cyrilzakka/clinical-trials huggingface dataset:
Heidelberg Edge Perimetry (HEP) Detecting Glaucomatous Visual Field Defects

The purpose of this study is to compare standard automated perimetry (SAP) using the Heidelberg Edge Perimeter (HEP) to the Octopus Visual Field (OVF) analyzer and determine test-retest reliability of both parameters in detecting glaucomatous visual field losses. This study will also investigate novel imaging parameters of the optic nerve head and new automated structure-function reports.

Each participant undergo the following tests:

1. Standard ophthalmic examination (usual care): Best-corrected visual acuity, biomicroscopy (look at front of eye), intraocular pressure (IOP) using Goldman applanation tonometry, central corneal thickness measurement and fundoscopy (look at back of eye).
2. Octopus Visual Field (OVF) Analyzer using G-top strategy recording mean deviation (MD) and pattern standard deviation (PSD).
3. Heidelberg Edge Perimeter (HEP) standard automated perimetry (SAP) using advanced staircase thresholding algorithm (ASTA).
4. Spectralis optical coherence tomography (OCT) using glaucoma module premium edition (GMPE) software to measure minimum rim width (MRW) and retinal nerve fiber layer (RNFL) thickness in 6 sectors (superior nasal, superior temporal, inferior nasal, inferior temporal, nasal and temporal) in the retina.

Order of HEP SAP III and OVF, and order of the eye tested (right vs. left) if both eyes of patients meet inclusion criteria will be randomized. Patients with glaucoma will be randomly chosen and asked to return in 3 to 6 months for repeat HEP and OVF testing.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Best corrected visual acuity of 20/40 or better in the tested eye.
* Spherical refraction within ±5.0 D, and cylinder correction within ±3.0 D.
* History of glaucoma, defined as:
* Characteristic of glaucomatous disc damage: (local narrowing, notching, or absence of the neuroretinal rim in the absence of disc pallor elsewhere).

Exclusion Criteria:

* Any condition preventing adequate examination of the pupil or visual field testing (e.g. ptosis, dense corneal opacities or lens opacities);
* Active infection of the anterior or posterior segments of the eye;
* Any intraocular surgical or laser procedure within the previous 4 weeks;
* Participants taking a medication known to affect visual field sensitivity, a coexisting intraocular disease affecting visual field, or a problem other than glaucoma affecting color vision will be excluded.
Epidemiological Study to Evaluate the Prevalence of Epidermal Growth Factor Receptor (EGFR) Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)

To estimate the prevalence of EGFR mutation in a representative sample of patients with newly diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity).


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV)

Exclusion Criteria:

* Mixed histology of small cell and non-small cell lung cancer
NeuroAiD Safe Treatment Registry

The NeST registry is a pro-active industry-academic collaboration to assess the use and safety of NeuroAiD in the real world setting. An online entry system was set up to allow easy data entry and retrieval of clinical information.

The NeST Registry is designed as a product registry that would provide information on the use and safety of NeuroAiD in clinical practice. An online NeST Registry was set up to allow easy entry and retrieval of essential information including demographics, medical conditions, clinical assessments of neurological, functional, and cognitive state, compliance, concomitant medications and side effects if any, among patients on NeuroAiD. Participation is voluntary. Data collected are similar to information obtained during standard care and are prospectively entered by the participating physicians at baseline (before initialization of NeuroAiD) and during subsequent visits. The follow up visits are timed with clinical appointments. Anonymized data will be extracted and collectively analyzed. Initial target sample size for the registry is 2000.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Any age
* Taking, or has been prescribed NeuroAiD for any duration as judged by the physician and/or the participant
* Agrees to be included in the registry and allows retrieval and analysis of data in accordance with local requirements

Exclusion Criteria:

* Unwillingness to participate
* Contraindication to NeuroAiD
Syrenity App for Depression

The goal of this clinical trial is to learn if the Syrenity mental health app reduces depressive symptoms when compared to a control condition. Secondarily, the trial will provide data on the usability and acceptability of the Syrenity app. The main questions it aims to answer are:

Does Syrenity reduce self-reported depressive symptoms compared to a waiting list control? How usable is the Syrenity app?


Eligibility Criteria:
Inclusion Criteria:

* PHQ-9 \>= 10
* Use an iPhone or Android
* Residing in the United States

Exclusion Criteria:

* PHQ-9 item 9 \>= 2
Post-Authorization Safety Study of GSK Biologicals' Pandemic Influenza Vaccine (H1N1) in the United Kingdom

The focus of this study is to assess the safety of GSK's H1N1 vaccine in real life conditions as soon as the vaccine is used, in a mass vaccination programme, and with a system for rapid generation, communication and evaluation of safety data.

