cyrilzakka/clinical-trials huggingface dataset:
Clinicopathologic Findings for Macular Disease

this study is to analyze and compare the ultrastructure of the retinal and vitreous plane of the epiretinal membrane and internal limiting membrane removed during macular surgery and to evaluate relation between the ultrastructure of the epiretinal membrane and internal limiting membrane and surgical outcomes.

prospective, interventional study and includes patients who underwent vitrectomy,peeling of an epiretinal membrane and internal limiting membrane excision with or without intraoperative intraocular ICG injection.

Excised specimens were placed on a Millipore filter, fixed in a paraformaldehyde solution, and examined by light and transmission electron microscopy. Ultrathin sections were stained with uranyl acetate-lead citrate and inspected in a Zeiss EM electron microscope. The assessment was done in a blinded, masked fashion so that the clinicians who reviewed the histologic specimens

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent vitrectomy,peeling of an idiopathic MEM and ILM excision with or without intraoperative intraocular ICG injectio

Exclusion Criteria:

* the presence of macular hole or lamellar macular hole previous vitreoretinal surgery the presence of any other macular pathologic features potentially interfering with histologic results (such as diabetic retinopathy or age-related macular degeneration).
BIIB033 In Acute Optic Neuritis (AON)

The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with their first episode of unilateral acute optic neuritis (AON). The secondary objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033 in this study population.


Eligibility Criteria:
Key Inclusion Criteria:

* Ability to provide written consent and any authorization required by law.
* Confirmed diagnosis of AON
* All male or female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment.

Key Exclusion Criteria:

* Prior episode(s) of optic neuritis or loss of vision not due to AON.
* Subjects with an established diagnosis of multiple sclerosis are excluded except if newly diagnosed based on the current episode of AON and positive brain magnetic resonance imaging results consistent with the 2010 revisions to the McDonald's criteria.
* Previous history of a clinically significant disease.
* Females who have a positive pregnancy test result, or who are pregnant, breastfeeding, or planning to conceive during the study.
* History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B virus.
* History or evidence of drug or alcohol abuse within 2 years prior to Screening.
* Current enrollment in any other study treatment or disease study within 3 months prior to Day 1/Baseline.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Interpretation of Transnasal Esophagoscopy Findings

The purpose of this study is to determine the prevalence of esophageal pathology in patients with voice disorders. In addition, , the intra- and interdisciplinary variability regarding the identification of esophageal pathology will be analyzed in this study.

Throat symptoms are common complaints for many patients. Some symptoms are thought to be attributable to laryngopharyngeal reflux (i.e. the reflux of stomach acid to the level of the larynx). It is unclear what role laryngopharyngeal reflux (LPR) has in producing throat symptoms and its relationship to laryngeal pathology. LPR may be more carefully diagnosed if knowledge could be obtained regarding the presence of esophageal manifestations of reflux of stomach acid. Although LPR may occur in the absence of esophageal manifestations, the presence may make this diagnosis more probable. If so, therapy can be more carefully directed.

Using a flexible endoscope, otolaryngologists perform transnasal flexible laryngoscopy. This requires only topical anesthesia and occurs in the clinic setting. The small caliber transnasal esophagoscope was developed in recent years and is performed in a similar manner. It can provide key information regarding esophageal pathology. This obviates the need for administration of anesthesia (i.e. other than the topical, non-sedating agent). Transnasal flexible laryngoscopy is considered to be the standard of care for evaluation of the larynx. Transnasal esophagoscopy is an extension of this standard of care.

There are a number of studies demonstrating the safety and utility of transnasal esophagoscopy in humans. Typically these studies are composed of retrospectively on a select group of patients. Additionally the TNE findings are reviewed by one medical discipline. This study will be the first prospective analysis of TNE in which the findings will be reviewed in a multidisciplinary manner (i.e. otolaryngologists and gastroenterologist). Also, the population involved will be more general than previous studies, representing a myriad of throat symptoms.

Eligibility Criteria:
Inclusion criteria:

* Study participants include persons 18 years and older
* Patients presenting to the Vanderbilt Voice Center and complaining of throat symptoms. These include hoarseness, throat clearing/pain/burning, heartburn, globus sensation, and acidic/sour taste.
* New and return patients will be included.

Exclusion criteria:

* Participants who are unwilling to undergo the study
* Patients who have had prior esophagoscopy
* Those who do not sign the consent
* Pregnant women.
Mapping and Characterization of Alveolar Cells During Smoking and Chronic Obstructive Disease

To evaluate the regenerative capacities of mesenchymal cells composing the microenvironment of alveolar type 2 cells in a population of patients, undergoing thoracic surgery for suspected cancer, who are smokers with and without COPD compared to non-smokers patients

Chronic obstructive pulmonary diseases (COPD) have a major public health impact, as evidenced by the 250 million patients affected by these diseases and the 50% 5-year mortality for severe stages of chronic obstructive pulmonary disease (COPD). One pathophysiological mechanism of COPD and emphysema is a depletion of alveolar progenitor cells inducing a loss of alveolar-reparation capacities after an aggression. The genesis of these alterations and the mechanisms involved remain unknown. Alveolar type 2 cells (AT2) are the alveolar epithelial progenitor cells. AT2 proliferate and differentiate into alveolar type 1 cells (AT1) which form the alveolar-capillary barrier, along with endothelial cells, through which respiratory gas exchanges take place. The proliferation and differentiation of AT2 into AT1 are under the control of mesenchymal cells and endothelial cells located in close proximity. Together these cells form the alveolar stem cell niche. The characteristics and interactions of the different cell populations have been well described during lung growth, in the normal adult lung or during pulmonary fibrosis; however, participants are poorly described during smoking exposure and chronic obstructive diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. Patient undergoing lung resection surgery (lobectomy, pneumonectomy, segmentectomy) for cancer or suspected cancer
3. Acceptance to participate in the protocol
4. Affiliated to a social security plan

Exclusion Criteria:

1. Chronic autoimmune disease
2. Patient under guardianship or curators
3. Neo-adjuvant chemotherapy
4. History of thoracic radiotherapy
5. Pregnant woman
6. Minor patient
7. Person not able to consent
8. Person deprived of liberty
Traditional vs Orthodontic Extraction of Impacted Teeth Related to the Inferior Alveolar Nerve

The aim of this clinical study was to compare the effects of traditional and orthodontic extraction methods on postoperative nerve damage in impacted third molars associated with the inferior alveolar nerve. The main question it aims to answer is:

-Does the orthodontic extraction method reduce the risk of nerve injury compared to traditional extraction?

Participants will:

* undergo either traditional or orthodontic extraction
* be monitored for postoperative paresthesia.

Researchers will compare traditional and orthodontic extraction methods to see if extraction methods affect postoperative nerve damage.

The extraction of an impacted mandibular third molar is one of the most frequently performed procedures by oral and maxillofacial surgeons. The close anatomical relationship between the root of an impacted mandibular third molar and the inferior alveolar nerve may result in inferior alveolar nerve damage. The incidence of inferior alveolar nerve injury during the removal of an impacted mandibular third molar ranges from 0.35% to 8.4%. In addition to radiographic analysis, various surgical techniques, such as coronectomy, have been proposed to reduce the incidence of inferior alveolar nerve injury.

The orthodontic extraction technique is an orthodontically supported surgical approach that reduces the risk of neurological complications that may occur in inferior alveolar nerve and facilitates the surgical removal of impacted mandibular third molars close to the mandibular canal, even if they are associated with cystic lesions.

The purpose of this study is to examine the effect of orthodontic extraction applied to minimize inferior alveolar nerve damage during the extraction of deeply impacted mandibular third molar teeth on postoperative nerve injury. For this purpose, the postoperative paresthesia findings of patients who underwent orthodontic extraction will be compared with those of those who underwent traditional extraction.

