cyrilzakka/clinical-trials huggingface dataset:
Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis

The goal of this observational study is to learn about the drug compliance of patients with juvenile idiopathic arthritis and, to figure our factors that affect the compliance.

The main questions it aims to answer are:

* Medication use and compliance in children with chronic diseases is an important problem, but do patients with JIA really use their medications in harmony?
* Does the level of adherence to medications affect the quality of life of patients with JIA?

Participants will be asked to fill the demographic form which includes personal information and nutritional habbits, Morisky Drug Compliance Scale - 8 and the pediatric quality of life inventory forms, with attending researcher Yesfa Sebnem Ozbay, M.D.

This study is not an interventional study.


Eligibility Criteria:
Inclusion Criteria:

* Being followed up with the diagnosis of Juvenile Idiopathic Artritis (JIA) from the pediatric rheumatology outpatient clinic of Istanbul University, Istanbul Faculty of Medicine

Exclusion Criteria:

* Refusal of patients or their parents to participate in the study
* Although the patient is followed up with the diagnosis of JIA, not using medication
Total Knee Arthroplasty and Augmented Reality-based Navigation System

The purpose of Total Knee Replacement (TKR) is to remove worn cartilage surfaces and replace them with artificial parts of the same shape. TKR can be used in cases of osteoarthritis, inflammatory rheumatism, bone necrosis of the knee or following malformative or traumatic sequelae.

Implant alignment is paramount in TKR and the last years have seen a proliferation of alignment techniques following the introduction of computer and robotic-assisted surgery. Among Computer-assisted surgery, the augmented reality-based navigation system can be an option to improve accuracy in orthopaedic surgery.

The hypothesis of this study is: the use of augmented reality-based navigation system allows a prosthesis alignment and positioning that is at least as good as with the traditional mechanically aligned technique, and therefore improves knee functional results. This study also aims at assessing the cost-effectiveness of this new technology.

In this randomised study, TKR will be performed either with the traditional mechanically aligned technique or with an augmented reality-based navigation system using Knee+ technology.

Knee+ is a Class Im software medical device (European classification, Directive 93/42/EEC, Annex IX) and obtained CE Mark 0459 in May 2020.

This technology is used in total knee replacement procedures, and offers the orthopedic surgeon intraoperative assistance in positioning the implants with the help of a pair of augmented reality glasses. The cutting planes are oriented with respect to the mechanical axes calculated according to anatomical landmarks acquired with a pointer. The connected glasses calculate precisely the 3D coordinates of the instruments thanks to the analysis of their specific markers (QR-Code), filmed by the integrated camera. The navigation information is displayed in the surgeon's field of vision, who interacts with the application thanks to the glasses' accelerometers.

Eligibility Criteria:
Inclusion Criteria:

1. Gonarthrosis on a varum knee requiring a Total Knee Replacement
2. Female or male, 18 years of age or older
3. Affiliation to a social security scheme
4. Patient has been informed of the study and has signed an informed consent form

Exclusion Criteria:

1. Osteonecrosis,
2. Post traumatic osteoarthritis with femoral or tibial callus,
3. History of tibial or femoral osteotomy,
4. Valgum knee,
5. Isolated patellofemoral osteoarthritis,
6. Significant hip dysplasia or other excessive pelvic deformity,
7. Patient already equipped with medical devices that may conflict with the instrumentation required for augmented reality navigation,
8. Pregnant or breastfeeding women,
9. Patients under legal protection.
Salvage HDR for Locally Recurrent Prostate Cancer

