cyrilzakka/clinical-trials huggingface dataset:
Myopic Control for High Myopes Using Orthokeratology

The purpose of this study is to evaluate and compare the eyeball elongation in high myopic children using partial correction orthokeratology and single-vision spectacles.

Orthokeratology (ortho-k) has been shown to have strong potential for retardation of myopic progression in low myopes. To date, clinical experience has shown the technique to be less effective in achieving full myopic reduction in high myopes. Would myopic control be possible for high myopes undergoing partial correction ortho-k treatment?

A randomized, longitudinal study is designed to investigate the efficacy of partial correction ortho-k in retardation of myopic progression in high myopic children. Eye growth in terms of axial length elongation in children wearing ortho-k and over-spectacles (to correct residual refractive errors) (study group) and those wearing single-vision spectacles (control group) will be evaluated and compared.

Eligibility Criteria:
Inclusion Criteria:

* Myopia (refractive sphere): \> 5.75D
* Astigmatism: \< ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D
* Spherical equivalent (SE): \> 5.75D
* Anisometropia: ≤ 1.50D in both refractive sphere, refractive cylinder and SE
* Best corrected monocular visual acuity: equal to or better than 0.10 in logMAR scale in both eyes
* Willingness for randomization
* Availability for follow-up for at least 2 years

Exclusion Criteria:

* Strabismus at distance or near
* Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex
* Systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication)
* Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)
Non-interventional Study of Cabozantinib in Adults With Advanced Renal Cell Carcinoma

The objective of this study is to understand the utilization of cabozantinib in subjects with advanced renal cell carcinoma (RCC) following prior VEGF-targeted therapy in real life settings in terms of dose modifications due to adverse events (AEs) when used as a second line therapy or third and later line therapy. Other patterns of use of cabozantinib will also be described.

The study will follow the real-life management of patients in clinical practice. Visits will take place according to the study site's clinical practice. Cabozantinib is to be administered as directed by the investigator according to the study site's usual clinical practice and the Cabometyx™ Summary of Product Characteristics (SmPC).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Has a diagnosis of advanced RCC
* Has received at least one prior VEGF-targeted therapy
* For whom the treating physician has decided to start treatment with cabozantinib tablets prior to inclusion
* No previous exposure to cabozantinib prior to inclusion
* Not concurrently involved in an interventional study
* Consents to participate in this noninterventional study

Exclusion Criteria:

* There are no exclusion criteria for this study.
Kidney Transplantation in Patients With Sickle Cell Disease

The purpose of this research is to better characterize the components and mechanisms of the immune systems of persons with sickle cell disease who have had a kidney transplant and are immunosuppressed. If we can improve our scientific understanding of the fundamental mechanisms involved in patient outcomes, we can potentially maximize the benefits that we seek from transplantation in sickle cell patients with end stage renal disease.

Sickle cell disease is a common disease in the African-American population. In sickle cell disease red blood cells are abnormal in shape and can damage organs. In particular, patients with sickle cell disease can have damage to the kidneys, resulting in renal failure. The number of patients developing renal failure with sickle cell disease is unknown. This is largely due to the high mortality of patients with sickle cell disease and renal failure.

There are two types of renal replacement therapy available to patients with sickle cell disease- dialysis and kidney transplantation. The best form of renal replacement therapy has not been determined for patients with sickle cell disease and renal failure. There have been approximately 190 renal transplants performed in the United States since 1988 in patients with sickle cell disease. Patients do well, but do not survive as long as patients with other causes of renal failure. It appears that patients with sickle cell disease who meet the criteria for kidney transplantation may derive a benefit from transplantation rather than undergoing dialysis.

We are performing this study to follow patients with sickle cell disease who have received a renal transplant. We hope to learn the best way to manage patients with sickle cell disease to improve both survival of the transplanted kidney and the patients.

