cyrilzakka/clinical-trials huggingface dataset:
Evaluation of an Investigational Multifocal Lens

The purpose of this study is to test the performance of an investigational multifocal test soft contact lens.


Eligibility Criteria:
Inclusion Criteria:

1. The subjects were required to have read, understand, and signed the Statement of Informed Consent and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Between 40 and 70 years of age.
4. Subjects must own a wearable pair of spectacles, if required for their distance vision.
5. Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration)
6. Already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire"\*
7. The subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye.
8. Refractive cylinder ≤ -0.75 D in each eye.
9. ADD power in the range +0.75 D to +2.50 D in each eye.
10. Best corrected visual acuity of 20/20-3 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who became pregnant during the study were discontinued).
2. Any ocular or systemic allergies that may have contraindicated contact lens wear.
3. Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear.
4. Any ocular abnormality that may have interfered with contact lens wear.
5. Use of any ocular medication, with the exception of rewetting drops.
6. Any previous intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
7. History of herpetic keratitis.
8. History of binocular vision abnormality or strabismus.
9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).
10. History of diabetes.
11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
12. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
13. Any ocular infection or inflammation.
14. Any corneal distortion or irregular cornea.
Does Addition of a Functional Knee Brace Improve Rehabilitation Outcome in Subjects With Osteoarthritis of the Knee?

The purpose of this study is to investigate the effect of functional knee brace in the subjects with medial compartment knee OA.

20 subjects with symptomatic medial compartment knee OA, with grade 2 to 4 on Kellgren and Lawrence scale, and showing willing to wear a functional knee brace will be recruited into this study. Another 20 subjects with comparable body height, weight, and sex will be served as a control group. All of the subjects received 4 weeks' rehabilitation treatment (3 times a week). VAS pain score, WOMAC index, and SF-36 will be evaluated before the treatment, and 1 month, and 3 months after the start of treatment. Patients' satisfaction will be evaluated at 1 month, and 3 months after start of treatment. Patients' compliance and any adverse events due to wearing of the functional knee brace will also be reported. A 2-by-3, 2-way mixed-model analysis of variance, which had 1 between-subject factor (group: knee brace + PT and PT only) and 1 within subject factor (evaluation time:T0, T1, T2) , was performed. Pair-wise comparisons between groups were performed using an independent t test (if in normal distribution) or Mann-Whitney U test (if not in normal distribution). Investigators hypothesize that addition of a functional knee brace would improve rehabilitation outcome in subjects with knee OA.

Eligibility Criteria:
Inclusion Criteria:

According to the American College of Rheumatology (American College of Rheumatology) diagnosis of unilateral medial knee osteoarthritis, according to Kellgren and Lawrence X-rays are classified as two to four acceptable month rehabilitation therapy, and for the first time dressed Thruster Legacy's functional knee brace. The control group of patients with knee osteoarthritis same conditions, but dressed Thruster Legacy functional knee brace.

Exclusion Criteria:

1. have undergone knee surgery
2. the lateral tibiofemoral joint severe (tibio-femoral joint) disease
3. serious knee ligament laxity
4. knee flexion contracture (flexion contracture) than 20 degrees
5. unable to walk
6. the skin of metal (aluminum) allergy
7. lower extremity vascular lesions or swelling
Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients

The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass. Evaluation of pulmonary complications and outcomes during mid-term follow-up, as well as comparison of ultrasound examination and traditional roentgenologic methods (X-ray examination and CT of the chest) will be performed. The main question\[s\] it aims to answer are:

* Is ultrasound examination of the lungs a more specific and sensitive method in identification of early postoperative pulmonary complications after on-pump cardiac surgical procedures, in comparison with traditional X-ray methods.
* Does early identification of interstitial pulmonary edema (based on number of visualised B-lines in the early postoperative period), influences mid-term outcomes in this cohort of patients Participants will undergo ultrasound examination of the lungs on postoperative day 1, 3, 5 and 7 after heart surgery. Based on ultrasound findings and degree of interstitial pulmonary edema, medical (diuretics, anti-inflammatory, e.t.c) therapy will be modified.

Researchers will compare this group of patients with control group, in which ultrasound examination will be performed in the same time frames, but no changes in medical management based on ultrasound findings will be made to see if timely administered medical therapy, based on ultrasound findings, can significantly improve symptoms, hospital lengths of stay and outcomes of this patients.


