cyrilzakka/clinical-trials huggingface dataset:
Impact of Remote Care in Patients Diagnosed With Thromboembolic Disease of Low Risk

The goal of this clinical trial is to learn about the feasibility and impact of remote care in patients diagnosed with thromboembolic disease of low risk. The main questions it aims to answer are:

* the evaluation of feasibility of organisation between different healthcare professionals (hospital physicians, primary care physician) at 6 months and 1 year
* the evaluation of complication rate, hospitalisation related to thromboembolic disease rate, compliance to treatment rate at 6 months and 1 year Participants will receive indication of treatment according to national recommendations. Additionnally, they will receive for the length of study a 4G tablet in order to fill questionnaires, learn information about their drugs (patient education), have a remote consultation and evaluate treatment compliance.


Eligibility Criteria:
Inclusion Criteria:

* patients identified in the emergency department with a thromboembolic disease, with a deep vein thrombosis or pulmonary embolism with a low risk of mortality according to recommendations
* affiliated or beneficiary of social protection

Exclusion Criteria:

* patient having a severe obstruction syndrome, a thromboembolic disease already under treatment or a suspicion of thrombocytopenia induced by heparin
* patient with an active hemorrhage or a major risk of hemorrhage, a renal severe failure, comorbidities such as cancer, or the impossibility to organise a consultation or a patient in a non favorable medico-social context
* patient with a caval thrombosis
* patient suffering of a disease at hemorrhagic risk or neurosurgery intervention done in the last month or other surgery in the last 15 days prior to inclusion
* patient with contraindication of direct oral anticoagulants, such as bitherapy with antiplatelet agent, imidazoles, macrolides, antiretroviral treatments or an anti-phospholipid syndrome
* patient that lives in an area not covered by internet
* patient that has no primary care physician
* patient not able to understand the study (language, psychological problem) or not able to read or write
* patient under legal protection
Chronic Pain and Vitamin D

Non-systematized chronic musculoskeletal pains are a frequent reason for consulting in general practice. The possible causes are numerous and sometimes nonspecific. In some cases, the etiologic investigation of patients with non-systematized and chronic musculoskeletal pain can not highlight any organic cause. Several studies have shown a link between these symptoms and vitamin D deficiency, characterized by a blood level of 25 (OH) vitamin D \< 20.8ng/ml. This deficit is easy to identify and to correct through proper vitamin D supplementation with few side effects. Nevertheless, it remains unknown and vitamin D deficiency is rarely considered as a possible etiology in patients with chronic pain. We hypothesize that vitamin D supplementation in patients with non-systematized musculoskeletal pain and deficient in vitamin D could improve painful symptoms. We aim to perform a double-blind randomized controlled trial, vitamin D versus placebo, to assess the pain improvement after vitamin D supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Women and men
* Aged 18-50 years (included)
* Consulting their general practitioner
* With chronic and diffuse musculoskeletal pain, without known etiology, lasting for at least 3 months
* With a 25(OH)vitamin D deficiency \<20.8 ng/ml (52 nmol/l) at inclusion
* Who signed the consent form

Exclusion Criteria:

* Identifiable source of pain requiring an appropriate specific management
* Disease or treatment that may interfere with the metabolism of vitamin D
* Current or previous hypercalcemia or hypercalciuria, treatment with digitalics and patients with history of nephrolithiasis
* Current treatment with vitamin D or at least one vitamin D vial taken over the previous 6 months
* Pregnancy or breastfeeding
* not affiliated to a social security system
* Refusal or inability to give consent
Effect of Extra-curricular Sports Activities After School on Primary School Children's Academic Performance

The process of urbanization and the rapid development of information technology have greatly reduced the space and time available for children's outdoor activities. In this study, we expect to study the effects of the addition of physical education classes after school on the academic performance, mental health, physical fitness, and myopia among primary school children.

Urbanization has led to a shrinking of the space suitable for residential activities and a dramatic change in the behavioural patterns, which is particularly evident in children. The spread and development of information technology has reduced children's time for physical activity. Previous studies have found that physical activity is essential for the growth and development of adolescents, preventing and reducing obesity, slowing the development of myopia, and is closely linked to mental health. However, parents in China are concerned that increased outdoor activity will reduce the amount of time spent studying and affect academic performance. Currently, there is a lack of strong evidence on the impact of physical activity on academic performance. In this study, we propose to provide after-school physical education classes for students in primary schools in a rapidly urbanizing area, and assess the effects of the intervention on children's academic performance, physical fitness, myopia, and mental health to provide evidence for the development of educational programs and arrangements for after-school activities.

Eligibility Criteria:
Inclusion Criteria:

1. Pupils in the third and fourth grades of primary schools in Yudu County;
2. Voluntary participation in this study with consent and informed consent signed by guardians.