In addition, we are studying the immune system and how it responds to receiving a kidney transplant in sickle cell patients. We hope the information we learn about the immune system will allow us to prevent injury to the new kidney transplant and allow for better outcomes in sickle cell patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients between 18 and 65 years of age
2. Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study.
3. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and must not be breast-feeding.
4. Patients must be diagnosed with Sickle Cell Disease (SS phenotype)

Exclusion Criteria:

1. Patients with any prior organ transplant or multi-organ transplant recipients.
2. Patients with evidence of an active systemic infection requiring the continued use of antibiotics, evidence of an HIV infection, or the presence of a chronic active hepatitis B or C.
3. Patients with history of malignancy in the last 5 years (except successfully treated localized non-melanotic skin cancer)
4. Patients with active illegal drug use
The Mobile Diabetes Mgmt. Study With Type 2 Diabetes

A Multi-center, Randomized, Parallel, Open Clinical Trial to Evaluate the Glycemic Control Effect of the Mobile Healthcare Service Using U-Healthcare Clinical Decision Support System (CDSS) and U-Healthcare Gateway in Patients with Type 2 Diabetes Mellitus

The Mobile Diabetes Intervention Study is evaluating a diabetes mgmt. algorithm system by using patient mobile application and physician web-based portal. The investigators hypothesize that patient self-monitoring of blood glucose, dietary and exercise by using application and physician's remote monitoring can additional decrease of HbA1c over 6 month.

Eligibility Criteria:
Inclusion Criteria:

* 20-80 years of age
* Type 2 diabetes patients (who have taken stably oral diabetic drugs or insulin, and been doing lifestyle improvement by doctor's advice for recent over 3 months)
* in case insulin treated, patients with basal insulin once a day or premixed insulin twice a day
* HbA1c between 7.0% and 10.0%
* ability to understand and use smartphone application

Exclusion Criteria:

* type 1 diabetes or patients using insulin pump
* severe complications (stage IV,V chronic kidney failure, diabetic food complications, unstable angina pectoris, MI or stroke, surgical procedure of coronary \& peripheral artery within recent 6 months)
* uncontrolled hypertension
* pregnant woman, fertile woman who will not use contraception
* unable to use application during treatment
* taking medication which can affect on glucose level
* alcohol abuse or dependency
* over 2.5 times from the upper limit of liver enzyme level
* DKA(diabetic ketoacidosis) or HHS(Hyperglycemic hyperosmolar syndrome) history during recent 6 months
18-Month Study of the Efficacy of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

The purpose of this study is to assess xaliproden's potential capacity of slowing the deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's disease. The patients participating in this study will take orally once daily xaliproden or placebo (inactive substance pill).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Alzheimer's disease using NINCDS-ADRDA criteria

  * Mild to moderate degree of severity of dementia as assessed by the Mini-Mental State Examination score of 16 to 26 (inclusive)
  * Potential participant may be treated with conventional Alzheimer's disease therapy and must be on stable dose for at least 6 months prior to the randomization and during the entire study period
  * Potential participant must have a reliable caregiver and must be living in a community or in an assisted living facility
  * Mother tongue is English, Spanish or French (oral and written fluency)
  * Signed informed consent from potential participant or legal representative and identified caregiver

Exclusion Criteria:

* Potential participant with any other cause of dementia.
* Potential participant with serious health problems other than Alzheimer's disease
* Use of an investigational drug within two months prior to randomization or during this study
Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

The primary objective of this investigation is to evaluate the feasibility and safety of implantable loop recorder implantation (using the LUX-DX™) in newborns undergoing stage 1 palliation. The secondary objective of the investigation is to evaluate the feasibility of continuous measurement of heart rate and arrhythmia using an implantable loop recorder (LUX-Dx™) during the interstage period.

An implantable loop recorder will be placed at the time of chest closure following stage 1 palliation (either at the time of index surgery or delayed). The device will be placed in a subclavicular pouch through the existing sternotomy incision. Participants will be in the study for 6 months to 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients with single ventricle physiology undergoing stage 1 palliation in the 1st month of life

Exclusion Criteria:

* Prematurity (\<36 weeks gestational age)
* Birth weight \<2.5 kg
* Hybrid stage 1 palliation (patent ductus arteriosus stenting, bilateral pulmonary artery bands)
* Presence and/or need for devices sensitive to magnetic fields such as hearing aids, pacemaker, and other implanted devices.
* Clinical team does not think that the patient is a good candidate
Acute Phase Response & Periodontal Treatment

This study has compared quadrant scaling and root planing (Q-SRP) versus intensive treatment performed within 24 hours (FM-SRP) in terms of acute phase responses following treatment of periodontal disease. The primary aim was to compare the differences in CRP acute increase following FM-SRP versus Q-SRP therapy (24 hours after therapy). Secondary outcomes included changes in a broad array of inflammatory and endothelial injury markers between groups. Patients were randomly assigned to either FM-SRP and Q-SRP. Data indicated that non-surgical periodontal therapy performed within 24 hours induced greater perturbations of systemic inflammation compared to conventional treatment.

Aim. A moderate acute-phase response occurs 24 hours following full-mouth non-surgical treatment (FM-SRP). Aim of this study will be to compare quadrant scaling (Q-SRP) versus FM-SRP in terms of systemic acute (24 hours) and medium-term (3 months) inflammation.

Material \& Methods. 38 periodontitis-affected subjects will be randomly allocated to FM-SRP or Q-SRP after a baseline visit. Periodontal and anthropometric parameters, such as systolic and diastolic bood pressure, BMI and temperature, will be collected at baseline and 3 months. Serum samples will be drawn at baseline, 1, 7 and 90 days after treatment. High sensitivity assays for a broad array of inflammatory (PCR, IL-6, TNF-alpha) and endothelial assays will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with probing pocket depths (PPD) ≥5 mm,
* bleeding on probing on at least 25% of their total sites
* documented radiographic alveolar bone loss

Exclusion Criteria:

* age earlier than 18 and older than 70 years;
* pregnant or lactating females;
* females using contraceptive methods;
* reported diagnosis of any systemic illnesses including cardiovascular, renal and liver diseases;
* any pharmacological treatment within the 3 months before the beginning of the study;
* PT in the previous 6 months.
The Comparative Clinical Study of Gamisoyosan on Anxiety of Generalized Anxiety Disorder According to Dosage Form

In this randomized, double blinded, Parallel-controlled study, the investigators planned to give Gamisoyosan extract, Gamisoyosan extract powder or controlled medication on Anxiety of generalized anxiety disorder according to dosage form.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 20-65
* (Structured Clinical Interview for DSM-Ⅳ Axis Ⅰ Disorder, SCID-Ⅰ) subjects who meet Structured Clinical Interview for DSM-Ⅳ Axis Ⅰ Disorder, SCID-Ⅰof generalized anxiety disorder

Exclusion Criteria:

* Currrent or past history of delusions, halucination
* Past history of at least one manic episode, hypomanic episode, or mixed episode
* Current or past history of alcohol abuse or alcohol dependence history
* Taking substances(e.g. antianxiety drugs, antidepressant, antipsychotic drug, steroids, female hormonal drug, L-dopa, digitalis, bromide, cyclosporin, disulfiram, isoniazid, yohimbine) which might affect symptoms
* Medical conditions(e.g. myocardial infarction,brain tumor, multiple sclerosis, pancreatic disease, hyperthyroidism, hypothyroidism, Addison disease, Cushing disease, rheumarthritis, cancer, CVA, epilepsy, anemia, pituitarium disease, Vit B12 deficiency disease, PMS) that might affect symptoms
* Current with hepatoma, hepatic cirrhosis, chronic renal failure, congestive heart failure
* Pregnancy, lactation, women not using medically accepted means of birth control
* Considered not apt to carry out clinical trial
Effects of Anti-IL5 Biological Treatments on Blood IgE Levels in Severe Asthmatic Patients

Real-life, observational, retrospective, multicenter study to evaluate the effects of anti-IL5 biological treatments on blood total IgE Levels in atopic patients with severe eosinophilic asthma.

Severe asthma, i.e. asthma that is not controlled despite maximal optimized therapy and/or that worsens when high dose treatment is decreased (GINA guidelines - available at https://ginasthma.or), is a major unmet medical need. Major advances in the management of severe asthma occurred in the past few years due to the new targeted biological therapies. Mepolizumab and Benralizumab are humanized monoclonal antibodies able to block interleukin (IL)-5 and the receptor for IL-5, respectively. These biological treatments block the eosinophilic driven inflammation. The effects of these treatments on an other key effector molecule of the T2-immune response, i.e. IgE, is virtually unknown.

To explore this issue, we set up a real life, observational, retrospective, multicenter study. The study will enroll patients with severe eosinophilic asthma already treated with Mepolizumab or Benralizumab. The following variable will be collected before the the biological treatment and at 4±2 months after the initiation of the pharmacological regimen:

* demographic data
* age of onset of asthma
* smoking habit
* concomitant pharmacological regimens
* number of asthma exacerbations since last visit
* concomitant diseases (particularly gastroesophageal reflux, nasal polyposis, atopic dermatitis, obesity, anxiety-depressive syndrome).
* White Blood Cell Count and Differential (and in particular the levels of total leucocytes, lymphocytes, eosinophils and basophils)
* Lung function tests (spirometry)

Eligibility Criteria:
Inclusion Criteria:

* atopy
* severe eosinophilic asthma (according to GINA guideline - available at https://ginasthma.org)
* patients treated with monoclonal antibody anti IL-5 (Mepolizumab) or with IL-5 anti-receptor monoclonal antibody (Benralizumab).
* stable asthma (free from asthma exacerbation for at least 8 weeks)

Exclusion Criteria:

* asthma exacerbation in last 8 weeks
* patients treated for COPD
A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.

This 2 arm study will compare the effects of aleglitazar and Actos, added to preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function. Eligible patients will be randomized to receive either aleglitazar 0.6mg p.o. or Actos 45mg p.o. daily. Renal function and efficacy parameters will be assessed at intervals during the treatment period. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes for \>=1 month;
* drug naive, or receiving stable oral antihyperglycemic medication;
* HbA1c 6.5-10.0% at screening.

Exclusion Criteria:

* type 1 diabetes;
* current or previous treatment with insulin;
* history of renal disease other than diabetic nephropathy;
* uncontrolled hypertension;
* clinically significant cardiovascular disease;
* Congestive heart failure (CHF) New York Heart Association (NYHA) 3-4.
Study of Bortezomib (BTZ) Treatment on Mantle Cell Lymphoma (MCL) in Chinese Participants

The purpose of the study (retrospective and prospective) is to describe participant and disease characteristics and treatment pattern of Bortezomib treated mantle cell lymphoma (MCL) participants in China.


Eligibility Criteria:
Inclusion Criteria:

* Participants that have been hospitalized for MCL after January 1st 2009.
* Biopsy proven MCL as evidenced by histology with either immunohistochemistry (IHC) or t(11,14) translocation
* Retrospective group: Participants who have finished BTZ treatment before the study initiation as judged by participating site physician
* If participant isn't accessible for oral or written informed consent, ICF can be waived after approved by the IRB
* Prospective group: Participants who are on BTZ at the time of study initiation or start BTZ after study initiation

Exclusion Criteria:

* Participants with documented diagnosis of other cancers prior to or at the presence of the diagnosis of MCL
* Participants enrolled in interventional clinical trials of BTZ or any other drug for MCL
* Prospective group: Participants with contraindication listed in the prescribing information of BTZ
Spectacles Lens in Concussed Kids

We will be looking at 3 treatment arms in the form of different type of glasses to see if one is superior to helping kids have sustained a concussion and are symptomatic.

Recent studies have shown children who sustain a concussion are susceptible to having chronic symptoms (post-concussion syndrome). This chronicity can lead to delays in returning to learn and returning to play. Blurry vision, double vision, eye strain and eye tracking problems are some of the reported chronic symptoms that can affect patients' daily activities. Concussion awareness has increased recently and there is a surge of interest to better understand and treat the symptoms of post-concussion syndrome. Currently, ocular treatment for patients are often empirically determined. Common treatments are vision therapy and/or bifocal glasses. There has yet to be any standardization or prospective studies looking into treatment for these concussed patients with ocular symptoms and findings. The objective of this protocol is to compare three different types of glasses (typical prescription glasses for kids, typical glasses for kids with anti-glare coating, and progressive addition lenses with anti-glare coating) as treatment options for participants who are still symptomatic four weeks out from their concussion. The main outcome is the effectiveness of these three different options in reducing patients' symptoms and improving the participants' visual findings.

Eligibility Criteria:
Inclusion Criteria:

* Sustained a concussion \> 6 weeks \< 16 weeks from date of initial visit
* Criteria for concussion: formally diagnosed by physician
* Minimum best corrected visual acuity: 20/25 in right and left eyes at distance and 20/30 both eyes at near
* Minimum Stereopsis: 500" global
* CISS score \> 16
* Refractive error at least + 0.50D sphere or cylinder
* Ability to clear \> 0.50 cycles per minute in monocular accommodative flipper of and binocular accommodative flipper of +/-1.50

Exclusion Criteria:

* Diplopia from nerve palsies
* Retinal pathology
* Previous treatment of any amount of bifocal lenses and base in prism since concussion.
* Vision therapy \> 6 weeks since concussion
Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents

This study will look at the safety of substituting exenatide for insulin in patients with type 2 diabetes who are currently taking insulin and oral antidiabetic agent(s).

This is an exploratory, multicenter, open-label, 2-arm, parallel trial. Approximately 30 patients with type 2 diabetes, currently on a sulfonylurea, or meglitinide and/or metformin and insulin therapy, will be randomized to discontinue insulin and substitute it with exenatide or remain on their current diabetes therapy regimen. All patients will continue their current diet and exercise regimen during the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients have been treated with insulin for \>=3 months up to 12 years.
* HbA1c \<=10.5%.
* Body mass index (BMI) between 27 kg/m2 and 40 kg/m2.

Exclusion Criteria:

* Patients previously received exenatide or GLP-1 analogs.
* Patients have been treated for greater than 2 weeks with thiazolidinediones or alpha-glucosidase inhibitors within 3 months prior to screening.
Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage in Intensive Care Unit

Head trauma and severe cerebral hemorrhage are major risk factors for development of ventilator-associated pneumonia. In a previous open labelled, single center study the investigators showed that repeated oropharyngeal decontamination with povidone-iodine may be an effective strategy to decrease the prevalence of ventilator-associated pneumonia in patients with head trauma. The present study aims to confirm these results in a multicenter, double blind study including patients suffering from head trauma or cerebral hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years
* Closed head trauma with a Glasgow Coma Score \<=8 or cerebral Hemorrhage with a Glasgow Coma Score of \<=8
* Expected need mechanical ventilation for \>=2 days
* Written informed consent from the patient's next-of-kin. If no relative is present at the time of inclusion, the patients will be included according to the emergency procedure

Exclusion Criteria:

* Impossibility to perform oropharyngeal decontamination within 12 h following the initial episode
* Facial injury with impossibility to perform the oropharyngeal decontamination
* Tetraplegia
* Known history of reaction to iodine
* Respiratory disease or pulmonary infiltrate(s) at inclusion
* Need for curative antibiotics
* Mercurial antiseptics treatment
* Pregnancy