cyrilzakka/clinical-trials huggingface dataset:
Cost-effectiveness of ISBCS vs. DSBCS

The purpose of this study is to evaluate the effectiveness and costs of immediately sequential bilateral cataract surgery (ISBCS) compared to delayed sequential bilateral cataract surgery (DSBCS) in order to determine whether ISBCS is an effective and cost-effective alternative to DSBCS.

With an estimated number of 180,000 cataract extractions per year in the Netherlands, cataract surgery is one of the most frequently performed types of surgery. The majority of patients suffer from bilateral cataract and while cataract surgery of one eye is effective in restoring functional vision, second-eye surgery leads to further improvement in health-related quality of life.

Currently, most patients undergo cataract surgery in both eyes on separate days as recommended in national guidelines, referred to as delayed sequential bilateral cataract surgery (DSBCS). An alternative procedure involves cataract surgery of both eyes on the same day, but as separate procedures, known as immediately sequential bilateral cataract surgery (ISBCS).

Potential benefits of ISBCS include less time between surgeries, a faster total recovery period and lower costs. Potential risks, however, are complications of cataract surgery in general, most importantly the risk of endophthalmitis and refractive surprise. In ISBCS, both eyes are at risk at the same time, while in DSBCS both eyes are exposed to these risks consecutively.

Since there is no consensus yet about the role of ISBCS in current regular practice, further investigation of functional and surgical outcomes and cost-effectiveness of ISBCS compared to DSBCS is required. Therefore, the purpose of this study is to evaluate the effectiveness and costs of ISBCS compared to DSBCS, in order to determine whether ISBCS is an effective and cost-effective alternative to DSBCS.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral cataract
* Indication for bilateral cataract surgery
* Expected uncomplicated surgery

Exclusion Criteria:

* Inability to comply with study procedures or to complete follow-up / Dutch questionnaires.
* Non-routine cataract surgery
* Cognitive or behavioural conditions that might interfere with surgery
* Cataract surgery with premium IOL implantation
* Conditions that increase the risk of endophthalmitis (e.g. current ocular/adnexal/periocular infections, immune-compromised, iodine allergy)
* Factors that increase the risk of refractive surprise (e.g. axial lengths \<21mm or \>27mm, difference between eyes of \>1.5mm, abnormal keratometry readings, previous refractive surgery)
* Conditions that increase the risk of corneal edema
* Factors that increase the risk of complicated surgery (e.g. previous surgery, trauma, anatomical abnormalities)
* Sight-threatening comorbidity, Glaucoma or IOP \> 24mmHg, Uveitis, Diabetes with diabetic retinopathy and macular edema
Consequences of Parenteral Nutrition Photoprotection on Oxidant Related Diseases Among Extremely Low Birth Weight Infants

The antioxidant system of very low birth weight infants is immature. This immaturity is implicated in the pathogenesis of diseases such as bronchopulmonary dysplasia or retinopathy. The main source of oxidant is oxygen, and parenteral nutrition is contaminated with oxidant. Photoprotection decreases the oxidant load infused with parenteral nutrition. In a preliminary study, photoprotection reduced the frequency of pulmonary bronchodysplasia, increased the quantity of enteral nutrition tolerated, and decreased the arterial blood pressure among very low birth weight infants. The aim of this study is to evaluate the impact of photoprotection on oxidant related diseases among very low birth weight infants. This study is a randomized multicenter trial. In the intervention group, photoprotection is applied until the infusion of parenteral nutrition with amber bags, tubing, and syringes. The quality of photoprotection is controlled by measuring malondialdehyde and cysteine after 24 hours of infusion. The control group will receive parenteral nutrition with transparent bags and tubing. The outcomes are evaluated at 36 weeks, and 680 infants will be enrolled, with stratification among centers and gestational age.


Eligibility Criteria:
Inclusion Criteria:

* Infants born before 30 weeks gestational age
* Postnatal age between 1 and 6 days
* Apgar score up to 2

Exclusion Criteria:

* Severe congenital abnormalities
* Intraventricular hemorrhage grade up to 2
* Proven sepsis before inclusion
* Transfusion before inclusion
* Use of intravenous lipids or parenteral nutrition before randomisation
Effect of Specific Diet and Physical Activity on Weight and/or Fat Loss

The main purpose of this study is to assess metabolic effects (decreased amount of body fat content, insulin sensitivity and lipid profile improvement) of weight loss intervention based on specific life style counseling (low calorie "metabolic stairs" diet and circuit-based exercise in a comparison to conventional diet and exercise. The main hypothesis is that more significant beneficial metabolic effects will have specific life style counseling effect than conventional diet and exercise. The main purpose of this study is to assess above mentioned metabolic changes before and after 6-8 weeks of weight loss intervention.

The investigators will also study the following:

1. The impact of life style counseling induced weight and/or fat loss on physical fitness
2. The impact of life style counseling induced weight and/or fat loss on metabolic parameters (e.g. insulin sensitivity, lipid profile, ect.)

I

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* BMI≥25 kg/m2

Exclusion Criteria:

* Thyroid disease
* Chronic diseases(rheumatic,liver, kidney, pulmonary, etc. diseases) have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease, or diabetes;
* chronic infections
* show evidence of malignancy
* be women who are pregnant, nursing
* medical treatment except allergy medicines
* tobacco, alcohol or drug addiction
Citicoline Concentration in Human Vitreous

Elegible patients were included in the study and underwent treatment with a solution of citicoline 1% eye-drops, 0.2% high molecular weight hyaluronic acid and 0.01% benzalkonium chloride prior to surgery. The vitreous samples were taken at the beginning of the surgery and analyzed for qualitative/quantitative determination of vitreous concentration of citicoline and its metabolites by means of high performance liquid chromatography.

At the visit all patients underwent comprehensive ophthalmological examination including best corrected visual acuity assessment, slit lamp evaluation, IOP measurement using Goldmann applanation tonometry, and fundus dilated indirect ophthalmoscopy.

Additionally, all patients had central retinal thickness measurements with spectral-domain optical coherence tomography associated with central corneal thickness (CCT) and corneal endothelial cells density (ECD) evaluations.

Patients started the treatment with 1 drop of a solution of citicoline 1% eye-drops, 0.2% hyaluronic acid and 0.01% benzalkonium chloride for 3 times/day over a total time of 14 days before surgery and 1 drop 2 hours prior to the surgery.

Five patients served as controls and received a vehicle solution without citicoline.

The primary aim of the study was to evaluate the presence and concentration of citicoline and its metabolites (choline, cytidine and uridine) in the vitreous body in vivo in human eyes after topical eye-drops administration by means of high performance liquid chromatography.

Secondary aims were the comparison of citicoline and its metabolites concentration in the vitreous of treated phakic and pseudophakic eyes and the correlations with age and ocular biometric parameters including CCT and ECD.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* ability to understand and sign the written informed consent
* diagnosis of epiretinal membrane (ERM) with surgical indication for pars-plana vitrectomy

Exclusion Criteria:

* laser treatments and ocular surgery in the past 6 months
* hypersensitivity to the active ingredients used in the study
* other systemic or ocular diseases different from ERM that could affect the outcome of the study
* aphakia or previous complicated cataract surgery
* intraocular lens (IOL) in the anterior chamber
* treatment with systemic citicoline or other potential neuroprotective agents in the past 6 months
* pregnancy or breastfeeding
Use of Injectable-platelet-rich-fibrin (I-PRF) to Thicken Gingival Phenotype

The main objective of this study is to investigate whether the for individuals with thin gingival thickness who are susceptible to gingival recession, the investigators will use i-PRF with microneedle to increase gingival thickness without the need for surgical procedures

Due to the thin gingival phenotype, gingival recession is a problem. The investigators aimed to increase the gingival thickness using i-PRF with microneedle without considering surgical procedures, considering the positive effects of platelet concentrations on revascularization and wound healing in individuals with bone defect, fenestration and gingival thickness which are prone to gingival recession .

Eligibility Criteria:
Inclusion Criteria:

* Never smokers
* Had no history of systemic disease
* Aged ≥18 years old

Exclusion Criteria:

* Patients with a history of diabetes mellitus or systemic disease
* Patients who were under any medication that was known to influence periodontal tissues
* Patients with hormonal changes such as pregnancy or lactation
* Toothless individuals
* Patients who were clotting disorders
Single Session of Anodal Cerebellar vs Cerebral Transcranial Direct Current Stimulation in Stroke Patients

To compare the effect of anodal cerebellar transcranial direct current stimulation (ctDCS) vs anodal cerebral direct current stimulation on balance, mobility and cognition in stroke patients in stroke patients


Eligibility Criteria:
Inclusion Criteria:

* ability to give written consent.
* Able to walk unassisted
* Functional status allowing the participants to participate in the balance training.
* Score 6 or above on Johns Hopkins fall risk assessment tool

Exclusion Criteria:

* Neurological diseases, such as Parkinson, Alzheimer
* Any history of psychological illnesses
* Receipt of electrotherapy that might affect the nervous system in the two weeks prior to the study
* Cerebellar disorders
* use of any sedative medicines in the two days prior to the study
* any symptoms of amnesia and depression;
* Memory disorders with scores below 21 on the Mini Mental Status Examination test
* Any signs of severe motor disorders in the lower extremity which cause any movement limitation or deformity
* Any signs of radiculopathy or root lumbar spinal cord involvement
* Any visual or auditory impairment, or vertigo reports
* Use of a heart rate regulator
* Any structural deformities in the lower extremities or the spine
* Any abnormalities in the vestibular system
* History of recent fracture
* Inability to move without assistance
A Neuropsychological Characterization of Social Feedback Processing in Social Anxiety

The purpose of this study is to characterize neuropsychological mechanisms (positive affect, negative affect and self-evaluation) mediating processing of social feedback in people with different levels of social anxiety, by implementing functional and structural MRI.

Social anxiety (SA) disorder is a relatively widespread emotional disorder which is associated with considerable impairment in social, educational, and occupational functioning (Kessler et al., 2005). This condition is characterized by a debilitating preoccupation with the evaluation of the self by others, ultimately leading to excessive fear and avoidance of interpersonal encounters. As opposed to healthy individuals who typically process social feedback in a positively biased manner, Individuals with high levels of SA tend to evaluate the feedback conveyed by others negatively. Such biases have a profound contribution to the maintenance of social-related concerns (Clark \& Wells, 1995).

Thus, the overreaching goal of this research is to provide a neuropsychological account of biased processing of social feedback evident in SA. To meet this goal, participants varying in their level of SA are asked to deliver a speech and evaluate it before and after receiving social feedback during an fMRI scan. Additional structural and resting-state fMRI scans, as well as physiological and psychological measures, are obtained throughout the experiment in order to explain individual differences in processing of feedback. fMRI tasks probing basic neuropsychological processes include a self-referential paradigm, wherein participants judge if different traits varying in valence and social domain (power vs. affiliation) are descriptive of them; a reward vs. punishment task, in which participants can win or lose money; and an emotional reactivity task, in which participants view faces with different emotional expressions.

The long-term goal of this study is to better delineate both neurobiological and psychological models of SA, as well as to help in directing future neuromodulation-based treatments of mood and anxiety disorders.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants
* With different levels of social anxiety as measured by the Liebowitz Social Anxiety Scale-Self-Report (LSAS-SR; Fresco et al., 2001)
* Normal or corrected-to-normal vision
* Compatibility with general MRI requirements

Exclusion Criteria:

- History of neurological or psychiatric diseases
Predictability of OSA With a Subjective Screening Scale (OSASSS1)

the study aims to evaluate the accuracy correlation between subjective perception of the air flow through airways from patients and survey and/or polysomnography they spent, using a brief clinical protocol they answered with a manual therapist

The subjects in the study are 18 to 77 years old and present the following conditions:

* polysomnography and sleep survey realized at the Center for Sleep Medicine André RENARD, without any informations of the results for the experience group
* sleep survey with no sleep trouble found for the control group

Eligibility Criteria:
Inclusion Criteria:

* Female or male subjects aged 18 to 77 years old
* subjects who have performed a PSG at the sleep medicine center André Renard for the study group
* subjects with no sleep disorder on sleep survey for the control group
* Subjects who agree to comply with the requirements of the study.
* Subjects who are of age (and know how to read and write) who have given their informed, explicit consent in advance to any procedure related to the trial, the study or the investigation conducted on human beings, with the objective of developing knowledge specific to the exercise of health care professions, as set out in Royal Decree No. 78 of 10 November 1967 on the practice of the health care professions (Act of 27 December 2005)

Exclusion Criteria:

* subjects with acute infections
* subjects with trauma within the last 72 hours
* subjects who already benefit from OSA treatment
* subjects with known perceptual disorders, for example post-stroke
* subjects with current or recent chemotherapy and radiotherapy treatment
* Pregnant women
* Criteria related to prior or concurrent treatments:

Treatment with antipsychotics, anxiolytics, soporifics or muscle relaxants started within the two months preceding the study.

Treatment with intraoral implants during the study or in the two months preceding the study
Vessel-based Ultrasound Registration

In this study we aim to develop an automatic pelvic artery segmentation algorithm, which is required for future clinical implementation of US registration for surgical navigation. Various registration methods will be evaluated with the data of this study to obtain most optimal results. If automatic segmentation and registration is successful, the final accuracy of the developed US registration method for tumor tracking should be evaluated in future studies in patients eligible for surgical navigation. Eventually, we aim to replace the CBCT-scan with an automatic tracked US registration pipeline for a more efficient and accurate registration procedure, which could improve the applicability and accuracy of surgical navigation and patient outcomes.

Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery and has the potential of reducing both irradical resections and morbidity. To use navigation, a registration procedure is required to correlate pre-operative imaging with the patient's position on the operating room (OR). Currently, registration is done by Cone-Beam CT (CBCT) scanning on the OR prior to navigation surgery. However, the main limitation of the CBCT method is that it cannot compensate for per-operative changes such as bed rotation, retractor placement and tissue displacement due to the surgery. Alternatively, by using intra-operative tracked ultrasound and vessel-based patient registration, changing conditions during surgery can better be dealt with. This improved patient registration method could lead to an increased navigation accuracy and improved clinical usability and outcomes.

The main difference between CBCT and proposed ultrasound registration is that CBCT is based on bones, while the ultrasound is based on vessels. Bones can be very easily imaged on the CBCT and therefore used for bone-bone registration with pre-operative CT-scans. However, vessels are more difficult to acquire, especially with ultrasound, and an automatic registration process with pre-operative imaging is needed for efficient clinical usability. For this, the vessels need to be extracted from the tracked ultrasound images to create a 3D representation that can be registered. Therefore, an algorithm needs to be developed that can automatically segment the pelvic vessels from ultrasound images.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Scheduled for laparotomy
* A clinical pre-operative abdominal CT scan is available
* Patient provides written informed consent

Exclusion Criteria:

* Metal implants in the pelvic area which could influence the 3D modelling or tracking accuracy
* Patients with a pacemaker or defibrillator
* Patient received pelvic-abdominal treatment, e.g. surgery or radiotherapy, between the pre-operative CT scan and laparotomy, which might altered the patient's anatomy
A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)

This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular hypertension (OH).


Eligibility Criteria:
Inclusion Criteria:

* Elevated IOP due to either primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* None
Efficacy and Safety of Jaktinib in Patients With COVID-19 Pneumonia.

This was a randomized, double-blind, placebo-controlled parallel study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age, male or female;
* History of COVID-19 infection within 1 week;
* Subjects with HRCT consistent with viral pneumonia (Judged by investigator) and meeting any of the following criteria: With fever, respiratory symptoms; Shortness of breath present,RR ≥30 breaths/min.
* Clear consciousness, Capable and voluntary informed consent.

Exclusion Criteria:

* Unable to take tablets orally Or suspected hypersensitivity to Jaktinib, drugs of the same class, or their excipients, Patients with severe gastrointestinal dysfunction affecting drug absorption;
* Any person meeting criteria for critical pneumonia;
* Patients considered unsuitable for this trial by the investigator.
Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving irinotecan together with carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with newly diagnosed extensive-stage small cell lung cancer.

OBJECTIVES:

Primary

* Determine the response rate in patients with newly diagnosed, previously untreated extensive stage small cell lung cancer treated with irinotecan and carboplatin.

Secondary

* Determine the progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive irinotecan IV and carboplatin IV on days 1 and 8. Treatment repeats every 21 days for 6 courses.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed small cell lung cancer

  * Extensive stage disease
* Newly diagnosed, treatment-naive disease
* At least 1 unidimensionally measurable lesion
* No massive pleural or pericardial effusion by chest CT scan

  * Manageable effusions allowed

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* ECOG 0-2

Life expectancy

* More than 3 months

Hematopoietic

* WBC ≥ 3,000/mm\^3
* Absolute granulocyte count ≥ 1,500/mm\^3
* Hemoglobin ≥ 9.0 g/dL

Hepatic

* ALT or AST ≤ 2 times upper limit of normal
* Bilirubin ≤ 1.5 mg/dL

Renal

* Creatinine normal

Cardiovascular

* No myocardial infarction within the past year
* No uncontrolled hypertension
* No unstable angina
* No congestive heart failure
* No ventricular arrhythmia requiring medical intervention
* No other serious cardiovascular disease

Pulmonary

* Arterial oxygen pressure (Pa O_2) ≥ 70 mm Hg
* No interstitial pneumonitis or pulmonary fibrosis by chest x-ray

Other

* Not pregnant or nursing
* No uncontrolled diabetes
* No severe infection
* No paralytic or obstructive ileus
* No serious diarrhea
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix that is in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy to the chest

  * Other prior radiotherapy allowed

Surgery

* At least 2 weeks since prior surgery and recovered