Eligibility Criteria:
Inclusion Criteria:

* Presence of indication for wisdom tooth extraction for reasons such as pericoronitis, pathological formation, orthodontic reasons, caries, etc.
* Mandibular impacted wisdom teeth close to the inferior alveolar nerve

Exclusion Criteria:

* Mandibular impacted wisdom tooth not close to inferior alveolar nerve
* Wisdom tooth whose apexification has not yet been completed
* Suspicion of a malignant pathological lesion
* Pathological lesion associated with inferior alveolar nerve
* Presence of an acute infection
Walking Characteristics of Patients With Amputation

The main purpose of the study is to reveal the early and late changes in the walking characteristics of patients with lower extremity amputation. Secondly, it is planned to reveal the factors affecting the walking characteristics of patients with amputation and to compare individuals with different levels of amputation in terms of clinical outcome measures.

It is important to investigate the long-term changes in walking characteristics of patients with amputation and the factors affecting walking characteristics in these patients regarding prosthesis rehabilitation.

The main purpose of the study is to reveal the early and late changes in the walking characteristics of patients with lower extremity amputation. Secondly, it is planned to reveal the factors affecting the walking characteristics of patients with amputation and to compare individuals with different levels of amputation in terms of clinical outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65
* Presence of lower extremity amputation

Exclusion Criteria:

* Conditions that prevent the use of prosthesis (wound, pain, etc.)
* Having a history of rheumatic disease
* Having cardiac pathology
* Having pulmonary pathology
* Having a situation that prevents communication
* Not giving written consent
Metaplasticity in Human Pharyngeal Motor Cortex

The purpose of the study is to determine the effects of giving 2 doses of brain stimulation through repetitive transcranial magnetic stimulation (rTMS) on swallowing neurophysiology (brain function) in healthy adults.

Recent studies have suggested that repetitive transcranial magnetic stimulation (rTMS), which is a well-established and tried and tested non-invasive (no surgical procedures involved) brain stimulation technique that can vary brain activities, may be used as a treatment for patients with swallowing difficulties. However, results have also showed that the response to the treatment is different among individuals. A possible explanation for this variation is related to the brain's level of activity preceding rTMS. The hypothesis of this study is that this variation may be minimized by regulating the brain state with an additional dose of rTMS prior to the intended rTMS session (preconditioned rTMS). This may subsequently improve the outcomes of rTMS.

Therefore, this study aims to better regulate the response of the brain to rTMS. The findings of this study will provide the basis for future development of optimal rTMS treatment protocols for patients with swallowing difficulties.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged 18 years old or above; and
* No medical complications or significant past medical history

Exclusion Criteria:

* History of epilepsy;
* Previous history of neurosurgery;
* Previous swallowing problem;
* Implanted brain electrodes, cardiac pacemaker; or
* Use of medications (predominantly taking multiple anti-depressants) that lower neural threshold
Simulation Based Emergency Brex Birth Management Training

The aim of this study is to determine the effect of SIMULATION-BASED EMERGENCY BREX BIRTH MANAGEMENT TRAINING IMPACT ON STUDENTS' SELF-CONFIDENCE AND COMPETENCE.

Hypotheses H01; There was no difference between the students'self-confidence and competence of the simulation-based emergency brex birth management training group and students'self-confidence and competence score control group.

The study will be carried out in two different groups. The practice will start with meeting the students who apply to the study. After the students are evaluated in terms of eligibility criteria for the research, the students who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.

Breech birth management training will be given by the responsible investigator, and then one of the groups separated by randomization will perform emergency breech birth on the second group model using High Reality Simulator. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one.

Eligibility Criteria:
Inclusion Criteria:

- Agreeing to participate in the research and obtaining written permission,

Exclusion Criteria:

-
Effects of an Ankle-Foot Orthosis on Gait While Performing an Attention Demanding Task

We hypothesize that: (1) gait stability will be increased when wearing an ankle-foot orthosis (plastic brace supporting the foot and ankle); (2) an attention demanding task will decrease gait stability and (3) the improvement in gait stability due to ankle-foot orthosis use will be greater during an attention demanding task.

A quasi-experimental, randomized 2 x 2 factorial within subjects study with the factor of walking condition (2 levels, walking with and without ankle-foot orthotic device) and attention condition (2 levels, walking with and without attention task).

Eligibility Criteria:
Inclusion Criteria:

* be over the age of 18;
* have the presence of hemiplegia after stroke;
* be wearing an ankle-foot orthosis for at least 6 weeks;
* be able to walk independently and comfortably for a minimum distance of 12 m with or without assistive aids (AFOs, canes and walkers);
* be able to read and understand English, follow verbal instructions and provide verbal answers to questions;
* be able to reach criterion on the attention task (described below)
* be competent to give informed consent as determined by clinical team and noted in the health chart

Exclusion Criteria:

* have history of balance deficits not related to stroke;
* be at high risk of falling during the study;
* suffer from severe aphasia or dementia as determined by health chart and/or initial cognitive screening using the Montreal Cognitive Assessment (MoCA) test.
Comparison of Levothyroxine Formulations in the Treatment of Congenital Hypothyroidism

Observational, retrospective, prospective, pharmacological, single-centre, non-profit study.

The aim is to evaluate, in newborns diagnosed with Congenital Hypothyroidism, the medium- and long-term efficacy and safety of the new formulation of levothyroxine in oral solution, compared to the liquid drop formulation and the tablet formulation.

The study will involve male and female patients referred to the Neonatal Screening Centre at the Centre for Endocrine-Metabolic Diseases of the Paediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola, Italy, who tested positive for Congenital Hypothyroidism.

The prospective cohort consists of patients with Congenital Hypothyroidism identified through Neonatal Screening, who come for observation at the Centre for Endocrine-Metabolic Diseases of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola, Italy, from the approval of the study until the number of patients stipulated in the protocol is reached, which is expected to be achieved in about 4 years. The recruited patients will be assigned, based on the therapy taken in normal clinical practice, to a pharmacological group (group A: drops, group B: oral solution, group C: tablets), and their medical history, clinical and biochemical data will be collected at diagnosis.

The retrospective cohort includes children born from January 1, 2019 to the date of study approval, who came for observation at the Centre for Endocrine-Metabolic Diseases of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola, Italy, for Congenital Hypothyroidism identified by Neonatal Screening. These patients had levothyroxine therapy in one of the three formulations (solid, drops, oral solution) assigned according to normal clinical practice and will therefore be divided into 3 groups as for the prospective cohort. For these patients, retrospective collection and analysis of anamnestic, clinical, biochemical and radiological data and clinical, biochemical and neurocognitive follow-up is planned with the same timelines defined for the prospective cohort.

Eligibility Criteria:
Inclusion Criteria:

Newborn screening test positivity for Congenital Hypothyroidism; Subjects born in Emilia-Romagna region, Italy, and undergoing diagnostic confirmation and initiation of replacement therapy; Diagnosis-confirmed subjects who underwent L-T4 replacement therapy in the first month of life at Center for Endocrine-Metabolic Diseases, Pediatrics Units of the IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S.Orsola, Italy; Age ≤11 years old; Obtaining informed consent from parents and/or legal guardians and assent from minors included in the study.

Exclusion Criteria:

Known chromosomal abnormalities or complex syndromes; Patients transferred to another center before completion of at least one year of follow-up from the start of therapy; Patients who started therapy at another center.
A Non-Interventional Study in Patients With Rheumatoid Arthritis Who Are Treated With RoActemra/Actemra (Tocilizumab)

This observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in monotherapy in routine clinical practice in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
* Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in accordance with the local label; this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
* Patients who for any reason do not take methotrexate and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy
* Patients who were previously on a TNF inhibitor as monotherapy, and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy
* Concomitant treatment with corticosteroids (orally and intra-articularly) and/or NSAIDs is allowed

Exclusion Criteria:

* Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
* Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
* Patients receiving concomitant DMARD treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)
* Patients who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
* Patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis