cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Dry Eye Disease's Signs in Patients Who Were Administered Intravitreal Anti-VEGF Injections

The goal of this interventional, monocentric, prospective, single-masked, case-control study is to evaluate the efficacy of Thealoz Duo (artificial tear containing trehalose 3 g and hyaluronic acid 0.15 g) in comparison to a saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate), to reduce the signs of ocular discomfort and ocular side effects in patients who have received Intravitreal injections.

The main questions it aims to answer are:

* can ocular instillation of Thealoz Duo solution, 1 week before intravitreal injection, in a fixed dose regimen, prevent ocular surface changes and dry-eye signs?
* can ocular instillation of Thealoz Duo solution, up 3 months after intravitreal injections, in a fixed dose regimen, reduce ocular surface changes, and dry-eye signs with improvement of quality of life and quality of vision?

Each participant will be randomized into each of two arms:

1. TREATMENT ARM: patients who will receive the instillation of Thealoz Duo, 10 ml, 1 drop, 4 times/day;
2. CONTROL ARM: patients who will receive the instillation of saline solution (Hydrabak), 10 ml, 1 drop, 4 times /day;

The decision of inclusion of a control group should minimize the risk of breaking the blinding condition by affecting the consistency and reliability of the outcome's achievement.

In any case, the instillation of saline solution should not alter the ocular surface.


Eligibility Criteria:
Inclusion Criteria:

* patient with retinal disease who required anti-VEGF therapy via intravitreal injections;
* patient who has already received at least 2 anti-VEGF therapy via intravitreal injections in the study eye during the last 6 months before the baseline;
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

* patient with naive retinal disease who has already received \< 2 anti-VEGF therapy via intravitreal injections in the study eye;
* subjects with autoimmune pathologies involving the ocular surface (e.g.Sjögren's syndrome), dry eye syndrome, eyelid disease that can induce changes in ocular surface (e.g. entropion, ectropion, lagophthalmos, trichiasis, ptosis), with any other systemic disease that may confound the interpretation of study results.
An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection

The purpose of this study is to evaluate the activity and safety of telaprevir on Hepatitis C Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is, pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with antiretroviral therapy) participants.

This is a Phase 2a, partially-blind, randomized (study drug assigned by chance) and multiple-dose study to evaluate the activity and safety of telaprevir on HCV early viral kinetics in treatment-naive participants who are chronically infected with HCV Genotype 4. The study consists of 4 parts: Screening period (6-week); Investigational Treatment period (consisting of 2-week treatment with telaprevir or telaprevir+standard treatment or placebo); Standard Treatment period (consists of 46 or 48-week standard treatment); and Follow-up period (24-week). The activity of telaprevir will be evaluated by early viral kinetic parameters along with viral response and pharmacokinetic assessments during the investigational treatment phase. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria: - Participant has chronic Genotype 4 Hepatitis C infection

* Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level greater than 10,000 International unit per milliliter (IU/mL) at Screening
* Participant never received treatment for HCV
* Participant was to be in good health (besides HCV infection), in the opinion of the Investigator, judged on the basis of medical history and physical examination (including vital signs and screening electrocardiogram \[ECG\]), with any chronic medical conditions under stable medical control
* Participant had to be willing to refrain from the concomitant use of any medications or substances Exclusion Criteria: - Participants with history or evidence of cirrhosis or history of suspicion of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, which in the Investigator's opinion would compromise the participant's safety and/or compliance with study procedures
* Participant has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
* Female participants who are pregnant, or planning to become pregnant, or breastfeeding, and partners of female participants who are pregnant or breastfeeding
* Participant has hypersensitivity to tartrazine
* Participant had participated in any clinical trial for an investigational drug within 90 days before drug administration or participated in more than 2 drug studies in the last 12 months
Effects of Continuous ESP Catheters on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery

Single-shot erector spinae plane (ESP) blocks (ESPB) are emerging as an intervention to improve pain and minimize opioid consumption after lumbar spine surgery. Although promising, there is minimal evidence to support routine use, and widespread clinical adoption may be limited to centers with advanced regional anesthesia resources and expertise. Continuous ESP catheter techniques may solve these problems but are associated with challenges of their own. This trial will investigate the role of adding surgeon-placed, continuous ESP catheters to single-shot ESPBs for patients undergoing multilevel spine surgery. It will assess whether adding ESP catheters with ropivacaine infusion for 48 hours after surgery offers opioid-minimizing analgesia and improves patient quality of recovery, compared to ESP catheters with saline/placebo infusion for 48 hours.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Presenting for elective multilevel (\>2 spinal levels) spinal fusion
* Lumbar, thoracic, and thoracolumbar procedures included
* Posterior surgical approach
* Willing and able to follow the study protocol
* Able to provide informed consent

Exclusion Criteria:

* Opioid tolerance (more than 60 morphine milliequivalents daily for more than 3 months)
* Daily gabapentin/pregabalin use for longer than 3 months
* Prior spine surgery at the index level
* Allergy or contraindication (including renal, liver disease) to included study medications
* Patient refusal
The Extended Salford Lung Study ("Ex-SLS") Data Access Project

The Salford Lung Study (SLS) subjects represent a group of COPD and asthma patients whose disease is extremely well-characterised over a short time period. Subjects in the SLS originally consented for information relevant to the study to be shared with the sponsor (GSK). These data were limited to three years prior to randomisation and the twelve-month interventional treatment period. Broadened access to patients' data would allow SLS subjects' entire disease journey to be researched, presenting a rare opportunity to improve scientific and clinical understanding of COPD/asthma disease risk, treatment and progression. This proposal seeks to collect additional subject-level data from SLS patients via their electronic medical records (encompassing past and future data for up to 10 years from the date of consent) and via a one-off patient questionnaire administered at the time of consent.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who were randomized to treatment in the original SLS studies
* Subjects who are able to, and choose to, provide written consent for the additional information to be collected.

Exclusion Criteria:

* Subjects who were lost to follow-up/moved away, withdrew consent or died during or subsequent to the original SLS studies.
* Subjects considered (at the discretion of the investigator) as too ill to participate or without the mental capacity to provide informed consent.
Effect of Post Isometric Relaxation Versus Myofascial Release Therapy in the Management of Non Specific Neck Pain

Non-specific neck pain (NS-NP) is the most prevailing musculoskeletal disorder (MSK) which has large socio-economic burden worldwide. It is associated with poor posture and neck strain which may lead to pain and restricted mobility. Post isometric relaxation a form of Muscle energy technique, that works on the principles of restoring biomechanics, reducing the movement restriction and pain. Myofascial release therapy will improve muscle immobility and pain by improving blood circulation lymphatic drainage and relaxing the contracted muscles. The aim of this study is to determine the effect of Post-isometric relaxation Versus Myofascial release therapy on pain, range of motion, disability and quality of life in the management of non-specific neck pain.

A randomized control trial will be conducted at IPMR (Institute of Physical Medicine and Rehabilitation) on 60 patients with non-specific neck pain with age group between 25-40 years. Initial screening of the patients will be carried out by referring physiatrist. Patients who fulfils inclusion criteria will be randomly allocated to either group by computer generated random sampling after taking written informed consent. All the patients will be evaluated using Visual analogue scale for pain, Neck disability index for functional status and disability, Universal goniometer for cervical range of motion and WHO BREF for quality of life on 1st and 6th sessions. Group 1 will receive Post isometric relaxation for Upper trapezius and levator scapulae along with Cryotherapy and strengthening exercises . Group 2 will receive myofascial release therapy for Upper Trapezius and Levator scapulae muscles along with cryotherapy and strengthening exercises. Data will be analyzed using the SPSS version 21. Baseline reading will be taken for further comparison at the end of treatment. Baseline variables are Pain, ROM, Functional disability and Qol. For within group analysis, paired sample t test will be used. For intergroup independent sample t test will be used. P value less than 0.05 will be set as threshold to detect statistical significance.

Eligibility Criteria:
Inclusion Criteria:

1. Non-specific neck pain for 2-6 weeks.
2. Unilateral neck pain
3. Patients' age group between 25 - 40.
4. On VAS scale pain intensity \>4.

Exclusion Criteria:

1. Cervicogenic headache.
2. Tumor of cervical spine.
3. Whiplash injury.
4. Cervical Fractures
5. Normal ROM of cervical spine.
Aquaporin-4 Single Nucleotide Polymorphisms in Patients with Idiopathic and Familial Parkinson's Disease

The purpose of this study is to understand the relationship between problems in sleep, genetic variations in the Aquaporin-4 gene (AQP4), and the development of Parkinson's Disease.

