cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens

The objective of this study is to evaluate the product performance of an investigational multifocal low add soft contact lens.


Eligibility Criteria:
Inclusion Criteria:

* Have physiologically normal anterior segments.
* Be adapted wearers of soft contact lenses and wear a lens in each eye.
* Be presbyopic and require near add correction in each eye.
* Have no active ocular disease or allergic conjunctivitis.
* Must not be using any topical ocular medications.

Exclusion Criteria:

* Any Grade 2 or greater finding during the slit lamp examination.
* Any scar or neovascularization within the central 4mm of the cornea.
* Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Allergic to any component in the study products.
* Any systemic disease affecting ocular health.
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* An active ocular disease, any corneal infiltrative response or are using any ocular medications.
LATE-COVID/LATE-COVID-Kids - Observational Study in Children and Adults

All consecutive patients admitted to the Polish Mother Memorial Research Institute (PMMHRI) in Lodz, Poland between 1st October 2020 and 31st December 2021 due to symptoms, which might reflect complications following COVID-19, will be included in the observational cohort study. Data concerning clinical characteristics, results of laboratory tests, other studies, such as: echocardiography, 24 hours ambulatory ECG recording will be collected. The study is planned also to be extended with the genetic predisposition in children to COVID-19 late complications (within independent grant).

A wide range of complications have been linked to COVID-19 - the coronavirus disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is well known that COVID-19 affects multiple organs. Most of the data however present the early complications during the acute phase of the infection, and there is still a lack of knowledge on the late complications that might appear after recovery. Additionally, the long-term complications in patients who were asymptomatic or had mild symptoms during the acute phase of infection, not requiring hospitalization, oxygen therapy or mechanical ventilation has not been fully studied. Therefore, our aim was to assess factors related to the severity of post-COVID complications among patients without severe symptoms in the acute phase of COVID-19. The study will include consecutive COVID-19 convalescents (the infection of coronavirus was confirmed with real-time polymerase chain reaction test or positive result of autoantibodies) admitted to the Departments of Polish Mother Memorial Research Institute (PMMHRI) in Lodz, Poland, for complications. Both children and adults will be included in the study. The patients will have laboratory testing and other studies due to the character of symptoms.

Eligibility Criteria:
Inclusion Criteria:

* consecutive COVID-19 convalescents (the infection of coronavirus was confirmed with real-time polymerase chain reaction test or positive result of autoantibodies) admitted to the Departments of Polish Mother Memorial Research Institute (PMMHRI) in Lodz, Poland, for complications

Exclusion Criteria:

* no history of COVID-19 infection,
* lack of complications post COVID-19,
* severe course of Sars-COV-2 infection,
* lack pf patient's agreement to be included in the study
Assessment of Foot Alignment and Pressure After Correction of Varus Knee by High Tibial Osteotomy or Total Knee Replacement

This study evaluated the change in foot alignment after TKA or HTO by prospectively analyzing the correlation between the knee joint and the foot deformity, the post-operative improvement in the foot deformity, and the long-term post-operative changes in foot alignment.

The mechanical alignment of the lower extremity is an important consideration in the long-term outcome following total knee arthroplasty (TKA) or high tibial osteotomy (HTO) . Alignment between the hip and the ankle through the knee joint has been used in determining coronal alignment, based on the assumption that weight-bearing forces pass through the centre of the knee joint during neutral mechanical. However, the weight-bearing vector can be affected by hindfoot and midfoot alignment because load is transmitted not from the ankle joint, but from the ground reaction point. Thus hindfoot alignment after knee correction may critically affect the longevity of the prosthesis

Most patients with some degree of knee joint deformity, which in turn may be associated with a deformity of the foot. In fact, an association between varus alignment of the knee joint and valgus alignment of the foot in osteoarthritis patients has been reported. Because the subtalar joint compensates for the knee joint deformity , correction of the deformity after TKA or HTO can affect foot alignment. Improvements in midfoot and hindfoot alignment have been noted in patients with osteoarthritis after correction of deformity. However, foot valgus may also persist, with little improvement after knee correction.

Eligibility Criteria:
Inclusion Criteria:

* all varus aligned knee admitted to Assiut University Hospitals (Total Knee Arthroplasty or High Tibial Osteotomy) .

Exclusion Criteria:

* patient with prior surgery of knee or foot . -secondary osteoarthritis. -valgus knee.
First in Human Study to Assess the Safety and the Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus

This Study is a first in human clinical study addressed to evaluate the safety and efficacy of a novel intra-corneal nitinol device (Investigational Device; GROSSO® implant) for the treatment of advanced keratoconus disease of the eye.

