cyrilzakka/clinical-trials huggingface dataset:
Ocular Surface Metabolo-lipidomics in Lateral Amyotrophic Sclerosis

Amyotrophic Lateral Sclerosis (ALS) is the most common neurodegenerative disease affecting the motor neuron. Currently, there is no diagnostic test and no examination that can predict the evolution of this pathology. The search for diagnostic and prognostic biomarkers is therefore essential for a better understanding of the pathophysiology of ALS, which remains poorly understood, and also for better clinical management. The ocular surface, made up of liquid elements, tears, and cells, is an accessible anatomical-physiological entity that has demonstrated its usefulness in the identification of biomarkers in neurodegenerative diseases such as Parkinson's or Alzheimer's. To date, no study has explored the ocular surface as a biomarker in ALS


Eligibility Criteria:
Case group selection criteria :

Inclusion Criteria:

* Patient with clinically defined or probable primary ALS according to Airlie House criteria(1)
* Familial or sporadic form
* ≥18 years of age
* Patient affiliated with a social security plan
* Informed consent signed by the patient

Exclusion Criteria:

* Motor neuron disease mimicking ALS
* Pregnant or breastfeeding woman
* Treatment that may have a neuroprotective effect
* Any eye drops or treatments that may interfere with tear production
* Lens wearer
* Eye surgery ≤3 months
* Any ocular pathology other than ametropia, oculomotor disorder, amblyopia
* Any general pathology other than ALS with ocular repercussions
* Protective measure of guardianship or curators

Control group selection criteria:

Inclusion Criteria:

* No diagnosed neurological pathology
* ≥18 years of age
* Patient affiliated with a social security plan
* Informed consent signed by the participant

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Treatment likely to have a neuroprotective effect
* Any eye drops or treatments that may interfere with tear production
* Lens wearer
* Eye surgery ≤3 months
* Any ocular pathology except ametropia, oculomotor disorder, amblyopia
* Any general pathology with ocular repercussions
* Protective measure of guardianship or curator
Plasma Citrulline Level in Relation to Absorptive Surface

Correlation between determination of citrulline in plasma or dried blood

Reference ranges for healthy children and babies

Longitudinal follow-up of citrulline in preterm babies


Eligibility Criteria:
Inclusion Criteria:

* 0-18 years
* preterm babies up to 1.500g
* preterm babies over 1.500g

Exclusion Criteria:

* gastro-intestinal problems (except for the preterm babies)
* congenital metabolic disorders
* dysfunction of the liver or kidneys
* congenital defects
Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate

Contrast nephropathy (CN) is a common cause of renal failure associated with prolonged hospitalization, significant morbidity/mortality, and cost. In addition, these patients may require temporary or permanent hemodialysis which, in turn, is associated with further morbidity, mortality, and cost. CN has been reported to account for 10% of hospital acquired renal failure. In recent years, studies have investigated preventive therapies with mixed results. Fenoldopam was found to be ineffective in a large randomized trial. Dopamine has been shown to be ineffective as a preventive strategy. Hemofiltration has been shown to be beneficial (New England Journal of Medicine \[NEJM\] 2003) but is costly and not practical. Mucomyst has shown mixed results. The single strategy which most would agree as being beneficial remains hydration, most commonly with intravenous 0.9% normal saline. Most recently, sodium bicarbonate has been shown to be beneficial in a small randomized trial (n=119). It is clear that the most cost effective strategies for treatment of CN should be aimed at prevention.

The general question is: "Is a sodium bicarbonate solution more efficacious in preventing contrast nephropathy compared to normal saline?" The general hypothesis is that sodium bicarbonate will be more efficacious.


Eligibility Criteria:
Inclusion Criteria:

* GFR \< 60 mL/min/1.73m2. GFR will be adjusted by a correction factor as reported by our laboratory for patients self identifying as black.
* \> 18 years and have at least one of the following risk factors for contrast nephropathy: diabetes (type 2), congestive heart failure, hypertension (\> 140/90), or age \> 75.
* Both inpatients and outpatients will be offered enrollment.

Exclusion Criteria:

* Patients unable to give consent
* Already receiving sodium bicarbonate solution
* Undergoing emergency cardiac catheterization
* Receiving a contrast agent other than Oxilan
* On hemodialysis
* Recent exposure to contrast within 2 days
* Pulmonary edema
* Active congestive heart failure
* Severe valvular abnormality
* Recent significant change in kidney function (\> 15% over 2d)
* One kidney
* Kidney transplant status
Italian Validation of a Tool for Assessing Sexual Function After Breast Cancer, FSFI-BC

This is a validation study of the italian language for the Female Sexual Function Index-Breast Cancer questionnaire.

The validation of the instrument in Italian will allow the identification of possible issues related to sexual health and enable the provision of adequate medical and psychosexual counseling to these patients, both in clinical practice and in research studies.

The original version of the questionnaire will be validated in two phases: a) translation, b) reliability.

1. Translation of the items and administration to a small sample of volunteers to assess usability.

   In the first phase, the questionnaire will be translated following the 5 steps:
   1. forward translation by two independent translators (from English to Italian);
   2. synthesis (discussion between translators to resolve any discrepancies);
   3. backward translation (from Italian to English) by two additional independent translators;
   4. expert committee (translators, psychologists, sexology consultants) comparing the two versions of the questionnaire; 5) testing the first version of the questionnaire with a sample (N=20) of native Italian speakers to evaluate the adequacy of content and clarity of terms used and proceeding to the final version.
2. Reliability of the questionnaire. To assess the reliability of the questionnaire, it will be administered again after a 2-week interval to a smaller sample compared to the recruited patient sample.

Eligibility Criteria:
Inclusion Criteria:

1. Women with operable breast cancer;
2. Operated on between 2012 and 2020;
3. Randomly selected from the institutional database; 18 years of age (Age stratification: equally represented women aged \<50 years and women aged ≥50 years);
4. Signing of the informed consent.

Exclusion Criteria:

1. Severe psychiatric or cognitive illness;
2. Ongoing psychological treatment.
Assessment of Pediatric Challenging Airway

The goal of these Observational study is to learn about pediatric airway the main question to answer is:

1-Is using point-of-care ultrasound provide an easy, early, and accurate preoperative assessment of the challenging pediatric airway and the endotracheal tube sizing more than traditional methods.


Eligibility Criteria:
Inclusion Criteria:

* Patient's parents' consent.
* Age:from one to 4 years old.
* Both sexes (male and female).
* BMI with in (5-85%) of body mass index of the child birth of same age and sex.
* Physical status: American Society of Anesthesiologists (ASA) physical status I and II.
* Type of operation: elective surgery under general anesthesia with endotracheal intubation

Exclusion Criteria:

* Pre-existing airway malformations or pathology like facial or cervical fracture
* Deformity of the airway anatomy \[by masses or tumors\].
* Pathology of the airway \[edema, burn and arthritis\].
* Anticipated difficult airway
Clinical Efficacy of Axillary Block in Cervical Radiculopathy

The primary endpoint of this study was to compare the clinical efficacy of axillary block in patients of cervical radiculopathy using 2 volumes of local anesthetics.

The interscalene brachial plexus block is an effective intervention for reducing postoperative pain but is related to side effects, Suprascapular nerve block and a block of the axillary nerve have been introduced as alternatives to the interscalene brachial plexus for the control of postoperative pain. Previous study demonstrated new method of axillary block using interfascial plane injection guided by ultrasoud. Axillary block has been used widely for the relief of postoperative arm pain.

Recent study deomonstrated good pain relief when ultrasound guided interfascial plane injection was performed in patients with cervical radiuculopathy.

There is no study showing clinical efficacy of interfascial plane injection of axillary block in patients of cervical radiculopathy.

Eligibility Criteria:
Inclusion Criteria:

* Cervical foraminal stenosis
* Cervical central stenosis
* Cervical disc herniation
* Cervical spondylolisthesis
* Prominent arm pain rather than neck pain

Exclusion Criteria:

* Infection
* Pregnancy
* allergy to local anesthetic agents
* previous cervical spine surgery
* Prominent neck pain rather than arm pain
Estimation of (suPAR) in Chronic Periodontitis With Post-radiotherapy on HNCs Patients

This study aims to improve a soluble urokinase plasminogen activator receptor suPAR is a reliable biomarker of chronic periodontitis and may be replaced in patients with head and neck cancer post-radiotherapy (HNC post-RT).

The urokinase-type plasminogen activator receptor (uPAR) plays an essential function in leukocytes and endothelial homeostasis and, therefore, in the development of chronic periodontitis. The study enrolled 150 participants, 50 chronic periodontitis with head and neck cancer post radiotherapy (CP+HNC post-RT) patients, 50 chronic periodontitis (CP) without HNC patients, and 50 healthy controls. Clinical Attachment Loss (CAL), Probing Pocket Depth (PPD), Plaque Index (PI), and Gingival Bleeding Index (GBI) were recorded. An enzyme-linked immunosorbent assay (ELISA) was constructed to quantify serum (suPAR) levels.

Eligibility Criteria:
Inclusion Criteria:

* A pathologically confirmed malignant neoplasm of HNC (derived from epithelial cells).
* Not having received radiation therapy previously.
* No distant metastasis.
* No history of salivary gland surgery (parotid, submandibular, or sublingual).
* A generally satisfactory physical condition with a performance score of 0 to 1 point and a planned survival period of more than a year and scores of 2 higher indicating increasing disability.

Exclusion Criteria:

* Previous oral disease or salivary gland disease history.
* Definitive diagnosis of multiple sclerosis, xerostomia, or systemic disease.
* Refusal to participate in the study.
A Multiple Ascending Dose Study of BCI-838 in Healthy Volunteers

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BCI-838 and its metabolite BCI-632 in healthy male and female subjects.

This study will evaluate the safety and tolerability following oral administration of multiple doses of BCI-838 in healthy male and female subjects. The pharmacokinetic profile of multiple oral doses of BCI-838 in healthy male and female subjects will also be assessed. In addition, the pharmacodynamic effects of BCI-838 on the central nervous system using quantitative electroencephalogram analysis will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female healthy volunteers, 18-55 years of age
* Body Mass Index (BMI) between 18.0 to 30.0 kg/m2 inclusive
* Female subjects must have a negative pregnancy test at screening and admission. Females of childbearing potential (not at least 2 years postmenopausal or surgically sterile) must be using a reliable, medically acceptable form of contraception for at least 30 days prior to the screening visit and must agree to continue such use throughout the duration of the study and for 3 months after the final dose of study drug.
* Good general health as determined by medical history and physical examination with no clinically significant medical findings and no clinically relevant medical or surgical history and no acute or ongoing conditions within the past 30 days
* Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria:

* Clinically significant medical abnormality, chronic disease or history or presence of significant pulmonary, gastrointestinal, metabolic, cardiac, hepatic, renal or neurological disorder
* History or current use of alcohol abuse or drug addiction
* Participation in a drug study within 60 days prior to drug administration.
* Participation in more than 3 other drug studies in the 10 months preceding the start of this study
* Donation or blood loss of more than 50 mL of blood within 60 days prior to the first drug administration. Donation of more than 1.5 liters of blood in the 10 months preceding the start of this study
* Illness within 5 days prior to drug administration
A Phase II Study of CP-4055 as Second Line Therapy in Patients With Advanced Colorectal Cancer

Patients with histologically or cytologically confirmed metastatic colorectal cancer (CRC) who have failed a first-line chemotherapeutic regimen containing oxaliplatin and 5-fluorouracil (5-FU) with or without bevacizumab, with or without other Investigational Medicinal Products (IMPs), will receive CP-4055 200 mg/m2/day intravenously (IV) on Day 1-5 every four weeks until complete response or disease worsening/progressing.

This is a multicentre clinical study conducted in the United Kingdom. It is an open label study designed to investigate objective response rate (RR), the time to progression (TTP) and the duration of tumor response in patients with colorectal cancer when treated with CP-4055. The quantitative and qualitative toxicities of the treatment will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically or cytologically confirmed metastatic CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and 5-fluorouracil (5-FU) with or without bevacizumab, with or without other Investigational Medicinal Products (IMPs)
2. Measurable disease according to Response Criteria In Solid Tumours (RECIST)
3. Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
4. Age 18 years or more
5. Life expectancy \> 3 months
6. Signed informed consent (IC)
7. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to CP-4055 treatment. Nursing patients are excluded.
8. Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last CP-4055 dose
9. Adequate haematological and biological functions

Exclusion Criteria:

1. Known brain metastases
2. Radiotherapy to more than 30 % of bone marrow
3. Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
4. Concomitant treatment with a non-permitted medication:

   * Alternative drugs
   * High doses of vitamins
5. History of allergic reactions to ara-C or egg
6. Any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
7. Any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
8. Pregnancy, breastfeeding or absence of adequate contraception for both male and female fertile patients
9. Known positive status for HIV and/or hepatitis B or C
10. Drug and/or alcohol abuse
11. Any reason why, in the investigator's opinion, the patient should not participate
Neutralizing Antibody Level After COVID-19 Vaccination

1. serial of neutralizing antibody at 2, 4, 6, 9, 12 month after COVID-19 vaccination
2. investigate the factors on antibody titer.

1. serial of neutralizing antibody at 2, 4, 6, 9, 12 month after COVID-19 vaccination 1) semi-quantitative measurement of neutralizing antibody at 2, 4, 6, 9, 12 month after COVID-19 vaccination 2) investigate the duration maintaining acceptable range (over 30% inhibition)
2. investigate the factors on antibody titer at 2 month after vaccination 1) potential factors: age, sex, body weight, height, use of medication, use of antipyretics (NSAID or tyrenol), side effect of COVID-19 vaccination 2) correlation between antibody titer and potential factors
3. Compare 4 diagnostic ELISA kit at 2 month after vaccination 1) measure neutralizung antibody using ELISA kits from 4 different companies 2) investigate correlation coefficient of antibody titer between companies

Eligibility Criteria:
Inclusion Criteria:

* healthcare works after completion of COVID-19 vaccination
* 20-60 years
* sign the agreement of study

Exclusion Criteria:

* serious underlying diseases
Older Volunteers' Competence Training

This project was aimed to evaluate the effectiveness of the competence training program in improving the knowledge and skills of volunteer work, the motivation for volunteering, self-efficacy, and satisfaction with volunteer work among older volunteers.

A cluster-randomized controlled trial was conducted to test the effects of a 3-month comprehensive competence training program in improving the knowledge and skills of volunteer work, the motivation for volunteering, self-efficacy, and satisfaction with volunteer work among older volunteers. Using convenience sampling, 10 senior activity centers with 162 older volunteers were recruited and cluster-randomized to the intervention group (5 centers) or wait-list comparison group (5 centers). The intervention group received a 3-hour weekly course training session in four consecutive weeks and provided services to community-dwelling older adults for two months; the comparison group provided their routine services at senior activity centers. Data were collected at baseline, one month, and three months into the study.

Eligibility Criteria:
Inclusion Criteria:

* older adults age ≥ 65
* able to read and write in Chinese
* being a volunteer at the senior activity center for at least 1 month

Exclusion Criteria:

* illiterate
Interest of Dynamic Measures of the Pupil in Optic Neuritis

The investigators' hypothesis is that measuring the PCTdynamics would be an easy and reliable symptom to evaluate in pathologies affecting the optic nerve

Physiopathologic study aiming to assess the interest of measuring the lenght of pupil cycle in the dynamic study of the pupillary light reflex.

Eligibility Criteria:
Inclusion Criteria:

* patients with unilateral optic neuritis or with multiple sclerosis and an optic neuritis in the previous 5 years

Exclusion Criteria:

* previous history of ophthalmic and neurologic pathology
* anisocoria
* minor
* Patient with a measure of legal protection
* Pregnancy
* patient opposition to participation in the study
* no affiliation to social security
A Trial of LY3056480 in Patients With SNLH

A phase 2 trial with LY3056480 in patients with stable SNHL

VESTA is a double blinded, randomized, placebo controlled, multi center efficacy phase 2 study comparing three dosing regimens of 250 µg LY3056480. Adult volunteers with stable mild to moderately-severe SNHL will be recruited through Adult Otolaryngology - Head \& Neck Surgery Services in the US. Four injections of 250µg LY3056480 or placebo administered trans-tympanically into one ear (worse hearing ear).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female between 18 - 65 years of age;
2. Minimum of six months of documented stable hearing loss (+/- 5dB);
3. A documented stable word recognition test (stable for \~ 6 months +/- 6%/3 words)

Exclusion Criteria:

1. Presenting with a primary complaint of tinnitus
2. Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10 dB at two or more contiguous octave frequencies in the study ear
3. History of suspected or diagnosed genetic cause of hearing loss;
4. Partial deafness as defined as hearing loss in any frequency (up to 8 kHz) greater than 80dB
5. Suspected or known diagnosis of the following inner ear pathology, congenital hearing loss, fluctuating hearing loss, Ménière's disease, or secondary endolymphatic hydrops, perilymph fistula, cochlear barotrauma, autoimmune hearing loss, radiation-induced hearing loss, retro-cochlear lesion, ototoxicity
6. Evidence of acute or chronic otitis media or otitis externa on examination; or a history of middle ear pathology and/or surgery (except for ear tubes as a child)
7. Any therapy known as ototoxic
8. Participant in a previous trial of LY3056480
Heterosexual HIV Transmission Study (HATS). Prospective Cohort Study

PRIMARY: To identify factors associated with risk of HIV infection through heterosexual activity among urban, inner-city women.

SECONDARY: To identify correlates of high-risk behaviors in order to provide a basis for future intervention studies.

At baseline and at 6-month intervals, participants are interviewed about their sexual behavior, drug and alcohol-related behaviors, and recent medical history, and are given a psychosocial assessment. They also undergo a physical exam, including pelvic exam and colposcopy, and have blood and urine specimens collected for HIV testing, drug screening, and STD evaluation. Additionally, participants are given pre- and post-test counseling and education, including information about social services. They are provided with basic gynecological care and either treatment or referral for medical problems.

Eligibility Criteria:
Participants must meet the following criteria:

* HIV-negative, sexually active women living in social and sexual proximity to men at high risk for acquiring HIV infection.
* Able to speak English, Spanish, or Creole.
* Living in the geographic area surrounding Kings County Hospital in Brooklyn, New York. (Hospital-based and community-based recruitment sites will be utilized.)

Personal history of parenteral drug use by self-report or urine test. Heterosexual contact with men at high risk for HIV infection.