cyrilzakka/clinical-trials huggingface dataset:
AOSEPT (CLEAR CARE) PLUS Study

The purpose of this post-market clinical follow-up (PMCF) study is to evaluate the long-term safety and performance of 2 commercially available contact lens cleaning and disinfecting systems in a pediatric population.

Subjects will participate in the study for approximately 90 days, with telephone calls scheduled on Day 30 ± 7 (Visit 2) and Day 60 ± 7 (Visit 3) and an in-office follow-up visit scheduled on Day 90 ± 7 (Visit 4). Subjects may have unscheduled visits if deemed necessary per the Investigator's judgment.

Eligibility Criteria:
Key Inclusion Criteria:

* Subject and parent/legally authorized representative able to understand and sign an Institution Review Board approved informed consent/assent form.
* Subject willing to follow and be able to attend all scheduled study visits as required per protocol.
* Successful wear of daily wear, reusable, soft (including hydrogel and silicone hydrogel) or rigid gas permeable (RGP) contact lenses in both eyes for the past 3 months for a minimum of 5 days per week and 8 hours per day.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any ocular disease or condition that would contraindicate contact lens wear.
* Use of systemic or ocular medication that would contraindicate contact lens wear.
* Any known sensitivity to any ingredients in the study products.
* Current or history of pathological dry eye in either eye that would in the opinion of the Investigator preclude contact lens wear.
* Any use of habitual/prescribed topical ocular medication or artificial tear or rewetting drop (habitual) that would require instillation during the study.
* Other protocol-specified exclusion criteria may apply.
To Compare Outcomes After Transurethral Enucleation of Prostate Versus Transurethral Resection of Prostate

The purpose of the study is to assess whether transurethral enucleation of prostate gives better or equivalent outcomes compared to the gold standard of transurethral resection of the prostate


Eligibility Criteria:
Inclusion Criteria:

* All who underwent TURP or TUERP

Exclusion Criteria:

* Those with prostate cancer, neurogenic bladder, previous urethral or prostate surgery
Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Adults

This study is a multi-center and open design, phase Ⅳ clinical trial of an inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd.The purpose of this study is to evaluate the safety of the SARS-CoV-2 Inactivated vaccine in population aged 18 years years and older and in people with pre-existing disease to provide reference for improving the immunization strategy of COVID-19 vaccine.

This study is a multi-center and open design, phase Ⅳ clinical trial in population aged 18 years years and older. The experimental vaccine will be manufactured by Sinovac Research and Development Co.,Ltd.The study is planned to be carried out in 11 provinces from May 2021 to December 2022, including Liaoning, Heilongjiang, Anhui, Fujian, Jiangxi, Hubei, Guangxi, Chongqing, Guizhou, Yunnan and Gansu. Each province will serve as a research center, and each research center will select the corresponding research site.A total of 121000 subjects will be enrolled with11000 for each research center, including at least 2000 people with pre-existing disease and at least 4000 people in the elderly group (60 years old and above) (including patients with pre-existing disease).And subjects will receive two doses of vaccine on day 0 and day 28.

Eligibility Criteria:
Inclusion Criteria:

* Have not received any COVID-19 vaccine in the past or at least one dose of CoronaVac manufactured by Sinovac Research and Development Co.,Ltd;
* Population aged 18 years and above;
* The subjects can understand and voluntarily sign the informed consent form and participate in the follow-up;

Exclusion Criteria:

* History of severe allergy to the vaccine such as acute allergic reaction,angioedema and dyspnea ;
* Severe neurological disease such as transverse myeliti,Guillain-Barre Syndrome and demyelinating disorders;
* Acute diseas,acute onset of chronic disease and severe chronic diseases.
Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.

The purpose of this study is to evaluate if retarded phosphatidylcholine is as effective as mesalazin in preventing an acute episode in ulcerative colitis.

The hypothesis is, that ulcerative colitis is cuased by a defect in the barrier function of the colonic mucus. The background of the study is the finding that the phosphatidylcholine content of the colonic mucus is reduced in patients with ulcerative colitis, in both healthy and inflamed parts of the colon.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of ulcerative colitis in remission (CAI 3 or less)
* signed letter of content
* no steroids or immunosupressants in the last 6 weeks
* at least 5 relapses in the last 3 years
* last relapse was 8 months ago or less
* complete colonoscopy at entry

Exclusion Criteria:

* pregnancy or breast feeding
* steroids or immunosuppressants
* acute episode of UC
* condition after complete or partial colektomy
* known intolerance to mesalazin
* severe medical disease other than colitis
Mitra v Fingerprick Tacrolimus Creatinine

Patients with kidney transplant have blood tests very often. This is normally done in hospital and using a needle inserted into the vein. Two tests are important for kidney transplant patients - creatinine to monitor the health of the kidney; and tacrolimus to measure the level of the medicine which prevents rejection. The investigators would like to compare a fingerprick microsampling method to the standard venous blood. The fingerprick test is the same done by patients with diabetes and we use a microsampling tip which looks like a cotton bud to draw up a small amount of blood. Each tip draws up exactly 10 microlitres which is two drops. The investigators want to compare the results of creatinine and tacrolimus done through the two methods. In the future, this would allow patients to do their creatinine and tacrolimus test at home. The tips dry completely and can be posted to a laboratory. We hope this will make life easier for transplant patients and also help them engage more with the care of their condition.


Eligibility Criteria:
Inclusion Criteria:

Kidney transplant recipients. Taking tacrolimus

Exclusion Criteria:

Unable to consent
The Effect of a Serious Health Game on Children's Eating Behavior

Background: Currently the dietary intake patterns of children do not meet the prescribed dietary guidelines. Consequently childhood obesity is one of the most serious health concerns. Therefore, innovative methods need to be developed and tested in order to effectively improve the dietary intake of children. Learning children how to cope with the overwhelming number of unhealthy food cues could be conducted effectively by serious health games.

Objective: The main aim of this study was to examine the effect of a serious health computer game on young children's eating behavior and attitudes towards healthy and unhealthy foods.

Methods: A cluster-randomized controlled trial with a between-subject design was conducted (N=157; 8-12 years), whereby children played a game that promoted a healthy lifestyle or were in the control condition. Children in the control condition attended regular classes and did not play a game. The game was designed in collaboration with researchers and pilot-tested before conducting the experiment among a group of children repeatedly. After one week of playing, attitudes towards food snacks and actual intake was assessed, whereby children could eat at libitum from fruits or energy-dense snacks.


Eligibility Criteria:
Inclusion Criteria:

* primary school between group 5 and 8

Exclusion Criteria:

* n.a.
Seasonal Variation of Blood Cholesterol Levels

To describe and delineate in a prospective study the nature and causes of seasonal variation of blood lipid levels in the general population.

BACKGROUND:

Significant seasonal variation of blood cholesterol levels has been shown in a number of cross-sectional studies, with important implications for national screening and therapeutic guidelines. However, the phenomenon has not been well studied: little is known about etiology or about seasonal variation of lipid subfractions.

DESIGN NARRATIVE:

The investigators assessed the magnitude and timing of the seasonal effect for total cholesterol and the important lipoprotein subfractions (low-density lipoprotein, high-density lipoprotein, triglycerides, apolipoproteins AI and B, and lipoprotein (a)) in both sexes and at different ages. They also identified and quantified the effects of the main factors determining the variation and assessed the seasonal variation of other blood elements thought to play a role in the development of coronary heart disease, including hemostatic factors and antioxidants Finally, they explored the implications of the phenomenon for public health policy.

Baseline and serial measures were repeated quarterly for one year. These included measures of: serum lipids and lipoproteins; antioxidant vitamins; platelets and hemostatic factors; demographic factors; weight, waist-hip ratio, height, body mass index (BMI) and blood pressure; dietary intake; physical activity; light exposure; and psychologic factors. Meteorologic data were also collected. Data were collected by written questionnaire and by the use of computer-assisted evening telephone interviews (CATI), which were used for the collection of dietary, physical activity and individual light-exposure and other lifestyle data. Activity and light data were verified in a subset of 80 patients by the use of a monitoring device. Analyses included methods to describe the seasonal variation in dietary, physical activity, psychologic, and light exposure data and repeated measures in linear regression models to determine the roles of specific dietary, physical activity, psychologic, and light-exposure related covariates in explaining variability in blood lipids, antioxidant vitamins, and hemostatic factors.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
CT 327 in the Treatment of Psoriasis Vulgaris

This study will look at how safe and effective, a novel agent, CT 327 cream is in treating patients with mild to moderate psoriasis vulgaris (PV). Patients will be treated twice daily for 8 weeks on specific lesions of PV and safety and symptoms of PV will be assessed throughout the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 and \< 71 years of age
* Able to give informed consent
* Diagnosis of mild (affecting \< 3% BSA) to moderate (affecting \< 10% BSA) Psoriasis Vulgaris, including, at baseline visit, two symmetrical lesions of at least 10 cm2 each

Exclusion Criteria:

* If female of childbearing potential not using an adequate and appropriate form of contraception such as oral contraceptive; intra-uterine device (IUD); contraceptive injection, implant or patch
* If female, are pregnant or lactating, or intend to become pregnant during the study period and one month thereafter
* Allergy to test drug or excipients
* Usage of topical corticosteroids or other topical treatments for PV within the last two weeks prior to study entry (including calcineurin inhibitor, topical H1 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment Within 4 weeks prior to study entry, have received systemic treatment for psoriasis (including systemic corticosteroids, nonsteroidals, immunosuppressants, or immunomodulating drugs, or treatment with light).
* Received treatment with systemic or locally acting medications which might counter or influence the study aim
* Presence of major medical illness requiring systemic therapy including cancers
* Clinical diagnosis of bacterial infection of the skin including impetigo and abscesses
* Any clinical relevant ECG abnormality
* Have any clinically significant abnormal clinical laboratory test results at screening
* Received any investigational drug or taking part in any clinical study within three months prior to this study
* History of drug, alcohol or other substance abuse or other factors limiting the ability to co-operate and to comply with this protocol
* Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
* Have immune-compromised status (such as known human immunodeficiency virus infection)
* Have a history of malignancy, excluding basal cell carcinoma of the skin
* Have an active intercurrent infection
* Suffer from erythrodermic psoriasis, psoriasis punctata and pustular psoriasis or extended chronic stationary forms of psoriasis
* Have symptoms of a clinically significant illness that may influence the outcome of the study
* Have any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate in or complete the trial, or which places the subject at undue risk
World Mosquito Program Noumea - Human Sample Component

The dengue, Zika and chikungunya arboviruses represent potentially severe infections to which the New Caledonian population is exposed. In the absence of specific treatment or vaccine, vector control remains the method of choice to limit their spread. However, the traditional methods of prevention and vector control measure today face their limits: mosquito resistance to insecticides, difficulty of access and destruction of breeding areas... The World Mosquito Program Noumea project is based on the artificial colonization of the mosquito vector Aedes aegypti by the endosymbiotic bacteria Wolbachia, which reduces its ability to transmit arboviruses. The breeding of mosquitoes carrying the bacterium Wolbachia in the laboratories of the Institut Pasteur of New Caledonia requires the use of human blood samples for mosquito gorging.

The objective of the research is to generate, maintain and amplify Aedes aegypti Caledonian lineages carrying the Wolbachia bacteria for the planned insect release program in Noumea.

The dengue, Zika and chikungunya arboviruses represent potentially severe infections to which the New Caledonian population is exposed. In the absence of specific treatment or vaccine, disease vector control remains the method of choice to limit their spread. However, the traditional methods of prevention and disease vector control must today face their limits: mosquito resistance to insecticides, difficulty of access and destruction of breeding areas... The World Mosquito Program Noumea project is based on the artificial colonization of the mosquito vector Aedes aegypti by the endosymbiotic bacterium Wolbachia, which reduces its ability to transmit arboviruses. The breeding of mosquitoes carrying the bacterium Wolbachia in the laboratories of the Institut Pasteur of New Caledonia requires the use of human blood samples for mosquito gorging.

The objective of the research is to generate, maintain and amplify Aedes aegypti Caledonian lineages carrying the bacterium Wolbachia for the planned insect release program in Noumea.

The establishment of Wolbachia in Aedes aegypti populations in Noumea should lead to the reduction of active transmission of dengue, Zika and chikungunya in the municipality.

Eligibility Criteria:
Inclusion Criteria:

* All adult hemochromatosis or polycythemia patients or healthy donors have given their written consent to participate in the study and for the collection of a blood sample.

Exclusion Criteria:

* Participation refusal
* Minor person
* Positive result by Reverse transcription polymerase chain reaction RT-PCR for arboviruses
* Invalid qualification of the blood donation
Polymorphism C677T MTHFR and Effects of Folate Intake

The C677T polymorphism in the MTHFR gene is related to several significant biochemical changes, as dyslipidemia, changes in serum levels of homocysteine, folic acid, vitamin B12 and some oxidative stress markers such as the CAT and MDA, leading to a high risk of the emergence of cardiovascular disease (CVD). A diet containing antioxidants, especially folate, is characterized by being beneficial for individuals with this genetic alteration to possess anti-inflammatory function, act on and oxidative stress play an important gene function. The aim of this study was to evaluate the influence of the C677T polymorphism of the MTHFR gene and the effect of a diet containing folate on oxidative stress, lipid profile and homocysteine levels in adult women are overweight or obese. This is an intervention study, double-blind, held in a city in northeastern Brazil. The study included 48 adult women (20-59 years old) with BMI of 26.19 kg / m² and 49.64 kg / m², in which we evaluated the CAT levels, MDA, lipid profile, folic acid, homocysteine and vitamin B12 addition genotyping for the C677T polymorphism in the MTHFR gene and the food consumption by the food recall 24 hours, being divided by randomization into two groups received daily for 8 weeks, 300g vegetables rich in folate containing 191 ug and 90 ug of this nutrient.

This work is linked to a population-based survey entitled "Diagnosis and Intervention II Cycle Situation Food, Nutrition and Noncommunicable Diseases prevalent over the city of João Pessoa Population / PB" (II DISANDNT / PB). For the realization of this dissertation home visits and the questionnaires related to anthropometric and food intake assessment were conducted by teams of undergraduate researchers and graduates of Nutrition Course, masters and doctoral students of the Post Graduate Program in Nutrition Sciences (PPGCN) of UFPB duly previously trained at the beginning of data collection and after completion of the pilot study.

After the selection of individuals from the sample of adults who participated in the II DISANDNT / JP and considering the inclusion criteria and genotyping of the C677T polymorphism in the MTHFR gene, they were invited to participate.

Eligibility Criteria:
Inclusion Criteria:

* Adult women, aged 20 to 59, sound overweight or obese
* Individuals of different socioeconomic conditions
* Users or not drugs
* Cognitive state preserved and accept participate

Exclusion Criteria:

* Drinkers, smokers or neuropsychiatric disorders
* Users drugs known to interfere with the metabolism of folic acid (the last 3 months), as prednisone, hydrocortisone, dexamethasone, chloramphenicol, acetylsalicylic acid
* Multivitamin supplement users, minerals, appetite suppressants and steroids
* Individuals with chronic diseases with influence on the endocrine and metabolic system
* Pregnant or planning to become pregnant during the study period
A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation

The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

This was a Phase 3, randomized, double-blind, placebo-controlled, parallel-group multicenter study of orally administered lumacaftor in combination with ivacaftor in participants aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation.

The study included a Screening Period (Day -28 through Day -1), a Treatment Period (Day 1 \[first dose of study drug\] to Week 24 ± 5 days), and a Safety Follow-up Visit (4 weeks ± 7 days after the Week 24 Visit).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF
* Homozygous for the F508del CFTR mutation
* Forced expiratory volume in 1 second (FEV1) greater than or equal to (\>=) 40 percent (%) and less than or equal to (=\<) 90% of predicted normal for age, sex, and height
* Willing to remain on a stable CF medication regimen through Week 24 or, if applicable, the Safety Follow up Visit

Exclusion Criteria:

* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before first dose of study drug
* History of solid organ or hematological transplantation
* History of alcohol or drug abuse in the past year
* Ongoing or prior participation in an investigational drug study (including studies investigating lumacaftor and/or ivacaftor) within 30 days of screening.
* Use of strong inhibitors, moderate inducers, or strong inducers of Cytochrome P450 3A (CYP3A) within 14 days before Day 1 of dosing
Study to Evaluate Multiple Doses of ERB-041 in Healthy, Female Japanese Subjects

The primary objective is evaluate the safety, tolerability, and pharmacokinetics of multiple doses of ERB-041, an investigational drug, in healthy, female Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by the investigator on the basis of medical history and screening evaluations.
Serum AMH Levels in Patients Who Underwent Hypogastric Artery Ligation

To observe the effects of hypogastric artery ligation on serum antimullerian hormone levels.

To measure and compare serum antimullerian hormone levels in patients who underwent hypogastric artery ligation/ hypogastric artery ligation+ hysterectomy and postpartum control. The procedures performed as an emergency life saving method during delivery. The reasons for hypogastric artery ligation/ hypogastric artery ligation+ hysterectomy were obstetric hemorrhage mainly uterine atony.

The serum levels of antimullerian hormone were measured 6 months after the operations and compared with matching postpartum controls. Serum levels of FSH, LH, PRL and TSH were also measured 6 months after the operation. Further, antral follicle count measured along with the aforementioned blood tests.

Eligibility Criteria:
Inclusion Criteria:

* age 18- 40 years
* no systemic or endocrine diseases
* patients who had hypogastric artery ligation and/or hysterectomy
* healthy postpartum patients as controls

Exclusion Criteria:

* history of chemotherapy and/or radiotherapy
* Obese patients
* patients with previous/present endometriosis
* patients with PCOS