Exclusion Criteria:

* Exclusion criteria for school

  1. Lack of a third or fourth grade;
  2. Average class size less than 30 students;
  3. No conditions for two classes to play sports at the same time.
* Exclusion criteria for students 4. Two or more days Monday to Friday not available to participate in studies under the project programme; 5. Unsuitability for health or physical reasons to participate in sports activities; 6. Refusal to sign informed consent.
Assessment of Exercise Capacity in Virtual Reality

The 20th century brought a dynamic development of new technologies, including virtual reality (VR). VR is an artificial image generated by IT technologies. It is most often associated with entertainment, but has a much wider application in other fields. The aim of the study is to assess the influence of the application of immersive virtual reality during an exercise capacity test on a bicycle ergometer.

Scientists suggests that there are four types of virtual reality: immersive virtual reality, desktop virtual reality (i.e., low-cost homebrew virtual reality), projection virtual reality, and simulation virtual reality. The sense of presence or immersion is a critical feature distinguishing virtual reality from other types of computer applications. It seems interesting whether immersion in virtual reality can influence the assessment of exercise capacity. The aim of the study is to assess the influence of the application of immersive virtual reality during an exercise capacity test on a bicycle ergometer. It is assumed that an exercise capacity test on a cycloergometer will be performed in a traditional form and in a virtual reality.

Eligibility Criteria:
Inclusion Criteria:

1. Female and male, age: 20-25 years

Exclusion Criteria:

1. diagnosed internal diseases
2. diseases and injuries of the locomotors system impairing the function of transport 3 Cognitive disorders preventing contact with the patient, Mini-Mental State Examination \< 24 points.
CHIPS (Control of Hypertension in Pregnancy Study): A Pilot Trial

Prior to undertaking CHIPS which will be a large and difficult trial, we believe we need to first determine whether clinicians will comply with the interventions of 'less tight' and 'tight' control of dBP, and whether the interventions will result in differences in mean dBP between groups. A pilot will also allow us to confirm the ability of centres to identify eligible women and the willingness of women to join CHIPS.

To determine whether 'less tight' control of mild-moderate non-proteinuric maternal hypertension, aiming for a diastolic blood pressure (dBP) of 100mmHg, can decrease the risks of adverse perinatal outcome without increasing maternal risk compared with 'tight' control, aiming for a dBP of 85mmHg.

Eligibility Criteria:
Inclusion Criteria:

* dBP 90-109mmHg due to pre-existing or gestational hypertension; live fetus(es); and 20-33+6 weeks.

Exclusion Criteria:

* dBP consistently \< 85mmHg by home BP monitoring; severe systolic hypertension; proteinuria; contraindication to either arm of the trial or to prolongation of pregnancy; or known lethal/major fetal anomaly.
A COMbined progRamme of Exercise and Dietary ADvice in mEn With Castrate Resistant Prostate Cancer

The proposed study will assess the feasibility of an exercise and dietary intervention in men with castrate resistant prostate cancer with secondary outcomes assessing improvements in physical functioning, fatigue, quality of life, and body composition.The study will have 2 arms, with one set of participants randomized to resistance exercise training intervention plus dietary advice and the other arm will be standard of care plus exercise advice.

Although there have been advances in recent years, therapeutic options remain limited for men with castrate resistant prostate cancer (CRPC). There is an unmet clinical need for interventions which can improve quality of life, functional capacity and cancer related fatigue. Adjunctive exercise therapy could be a potentially effective treatment for these men. A growing body of evidence has demonstrated numerous benefits in physiological and psychosocial outcomes in men with advanced prostate cancer. Further, there is observational evidence linking physical activity with reduced disease specific mortality after a diagnosis of cancer. Observational data also indicates that preserving skeletal muscle mass can improve responses to chemotherapy. The proposed study will assess the feasibility of an exercise and dietary intervention in men with castrate resistant prostate cancer with secondary outcomes assessing improvements in physical functioning, fatigue, quality of life, and body composition.

Eligibility Criteria:
Inclusion Criteria:

* Men with Castrate resistant prostate cancer
* Men with histologically confirmed PCa on long-term ADT with either

  * PSA\>2ng/ml above nadir or PSA level that has risen serially on at least two occasions (each at least 4 weeks apart) in the presence of castrate levels of testosterone or;
  * Evidence of symptomatic disease progression whilst undergoing first line androgen deprivation therapy (ADT) in the presence of castrate levels of testosterone or;
  * Radiographic disease progression whilst undergoing first line ADT in the presence of castrate levels of testosterone

Exclusion Criteria:

* • Participation in other trials which might bias the evaluation of the primary objectives of the present study.

