cyrilzakka/clinical-trials huggingface dataset:
Diabetic Retinopathy and Visual Function Study

The purpose of this study is to evaluate possible mechanisms of central visual loss in patients with diabetes mellitus. The visual loss of interest to be investigated is that associated with macular edema (prior to and following laser photocoagulation treatment) and that associated with panretinal photocoagulation. The evaluation will be performed with psychophysical testing, i.e., static perimetry and contrast sensitivity function. Of particular interest, the mechanisms of visual loss associated with macular edema (prior to and following laser photocoagulation) will be further investigated. Photoreceptor-mediated visual loss will be assessed by measurements of the Stiles-Crawford effect. Visual loss mediated by post-receptoral retinal changes will be assessed by measuring the Westheimer spatial desensitization/sensitization effect.

The purpose of this study is to evaluate possible mechanisms of central visual loss in patients with diabetes mellitus. The visual loss of interest to be investigated is that associated with macular edema (prior to and following laser photocoagulation treatment) and that associated with panretinal photocoagulation. The evaluation will be performed with psychophysical testing, i.e., static perimetry and contrast sensitivity function. Of particular interest, the mechanisms of visual loss associated with macular edema (prior to and following laser photocoagulation) will be further investigated. Photoreceptor-mediated visual loss will be assessed by measurements of the Stiles-Crawford effect. Visual loss mediated by post-receptoral retinal changes will be assessed by measuring the Westheimer spatial desensitization/sensitization effect.

Eligibility Criteria:
Patients with diabetic retinopathy that has not been previously treated are eligible for the study.

Patients who have had laser photocoagulation (either focal or scatter) are not eligible.
Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome

To provide treatment opportunity to children and adolescent patients with hematologic malignancies by supplying the delayed marketed product and also to observe the efficacy and safety of rasburicase used in the treatment of hyperuricemia


Eligibility Criteria:
Inclusion Criteria:

* Acute hyperuricemia patients before / during chemotherapy for hematologic malignancies ( uric acid greater than 7.5 mg/dL )

  * With a minimum life expectancy of 3 months
  * Having previously signed a written informed consent.

Exclusion Criteria:

* Hypersensitivity to uricase or any of the excipients.
* Known history of G6PD deficiency.
* Previous treatment with Rasburicase or Uricozyme.
* Treatment with any investigational drug within 30 days before planned first Rasburicase administration.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity for CABG Surgery

After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing CABG surgery are enrolled in this prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES (n=15).

All recruited patients will be given patient identification number (PIN) for the present study of 01-30 according to their order of interview and recruitment. Investigators will prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30 (Envelop number).

According to the color of the card, attending anesthesiologists will give crystalloid for yellow card or HES for green cards, respectively, to maintain stroke volume variation \< 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.

Patient data and statistical analyses:

Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be determined from the patients' medical record after patient's discharge.

All statistical analyses will be performed after the 30th patient's discharge and data acquisition


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing CABG Surgery
* Patients provided a written informed consent.
* Patients with preoperative serum hemoglobin concentration \>13 g/dL (male) and \>12 g/dL (female)
* Patients with PaO2/FiO2 ratio \>150

Exclusion Criteria:

* Patients with history of anemia, dyspnea, active infection.
* Patients with endocrine disease
Bariatric Surgery and Pharmacokinetics of Lisdexamphetamine

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on lisdexamphetamine are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Post-occlusive Reactive Hyperemia and Basal-cell Carcinoma

The investigators aim to test the hypothesis and to proof thank to laser speckle contrast imaging that post-occlusive reactive hyperemia (PORH) can be induced through a tumor, in this case, through a basal cell carcinoma, which will be used as a model of study of tumor vasculature.

This new concept of tumor perfusion artificial increase could be used in the future for malignant tumors treatment, in order to increase tumor mean oxygen partial pressure (thus decreasing tumor hypoxia, hallmark of malignant tumors) during cancerology therapies, like radiotherapy and/or chemotherapy, and increase their efficacy.

This clinical trial will use skin flap model for trunk and facial basal cell carcinoma (BCC), with respect the classical excision margin of BCC surgery (3-4mm): after local anesthesia, a little random pattern skin flap will be raised around the BCC, then the cutaneous pedicle will be clamped with surgical clamp for 3 minutes and clamp released.

In case of limb BCC, limb tourniquet will be used, and occluded during 3 minutes upstream to the BCC location.

During all steps of experimentation, laser speckle imaging will be used to measure continuously the peri-tumoral and tumoral perfusion, start from tumor excision, up to10 minutes after tumor pedicle clamp or tourniquet release.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Histologically proved cutaneous BCC
* Patient being informed and having signed the consent to participate to the study

Exclusion Criteria:

* Counter-indication to surgery
* Patient being unable to attend future follow-up visits
* Patient with severe cognitive impairment
* Patient not affiliated to a social security regimen
* Patient with limb BCC and history of peripheral vascular artery surgery like bypass and/or vascular prothesis on the same limb (tourniquet counter-indication)
* Local bone invasion of BCC detected with imagery
Web-based Programs to Improve and Strengthen Romantic Relationships

This study investigates the effectiveness of www.OurRelationship.com, which provides self-help, web-based programs to improve romantic relationships and related outcomes. Couples will be randomly assigned to complete the OurRelationship program, the PREP Online program, or a wait-list control group and followed for six months.

Nationwide, lower-income (LI) couples (those with household incomes \<200% of the federal poverty level) - many of whom are also African American, Hispanic/Latino, or rural couples - face numerous challenges to their relationships. Chief amongst those challenges are: 1) higher risk of relationship problems and 2) lack of access to effective relationship services to prevent or intervene with relationship distress. Compared to higher-income couples, LI married and cohabiting couples are significantly more likely to divorce or separate and report lower relationship quality. Unfortunately, LI couples are least likely to receive interventions to prevent or solve relationship problems. To overcome these barriers, we propose to test the effectiveness of two effective web-based curricula - OurRelationship and PREP Online.

A total of 750 LI couples will be recruited nationwide and randomly assigned to the PREP Online program, the OurRelationship program, or a wait-list control group and followed for six months. Once randomly assigned to group, couples will be assessed at one month, two months, four months, and six months following randomization. After couples randomized to the wait-list control group finish their waiting period, they will be able to select the program they would like to complete (OurRelationship or ePREP) but will not complete research assessments during or following their participation in the program. Interested couples can find out more information (and sign up for the study) at www.OurRelationship.com

Eligibility Criteria:
Inclusion Criteria:

1. They are married, engaged, or have been cohabiting with their partner for at least six months
2. They are both located in the United States
3. Both partners are willing to participate in the study
4. Both partners are between the ages of 18 and 64 (inclusive)
5. Both partners are fluent readers of the English language (as the program materials are currently only available in English).
6. Couples report a household income at or below 200% of the Federal Poverty Level.

Exclusion Criteria:

1. Severe domestic violence
2. Inadequate internet connection
3. Previous participation in OR, PREP-O, in-person PREP, or its variants
4. Current participation in other relationship programs
5. Current participation in an evaluation funded by Administration for Children and Families
Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components

The purpose of this study is to determine if there are any clinical or radiographic differences in cemented total knee arthroplasty with an oxidized zirconium and a cobalt-chromium femoral knee component.

Although it has been claimed that total knee arthroplasties with an oxidized zirconium femoral knee component had beneficial wear properties in vitro, there are conflicting clinical results. The purpose of the present study was to compare the clinical, subjective, and radiographic results as well as the weight, size and shape of polyethylene wear particles in the patients with an oxidized zirconium and a cobalt-chromium femoral knee component.

Eligibility Criteria:
Inclusion Criteria:

* End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion Criteria:

* Inflammatory disease
* patient with other Lower extremity disease which may affect functional outcome
* Neurologic disease effecting patients lower extremity
* Revision surgery
* Patient not medically cleared for bilateral surgery
Cardiovascular Comorbidities and Bronchiectasis

Bronchiectasis have multiple etiologies but share a similar bronchial injury associated with inflammation, which leads to a progressive lung deterioration. This disease is responsible for a frequent access to care with an exacerbation rate of 1.8 per year with a high risk of hospitalization. Natural history is marked by recurrent infectious diseases which are the main prognosis factor. This disease is associated with an inflammation rate in the lung as well as in the blood. Up to now, no study has been described comorbidities associated with this chronic disease but our hypothesis is that cardiovascular diseases will be more frequent in these patients. In fact systemic inflammation driven by bronchial infections may increase frequency of cardiovascular diseases.

The investigators decide to conduct a monocentric observational study to define the prevalence and characterization of cardiovascular comorbidities as well as markers of accelerated aging. We would like to test the hypothesis that cardiovascular comorbidities are frequent in bronchiectasis and may be associated with markers of inflammation and aging.

Phenotype of the lung disease will include: spirometry, plethysmography, DLCO measurement according to the ATS/ERS guideline. 6M walking test and echocardiography will be also performed.

Frequency of comorbidities will be calculated with data from questionnaire as well as standardized explorations.

Aging related manifestations will be measured: arterial stiffness using aortic pulse wave velocity, bone mineral density using dual energy X-ray absorptiometry. Appendicular skeletal muscle mass and grip test were also performed.

Blood test were also performed to measure inflammatory markers, cytokines and length of telomere in circulating leucocytes.

Phenotype of the lung disease will include: spirometry, plethysmography, DLCO measurement according to the ATS/ERS guideline. 6M walking test and echocardiography will be also performed.

Frequency of comorbidities will be calculated with data from questionnaire as well as standardized explorations.

Aging related manifestations will be measured: arterial stiffness using aortic pulse wave velocity, bone mineral density using dual energy X-ray absorptiometry. Appendicular skeletal muscle mass and grip test were also performed.

Blood test were also performed to measure inflammatory markers, cytokines and length of telomere in circulating leucocytes.

Eligibility Criteria:
Inclusion Criteria:

* 40 ≤ Age ≤ 80 years
* Formal diagnosis of bronchiectasis by imaging (CT-scan)
* For women, pregnancy test negative
* Affiliation to a social Security
* written inform consent

Exclusion Criteria:

* Patients with a diagnosis of Cystic Fibrosis
* Contre indication of one of the tests
* Exacerbation with hospitalization or outpatient clinic visit in the last 4 weeks.
* Unability to obtain an informed consent
* Pregnancy or Breast feeding
Effect of Job Crafting Intervention Program on Harmonious Work Passion and Career Commitment

effect of job crafting intervention program on nurses' job crafting behaviors, harmonious work passion and career commitment.

the study aims to evulate the effectiveness ofjob crafting intervention program on nurses' job crafting behaviors, harmonious work passion and career commitment.

Hypotheses:

H1: Nurses participating in the job crafting intervention will report, post intervention, high level of job crafting behaviors compared with those nurse nurses in control group H2: Nurses participating in the job crafting intervention will report, post intervention, high level of harmonious work passion compared with those nurse nurses in control group H3: Nurses participating in the job crafting intervention will report, post intervention, high level of career commitment compared with those nurse nurses in control group this is RCT study among nurses work in EL-Nasar hospital, port said, Egypt

Eligibility Criteria:
Inclusion Criteria:

* licensed nurses who worked in direct contact with patients in their services
* had at least six month of experience in the nursing profession,
* agreed to participate in the study

Exclusion Criteria:

* participating in any intervention program within the last 12 months
PET Study of Acetylcholine Esterase Activity in Alzheimer's Disease

The aim of this study is to understand regional variations in acetylcholine esterase activity in Alzheimer's disease. In this study the aim is to identify by PET the physiological values of the regional activity of acetylcholine esterase using the 11C PM4 tracer and to study by PET and 11C PM4 the brain activity of acetylcholine esterase in a group of patients with Alzheimer's disease, enrolled according to the inclusion and exclusion criteria. The PET data will be correlated with the clinical, neuropsychological and morphological data acquired by MRI and with the clinical-cognitive outcome.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with Alzheimer's disease;
* patients must have undergone an instrumental morphological examination to exclude other neurological pathologies.

Exclusion Criteria:

* positive history of major head trauma;
* clinically active somatic diseases.
The Clinical and Socio-demographic Characteristics of Young People Aged 12 to 25 Consulting on Ambulatory Structures in the Seine Saint-Denis

A prospective study of the clinical and socio-demographic characteristics of young people aged 12 to 25 consulting on ambulatory structures in the Seine Saint-Denis.

This research project, intersectoral and inter-institutional, built in a territorial logic, is therefore intended to study longitudinally over a year the population of young consultants in the different units participating in it, to highlight their common profiles and differences.

This will be the first clinical research work concerning adolescents and young adults using mental health services in the Seine Saint Denis Ouest.

The main objective of the study will be to quantify the rate of subjects seeking help in our units meeting the criteria of subject with an ultra-high risk of psychosis (UHR).

Secondary objectives:

* Observe the transition rate of these high risk patients at one year.
* Study the socio-demographic and general psychopathology profiles of 12 - 25 year olds using the services of CMP, CASADO, mobile team and RCL.
* Monitor the development of school and professional integration, the overall functioning and self-esteem of subjects at six months and one year.

Eligibility Criteria:
Inclusion Criteria:

* Boys and girls consulting in the structures involved in the study of the Seine-Saint-Denis department.
* Aged 12 to 25.
* Patients with an ultra high risk of psychosis.
* Affiliated with social security or with State Medical Aid (AME).

Exclusion Criteria:

* Subject with known neurological pathology
* Subject with insufficient knowledge of French
The Correlation Between Pupil Size and Retinal Nerve Fibers Changes in Pseudoexfoliation Syndrome.

To study the possible correlation between pupillary diameter before and after dilation with intraocular pressure, lens stability and glaucomatous damage (represented by optic disc changes using cup to disc ratio and OCT changes in retinal nerve fiber layer and ganglion cell complex) in each eye of the same patient with PEX.

Pseudoexfoliation (PEX) is a widespread condition that is often considered as a generalized disorder involving ocular manifestations as well as other body systems. It is characterized by the deposition of a distinctive fibrillar material in the anterior segment of the eye. The effect of pseudoexfoliation on various ocular tissues has been well studied in the past decades, especially both lens and optic disc damage. Key signs in pseudoexfoliative eyes are attributed to the effect of pseudoexfoliation material on pupillary muscles, lens and optic disc. Pseudoexfoliation appears to be a common disorder in older individuals in Upper Egypt with a prevalence of 4.14%. PXF was bilateral in 82.2% of cases. It was significantly associated with cataract, glaucoma and hearing loss. Of the PXF patients, 65% had cataract, 30.3% had glaucoma and 8.1% had hearing loss. Cardiovascular and cerebrovascular diseases such as angina, aortic aneurysm, and dementia have been linked to PXS. Subjects with PXF had a two- to three-fold increased risk for glaucoma according to the Blue Mountains Eye Study. The classic sign of PXF is the visualization of white pseudoexfoliative material on the pupil margin and on the anterior lens surface. It is believed that pupil size is another indicator for the severity of the disease. In this study we correlate the pupil size with other common ocular signs in PEX such as; lens subluxation and glaucomatous damage.

Eligibility Criteria:
Inclusion Criteria:

* All patients with pseudoexfoliation syndrome.

Exclusion Criteria:

* previous ocular surgery or ocular trauma affecting the pupil. Any systemic or neurologic disease affecting the pupil
Printed Aligners for Nasoalveolar Molding Treatment

study will provide nasoalveolar molding (NAM) treatment, special care for infants born with cleft lip and palate. This novel appliance will help to provide the care in accurate and easy form by help of both digital work flow and new material which provide a unique properties.

A sample of 10 infants born with unilateral cleft lip and palate (UCLP) ranging in age from seven to 45 days who meet the inclusion criteria will be recruited and subjected to the following study procedures: maxillary impression, extraoral scanning for nasolabial area and facial photos.

For digital workflow; the following steps will be done:

1. Digital model preparation.
2. Model segmentation and modification.
3. Virtual treatment simulation.
4. Virtual appliance construction.
5. Three-dimensional aligner printing.

After aligners printing, each infant will be delivered his own set of aligners. The nasal stent will be fixed to the aligner then delivered with a meticulous demonstration for parents regarding adhesive placement, insertion, and removal. Parents will be instructed to remove the aligner once per day for proper cleaning.

Infants will be followed up every two weeks till maxillary arch segments approximation and improvement of nasolabial tissue morphology. Finally, post-treatment records will be taken.

• Study Setting: The study will be performed in the clinic of the Orthodontic Department, Faculty of Dentistry, Ain-Shams University.

• Study procedure: Infants who meet the inclusion criteria and approve participation in the study will be included. An informed consent will be signed by the infant's parents before their enrollment in the study in which the aim of the study, the methodology, and possible complications will be clearly described. This research will be reviewed by the Research Ethics Committee, Faculty of Dentistry, Ain Shams University.

IX. Statistical Analysis Methods of assessment

1. Pre-operative T1 and postoperative T2 models will be digitally measured, assessed and compared.
2. Pre-operative T1 and postoperative T2 soft tissue scans will be digitally measured, assessed and compared.
3. Final virtual models and final infant models will be digitally compared.
4. Total treatment duration will be calculated. Finally, data will be tabulated and statistically analyzed

Eligibility Criteria:
Inclusion Criteria

1. Non-syndromic complete unilateral cleft lip, alveolus, and palate.
2. Age is up to 45 days.
3. Cleft size more than 5mm between anterior margins of cleft segments.

Exclusion Criteria

1. Infants are diagnosed with other congenital malformations.
2. Parents refusing NAM treatment.
3. Parents are unable to attend the clinic every 2 weeks.
4. Infants are born with another form of clefts like facial and median clefts.