The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy

The aim of this study is to examine the efficacy and toxicity of focal salvage high dose rate brachytherapy (HDR BT) for patients with locally recurrent prostate cancer after definitive external beam radiotherapy. Furthermore, the investigators want to assess, whether it is feasible to perform salvage HDR BT as a focal treatment based on multiparametric (mp) pelvine MRI and PSMA PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* Man ≥ 18 years, who had definitive EBRT or BT for prostate cancer T1-3b, N0-1, M0
* ≥ 2 years since the end of primary radiotherapy
* PSA recurrence Phoenix criteria (nadir + 2)
* No evidence of regional lymph nodes or distant metastases on PSMA PET/CT
* MRI guided biopsy-proven local recurrence of adenocarcinoma in the prostate gland or seminal vesicles
* GTV identifiable on mpMRI
* No current endocrine therapy
* Plasma testosterone ≥1.75 nm/l
* PSA doubling time ≥ 6 months and ≤ 24 months
* Performance status 0-1
* DAN PSS score ≤ 20
* Maximal urinary flow ≥ 10 ml/s
* Life expectancy \> 5 years
* PSA ≤ 10 ug/L at recurrence

Exclusion Criteria:

* Pubic arc interference or major calcifications within the prostate gland.
* Contraindication for spinal or general anaesthesia.
* Conditions indicating that the patient cannot go through the radiation therapy or follow-up, or a condition where the treating oncologist thinks the patient should not participate in the trial, for example due to language problems.
* Inflammatory bowel disease
* Contraindications to 3T MRI
* eGFR \< 30 ml/min
* ≥ Gr 3 urinary toxicity at baseline as assessed by CTCAE 4
Evaluation of Different G6PD Testing Platforms

In this study the investigators propose to evaluate the performance of several G6PD testing platforms.

In this study we propose to evaluate the performance of several G6PD testing platforms. We will also determine the concordance between point-of-care G6PD tests and the spectrophotometric gold standard. This study will also access the sensitivity and specificity between the point-of-care G6PD tests. This study will take place in Indonesia, specifically in the SW Sumba region. We will enroll 700 volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least five years of age
* Patient / parental consent
* Patient willing to allow donated sample to be used in future research

Exclusion Criteria:

* Patients with severe malaria or other severe illness
* Patients who received a blood transfusion in the last three months
* Patients unwilling to allow donated blood to be used in future research
Measuring Subjective Visual Vertical (SVV) Using a Smartphone Application

A comparison between two methods evaluating SVV: Bucket Test and A smartphone-based test.


Eligibility Criteria:
Inclusion Criteria:

* Vestibular Disorder

Exclusion Criteria:

* Chronic ear disease, Neurological disorder, s/p Ear surgery
Study Of SU011248 In Combination With Docetaxel In Patients With Metastatic Breast Cancer

This study is to evaluate the safety of SU011248 (Sunitinib/Sutent) in combination with docetaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer with evidence of unresectable, locally recurrent or metastatic disease
* Candidate for treatment with docetaxel

Exclusion Criteria:

* Prior chemotherapy in the advanced disease setting
* Inflammatory breast cancer
* HER2 positive disease
Impact of the Covid-19 on RSV Epidemic in the Metropolis of Lyon

The magnitude of seasonal RSV epidemics brings each year new logistical challenges for the hospitalization of young infants with bronchiolitis that overwhelm hospital capacities and lead to specific winter plans with deprogramming and mobilization of human and logistical resources. The Covid-19 pandemic has changed the way winter epidemics are presented. For example, the seasonal RSV epidemic was shifted by several months in Lyon, with an impression of a lower incidence of hospitalized cases, with a population of older children and with fewer signs of clinical severity. This is largely attributable to the widespread use of barrier gestures and social distancing measures, known as "non-pharmacological interventions" or NPI. Given the magnitude of the reduction of the RSV epidemic, it is legitimate to analyze the benefits of NPIs to draw lessons for maintaining preventive measures around RSV-vulnerable populations; moreover, new preventive pharmacological interventions are soon to be marketed, whether they are particularly refined and long half-life anti-RSV monoclonal antibodies, RSV vaccines for mothers or for newborns and infants. In this perspective, it is crucial to properly define the populations at risk of severe disease to establish a legitimate hierarchy in the implementation of different preventive strategies. The study of the RSV epidemic is a high potential model because of the convergence of epidemiological, virological, and pharmacological knowledge. However, the study of the impact of the pandemic on the epidemiology of rhinovirus also seems promising because, for reasons unknown to date, it seems that the pandemic did not have the same reducing impact on the rhinovirus epidemic; in the latter case, the interest is to confirm the resistance of this virus and to look for more fundamental explanations, for example, on viral interactions.