  * Current participation in regular physical activity (defined as purposeful physical activity of a moderate intensity for 90 minutes per week for at least six months).
  * Unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers.
  * Uncontrolled painful or unstable bony metastatic lesions.
  * Within two months of invasive surgical treatment (transurethral surgery allowed).
  * Any physical, neurological or psychiatric impairment or disease or other condition that would limit the ability to understand and complete the study assessments and complete the required questionnaires, recall and record of dietary information would be excluded.
Percutaneous Coronary Intervention Registry FRIBOURG

The registry aims to follow clinically all consecutive patients treated by percutaneous coronary interventions at hospital \& university Fribourg.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients treated by percutaneous coronary intervention at our institution
* Able to give informed consent and willing to participate

Exclusion Criteria:

* Unwillingness to participate
* Enable to provide inform consent
A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects

The primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every 2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) when used in addition to statin therapy in Japanese adults with hypercholesterolemia and high cardiovascular risk.


Eligibility Criteria:
Inclusion Criteria: Japanese adult, on statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks, fasting LDL-C greater than or equal to 115 mg/dL (3.0 mmol/L), fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L); Exclusion Criteria: New York Heart Association (NYHA) class III or IV, poorly controlled hypertension, recently diagnosed or poorly controlled type 2 diabetes, last known left ventricular ejection fraction \< 30%, myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), stroke, planned cardiac surgery or revascularization within 6 months of randomization, uncontrolled cardiac arrhythmia.
Pharmacokinetic Evaluation of MDZ028

Plasma concentration data were collected from 37 paedriatic patients and 12 healthy adults recruited in a single dose, open-label phase II pharmacokinetic study and in a single dose, randomised, open-label two-peiod crossover bioavailability study, respectively. Data were analysed using non-linear mixed effect modeling.

In the absence of a licensed formulation in many countries worldwide, ADV6209, an innovative 2mg/ml oral solution of midazolam containing cyclodextrin, has been developed for moderate sedation in paediatric patients. Population pharmacokinetics for ADV6209 is reported.

Plasma concentration data were collected from 37 paedriatic patients and 12 healthy adults recruited in a single dose, open-label phase II pharmacokinetic study and in a single dose, randomised, open-label two-peiod crossover bioavailability study, respectively. Data were analysed using non-linear mixed effect modeling. Plasma concentrations of midazolam were discribed by a two-compartement model. An additional one-compartement model was added for a α-hydroxymidazolam.

Eligibility Criteria:
Inclusion Criteria:

* Child (boy or girl) for whom surgery under general anesthesia is scheduled.
* Child aged 6 months to 17 years old.
* Child with a body mass index between the 3rd and 97th percentile.
* Child with ASA (American Society of Anesthesiology) status of I or II. Young girl of childbearing age (ie after puberty) and sexually active to have a result negative to the pregnancy test.
* Child whose parents / legal representative (s) agree to sign a consent form.
* Child whose opinion / agreement was / tried to be collected.
* Child and parents / legal representative (s) being ready and able to participate in the study, understanding and undertaking to respect the study procedures throughout the duration of the study.
* Child enrolled in a social security scheme.

Exclusion Criteria:

* Child with midazolam allergy, benzodiazepine hypersensitivity or hypersensitivity known to one of the excipients of the formulation of the study.
* Child with respiratory disease (severe respiratory failure, acute respiratory depression).
* Child with heart disease.
* Child with gastrointestinal disorders that may affect absorption or gastroesophageal reflux.
* Child with growth disorders or abnormal weight-of-weight.
* Child taking Cytochrome P450 Interactions Within 60 Days of Inclusion in the study.
* Child with kidney failure, liver failure, history of myasthenia gravis, or neurological disease.
* Pregnant or lactating girl.
* Child who has a known human immunodeficiency virus (HIV) infection, or active hepatitis B, or active hepatitis C.
* A child who could present any condition that may prevent his participation in the study, according to the judgment of the investigator.
Rehabilitation Training Games for Children With Amblyopia

A gamification product was developed to guide children with amblyopia to develop rehabilitation training habits by combining cognitive evaluation theory and occlusion therapy. A randomized controlled trial was conducted to examine the ease of use, acceptability and treatment compliance of the game.

The experimental group was subjected to a 20-minute daily, 4-week intervention experiment, which included a story background on the start page, eye patches to be put on according to the guidelines, fine eye training, and visual stimulation training, with short breaks between the different modes. The control group was given an experimental intervention using a competing product, with the same duration and format as the experimental group. After completion of the intervention, the participating children completed the MMAS-8 adherence scale with the help of their parents.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of amblyopia (including refractive amblyopia, strabismic amblyopia and mixed).
* The child has no significant IQ deficits and has no difficulty communicating with others.
* The children's teachers and parents gave their informed consent to participate in the experiment. The informed consent form was signed by the parents and is shown in the Appendix.

Exclusion Criteria:

* