cyrilzakka/clinical-trials huggingface dataset:
Comparative Analysis of the Visual Performance After TICL Implantation in Patients With Stable Keratoconus

To report on 4-year postoperative safety, efficacy, stability and predictability outcomes(to evaluate the visual, refractive, contrast sensitivity, defocus curve and aberrometric data preoperation, and compare with a similar postoperative outcomes) with the Toric Implantable Contact Lens (TICL) for Stable keratoconus. Investigators will study the four-year follow-up from this standardized, multi-center clinical investigation, support from clinical and optical viewpoints TICL implantation, in stable keratoconus.


Eligibility Criteria:
Inclusion Criteria:

* age (25-38).
* Stable refraction was distinctive by 6 subjective refractions within ± 0.50 diopters(D) of spherical equivalent during 6 months after CXL.
* best spectacle-corrected visual acuity (BCVA) of +0.4 LogMAR (20/40) or better, -clear central cornea.
* normal anterior chamber depth at least 3 mm to endothelium .
* intraocular pressure (IOP)\<20 mm Hg and preoperative endothelial cell count related to age and the anterior chamber depth with regard to Food and Drug Administration recommendations.
* Width of Angle greater than 30°, a pupil diameter of less than 6.25 mm.

Exclusion Criteria:

* Patients with central corneal thickness of less than 450 μm.
* endothelial cell count of less than 2,000 cells/mm2 .
* anterior chamber depth of \<3 mm from endothelium to anterior capsule .
* Corneal opacification or scars, cataract, retinal detachment, glaucoma, retinopathy, macular degeneration, neuro ophthalmic diseases or ocular inflammation, history of keratitis (any form), peripheral marginal degeneration, previous corneal and/or intraocular surgeries, and autoimmune and/or connective tissue disease. The central corneal thickness limit of 450 μm would account for around 400 μm of remaining stromal thickness after removal of the epithelium, which is considered as the safety thickness for the residual stroma to avoid endothelial cell damage during the CXL procedure.
CDSS-assisted UGI Endoscopy vs. Routine Screening Endoscopy

This study aimed to find the CDSS-assisted upper GI endoscopy has clinical benefit compared to conventional routine screening upper GI endoscopy. Investigators will conduct a pilot randomized controlled study. Consecutive patients will be allocated either to CDSS-assisted upper GI endoscopy or conventional routine screening upper GI endoscopy. The lesion detection rate will be compared between both groups.

Artificial intelligence has been adopted in the field of gastrointestinal endoscopy. Investigators previously established deep-learning models to predict the histology and invasion depth of gastric lesions using endoscopic stillcut images. However, clinical benefit of this model has not been evaluated. This study aimed to find the CDSS-assisted upper GI endoscopy has clinical benefit compared to conventional routine screening upper GI endoscopy. Investigators will conduct a pilot randomized controlled study. Consecutive patients who visited Chuncheon Sacred Heart hospital will be allocated either to CDSS-assisted upper GI endoscopy or conventional routine screening upper GI endoscopy. The lesion detection rate will be compared between both groups. Expert endoscopists will conduct this randomized study.

Eligibility Criteria:
Inclusion Criteria:

* Participants who visited for routine screening upper gastrointestinal endoscopy

Exclusion Criteria:

* Participants who refuse to participate in this study
* Participants who showed paradoxical reaction prohibiting routine examination
Detection of Electrodermal Activity in Pain 2

The goal of this study is to investigate the association between self-reported pain and electrodermal activity and to create an algorithm that detects pain and provides timely alarms for rising pain levels in patients with life-threatening illnesses suffering from persistent pain. The study is exploratory.

Hypothesis: Electrodermal activity can distinguish different pain intensity levels in patients with chronic pain and a life-threatening disease.

Methodology: Thirty-seven patients with cancer and/or chronic obstructive pulmonary disease (COPD) will be identified through hospital record screening. These patients will wear a monitoring device for a maximum of one week and report their pain intensity throughout the day.

Analysis: Discriminant analysis will be used to differentiate between mild, moderate, and severe pain. This study is exploratory, generating hypotheses for subsequent phases of the project.

Methods The study is a phase 2 trial, preceded by a phase 1 trial that included healthy volunteers.

Patients will be inpatients and outpatients at Department of Pulmonary and Endocrine Diseases, Hvidovre Hospital.

Measures Subjective measures (self reported) Pain. Pain intensity (interval, 0 to 10) is measured using the NRS, a commonly used tool asking patients to rate their pain intensity on a scale from 0 to 10, with 0 indicating no pain and 10 reflecting the worst possible pain.

Patient Health Status. The Patient Health Questionnaire (PHQ-9) is used to provisionally diagnose depression and grade severity of symptoms in general medical and mental health settings. The PHQ-9 is the depression module.

Ambulatory assessment. The patient group in phase 2 will be asked to wear a wristband device for 1 week. During this period, a prompt will be sent on a smartphone connected to a wearable device provided by Movisens GmbH, five times a day (9 am, 12 pm, 3 pm, 6 pm, and 9 pm) to answer questions about their current pain levels using the NRS scale.

Objective measures Electrodermal activity. A wearable device provided by Movisens GmbH will be used to record skin conductance measured in microsiemens (μS).

Wearable device The EdaMove 4 device provided by Movisens GmbH consists of an EDA and activity sensor. It records EDA signals to monitor both tonic and phasic electrical activity in the skin.

Eligibility Criteria:
Inclusion Criteria:

* Danish
* Age over 18
* Persistent or recurrent pain (longer than three months)
* Cancer: DC01-DC9 or Pulmonary Diseases:DJ40-DJ47

Exclusion Criteria:

* A current diagnosis with psychological/ psychiatric disorders
* Impaired cognitive function
* Substance abuse
* A skin condition on the to-be-tested body parts
* PHQ-9 reveals suicidal ideation
Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With Vaginal Infections

Randomized, Parallel Group, Active Controlled Trial to compare effectiveness and tolerability of 2 different vaginal formulations containing 200mg clotrimazole and clindamycin phosphate equivalent to 100mg clindamycin for 3 days in women clinically diagnosed to have infective vaginitis.

* This is a Randomized, Comparative, Prospective, Open label, Single center study to compare the 3 day treatment course of intravaginal soft gelatin capsule containing clindamycin and clotrimazole versus intravaginal ER tablets of clindamycin and clotrimazole in patients with vaginal discharge and clinical diagnosis of bacterial, trichomonal, candidal or mixed vaginitis with respect to efficacy and tolerability; and to study the in vitro drug release pattern of intravaginal soft gelatin capsule and intravaginal ER tablets containing clindamycin and clotrimazole.
* The study will be conducted in B.J. Medical College \& Sassoon General Hospitals, Pune. The study will be completed in 60 patients \[30 patients in each group\].
* The primary outcome measure is absence of any clinical sign suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis at 8th day after start of treatment \[Effectiveness in inducing a remission\].
* The secondary outcome measures will be

  1. absence of any clinical sign suggestive of infective vaginitis and
  2. a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis at 29th day after start of treatment \[Effectiveness in maintaining a remission\] and ability to complete the 3day course without any break or experiencing intolerable side effects \[Tolerability\].

Eligibility Criteria:
Inclusion Criteria:

* Women with symptoms of vaginal discharge and/or odor and a clinical diagnosis of vaginitis of infective origin \[based on symptoms and signs on per speculum examination\]
* Age at least 18 years
* Capable of giving written informed consent
* Agree to no intercourse for 8 days from the day of start of treatment
* Agree not to douche or use any intravaginal products during the study period (including tampons, medications and devices)

Exclusion Criteria:

* Post-menopausal women
* Menstruating at diagnosis
* Pregnancy
* Any antifungal or antibiotic use 14 days prior to enrolment
* Use of oral or intravaginal antibiotics within the past 2 weeks
* Immunosuppressive drug within 4 months
* Presence of vaginal / vulval ulcer
* Presence of any other vulval, vaginal or medical condition, including cervical neoplasia/ treatment that might confound treatment response
* Inability to keep return appointments
* History of hypersensitivity to clotrimazole, clindamycin or lincomycin
* History of regional enteritis, ulcerative colitis or antibiotic associated colitis
* Significant disease or acute illness that in the Investigators assessment could complicate the evaluation
* Intrauterine Device
Pharmacokinetics of Vildagliptin in Mild, Moderate and Severe Renal Impaired Patients