Eligibility Criteria:
Inclusion Criteria:

* open heart surgery with cardiopulmonary bypass (CPB) between 15 December 2023 and 15 December 2024
* signed informed consent for participation in the study

Exclusion Criteria:

* reoperations on the open heart with CPB
* surgical procedures on lungs and lung cancer in the anamnesis
* chronic obstructive pulmonary disease, stage III
* chronic kidney disease, stages 4 and 5
* patients with low Risk Score profile by the Society of Thoracic Surgeons
Echocardiographic Study of a Single Dose Bisoprolol Versus Nebivolol in Healthy Subjects

This is a randomized, double-blind, crossover study in healthy adult subjects. Each subject will receive a single dose of bisoprolol 5 mg p.o. and nebivolol 5 mg p.o. with 1 week washout period. All subjects will undergo a physical examination, 12-lead electrocardiography and a comprehensive echocardiographic study before the administration of the study drug and 5 hours thereafter.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects (male and female)
2. Age interval: 20-60 years old (inclusive)

Exclusion Criteria:

1. Any known absolute or relative contraindication to beta-blocker therapy
2. Poor echogenicity
3. A resting heart rate \<60 bpm
4. A resting blood pressure \< 110/70 mmHg
A Single-dose, Dose-escalation Study of a Long-acting MOD-6031 in Healthy Overweight or Obese Subjects

MOD-6031 is a long-acting reversibly PEGylated oxyntomodulin (OXM) therapeutic. The active moiety is a gastrointestinal neuropeptide with a sequence identical to endogenous human OXM and is an agonist for both glucagon-like peptide-1 (GLP1) and glucagon (GCG) receptors. The peptide is a natural appetite suppressant, secreted by L-cells in the digestive system following food intake leading to a decrease in gastric emptying, satiety after crossing the blood-brain barrier, and regulation of insulin and glucose levels. Thus, MOD-6031 is being developed as a treatment for high risk subjects (obese) to increase weight loss, reduce food intake and increase glycemic control.

This will be a a randomized, single-blind, placebo-controlled, single-dose, dose-escalation study. Five escalating dose groups are planned, with 8 subjects per dose group, randomized in 3:1 ratio to receive a single dose of MOD-6031 or matching Placebo (6 MOD-6031 to 2 placebo subjects). The initial MOD-6031 dose will be 20 mg, followed by single doses of 50 mg, 100 mg, 150 mg and 200 mg. Each subject will receive a single study drug injection in the morning (dosing day designated as Day 0) and will be monitored for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male, between 18 to 55 years of age.
* BMI 27-35 Kg/m2 (inclusive).
* Generally good health.
* Triglyceride ≤ 400mg/ml
* ECG with no clinically significant abnormalities.
* Negative HIV, hepatitis B or hepatitis C serology tests at screening
* No significant abnormalities in clinical laboratory parameters
* No history of alcohol or drug abuse.

Exclusion Criteria:

* History of clinically significant medical condition.
* Any cardiac conduction defect.
* Any acute or unstable disease.
* History of malignancy diagnosed within the past 5 years.
* Known or suspected diabetes and/or HbA1C \>6.4% on screening.
* Known allergy to any drug.
* Treatment with weight loss drugs (within 3 months prior to dosing).
* Liposuction or other surgery for weight loss within the last year.
* Evidence of eating disorders (bulimia, binge eating).
* History of regular alcohol consumption exceeding.
* Use of tobacco or nicotine-containing products.
* Subjects that have difficulty fasting or consuming the standard meals that will be provided.
Correlation of Lung Biopsy, BAL, and High Resolution CT Scan in Lung Transplantation

A major source of graft failure and dysfunction in lung transplantation is known to be bronchiolitis obliterans (BO)and its clinical correlate called bronchiolitis obliterans syndrome(BOS). In fact, BOS is the leading cause of death in lung recipients beyond one year post transplant. Currently, our ability to assess lung injury after transplant is less than ideal.

The purpose of this study is to use new computerized tomography(CT) technology, specifically , 64 bit acquisition, to detect and predict the onset of lung injuries, with the hope of finding better therapies that currently exist.

Total enrollment : 10

Lung transplant patients will undergo CT Scans before scheduled bronchoscopies which are routinely performed at 1, 3, 6, 9, and 12 months post transplant. Imaging will be done with the newest generation scanner, with intent to analyze all pertinent areas of the lung for pathology, but especially the bronchial anastomoses, the lung parenchyma with focus on gas exchanging lobules of the lung, and any suspected abnormalities from physical exam, laboratory tests, or prior chest xray.

