cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process

This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.


Eligibility Criteria:
Inclusion Criteria:

-Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.
4. The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lens in both eyes (at least 1 month of daily wear).
5. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
6. The subject's required spherical contact lens prescription must be in the range of -1.00 to -4.50 D in each eye.
7. The subject's refractive cylinder must be \< 0.75 D in each eye.
8. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
4. Any ocular infection.
5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
6. Monovision or multi-focal contact lens correction.
7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
8. History of binocular vision abnormality or strabismus.
9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
10. Suspicion of or recent history of alcohol or substance abuse.
11. History of serious mental illness.
12. History of seizures.
13. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).
Pre-emptive Prevention for Patients at High Risk for Hospital-onset Clostridioides Difficile

Clostridioides difficile (C. difficile) is the most common healthcare-associated pathogen, causing \>500,000 infections and \>29,000 deaths per year in the US. Traditional approaches to reduce hospital-onset CDI focus on identifying, isolating, and treating symptomatic patients to prevent transmission to other patients. Recent genomic epidemiology studies, however, suggest that most hospital-onset CDI cases are attributable to asymptomatic carriers who either progress from colonization to active infection themselves or transmit C. difficile to other patients while asymptomatic. This trial will evaluate an intervention to pre-emptively identify asymptomatic C. difficile carriers and then implement a patient-tailored prevention package to protect the carrier from progression to active infection and to prevent transmission from the carrier to other patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to ICU or Oncology units and identified to carry C. Difficile via VRE swab

Exclusion Criteria:

* Patients not identified as carriers of C. difficile and patients not admitted to ICU or oncology units
Conquering Hepatitis C Via Micro-Elimination in Southwest Virginia

The objective of this protocol is to conduct a comprehensive quantitative and qualitative assessment of the impact of our innovative collaborative telehealth HCV care model on patient treatment experiences and quality of life.

The investigators will evaluate the proportion of patients at each step of the HCV care cascade before and after implementation of the collaborative care model. Additionally, participants will complete questionnaires at three time points: at the initiation of hepatitis C treatment, at treatment completion, and at the assessment of sustained virologic response. Questionnaires will assess quality of life, mental health, chronic liver disease outcomes, and substance use. A subset of participants will also complete semi-structured interviews at each of the three time points. Then, a smaller subset of participants will be selected for a detailed ethnographic case study focusing on treatment experiences, quality of life, forms of social support, and illness experience.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Detectable HCV viral load
* Attended a clinic appointment at one of our participating sites

Exclusion Criteria:

* Cognitive disability such that informed consent cannot be obtained
* Prisoners
* Unable to understand English
Evaluation of Fusion After ALIF With an Osteoinductive Material or With Homologus Bone

The aim of this study was to determine whether instrumented anterior lumbar interbody Fusion with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2) was associated with superior radiological and clinical outcomes at 12 months follow-up compared with instrumented ALIF with homologous bone

This randomized clinical trial included two groups of 20 mature patients with mono- or multisegmental degenerative disease of the lumbar spine who were suitable to undergo mono- or bisegmental ALIF fusion at the level L4/L5 and L5/S1 with a carbon fiber reinforced polymer ALIF cage filled with either NH-SiO2 or homologous bone (HB). Patients were followed 12 months postoperatively. The primary aim was to compare postoperative disability as measured by the Oswestry Disability Index (ODI). Secondary aims were to compare postoperative radiographic outcomes and differences in pain and quality of life between these groups.

Eligibility Criteria:
Inclusion Criteria:

* chronic low back pain
* sensorimotor deficits
* radiculopathy and spinal claudication symptoms, all caused by degenerative changes in the lumbar spine, which were resistant to conservative pain therapy and / or physiotherapy

Exclusion Criteria:

* previous surgeries in the abdominal Region
* previous fusion surgery in the lumbar spine.
Evorpacept (ALX148) in Combination with Pembrolizumab and Chemotherapy in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab + 5FU + platinum and of pembrolizumab + 5FU + platinum in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated for their advanced disease. The study comprises of an initial safety lead-in followed by a randomized portion.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated metastatic or unresectable, recurrent head and neck squamous cell carcinoma.
* Adequate bone marrow function.
* Adequate renal and liver function.
* Adequate ECOG performance status.

Exclusion Criteria:

* Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.
* History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
* Prior treatment with any anti-CD47 or anti-SIRPα agent.
* Prior treatment with anti-PD-1 or PD-L1.
Probiotic Enteral Administration in Mechanically Ventilated Patients

The objective of this study is to assess the effects of a daily enteral supplementation with probiotics within a population of critically ill, mechanically ventilated patients. Especially, the effects of probiotics on mortality rate in intensive care medicine will be analysed.

In a critically ill patient, the gut integrity is rapidly compromised either by the treatments used (such as catecholamine or antibiotics) or by the disease itself. This gut alteration favours the adhesion and/or internalisation of bacteria by intestine cells which lead to the production of large amounts of cytokines that rapidly reach the blood compartment, inducing neutrophils activation and then organ damage. Moreover, the imbalance in the normal intestinal flora (demonstrated as early as 24 hours after ICU admission) is one of the mechanisms involved in the development of ventilator associated pneumonia (VAP). VAP is the leading cause of ICU-acquired infection and is responsible for prolonged ICU stay, increased mortality and costs. Probiotics, and especially Lactobacillus Rhamnosus GG ('LGG'), have been demonstrated to possess beneficial effects in terms of intestine flora imbalance and immune response.

Objective: To study the effects of a probiotic mixture (containing LGG) enteral administration on the survival and the incidence of VAP in mechanically ventilated patients.

Patients and Methods: Prospective, randomized, double-blind, placebo-controlled study. After randomization, 740 intubated patients with a predictive length of mechanical support of more than 48 hours will enterally receive either 10.10 cfu of probiotic (Ergyphilus, Nutergia, France) or a identical placebo daily until withdrawal of mechanical support. The main endpoint is the mortality rate in ICU. Secondary endpoints include hospital length of stay and mortality rate, VAP incidence and the number of days free from antibiotics. Length of the study 24 months.

Perspectives: The objective is to demonstrate a survival advantage due to LGG administration, along with a reduction of VAP episodes and antibiotic use.

Eligibility Criteria:
Inclusion Criteria:

* Patients under mechanical ventilation for at least 48 hours

Exclusion Criteria:

* Age under 18
* Pregnancy
* Immunocompromised status
* Short bowel disease
* Moribund condition
Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.

During a first consultation with an indication of total hysterectomy for a benign lesion, we will study the patient's eligibility. After explanations of the study and submission of the forms, the patient will benefit from a second consultation with the investigator to give her consent. The surgeon will randomize the patient using RedCap computer software. The patient will then be referred either to the vNOTES group or to the laparoscopy group. The surgery will be performed by surgeons called "expert" in one of the ways first. For this, it will be necessary to have performed at least 25 hysterectomies by laparoscopy or vNOTES. The surgery will take place using the usual techniques. Per and postoperative complications will be studied and noted up to six months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Adult woman eligible for total hysterectomy for benign lesions with or without bilateral adnexectomy.
* Able to give informed consent to participate in research.
* Affiliation to a Social Security scheme.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Contraindication to the laparoscopic approach
* Contraindication to first vNOTES, in particular: virginity, history of rectal surgery, rectovaginal endometriosis, high active genital infection
* Indications for another concomitant surgical procedure (other than procedure on the appendix)
* Indication of hysterectomy for malignant lesion.
* Any concomitant pathology deemed incompatible with the study.
* COVID not cured or SARS-COv2 positivity dating less than 3 days before surgery.
* Adult patient protected, under guardianship or curatorship or legal safeguard
* Refusal of participation.
HPV Vaccine Confident Families

The objectives of the study are to pilot test a tailored intervention among Black families with adolescents. The hypotheses are that the study protocol will be feasible and messages tailored to parents' needs will increase vaccine confidence and intention to vaccinate.


Eligibility Criteria:
Inclusion Criteria:

* parent or legal guardian of at least one child aged 9-13 years who has received 0 or 1 dose of HPV vaccine;
* identify as Black or African American adult;
* have access to personal mobile phone and agree to send/receive MMS messages;
* able to speak and understand English; and
* able to provide informed consent to participate

Exclusion Criteria:

* parent or legal guardian of child outside of participation age range or who has completed multiple doses of HPV vaccine;
* does not identify as Black or African American adult;
* does not have personal mobile phone;
* unable to speak and understand English;
* not willing to consent to participate
A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

Study M15-722 is a Phase 2a study to investigate the efficacy and safety of Ravagalimab (ABBV-323) in participants with moderate to severe UC who failed prior therapy.


Eligibility Criteria:
Inclusion Criteria:

* Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
* Diagnosis of UC for at least 3 months prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the Investigator, must be available.
* Participant meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review).
* History of inadequate response, loss of response, or intolerance to one or more of the approved biologic therapies: infliximab, adalimumab, golimumab, vedolizumab, and/or tofacitinib (Note: If tofacitinib was received in a clinical trial, subject must have received open-label drug).

Exclusion Criteria:

* Participant having an active, chronic, or recurrent infection that based on Investigator's clinical assessment makes the participant an unsuitable candidate for the study.
* Participant having any malignancy except for successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
* Participant with history of dysplasia of the gastrointestinal tract or evidence of dysplasia in any biopsy performed during the screening endoscopy other than completely removed low-grade dysplastic lesions.
* Laboratory values not meeting the following criteria : Serum aspartate transaminase (AST) and alanine transaminase (ALT) \<= 2\* upper limit of normal (ULN); Total white blood cell (WBC) count \>= 3.0\*10\^9/L.
A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders

The study will evaluate the safety of ophthalmic bevacizumab in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.


Eligibility Criteria:
Inclusion Criteria:

* Active clinical diagnosis and OCT confirmation of one of the following retinal disorders: exudative age-related macular degeneration (AMD), diabetic macular edema (DME), or branch retinal vein occlusion (BRVO) and, in the opinion of the Investigator, requires treatment with an anti-VEGF therapy

Exclusion Criteria:

* Previous use of approved anti-VEGF or Avastin® within 4 weeks preceding randomization
* Macular edema due to something other than exudative AMD, DME or BRVO, in the study eye
* History of inadequate response to previous intravitreal anti-VEGF therapy
* History of any intraocular or periocular corticosteroid injection or implant, in the study eye
* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization
* Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss during the study period
* Active intraocular inflammation in the study eye
* Current vitreous hemorrhage in the study eye
* Polypoidal choroidal vasculopathy (PCV) in the study eye
* History of idiopathic, infectious or autoimmune-associated uveitis in either eye
* Current ocular or periocular infection, such as conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
* Premenopausal women not using adequate contraception
* Current treatment for active systemic infection
* Known allergy to any component of the study drug , not amenable to treatment
Evaluation of the Quality of Cardio-Pulmonary Resuscitation (CPR) in Cardiac Arrest Patients

The prognosis of cardiac arrest patients is generally poor. Recent studies have showed that the high quality of CPR increases the survival after cardiac arrest. Therefore the investigators planned this prospective observational study to determine the epidemiology of sudden cardiac arrest in the prehospital setting of Tampere area, the quality of the CPR, and also the associations between depth and frequency of chest compressions and invasive arterial pressure, EtCO2,cerebral oxygenation and iatrogenic injuries associated to chest compressions 1) in patients resuscitated out of hospital by emergency medical service's (EMS's) personals and 2) in-hospital by hospital resuscitation team members. In addition, the investigators will analyze the effects of the chosen method of resuscitation on critical vital signs (Etco2 and invasive pressures): closed-chest CPR is compared to open-chest CPR, or mechanical CPR with a device (AutoPulse-CPR, Cardio Pump) compared to manual CPR guided with quality CPR device. The results will give the investigators important insights into the haemodynamics of CPR which may guide future strategies for the management of cardiac arrest. The research group is also interested in CPR related injuries and mattress effect. Quality of life after CA is evaluated among survivals and the cause of death among non-survivors.


Eligibility Criteria:
Inclusion Criteria:

* cardiac arrest
* \> 18 years of age

Exclusion Criteria:

* \< 18 years of age
Mechanisms of CBD for Chronic Pain

This is a study designed to examine the neurochemical mechanisms associated with Cannabidiol (CBD) versus placebo for chronic non-cancer pain.

The aim of this trial is to examine the neurochemical mechanisms associated with Cannabidiol (CBD) versus placebo for chronic non-cancer pain. Participants will include individuals with chronic pain, who will be randomized into one of two intervention conditions: low THC/high CBD or placebo. In addition to receiving CBD or placebo, participants also will complete symptom assessments of chronic pain data (intensity, quality, interference/disability) throughout the study. These measures will be gathered prior to and following the fifth doses (dosing will occur once per day for five days) of CBD or placebo. A secondary objective will be to examine the association between clinical and inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-50 yrs.
* Chronic musculoskeletal and joint pain for at least 3 months or longer.
* Participants must live within a 60 mile radius of Salt Lake City, Utah to be eligible.

Exclusion Criteria:

* Current or past neurological illness.
* Substance abuse or dependence within the prior 90 days.
* Contraindication to brain MRI.
* Type I and type II diabetes.
* Unstable medical conditions.
* Consumption of more than 2 drinks of alcohol per night.
* Current pregnancy or planning to become pregnant or breastfeeding.
* History of seizures or head trauma at PI discretion.
* Active or history of major mental illness
* Use of opioid medications in the past 30 days.
* LFT results 3 times greater than the upper limit of normal at the screening.
* Participants may be excluded if the PI feels they do not meet safety criteria.
A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients

To evaluate the healing rate and safety of Lafutidine in erosive esophagitis


Eligibility Criteria:
Inclusion Criteria:

* Patients who had symptoms of heartburn with a diagnosis of grade A to D reflux esophagitis according to the Los Angeles classification

Exclusion Criteria:

* Gastric or duodenal ulcers (excluding ulcer scars)
* Concurrent presence of Barrett's esophagus
* A history of a poor response to H2RA or PPI given in the recommended dose for 8 weeks
* Other conditions considered by the attending physician to potentially affect the assessment of efficacy and safety
Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel

To establish Oraqix is safe when used on adolescent volunteers.

This is a single-center, uncontrolled, open-label, single administration patient study. Male and female subjects aged 6 through 17 years of age in need of primary tooth extraction will be recruited from the Principal Investigator's database and may be supplemented by advertising. Subjects who withdraw from the study prematurely will be replaced.

Subjects will undergo an initial screening visit at which eligibility will be determined. After completion of informed consent/assent a physical examination, vitals, 12-lead ECG, and dental examination will be conducted. A medical history will be documented and a blood sample will be collected for analysis of biochemistry, hematology and as appropriate, serum pregnancy assessment for females.

Subjects will return to the office approximately 1 to 10 days after Visit 1 for Visit 2. At Visit 2, study treatment will be administered and PK blood samples will be collected for analysis, and monitored for safety parameters. Up to a total of five cartridges of Oraqix® will be administered to the oral cavity in the area of the tooth extraction, based on the body weight of the subject. No more than five cartridges will be dispensed, since this is the maximum dose for this agent. The final sample will be collected 4 hours after administration of study material. An abbreviated dental examination will be conducted, any adverse events (AEs) will be documented and the subject will be discharged from the clinic.

All subjects will be contacted by telephone approximately 24 hours after administration of study treatment. Study personnel will enquire about the occurrence of any AEs that have occurred since leaving the office. If appropriate, further follow-up of AEs will be arranged. In the absence of any ongoing AEs requiring follow up the subject will be considered to have completed the study at the completion of the telephone call.

Eligibility Criteria:
Inclusion Criteria:

* 6 and 17 and eleven twelfths
* requires tooth extraction
* healthy having not taken any prescription or over the counter medications within 60 days of first visit
* must be a minimum of 15 kg

Exclusion Criteria:

* anesthesia required for treatment other than study material
* given blood within 90 days of first visit
* pregnant
* allergic to local anesthetic
* documented history of glucose-6-phosphate dehydrogenase deficiency
* history of congenital idiopathic methemoglobinemia
* does not have a loose tooth easily extracted or who, in the opinion of the Investigator, is not suitable for tooth extraction using only topical anesthetic