On a previous study (see NTC 04944160), 519 infants were recruited in the Pre-Covid-19 season population, and 277 infants were recruited in the first Per-Covid-19 season population.


Eligibility Criteria:
Inclusion Criteria:

* Child hospitalized at " Hôpital Femme Mère Enfant ", Lyon, France
* Positive RSV-PCR

Exclusion Criteria:

* Parent's refusal to participate
Effect of Virtual Reality Glasses Application on Surgical Fear and Anxiety

Purpose and Type of Research:This study will be conducted to examine the effect of virtual reality glasses on surgical fear and anxiety in patients scheduled for cardiovascular surgery. The study is a randomized controlled experimental research.

Method:The population of the research was approximately 2900 patients who underwent cardiovascular surgery in a year at Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital. The sample size of the study was calculated using the G\*Power software program.The study will be completed with 60 people by taking 30 people into the experimental and control groups.Data will be collected with a personal information form, surgical fear scale and state anxiety scale.

Hypothesis of the Research:

H1: Application of virtual reality glasses reduces surgical fear in patients planned for cardiovascular surgery.

H2: Application of virtual reality glasses reduces anxiety in patients scheduled for cardiovascular surgery.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and over,
* Those who will undergo open heart surgery,
* Those who have not had cardiovascular surgery before,
* No communication problems,
* Is conscious and able to answer questions and does not have any disorder/disease that affects decision-making ability (dementia, Alzheimer's, etc.),
* Does not have a psychiatric disease such as anxiety disorder, panic attack, depression,
* Individuals who do not receive psychiatric treatment such as antipsychotics/anxiolytics will be included in the study.

Exclusion Criteria:

* Being under the age of 18,
* Not having open heart surgery,
* Those who have previously undergone cardiovascular surgery,
* Having communication problems,
* Those who are unconscious and unable to answer questions Having any disorder/disease that affects decision-making ability (dementia, Alzheimer's, etc.),
* Having a psychiatric disease such as anxiety disorder, panic attack, depression,
* Individuals receiving psychiatric treatment such as antipsychotic/anxiolytic will not be included in the study.
"Assessment of Risk Factors for Depression Treatment at a Safety Net Clinic"

The purpose of the study is to identify the barriers for effective treatment of depression, specifically whether modified CHIS Scale is a valid tool for identifying the high risk patients for depression.

Depression is a major illness that affects 10% of the population in a medical setting. It is often under diagnosed and under treated. It is an illness that can challenge a persons ability to perform even routine daily activities. Review of the charts of patients diagnosed with depression showed 80% of the patients do not have follow up appointments. We wondered if modified CHIS scale could identify the risk factors for medication non-adherence.

We hypothesised that modified CHIS Scale an effective tool ,for identifying the compliance of patients with the antidepressant medication.

We are conducting a retrospective cohort study at two of our residency based clinics by interviewing approximately 100 patients with CHIS Scale and PHQ9 Questionnaire on their office visits

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of depression before April 15, 2009
* At least one visit since April 15, 2008
* Age 18+

Exclusion Criteria:

* None
Defining an Immunological Signature Related to Lesion Location in Multiple Sclerosis

The objective of APOLLO is therefore to identify biomarkers associated with the CNS involvement phenotype in early MS patients.

This is a multicenter, non-interventional, retrospective cohort study. In MS patients, a recent study suggests that the location of lesions in the brain relative to the ME is associated with different effector T cell responses (Th17 vs. Th1) to myelin proteins. Thus, lesion localization may be associated with different immune profiles.

Recently, high-resolution techniques such as mass cytometry (CyTOF) have allowed to better decipher immune diversity and thus to identify new potential therapeutic targets. The combination of CyTOF and high dimensional analysis techniques (viSNE, SPADE, MEM) offers robust and reliable methods to identify new subgroups within heterogeneous cell populations. Several studies have explored immune subpopulations by these methods, including B, T, NK or myeloid populations, from peripheral blood or tissues in other pathologies.

