cyrilzakka/clinical-trials huggingface dataset:
A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery

Pterygium is a fibrovascular wing shaped encroachment of conjunctival fold on to the cornea with elastotic degeneration of a subconjunctival tissue, The standard treatment for pterygium is surgical excision, but the recurrence rate after surgery can be as high as 24%-89%, which compromises outcomes. Based on the simple excision of pterygium, multiple strategies and techniques have been developed to reduce the high rate of pterygium recurrence. The investigators aim was to compare the safety, efficacy, overall patient satisfaction and recurrence rate of suturing, fibrin gluing and sutureless glue-free technique for attaching conjunctival autograft in primary pterygium surgery.

Design: Prospective randomized comparative interventional clinical study Setting: Assiut university hospital \& El-Mabarah hospital for health insurance Methods: The study included 60 eyes of 60 consecutive patients of primary nasal pterygium were enrolled in the study. Simple excision under local anesthesia was performed then closure of the bare sclera by conjunctival autograft with fibrin glue in 20 eyes of 20 patients (group 1), versus sutured free conjunctival autograft in 20 eyes of 20 patients (group 2) ), versus sutureless and glue-free conjunctival autograft in 20 eyes of 20 patients (group 3).

Eligibility Criteria:
Inclusion Criteria:

1. Patients complaining of primary Progressive nasal pterygium.
2. Patients with pterygium threatening the visual axis.

Exclusion Criteria:

1. Double head pterygium.
2. Pseudopterygium
3. Recurrent pterygium
4. Patients with history of any bleeding abnormalities
5. Patients with ocular surface diseases eg- blepharitis, Sjogren syndrome and dry eye.
COVID-19 Vaccination of Immunodeficient Persons (COVAXID)

The study is designed as an open, non-randomized, phase IV cohort study in which the mRNA vaccine Comirnaty will be given in two doses. Analyses will be performed on blood and saliva, investigating humoral and cellular vaccine responses. Occurence of local or systemic reactogenicity will be evaluated, as well as adverse events. The study will include persons with primary or secondary immunosuppressive disorders, as well as immunocompetent persons, with the aim of investigating if the immune responses after given Comirnaty mRNA vaccine against COVID-19.

In this study with 450 patients with primary or secondary immunosuppressive disorders (patients with primary immunodeficiency, HIV infected patients, patients with allogenic stem cell transplantation/CAR T cell treated, solid organ transplanted, and patients with chronic lymphatic leukemia) from Karolinska University Hospital, and healthy controls of 90 individuals for comparison, we will investigate the safety and the immune responses after mRNA vaccination with Comirnaty after two doses, under 6 months of time for each participant. The study is In collaboration with research groups at Karolinska Institutet and SciLifeLab, with planned in-depth detailed analyses of antibody responses as well as cellular responses. The study has obtained permission from Swedish Medical Agency and Swedish Ethical Review Authority.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals ≥18 years old

2a. In the opinion of the investigator, individuals with immunosuppressive disease who meet one of the following criteria:

* Primary immunodeficiency
* Human immunodeficiency virus (HIV)-infection
* Allogeneic stem cell transplantation / Chimeric antigen receptor (CAR T cell) therapy
* Solid organ transplant
* Chronic lymphatic leukemia

or

2b. In the opinion of the investigator, individuals without immunosuppressive disease or treatment without significant co-morbidity

3. Provision of signed informed consent to participate in the study

Exclusion Criteria:

1. Previous or ongoing Coronavirus Disease-19 (COVID-19).
2. Coagulation disorders, other conditions associated with prolonged bleeding time or anticoagulant treatments, which according to the investigator contraindicate intramuscular injection. Conditions which can be corrected with measures such as platelet concentrate treatments, coagulation factors or other measures for people responsible for anticoagulants are not exclusion criteria.
3. Planned to receive another vaccine within 14 days before the first dose of the study vaccine, or during the period from the first dose of the study vaccine up to 14 days after the second dose of the study vaccine, and vaccination with another vaccine which in the investigator's opinion cannot be planned outside these time periods
4. Pregnancy or breast feeding.
5. Hypersensitivity to the active substance or to any of the excipients contained in the vaccine
6. Individuals who cannot understand the informed consent.
7. Individuals who for other reasons are considered by investigators as not suitable for inclusion
Enhanced Nurse Home Visitation to Prevent Intimate Partner Violence

An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence; This randomized trial of an intervention to assess and prevent intimate partner violence during pregnancy and the post-partum builds upon the David Olds model of nurse home visitation (Nurse Family Partnership or NFP) for high risk mothers and infants that has shown to be effective in multiple settings in preventing child abuse and enhancing maternal and child health and psychosocial outcomes. However, prior research has shown that the NFP intervention is not as effective in homes where there is intimate partner violence (IPV). Although the NFP by itself has reduced IPV in one setting, it has not in another. The proposed study will test the efficacy of an enhanced NFP intervention, the ECI or Enhanced Choice Intervention among women referred to an existing NFP program in Portland, Oregon. The ECI is based on a choice or empowerment model whereby women can choose among interventions related to her goal for her current intimate relationship. If IPV or emotional abuse or controlling behaviors are assessed, the intervention is based on two interventions shown to be effective in assessing for and reducing repeat IPV (the Sullivan Advocacy Intervention and the McFarlane and Parker brochure driven intervention). For women desiring to enhance marital quality, the Markman and Stanley PREP model that has been shown to enhance relationship quality will be offered. The PREP model also has some preliminary evidence of preventing IPV. For women with other risk factors for IPV in their own or their partners' history (e.g. exposure to parental IPV, child abuse, substance abuse), community resource linkage (beyond referral) strategies as with the NFP model will be used to obtain community resources to address these risk factors. 250 women referred to the Multnomah County Health Department will be randomized to the experimental (NFP plus ECI) or control condition (NFP) and visited according to the regular NFP schedule during pregnancy and until the infant is 24 months old. The intervention will concentrate on the prenatal and immediate (first 6 months) post partum period with regular IPV, emotional abuse and controlling behavior assessments throughout the NFP period. Baseline and outcome measurement (CTS2, WEB, TPMI, depression - Edinborough, \& parenting stress), will occur at 3 months before delivery, 9 months \& 21 months post-partum with multivariate MANOVA, SEM and growth curve analyses.


Eligibility Criteria:
Inclusion Criteria:

* No more than 28th week of gestation
* Low income
* Speak English or Spanish
* Pregnant with first child
* Minimum of 15 years of age at time of entrance into study

Exclusion Criteria:

* Women experiencing high risk pregnancies
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal Hyperplasia

This is a Phase 2, open-label, multiple-dose, study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-74788 (crinecerfont) in pediatric participants (14 to 17 years of age) with a documented medical diagnosis of classic 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH).


Eligibility Criteria:
Inclusion Criteria:

1. Be in good general health.
2. Have a medically confirmed diagnosis of classic 21-hydroxylase deficiency CAH.
3. Be on a stable regimen of steroidal treatment for CAH that is expected to remain stable throughout the study.
4. Participants of childbearing potential must be instructed on the proper use of barrier methods of contraception and agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently from screening until the final study visit or a prespecified window after the last dose of study drug, whichever is longer.
5. Participants of childbearing potential must have a negative pregnancy test at screening and negative urine pregnancy test at baseline.
6. Have a negative urine drug (for illegal drugs) and alcohol breath test at screening and baseline.
7. Be willing and able to adhere to the study regimen and study procedures described in the protocol and informed consent/assent form, including all requirements at the study center and return for the follow-up visit.

Exclusion Criteria:

1. Have a clinically significant unstable medical condition or chronic disease, or malignancy.
2. Had a medically significant illness within 30 days of screening.
3. Have a known or suspected differential diagnosis of any of the other known forms of classic CAH.
4. Have a history that includes bilateral adrenalectomy, hypopituitarism, or other condition requiring daily therapy with orally administered glucocorticoids.
5. Are pregnant or lactating females.
6. Have a history of epilepsy or serious head injury.
7. Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
8. Have hypersensitivity to any corticotropin releasing hormone antagonists.
9. Test positive at screening for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), or have a history of a positive result.
10. Have a recent history of alcohol or drug abuse, or current evidence of substance dependence or abuse criteria.
11. Used any anticoagulants or antiplatelet therapies within 30 days before screening.
12. Have an active bleeding disorder.
13. Used any other investigational drug within 30 days before initial screening, or plans to use an investigational drug (other than the study drug) during the study.
14. Have a blood loss ≥250 mL or donated blood within 56 days or donated plasma within 7 days before baseline.
Total Hip Arthroplasty (THA) Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach

The purpose of this study is to compare the short term effectiveness and return to function of subjects undergoing primary Total Hip Arthroplasty using an Anterior Approach (incision on the front part of the hip joint) versus Posterior Approach (incision over back part of the hip joint).

The anterior approach may provide better early post-operative outcomes because there are fewer muscles at the front of the hip so the surgeon works between them rather than cutting through muscle fibers. However, the anterior approach is more difficult to access so usually requires a specialized table.

The posterior approach is easier to access, but the incision cuts through muscle fiber. This may lengthen recovery time. However, a specialized table, which can be quite expensive, is often not required.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is able to or capable of providing consent to participate in the clinical investigation.
2. Subject is between the ages of 20-75 years, inclusive.
3. Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD)
4. Subject has sufficient bone stock for the hip replacement device.
5. Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either surgical approach.

Exclusion Criteria:

1. Subject in the opinion of the Investigator has an existing condition that would compromise his /her participation and follow-up in this investigation.
2. Subject has had previous surgery on the affected hip.
3. Subject has significant osteoarthritis of the contra-lateral hip requiring a total hip arthroplasty within 12 months.
A Phase 1 Dose Escalation Study of Oral VX-708 in Healthy Participants

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of VX-708 in healthy participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Male and female of non-childbearing potential are eligible
* Body mass index (BMI) of 18.0 to 32.0 kilograms per meter square (kg/m\^2)
* A total body weight greater than (\>) 50 kg

Key Exclusion Criteria:

* History of febrile illness or other acute illness within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption, distribution, metabolism, or excretion
* History of cardiac dysrhythmias

Other protocol defined Inclusion/Exclusion criteria may apply.
Assessing Imaging as a Tool in Monitoring and Predicting the Progression of Parkinson Disease

The purpose of this study is to investigate the utility of dopamine transporter imaging in monitoring and predicting the progression of Parkinson disease. This study will be performed in the PRECEPT cohort, an already existing cohort of 806 subjects recruited to participate in the study called, A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of CEP-1347 in Patients With Early Parkinson's Disease - (PRECEPT), sponsored by Cephalon and Lundbeck and coordinated by the Parkinson Study Group. The imaging data from this long-term PRECEPT follow-up study will allow us to evaluate the long-term progression of DAT loss in PD, the long-term follow-up of SWEDD subjects, the relationship between long-term clinical and imaging PD outcomes, and the relationship between long-term imaging outcomes and genetic and biochemical biomarkers of PD progression.

The 800 early PD subjects in this study have already been evaluated clinically and have undergone longitudinal dopamine transporter (DAT) imaging with \[123I\] ß-CIT (baseline and 22 months). In Follow-up imaging will be performed at 24-month intervals (46 and 70 months following PRECEPT baseline). All scanning procedures will be performed at the Institute for Neurodegenerative Disorders (IND) using methods previously employed in the PRECEPT study.

Subjects willing to participate will travel to New Haven for their 46-month imaging visit. At IND a study coordinator and a neurologist will evaluate all subjects. The coordinator and neurologist will discuss the study procedures and evaluate the patient for eligibility. Written informed consent for the study will be obtained prior to performing any study-related procedures.

If eligible, participants will be injected with ß-CIT and 24 hours later an imaging procedure will be used to obtain pictures of brain activity using single photon emission computed tomography (SPECT). This 2-day procedure will be repeated at 70 months (following PRECEPT baseline).

Eligibility Criteria:
Inclusion Criteria:

* Subject was a participant in the PRECEPT clinical and imaging study
* Participant must be willing and able to comply with study procedures
* Participant must be willing and able to give informed consent.

Exclusion Criteria:

* The participant has a clinically significant clinical laboratory value and/or medical or psychiatric illness
* The participant has dementia (MMSE≤24)
* Pregnancy
Effect of Implant Position on Magnetic Resonance Image Distortion

Patients with Neurofibromatosis type 2 (NF2) almost always develop acoustic neuromas in both ears. As a result of the tumours themselves or the treatment of the tumours, many patients become profoundly deaf in both ears. It is possible to restore a degree of hearing by placing a hearing implant in the brainstem adjacent to the hearing pathways within the brain. This is termed an auditory brainstem implant (ABI).

The aim of this study is to find the optimum head position in relation to the MRI magnet field, which would produce least area of image distortion in patients with ABIs. This will be of benefit in optimising the MR imaging in future patients with implants.

Auditory brainstem implants (ABI) are placed against the auditory centres in the brainstem if it is not possible to implant the cochlea or if the cochlear nerve, which conveys neural signals from the cochlea to the brainstem, is damaged or absent. The latter device is usually used in patients with Neurofibromatosis type 2 (NF2) who develop bilateral benign inner ear tumours called vestibular schwannomas as well as other neurological tumours1. These patients often become bilaterally profoundly deaf either as a result of the disease or because of surgery to remove the tumours and require an ABI.

Patients with NF2 require monitoring of their tumours. In the absence of an auditory implant it is possible to use magnetic resonance imaging. This is the gold standard imaging technique as it gives excellent views of the soft tissues of head. However, there has been concern regarding the use of MRI in patients with auditory implants until recently because of potential problems such as demagnetisation of the magnet within the implant, implant magnet displacement and risk to the integrity of the implant electronics. In addition, the magnet field of the implant magnet results in imaging artefact (manifesting as a signal void) around the implant site that limits the information that can be obtained.