CT imaging will precede bronchoscopy and biopsy so that CT interpretation will be unencumbered by changes due to the bronchoscopic procedure.

Eligibility Criteria:
Inclusion Criteria:

* Lung transplant patients who are at least 18 years of age.
* All patients must be able to give written informed consent.

Exclusion Criteria:

* Lung transplant patients who are unable to undergo a CT Scan.
* Lung transplant patients who are unable to give informed consent.
Postoperative Opioid-Sparing Effect of a Pecto-Intercostal Fascial Block and Opioid-Free Anesthesia.

The present study aims to assess the difference in postoperative opioid consumption between patients who intraoperatively receive a pecto-intercostal facial block combined with opioid-free anesthesia versus a traditional opioid-based regimen for cardiac surgery. The literature on opioid-free anesthesia for cardiac surgery is minimal and solely consists of case reports and retrospective studies. Nevertheless, these reports show the feasibility of opioid-free anesthesia. The purpose of this study is to assess the opioid-sparing effect and efficacy of combining an opioid-free anesthetic regimen with a pecto-intercostal fascial plane block (PIFB) in patients undergoing cardiac surgery.

We hypothesize that opioid-free cardiac anesthesia with an intraoperative PIFB significantly reduces postoperative opioid consumption in comparison to a high-dose opioid intraoperative regimen.

Patients, aged 18 years or older, scheduled for coronary artery bypass graft surgery (CABG) with a complete midline sternotomy as surgical approach will be recruited for this study.

Patients planned for this particular surgical procedure will be recruited and allocated to one of 2 groups:

1. "Intervention" group: Opioid-free anesthetic regimen with a pre-incisional pecto-intercostal fascial plane block (PIFB);
2. "Control" group: traditional opiate-based anesthetic regimen in which the dosage of the opioids is at the discretion of the attending anesthesiologist.

Based on our power analysis, each group will consist of 64 patients.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Patients scheduled for coronary artery bypass graft surgery (CABG), which includes a complete midline sternotomy.

Exclusion Criteria:

* CABG surgery which did not include a complete midline sternotomy
* Valve surgery
* Aortic surgery
* Emergency cardiac surgery
* Known allergy for ropivacaine
* Participation in another clinical trial
* Known drug abuse
* Preoperative cognitive dysfunction
* Preoperative pain therapy with opioids or anticonvulsants 14 days before surgery
* Patients unable to use Patient Controlled Analgesia (PCA)
* Need of reintubation after initial extubation
Efficacy of Mouthwashes in Reducing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load in the Saliva

This is a single-blind, parallel-group, randomized pilot study designed to evaluate and compare the efficacy of 3 different mouthwashes containing 0.2% Chlorhexidine digluconate, 1.5% Hydroxide peroxide or Cetylpyridinium chloride in reducing Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in the saliva of COVID-19 positive patients at different time-points.

A convenient sample of up to 40 COVID-19 positive patients diagnosed via test and/or presenting COVID-19 clinical symptoms will be identified in the inpatients and/or outpatient clinics at the Newham University Hospital and at The Royal London Hospital, Barts Health National Health Service (NHS) Trust, United Kingdom (UK).

The study will consist of one visit. Unstimulated saliva samples will be collected from all COVID-19 positive patients before and at 30 minutes, 1, 2, and 3 hours after mouth rinsing (Group 1-3 ) or no rinsing (Group 4). Viral load analysis of saliva samples in the different time-points will be then assessed by Reverse Transcription quantitative PCR (RT- qPCR).


Eligibility Criteria:
All of the following criteria must be fulfilled for inclusion:

* Patients must have willingness to read and sign a copy of Informed Consent Form.
* Males and females, ≥ 18 years old.
* COVID-19 positive patients confirmed via any diagnostic test and/or presented with COVID-19 clinical symptoms at point of consent.

Exclusion criteria for patients

Patients presenting with any of the following will not be included in the trial:

* Known pre-existing chronic mucosal lesions e.g. lichen planus or other oropharyngeal lesions, reported by patient or recorded in the existing patient' medical notes;
* Patients currently intubated or not capable of mouth rinse or spit;
* History of head and neck radiotherapy or chemotherapy;
* Self-reported xerostomia;
* Known allergy or hypersensitivity to chlorhexidine digluconate or one of the mouthwashes constituents;
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial;
* Inability to comply with study protocol.
Effectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures

To compare outcomes over 12 months of treatment with antiepileptic drugs (AEDs) alone or vagus nerve stimulation (VNS) therapy plus AEDs in patients who have partial seizures refractory to at least two, but not more than five, AEDs.

