SPSS 20.0). The investigators used descriptive statistics (minimum, maximum, means and standard deviations), the Shapiro Wilk test for testing the normality of the sample, inferential statistics (non-parametric Mann-Whitney tests, Friedman's Anova, and for the calculation of the effect magnitude the d-Cohen test). After the data treatment, regarding the inter-group analysis (comparison between the swimming group and the swimming group with water walking) the investigators observed that there were significant differences in three variables at the end of the study, that is, at the end of the 3 moments. These variables were weight relative to body composition, forced expiratory volume in 1 second (FEV1) and peak expiratory flow (PEF), these values are relative to the spirometry evaluation. Concerning intra-group differences (improvement in the swimming group and the swimming with water walking group in the three moments evaluated), the SWWG showed significant improvements in the variables of weight, muscle mass, fat mass, percentage of water, body mass index (BMI), body percentiles, forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1).

Eligibility Criteria:
Inclusion Criteria:

* Children inside this age range;
* water experience between 6 and 12 months
* children with no other activities besides swimming

Exclusion Criteria:

* Children with Asma;
* Children with DPOC
* Children with pulmonary limitations.
Ayres Sensory Integration Therapy on Occupational Performance in Children With Autism Spectrum Disorder

Ayres Sensory Integration (ASI) Therapy is an individualized intervention designed to address specific underlying sensorimotor issues that may affect children's performance during daily routines and occupations. The intervention takes place in the context of play, emphasizes the active participation of the child, involves a collaborative relationship between the occupational therapist and the child, and focuses on participation-oriented outcomes that are collected at regular intervals throughout the intervention program. In general, its content is to improve the child's occupational performance.

The program, which will be carried out in accordance with the Ayres Sensory Integration Fidelity Measure®, it is aimed to reduce the autism-specific symptoms of the child with autism and the dependence of the child on the caregiver in self-care activities. It is predicted that this whole process will increase the participation and his performance of the child with autism in his occupations related to his daily life.

H0: Ayres Sensory Integration Therapy has no effect on the occupational performance of the child with autism spectrum disorder.


Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with Autism Spectrum Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
* Level 1 (requiring support) and Level 2 (requiring substantial support) are severity levels for Autism Spectrum Disorder
* Age at first and second test between 3 years and 10 years

Exclusion Criteria:

* Accompanying neurodevelopmental, psychiatric, neurological or physical diagnosis
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will be provided to all subjects in addition to study drug.

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Eligibility Criteria:
Inclusion Criteria:

* low back pain for 3 months or longer, confirmed by radiographic evidence.
* receiving a stable dose of an opioid analgesic for low back pain.

Exclusion Criteria:

* taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
* requiring frequent analgesic therapy for chronic condition(s), in addition to low back pain.

Other protocol-specific exclusion/inclusion criteria may apply.
Validation of Hemorrhoidal Bleeding Score

The principal manifestation of hemorrhoidal disease is bleeding; however the severity evaluation is today based on prolapsus (Goligher classification) and bleeding factor is not included.

Even if there was some rare score including bleeding in literature , none of them were validated.

The aim of the study is first validation of bleeding score .


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* consulting for hemorroidal bleeding
* accept to participate

Exclusion Criteria:

* paraplegic or hemiplegic patient
* Misunderstanding of the French language
Targeting Neuroinflammation as a Contributing Pathology in Alzheimer's Disease Dementia

This study is being done to research the usefulness of PET/CT imaging for measuring brain inflammation and its relation to Alzheimer's Disease. Additionally, researchers as looking to learn more about the side effects of a new radioactive tracer (radiotracer) C-11 ER176.

