cyrilzakka/clinical-trials huggingface dataset:
Providing Access to the Visual Environment

Providing Access to the Visual Environment is a pediatric low vision grant which has the ability to provide comprehensive, interdisciplinary low vision rehabilitation services to every child in Tennessee with a vision impairment. Children, ages 3-21, with best-corrected vision of 20/50 or worse in the better seeing eye are prescribed optical devices to improve their visual functioning and trained to use the devices.

Subjects are enrolled each school year based on referrals from school systems in Tennessee, ophthalmologists, and optometrists. A total of 90 new students are enrolled each year. Students are provided a comprehensive low vision rehabilitation evaluation by a low vision optometrist and prescribed optical devices to improve distance appreciation, near reading, and other tasks based on individual needs. Students are then trained to use the devices efficiently by master's level teachers of the visually impaired. The teachers travel to the students environment (school/home/work) for the training.

Variables such as ocular disease, age, visual acuity, visual improvement with optical devices, type of optical device, and reading speed are defined for each student. Providing Access to the Visual Environment also provides...

Eligibility Criteria:
Inclusion Criteria:

Children age 3 to 21 years of age Enrollment in a school in Tennessee (private or public)

- Children that are eligible for services due to visual impairment Low vision

Exclusion Criteria:

* Children who do not have the potential to become readers or use their vision for reading
Visual Performance of Functional Intraocular Lenses in Cataracts

This is a prospective, multi-center, randomized comparative study. The purpose of the study is to evaluate and compare the postoperative visual outcomes and quality of vision of two diffractive trifocal intraocular lenses (IOLs) in patients with high myopic cataracts.

Binocular implantation of two types of trifocal IOLs was performed in patients with high myopic cataracts. Postoperative uncorrected distance (UNVA), intermediate (UIVA), near (UNVA), and best-corrected distance visual acuity (BCVA) were measured. Defocus curve, high-order aberrations, modulation transfer function curve, Strehl ratio and reading ability were compared between the two groups. The functional vision and incidence of photic phenomena were surveyed using questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* required binocular cataract extraction
* age \> 21 years
* length of optic axis \> 26 mm

Exclusion Criteria:

* irregular corneal astigmatism \> 0.3 um;
* amblyopia; previous ocular surgery;
* ocular pathologies such as diabetic retinopathy, macular degeneration, glaucoma with field defects;
* requirements for further ocular surgery (other than Nd:YAG capsulotomy) or retinal laser treatments during the study
Defining, Evaluating, and Sharing Methodologies for Quality Control in Diagnostic Imaging

The purpose of the study is to validate a radiological quality control (QC) system on the performance of diagnostic imaging. Patient images, previously anonymized by each radiologic diagnostic structures (SDR), will be sent to the QC service, which will blindly submit the images for evaluation external peer review by experts in the field. Through the blinded approach, the information obtained from the QC will allow the SDR to know its own performance analytics, but not those of other SDRs using the service, and to a centralized system to have an anonymized estimate of the quality of performance delivered. Finally, the analyzed data will provide not only a mere count, but will allow to reduce and prevent errors in the appropriateness, execution, reporting and diagnostic content of the examinations


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic examinations related to imaging modalities (RX, CT, MR, PET, SPECT...), agreed with SDRs, of body districts on which diagnostic images are available in DICOM format, medical history data and clinical question, report

Exclusion Criteria:

* Incompleteness of data for the purpose of the review process
Correlation Analysis Between Corneal Biomechanics and Anterior Segment

Evaluation of the ciliary muscle thickness, area, and anterior chamber angle, as well as anterior sclera thickness in subjects, to investigate the relationship between these measurements and corneal biomechanics. Clarify whether aqueous humor displacement, anterior sclera, and ciliary muscles influence the assessment of in vivo corneal biomechanics.


Eligibility Criteria:
Inclusion Criteria:

1. Best corrected visual acuity (BCVA) ≥ 20/20;
2. No other eye diseases except myopia and astigmatism;
3. The cornea was transparent, and there was no cloud or pannus;

Exclusion Criteria:

1. Corneal disease;
2. Ocular trauma;
3. Previous ocular surgery;
4. Any anterior segment diseases except cataract;
5. Patients were required to stop wearing soft contact lenses for at least 2 weeks and rigid contact lenses for at least 4 weeks before examination;
6. Pregnant and lactating women;
A Study of Azelaic Acid (AzA) 15% Gel in the Treatment of Seborrheic Dermatitis of the Face

This study is to determine whether a medication on the market for other indications is effective and safe in treating seborrheic dermatitis of the face.

To test the efficacy and safety of azelaic acid 15% gel in the treatment of seborrheic dermatitis of the face

Eligibility Criteria:
Inclusion Criteria:

- Stable or exacerbating seborrheic dermatitis in the facial area

Exclusion Criteria:

* Psoriasis
* Atopic dermatitis
* Facial acne and rosacea
* Dermatophytic skin infections
* Parkinson's disease
* Known immunosuppression; HIV infection
* Any condition requiring continuous systemic or topical corticosteroid or antimycotic therapy
* Continuous asthma inhalation treatment requiring \> 800 mg corticosteroids
* Any severe disease likely to interfere with the conduct or the planned termination of the study
Pneumococcal Vaccination in Patients with Anti-TNF Alpha Therapy

As the vaccination of immunosuppressed people is insufficiently performed in France, it seems interesting to carry out an evaluation of the situation on the site of the NOVO - Pontoise hospital.

The aim of this study is to assess the status of pneumococcal vaccination in patients at the NOVO hospital - Pontoise site, who have received anti-TNF alpha therapy.

Immunosuppressed patients are at risk of infections, sometimes severe with life-threatening consequences. Some of these are vaccine-preventable, notably pneumococcal infections. Specific vaccination recommendations have been published since 2012 by the French High Council for Public Health. However, vaccine coverage is below the desired immunisation objectives for immunosuppressed patients.

As the vaccination of immunosuppressed people is insufficiently performed in France, it seems interesting to carry out an evaluation of the situation on the site of the NOVO - Pontoise hospital, in order to propose, if necessary, measures, in particular a specialised consultation, with the aim of improving the vaccination coverage of this population at risk The aim of this study is to assess the status of pneumococcal vaccination in patients who have received anti-TNF alpha therapy.

Eligibility Criteria:
Inclusion Criteria :

* Patients treated with anti-TNF alpha between 2020 and 2022 at the NOVO Hospital - Pontoise site

Exclusion Criteria :

* Patients with an indication for pneumococcal vaccination who have received a full vaccination regimen prior to the decision to start anti-TNF alpha
MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function

This study is for patients with cirrhosis and hepatic encephalopathy who are in the hospital. This means they have a high ammonia level which is affecting their brain function.

All patients will receive the standard of (regular) care. Each will have an equal chance (like flipping a coin) of receiving the experimental drug or placebo along with the standard care.

Each patient will have tests during the first 24 hours, receive treatment for up to 5 days, and have 30 days of follow-up.


Eligibility Criteria:
Inclusion Criteria:

To be included, a patient must:

* Be the age of majority in their country (considered an adult)
* Be male or non-pregnant, non-lactating female
* Have OHE (Stage 2, 3, or 4) as a complication of cirrhosis
* Have been hospitalized within 24 hours before start of infusion (SOI)
* Receive at least 6 hours of SoC treatment

Exclusion Criteria:

Patients will be excluded if they have inadequate renal function or any other disease, laboratory value, or condition (including allergy, drug use or treatments) that per protocol or in the opinion of the investigator, might increase the risk of compromising:

1. health or well-being of the patient
2. safety of study staff
3. analysis of results
A Single Dose Metabolism and Mass Balance Study of 14C-ABR-215050 in Healthy Subjects

This is a single site, open label, single dose, non-randomized study in healthy male and female subjects. The subjects will be evaluated for plasma, urine and feces levels of 14C-ABR-215050 during 21 days.

As a part of the pharmacokinetic documentation, the metabolism and mass balance of 14C-ABR-215050 will be studied in healthy subjects. Female healthy subjects are included in the study in case of expanding the indication to female forms of cancer. In this study a single dose of 1.0 mg of the study drug will be administered orally as a solution under fasted conditions. The absorption and safety profiles for the oral water solution will also be documented.

Eligibility Criteria:
Inclusion Criteria:

1. 40-65 year old male and female subjects.
2. Healthy according to medical history, physical examination and clinical chemistry, urine and hematological laboratory tests.
3. Body Mass Index (BMI) of 18-30.
4. Negative screen for Hepatitis B / C and HIV-infection.
5. Be willing and able to comply with the protocol for the duration of the study.
6. Women of childbearing potential must be neither pregnant nor breast-feeding. Confirmation that the subject is not pregnant must be established by a pregnancy test before the single dose and at study end. Fertile women must be willing to practice reliable methods of contraception. Medically accepted safe methods of contraception for the purpose of this study will include surgical sterilisation, intra-uterine device, diaphragm with spermicide, or condom with spermicide. As interaction studies between ABR-215050 and hormonal (oral or depot) contraceptives have not yet been performed, women using such devices must also use a complementary contraceptive device.
7. Have given written signed informed consent, prior to start of any study-related activities.

Exclusion Criteria:

1. Gastrointestinal disorders that may affect drug absorption.
2. Any vaccination within 30 days before start of this study and throughout the study.
3. Blood donation within 90 days before start of this study and for 90 days after the study.
4. Participation in other clinical studies or who have received other investigational drugs within 90 days prior to enrolment. Additionally, subjects previously included into this study and then are withdrawn from the study is not to be re-entered into the study.
5. Perform any planned surgery
6. Any use of nicotine within three (3) months before start of this study and throughout the study.
7. Known or suspected history of alcoholism or drug abuse.
8. Intake of alcoholic beverages for 24 hours prior to the administration of investigational product and for 24 hours after the dose.
9. Intake of caffeine containing beverages 10 hours prior to the administration of investigational product and for 6 hours after the dose.
10. Medication including herbal remedies (vitamins and paracetamol excluded) within 14 days before and throughout the study.
Tumescent Stretching Measurement Technique

Introducing and evaluating the accuracy of a novel method for estimating inflatable penile prosthesis cylinders length by stretching the tumesncent penis intraoperatively instead of taking proximla and distal measurement to the corporotomy

Objectives:

Introducing and evaluating the accuracy of a novel method for estimating inflatable penile prosthesis cylinders length.

Methods:

24 patients undergoing a Coloplast Titan ® Touch implantation procedure will berandomly divided into two groups.

The "Tumescent Stretching Measurement Technique" (TSMT) group (N=12) will be administered an intracorporal injection (ICI) of 20 microgram Alprostadil. Hegar 7 dilator will be introduced through the corporotomy until reaching a bone stopping point. The tumescent penis will be stretched maximally, and the proximally inserted dilator measured externally to the coronal sulcus.

The control group (N=12) will receive no intraoperative ICI. Following maximal corporal dilatation, cylinder length will be estimated by adding up the internally measured distal and proximal corpora to the length of the corporotomy.

Implants are deemed correctly sized when cylinders reached the proximal third of the glans with no buckling of cylinders or floppy glans.

Eligibility Criteria:
Inclusion Criteria:

Males needing Penile implant surgery, not responding to oral pharmacological drugs for ttt of ED -

Exclusion Criteria:

Previouys penile surgery Previous implanted penile prosthesis

-
Weekly Docetaxel and Four Weekly Carboplatin in Non-small Cell Lung Cancer Carbo-Tax

The purpose of this study is:

* to assess the efficacy of the combination in terms of Objective (clinical and radiological) Response Rate
* to assess the time to progression of the disease; assess the safety profile of the combination, and assess the survival time.


Eligibility Criteria:
Inclusion Criteria:

* Histologically/cytologically confirmed inoperable locally advanced or metastatic non-small cell lung cancer
* ECOG Performance Status is 0-2
* At least one measurable lesion in two dimensions by means of CT scan
* No brain metastases
* No prior chemotherapy for this malignancy,
* Acceptable hematological profile (as defined by a leukocyte count ≥ 3000/mm3, a platelet count ≥ 100.000mm3 and Hb ≥ 9g/100mL), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl or creatinine clearance measured in 24 hours urine ≥ 60 mL/min), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (ALT, AST) ≤ 2.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis)

Exclusion Criteria:

* Concomitant use of another anti-cancer therapy
* Chemotherapy, radiotherapy or curative surgery
* Evidence of intracerebral metastasis
* Unstable medical condition that makes the patient to take part in a clinical study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 3 months, massive pleural or peritoneal effusion; or presence of serious uncontrolled infection, diarrhea, ileus, interstitial pneumonia, pulmonary fibrosis.
* Presence of other tumours different from basal cell carcinoma of the skin, with disease free survival less then 3 years.
* Pregnancy or breastfeeding. In women of childbearing potential and in men, an adequate contraceptive method must be used
* Social or psychological condition that render the patient inadequate for the follow-up of the study
* Contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Vashe Wound Therapy Study

This study will evaluate the efficacy, safety, and tolerability of topical Vashe™ Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist versus 5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 years and over requiring hospitalization for burn injury
* Burn injury requiring wound excision and auto-grafting
* Less than or equal to 20% Total Body Surface Area burns

Exclusion Criteria:

* Pregnant or lactating females
* Individuals with chlorine sensitivity
* Electrical, chemical and cold injury
* Burns to the face, hands, feet and or perineum area
* Steroid therapy
Comparıson Of PENG Block wıth Intra-articular And Quadratus Lumborum Block İn Primary Total Hip Arthroplasty

90 patients ASA I-III, undergoing Total hip arthroplasty (THA) under spinal anesthesia, will be randomly assigned into one of three groups, namely group A (n=30), where an PENG block, group B (N:30) where an inra-articuler, and group C (n=30) where Quadratus lumborum block will be performed preoperatively. All patients will receive a standardized postoperative analgesia regimen. NRS scores will be evaluated in static and dynamic conditions during the first 48 hours postoperatively.

Total hip arthroplasty (THA) is the second most common joint replacement surgery, partly due to the aging population. The primary aim of this study is to compare the analgesic efficacy of Pericapsular nerve group (PENG) block with intra-articular and Quadrotus lumborum block (QLB). Regional anesthesia (RA), such as the recently described pericapsular nerve group (PENG) block, may provide additional analgesic benefit in this situation. Pericapsular nerve group (PENG) block is a new regional anesthesia technique to provide analgesia after hip fractures and hip arthroplasty. The aim of this single-center, double-blind, randomized controlled trial is to confirm the efficacy of PENG block for postoperative recovery after primary THA.

Routine multimodal analgesia will be used for postoperative analgesia

Eligibility Criteria:
Inclusion Criteria:

* Physical status according to American Society of Anesthesiologists (ASA ) I-III

Exclusion Criteria:

* Previous operation on the same hip
* Hepatic or renal insufficiency
* Younger than 18 years old and older than 85
* Patients undergoing general anesthesia
* Allergy or intolerance to one of the study medications
* BMI \>40
* ASA IV
* Chronic gabapentin/pregabalin use ( regular use for longer than 3 months)
* Chronic opioid use ( taking opioids for longer than 3 months, or daily oral morphine equivalent of \>5 mg/day one month
Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis

A phase IV, randomized, single-blind, single-center study measuring the effects of Pecs II block with 0.25% bupivacaine versus surgeon infiltration with 0.25% bupivacaine on postoperative pain control and opioid utilization in participants who undergo open subpectoral tenodesis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients between 18 and 75 years of age
2. Patients undergoing shoulder arthroscopy with open subpectoral biceps tenodesis

Exclusion Criteria:

1. Patients younger than 18 and older than 75;
2. Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;
3. Patients who are allergic to oxycodone;
4. Patients with diagnosed or self-reported cognitive dysfunction;
5. Patients with a history of neurologic disorder that can interfere with pain sensation;
6. Patients with a history of drug or recorded alcohol abuse;
7. Patients who are unable to understand or follow instructions;
8. Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
9. Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
10. Patients with a BMI over 45;
11. Any patient that the investigators feel cannot comply with all study related procedures;
12. NYU Langone Health students, residents, faculty or staff members.
Effect of Myofascial Release on Menstrual Pain Post Caesarean Section

The purpose of this study is to investigate the effect of myofascial release on menstrual pain post cesarean section.

Egypt has the highest cesarean section (CS) rate that has increased from 20% in 2005 to 52% in 2014. This exceptionally high CS rate without a corresponding improvement in maternal and child mortality suggests that although CS is available for populations at risk, numbers of medical unjustified CSs are on the rise.

The CS scar is assumed to be related to adverse clinical gynecological symptoms such as intermenstrual bleeding, dysmenorrhea, dyspareunia and chronic pelvic pain.The incidence of postpartum dysmenorrhea was significantly higher in the cesarean section delivery than in the vaginal delivery.

Cesarean scars have direct links to the perineal fascia and its connection with the transversalis fascia. These scars can interfere with fascial load distribution, which create adhesions to neighboring tissues, the abdominal and pelvic viscera and surrounding anatomical structures are then potentially disrupted, causing inadequate nutrition and inappropriately distributed tension among the various structures affected.

Fascial restrictions obviously decrease blood flow by vascular compression. When the dermis and fasciae are affected by a scar, the sliding structure of the fasciae is altered and when the scar tissues are not capable of adapting to the new stressor, their function is impaired.

MFR procedure lead to vasodilation by increasing capillary permeability. MFR directs force to fascial fibroblasts, as well as indirect strains applied to nerves, blood vessels, the lymphatic system and muscles. There is lacking of studies at this point, so the aim of the study is to investigate the effect of myofascial release on menstrual pain post CS.

Eligibility Criteria:
Inclusion Criteria:

* Women complaining of menstrual pain post - caesarean section (CS).
* Their age will range from 20 to 35 years.
* Their body mass index will range from 20-30 kg/m2.
* Women who gave birth once or twice.
* Women who had C-section 6 weeks to 6 months ago.

Exclusion Criteria:

* Active infection/ infectious skin disease, burn or scars.
* Less than six weeks after CS.
* Any abdominal surgeries other than CS.
* Any spinal deformity as scoliosis or kyphosis.
* History of cancer or radiation to the abdominopelvic region.
Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa

OBJECTIVES:

I. Determine the safety of isotretinoin in patients with recessive dystrophic epidermolysis bullosa.

PROTOCOL OUTLINE:

Patients receive oral isotretinoin daily for 8 months in the absence of disease progression or unacceptable toxicity.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of recessive dystrophic epidermolysis bullosa (RDEB) RDEB Hallopeau-Siemens OR RDEB non-Hallopeau-Siemens
* Concurrent enrollment in the National Epidermolysis Bullosa Registry
* No regional or distant metastasis in patients with previous or concurrent squamous cell carcinoma

--Patient Characteristics--

* Hepatic: No clinically significant hypertriglyceridemia No clinically significant hepatic dysfunction
* Renal: No clinically significant renal dysfunction
* Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception