cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study on the Efficacy and Safety of VEC Intravenous Chemotherapy Combined With Conbercept Intravitreal Injection in the Treatment of Retinoblastoma

This prospective, multi-center, open single-arm Phase II clinical trial is designed to investigate the efficacy and safety of intravenous chemotherapy combined with Conbercept intravitreal injection in the treatment of retinoblastoma.


Eligibility Criteria:
Inclusion Criteria:

1. The patient's guardian signs an informed consent form and is willing to receive follow-up according to the schedule of the trial;
2. Children of more than 3 months and under 5 years of age who have not received any anti-cancer treatment;
3. The target eye must meet the following requirements:

   Clinically diagnosed as monocular retinoblastoma; According to the IIRC diagnostic criteria, the treatment eye is classified as Group E stage without clinical high-risk factors (Table 1); No refractive medium turbidity and/or pupillary abnormalities that affect the fundus examination; IOP≤21mmHg.
4. Sufficient organ function at baseline.

Exclusion Criteria:

Subjects with any of the following eye conditions:

1. Patients diagnosed as stage E retinoblastoma in one eye, but with high-risk factors: neovascular glaucoma; refractive interstitial opacity caused by anterior chamber, vitreous or subretinal hemorrhage; tumor invasion of optic nerve posterior to the cribriform plate and choroid (range of diameter\> 2 mm), sclera, and anterior chamber;
2. Treatment-naïve pediatric patients;

Patients with any of the following systemic diseases:

1. With a history of allergies or have allergic reactions to fluorescein sodium, with a history of allergies to protein products for treatment or diagnosis, and have allergic reactions to two or more drugs and/or non-drug factors, or suffering from allergic diseases;
2. Low birth weight children, and severely growth-stunted children;
3. Children who need systemic treatment for other system diseases;
4. Any condition that should be excluded from the study in the opinion of the investigator.
The Effects of FODMAPs in Patients With Irritable Bowel Syndrome

Patients with Irritable Bowel Syndrome (IBS) often link their symptoms to foods. Interest in dietary management recently increased, including the use of a low FODMAP diet.

To investigate relation of FODMAPs and IBS, a randomized, double-blind, cross-over trial will be carried out in adult (\>18) patients with IBS according to Rome IV criteria. The aim is to assess low FODMAP diet versus moderate/high FODMAP diet in IBS patients.

The study is a randomized, double-blind, cross-over trial.

The aim is to assess the effects of low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet compared to moderate/high FODMAP diet in IBS patients on gastrointestinal symptoms and psychological factors. The primary hypothesis is that the low FODMAP diet decreases gastrointestinal symptoms compared to moderate/high FODMAP diet, and that this change is accompanied with reduced psychological distress.

IBS patients (Rome IV) are challenged with FODMAPs in this randomized, double-blinded, cross-over study. The subjects will start with the low FODMAP diet or moderate/high FODMAP diet and cross over to the other intervention (both for 7 days). In between the interventions, there is a wash-out period of at least 14 days. The subjects will receive ready-made meals from the hospital kitchen (lunch and dinner) and in between snacks. The subjects are instructed to buy breakfast themselves and the subjects will receive information on which other foods to avoid, without mentioning 'FODMAPs'. The subjects will follow their usual diet (as before initiation of the study) during the wash-out period.

Primary outcomes are change in gastrointestinal symptoms, assessed by questionnaires, including IBS Severity Scoring System (IBS-SSS) (7-10 day recall and modified daily) and Gastrointestinal Symptom Rating Scale -IBS (GSRS-IBS). A 50-point reduction in IBS-SSS indicates clinical response. Bacterial fermentation (exhaled hydrogen and methane) and visceral sensitivity will be measured using the Lactulose Nutrient Challenge Test. Secondary outcomes are change in psychological factors and assessed by questionnaires, including Central Sensitization Index (CSI), Hospital Anxiety and Depression Scale (HADS), Patient Health Questionnaire (PHQ)-15 and Visceral Sensitivity Index (VSI).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with IBS according to Rome IV criteria

Exclusion Criteria:

* allergy or documented intolerance to food
* severe cardiovascular disease
* severe hepatic disease
* severe neurological disease
* severe psychiatric disease
* celiac disease
* inflammatory bowel diseases
* diabetes
* bowel dysfunction related to previous surgery
* pregnant or lactating women
* use of antibiotics within four weeks before inclusion
* strict avoidance of foods
Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans

To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.


Eligibility Criteria:
Inclusion Criteria:

* African American (self-reported)
* Documented clinical diagnosis of asthma as defined by the American Thoracic Society (ATS) for at least 6 months prior to Visit 2 and be in stable condition.
* FEV1, measured ≥6 hours after the last dose of short-acting β2-agonist and at least 48 hours after LABA, of 45%-85%, inclusive, of predicted normal.