Alzheimer's disease (AD) dementia is a devastating illness with no cure. Treatments targeting known pathologic hallmarks of AD, such as amyloid-beta (AB), in symptomatic individuals have proved largely fruitless so other potential disease targets warrant exploration. Neuroinflammation has interesting possible associations with AD dementia and may contribute to AD dementia in different ways among different individuals. Previous PET neuroinflammation data are not entirely consistent and new methods of PET imaging and studies with larger cohorts are needed to further investigate the role of neuroinflammation in AD dementia and the utility of PET as a biomarker. This project seeks to test new PET neuroinflammation imaging methods in unimpaired and AD dementia individuals with biomarker-identified brain pathology to help address these gaps in knowledge in the field.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 60 years of age or older.
* Meet the requirements for one of the four groups (CU A-, CU A+, MCI A+, AD A+).
* Undergoing neurologic evaluation procedures with cognitive testing in the MCSA or - ADRC for a minimum of about 3 years.
* All participants must have had an amyloid PiB PET scan and MRI brain scan within the previous 6 months.
* Capacity to sign consent or have a legally authorized representative to sign the consent.

Exclusion Criteria:

* Participants unable to lie down without moving for 20 minutes.
* Women who are pregnant or cannot stop breast feeding for 24 hours.
* Actively taking daily anti-inflammatory medications (NSAIDs, corticosteroids, etc.) except for a small control group.
* Generalized inflammatory condition and treatment with immunosuppressive, corticoid/glucocorticoid, steroidal or non-steroidal anti-inflammatory medication within 2 weeks of scanning (only acute medication use as an exclusion so as to limit medication interaction but preserve possible chronic systemic inflammation interaction).
* Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc., since the quantitative PET data analysis is based on anatomic criteria that are established uniquely for each subject by registration to his/her MRI.
Deep Tissue Injury Treatment With MIST Therapy Versus Standard Care: REVERSE DTI Study

The purpose of this study is to evaluate the effectiveness of MIST Therapy in conjunction with standard of care (SOC) compared to SOC alone in the prevention of deep tissue injury (DTI) progression to advanced stage pressure ulcers.

Enrolled subjects will be randomized to receive one of two treatment courses: a) MIST Therapy in conjunction with Standard of Care (MIST + SOC) (treatment group) or b) SOC only (control group).

A randomized subject will be required to undergo a Baseline Evaluation. The Baseline Evaluation. A digital photo will be taken of the wound.

The subject will receive the assigned study treatment. Each subject will receive SOC wound care and off-loading daily throughout the study. Subjects will be treated daily for 5 days and then every other day until discharged or up to 14 days post enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject of any race 18-90 years old.
* Subject presents with an index DTI. This is defined by the National Pressure Ulcer Advisory Panel (NPUAP) as a purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear. The area may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as compared to adjacent tissue.
* Subject's DTI has been discovered ≤ 72 hours after causative event
* Causative event of DTI is identified.
* Subject's index DTI is located on torso or body extremities.
* Subject is currently admitted to the hospital.
* Subject is able to be maneuvered into a position that is acceptable for MIST treatment.
* Subject's DTI presents with no clinical signs of acute infection.
* Subject or subject's legally authorized representative understands the nature of the procedures and provides written informed consent prior to study enrollment.

Exclusion Criteria:

* Subject's primary wound is a Stage I, Stage II, Stage III or Stage IV pressure ulcer.
* Subject's wound presents with a malignancy in the wound bed.
* Subject has a history of pressure ulcer / DTI in same location.
* Subject's DTI would require ultrasound near an electronic implant or prosthesis, e.g., near or over the heart, or over the thoracic area if the patient is using a cardiac pacemaker.
* Female subjects that are pregnant or refuse to utilize adequate contraceptive methods and are of childbearing age during the trial.
* Subject is terminally ill, defined as unable to survive beyond 14 days.
* Subject is known to be suffering from a disorder or other situation that the subject or investigator feels would interfere with compliance or other study requirements.
* Subject is currently enrolled or has been enrolled in the last 30 days in another device or drug trial.
The Impact of RPh201 on Chronic Vegetative State (CVS): fMRI Study

The aim is to evaluate the impact of RPh201 on brain activity in chronic vegetative state patients. The assessment will be done using clinical measurements and functional MRI studies.


Eligibility Criteria:
Inclusion Criteria:

* chronic vegetative state patients

Exclusion Criteria:

* allergic reaction to treatment
* patients that can not undergo MRI
* Pregnancy
Long-term Safety Follow-up Study of Patients Having Received HepaStem (SAF001)

The purpose of this study is to assess the long-term safety follow-up of patients having been treated with HepaStem.

The primary objective of the SAF001 study is the long-term safety surveillance of the patients post infusion with HepaStem. Furthermore, the evolution of both the metabolic condition and the quality of life are followed. As much as possible, the surveillance will mimic the standard follow-up of the respective diseases (standard of care). The surveillance will end when the patient is undergoing an organ transplant or takes part in another research study. This surveillance will last up to a maximum of 48 months.

Eligibility Criteria:
Main Inclusion Criteria:

- Subject having received HepaStem during a former interventional clinical study and who have terminated their participation in that study.

Exclusion Criteria:

- Subject has received mature liver cells, stem cells transplantation other than HepaStem, or organ liver transplant.
Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures

This study is aimed to collect additional data regarding the efficacy in reducing the frequency of partial seizures, as well as the safety and tolerability, of oxcarbazepine monotherapy in children.


Eligibility Criteria:
Inclusion Criteria:

* males and females, 6 months - 17 years of age;
* diagnosis of epilepsy, partial seizures;
* ineffective or intolerable present therapy with 1 antiepileptic drug, or none of previous antiepileptic therapy

Exclusion Criteria:

* progressive lesion of brain revealed by CT/MRI that performed no earlier than 2 years prior to screening;
* non-epileptic seizures;
* drug or alcohol dependence during a year prior to screening;

Other protocol-defined inclusion/exclusion criteria may apply.
Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema

The goal of this clinical trial es to learn about the short term effects of intravitreal dexamethasone implant (IDI) in patients with refractory diabetic macular edema. The main question it aims to answer is:

How fast does the diminishing in central retinal thickness has statistical significance after IDI in patients with refractory diabetic macular edema? Patients will be evaluated by OCT before and after the implant.

Patients were evaluated at baseline, 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI

Eligibility Criteria:
Inclusion Criteria:

* patients with type 1 or type 2 diabetes
* diabetic macular edema involving the foveal center with CRT \>300 μm measured by OCT
* at least 3 and maximum 9 monthly intravitreal injections of anti-VEGF

Exclusion Criteria:

* uncontrolled diabetes (blood glucose ≥ 250 mg/dL at any time
* previous IDI
* any condition precluding adequate fundus visualization
* uncontrolled glaucoma
* papillary excavation ≥ 0.7
Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri

It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic.


Eligibility Criteria:
Inclusion Criteria:

* Ifants aged between 14 and 60 days
* Breast fed, exclusively during length of trial
* Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week.
* Debut of colic symptoms 6+/-1 days before randomization
* Gestational age between 37 and 42 weeks
* Apgar score higher than 7 at 5 minutes
* Mothers willing to follow a cows mild-free diet (free from mild, yoghurt, cheese etc) during the study period
* Written informed consent from one or both parents
* Stated availability throughout the study period

Exclusion Criteria:

* Major chronic disease
* Gastrointestinal disease but controlled GERD with or without medication is not an exclusion criteria
* Administration of anitbiotics the week before randomization
* Administration of probiotics the week before randomization
* Participation in other clinical trials
Post Approval Study to Evaluate the Trulign™ Toric Posterior Chamber IOL

To evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery.