Parkinson's Disease (PD) is a progressive neurodegenerative disease characterized by the abnormal deposition in the brain of aggregates called Lewy Bodies, packed with a protein called α-synuclein. The mechanisms why this protein accumulates in the brain of patients with PD, as well as its relationship with clinical symptoms, is unknown.

Recently, an internal mechanism of drainage of waste proteins called glymphatic system has been identified and characterized. This system is silent during wakefulness and works during sleep. When it is active, a virtual space between the blood capillaries and cells of the brain called astrocytes opens and lets out waste products from the brain. This process is mediated by a protein of the astrocytes called Aquaporin-4 (AQP4). Preclinical studies have shown that the function of this system could be critical for the clearance of β-amyloid, a protein linked with the development of Alzheimer's Disease. Studies in humans have shown that genetic variations some parts of the AQP4 gene, defined as single nucleotide polymorphisms, may increase the likelihood to develop an aggressive form of Alzheimer's Disease. However, no studies in humans have ever been performed in Parkinson's disease and α-synuclein.

In this study, the investigators aim to elucidate whether genetic variations in the AQP4 gene contribute to variations in the clinical presentation and progression of sporadic and genetic forms of Parkinson's disease. To do so, the genetic profile of patients will be determined through a small venous blood sample collection. This will be coupled with clinical and sleep assessment.

Eligibility Criteria:
Inclusion Criteria:

* 18-85 years of age
* Able to give informed consent
* Able to perform online neuropsychological examinations
* Diagnosis of PD according to Brain Bank Criteria
* No presence or personal or family history of other neurological or psychiatric disorders

Exclusion Criteria:

* Presence of other neurological disorders and known intracranial co-morbidities such as stroke, haemorrhage, space-occupying lesions
* Inability to perform online neuropsychological assessment
* Inability to have access to informatics technology to perform the online assessment tests
* Inability to travel for the assessments
* Native language different from English
A Comparison of CBTi and Usual Treatment for Tinnitus Related Insomnia

There is evidence that CBT for insomnia (CBTi) is an effective treatment for sleep disturbance both as a primary problem and when co-morbid with other health problems, such as chronic pain.

This study will investigate the effectiveness of CBTi as a treatment for tinnitus related insomnia. Tinnitus patients reporting clinically significant insomnia will be offered sleep-specific treatment. Six sessions of CBTi will be offered to one group of patients and 2 sessions standard audiological care (psycho-education and sleep hygiene) will be offered to another group. Both groups will be offered sound enrichment at night. In order to take account of the possible effects of clinical contact a third group will be offered 6 sessions of support without a focused tinnitus or sleep intervention. Accepted measures of sleep disturbance will be used as well as measures of tinnitus complaint.

All treatment/contact will be provided at the Royal National Throat Nose \& Ear Hospital. Participants will be involved in the study (inc. baseline period {2 weeks}, intervention {8 weeks} and follow-ups {4 and 20 weeks}) for 34 weeks.


Eligibility Criteria:
Inclusion Criteria:

* At least moderately distressing tinnitus (above a set minimum score on the Mini TQ) for at least six months and problematic insomnia (above a set minimum score on the Insomnia Severity Index (ISI) and for tinnitus related insomnia to be identified in clinical interview) as result of tinnitus, for at least three months.
* Patient wishes to work on improving sleep.
* Sufficient understanding of English and sufficient hearing ability to take part in for group discussions and to complete questionnaires.
* Patient has had tinnitus assessed by a doctor and an audiological specialist.
* Willing and able to provide written consent. Able to regularly attend clinic in London, United Kingdom.

Exclusion Criteria:

* • Organic sleep disorders present (e.g. Obstructive Sleep Apnoea, delayed phase sleep, etc.) assessed with a subscale of the hospital sleep unit's sleep disorder and snoring proforma.