Genetic analysis of regions of interest in MS patients could thus allow the establishment of stratification elements potentiating the contribution of immunological markers.

The main objective is to evaluate the relevance of an immunological stratification by CyTOF, allowing the identification of new immune subpopulations associated with the lesion phenotype (brain or brain + ME), in a cohort of MS patients at the beginning of the disease (CIS+) The second objective will focus on genomic profiling of our two groups of MS patients (brain/brain + ME) for different genetic burdens of MS

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically isolated syndrome (CIS) participating in the OFSEP cohort (French MS Observatory)
* At least 18 years old
* Diagnosed with MS according to the 2017 criteria at the time of their last visit
* Not opposed to participating in the study
* Had at least one visit in the year following sampling
* Followed up for at least 1 year after collection.
* Signed OFSEP consent form

Exclusion Criteria:

* CIS patients with progressive MS
An Observational Study of Type II Diabetics Treated With Dual Therapy With or Without Sitagliptin (Januvia®/Xelevia®, MK-0431-201)

This is an observational study to compare the effectiveness of dual therapy of Type II diabetes mellitus with metformin + sitagliptin versus metformin + a sulfonylurea in routine clinical practice in France.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes participants
* De novo treatment (first prescription or dated within the past 8 weeks) with:
* Metformin + sitagliptin dual therapy,
* Metformin + sulfonylurea dual therapy,
* Sitagliptin as part of another treatment regimen
* Participants also eligible for treatment with sitagliptin (Januvia®/Xelevia®) or a sulfonylurea.
A Novel fNIRS Neurofeedback Intervention for Enhancement of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD)

The proposed study is to test and validate a novel intervention that integrates computerized cognitive training with real-time neuromonitoring and neurofeedback to enhance working memory by probing the individualized neural systems underlying working memory. We will test the proposed intervention on children with ADHD with working memory deficits. The R61 proof-of-concept phase will assess the target engagement, effective dose and feasibility.


Eligibility Criteria:
Inclusion criteria include:

* Age from 7 to 11 years
* Diagnosis and/or current symptoms of ADHD
* Full-scale Intelligence quotient (IQ) ≥80
* Behavior Rating Inventory of Executive Functions (BRIEF), Working Memory Scale t-score \> 65
* Allowed comorbidities include oppositional defiant disorder, learning disabilities excluding dyslexia, and mild anxiety and/or depression.

Exclusion criteria:

* Presence of severe neurological or psychiatric disease other than those allowed under inclusion
* Sensory deficits that would preclude participation in assessments or imaging
* History of significant head trauma with loss of consciousness
* Contraindications to MRI (e.g. metal implants or claustrophobia)
* Enrollment in other intervention studies
EPO906 Therapy in Patients With Advanced Breast Cancer

This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause breast cancer.


Eligibility Criteria:
Inclusion Criteria:

The following patients may be eligible for this study:

* Histologically or cytologically documented evidence of disease with at least one measurable lesion;
* Life expectancy of greater than three (3) months;
* Patients who have had only one prior therapy for metastatic disease;
* Patients who have received prior treatment with hormonal agents or who have had prior treatment regimens of radiotherapy in addition to one or no previous chemotherapy regimens are eligible;
* Patients who have had no prior therapy for metastatic disease, but who have received a taxane and an anthracycline (single or combination therapy) as adjuvant treatment, are eligible. For patients who have had previous radiation therapy to the target lesion(s), the lesion(s) must since have demonstrated progression.