The medical device under investigation is a sterile thin 8-mm diameter circular scaffold made of a nickel-titanium alloy (nitinol) that is intended as a permanent implant that is surgically inserted into the cornea in order to modify force by inducing a change in corneal shape and consequently improving vision. This Study is aimed at adults with a stage 3-4 keratoconus, a central K reading \> 53.00 D and RMS of coma aberration \> 3.5, which are not eligible for Intrastromal Corneal Ring Segments (ICRS) and are recommended for keratoplasty.

Therefore, this study represents a salvage route to preserve the cornea. Envisaged worst case scenario of failure of the experimental device patients would be redirected to keratoplasty.

Eligibility Criteria:
Inclusion Criteria:

* Male and female ≥ 18 years old
* Not suitable for ICRS and are recommended for keratoplasty
* Best distance spectacle corrected visual acuity (BDCSVA) 1.30 - 0.40 logMAR (0.05-0,40 decimal notation)
* Have stable or stabilized disease for 12 months (in case of cross-linking, it must have been done 12 months prior to intervention)
* Have a KC stage 3-4 (Amsler-Krumeich) with a Central K readings \> 53.00 D and RMS of coma aberration \> 3.5.
* Signed and dated informed consent form

Exclusion Criteria:

* Inability of patient and/or relatives to understand the clinical investigation procedures and thus inability to give informed consent
* Untreated progressive KC
* Single functioning eye
* Minimum Corneal thickness \< 400 μm
* Other ocular diseases (eyelids malposition, uveitis, ocular hypertension, glaucoma, cataract, retinal disorders) or corneal surgeries (refractive corneal surgery, keratoplasty), except corneal crosslinking
* Systemic collagenopathies and/or vasculitis, and other diseases that in the opinion of the principal investigator may be contraindicated
Statin Combined with Amlodipine Treats Primary Aldosteronism

The drug treatment for primary aldosteronism (PA) is limited and difficult to improve long-term cardiovascular outcomes. This study plans to enroll patients with primary aldosteronism and randomly divide into 3 groups: scheme 1: Statin combined with amlodipine besylate, scheme 2: Statin combined with Spironolactone and Amlodipine besylate. scheme 3: Amlodipine besylate combined with Spironolactone , to observe the changes in plasma aldosterone level, 24-hour urinary aldosterone, blood pressure, and long-term cardiovascular risk.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of primary aldosteronism

Exclusion Criteria:

* Allergy to drugs in this study
* Pregnancy
* Severe liver and kidney dysfunction
* Mental illness
Long-Term IOP Fluctuation and VF Progression After Triple Procedure

Long-term intraocular pressure (IOP) fluctuation may be significantly associated with the progression of glaucomatous visual field loss, even in patients kept always low IOP after triple procedure, an effective approach for patients with coexisting glaucoma and visually significant cataracts.

Previous studies reported that lowering intraocular pressure (IOP) slowed the advancement of visual field damage in glaucoma patients. However, even if the IOP can been substantially lowered, reduction of mean and peak IOP does not always prevent visual field progression.We believe that the long-term IOP fluctuation may play a significant role in visual field deterioration in those patients.

Eligibility Criteria:
Inclusion Criteria:

1. Underwent triple procedure
2. At leas 3 years of follow-up after surgery
3. IOP \<18mmHg at each postoperative visit
4. A minimum of 5 visual field examinations
5. A reference visual field defect score of 16 or less
6. Good reliability indices of visual field

Exclusion Criteria:

1. Any other significant ocular diseases or intraocular surgical histories,
2. Diseases that may affect visual field or diabetes
Stellate Ganglion Block in Cerebral Palsy

The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are:

• Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Cerebral palsy is a common non-progressive clinical condition characterized by motor disorders and abnormal postures, which significantly impact the quality of life of affected children. Swallowing dysfunction is a common complication in children with Cerebral palsy , affecting their daily eating and communication skills, and hindering their nutritional development and social interaction. Stellate ganglion block has shown certain efficacy in improving swallowing function in children with Cerebral palsy. However, there is limited research on the effects of stellate ganglion block treatment on swallowing dysfunction in children with Cerebral palsy. Therefore, this study aims to explore this topic and provide scientific evidence for its clinical application.

The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are:

• Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Eligibility Criteria:
Inclusion Criteria:

* meeting the diagnostic criteria of cerebral palsy formulated by the 13th National Conference on Pediatric Cerebral Palsy Rehabilitation;
* age between 4 to 7 years;
* diagnosed as dysphagia confirmed by Dysphagia Disorder Survey or pediatric esophagoscopy;

Exclusion Criteria:

* with dysphagia caused by other diseases or factors;
* with progressive neurological disease or degenerative neurological disease;
* with severe heart disease, liver or kidney dysfunction, hematological disorders, or other acute and severe symptoms;
* with abnormalities in the oral cavity, pharynx, esophagus, or other parts of the digestive tract;
* with poor compliance.
Lactic Acidosis During and After Seizures

This project looks at the time course of lactic acid rise (if any) after seizures. Salivary and capillary lactic acid are tested. This type of measurement may be useful in signalling the occurrence or recent history of a seizure.

Lactic acid is released from cells during seizures and elevates lactic acid levels in blood and saliva. The time course of this rise is unknown. If lactic acid rises within a few minutes of a seizure, than it might be feasible to develop lactic acid sensors to provide notification of a recent seizure. This could lead to better safety monitoring for people with epilepsy. This study was designed to utilize a commercially available lactic acid sensor (investigators have no connection with the sensor manufacturer and purchased the device at list price) to measure salivary lactic acid levels after a seizure during inpatient video-EEG epilepsy monitoring.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 inclusive.
2. History of at least one generalized tonic-clonic (grand mal) seizure prior to enrollment in the study.
3. Undergoing monitoring in the Stanford Epilepsy Monitoring Unit.

   Exclusion Criteria:
4. Not pregnant.
5. Inability to understand and sign the consent form.
6. No known history of mitochondrial disease or other metabolic disorders expected to affect blood lactate.
7. No known history of thrombophlebitis or excessive tendency to bleeding. Not on coumadin. Aspirin or anti-platelet agents are not an exclusion.
8. No known peripheral vascular disease affecting blood circulation to the fingers.
9. No painful peripheral neuropathy.
10. No Raynaud's disease or phenomenon.
Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine

Vaccination against SARS-Cov2 is a necessity for haemodialysis patients because difficulties to maintain a self-isolation (leading to a higher contamination than general population) and an increase of mortality in case of contamination (more than 20% of mortality in this population). However, vaccine efficiency is known to be decreased in haemodialysis patients. This lead critical the rapid description of immunogenicity of anti SARS-Cov2 vaccine in haemodialysis patients.

The aim of this study is to describe the immunogenicity of the BTN162b2 SARS-Cov2 vaccine in haemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Medical prescription of BTN162b2 mRNA Cov-19 vaccine
* Treatment by chronic (\>1 month) haemodialysis

Exclusion Criteria:

* Non-recommended vaccination scheme
* Refusal to consent
Can Insulin Glargine Improve Myocardial Function in Patients With T2D and Coronary Artery Disease (CAD)

The field of secondary prevention remains an extremely important goal for diagnostic and therapeutic approaches keeping in mind that 40% of all patients with acute myocardial infarction have prediabetes, commonly as impaired glucose tolerance, which has not been known and treated and for which there are no guidelines for treatment. In this context, accumulating evidence shows beneficial effects for treating diabetes mellitus early in the course of disease, whereas other evidence shows that aggressive antidiabetic therapy may be associated with undesired risks. Accordingly, the present randomized and controlled pilot study is designed as hypothesis creating study to create first data about potential medication in early type 2 diabetes including impaired glucose tolerance of patients with known coronary artery disease as means of secondary prevention by comparing oral antidiabetic therapy with metformin with insulin glargine o.d. and by studying the respective effects on cardiovascular function and metabolism both in the fasting state and after a standardized meal. As diastolic myocardial function has emerged as important prognosticator, the hypothesis was tested that treatment with insulin glargine improves myocardial function in patients with coronary artery disease and newly diagnosed type 2 diabetes including impaired glucose tolerance.

This is a single centre, short term (24 weeks), therapy controlled and randomized prospective study with blinded analysis of the ultrasound data in 28 patients with known coronary artery disease, normal systolic cardiac function and with newly diagnosed type 2 diabetes including impaired glucose tolerance who are treated by ≤1 oral antidiabetic medication. After recruitment and informed consent, patients are randomized to two treatment arms which takes into account age and presence or absence of therapy with statins.

In one treatment arm, therapy is based on insulin glargine sc o.d., while in the other treatment arm, therapy is based on oral metformin, up to 2000 mg daily. Both treatment arms will be titrated to the target of fasting glucose ≤110 mg/dl during the first 12 weeks. The patients in the insulin treatment arm will be instructed in the skills of self-medication by the departmental diabetic teaching programme prior to starting study medication and are encouraged to keep records of any episode of hypoglycemia throughout the study.Outpatients visits for metabolic control and ultrasound assessment are at weeks 4, 12 and 24 after baseline and are associated with life style instructions for all patients.

Eligibility Criteria:
Inclusion Criteria:

* coronary artery disease
* type 2 diabetes of short duration including impaired glucose tolerance and impaired fasting glucose
* treatment by ≤1 OAD

Exclusion Criteria:

* contraindications for metformin or insulin glargine
* on insulin therapy
* pregnancy and breastfeeding
Robotic Therapy Early After Stroke Events

Weakness and impairment of the upper limb is a common contributing factor to post stroke disability. Specially designed robotic systems have been developed to try to improve this. The investigators already know that their use helps improve limb function after stroke when it has been present for many months. The investigators do not know whether they can help early after stroke and enhance recovery of limb function, and perhaps prevent weakness becoming chronic.

The investigators plan a randomised controlled blinded study to explore the benefits of robot assisted therapy early after stroke in 80 stroke survivors. Participants will be randomised by 7 days after stroke to standard care or to robotic therapy (40 participants per study group).

Standard of care will be rehabilitation therapy according to local guidelines delivered by NHS multidisciplinary team.

Robotic therapy sessions lasts approximately one hour and consists of a series of tasks in first the unimpaired then impaired limb. The robotic-assisted therapy will consist of a series of taks including circle-drawing, reaching targets and holding/moving against moderate resistance. Twelve sessions of therapy within the first 4 weeks after randomisation will be delivered. This study will take 3 years to complete.


Eligibility Criteria:
Inclusion Criteria:

1. Aged \> 18 years
2. Confirmed diagnosis of stroke
3. Randomisation by seven days
4. Upper limb impairment, defined as a measurable upper limb impairment on the NIHSS and a baseline upper limb FuglMeyer score of \<50 at randomisation
5. Able to comply with the requirements of the protocol

Exclusion Criteria:

1. Other significant upper limb impairment e.g. fixed contracture, fracture, frozen shoulder, severe arthritis, amputation.
2. Diagnosis likely to interfere with rehabilitation or outcome assessments such as registered blind or terminal illness.
3. Participation in other stroke rehabilitation trial.
Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index

The purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect of norepinephrine on inferior vena cava collapsibility index (IVC-CI).

Post-spinal hypotension is a frequent complication during spinal anesthesia for cesarean delivery. It affects nearly 50-60% of patients without appropriately treat. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal hypotension. Norepinephrine is new vasopressor that has been suggested as a potential alternative to phenylephrine and was recently introduced in obstetric anesthesia because of the minimal cardiac depressant effect. The purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect on inferior vena cava collapsibility index (IVC-CI).

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* American Society of Anesthesiologists physical status classification I to II
* Scheduled for elective cesarean delivery under spinal anesthesia
* Full-term, singleton, pregnant women

Exclusion Criteria:

* Height of no more than 150 centimeters
* Body weight greater than 100 kg or BMI greater than 30
* Labor analgesia had been performed
* Contraindication of spinal or epidural anesthesia
* Eclampsia or chronic hypertension or baseline blood pressure ≥160mmHg
* Hemoglobin \<7g/dl
* Fetal distress or known abnormal fetal development
* Severe vascular disease
* Diabetes mellitus or cardiovascular disease or nervous system disease
Effects of Nutritional Support on Postoperative Delirium

This study is a prospective, single-center, randomized controlled trial to compare whether applying nutritional supplementation therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium.


Eligibility Criteria:
Inclusion Criteria:

* Elderly patients aged 65 and above.
* Patients undergoing non-cardiac major surgery in thoracic surgery, lung cancer surgery, multi-level spinal surgery in neurosurgery and orthopedics, or liver cancer surgery in hepatobiliary and pancreatic surgery, under general anesthesia with an expected surgery duration of 2 hours or more.
* Patients scheduled for arterial catheterization.
* Patients who are able to take oral intake from postoperative day #1.

Exclusion Criteria:

* Patients with uncontrolled systemic conditions such as diabetes, hypertension, renal disease, liver disease, and other systemic illnesses.
* Those with visual impairment.
* Patients with cognitive impairment based on the Mini-Mental State Examination for Dementia Screening criteria.
* Individuals experiencing difficulty in communication.
* Those diagnosed with neurological disorders (such as brain hemorrhage, stroke, brain tumor, dementia, Parkinson's disease, cognitive impairment, depression, etc.).
* Patients diagnosed with alcohol or substance addiction.
* Patients with cancelled scheduled surgeries.
* Patients undergoing minor surgeries with expected anesthesia durations of less than 2 hours.