cyrilzakka/clinical-trials huggingface dataset:
Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency

The study " Autologous cultured corneal epithelium (CECA) for the treatment of corneal lesions associated with limbal stem cell deficiency" is the first clinical trial of this product manufactured at the LOEX laboratory. The culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency. The study is a phase I/phase II study with the goal to evaluate safety and efficacy of the CECA graft for the treatment of human patients suffering from limbal stem cell deficiency.

The trial is open to all genders. The inclusion of 5 minors is planned.


Eligibility Criteria:
Inclusion Criteria:

All genders

* Adults
* Minors
* LSCD in one or two eyes. A minimum of 1-3 mm2 of undamaged limbus is required for a biopsy to be taken without foreseeable adverse consequences for the donor eye

Exclusion Criteria:

* Donor eye not sufficiently healthy to allow for the harvesting of a 1-3 mm2 limbal biopsy without foreseeable consequences for the donor eye
* Pregnancy
* Breast-feeding
* Incapacitated person
* known allergy to aprotinine (Trasylol (R))
* Hypersensibility to bovine proteins
Intravenous Infusion of Prostaglandins as Therapy in Patients With Anterior Non-arteritic Ischemic Optic Neuropathy

Correction of the deficit in the perfusion pressure of the microcirculation that supplies the nerve by intravenous infusion of Prostaglandin E1 (PGE1) (Alprostadil), expected to improve visual function in patients with ischemic optic neuropathy previous non-arteritic (NOIANA).


Eligibility Criteria:
Inclusion criteria:

* Patients of both sexes between the ages of 50 and 80, both inclusive. Patients with the first episode of ischemic optic neuropathy previous non-arteritic / NOIANA. Patients with NOIANA with an evolution time from the beginning of the clinic less than or equal to 15 days.
* Potentially fertile patients should have a negative pregnancy test in serum (beta-HCG / human chorionic gonadotropin) or urine.
* Patients who offer sufficient guarantees of adherence to the protocol.
* Patients who give written informed consent to participate in the study.

Exclusion Criteria:

* Patients with previous optic of any etiology in the affected eye.
* Patients with previous diagnosis or symptoms at the time of arteritis of the temporal artery.
* Patients with optic neuropathy with bilateral clinical presentation of any etiology.
* Patients with loss of vision due to acute hypotension in the context of a surgical intervention, acute hemorrhage or hemodynamic shock.
* Patients with severe loss of previous vision in the eye affected by ophthalmologic causes: severe cataract, glaucoma or intraocular pressure greater than 30 millimeters of mercury, severe diabetic retinopathy, macular degeneration associated with severe age.
* Patients with clinical onset in the month following major non-ocular or intraocular surgery
* Patients with abnormal elevation of CRP / C-reactive protein (\> 2 times the upper limit of normal)
* Patients with creatinine levels above 1.5 mg / dL.
* Patients on steroid treatment in the month prior to the episode.
* Patients under treatment with oral anticoagulants.
* Patients on treatment with hydroxychloroquine, ethambutol, vigabatrin at any time before the episode.
* Patients in whom the use of PGE1 (Alprostadil) is contraindicated:
* Patients with participation in a clinical trial in the last 6 months.
* Patients with inability to understand informed consent.
* Pregnant patients, in the postpartum period or during the active lactation period.
* Physically fertile patients
Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell Carcinomas

This is a comparative, randomized, prospective, multicenter clinical investigation aimed at evaluating the efficiency and economic impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the diagnosis and management of basal cell carcinomas.

Basal cell carcinoma (BCC) is the most common type of skin cancer. The diagnosis and subtyping of suspicious lesions can be challenging for certain \&#34;equivocal\&#34; lesions where clinical and dermoscopic criteria do not allow for a definite diagnosis or subtyping, which determines the treatment. The most commonly used technique for the diagnosis and selection of appropriate treatment for BCC is skin biopsy. Microscopic imaging techniques allow for \&#34;optical\&#34; biopsies, which appear as an attractive alternative to traditional biopsies.

The deepLive™ device integrates LC-OCT (Line-field Confocal Optical Coherence Tomography), which is a novel microscopic imaging technology with unmatched imaging performance to date, including cellular isotropic resolution (1 μm), a penetration depth of 500 μm, and the ability to obtain real-time cross-sectional and 3D images in the same orientation as histology. Numerous multicenter studies have confirmed the high performance of this technique for the diagnosis and subtyping of BCC. However, its usefulness in the diagnostic and treatment management of BCC has not been investigated prospectively. This clinical investigation is based on the hypothesis that the use of the deepLive™ device will enable diagnostic and therapeutic management by reducing the number of consultations/procedures without compromising patient outcomes compared to a traditional management approach with biopsy(ies). This strategy could optimize the entire care pathway by reducing invasive diagnostic or therapeutic procedures and freeing up dermatological resources for other procedures. This optimization of the care pathway is expected to result in a favorable economic impact on the healthcare system.

Eligibility Criteria:
Inclusion Criteria:

Patient with one or more clinically suspicious lesions of BCC for which:

1. The diagnosis is uncertain following clinical and dermoscopic examination, and diagnostic biopsy is necessary according to the latest European guidelines from EADO.
2. And/or for which the knowledge of the histological subtype determines the subsequent management.
3. And/or for which diagnostic biopsy is necessary in the standard practice to confirm the clinical diagnosis (peri-orificial facial lesions, any lesion that may require complex surgical reconstruction).

Exclusion Criteria:

* The lesion is suspected to be a recurrent BCC.
* The suspicious lesion has been previously treated by other surgical or non-surgical methods (cryotherapy, topical treatment, PDT, etc.).
* Lesions within 3 cm of the eye.
* Presence of cutaneous comorbidities that could interfere with a proper evaluation of the studied lesion according to the investigator.
Trial of Identifying the Lung Intersegmental Plane by Iron Sucrose Injection Staining

This is a protocol to determine the safety and feasibility of using Iron Sucrose Injection to identify the intersegmental plane,not only on the pleural surface but also the parenchyma of the lung.

This is a protocol to determine the safety and feasibility of using Iron Sucrose Injection to identify the lung intersegmental plane. This is relevant because the detection of small and early lung cancer is becoming increasingly common. segmentectomy may become a more prominent procedure for early-small lung cancer. One of the most difficult aspects of complete segmentectomy is detection of the intersegmental plane while maintaining an adequate surgical margin and remaining lung function. The method used to detect the intersegmental plane remains controversial. It is hoped that this technology can be used to recognize the intersegmental plane on the pleural surface and the pulmonary parenchyma and will save lots of money for patients in developing countries.

Eligibility Criteria:
Inclusion Criteria:

* 18 years ≤age ≤80 years
* The patient must be scheduled to undergo segmentectomy or combined subsegmentectomy.
* The patient must be willing and able to comply with all study requirements and have understood and signed the informed consent.

Exclusion Criteria:

* A known allergy to Iron Sucrose Injection
* The patients who have Iron overdose or iron utilization barrier Intra-operative founding of extensive pigmentation Silicosis or extensive carbon deposition in the lung.
* Patients who have not received segmental resection.
* Patients who converted to thoracotomy.
Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents

The main purposes for conducting the study are firstly to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine (Bexsero™) in terms of hSBA GMTs at one month after the second vaccination, secondly to give the flexibility for the national vaccination program by showing the safety and immunogenicity of MenABCWY administrated according to four different vaccination schedules and additionally to evaluate a potential benefit of the 3-dose vaccination series.


Eligibility Criteria:
Inclusion Criteria:

1. Adolecents from 10-18 yearsof age, generally in good health, and available for all study visits, and who/whose legally acceptable representative has given written informed consent at the time of enrollment.
2. Individuals of who the investigator believes can and will comply with the requirements of the protocol (e.g. use of an eDiary, return for follow-up visits, available for phone contacts).
3. Female subjects of childbearing potential must have a negative urine preganancy test.

Exclusion Criteria:

1. Serious, acute, or chronic illness. Previous or suspected disease caused by N. meningitidis. Previous immunization with any menincococcal or Hepatitis A vaccines.
2. Exposure to individuals with clicically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characteriszation.
Regulation of Extracellular Sodium in End Stage Renal Disease Upon Volume and Electrolyte Challenges

Hyponatremia is the most common electrolyte disorder of all and can be observed in more than 30% of all patients in hospitals. Osmotic homeostasis of body fluids is essential for survival of all living creatures. It is widely accepted that extra- and intracellular osmolalities are in equilibrium at all times and thus, changes in the extracellular osmolality will lead to either shrinkage or swelling of cells which can be detrimental. In severe cases, it can lead to swelling of the brain and death. Even in less dramatic scenarios, symptoms such as epileptic seizures, headaches, depression and dizziness exist, leading to an increased risk of fractures, hospital admissions and a considerable burden for affected patients.

As short-term defense against osmotic stress, each individual cell is capable of actively externalizing or internalizing osmotically active solutes which restores normal or near-normal cell volume at the expense of an altered milieu interior. Obviously, there must be limitations to this strategy if intracellular integrity is meant to be kept stable. It has therefore been postulated that, apart from this cell-immanent mechanism, extracellular and intracellular electrolyte stores could assist in buffering osmotic imbalances.

The Edelman formula states that extracellular sodium is determined by the total amount of exchangeable body sodium (the major extracellular cation) plus potassium (the major intracellular cation) divided by total body water. Several studies have shown, that it only partially explains the changes in patients outside the osmotic equilibrium.

To better understand these physiological responses might not only promote the researcher's insight into the most basic cellular self-defense systems by measuring and comparing extra- and intracellular electrolyte concentrations with estimated changes in a patient that will be intravenously challenged with either water or sodium chloride 3%.

The evolution over time of extra- and intracellular sodium and other electrolytes will be assessed quantitatively in patients with impaired renal function after water or sodium chloride (NaCl) administration.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥18 years
* Requirement of renal replacement therapy due to surgical (i.e., nephrectomy) or non-surgical (chronic kidney disease) reason
* Stable hemodialysis treatment for at least 3 months
* Urine output \<100ml in 24 hours
* Glucose-corrected plasma sodium between 135 mmol/l and 145 mmol/l
* Plasma potassium between 3.5 mmol/l and 5 mmol/l
* Written informed consent

Exclusion Criteria:

* Peritoneal dialysis patients
* Signs of volume expansion or contraction
* Congestive heart failure (NYHA ≥2)
* acute illness (infection, congestive heart failure, liver cirrhosis, etc.) requiring hospital admission
* Uncontrolled arterial hypertension
* Hemoglobin ≤8g/dL
* Alcohol abuse
* Malnutrition
* Persons, who are in a dependency/employment relationship with the investigators
* Accommodation in an institution by judicial or administrative order
Effect of Prebiotics on Blood Pressure Management

This survey is designed to investigate the effect of highland barley β-glucan supplementation on the regulatory of blood pressure, gut microbiota and cardiovascular risk fators in subjects with hypertention.

Highland barley β-glucan belongs to the group of prebiotics and has been found to be associated with multiple health benefits. However, its protective role in subjects with hypertension are remain unclear. This study aims to examine the effect of 12-week prebiotics supplementation on blood pressure management in subjects with hypertension. By understanding the mechanism by which prebiotics exert the beneficial effects, we can better control the rising prevalence of hypertension, which is a major risk factor for cardiovascular diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Age:30-65 years old
2. Newly diagnosed hypertension did not use antihypertensive drugs OR Systolic blood pressure ≥140mmHg on the physical examination OR Diastolic blood pressure ≥90mmHg on the physical examination.
3. BMI≥18 kg/m2

Exclusion Criteria:

1. Receiving or have been treated with antihypertensive drugs.
2. Complications including cardiovascular and cerebrovascular diseases such as coronary heart disease and stroke.
3. Severe liver or renal insufficiency (alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase is greater than 3 times the upper limit of normal OR GFR\<30ml/min/1.73m2).
4. Autoimmune diseases or thyroid diseases.
5. Women who are pregnant, nursing, or prepare to give birth during the trail.
6. Malignant disease, infectious disease, inflammatory disease and advanced liver disease.
7. Mental or intellectual abnormalities, unable to sign informed consent.
8. Complications including chronic gastrointestinal disease; or suffered from acute gastrointestinal diseases within 1 months before screening visit.
9. Received antibiotics, probiotics within 3 months before screening visit or throughout the trail.
10. Major operations were performed within six months of screening visit, or will be made during the trial.
11. Alcohol abuse (alcohol intake\>60g/d for male and alcohol intake\>40g/d for female)
Safety of Lactobacillus Fermentum in Newborn Infants

In the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk. However, there are few studies studying the effects of probiotics in newborns. The objective of the present study is to analyze safety and tolerance of the probiotic Lactobacillus fermentum CECT5716 isolated from human milk.


Eligibility Criteria:
Inclusion Criteria:

* Healthy 1 month infants exclusively formula-fed

Exclusion Criteria:

* gastrointestinal disorders (history of chronic diarrhoea or constipation, gastroesophageal reflux)
* gastrointestinal surgery
* cow's milk protein allergy
* metabolic disorders (diabetes, lactose intolerance)
* immune deficiency
* antibiotic prescription 1-week prior to inclusion and previous use of formula containing prebiotics or probiotics
Comparison of PEG-Intron and Two Different Doses of Ribavirin for the Treatment of Chronic Hepatitis C In Treatment Naïve Subjects

The purpose of this study is to compare PEG-interferon alfa-2b and two different doses of rivavirin for the treatment of chronic hepatitis C in previously untreated adult subjects

Primary Objective:

This study will evaluate the safety and efficacy of two different PEG-interferon and Ribavirin regimens in patients who have not previously been treated for Hepatitis C. Patients have an equal chance to assignment to one of two treatment arms:

Treatment Arm A:

PEG-interferon 1.5 mcg/kg2 QW + Ribavirin 800 mg/day

OR

Treatment Arm B:

PEG-interferon 1.5mcg/kg2 QW + Ribavirin 800 to 1400 mg/day

Arm A \& Arm B: Duration of treatment will be 48 weeks for genotype 1 patients and 24 or 48 weeks for genotype 2 or 3 patients.

Eligibility Criteria:
Adult naive subjects with a diagnosis of compensated chronic hepatitis C (HCV RNA+) who have not previously been treated with interferon, PEG-interferon, ribavirin, or combination interferon + ribavirin are being selected for the study.
Increasing Primary Care Physician Colorectal Cancer Screening Rates

The purpose of the study is to determine if a Web-based intervention increases physician rates of colorectal cancer recommendation rates in a group of physicians participating in the American Board of Internal Medicine's Maintenance of Certification Program. This study will also compare the content of practice improvement plans submitted by the diplomats in each study arm to determine the components of the plans that are associated with colorectal cancer rates.

Colorectal cancer is the 2nd leading cause of cancer deaths in the U.S. Although colorectal cancer screening (CRCS) is effective, cost-effective and consistently recommended by clinical practice guidelines, only 57.3% of the adults over 50 years have been screened within the recommended interval. Preliminary research conducted by this PI demonstrates that approximately 90% of patients who have not had CRCS report that a doctors recommendation would motivate them to undergo screening. However, research also shows that physicians do not consistently recommend CRCS to each eligible patient. In this study the barriers of and facilitators to physician recommendation of CRCS are tested in the to proposed randomized controlled trial. The trial will pilot test an interactive, multifaceted, Web-based intervention (eToolbox) to increase primary care physician rates of CRCS. This application innovatively proposes to pilot test the eToolbox in the setting of the American Board of Internal Medicine (ABIM) Maintenance of Certification process within the Preventive Services Practice Improvement Module, a physician-directed measurement of their performance and quality improvement requirement for board re-certification.

Eligibility Criteria:
Inclusion Criteria:

* ABIM certification and have or plan to enroll in the Maintenance of Certification program
* Primary Care Physicians

Exclusion Criteria:

* Diplomats are not able to participate in this study if they are retired physicians, do not practice a primary care practice or who have already taken part in the study
Vitamin A to Reduce HIV in Vaginal Secretions and Prevent Viral Transmission

HIV infected individuals with vitamin A deficiency may be more likely to transmit the virus to others than HIV infected individuals who have normal levels of vitamin A. The presence of HIV DNA in vaginal secretions may indicate a greater risk for transmission of HIV to others. The purpose of this study is to determine if taking vitamin A decreases the level of HIV DNA in vaginal secretions.

Vitamin A deficiency leads to pathological changes in mucosal epithelium, including the vagina, and is correlated with immune dysfunction in both HIV-1 infected and uninfected individuals. Recent studies of genital tract shedding of HIV-1 DNA in infected women have found that lower serum concentrations of vitamin A were strongly associated with detection of HIV-1 in vaginal secretions. In addition, maternal vitamin A deficiency has been associated with significantly increased risk of vertical HIV-1 transmission. This study will assess the effect of vitamin A supplementation on the prevalence and quantity of HIV-1 DNA and RNA in cervical and vaginal secretions.

Participants in this study will be HIV infected nonpregnant women in Mombasa, Kenya. Participants will be randomized to receive 6 weeks of daily dosage of either 10,000 IU vitamin A or placebo. Cervical and vaginal swabs will be obtained at enrollment and at Week 6 for detection and quantification of HIV-1 DNA and RNA. In addition, venous blood will be obtained at the two time points for quantification of plasma HIV-1 RNA, CD4 lymphocyte count, and serum vitamin A levels.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected

Exlusion Criteria:

* Pregnant
Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis

The purpose of this study is to determine:

1. If vacuum assisted closure (VAC®) therapy results in altered proteomic expression of angiogenic markers compared to moist wound therapy.
2. If VAC® therapy results in increased angiogenesis compared to moist wound therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female and \> 18 years old.
* Patient or patient's legal authorized representative is willing to sign informed consent.
* Patient has a post surgical dehisced wound of the lower extremity for longer than two weeks and less than one month.
* Patient has transcutaneous oximetry (TcPO2) evaluation that demonstrated tissue hypoxia in the periwound region, as indicated by a reading of 10-40 mmHg within the prior two weeks.
* Ankle Brachial Index \> 0.7 within the prior two weeks.
* Patient is not pregnant (pregnancy test is negative) and non-lactating at Visit 1.
* Patient does not plan on becoming pregnant during the course of the study.
* Patient is willing to use effective method of contraception for the duration of the study, is permanently sterilized, or post-menopausal as defined by cessation of menses for at least one year prior to enrollment in study.

Exclusion Criteria:

* Diagnosed and untreated wound infection.
* Poor nutrition status as evidenced by pre-albumin \< 12mg/dl within the past 30 days or extracellular mass \< 95%.
* Presence of sickle cell disease.
* Presence of connective tissue disease (e.g. history of or active lupus).
* Hemoglobin A1c (HbA1c) levels greater than 9% thirty days prior to screening visit (if patient is confirmed diabetic).
* Treatment with an investigational therapy within the previous 30 days.
* Lower extremity wound (under consideration for study) with malignancy.
* Lower extremity wound (under consideration for study) with untreatable cellulitis.
* Presence of untreated osteomyelitis.
* Presence of any systemic hematologic disorder or condition that would impede healing.
* History of radiation to the wound area.
* History of drugs that may delay wound healing.
* History of thermal injury to the wound area.
* Prior VAC® therapy to the wound within 30 days of enrollment.
* Current or prior treatment with hyperbaric oxygen therapy (HBO) or warm-up therapy to the same wound.
* Recent diagnosis of cancer or active management of cancer within the last year.
* Treatment with skin or dermal substitutes or dressings with living cells capable of producing growth factors within the previous 30 days.
* End stage renal disease.
* History of alcohol or drug abuse that may impact protocol compliance or delay wound healing.
* Known hypersensitivity to hydrogel or any disposable component of the VAC® Therapy System.
* Necrotic tissue with eschar present which cannot be debrided.
* Any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into the study.