cyrilzakka/clinical-trials huggingface dataset:
Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal

The purpose of this study is to evaluate the changes in visual acuity, metamorphopsia, and thickness of retinal layers after epiretinal membrane removal and to investigate factors associated with visual function.

Eyes with idiopathic Epiretinal Membrane Removal (ERM) scheduled to underwent ERM removal were included. Changes in visual acuity, metamorphopsia score (M-score) using M-chart, and parafoveal thickness of each retinal layer were evaluated preoperatively and at 2-month and 6-month postoperative follow-up visits. Factors associated with visual acuity and M-score were investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with idiopathic epiretinal membrane and were scheduled for epiretinal membrane removal

Exclusion Criteria:

* evidence of ocular inflammation, diabetic retinopathy, hypertensive retinopathy, and retinal vasculitis, media opacity that would influence visual acuity or preclude acquisition of clear spectral domain optical coherence tomography images,
* presence of cataract judged to affect visual function, -6.0 diopters or more of spherical equivalent, prominent staphyloma, history of intraocular surgery other than uncomplicated cataract surgery, history of retinal detachment, other ocular diseases that may influence the macular microstructure or visual function, immeasurable fovea location on the spectral domain optical coherence tomography image due to severe retinal contraction, and indistinct intraretinal structure on spectral domain optical coherence tomography images.
* patients who underwent combined epiretinal membrane removal and cataract extraction, less than six months follow-up after epiretinal membrane removal, who had occurrence or progression of cataract after the surgery judged to affect visual function, or who experienced recurrence of epiretinal membrane during the follow-up period
Surgical Treatment of Gingival Recessions

The purpose of this study was to compare the effectiveness of microsurgical and macrosurgical approaches on CPFs plus SCTGs for the treatment of localized gingival recession defects (Miller class I or II) over the course of 6 months based on clinical periodontal parameters, periodontal phenotypes, and the postoperative complaints and satisfaction levels of the patients. We hypothesized that root coverage achieved through microsurgery in Miller I or II gingival recessions would improve clinical periodontal outcomes and the periodontal phenotype, with greater postoperative comfort and aesthetic satisfaction in comparison with conventional macrosurgical techniques. Miller Class I and II gingival recession defects, at least 3.0 mm deep, were selected and randomly assigned to receive micro or macrosurgical techniques. Both techniques were performed using a coronally positioned flap with a subepithelial connective tissue graft. Plaque and gingival indices, gingival recession depth and width, probing pocket depth, bleeding on probing, clinical attachment level, width of keratinized gingiva, aesthetic score and percentage of root coverage, postoperative complaints, and satisfaction of the participants completing the study were evaluated at follow-up 1st, 3rd and 6th months.


Eligibility Criteria:
Inclusion Criteria:

-

All participants were:

* adults aged 18 years or over
* systemically and periodontally healthy
* met the eligibility criteria for localized gingival recession of the canine or premolar teeth according to the Miller classification scheme

Exclusion Criteria:

-

Exclusion criteria included the following:

* medical disorders such as diabetes mellitus, immunologic disorders, and hepatitis;
* a history of chemotherapy or radiotherapy;
* a history of alcoholism or drug abuse;
* a history of previous mucogingival surgery at the gingival recession site;
* medications known to affect gingival tissues;
* antibiotic treatment in the past 6 months;
* smoking \>10 cigarettes per day for \>5 years, and;
* current pregnancy or lactation.
Open, Prospective Pilot Study to Obtain Aerosol Distribution in Asthmatic Patients Using Single Photon Emission Computed Tomography (SPECT) for Comparison With Functional Imaging Using Computer Methods

In this open prospective study, 6 well controlled asthmatic patients will undergo a high-resolution multi-slice computed tomography (CT) scan, lung function tests and a SPECT scan to obtain patient specific geometries of the central and peripheral small airways, patient specific boundary conditions and the in-vivo spatial distribution of inhaled aerosols.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with well controlled asthma as defined by the current GINA guidelines
2. Male or female patients aged ≥18 years
3. Patients with a documented positive response to the reversibility test (i.e. FEV1 increase ≥ 12% and 200mL from baseline value after 4 puffs of 100 µg of inhaled salbutamol pMDI) within the 12 months preceding the screening visit or performed at screening visit after a wash-out of 2 days for long acting β2 agonists or a documented positive response to the methacholine challenge test
4. Patients with a co-operative attitude
5. Written informed consent obtained
6. Patients maintained on stable respiratory medication for 4 weeks prior to visit 1

Exclusion Criteria:

1. Patients who are pregnant or are breast-feeding
2. Inability to carry out pulmonary function testing
3. Diagnosis of COPD as defined by the current GOLD guidelines
4. History of near fatal asthma
5. Hospitalization due to exacerbation or respiratory infection of the airways 4 weeks prior to visit 1
6. Current smokers or ex-smokers
7. Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
8. Cancer or any other chronic disease with poor prognosis and/or affecting patient status
9. BMI ≥ 35 kg/m2
10. Patients treated with CPAP or BiPAP
11. Known active tuberculosis
12. A history of cystic fibrosis, central bronchiectasis or interstitial lung disease
13. A history of thoracotomy with pulmonary resection
14. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
15. Patients who received any investigational new drug within the last 4 weeks prior to the screening visit
Autism Spectrum Disorders (ASD) Driving Study

The proposed pilot study will begin to assess whether driving impairments are included in the functional deficits associated with Autism Spectrum Disorders (ASDs). This will be completed by obtaining data on velocity, collision risk, and visual attention of subjects with ASDs who drive in a simulator. The study includes 2-3 visits for the screening period (approximately 6 hours of assessments) and one driving simulation visit (approximately 2.5 hours). The investigators expect to enroll 20 adolescents and adults (ages 16-50, inclusive) who have been identified as having an ASD from a prior diagnosis or participation in community conferences for individuals with ASDs.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, aged 16-50 years
* Identification as having ASD from a prior diagnosis or participation in community conferences for individuals with ASD

Exclusion Criteria:

* Major sensorimotor handicaps (e.g. deafness, blindness)
* Inadequate command of the English language
* Individuals who have never held a valid driver's license
* Mental retardation (IQ \< 80)
Exhaustive French National Registry of AF Ablation Using Pentaspline Pulsed Field Ablation Catheter

Pulsed field ablation (PFA) is a nonthermal ablative modality using a strong electrical field created around a dedicated catheter to produce pores in the cellular membrane. As the amount of energy required to produce electroporation is highly tissue dependent, the atrial myocardium can be specifically targeted while sparing adjacent tissues. This new ablation modality could increase the safety of pulmonary vein isolation (PVI) procedures compared to PVI using thermal energies. The investigators aim to provide the first exhaustive Nationwide registry using the pentaspline PFA catheter to treat atrial fibrillation patients.

This is a multicenter observational research project, that prospectively included patients undergoing a first time atrial fibrillation ablation using the Farapulse technology (Boston Scientific) since the start of this technology in France.

All patients treated with the Farapulse technology for atrial fibrillation in France from March 2021 to February 29th of 2024 will be included in the registry. The number of participating centers is 33.

A one-year and 2-year follow-up will be performed according to the standard practices of the different centers. The study duration will be 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years
* Patients who received catheter ablation for paroxysmal AF, persistent AF, or long-standing persistent AF.

Exclusion Criteria:

* Previous left atrial ablation.
* Patient's opposition to participating in this registry
Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign

The purpose of this study is to determine if computed tomography angiography can predict which individuals with intracerebral hemorrhage will experience significant growth in the size of the hemorrhage. For individuals who are at high risk for hemorrhage growth, the study will compare the drug Tranexamic acid to placebo to determine the effect and safety of on intracerebral hemorrhage growth

The Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign (TRAIGE) is a is a multicentre, randomized, placebo-controlled, double-blind, prospective, investigator-led, clinical trial of tranexamic acid within 6 hours of intracerebral hemorrhage in patients with contrast extravasation on CTA, 'the spot sign'. ICH patients within 6 hours of symptom onset, with the spot sign as a biomarker for ongoing hemorrhage, and no contraindications for antifibrinolytic therapy were enrolled in TRAIGE. The patient with a spot sign will be randomized to receive either the active treatment or placebo, the patient with no spot sign will be given regular treatment as observation. The trial is anticipated to complete in 36 months from the first subject recruitment , with 240 subjects recruited. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by IRB(Institutional Review Board) /EC(Ethics Committee) in Beijing Tiantan hospital, Capital Medical University.

Eligibility Criteria:
Inclusion Criteria:

Patients presenting with an acute spontaneous hypertensive Intracerebral hemorrhage

1. CTA evaluation can be accomplished within 6 hours of symptom onset, with "spot sign" positive in CTA original image
2. Age range from 18 to 79 years
3. Randomization can be finished and treatment can commence within 8 hours of symptom onset
4. Informed consent has been received in accordance to local ethics committee requirements

Exclusion Criteria:

1. ICH known or suspected to be secondary to tumour, vascular malformation, aneurysm or trauma
2. Infratentorial ICH
3. Glasgow coma scale (GCS) total score of \<8
4. ICH volume \>70 ml
5. Parenchymal hemorrhage with ventricle involved, blood completely fills one lateral ventricle or more than half of both lateral ventricles
6. Contraindication of CTA imaging (e.g. known or suspected iodine allergy or significant renal failure)
7. Any history or current evidence suggestive of venous or arterial thrombotic events within the previous 6 months, including clinical, ECG, laboratory, or imaging findings. Clinically silent chance findings of old ischemia are not considered exclusion.
8. Planned surgery for ICH
9. Pregnancy or within 30 days after delivery, or during lactation
10. Use of heparin, low-molecular weight heparin, or oral anticoagulation within the previous 1 week, with abnormal laboratory values
11. Known allergy to tranexamic acid
12. Prestroke modified mRS score of \>2
Inspiratory Muscle Training in Patients With Acute Myocardial Infarction

Pneumonia is uncommon high among patients with acute myocardial infarction (AMI), which increases adverse clinical events and prolongs the hospital stay. Inspiratory muscle training (IMT) is able to improve inspiratory muscle strength and prevent pneumonia in patients undergoing cardiac surgery including coronary artery bypass grafting. Thus, the investigators design the study mainly aim to evaluate the 30 days IMT for the change of inspiratory muscle strength, and also to observe its potentially effect on reducing pneumonia, in participants who accepted primary percutaneous coronary intervention (PCI) and at a high risk of pneumonia.

This is a single center, prospective, randomized controlled study. All participants will be followed up until 30 days after randomized.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years, patients with AMI undergoing primary PCI, admitted to cardiac intensive care unit and at a high pneumonia risk \[2 or more of the following parameters are regarded as high risk for pneumonia: 1. Age \> 55 years, 2. Diabetes mellitus, 3. Smoking at present, 4. Chronic kidney disease: estimated glomerular filtration rate \< 60 mL/min/1.73m2, 5. Forced expiratory volume in the first second of expiration (FEV1) \< 80% predicted and FEV1/forced vital capacity (FVC) \< 70% predicted\]
* be able to understand and agree with informed consent

Exclusion Criteria:

* a history of cerebrovascular accident
* treat with immunosuppressive medication for 30 days before
* neuromuscular disorder
* cardiovascular instability (such as aortic dissection or unstable hemodynamics)
* a history of Coronary Artery Bypass Grafting (CABG)
* expected survival is less than 6 months due to noncardiogenic disease
* participated in other drugs and devices studies within 30 days
* confirmed as ventricular aneurysm
* other conditions not suit for the study after the discussion among the researchers (eg: poor compliance, unable to cooperate for the training)
Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis

RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568 ameliorates the nasal symptoms to low doses of grass pollen in healthy subjects with seasonal allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Subject is healthy
* History of seasonal allergic rhinitis
* Male aged between 18 and 55 years
* Body weight \>/= 50 kg with BMI in range 19 - 29 kg/m2 (inclusive)
* Exhibits a moderate response to 4 hour exposure to grass pollen in the challenge chamber with a total nasal symptom score (TNSS) of \>/= 6
* Positive skin prick test (wheal \>/= 4 mm) for grass pollen
* Positive total IgE result (RAST class \>/= 2) for grass pollen
* Current non-smoker who has not used tobacco in the past 6 months with a pack history of \</= 10 pack years
* Baseline FEV1 \>/= 80% and FEV1/FVC \>/= 70% of predicted values
* No conditions or factors that may preclude subjects ability to remain in the challenge chamber for a period of 6 hours
* capable of giving informed consent and is compliant with protocol requirements
* available to complete all study measurements

Exclusion Criteria:

* structural nasal abnormalities or nasal polyps, history of frequent nosebleeds, recent nasal surgery or recent (within 3 weeks) or ongoing upper respiratory tract infection
* history of drug allergy
* participation in another clinical trial or has participated in a study using an NCE within the previous 3 months, or any clinical study within 1 month
* taking regular (or a course of) medication whether prescribed or not, including steroids, vitamins, macrolides, anti-fungal agents and herbal remedies. Paracetamol (\</= 2g / day) and occasional short acting beta agonists are permitted
* use of oral, injectable or dermal steroids within 5 weeks or intranasal and/or inhaled steroids within 1 week of the screening visit
* past or present disease, which as judged by the investigator, may affect the outcome of the study
* regular consumption of \> 21 units alcohol per week
* infected with Hepatitis B, Hepatitis C, or HIV virus
* current or chronic history of liver disease, or known hepatic or biliary abnormalities
* positive test for drugs of abuse or alcohol at screening
* previously known allergy to any of the active or inactive ingredients in the study medication
* mentally or legally incapacitated
* any other reason that the investigator considers makes the subject unsuitable to participate
Immunohistochemical Expression of Inhibin Beta A (INHBA) in Colorectal Carcinoma

A retrospective observational study to evaluate immunohistochemical expression of Inhibin Beta A (INHBA) in 60 cases of Colorectal Carcinoma, and compare levels of its expression to different clinicopathological criteria.

Colorectal Carcinoma is an aggressive malignant epithelial tumor with an observable high incidence. Tumor invasion and metastasis to distant sites are two important issues which determine patient's outcome, so detecting novel biological markers that are involved in tumor proliferation and invasion with subsequent targeting by future medical drugs will positively improve patient's prognosis.

Inhibin Beta A (INHBA) is a glycoprotein molecule that has a role in tumor cells proliferation and invasion in different human malignancies. The aim of this study is to detect expression of INHBA in 60 archived formalin-fixed Paraffin-embedded tissue blocks of patients suffered from Colorectal Carcinoma, and to correlate different levels of its expression to some studied clinical and pathological criteria (Age, Sex, Tumor size, location, depth of tumor invasion, status of regional lymph nodes, vascular and perineural invasion).

Eligibility Criteria:
Inclusion Criteria:

Specimens from patients with Colorectal Carcinoma. Tissue blocks with sufficient material. Specimens with sufficient clinical data.

Exclusion Criteria:

Tissue blocks with insufficient, destroyed or necrotic material. Specimens with insufficient clinical data.
Optical Coherence Tomography of Airway and Pleural Disorders

The researcher can use Optical coherence tomography a near-infrared diode to emit light that can produce images of the specimen under investigation and provide information about tissue abnormalities without causing damage.

The researcher can use Optical coherence tomography endoscopic imaging to improve diagnosis and treatment of airway and pleural malignancy. In the events of burn injury and smoke inhalation injury, the Optical coherence tomography can determine the change of the airway tissues and severity of airway injury.

During endoscopic procedure the lesions will be biopsied and prepared by standard histologic methods. The Optical coherence tomography endoscopic imaging can measured histologic of the tissue samples and compared to standard histologic examination. The Optical coherence tomography endoscopic imaging can measured the epithelial thickness and compared to visual inspection of the mucosa on bronchoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 or older, male or female.
* Plans for bronchoscopic with possible biopsy procedures.

Exclusion Criteria:

* Age less than 18 years of age
* Not plan for bronchoscopic with possible biopsy procedures.
* Pregnant or breastfeeding.
Role of Concentration of Biomarkers S100B and NSE in Serum in Mild and Moderate Head Trauma

In pediatric age groups communication difficulties very sometimes may present further obstacles in obtaining a detailed injury history and early identification of TBI symptoms.

Most emergency management protocols are focused exclusively on the identification of the relatively small number of patients who may require operative intervention, as early surgery is believed to improve outcome.

However early rehabilitation can also be effective for the much larger number of patients who do not require surgery\[1\] In addition, Hall and others recently reported that low doses of ionizing radiation to the brain in infancy may influence cognitive abilities in adulthood. \[2\] Accordingly, increased serum concentrations of, for example S100B ( a calcium-binding protein present in high concentrations in glial cells) and neurone-specific enolase ( NSE: a cytoplasmatic enzyme occuring predominantly in neurones ) have been demonstrated to reflect the presence and severity of brain tissue damage in acute head injuries. \[3\] In both pediatric age and adults.

Eligibility Criteria:
Inclusion Criteria:

* Only head trauma without any other body injury

Exclusion Criteria:

* Blood thinner, hydrocephalus , previous brain infarcts, encephalopathy, birth trauma.
Parent eReferral to Tobacco Quitline

Secondhand smoke (SHS) exposure is a significant public health problem in that it both harms children and is widely prevalent, affecting more than 40% of US children. Tobacco cessation quitlines are effective in helping smokers quit, but few smokers make use of their services. Electronic health record-based systems that automate referral of interested parents to quitlines through pediatric settings may increase the proportion of smokers who successfully enroll in treatment.

This is a randomized controlled study of electronic quitline referral compared to standard practice. Parent enrollment in the quitline will be reported to the study team by the state tobacco quitline, managed by the Pennsylvania Department of Health.

This is a single site study at one large outpatient pediatric practice. Eligible study participants are parents/caregivers (hereafter referred to as "parents"), 18 years of age or older, who are present for the child's healthcare (both well-child and acute) visit, who smoke, and who are interested in receiving treatment through the tobacco quitline.

The intervention is electronic referral to the tobacco quitline for parent smokers. The referral process will be embedded in a tobacco treatment clinical decision support (CDS) tool, created to help pediatricians provide counseling and treatment to parent smokers. The primary outcome of interest is smoker enrollment in the quitline, defined as the proportion of parent smokers identified in the clinic that enroll in quitline treatment compared across the intervention (electronic referral) and control (standard practice) approaches. Secondary outcomes include patient and parent demographic and behavioral factors associated with successful enrollment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Parent/caregiver who presents for their child's healthcare (both well-child and acute) visit
* Current smoker
* Interested in being referred to the tobacco quitline

Exclusion Criteria:

* Less than 18 years of age
* Parent/caregiver who smokes but is not present during their child's healthcare visit
* Not interested in referral to the tobacco quitline