cyrilzakka/clinical-trials huggingface dataset:
Light Filters in Intraocular Lenses (IOLs) and Its Influence on Colour and Contrast Vision.

Visible-light-filtering IOLs are implanted increasingly often in cataract surgery. Several studies examined the effect of light-filters on contrast and colour vision. However, the study outcomes were varying. The present study investigated the effect of two light-filtering IOL on colour perception and contrast acuity using highly sensitive measurement methods.

Prospective, randomized, double-masked study with intraindividual comparison. Implantation of a Polylens Y30 IOL in one eye and an Orange Series Model PC 440 Y in the contralateral eye.

Eligibility Criteria:
Inclusion Criteria:

* bilateral age-related cataract
* age 55 to 80 years
* expected postoperative visual acuity of at least 1.0

Exclusion Criteria:

* amblyopia
* corneal scars
* diabetes
* arterial hypertonia
* pseudoexfoliation-syndrome
* earlier ocular surgeries or laser treatments
* intraocular tumors
* color abnormalities
* expected postoperative visual acuity lower 1.0
ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer

The primary objective of this study is to compare the effect of panitumumab versus cetuximab on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among patients with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum, metastatic disease
* Wild-type KRAS tumor status
* Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2
* Must have failed a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease
* Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of colorectal cancer (CRC)
* Adequate hematologic, renal, hepatic and metabolic function

Exclusion Criteria:

* Symptomatic brain metastases requiring treatment
* Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
* Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy), or investigational agent or therapy ≤ 30 days before randomization.
* Clinically significant cardiovascular disease
* Active infection requiring systemic treatment or any uncontrolled infection ≤14 days prior to randomization
Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care

A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, on dexmedetomidine administered for analgesia and sedation to postsurgical and other newborn sick infants needing the drug for clinical reasons during neonatal intensive care. Phase III - therapeutic confirmatory study.

The patients will be treated according to clinical guidelines and judgement as decided by the responsible clinical doctor.

The dosing and administration of dexmedetomidine will be implemented according to an algorithm based on pain scoring results.

Apart from extra blood sampling and extended bedside monitoring for amplitude-integrated EEG (aEEG), Near InfraRed Spectroscopy (NIRS), and Galvanic Skin Response (GSR) the care is according to clinical routine.

In total 100 infants will be included.

Eligibility Criteria:
Inclusion Criteria:

* Newborn infants: - born 34+0 gw with a need for dexmedetomidine for analgesic and/or sedative treatment after postnatal surgical correction of congenital malformations and who will be cared for in the PICU (postoperative intensive care unit) and in a some few cases in the NICU (neonatal intensive care unit), or
* with a corresponding age of 37 gw, who are in need for dexmedetomidine according to clinical judgment and cared for in the NICU.
* Existing arterial or venous cannulas/catheters for repeated nontraumatic blood sampling
* Informed and written parental consent obtained before study start.

Exclusion Criteria:

* Infant older than age corresponding to gw 46+0
* Previous treatment with the dexmedetomidine within 72 hours (only for postoperative infants).
* Congenital cardiac malformations requiring surgery on extracorporeal circulation and treatment with hypothermia.
* Ongoing renal replacement treatment
* Any serious medical condition or ethical issues that could, in the investigators opinion, interfere with the study procedures.
Face Mask Habits and COVID-19 Among University Students in Cairo

The World Health Organization officially declared the pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a public health emergency. The virus can remain viable in aerosol form for approximately three hours before being inhaled. Face masks have become an essential component of the ensuing fight against coronavirus disease 2019 (COVID-19).Therefore, a multicenter cross-sectional study was conducted during the pandemic to investigate university students' face mask habits in Greater Cairo, Egypt.

Study design and participants:

This cross-sectional study is going to be carried out at a time when wearing masks in public places, transportation and universities is mandatory. The questionnaire which is designed to collect the data is targeted to college students who are attending universities in Greater Cairo, Egypt. The questionnaire will be left open for a duration of 10 days to collect the required responses.

Data collection:

The data is going to be collected from a questionnaire that we created using Google forms, consisting of 33 questions. It was written in English then translated to Arabic to be understandable to as many people as possible. The survey will be sent using a snowball sampling method to the participants through various social media applications such as: Facebook, Twitter, WhatsApp, Snapchat, and Telegram. A pilot study of the questionnaire will be pre-tested on a small sample of participants to confirm the practicability and clarity of questions to check content and face validity. In addition, the reliability will be determined by calculating Cronbach alpha. Observations of the pilot study will not be included in the final analysis.

Statistical analysis:

Dichotomous data will be expressed by numbers and frequency. Continuous variables will be expressed by means and standard deviation if within the normal distribution. Range and interquartile range will be used to express continuous data within the non-normal distribution. Data will be exported to an excel sheet from Google forms and will be analyzed by an expert using IBM SPSS Statistics program.