Exclusion Criteria:

* Has been hospitalized at least once for an asthma related condition during the 6 months prior to Visit 2, or has required emergency treatment due to an asthma related condition more than once in the 3 months prior to Visit 2.
* Has required treatment with systemic corticosteroids (eg, oral, parenteral, ocular, or rectal) for any reason within the 30 days prior to Visit 2.
* Has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 3 that, in the Investigator's opinion, will interfere with the subject's lung function and/or ability to perform spirometry
Unidirectional Barbed Sutures in Mucogingival Procedures

The aim of the study is to compare the efficacy of barbed suture with conventional suture in muco-gingival surgeries.

Experimental: Main treatment group, flap will be approximated using conventional, simple continuous suturing with barbed sutures.

Comparator: In patients allocated to control group, flap will be approximated using conventional, simple continuous suturing with conventional sutures.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy individuals within an age group of 20-50yrs with presence of attached gingiva, shallow vestibule and frenum interfering with the marginal gingiva.

Exclusion Criteria:

* Medically compromised patients.
* Subjects who underwent radiotherapy or chemotherapy in the past 12 months.
* Smokers
COMParison of Algorithms for Rotational Evaluation in Atrial Fibrillation

This is a cohort study to evaluate algorithms for mapping atrial fibrillation by mapping atrial structure and mapping electrical activity to detect focal and rotational activity.

In this study, the investigators will compare mapping approaches for atrial fibrillation ablation.

First, investigators will compare approaches to map atrial structure from collected computed tomography (CT) scans or magnetic resonance imaging (MRI) scans acquired routinely in patients undergoing ablation for atrial fibrillation. Imaging will be acquired from a variety of clinically approved

Second, investigators will compare approaches to analyze electrograms collected routinely at clinical electrophysiology study (EPS) in patients undergoing ablation for atrial fibrillation. Electrograms will be recorded from a variety of clinically approved catheters under standard of care conditions, and will be analyzed to better understand the mechanisms for atrial fibrillation and its relationship to outcomes.

The investigators anticipate analyzing data from 200 patients through December 2017.

Eligibility Criteria:
Inclusion Criteria:

* aged 21-80 yrs who underwent electrophysiology study for ablation of Atrial Fibrillation

Exclusion Criteria:

* Poor data quality of recordings of AF
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults

The purpose of the study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged \>= 18 to \< 65 years at the time of providing informed consent.

Exclusion Criteria:

* Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thiomersal, neomycin, polymyxin, or any components of the Study Vaccine.
Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy

Patients with a biochemical recurrence after radical prostatectomy for moderate- or high- risk prostate cancer are randomly assigned to hypofractionated, accelerated high dose radiation therapy group (65 Gy, 26 fractions) and a control group of standard treatment group (66 Gy, 33 fractions). The criteria for stratification at randomization include 1) risk groups, 2) androgen deprivation therapy, and 3) PSA before salvage radiation therapy, which affect biochemical recurrence.

It is expected that hypofractionated, accelerated high dose radiation therapy will have a superiority in terms of biochemical control to conventional radiation therapy, and the present study would like to confirm this. In addition, we aimed to evaluate and compare the toxicity and quality of life index of two radiation therapy regimens.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed intermediate- or high-risk prostate cancer
* Biochemical recurrence after radical prostatectomy (Definition: Serial elevation of PSA over 0.2 ng/mL and \<=1.0 ng/mL)
* ECOG performance status 0-1
* Appropriate values of blood tests within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 Platelets ≥ 50,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl
* Appropriate values of kidney function within 6 months after enrollment Creatinine \< 2.0 ng/dL
* Appropriate values of liver function within 6 months after enrollment total bilirubin \< 1.5 X maximum normal value alanine aminotransferase or aspartate aminotransferase \< 2.5 X maximum normal value

Exclusion Criteria:

* Clinically gross recurrent tumor
* Presence of distant metastasis
* Presence of pelvic LN metastasis
* History of pelvic irradiation
* History of cryotherapy or brachytherapy for prostate cancer
* Double primary cancer other than skin/thyroid cancer
* Combined serious morbidity
Safety & Efficacy of EPO-018B for the Treatment of Anemia in Participants With ERSD Receiving Maintenance Hemodialysis

The purpose of this study is to evaluate the safety,efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of EPO-018B in participants with chronic kidney disease (CKD) who are on hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females\>=18 and≤65.
2. Receiving dialysis for at least 2 weeks before the first study dose.
3. Patients who have not received any erythropoietic agents within 6 weeks prior to the first study dose.
4. Two hemoglobin values of ≥ 6.0 and \< 10.0 g/dL at Screening
5. Patients with a transferrin saturation ≥ 20% or a ferritin≥ 100 ng/mL. vitamin B12 and folic acid level above lower limit of normal.
6. Signed informed consent.

