cyrilzakka/clinical-trials huggingface dataset:
Bilateral Dispensing Study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric Lenses

Bilateral dispensing study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric lenses

Prospective, double-masked (investigator and participant), bilateral, randomized, cross-over dispensing study comparing the MyDay Toric (test) against the 1-day Acuvue Moist for Astigmatism (control), and Dailies Aquacomfort Plus Toric (control) lenses

Eligibility Criteria:
Inclusion Criteria:

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has had a self-reported oculo-visual examination in the last two years.
3. Has read and signed an information consent letter;
4. Is willing and able to follow instructions and maintain the appointment schedule;
5. Is an adapted soft contact lens wearer;
6. Is willing to wear contact lens in both eyes for the duration of the study;
7. Has a minimum spectacle astigmatism of - 0.75;
8. Can be fit with the three study contact lens types in the powers available;
9. Has a visual acuity of 20/30 or better in each eye with habitual correction, or 20/20 best corrected vision (for binocular distance acuity);
10. Can achieve a distance visual acuity of 20/30 (0.18 logMar) or better in each eye with the study contact lenses.
11. Has clear corneas and no active\* ocular disease;

    * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Exclusion Criteria:

1. Is participating in any concurrent clinical trial;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to fluorescein dye or products to be used in the study;
6. Appears to have any active\* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
7. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
8. Is aphakic;
9. Has undergone refractive error surgery.
Phase I, Open Label, Single Center Safety Study of [F-18]FLT

This is a ten subject, phase 1 study. The purpose of the Phase 1 study is to demonstrate drug safety in a target group of subjects with high grade brain cancer. This population represents a potential clinical population that may benefit from this PET imaging tracer. The study will also begin collection of baseline imaging data and allow us to gain information to improve design and conduct of future trials.

This is a ten subject, phase 1 study. The purpose of the study is to demonstrate drug safety in a group with high grade brain tumors and to evaluate cell proliferation with F-18 FLT. FLT is known to clear out of normal brain and detect brain tumor. This population represents a potential clinical population that may benefit from this PET imaging tracer. This information will help improve the design and conduct of future F-18 FLT clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Subject may be male or female and of any race / ethnicity;
* At the time of study drug dosing, the subject has reached his or her 18th birthday;
* Subject has histologic diagnosis of one of the following malignancies - glioblastoma gliosarcoma, anaplastic mixed/anaplastic oligodendroglioma or (anaplastic) astrocytoma with lesion visible on CT or MR and minimum histological grade of III/IV;
* Subject with suspect radiation necrosis that are planned for re-section;
* Subject or subject's legally acceptable representative provides informed consent;
* Subject is capable of complying with study procedures and able to lie still in the PET scanner;
* Subject is capable of communicating with study personnel;
* Subject has adequate liver and kidney function

Exclusion Criteria:

* Subject is pregnant or nursing;
* Subject is anemic (as defined as a hemoglobin level \<10);
* Subject has not received chemotherapy or radiation therapy within the two weeks prior to imaging.
* Subject has as reflected by a serum liver enzymes outside the normal laboratory reference range;
* Subject has a history of chronic liver disease, which may compromise liver function;
* Subject has kidney disease as reflected by a serum creatinine outside the normal laboratory reference range;
* Subject has prior history of stroke or other condition of the head or neck that, in the investigator's opinion, might affect circulation to the brain or image interpretation (examples include, but are not limited to, previous stroke with cystic softening and cerebral deformity, or arteriovenous malformation);
* Subject has a history of significant cerebrovascular disease;
* Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data
* Subject has previously received \[F-18\]FLT at any time, or any other investigational product within the past two weeks.
the Analgesic Duration of Dexmedetomidine Compared to Dexamethasone as Adjuncts to Single Shot Interscalene Block

The purpose of the study is to determine if perineural dexmedetomidine can provide increased prolongation of analgesia when compared to perineural dexamethasone in patients receiving regional block for shoulder surgery. If so, dexmedetomidine may serve as a superior adjunct to peripheral nerve blocks in a rapidly evolving, ambulatory-centered surgical setting.

Currently, the most commonly employed adjunct to peripheral nerve blockade is perineural dexamethasone. In general, at the doses used in regional anesthesia, dexamethasone has a minimal side effect profile. However, while it has been shown to increase duration of analgesia, there have been concerns regarding its neurotoxicity in animal studies. In addition, dexamethasone has the potential to cause hyperglycemia in patients with impaired glucose metabolism as well as perineal pain and pruritis when administered peripherally.

Dexmedetomidine is a highly selective alpha-2 agonist that is commonly used in patients undergoing anesthesia or requiring sedation in a non-operative setting. As a peripherally administered medication, it has both sedating and analgesic properties, as well as the added benefit of avoidance of respiratory depression. Although it can rarely produce cardiac depression at high doses, its side effect profile is otherwise minimal and is generally very well tolerated by most patients. When administered peripherally, dexmedetomidine has most commonly been associated with side effects such as hypotension, respiratory depression, and bradycardia - although all at significantly higher doses than planned in our study. The safe use of perineural dexmedetomidine together with local anesthetics has been described on numerous occasions. Nevertheless, although it has been shown to potentiate peripheral nerve blockade and prolong duration of analgesia in various studies , it remains rarely used as an adjunct to regional anesthesia.

Eligibility Criteria:
Inclusion Criteria :

* ASA 1 and 2
* 18-60 years old
* Patients scheduled for ambulatory arthroscopic or open surgery

Exclusion Criteria:

* ASA 3 and 4
* Pre-existing pain disorder
* Regular consumption of chronic pain medication
* Anatomical abnormalities of upper extremity
* Known allergy or hypersensitivity to Ropivacaine or other amide local anesthetics
* Known allergy to dexmedetomidine
* Coagulopathy
* Uncontrolled Diabetes
Intracranial Arterial Stenosis in Young Patients

The goal of this study is to evaluate the characteristic of intracranial arterial stenosis among young patients.


Eligibility Criteria:
Inclusion Criteria:

* age \< 45 years.
* stenosis of a major intracranial artery.

Exclusion Criteria:

-
Changes in the Immune Response and Skin Reactivity of Grass Pollen Allergic Patients Treated With ALK Grass Tablets

We plan to determine changes in the immune system during the allergic response to grass pollen allergens. We have chosen a particular element of the immune response, the immunoglobulin G4 (IgG4) as an indicator.

We hypothesize that treatment with Grazax will increase serum levels of Phleum pratense specific IgG4 and IgE, as well as reduce the cutaneous sensitivity of the early (IgE mediated) and late (cell mediated) allergic response.


Eligibility Criteria:
Inclusion Criteria:

* A history of grass pollen allergy
* Positive skin prick test to grass
* Positive specific IgE to grass

Exclusion Criteria:

* Treatment with anti-IgE
Adoptive Cell Transfer Combined With Peptide Vaccination in Transiently Immunosuppressed Melanoma Patients

Patients with advanced stage melanoma who underwent vaccination with the Melan-A/MART-1 peptide and who display detectable levels of Melan-A specific CD8+ T cells in peripheral blood are eligible for this trial. After collecting and freezing of these tumor specific T cells via apheresis, patients undergo a single cycle of immunosuppressive chemotherapy. 3 days after, cells are reinfused and peptide vaccination continued. The aim of this immunotherapy protocol is to boost tumor specific T cells during the immune recovery period in order to reinforce the patients' immune response against the tumor.

Patients who have previously been vaccinated with Melan-A/MART-1 peptide are eligible. Whole PBMC's containing Melan-A specific CD8+ lymphocytes are collected via lymphocytapheresis and freezed. Lymphodepleting chemotherapy consists of 2 days of Busulfan 2mg/kg at days -7,-6, followed by Fludarabine 30mg/m2 at days -5,-4,-3. At day 0, whole untreated PBMC's are reinfused to the patient and vaccination with Melan-A analog peptide is restarted and repeated every 4 weeks. Immunomonitoring with detailed FACS analysis using tetramers is performed at day 0,8,15,30, and then monthly. The aim is to boost Melan-A specific CD8 T cells in vivo during homeostatic proliferation after lymphodepletion and antigen driven proliferation due to peptide vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Stage IV melanoma
* tumor expressing Melan-A
* patient of HLA-A2 subtype
* Detectable immune response after peptide vaccination with Melan-A
* Disease progression during peptide vaccination

Exclusion Criteria:

* Cerebral metastases
* rapidly progressive disease, that necessitates systemic chemotherapy
Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

This is a two-arm randomized clinical trial in which 80 participants with Vitamin D deficiency and scheduled to begin taxane-based chemotherapy will be randomized to either: 1) prescribed vitamin D replacement or 2) standard of care.

This is a two-arm randomized clinical trial in which 80 participants with Vitamin D deficiency and scheduled to begin taxane-based chemotherapy will be randomized to either: 1) prescribed vitamin D replacement or 2) standard of care (advised to take over the counter (OTC) vitamin D).

All participants will have blood drawn for serum vitamin D analysis at Weeks 4, 8, 12, and 24 in order to document Vitamin D levels and titrate vitamin D dose (if needed in the treatment arm). Participants in both arms will complete self-report measures of neuropathic pain at baseline, Week 12, and Week 24.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage I-III cancer of any type, OR diagnosis of stage IV cancer being treated with curative intent
* Receiving or scheduled to begin taxane-based chemotherapy at Virginia Commonwealth University (VCU) Health Massey Comprehensive Cancer Center
* Vitamin D serum level \<20 ng/mL Note: study participants with Vitamin D serum level ≥20 ng/mL may be enrolled in the observational arm.

Exclusion Criteria:

* Pre-existing diagnosis of neuropathy
* Currently taking prescription Vitamin D (ergocalciferol)
* Inability to converse in English
* Pregnancy
* Chronic kidney disease (stage IV or greater)
* Known hyperparathyroidism
* Hypercalcemia: Calcium levels \>10.5 mg/dL Note: study participants with calcium levels \<10.5 mg/dL may be enrolled in the observational arm.
Vagal Nerve Stimulation in Coma Patients

Minimally Conscious (MCS) or Vegetative State (VS) are disorders of consciousness which often occur following traumatic brain injury or ischemia. These alterations result most of the time in patients' loss of autonomy and require long years of special care. No efficient therapy to improve patients' consciousness has been found so far. Investigators propose to use vagal nerve stimulation (VNS) to restore cortical activity and patients' embodied self. The investigators' main hypothesis is that VNS will reestablish the thalamo-cortical connectivity leading to an improvement of the consciousness state. To test this hypothesis, investigators will use behavioral measures as well as fMRI, PET scan and EEG to assess brain activity. Patients will be evaluated before and during eight months following implantation of the stimulation device.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 60 years old
* Patients with history of cranial trauma, cerebrovascular accident, or other event leading to cerebral anoxia, suffering of chronic alteration of consciousness (Vegetative State, Minimally Conscious State, akinetic mutism). The diagnostic will be based on clinical scales
* Patients already having a neurophysiologic checkup (EEG)
* Patients breathing without invasive help, and who are in a stable medical state
* Patients with a history of disease of at least 6 months
* Patients without clinical evolution for several months
* Patients with social security
* Patients for whom a family member have signed a written consent

Exclusion Criteria:

* Patients with tracheotomy
* Pregnant women
* Intubated patients
* Patients with damaged vagus nerves
* Patients with pre existing neurological conditions other than the one responsible for the consciousness disorder
* Patients with medical complications
* Patients suffering of septic infection
* Patients with a significant dysphagia
* Patients with dyspnea or shortness of breath
* Patients with obstructive sleep apnea
* Patients with any conditions non authorized by the stimulating device manufacturer (Cyberonics)
A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)

The objective of this study is to investigate the long term safety of ALS patients taking ONO-2506PO.

This is an extension study which consists of two phases:

Double-blind phase; Patients will continue to take blinded study medication, as allocated in study ONO-2506POE014 by the central randomization system, in the presence of stable standard Riluzole therapy, until un-blinding of the study results.

Open label phase; Patients who were allocated to ONO-2506PO in the ONO-2506POE014 study will be offered entry into the open label phase of ONO-2506POE015 study and will continue to take 1200 mg of ONO-2506PO for the duration of their participation in the study, in the presence of stable standard Riluzole therapy. Patients who were allocated to placebo in ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be followed up by their site with standard care.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients with diagnosis of ALS over the age of 18 years.
* Previous randomization and completion of the last visits in ONO-2506POE014 study.
* Patients whom the investigator has no concern and judges tolerable for the continued treatment with ONO-2506PO and Riluzole from a risk and benefit point of view.

Exclusion Criteria:

* A clinically relevant medical history or presence of cardiovascular, gastrointestinal, renal, hepatic, endocrine/metabolic, neurologic, lymphatic, haematologic, immunologic, musculoskeletal, connective tissue, dermatologic, genito/urinary, psychiatric diseases or disorders that, in the opinion of the investigator may pose an unwarranted risk to the patient
Antibodies in Repeated Influenza Vaccination (ARIVA) Study

Viruses with high mutation rates, such influenza or HIV, pose a major challenge for vaccine design. The current influenza vaccination strategy of yearly vaccination with adapted strains aims to maximally diversify the antibody immune response to prevent viral escape. There is, however, growing evidence, that repeated vaccination with very similar viral proteins might limit, instead of broaden, diversification and thereby reduce vaccine efficacy.

The ARIVA Study prospectively studies the immunological impact of repeated influenza vaccination on viral variant recognition and antibody responses in healthy subjects cross-sectionally and over three consecutive vaccination seasons.


Eligibility Criteria:
Inclusion Criteria:

* influenza vaccination (QIIV) independent of the study
* age \>18 yo

Exclusion Criteria:

* no vaccination
* current acute illness
A Pharmacogenomic Study of Candesartan in Heart Failure

The purpose of this study is to evaluate the impact of genetic variations on the response to candesartan in patients with heart failure who are already treated with an ACE inhibitor.


Eligibility Criteria:
Principal Inclusion Criteria:

1. Male or female \> or = 18 years old.
2. Symptomatic CHF corresponding to NYHA class II-IV symptoms for at least 4 weeks prior randomization.
3. LVEF \< or = 40%
4. Treatment with an optimal and stable dose of ACE inhibitor for at least 4 weeks prior to enrolment in the study.

Principal Exclusion Criteria:

1. Treatment with an ARB within 8 weeks prior to randomization.
2. Known hypersensitivity to ARBs or ACE inhibitors.
3. Creatinine clearance \< 30 ml/min or serum creatinine \> 221
4. Current serum potassium \> or = 5.0 mmol/L or a history of marked ACE inhibitor or ARB induced hyperkalemia.
5. Known bilateral renal artery stenosis.
6. Current symptomatic hypotension and/or systolic B.P. \< 90 mmHg.
7. Decompensated heart failure described as hospitalization or I.V. administration of medication in emergency room or heart failure clinic within 4 weeks
8. Stroke, acute coronary syndrome, PCI within the last 4 weeks before randomization.
9. Connective tissue disease or chronic inflammatory condition
10. Acute inflammatory process such as an infection or gout attack in the last 2 weeks.
11. Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception.
Data Collection for Validation of an NIBP Algorithm in Pregnant Women

The purpose of the study is to collect per subject blood pressure data on the device's intended population as described in the International Organization for Standardization (ISO) Standard 81060-2:2018+A1:2020 Non-invasive sphygmomanometers.

The purpose of the study is to collect data per subject NIBP measurements by (1) oscillometric means using the GE NIBP Auscultatory Algorithm and (2) by conventional auscultatory means in a pregnant population. These measurements include Systolic BP (mmHg) and Diastolic BP (mmHg). The secondary objective of this study is to collect per procedure and log files from the device. The safety objective of this study is to collect safety information, including type and number of adverse events, serious adverse events and device issues.

This is an open label, single-site, single arm, prospective, pivotal study including a training phase and a validation phase with demographics-based stratification quota. Subjects are sequentially tested with investigational and reference blood pressure measurements.

Eligibility Criteria:
Inclusion Criteria:

Are pregnant female volunteers aged 18 years or older;

Gestation beyond the first trimester as evidenced by gestational age of greater than or equal to 14 weeks and 0 days;

Have compatible anatomy to fit a standard air-filled occlusive cuff size (an upper limb circumference ranging 17 cm to 40 cm);

Are willing and able to volunteer to provide multiple blood pressure measurements as required for study procedures;

Are able and willing to provide written informed consent.

Exclusion Criteria:

Exhibit signs or symptoms or have a current diagnosis of peripheral vascular disease;

Have current, uncontrolled circulatory shock or cardiac arrhythmias that pose risk to the patient or could interfere with completion of study blood pressure determinations;

Exhibit injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the investigator, may prevent proper occlusive cuff application or functioning; the investigator, may prevent proper occlusive cuff application or functioning;

Have contraindications to blood pressure measurement methods used in the study or any medical condition where study procedures could pose a risk to the subject/patient's physiological stability, in the opinion of a medically qualified investigator.
Study The Knowledge and Attitude Towards Epilepsy Among Relatives of People With Epilepsy and Their Impact on The Patient's Quality of Life

Epilepsy is a common neurological condition that affects personal and familial behavior and social support . About 50 million people worldwide suffer from epilepsy and the prevalence of active epilepsy in developing countries is 5 to 10 per 100 persons . Individuals with epilepsy may suffer from psychological issues such as depression, anxiety, and psychosis . Accordingly, living with a person with epilepsy will provide some challenges, particularly at home. Studies have reported that relatives of people with epilepsy have an increased risk of anxiety. Epilepsy can inflict an enormous burden on both the people with epilepsy (PWE) and their family caregivers, decreasing their quality of life and daily efficiency.


Eligibility Criteria:
Inclusion Criteria:

* The participants Will be the close relatives of people with epilepsy who had a close relationship with the patient and living in the same house. The respondents will include the mothers, fathers, brothers, sisters, or the husband/wife, sons of patients.

The patients will be patients diagnosed of epilepsy for at least 6 months, who were using antiepileptic drugs.

Exclusion Criteria:

* The Relatives not living in the same house or not in direct contact with the patients or younger than 16 years old will be excluded from the study.

The persons who had major medical or mental health problems other than epilepsy that would affect QOL will be excluded.
Testing the Efficacy of 100mg Vitamin-B6 Daily for Sensory Reactivity in Autism

This clinical trial aims to explore the effect of Vitamin B6 supplementation on anxiety sensory hyperreactivity in autistic adults. Researchers will compare a placebo group to high-dose Vitamin-B6 to see if vitamin B6 reduce anxiety and sensory reactivity differences in autism.

The main question it aims to answer is:

* Does high-dose Vitamin B6 supplementation reduce sensory hyperreactivity differences in autism?
* Does high-dose Vitamin B6 supplementation reduce anxiety differences in autism?
* Explore the effects of vitamin B6 on sleep quality, Attention Deficit Hyperactivity Disorder (ADHD) scores, and various visual perception tasks that are indicative of GABAergic activity

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 to 60
* With a diagnosis of autism

Exclusion Criteria:

* Taking any supplement that contains more than 2mg of Vitamin B6 or taking GABA agonist drugs
* Have a medical history of peripheral neuropathy
* lactose intolerance (placebo tablet is lactose based)