Exclusion Criteria:

The following patients are not eligible for this study:

* Bone-only disease;
* Symptomatic pleural effusions;
* Symptomatic CNS metastases or leptomeningeal involvement;
* Any peripheral neuropathy or unresolved diarrhea greater than Grade 1;
* Severe cardiac insufficiency;
* Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports;
* History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma ckin cancer or cervical cancer in situ;
* Active or suspected acute or chronic uncontrolled infection including abcesses or fistulae;
* HIV+ patients;
* Pregnant or lactating females;
* Patients who have had radiation, chemotherapy, or hormonal therapy within the last four (4) weeks excluding palliative radiotherapy to isolated peripheral bone metastases not being used as markers for efficacy;
* Patients taking Herceptin less than three (3) weeks prior to study start.
Longitudinal Study on the Influence of Iodine Nutrition Status on Thyroid Function of Childbearing Age Women During Pregnancy and 6 Weeks Postpartum

The goal of this observational study is to provide a reference for formulating individual appropriate iodine intake programs for women during pregnancy and postpartum and improving the monitoring and evaluation system of maternal iodine nutrition status. The main questions it aims to answer are:

* To analyse the longitudinal changes of urinary iodine, urinary iodine/creatinine ratio, thyroid function and related factors in different periods of early, middle, late pregnancy and 6 weeks postpartum in Beijing area.
* To explore the relationship between iodine nutrition status and the changes of thyroid function and to further clarify the effect of iodine nutrition status on thyroid function of women of childbearing age during pregnancy and postpartum in combination with dietary intake of iodine questionnaire.

Participants will be detected there thyroid function, the level of median urinary iodine and urinary iodine/creatinine.

Researchers will compare healthy women of childbearing age served as the control group in the same period.


Eligibility Criteria:
8-12 weeks healthy maternal:

Inclusion Criteria:

* primigravida
* no chronic hypertension, thromboembolic disease, severe gastrointestinal, cardiopulmonary and liver diseases before pregnancy
* no systemic lupus erythematosus, rheumatic diseases and other connective tissue diseases or immune diseases before pregnancy
* no adrenocortical hyperplasia, pituitary endocrine diseases and other diseases before pregnancy

Exclusion Criteria:

* multiple pregnancies and multigravida
* a history of type I or type II diabetes before pregnancy
* a clear history of thyroid diseases before pregnancy
* taking drugs that affect thyroid function and/or blood sugar before or during early pregnancy

Healthy women of childbearing age:

Inclusion Criteria:

* 20-40 years old
* no chronic hypertension, thromboembolic disease, severe gastrointestinal, cardiopulmonary and liver diseases
* no systemic lupus erythematosus, rheumatic diseases and other connective tissue diseases or immune diseases
* no adrenocortical hyperplasia, pituitary endocrine diseases and other diseases

Exclusion Criteria:

* a history of type I or type II diabetes
* a clear history of thyroid diseases
* taking drugs that affect thyroid function and/or blood sugar
Perforating Cutaneous Nerve Injection Efficacy in Chronic Coccydynia: A Randomized, Double-Blind Study

Interventions targeting the perforating cutaneous nerve are relatively new to the literature, with a safe side-effect profile but lacking high-quality studies. Their effectiveness remains at the level of case presentations. According to the hypothesis expressed in these publications, coccydynia might be an overlooked cause due to the compression of the perforating cutaneous nerve where it pierces the sacrotuberous ligament and becomes superficial. Ultimately, it is hypothesized that injection of dextrose into this ligament and the sensory area of this nerve will resolve these symptoms due to nerve entrapment, similar to other entrapment neuropathies treated with 5% dextrose, like carpal tunnel syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 50 years.
2. Chronic coccyx pain (≥3 months).
3. Pain Visual Analogue Scale (VAS) score ≥4.
4. Pain not alleviated by first-line treatment (physical therapy/oral analgesic therapy + sitting cushion).

Exclusion Criteria:

1. Injection to the area in the last 3 months.
2. Concurrent mechanical or inflammatory low back pain.
3. Coccyx pain that started during pregnancy or postpartum.
4. History of myelomeningocele or spina bifida.
5. History of sacrococcygeal luxation or subluxation (confirmed by radiography).
6. History of coccyx fracture.
7. Concurrent neurological deficit.
8. Skin disease affecting the injection area.
9. History of malignancy.
10. Pregnancy or breastfeeding.
11. Severe coagulopathy.
12. Infection at the injection site.
13. Neurological or psychiatric diseases, including ongoing depression (Beck Depression Inventory Score \>14).