cyrilzakka/clinical-trials huggingface dataset:
Tear Film Stability of DAILIES® AquaComfort Plus® Contact Lenses vs. MyDay® Daily Disposable Contact Lenses

The purpose of this study is to evaluate tear film stability of DAILIES® AquaComfort Plus® (DACP) compared to MyDay® after 12 hours of lens wear.


Eligibility Criteria:
Inclusion Criteria:

* Must sign an Informed Consent form;
* Adapted, current soft contact lens wearer;
* Required contact lens prescription within the power range specified in the protocol (+6.00 to -10.00 diopters (D));
* Cylinder ≤ -1.00 D in both eyes at Visit 1;
* Vision correctable to 0.1 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye at distance with pre-study lenses at Visit 1;
* Willing to wear study lenses up to 12 hours and attend all study visits;
* Able to be successfully fitted with study lenses;
* Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* Use of artificial tears and rewetting drops during the study;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Any abnormal ocular condition observed during Visit 1;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Pregnant or lactating;
* Participation in any clinical study within 30 days of Visit 1;
* Current MyDay® or DAILIES® AquaComfort Plus® lens wearer;
* Other protocol-defined exclusion criteria may apply.
Addiction Health Evaluation And Disease Management (AHEAD) Study

The objective of this study is to test whether a chronic disease management (CDM) program for substance abusers in primary care leads to improved alcohol and drug-related outcomes (such as reduced consumption and health problems) and health care utilization patterns.

Chronic disease management (CDM) is a collaborative, longitudinal, proven effective approach to the treatment of chronic medical illnesses that addresses individual patient and health systems barriers to receipt of needed treatment. The objective of this Addiction Health Evaluation And Disease management (AHEAD) Study is to test the effectiveness of CDM for substance dependence in primary care. The study will enroll and randomize subjects to attend a substance dependence CDM program (the AHEAD Unit) integrated into a real-world primary care clinic or to referral to usual primary care. All subjects will be assessed regarding alcohol and/or drug diagnosis, consumption and problems, readiness to change, health-related quality of life, and medical and substance abuse treatment utilization. Primary outcomes are alcohol and drug use, alcohol and drug-related problems, emergency department visits, and hospitalizations. Additional outcomes are health-related quality of life, readiness to change, medical and psychiatric comorbidity, HIV risk behaviors, and treatment utilization and costs. The hypothesis is that compared with standard care, a health services intervention -- chronic disease management for alcohol and drug dependence integrated in primary care -- will decrease alcohol and drug use and related problems, and improve health care utilization patterns.

This study contains two studies (and study populations):

* 1. 320 alcohol dependent subjects with current risky drinking, and
* 2. 320 drug dependent subjects with current drug use.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Fluent in English or Spanish
* Alcohol or drug dependent
* Heavy drinking in the past 30 days or recent drug use
* Provide 2 contacts to assist with follow-up
* Have no plans to move from the local area within a year of screening
* Score \>21 on Mini-Mental State Examination (no serious cognitive impairment)

Exclusion Criteria:

* Pregnant (self-report)
* Breath alcohol \>100 mg/dL
* Inability to provide informed consent determined by trained research associates
Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.


Eligibility Criteria:
Key Inclusion Criteria:

* Chronically HCV-infected males and non-pregnant/non-lactating females aged 18 years or older who did not achieve sustained virologic response (SVR) in a prior Gilead-sponsored HCV treatment study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Regional-anaesthesiological Infiltration Techniques for the Management of Chronic Pain: a Retrospective Study

There is a significant debate whether local infiltration techniques may be a method to treat complicated chronic pain syndromes, e.g. refractory headache. Until now there is a lack of evidence regarding efficacy of this treatment especially in long term follow up. Similarly, indication and management are under debate. Aim of this trial is to analyse pain scores during first treatment with anaesthesiological infiltration series.


Eligibility Criteria:
Inclusion Criteria:

* patients with chronic pain disease undergoing regional-anaesthesiological infiltration series

Exclusion Criteria:

* pregnancy
* patients in legal custody
* age \<18 years
The Efficacy of Neural Stimulation in Individuals With Schizophrenia

The purpose of this study is to understand the relationship between psychotic symptoms and social functioning in individuals with schizophrenia spectrum disorders. Our goal is to determine whether stimulating the brain using transcranial Direct Current Stimulation (tDCS) can improve symptoms and daily functioning.

Paranoid ideation is a common delusion experienced by individuals with schizophrenia spectrum disorders (SSD) that negatively impacts social interactions and quality of life. Therefore, efforts to reduce paranoid thinking via neuromodulation techniques \[e.g., transcranial direct current stimulation (tDCS)\] are in development, with amygdala-prefrontal cortex (PFC) circuits targeted as critical components of the neural mechanisms underlying paranoia.

This project aims to alleviate paranoia and improve social functioning in individuals with SSD by implementing tDCS to ventrolateral PFC. A double-blind, within-subjects, crossover design will be used to compare the effects of active vs. sham tDCS. Ecological Momentary Assessments (EMA) will also be utilized to quantify any delayed stimulation effects in daily social interactions.

Eligibility Criteria:
Inclusion Criteria:

* Age = 18-64
* Diagnosed with schizophrenia or schizoaffective disorder
* Having current (in the past week) or recent (in the past month) paranoia

Exclusion Criteria:

* Presence or history of a pervasive developmental disorder or mental retardation as defined by IQ \< 70
* Presence or history of neurological or medical disorders that contraindicate neural stimulation (e.g. presence or history of epilepsy, seizures, etc.)
* Demonstrating sensory limitations, including uncorrectable visual or hearing impairments that interfere with assessment
* History of electroconvulsive therapy
* Lack of proficiency in English
* Substance use disorder not in remission in the past 6 months
* Any implanted devices such as pace maker, neurostimulator
* Pregnancy
Seat Cushions Adaptations on Upper Extremity Function In Cerebral Palsy Children

As the seating adaptations, ranging from simple to complex, standard and customized may facilitate optimal health and maximize functional participation despite limited postural control; the study will be conducted for determine the effect of contoured cushions as a seat adaptation on upper extremity function in children with spastic cerebral palsy and compare between the effect of flat cushion and contoured cushion in adaptive seating system on upper extremity function in children with spastic cerebral palsy.

As research continues to reveal the efficacy of ramped and contoured cushions on postural stability and alignment (Macdonald et al.,2015), it is likely that it will become accepted that such modifications will affect the UL functional level , mobility and rang of motion. Therefore, the purpose of this study was to examine the effect of contoured cushions as adaptive seating intervention on Upper extremity function in children with spastic cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

1. Their age ranged from three to six years old .
2. Spasticity ranged from 1+ to 2 grade according to Modified Ashwarth Scale .
3. All children should be able to sit on the adaptive seat while head is upright independently and hands are free; preliminary test by Gross Motor Functional Measurement (GMFM) scale ranged score from ( 21 to 25 ) in sitting domain.

Exclusion Criteria:

Any child with the following criteria will be directly excluded from the evaluation for the consistency of the sample and statistically obtained results:

1. Visual and/or auditory defects which interfere with upper extremity functions.
2. Fixed deformity of one or both upper limbs which limit passive ROM in shoulder and elbow.
3. Children with mixed type, dyskinetic or ataxic cerebral palsy are excluded.
4. surgical intervention in both upper limbs or botulinum toxin injection in the last 6 months before the time of assessment .
5. Any recent trauma of one or Both upper limbs.
Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)

This project proposes to use bronchoscopic intratumoral chemotherapy for small cell lung cancer in two fashions:

1. to implement a prospective clinical trial to test the feasibility and efficacy of intralesional chemotherapy as consolidative therapy immediately following standard systemic chemotherapy and radiation therapy for patients with limited stage SCLC by comparing tumor growth and survival rates of the treatment group and compare the outcomes to historical controls
2. to implement a prospective clinical trial to test the feasibility and efficacy as measured by tumor growth and survival rates of intralesional chemotherapy for patients with recurrent SCLC after standard treatment.