Eligibility Criteria:
Inclusion Criteria:

* The target population was limited to individuals aged 18 to 28 years, as those individuals can provide consent and represent the undergraduate and graduate sections.
* The participants were asked about the location of their campuses to ensure that their responses were limited only to the universities in Greater Cairo.

Exclusion Criteria:

* Individuals below the age of 18 years old are not old enough to provide consent, and individuals above the age of 28 are considered postgraduate.
* To make sure that responses arrived only from Greater Cairo universities, a question asking about the location of university campus is added to exclude responses from outside the specified area which only includes the cities of Cairo, Giza, Helwan (15th of May), Shubra El Kheima, 6th of October, Sheikh Zayed City, Badr, New Cairo (including Rehab and Fifth Settlement), New Heliopolis, Obour, Shorouk, Madinaty21.
Early and Systematic Screening in Chronic Neuropathy

TTR-FAP is a rare disabling inherited disorder that predominantly affects the peripheral nervous system and the heart. Due to an important phenotypic and genetic heterogeneity, the diagnosis is often delayed, preventing therefore early onset treatment. Our project is to evaluate the prevalence of TTR-FAP in a series of 130 patients with from chronic neuropathy of undetermined aetiology through a systematic screening of TTR mutations.

Transthyretin familial amyloid polyneuropathy (TTR-FAP) is an autosomal dominant disorder, highly disabling and life-threatening, resulting of transthyretin (TTR) gene mutation. Clinically, TTR FAP is characterized by progressive sensorimotor and dysautonomic neuropathy, usually fatal within a few years. The disease prevalence is highly variable, with a large genotypic and phenotypic heterogeneity. Early and accurate diagnosis remains essential to propose early treatment. New pharmacotherapies have been developed, such as Tafamidis®, and many patients can avoid liver transplant formerly considered as the only therapeutic option. The prevalence of TTR-FAP disease has been previously estimated in series of patients with severe and progressive neuropathy, frequently leading to a delayed diagnosis. TTR-FAP is also easily suspected when neuropathy is associated with cardiac symptoms or dysautonomia.

Currently, genetic testing of TTR-FAP is targeted and is only prescribed to patients in whom the first-line assessment recommended by the High Authority for Health (HAS) did not identify a cause, and on the basis of a worsening of symptoms. An early diagnosis in those cases would allow earlier treatment and monitoring. No data are available about the prevalence of TTR-FAP in populations of patients with from chronic neuropathy of unknown aetiology, through a systematic screening of TTR mutations.

The diagnosis of TTR-FAP will be performed using standard procedures following international recommendations, requiring genetic analysis of the TTR gene.

The patients with a diagnosis of TTR-FAP confirmed during this study will be seen for an additional visit in the Investigating Centre and proposed suitable follow up, treatment and care.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes presenting chronically (\> 3 months):

  * neuropathy confirmed by an electroneuromyography
  * without obvious etiology (diabetes, alcohol consumption, renal insufficiency, neurotoxic substances intake, family history of diagnosed hereditary neuropathy)
  * without anomaly of the following biological examinations: fasting blood glucose, blood count, gamma-glutamyl transferases, average cell volume, transaminases, serum creatinine clearance, C-reactive protein, TSH
* Aged 18 to 90 years Patients giving their free and informed consent to participate, after research information

Exclusion Criteria:

* People placed under the protection of justice.
* Patients who are not affiliated or who are not beneficiaries of a social security scheme
* Patients with chronic neuropathy related to a known etiology
Project Legacy Impact Evaluation Study

This study will design and rigorously evaluate the efficacy of Project Legacy, a five week positive youth development intervention to decrease sexual risk for unintended pregnancies and STIs among youth experiencing homelessness or at risk of homelessness aged 14-19. This randomized control trial will compare Project Legacy to a usual services control.

The study uses a multi-site randomized group trial (RGT) cohort design to evaluate the Project Legacy intervention curriculum for reducing sexual risk behaviors among homeless youth age 14-19. CHLA project staff will work with 6 homeless youth serving sites in Southern California (Los Angeles, San Diego) to recruit 600 youth. Randomization to the intervention or control condition will occur at the group level and will be stratified by site. Field staff will survey all eligible homeless youth who provide consent to participate in the study at baseline (before randomization and implementation) and at 3 and 9 months post intervention (5-5.5 and 11-11.5 months post-baseline). The program group will receive an additional intervention-based survey immediately upon completion of the program.

Youth in the control condition will receive the normal standard of care provided at the recruitment sites. Services available as standard of care at the recruitment sites include: medical care; mental health services; substance abuse services; educational, career, and vocational services. Intervention participants will not be excluded from receiving these services as well. Surveys will capture mental and physical health care service utilization and services to reduce substance use across both groups. The study team will monitor HIV and pregnancy prevention programming and other similar goal-planning/decision-making interventions offered to homeless youth in the study areas during the program implementation and follow-up period via interviews with site staff. The study team will include selected program exposure items on the follow up surveys to assess youth's self-reported exposure to similar goal-planning/decision-making and sexual health (pregnancy prevention and STI/HIV) education.

Eligibility Criteria:
Inclusion Criteria:

* Served or identified on outreach by one of our partner homeless youth serving agencies in Los Angeles or San Diego
* 14-19 years of age
* English-language speaker (able to complete consent and survey in English)
* not currently pregnant
* no immediate travel plans (are planning on being in the area for the length of the intervention - 8 weeks).

Exclusion Criteria:

* Outside of age range
* Currently pregnant
* Not planning to be in the area for the length of the intervention
* Previously enrolled in the study
Phase II Cont. IV of ON 01910.Na in MDS w/ Trisomy 8/Intermed-1, 2/High Risk

This study is under Molecular and Cellular Characterization of Myelodysplastic Syndromes (MDS) (eProtocol 15369). The purpose of this proposed study is to analyze existing samples taken from participants participating in a clinical trial evaluating the efficacy and safety of investigational agent ON 01910.Na (eProtocol 16214). This study will use existing blood and marrow samples to determine the rate and duration of objective hematologic and marrow responses, and duration of progression-free survival in ON01910.Na-treated MDS patients.

This study will use existing blood and marrow samples to determine the rate and duration of objective hematologic and marrow responses, and duration of progression-free survival in ON01910.Na-treated MDS patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IPSS Intermediate or High risk MDS by bone marrow biopsy, marrow cytogenetics and blood counts, using FAB morphologic criteria
* Eastern Cooperative Oncology (ECOG) performance status of 0-2
* Adequate Liver Function, as evidenced by a serum bilirubin less or equal to 1.5 times the laboratory normal range (except for patients with a confirmed diagnosis of Gilberts Disease) or an ALT and AST 3 times the laboratory normal range
* A serum creatinine concentration less or equal to 2mg/dl
* Subjects must be equal or greater than 18 years of age at the time of obtaining informed consent
* Written informed consent

Exclusion Criteria:

* Prior history of leukemia or aplastic anemia
* Prior history of bone marrow transplantation
* Platelet count \<100,000/mm\^3

  \*Prior malignancy (other than in situ cervical cancer, controlled prostate cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for greater or equal to 3 years before randomization
* Active or uncontrolled infections
* Unstable angina, congestive heart failure \[NYHA\>classII\], uncontrolled hypertension \[diastolic \>100mmHg\], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction
* Less than 4 weeks since receipt of any investigational product or device
* Pregnant or breast feeding
* Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
* Previously enrolled in this study
* Will not be available for follow-up assessments
* Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Multidisciplinary Collaboration Care in Pulmonary Arterial Hypertension (PAH)

Pulmonary arterial hypertension (PAH) is a severe pulmonary vascular affection, which treatment has evolved in the last few years, improving quality of life. However, adherence to treatment has not been assessed in such patients. The investigators developed a collaborative care model involving clinical pharmacists in PAH. The objective of this work is to evaluate the impact of such model of care on medication errors and adverse events, quality of life and clinical criteria.

This randomized multicentre controlled study will include approximately 100 PAH patients (NYHA II to IV). After inclusion, patients will receive either collaborative care including consultations with specialized pharmacist and nurse, or classic follow-up. Each patient will be followed during 18 months from the date of inclusion.

The investigators hope to show the positive impact of a collaborative care model in PAH. More specifically, the investigators aim to show the interest of long-term patient education to improve patient safety related to drugs, but also their quality of life, and have preliminary data about usual clinical criteria.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18;
* Pulmonary arterial hypertension (NYHA II to IV);
* Any specific PAH treatment or oral anticoagulant.

Exclusion Criteria:

* Patients under 18 or protected by law;
* Patients who do not speak/understand French;
* Pregnancy;
* Patients enrolled in other clinical trials.
Accuracy and Precision of Train-of-Four Ratios Obtained With Acceleromyography and Electromyography in Restricted-Movement Settings in the Absence of Neuromuscular Blocking Drugs

The purpose of this research is to compare the performance of acceleromyograph and electromyograph-based quantitative neuromuscular monitors when the arms are tucked for surgical positioning.


Eligibility Criteria:
Inclusion Criteria:

* Patients willing to participate and provide an informed consent.
* Patients undergoing elective surgical procedures that require general anesthesia without use of NMBA agents administered intraoperatively, and tucked arms.
* Anticipated surgery duration \< 120 minutes.

Exclusion Criteria:

* Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
* Patients with systemic neuromuscular diseases such as myasthenia gravis.
* Patients having surgery that would involve prepping the arm into the sterile field.
2015-Metabolomics&Microbiome-infertility

The study aims to carry out a translational analysis of the microbiome and metabolomics in patients suffering from non-obstructive azoospermia, with the aim of investigating prognostic factors predictive of the possible finding of spermatozoa following testicular pulp extraction and differences in blood and seminal level with the fertile population to identify etiopathogenic pathways of this condition.

The study aims to carry out a translational analysis of the microbiome and metabolomics in patients suffering from non-obstructive azoospermia, with the aim of investigating prognostic factors predictive of the possible finding of spermatozoa following testicular pulp extraction and differences in blood and seminal level with the fertile population to identify etiopathogenic pathways of this condition.

Furthermore, the study aims to assess if the blood and seminal alterations of infertile patients have similarities with the same fluids of elderly patients, validating from a metabolomic and microbiomic point of view the hypothesis of premature aging of infertile patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of idiopathic non-obstructive azoospermia
* fertile men (pregnancy within 12 months from the start of the couple's search)
* men known to have been fertile aged between 65 and 75 (pregnancy within 12 months of the couple starting searching)

Exclusion Criteria:

* diagnosis of varicocele
* endocrine alterations
* chromosomal alterations
* known genetic alterations
Registry Study on Primary Ciliary Dyskinesia in Chinese Children

This study is a multicenter, prospective cohort study of patients diagnosed with primary ciliary dyskinesia, the clinical information of recruited patients, including clinical manifestations, lung function, chest imaging, quality of life and other indicators, will be followed for 10 years.

All new cases of primary ciliary dyskinesia which was confirmed or diagnosed at each center from the beginning of the study are made the investigation of the clinical manifestations and specific tests by the standard diagnostic process.Then all the patients' following clinical data will be followed for 10 years (once per six month): clinical manifestations, lung function, chest imaging (once per year), quality of life and other indicators.

Eligibility Criteria:
Inclusion Criteria: A included patient must be coincident with all the following items:

* Age 0\~18 years old
* Any organ system symptoms consistent with PCD and being conform to the clinical diagnostic standard of Katergener syndrome or being coincident with at least two following specific tests:
* Abnormal ciliary beat frequency or movement by the high speed photography microscope
* Abnormal ciliary structure through the electronic microscopy
* The nasal NO decreased significantly
* The target gene mutation found
* The clinical diagnostic criteria of the Katergener syndrome: ① bronchial expansion; ② sinusitis or nasal polyps; ③ transposition of viscera and (or) dextrocardia.
* If all the typical clinical manifestations but only 1 specific test with positive results, can also be included in the registration of suspected PCD cases
* Consent to provide the related clinical specimen to the certain hospital
* The guardians of the patients fully understand the purpose of the study, volunteer their children to participate in this study, and sign informed consent.

Exclusion Criteria: Subject will be excluded if she or he has one of the following:

* It is unable to provide complete medical records or the current condition can not accept the diagnosis process
* She or he cannot agree to participate in the study.
Practicing Restorative Yoga or Stretching for the Metabolic Syndrome

The purpose of this study is to determine whether Restorative yoga versus stretching exercises will reduce risk factors for metabolic syndrome in adults with metabolic syndrome.

Metabolic abnormalities, including visceral adiposity, insulin resistance, hyperglycemia, hypertension and dyslipidemia, occur together and are associated with excessive caloric intake and inadequate physical activity. Persons with the metabolic syndrome are at high risk of developing type 2 diabetes and cardiovascular disease. Lifestyle and behavioral interventions reduce these risks, but many individuals with increased metabolic risk find it difficult to achieve and maintain weight loss and increased physical activity.

We are conducting a rigorous randomized controlled trial at two clinical sites to determine if Restorative yoga compared to stretching exercises improves the metabolic syndrome among overweight and underactive individuals who meet criteria for the metabolic syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Anyone between the ages of 21 and 65 who may meet the criteria for the metabolic syndrome can sign-up for the screening process. A more thorough screening process will be conducted to determine whether or not you are eligible to enroll in the study
* Underactive
* Overweight

Exclusion Criteria:

* Pregnancy or breast feeding
* Chronic illnesses: cancer, kidney disease, cirrhosis of the liver, rheumatologic diseases, or chronic infections
* Not ambulatory or neurological condition causing impaired mobility
* Weight over 400 pounds
* History of or plans for bariatric surgery
* Inability to speak and read English