The objective of this post approval safety study is to evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery at up to three years post implantation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are able and willing to comply with the follow-up schedule
* Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction
* Subjects must require a lens power from 4 to 33 D
* Subjects must have a Best Corrected Visual Acuity (BCVA) equal to or worse than 20/40, with or without a glare source

Exclusion Criteria:

* Subjects with any anterior segment pathology in the study eye likely to increase the risk of complications from phacoemulsification cataract surgery
* Subjects with associated ocular conditions which could affect the stability of the IOL
* Subjects with clinically significant irregular corneal astigmatism in the study eye
Phase 2 Dasatinib Combo With Smoothened (SMO) Antagonist (BMS-833923)

The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP) CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.

1. Design:

   Study Design and Duration as current described are no longer applicable since enrollment was prematurely concluded due to a decision by the sponsor. Subjects currently enrolled in the trial will continue to receive dasatinib alone at a starting dose of 100 mg QD for:
   1. a maximum of 5 years after entry into the study
   2. until progression by Investigators determination/judgment
   3. intolerance to Dasatinib
   4. the study is terminated due to safety concerns or
   5. other administrative reasons as communicated by the sponsor
2. Research Hypothesis :

The research hypothesis and primary objective of this study as originally designed are no longer applicable as subjects enrolment has been terminated due to administrative reasons by the sponsor. The objective of the altered design of this study is to describe the safety profile and tolerability of dasatinib

Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 years of age who have signed informed consent
* Philadelphia positive Chronic Myeloid Leukemia (CML) in chronic phase
* Previously untreated chronic phase CML, except for Anagrelide or Hydroxyurea.
* Eastern Co-Operative Group (ECOG) Performance Status (PS) Score 0 - 2

Exclusion Criteria:

* Known Abl-kinase T315I or T315A mutation
* Serious or uncontrolled medical disorder (including infection or cardiovascular disease) or dementia or other serious psychiatric condition
* Prior chemotherapy.
* Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy during the entire study period.
Maximum Expiratory Pressure in Induced Cough as a Predictor of Extubation Failure

Clinical trial for the evaluation of diagnostic tests. The sample was composed of adults under mechanical ventilation who passed the spontaneous breathing trial and was ready to be extubated. The maximum expiratory pressure measured in the usual way and the maximum expiratory pressure generated during the induced cough were taken as predictor variables. The outcome variable was extubation failure, measured at 72 hours and at 7 days.

After completing the spontaneous breathing trial (SBT), with the extubation decision defined by the physician in charge of the patient and maximal expiratory pressure (MEP) as usually measured greater than 30 centimeters of water (cmH2O). Following this, the patient was allowed to rest for 5 minutes in the same condition. With the patient in the supine position sitting 45 ° to 60 °, the closed suction catheter was removed, an elbow was placed at 90 ° and a bacterial filter in series with the endotracheal tube (ET), an adapter was also coupled with a outlet port to the aneroid pressure gauge. In series an inspiratory unidirectional valve was placed that did not allow expiration. Immediately 2 ml of physiological solution was slowly instilled through the port in the 90º elbow to trigger the cough reflex. The presence or absence of reflex cough and the MEP during induced cough (MEPic) value were verified.

As a safety method, the procedures were stopped if the patient presented signs of intolerance such as respiratory rate (RF)\> 35 breaths per minute, saturation \<90%, heart rate (HR)\> 140 beats per minute or increase of 20 % of resting levels.

Eligibility Criteria:
Inclusion Criteria:

* Under mechanical ventilation via endotracheal tube in a period greater than 48 hours
* Passing the spontaneous breathing trial an be ready for extubation.
* Agree to participate in the study and sign the informed consent by the patient or family member

Exclusion Criteria:

* tracheostomized prior to admission to mechanical ventilation
* history of neuromuscular disease
* presence of unstable heart disease
* received upper digestive surgery
* presence of uncontained enterocutaneous fistula
* candidates for non-invasive ventilation as a modality of interface exchange for extubation or as a preventive modality
* patients who did not reach a MEP (habitual) of 30 cmH20 since they are not extubated by the extubation protocol of our institution.