Subjects will receive standard of care treatment for SCLC with added treatment of Cisplatin injection via endobronchial ultrasound aided bronchoscopy a total of four times. Outcome measurements of tumor growth and survival will be compared to subjects receiving standard of care treatment only.

Eligibility Criteria:
Inclusion Criteria: Competent adult English speaking subjects

* With limited stage SCLC who have completed standard of care treatment who are responders with no evidence of disseminated disease other than CNS metastasis,
* With recurrent disseminated SCLC after standard of care treatment with symptoms related to central tumor obstruction,
* With recurrent limited stage SCLC with mediastinal/hilar recurrence not previously treated with intratumoral cisplatin

Exclusion Criteria:

* Subjects who do not meet the inclusion criteria
* Subjects who, in the opinion of the investigator, are at risk undergoing a bronchoscopy
Optimizing Vancomycin Therapy in Children

The purpose of Opt Vanc is to evaluate the feasibility of Bayesian dose adaptation, based on a previously-developed population pharmacokinetic (PK) model and a single optimally timed PK sample, to predict vancomycin area under the curve (AUC) in critically ill children.

Opt Vanc is an observational study of critically ill children prescribed IV vancomycin for a suspected infection at the Children's Hospital of Philadelphia. This study will evaluate how well Bayesian dose adaptation, based on a previously-developed population pharmacokinetic (PK) model for vancomycin and a single optimally timed vancomycin concentration, can predict vancomycin area under the curve (AUC) in critically ill children. Eligible subjects will be prescribed vancomycin and undergo routine therapeutic drug monitoring (TDM) per standard of care. At the time of TDM, each subject will have a vancomycin concentration obtained at the most informative sampling time to estimate AUC, as determined by the multiple-model optimal sampling function in PMetrics (population PK modeling program). Investigators will then compare the AUC determined using Bayesian estimation and the subject's optimally timed vancomycin concentration to the AUC determined using Bayesian estimation with all available concentrations (TDM samples plus the optimally timed sample). Investigators will also examine how AUC estimation compares to AUC calculated using standard-of-care methods (ie, log-linear equations). Further, Investigators will evaluate how well the population PK model, along with a subject's measured covariates and the optimally timed PK sample, can predict a subject's future vancomycin AUC.

Eligibility Criteria:
Inclusion Criteria:

* Administered intravenous vancomycin via intermittent infusion,
* Eligible for vancomycin AUC monitoring, per the subject's clinical team, and
* Parental/guardian permission (informed consent).

Exclusion Criteria:

* Receipt of renal replacement therapy, plasmapheresis, or extracorporeal membrane oxygenation (ECMO), or
* Unable to provide urine and blood samples.
Greens-Based Crossover Trial to Improve Epigenetic Aging in Adults

The primary purpose of this study is to assess changes in epigenetic markers of aging and physiological parameters in overweight older adults consuming a mixed greens-based supplement over a 30-day period in a randomized crossover design.

Investigators will recruit 20 overweight/obese but otherwise healthy participants aged 50-65. Participants will be randomized to consume the greens-based supplement each morning for the first 30 days or second 30 days of the study. Usual diet, physical activity, and sleep patterns will be encouraged and monitored during the duration of the study.

Phlebotomy will be conducted at baseline, 30-day crossover, and 60-day follow-up to assess DNA methylation in peripheral blood mononuclear cells. Visceral and total body fat, stool microbiome composition, and actigraphy will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Men and women of any ethnicity (women must be postmenopausal)
* Body Mass Index \> 30 kg/m\^2
* Low habitual dark green leafy vegetable consumption
* Willing to adhere to study protocol and measures
* Willing to communicate via smartphone technology
* Able to read, write and speak English

Exclusion Criteria:

* Overt cardiometabolic diseases such heart attack, stroke, diabetes, insulin resistance and non-alcoholic fatty liver disease, etc.
* Diagnosis of a transient ischemic attack in the 6 months prior to screening
* Diagnosis of cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
* Food allergies
Tumor Recurrence After Abdominal-perineal Amputation in Squamous Cell Carcinoma of the Anus

Squamous cell carcinoma of the anal canal is a rare cancer with an increasing incidence. It represents 2.5% of digestive cancers and occurs more frequently in immunocompromised persons, in particular HIV positive. It is a cancer that develops essentially locally, with only 5% of metastases at diagnosis. The reference treatment for forms deemed localized after clinico-bio-radiological pre-therapeutic evaluation is radiochemotherapy allowing a 5-year survival rate of about 80%. However, up to 30% of patients fail radiochemotherapy. Failure is defined as persistent disease (non response or progression in 10 to 15% of patients) or relapse (local or metastatic in 10 to 15% of patients). Salvage surgery by abdominoperineal amputation is indicated in this case after elimination of the metastatic character with an overall survival rate at 5 years varying from 23 to 69%. This complex and cumbersome surgery is burdened with significant postoperative morbidity with alteration of the quality of life. Investigators would like to perform a retrospective and prospective study in the Paris Saint-Joseph hospital group to evaluate the interest of abdominoperineal amputation in case of failure of radiochemotherapy in patients with squamous cell carcinoma of the anal canal.


Eligibility Criteria:
Inclusion Criteria:

* Patient with abdominoperineal amputation for squamous cell carcinoma of the anus
* Patient whose age ≥ 18 years
* French speaking patient

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of his data for this research
Mapping the Areas of the Brain Associated With Language in Children With Epilepsy

Researchers are interested in studying if magnetic resonance imaging (MRI) is practical for locating the areas of the brain associated with language in children with epilepsy.

When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also.

Patients participating in the study will be asked to perform tasks designed to test language skills while undergoing an MRI to detect areas of the brain using oxygen and receiving blood flow.

We propose to study the feasibility of utilizing MRI to perform functional mapping of language cortex in children with epilepsy. We will use 1.5 Tesla MRI to study cerebral blood flow and tissue oxygenation during cognitive activation tasks derived from previous adult studies.

Eligibility Criteria:
Children aged 5-17 years.

Partial epilepsy (localized).

Ability to cooperate with task paradigms (IQ greater than 65).

No cardiac pacemakers, cochlear implants, shrapnel, vascular clips, braces, or claustrophobia.

No one with inability to cooperate with task paradigms.
Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients

This study has been designed to evaluate a new oral test for therapeutic monitoring of HIV/AIDS patients that are receiving the combination Anti-Retroviral Therapy (cART). The test will measure saliva-based Stress Response Profiling(SRP) biomarkers using laboratory assays. Results of the test will show if HIV/AIDS patients successfully responded to cART. Preliminary studies showed that SRP biomarkers were strongly increased in cART-unresponsive AIDS patients. However, the diagnostic accuracy of the oral test, patients will be recruited to donate saliva: AIDS patients responsive or unresponsive to cART, and controls (acute or early HIV patients, and HIV-negative patients with hepatitis).

The saliva samples will be used to measure SRP biomarker concentrations. Results will show whether the biomarker measurements provide accurate and specific diagnostics for ART response.


Eligibility Criteria:
Inclusion Criteria:

Group 1, cART-unresponsive

* Documented HIV-positive before obtaining AIDS diagnosis
* cART for 18 months or longer
* consistent lab tests in previous 3-6 months: \< or equal to 200 CD4 T cells/mm3, viral load \>5000 HIV RNA copies/ml

Group 2, cART-responsive

* Documented HIV-positive before obtaining AIDS diagnosis
* cART for 18 months or longer
* consistent lab tests in previous 3-6 months: \> or equal to 350 CD4 T cells/mm3, viral load \< or equal to 50 HIV RNA copies/ml

Group 3, acute/early HIV

Acute HIV:

* Signs and symptoms of acute retroviral syndrome in a person with either a negative or evolving antibody response (western blot or ELISA) in presence of a positive HIV p24gag antigen or HIV-1 proviral DNA PCR or positive HIV-1 RNA

Early HIV:

* A positive antibody response (western blot or ELISA) with a documented negative serological test or plasma HIV-1 RNA within the past 12 months or a positive ELISA and a negative de-tuned ELISA within 30 days of a positive ELISA specimen in an untreated person with no clinical or immunological evidence of advanced HIV disease (CD4 count \>200 cells/mm3 or \>14%)

Group 4, HIV-negative Hepatitis-positive

* HIV test negative (western blot, ELISA or viral load)
* Positive Hepatitis B surface antigen and detectable hepatitis B viral load (HCV B RNA), treated or not OR Positive Hepatitis C antibodies and detectable hepatitis C viral load (HCV C RNA), treated or not

Exclusion Criteria:

* Pregnant or lactating women
* Non-adherent patients
* Any conditions which will affect saliva production: e.g. Sjogren's syndrome or chronic mouth dryness
* Cytotoxic chemotherapy, interferon treatment, or radiation therapy within the preceding 3 weeks
* Active alcohol or substance abuse (narcotics or other controlled substances) within 6 months prior to the saliva sampling
* Significant psychiatric illness that in the opinion of the principle investigator might interfere with making an informed decision
* Incapable to give informed consent
Tracers for Endometrial Cancer Sentinel Node Labeling

Sentinel lymph node (SLN) biopsy is currently used in the management of vulvar and breast cancers as well as in malignant melanoma, and is being intensively studied in patients with cervical and endometrial cancers. The role of lymphadenectomy in the surgical management of early-stage endometrial cancer is still controversial. The main reason to perform a SLN biopsy is to detect the lymph node that will be the first involved with metastatic disease in the nodal basin. The SLN biopsy is performed after the SLN is located with the use of different tracers in a concept called SLN mapping. Moreover, SLN evaluation has been reported to improve the accuracy of lymph node staging due to SLN pathologic ultrastaging, which includes multiple serial sectioning and immunohistochemical assessment. The aim of this project is to conduct a multicentre, prospective, observational trial to compare two different SLN labelling methods (radioactive tracer with/without blue dye vs. indocyanine green-ICG) in the same patient and to evaluate the unilateral detection rate, sensitivity, number of detected SLN, anatomical localisation of detected SLN and bilateral detection rate of SLN. The main aim of the trial is the comparison of SLN mapping between two SLN labelling methods in the same patient. The trial will answer a question whether a combination of labelling methods in the same patient increase importantly the sensitivity of SLN biopsy.

The trial has a high potential to reach the calculated number of cases and thus bring in evidence/data that will be essential for future management of SLN biopsies in endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven endometrial cancer (any tumour type).
* Apparent early-stage endometrial cancer with intermediate or high risk prognostic factors (deep myometrial invasion or G2/G3 disease or non- endometrioid histological type), no evidence of bulky or suspicious pelvic/para-aortic lymph nodes or distant metastases on preoperative conventional imaging studies; minimum requirement for clinical staging includes expert US or pelvic MRI for local staging and abdominal US or abdominal CT scan or PET CT for distant staging.
* Performance status ECOG: 0-1.
* Age ≥18, ≤85.
* History of second primary cancer only if more than 5 years with no evidence of disease.
* Approved and signed informed consent form to participate in the study.

Exclusion Criteria:

* Pregnancy
* Desire for fertility sparing
* History of pelvic or abdominal radiotherapy