Published data suggest that patients who continue to experience seizures after trials of two or three AEDs are unlikely to become seizure-free with further attempts at pharmacotherapy. Such patients may experience poor quality of life and functional outcomes from continuing seizures and the adverse effects associated with further attempts at pharmacotherapy. VNS is a non-pharmacologic treatment for epilepsy with well-established effectiveness as an adjunctive treatment (to AEDs) for partial seizures refractory to AEDs, but there are no randomized clinical trials comparing the effectiveness of adjunctive VNS therapy with further pharmacotherapy alone in such patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient has a diagnosis of partial seizures with onset before age 50, and the patient's prior electroencephalography and magnetic resonance imaging studies are consistent with the diagnosis of partial seizures.
* Patient has at least 4 complex partial seizures, but less than 25 seizures (any type), per month during the 3 months preceding randomization; for the 8 weeks preceding randomization, the seizure frequency should be confirmed from a patient diary.
* Patient has not had an adequate response to an adequate dosage of -- or was intolerant to -- a minimum of 2 different AEDs.
* Patient has (in the investigator's judgment) sufficient impairment from his/her epilepsy and/or epilepsy treatment that the potential benefits/risks of VNS therapy are warranted.
* Patient must currently be receiving at least one AED, but not more than three AEDs, in a stable dosage regimen for at least one month before randomization.
* Patient must be 12 years of age or older.
* Patient must be able to provide reliable seizure counts and to complete the evaluations specified in the study procedures flow chart.
* Patient must provide written informed consent, or legal guardian must give written permission and the minor provide written assent.

Exclusion Criteria:

* Patient has a history (lifetime) of having received more than 5 different AEDs.
* Patient has had a bilateral or left cervical vagotomy.
* Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
* A VNS Therapy System implant would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the patient.
* Patient is expected to require full body magnetic resonance imaging during the clinical study.
* Patient has had a previous VNS Therapy System implant.
* Patient has a previous neuroimaging study that demonstrates mesial temporal sclerosis, cortical dysplasia, or a suspected brain tumor.
Response to Massage in Neck Pain

This study is interested in whether baseline measures of pain sensitivity i.e. the amount of pressure required to feel pain predicts pain relief following a pain inducing massage AND whether pain relief following a pain inducing massage is different than a pain free massage or placing your hand in a cold water bath. Participants with neck pain will be randomly assigned to receive a pain inducing massage, pain free massage, or to place their hand in a cold water bath.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 60 years old
* Currently experiencing neck pain with or without arm pain
* Neck pain symptom intensity rated as 4/10 or higher during the last 24 hours
* Neck pain for greater than or equal to 3 months

Exclusion Criteria:

* Non- English speaking
* Systemic medical conditions known to affect sensation (e.g. diabetes)
* History of neck surgery or fracture within the past 6 months
* Current history of chronic pain condition other than neck pain
* Diagnosis of cervical radiculopathy or cervical myelopathy
* History of whiplash
* Currently using blood thinning medication
* Any blood clotting disorder such as hemophilia
* Any contraindication to application of ice, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, and circulatory compromise
* Pregnancy
Electrophysiological Activity of the Subthalamic Nucleus During the Processing of Emotional and Motivational Information

The role of the basal ganglia in the processing of information with emotional or motivational content has been demonstrated by several lesion and functional imaging studies in humans and animals. Deep brain stimulation surgery provides an opportunity to study these structures in humans in electrophysiological terms. The aim of this study is to investigate modifications in the electrophysiological activity of the subthalamic nucleus (STN) during the perception of auditory and visual stimuli with emotional or motivational connotations in patients with Parkinson's disease who have just undergone implantation of a deep brain stimulator in the STN.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Parkinson's disease selected for deep brain stimulation (DBS) of the subthalamic nucleus (STN) in accordance with the criteria established by Welter and colleagues (Welter et al., 2002);
* Aged 18 years or above;
* Written informed consent from the patient.

Exclusion Criteria:

* Patient under a legal incapacity or with limited legal capacity;
* Patient who has perioperative complications or postoperative confusion;
* Patient displaying cognitive disturbances involving the early stages of speech processing (on the basis of an audiogram systematically conducted prior to surgery) ;
* Patient displaying cognitive disturbances involving the early stages of face processing (on the basis of the Benton Facial Recognition Test (Benton, Hamsher, Varney, \& Spreen, 1983) systematically administered prior to surgery);
* Patient incapable of understanding the information given about the study, performing the tasks or providing informed consent.