This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild (CrCl from 50 to ≤80 ml/min), moderate (CrCl from 30 to \<50 ml/min) and severe (CrCl of \<30 ml/min) renal function, preferably type 2 diabetic and matching healthy volunteers CrCl of \>80 ml/min

Exclusion Criteria:

* Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, acute metabolic diabetic complications, treatment of a DPP-4 inhibitor 30 days prior to baseline, renal transplant history

Other protocol-defined inclusion/exclusion criteria may apply
Montelukast Use in Rheumatoid Arthritis

Montelukast is widely used in patients with asthma. Several preclinical data suggest that it could be repositioned as novel strategy for managing rheumatic patients by decreasing inflammatory mediators.

Considering the probable enhanced antiarthritic effects of montelukast; it could be hypothesized that its adjuvant use might improve treatment outcomes in rheumatic patients who remain poorly controlled despite initial optimal guidelines directed medical treatment. Therefore, this study aims to evaluate the potential added benefits of montelukast use in conjunction with csDMARDs in RA patients with moderate and high disease activity.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ages ≥ 18 years old.
* Patients diagnosed with RA according to American College of Rheumatology/European league Against Rheumatism (ACR/ EULAR) 2010 criteria (25) presented with disease activity score-28 based on C-reactive protein (CRP) levels (DAS-28-CRP) \>3.2.
* Patient received stable regimen of one or more csDMARDs for at least the past 3 months.

Exclusion Criteria:

* Patient taking biological DMARDs.
* Known hypersensitivity to montelukast.
* Patients receive montelukast for any other indications.
* Patients with impaired liver functions (liver transaminases level ≥ three times upper normal limits).
* Patients with impaired kidney (estimated glomerular filtration rate (eGFR) \< 30 ml/min).
* Pregnancy and lactation.
* Patients with active or severe infections.
* Patients with other inflammatory or autoimmune diseases and malignancies.
* Patients with any psychiatric disorder.
* Patients taking IV, IM, orally (dose \> 10 mg daily) or intra articular corticosteroides,
* Smokers.
Assessing Patient Comfort, Anxiety, and Satisfaction During CR Comparing Conventional Drops With ROC

This study aims to compare the efficacy of conventional cycloplegic agents, such as cyclopentolate, with rapid-onset cycloplegics, like a combination of tropicamide and phenylephrine, in reducing patient anxiety and discomfort during cycloplegic refraction. Cycloplegic refraction is an essential procedure for diagnosing refractive errors, particularly in children, by temporarily paralyzing the ciliary muscle to inhibit accommodation. While cyclopentolate has a relatively quick onset, tropicamide is preferred due to its faster onset and shorter duration. Despite its advantages, concerns about patient discomfort and anxiety during the procedure remain, especially in pediatric populations.

The study will involve participants aged 3-16 years, with no significant refractive error or ocular pathologies. Patients will be randomly assigned to receive either cyclopentolate or tropicamide with phenylephrine. The primary outcomes include patient comfort, anxiety levels, satisfaction, and procedure time. Discomfort and anxiety will be measured using questionnaires such as the Visual Analog Scale for Comfort and the State-Trait Anxiety Inventory. The study will help determine if rapid-onset cycloplegic provide a better patient experience by reducing discomfort and anxiety. By evaluating these factors, the research seeks to improve clinical practices in optometry and ophthalmology, particularly in pediatric eye examinations.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 10-20years.
* Both Male and Female
* Healthy participants with no abnormalities detected in anterior segment structures or fundus examination using slit-lamp biomicroscopy and a 90-diopter lens.
* No significant refractive error (within the range of ±1 diopter in spherical equivalent).

Exclusion Criteria:

* History of severe allergic reactions or adverse effects to cycloplegic agents
* Severe anxiety, panic disorders, or other psychological conditions that may interfere with reporting the experience accurately.
* Uncontrolled systemic diseases (e.g., uncontrolled diabetes or cardiovascular conditions) that may impact the response to cycloplegic agents.
* Recent ocular surgery (e.g., LASIK, cataract surgery) or eye trauma affecting refraction accuracy or comfort.
* Presence or history of any intraocular diseases, including glaucoma, uveitis, and retinal disorders.
* Systemic disorders such as hypertension, cardiovascular disease, or respiratory disease.
REmote Assessment and Dynamic Response Intervention II

The purpose of the READyR II Study is to test a dynamic tailoring phase of a remote assessment for changing dementia-related care needs.

Unmet dementia-related care needs are highly prevalent, and are detrimental to the care dyad's (person with dementia and their family care partner) health, safety, mortality, and likelihood of nursing home placement. READyR II tests a dynamic tailoring phase of an intervention program that was previously developed to remotely assess dementia-related care needs using digital data on behavioral patterns (from sensors and wearables) in the home. READyR II follows participants who have completed READyR for a total of six months in order to detect anomalies in activity patterns that may indicate new and unforeseen care needs.

People who voluntarily decide to participate in this follow-up intervention study will be asked to continue participating with the in-home monitoring sensor platform, complete weekly questionnaires, and receive regular follow-up telephone calls from the study team.

Eligibility Criteria:
Inclusion Criteria:

* 62 years or older;
* Able to identify a family care partner over age 20 who is living with you and will also consent to fully participate in the study
* Probable or confirmed diagnosis of mild cognitive impairment or early-stage dementia
* Age and education adjusted MOCA score \> 15 (at most recent measurement by parent study) corresponding to early to moderate stage dementia

Exclusion Criteria:

* Inability to speak English or read printed materials in English
* Conditions that would limit participation at entry to study (e.g. visual or hearing impairments prohibiting reading and discussing the intervention materials)
* Any uncontrolled medical condition that is expected to preclude completion of the study, such as late stage cancers

Family Care Partners

Inclusion:

* 21 years or older;
* Self-identifying as a family member and care partner residing with the PwD participant;

Exclusion:

* Inability to speak English or read printed materials in English
* Conditions that would limit participation at entry to study (e.g. visual or hearing impairments prohibiting reading and discussing the intervention materials);
* Any uncontrolled medical condition that is expected to preclude completion of the study, such as late stage cancers.
The Standard Management of HPV Infection

High-risk human papillomavirus (HR-HPV) infection is a necessary condition in the occurence and development of cervical squamous intraepithelial lesion (SIL) and cervical cancer. There are cases that high-grade SIL (HSIL) and stage IA1 cervical squamous cancer remain or reoccur, or even become more severe after conization. The infection situation of HR-HPV, which plays an important role in the prognosis of cervical lesion, should be consulted in the management and follw-up after conization. It is worthwhile making further study in the specific practical significance of the HR-HPV in the prognosis of cervical lesion, as well as the high-risk factors that influence the prognosis of HR-HPV.

Main purpose:To work out the standard management of HPV infection by following up the HPV infection situation of the patients with high-grade SIL (HSIL) and stage IA1 cervical squamous cancer after conization.

Research design:First, to do the retrospective analysis toward the patients who received conization between Jan 2009 to Aug 2016.Second,to do the prospective analysis toward the patients who received conization between Spt 2016 to Aug 2018.

Inclusive criteria of study population:The patients who had finished HPV genotype testing before conization;who had never received treatment other than conization;who were histologically diagnosed as HSIL or IA1 cervical squamous cancer;who had not been diagnosed as any cervical diseases before;who were under age 70;who did not have any severe diseases that influence the follow-up.

Follow-up methods:to do the follow-up to the target patients by 3,6,9,12,18,24 months after conization.

Follow-up contents:the HR-HPV genotype infection before conization;the grade of lesion;the age when received conization;the gravity and parity;the situation of the glands invovement

Eligibility Criteria:
Inclusion Criteria:

* age not above 70
* histologically diagnosed as HSIL or stage IA1 cervical squamous cancer
* received conization in Beijing Obstetrics and Gynecology Hospital
* HR-HPV infected without any treatment other than conization
* HR-HPV genotype tested before coniztion

Exclusion Criteria:

* age above 70
* with severe desease that influence the follow-up
* received other treatment on cervical lesion
* data incompleted
* not meet the inclusive criteria
Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery

Children with congenital heart defects often need cardiac surgery with cardiopulmonary bypass (the "heart-lung machine"). Approximately 35 to 50% of these children will have "acute kidney injury," or damage to the kidneys, after the procedure. We currently have few medications to prevent this kidney injury. The hypothesis of this study is that giving aminophylline after heart surgery can decrease the acute kidney injury.

Patients are randomized to receive aminophylline or placebo for 72 hours, in a blinded fashion. Serum theophylline levels monitor for safety of aminophylline dose. Goal theophylline levels is 5-7 mcg/ml. Laboratory results will be faxed directly to the pharmacy who will adjust subsequent aminophylline dosing to maintain appropriate theophylline levels. Urine output and serum creatinine levels will be monitored to assess acute kidney injury. Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) levels will also be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Less than 18 years old, undergoing cardiac surgery with bypass
* neonates must be at least 36 weeks gestational age

Exclusion Criteria:

* History of arrythmia or seizure, on extracorporeal membrane oxygenation (ECMO) support, already taking aminophylline/theophylline, liver failure, sepsis, on renal replacement therapy
Preoperative and Peroperative Comparison Between 3D Spine Reconstructions

The objective is to collect data from a per-operative navigation system called SURGIVISIO during scoliosis surgeries. A research program is in progress in order super-impose pre-operative 3D reconstructions of the spine performed with the EOS system on the per-operative 3D reconstructions performed with the SURGIVISIO system.

The purpose of the study is to collect the pre and per operatives data in order to perform the research and development program.


Eligibility Criteria:
Inclusion Criteria:

* patients aged between 12 and 20
* Adolescent idiopathic scoliosis
* Fusion surgery planned

Exclusion Criteria:

* Patient under "tutelle" or privation of liberty
* Opposition of parents or patient
The Role of Cycling-cognitive Dual-task Training in Early Parkinson's Disease

The purpose of the study will investigate the safety and effectiveness with eight-week cycling-cognitive dual-task training for early Parkinson's disease.

Background: Parkinson's disease is a neurodegenerative disorder of the basal ganglia in which the production of dopamine is reduced, leading to the motor and non-motor impairment and the loss of automaticity. Recently, the results across studies have indicated that motor-cognitive dual-task deficits in individuals with neurologic disorders appear to be amenable to training. Improvement of dual-task ability in individuals with neurologic disorders holds potential for improving gait, balance, and cognition. The most recent European guideline provides a more graded view, stating that in Hoehn and Yahr stages 2 and 3 dual-task training may be safe and effective. An overview of current ongoing randomized controlled trials focusing on dual-task rehabilitation, gait training or treadmill training was the major motor-task. However, cycling augmented by cognitive training has not been evaluated. In addition, antioxidant capacity is unclear for Parkinson's disease patients with long-term, regular cycling training.

Study purpose: The purpose of the study will investigate the safety and effectiveness with eight-week cycling-cognitive dual-task training for early Parkinson's disease. The antioxidant capacity will be assessed as well.

Methods: Parkinson's disease patients will be assigned to cycling training, cycling-cognitive dual task training, and following 8 weeks. All of the subjects will complete 3 assessments at pre-training, post-4 weeks, and post-8 weeks. The outcome measures are clinical severity and disability, performance of gait-cognitive and cycling-cognitive, cognitive-task performance, peripheral-blood oxidative stress, adverse events, etc.

Significance: In this study, evidence-based practice as the foundation, and perspective to design a safe and effective cycling-cognitive dual-task training for early Parkinson's disease. It can be verified in the clinical application of these experiments feasibility (practice-based evidence).

Eligibility Criteria:
Inclusion Criteria:

* patients with Idiopathic Parkinson's disease (IPD)
* an age between 45 to 70 years
* asymmetrical onset of at least 2 of 3 cardinal sign
* Modified Hoehn and Yahr staging from 1 to 2.5 during off state
* Montreal cognitive assessment score of 26 or greater

Exclusion Criteria: The patients were ineligible if they had

* a neurological history other than Parkinson's disease
* ever undergone neurosurgery for Parkinson's disease
* had moderate to severe dyskinesia
* been unstable with medical or psychiatric co-morbidities, orthopedic conditions restricting exercise
* done more than 20 min of aerobic exercise over 3 sessions per week on their own