  * Currently pregnant, planning pregnancy or breastfeeding.
  * Alcohol or drug dependent.
  * Currently suffering with severe mental illness (psychosis, severe anxiety or mood disorder).
  * Reports active risk to themselves or others. Still undergoing medical investigations into sleep and / or tinnitus.
A Study of LY3537021 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

The main purpose of this study is to learn more about the safety of LY3537021 and any side effects that might be associated with it in healthy participants and participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to check how much LY3537021 gets into the bloodstream and how long the body takes to eliminate it.

This study will last up to about 19 weeks including screening period.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females not of childbearing potential, as determined through medical history and physical examination
* Contraceptive use by men should also be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Have a body mass index of 18.5 to 40 kilograms per square meter (kg/m²), inclusive
* Have hemoglobin A1c level of less than or equal to (≤)6.5 percent (%)

Patients with Type 2 Diabetes Mellitus (T2DM):

* Have T2DM for at least 6 months
* For Part A, have a hemoglobin A1c value at screening of 6.5% to 11% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening. For Part B, have hemoglobin A1c value at screening of 6.5% to 10% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening with or without 1 other OAM, such as DPP-IV inhibitors, SGLT-2 inhibitors, or sulfonylureas

Exclusion Criteria:

* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis
* Have a history of malignancy within 5 years prior to screening
* Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
* Have evidence of significant active psychiatric disorder(s) as determined by the investigator
* Have undergone any form of bariatric surgery
* Have donated blood of 450 milliliters (mL) or more in the past 3 months or any blood donation within the past month from screening
* Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65 years) and 14 units per week (females and males above 65 years), or are unwilling to stop alcohol consumption 24 hours prior to dosing until discharge from the investigative site
* Smoke \>10 cigarettes per day or the equivalent or are unable or unwilling to refrain from nicotine during investigative site admission

Patients with T2DM:

* Have had any of the following within the past 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure
* Are currently treated with or within the past 3 months had treatment with GLP-1 receptor agonists, or insulin
* Have had severe hypoglycemic event in the last 3 months
Prospective 2-year Data Collection of the First 10 Patients After Ankle Spacer Implantation

Osteochondral defects (OCD) of the talus are pathologic lesions of the talar cartilage and its subchondral bone and might severely deteriorate the quality of life. For the treatment of multiple and/or large talar OCDs and in patients with failed previous surgical treatment the Ankle Spacer was developed. Six patients are included in a prospective clinical and radiological study with a follow-up of two years.

One surgeon in the investigator's center implanted 10 Ankle Spacers between April 2018 and October 2020. The average age was 41.7 years (20 - 70 years). All patients get a standard followed-up at 6 weeks, 12 weeks. After the first four patients, all following patients are enrolled in a prospective study and where followed up after 1 and 2 years additionally. The American Orthopaedic Foot and Ankle Society (AOFAS) Score, the Foot and Ankle Outcome Score (FAOS), the European Foot and Ankle Score (EFAS), the Visual Analogue Scale (VAS) for pain are collected. Radiographic parameters such as implant loosening, cystic changes, lateral/medial prominence of the implant, congruency to the talar rounding, progression of osteoarthritis or bone ware of the tibia plafond are recorded. The Ankle Spacer is a one-piece implant system that replaces the articulating upper talus surface of the tibio-talar joint, and offers several implant sizes in order to fit to the different talus sizes. It is anatomically designed to the native upper talus surface to provide an optimal fit to the distal articular surface. It has a rough titanium plasma spray (TPS) coated under surface with two posts and spikes for implant fixation. The rough surface enables secondary fixation by means of bone ingrowth and the spikes at the posterior part of the prosthesis allowing for optimal adherence of the implant and for minimal iatrogenic damage upon fixation. By these means, the anatomical situation and the natural congruency of the ankle joint are mirrored to an optimal extent.

Eligibility Criteria:
Inclusion Criteria:

* Women and men aged 18-80 years
* Indication for implantation of the ankle spacer

Exclusion Criteria:

* Florid infections
* Relevant circulatory disorders on the affected leg
* Malposition of the OSG (upper ankle Joint) greater than 5 ° varus or valgus
* Fractures of the OSG or near the ankle that were less than 6 months ago
* Obesity with a BMI greater than 30 kg / m2
* Known insulin-dependent diabetes mellitus
* Known rheumatoid Arthritis
* Osteoarthritis of the OSG II ° or higher according to Kellgren / Lawrence
* Deformation of the OSG, which does not allow implantation of the ankle spacer