Exclusion Criteria:

1. Pregnant or lactating females.
2. Red blood cell transfusion within 3 months prior to study drug administration.
3. Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products.
4. Hemolytic syndromes or coagulation disorder.
5. Hematological disease (including but not limited to myelodysplastic syndrome, hematological malignancy, , hemoglobinopathy, pure red cell aplasia).
6. Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis,systemic lupus erythematosus, etc.).
7. C reactive Protein (CRP) level greater than 30 mg/L within the 4 weeks prior to study drug administration.
8. Uncontrolled or symptomatic secondary hyperparathyroidism，iPTH\>500pg/ml.
9. Poorly controlled hypertension within 2 weeks prior to study drug administration, per investigator's clinical judgment (e.g. systolic ≥ 160mm Hg, diastolic ≥ 100 mm Hg).
10. Chronic congestive heart failure (New York Heart Association Class IV).
11. Significant symptom within 6 months prior to study drug administration (e.g. myocardial infarction, serious or precarious coronary artery disease,stroke, respiratory disease, autoimmune disease, neuropathy, phrenopathy, hepatopathy including Active hepatitis B, Active hepatitis C, or ALT\> 2 x upper limit of normal (ULN), AsT\> 2 x upper limit of normal (ULN) , etc.).
12. A positive test for HIV antibody.
13. Tumor malignancy
14. Expected survival less than 12 months,
15. A scheduled kidney transplant
16. Major surgery (may Massive bleeding) during the study
17. Expected conception within 4 Weeks after the end of the Study Treatment
18. The subject has participated in other clinical trial within the 6 weeks prior to study drug administration
19. Have any other condition or prior therapy that, in the investigator's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures.
Aripiprazole Open-Label, Safety and Tolerability Study

The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent patients with schizophrenia, or child and adolescent patients with bipolar I disorder, manic or mixed episode

Exclusion Criteria:

* Patients with a co-morbid serious, uncontrolled systemic illness
* Patients with a significant risk of committing suicide
RESTORE in Patients Who Had COVID-19 and Close Others

There is considerable need for psychological intervention targeting stressor-related mental health symptoms related to COVID-19. The investigators have developed an online self-directed transdiagnostic intervention to address this need called RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health. The specific aims of this project are to refine and investigate the initial safety, efficacy, and desirability of RESTORE for addressing mental-health symptoms in individuals who have recovered from severe COVID-19 and close others.

This uncontrolled pilot interventional study will examine the feasibility and preliminary efficacy of RESTORE. RESTORE is a guided self-directed online intervention to improve anxiety, depression, and posttraumatic stress disorder (PTSD) in individuals exposed to COVID-19 related traumatic or extreme stressors. RESTORE is based on evidence-based psychotherapies and has been designed to overcome many of the barriers associated with accessing evidence-based psychotherapies. The intervention will be iteratively refined over the course of the study. The guidance methods will also be refined over the course of the study

The primary hypotheses are that RESTORE will be safe, feasible, and desirable to participants, and will lead to improvements in mental health symptom severity from baseline to post-intervention. Secondary hypotheses are that RESTORE will lead to significant improvements in perceived health, quality of life, and functioning that will be maintained at one-month follow-up. Participants will be assessed at baseline, pre-intervention, during the intervention (after module 4), immediately after the intervention, and 1 month after completion of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Experienced a traumatic or extremely stressful experience related to being COVID-19+ or having a close other who was COVID-19+
* Participants who were COVID+ will be eligible once they are no longer exhibiting COVID-19 symptoms and those who were hospitalized will be eligible post-discharge
* Close others will be eligible once their close other with COVID-19 has recovered or if their loved one is deceased
* ≥ 18 years of age
* Scores at above clinical threshold on at least one of: Patient Health Questionnaire-9 (\[PHQ-9\] score ≥ 10), Generalized Anxiety Disorder Scale-7 (\[GAD-7\] score ≥ 10), and/or Posttraumatic Stress Disorder Scale-5 (\[PCL-5\] score ≥ 33)
* Access to a computer or a tablet with high speed internet access, be able to clearly see the screen of a computer or tablet, and be fluent in English
* Ability to provide consent

Exclusion Criteria:

* Elevated risk of suicide
* Currently enrolled in another intervention or treatment (e.g., cognitive behavioural therapy) for stress responses related to the COVID-19 pandemic
Soluble VE-cadherin in Prediction and Diagnosis of Early Postoperative Hypoxemia After Cardiopulmonary Bypass

More than 2 million patients worldwide receive heart surgery every year, majority of these surgical patients will undergo cardiopulmonary bypass. However, the incidence of postoperative acute lung injury due to cardiopulmonary bypass is still as high as 20% to 35%. According to clinical experience, the earlier lung damage is detected, the more successful the treatment will be. On the basis of traditional detection, the investigators found a new indicator, serum soluble vascular endothelial-cadherin, which are easy to obtain and have certain specificity. Importantly, they can predict postoperative acute lung injury within 1 hour after cardiac surgery. It is meaningful that this indicator can provide clinicians with early decision-making advice and immediate treatment for patients who may be at risk.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Underwent cardiac surgery using CPB technology.

Exclusion Criteria:

* Patient's lack of consent to participate;
* Presence of abnormal liver, kidney or other organ function;
* Pulmonary inflammation, chronic obstructive pulmonary disease or tumors;
* Underwent cardiac surgery without CPB technology;
* Postoperative need for extracorporeal membrane oxygenation support.
Bicarbonate Administration in Kidney Transplant Recipients

Metabolic acidosis is associated with vascular endothelial dysfunction and is a common complication in patients who have received a kidney transplant. Kidney transplant recipients (KTR) with lower serum bicarbonate levels, even within the normal range, have an increased risk of graft loss and mortality. The investigators propose a prospective, double-blind, randomized, placebo-controlled, 18-week crossover pilot study to examine the effects of sodium bicarbonate on vascular endothelial function, graft function, and cognitive function in 20 KTR patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Kidney transplant received at least 1 year ago
* Serum bicarbonate 20-26 mEq/L on 2 separate measurements (at least 1 day apart)
* eGFR \>45 ml/min/1.73m2
* Blood pressure \<140/90 mm Hg prior to randomization
* BMI \< 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients).
* Able to provide consent
* Stable kidney transplant medication regimen for at least 1 month prior to randomization
* Stable anti-hypertensive regimen for at least one month prior to randomization
* Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin).

Exclusion Criteria:

* Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
* Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
* Uncontrolled hypertension
* Serum potassium \< 3.3 or ≥ 5.5 mEq/L at screening
* New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months · Factors judged to limit adherence to interventions
* Current participation in another research study
* Pregnancy or planning to become pregnant or currently breastfeeding
* Chronic use of supplemental oxygen
Postmarketing Surveillance Study of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease

To obtain further information on the tolerability and efficacy of Atrovent® inhalets in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice


Eligibility Criteria:
Inclusion Criteria:

* Patients of both gender, older than 40 years, who suffer from chronic obstructive Pulmonary disease
* Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion

Exclusion Criteria:

• Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® Inhalets
In the Era of the HPV Vaccine, What Are The Current HPV Subtypes Contributing to High Grade Cervical Dysplasia, Adenocarcinoma in Situ, and Early Cervical Cancer?

This study will look at cervical tissue samples in women with abnormal cervical cells to see if the frequency of the HPV 16/18 subtypes has changed in female populations today, after the introduction of the HPV vaccine. It will compare women who have been exposed to the HPV vaccine with those who have not.

The development of cervical dysplasia (precursor to cervical cancer) and cervical cancer requires infection with one of several cancer causing subtypes of the human papilloma virus (HPV). There are over 100 subtypes of HPV, and most are not cancer causing. In the past, North American data has shown that 70% of early cervical cancers were associated with HPV subtypes 16 and/or 18. The first HPV vaccines to be approved protected against the common subtypes of HPV 16 and 18. The traditional HPV vaccination consists of 3-doses administered over a 6 month period.

Since the 8 years after the introduction of the vaccine, there have not been any studies analyzing HPV subtype changes. It is important to determine if the prevalence of the HPV subtypes associated with precancerous and/or early cervical cancer have changed, and what preventative outcomes have arisen from the HPV vaccination. This will have implications regarding the importance and anticipated effects of immunization with the nanovalent vaccine that includes other oncogenic subtypes.

This study will look at tissue samples to see if the frequency of the HPV 16/18 subtypes has changed in female populations today, after the introduction of the HPV vaccine. It will compare women who have been exposed to the HPV vaccine with those who have not.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 years old
* Presenting with cervical high grade intraepithelial dysplasia (HSIL), adenocarcinoma in situ (ACIS), or early cervical cancer
* Fulfills one of the following two criteria:

Expected to have a cervical biopsy, loop electrosurgical excision procedure (LEEP), or cone biopsy as part of standard of care treatment OR Has already had a cone biopsy of LEEP and the archived tissue is located at Sunnybrook Health Sciences Centre and was taken within two years from the time of consent.

Exclusion Criteria:

* A history of HSIL, ACIS, or early cervical cancer prior to 2010
* Patients who are unable to provide consent
* Women who have had a previous LEEP or cone biopsy and tissue removed is greater than 2 years old, from the time of consent
* women who have had a previous LEEP or cone biopsy and tissue is archived at an outside institution