Eligibility Criteria:
Inclusion Criteria:

- Any patient over the age of 18 with NF2 who has an auditory implant (cochlear or auditory brainstem implant) in situ and requires MRI scanning.

Exclusion Criteria:

Children under the age of 18 years Claustrophobia Bilateral implants

Contraindications and relative contraindications for MRI (as per the Radiology Department MRI protocol) including:

Pacemaker Certain metallic heart valves Ferromagnetic implanted materials and foreign bodies
Safety Study of Non-invasive Ventilation Versus High-flow Oxygen in Patients With Hypoxemic Respiratory Failure Undergoing Fiberoptic Bronchoscopy.

Bronchoscopy with broncho-alveolar lavage is a diagnostic tool in patients with pneumonia. Especially patients with acute or chronic pulmonary diseases are at risk of respiratory failure during or after bronchoscopy. It is known that in these cases bronchoscopy can be performed safely using non-invasive ventilation. It seems probable that high-flow oxygen, which is used in the treatment of patients with hypoxemic respiratory failure, is equally effective in preventing the development of respiratory failure during fiberoptic bronchoscopy while improving patient comfort. In this prospective randomised study the safety of high-flow oxygen is compared with non-invasive ventilation in patients with hypoxemic respiratory failure undergoing fiberoptic bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

* patients treated in an intensive care unit
* indication for bronchoscopy and broncho-alveolar lavage
* presence of hypoxemic (SaO2/fraction of inspired oxygen(FiO2): 300 or less) and/or hypercapnic respiratory failure

Exclusion Criteria:

* patients already on invasive ventilation
* indication for intubation
* blocked nasopharynx
* contraindications for non-invasive ventilation or high-flow oxygen
The Role of Genetic Factors in the Development of Bronchial Asthma in the Kazakh Population

To research for a genetic marker of bronchial asthma, a single nucleotide polymorphism (SNP) analysis of DNA obtained from the peripheral blood of patients with bronchial asthma and normal control will be performed.

Unrelated Kazaks subjects who have bronchial asthma were recruited in the current study. Genotyping for various SNP associated due to the linkage disequilibrium patterns is to be performed. Genotypes would be statistically compared between patients with bronchial asthma and normal control subjects free of bronchial asthma

Eligibility Criteria:
Inclusion Criteria:

* Persons with bronchial asthma confirmed by a doctor;
* The age of the patients is from 5 to 60 years;
* Persons of Kazakh nationality, whose paternal and maternal grandparents are Kazakhs.
* Persons who are able and willing to provide written informed consent;
* Persons capable and willing to comply with the research protocol;

Exclusion Criteria:

* Persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent;
* Pregnant or lactating women;
* Tuberculosis of any localization in the active phase and in history;
* Severe and decompensated diseases of the liver and kidneys, cardiovascular system;
* Severe and decompensated course of endocrine diseases;
* Autoimmune diseases;
* Systemic diseases;
* Oncological diseases;
Impact of Fluoride Vanish Application in Dental Prevention for Elderly

This study questions the interest of fluoride varnish dental application in preventing tooth decay in a population of institutionalised elderly people.

Application of fluoride varnish on one side of the mandibles (left or right, randomly selected) in a population of institutionalised elderly people.

Eligibility Criteria:
Inclusion Criteria:

* patient hospitalised in nursing home or long-stay hospital department
* patient older than 18 years old
* obtention of informed consent
* 3 or more healthy or treated teeth on each side (left and right) of the mandibles

Exclusion Criteria:

* patient in palliative care or end-of-life care
* patient without social security affiliation
* patient participating in another research dealing with dental care
* contra-indication to fluoride varnish
Correction of Enophthalmos and Orbital Volume Using Pre-bent Mesh Versus 3d Printed Onlay in Orbital Fracture Cases

this study evaluates the post-surgical correction of enophthalmos and orbital volume using 3D printed only versus pre-bent titanium mesh in blow-out fracture cases

Many materials had been used in reconstruction of blow out fractures, the aim of this study is to evaluate the enophthalmos correction and orbital volume restoration using 3D printed onlay versus pre-bent titanium mesh

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≤17 years old).
* Blow-out Orbital Fracture.
* Unilateral Orbital Trauma.
* Enophthalmos (≤ 2 mm).
* Patients with contralateral healthy, non-surgically operated orbit.

Exclusion Criteria:

* Young Patients (\> 17 years old).
* Patients with Systemic diseases.
* Bilateral Orbital Trauma.
* Enophthalmos (\>2 mm).
* Patients whom cannot tolerate follow up intervals.