This study is a commitment to the European Medicines Agency (EMEA), as part of GlaxoSmithKline Biologicals' (GSK Biologicals') risk management plan for pandemic influenza vaccination.

Collaborator: Medicines and Healthcare products Regulatory Agency

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent, and assent where appropriate, obtained from the subject/from the subject's parent(s)/ Legally Acceptable Representative(s) (LAR).
* A male or female subject vaccinated with a first dose of GSK Biologicals' H1N1 pandemic influenza vaccine
* shortly (\<24h) before being recruited in the study, and
* within a GP practice participating in the study and where the subject is registered.
* Subjects who the Investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol

Exclusion Criteria:

* Subjects already vaccinated with any other H1N1 pandemic vaccine before study enrolment.
* Child in care
Genetic Analysis of Familial Melanoma

In collaboration with members of The International Melanoma Consortium, we propose to study melanoma in families lacking mutations in the cyclin-dependent kinase inhibitor 2 (CDKN2 or p16) gene, or the cyclin-dependant kinase 4 (CDK4). CDKN2 and CDK4 are both genes that encode presumed tumor suppressor genes, mutant forms of which are known to cause increased susceptibility to melanoma. The purpose of the present study then is to confirm the existence of and to identify additional gene(s) involved in heritable melanoma (cutaneous and ocular) and their precursor lesions (atypical nevi) by linkage analysis and gene mapping strategies. It is clear that the risk to develop atypical nevi and/or melanoma is strongly influenced by genetic and environmental factors (e.g. sun exposure). Characterization of such genes could provide important insights into the inheritance, pathogenesis, and treatment of this increasingly important disease.

In collaboration with members of The International Melanoma Genetics Consortium, we propose to study melanoma in families lacking mutations in the cyclin-dependent kinase inhibitor 2 (CDKN2A), or the cyclin-dependant kinase 4 (CDK4) genes. CDKN2 and CDK4 are both genes that encode presumed tumor suppressor genes, mutant forms of which are known to cause increased susceptibility to melanoma. The purpose of the present study then is to confirm the existence of and to identify additional gene(s) involved in heritable melanoma (cutaneous and ocular) and their precursor lesions (atypical nevi) by linkage analysis and gene mapping strategies. It is clear that the risk to develop atypical nevi and/or melanoma is strongly influenced by genetic and environmental factors (e.g. sun exposure). Characterization of such genes could provide important insights into the inheritance, pathogenesis, and treatment of this increasingly important disease.

Eligibility Criteria:
* INCLUSION CRITERIA:

Inclusion into this study was restricted to families containing at least three CMM cases with DNA available for genotyping, and CDKN2A and CDK4 involvement and had been excluded.

All families must be mutation negative for both CDKN2A and CDK4.

This study will also include families with at least one case of ocular and two cases of other cutaneous melanomas, or at least 2 ocular melanomas (except where they occur in parent and child).

EXCLUSION CRITERIA:

Any family showing evidence of haplotype sharing in the 9p21-p22 region, where CDKN2A is located, was also excluded.
A Trial to Evaluate Epothilone D in Patients With Advanced Solid Tumors

Epothilone D represents one of a class of cytotoxic macrolides capable of causing mitotic arrest by stabilizing tubulin polymerization. Since microtubules are essential for mitosis, motility, secretion and proliferation, the observed antitumor effects of epothilones have been attributed to their ability to initiate cell death by inhibiting such processes. Epothilone D has demonstrated in vitro cytotoxic activity in a panel of human cell lines, equipotent to that of paclitaxel. In vivo, Epothilone D has also shown significant antitumor activity in a range of xenograft models, including paclitaxel-resistant xenografts. Epothilone D is more potent than paclitaxel in cell lines that demonstrate multiple drug resistant activity overexpressing p-glycoprotein.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of histologically documented, advanced stage, primary or metastatic adult solid tumors that are refractory to standard therapy or for which no curative standard therapy exists. This includes but is not limited to cancers of the breast, ovary, head and neck, esophagus, lung, gastrointestinal tract, and sarcomas.
2. Evidence of radiographically measurable or evaluable disease.

Exclusion Criteria:

1. Pre-existing peripheral neuropathy of CTC Grade \> 2 due to any cause.
2. Documented hypersensitivity reaction (CTC Grade \> 2) to prior paclitaxel or other therapy containing Cremophor.
Sorafenib-induced Hand- Foot Skin Reaction Treatment

The purpose of this study is to evaluate treatments for a rash caused by sorafenib.

This study will compare compare the effectiveness of four creams (urea 40% cream, fluocinonide 0.05% cream, tazarotene 0.1% cream, and Udderly smooth® Udder Cream) in treating hand-foot skin reaction (HFSR), a rash caused by sorafenib.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving sorafenib as monotherapy or in combination if other agents are not known to cause HFSR.
* Subjects must be 18 years or older.
* Patients must provide written informed consent to participate in the study.
* Women of childbearing potential and men must be willing to use an effective method of contraception while participating in this study and for at least two weeks after completing treatment in the study.
* Women in this study need to have a negative urine pregnancy test before starting study medications.

Exclusion Criteria:

* Patients simultaneously taking another anti-cancer agent or combination of anti-cancer agents known to cause hand foot syndrome (pegylated doxorubicin, 5-fluorouracil, cytarabine).
* Patients with an active dermatological condition due to previous chemotherapy or biologic therapy affecting the hands.
* Patients with pre-existing dermatological condition affecting the hands or feet.
* Women who have a positive pregnancy test or are lactating.
Pre-emptive Treatments in Lupus Nephritis Patients With Serological Reactivation

The optimal management of asymptomatic serological reactivation (ASR) in lupus nephritis (LN) patients remained undefined. This project aims to investigate the impact of pre-emptive treatment on disease relapse in LN patients who experienced ASR.

LN patients who presented with ASR \[defined as 1) increase in anti-dsDNA \>100 IU/mL , with or without drop in serum complement; or 2) increase in anti-dsDNA to higher than the normal range and \>2 times of the preceding value, with or without drop in serum complement; and 3) Absence of renal or systemic manifestations of SLE) will be randomized to receive pre-emptive increase in immunosuppression or had their current immunosuppressive therapies unchanged.

Patients will be followed at 4-, 12-, 24-wk and then every 12 weeks up to 24 months to monitor for renal or extra-renal relapses. Bloods and urine will be collected for measurement of renal and serological parameters, and also B cell signatures.

Primary outcomes: Renal Flare (denoted as proteinuria \>1g/D; presence of urinary RBC \>30 hpf/RBC casts, or increase in SCr \>15% and positive anti-dsDNA)

Secondary outcomes:

* Safety \& tolerability of pre-emptive increase of immunosuppressive treatments
* Extra-renal flares
* Renal function at 24 months
* Changes in serological parameters

Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy-proven lupus nephritis who experienced an episode of Asymptomatic Serological Flare (ASF) as defined by:

  1. Increase in anti-dsDNA to \>100 IU/mL, with or without drop in serum complement levels OR
  2. Increase in anti-dsDNA to higher than the normal range and more than two times of the preceding value, with or without drop in serum complement levels

     AND
  3. Absence of renal or systemic manifestation of SLE.

Exclusion Criteria:

1. Patients who cannot provide informed consent.
2. Patients whom the clinicians opined to have excessively high risk of infection or malignancy.
3. Patients who are pregnant or lactating.
TuLip : Role of the Tumor Environment in Cancer-related Fat Loss

Cancer cachexia is defined as a weight loss of more than 5% over the last 6 months, a loss of body fat and muscle atrophy. It is found in 80% of patients with advanced cancer. In this context, white adipose tissue is a particularly interesting target since its depletion precedes the loss of muscle mass, and is sufficient to induce a decrease in the response to anti-cancer treatments and in the survival of patients.

This cachexia is associated with advanced tumors that present acidosis and metastasis. In this clinical study the investigators would like explore the acid environment effect on the human adipose tissue depletion and more specifically on adipocyte lipolysis.

The main objective of the "TuLip" clinical study is therefore to validate in human subcutaneous and visceral adipocytes that factors secreted by tumor cells cultivated in acid tumor environment stimulate the release of lipids from adipose tissue. Adipocytes retrieves from this study will also be used to validate identified potential lipolytic factors derived from these cells.

This study is a monocentric clinical study. Patients with BMI \< 30 kg/m2 will be recruited in the context of programmed abdominal surgery. In this context, subcutaneous and visceral adipose tissue pieces (1-2 cm3) will be collected to explore the lypolytic response of adipocytes ex-vivo to factors secreted by human cancer cell lines.

Eligibility Criteria:
Inclusion Criteria:

* Programmed surgeries in the abdominal area in the Department of Surgery and Transplantation at Cliniques Universitaires Saint-Luc under the supervision of Prof. Dr. Benoit Navez.
* Hospitalization in the context of surgery
* Caucasian
* Age between 18 and 60 years (included).
* Body mass index less than 30 and greater than or equal to 18.5
* Programmed Nissen fundoplication (to treat hiatal hernia and gastroesophageal reflux) or cholecystectomy (to treat vesicular lithiasis), eventration, or parietal surgery .
* Adults capable of expressing their wishes.
* Understanding French

Exclusion Criteria:

* Body mass index below 18.5 and above 30.
* Patients with cancer, infection, autoimmune or inflammatory disease, metabolic syndrome.
* Patients with beta-blockers, hypoglycemics, anti-diabetics, hypolipidemics.
* Adults unable to express their will.
* Not understanding French
* Patients participating in a clinical trial for a drug treatment.
Oral and Maxillofacial Pathology in Pediatric Patients

determination of the relative frequency of oral and maxillofacial pathological lesions among the Egyptian children and compare it with the global reports.

Oral and maxillofacial pathology in pediatric patients differs from the general population, as the nature of lesions in children changes with growth and development. Oral and maxillofacial pathology encompasses a wide spectrum of diseases, some of which (i.e. aphthous ulceration, geographic tongue, and herpes labialis) can be diagnosed on clinical presentation alone. For other soft tissue diseases and for pathology with bony components, incisional or excisional biopsy is mandatory to establish a definitive diagnosis .

Several studies illustrated that oral and maxillofacial pathology in pediatric populations varies based on the geographic location of the population as racial and environmental specificities and the lifestyle of each population may influence the prevalence of these diseases .

Although there is increasing literature regarding the incidence and prevalence of pediatric oral and maxillofacial pathology, there is no study investigating the range and frequency in Egyptian children.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy records for children aged from 0 to 18 years

Exclusion Criteria:

* Biopsy records for patients older than 18
* Incomplete record regarding age, gender, location
Changes in Sleep Patterns and Stress in Infants Entering Child Care

When babies start day care, they experience many changes, some of which may affect their risk for sudden infant death syndrome (SIDS). The investigators want to find out if stress or change in the baby's sleep patterns can be a reason for this increased risk for SIDS.

The overall aim of this study is to describe sleep patterns in infants as they transition from home to child care, including 24-hour sleep duration, changes in the timing of daytime naps, and changes in nocturnal sleep periods; to describe potential sleep disrupters, such as temperature, light and noise, in home and child care settings that may impact sleep quality and sleep patterns; to describe markers of parent and infant stress levels during the transition to child care; to describe markers of infant circadian rhythm during the transition to child care.

Eligibility Criteria:
Inclusion Criteria:

* Infants who are less than 3 months of age from English-speaking families where one or both parents live in the household will be eligible to participate. If the infant will be entering child care, the infant must be entering a licensed child care center, and child care entry must be between 60 and 120 days of age.

Exclusion Criteria:

* S/he was born prematurely, with a gestational age less than 37 weeks at birth, or had a birth weight \<2500 grams (5-1/2 lbs)
* S/he has any medical problems that require ongoing care by a subspecialty physician
tDCS Applied to the OFC: Effects on Decision-Making and Impulse Control

In this study the investigators aim to assess whether transcranial direct current stimulation (tDCS; a safe and non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (OFC) is able to modulate decision-making and impulse control in healthy participants.

In this single-blind, three-arm and sham-controlled study, we will assess whether transcranial direct current stimulation (tDCS; a safe and non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (OFC) is able to modulate decision-making and impulse control in healthy volunteers. We hypothesize that tDCS applied to the OFC, in comparison to sham tDCS, will significantly enhance decision-making and impulse control. For this study we will enroll 45 healthy individuals aged 18-60 years. These individuals will be assessed with a battery of computerized tasks as well as clinician-administered and self-reported questionnaires on depression and anxiety. Assessments will be carried out before and after a single 30-minute tDCS session.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 to 60 years

Exclusion Criteria:

* Presence any psychiatric and/or neurological illness
* Psychoactive substance abuse/dependence in the past 6 months
* Current use of medication(s) that might influence cognition and/or affective status
* Presence of an uncontrolled medical disease (e.g., cardiovascular, renal)
* Pregnancy and/or lactation
* Specific contraindication for tDCS (e.g., metallic head implant).
Association Between Sleep and Psychomotor Development in Early Childhood

Sleep is a neurophysiological active process essential for healthy physical and cognitive development. In Portugal, there is no recent and objective data on how children sleep.

Given the importance of sleep in child health and development as well as the health gains achieved by establishing healthy sleep patterns since childhood, it seems extremely relevant to assess the various sleep parameters of Portuguese children and correlate them with their psychomotor and anthropometric development indicators. The results of this research work may support the implementation of sleep health education measures among parents, educators and policy makers, thus contributing to support the implementation of practices that promote sleep quality, napping until later in life as well as to promote the health of future adults.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 2 and 6 months year until the first assessment;
* Gestational age at birth 37 weeks or more;
* Delivery without serious complications for the child;
* Absence of developmental pathologies or pathologies that interfere with psychic and motor development;

Exclusion Criteria:

* Non-preterm birth but with severe growth restriction;
* Diagnosis of psychomotor development pathology;
* Diagnosis of pathology that interferes with psychomotor development;
* Taking daily medication, except vitamin supplements.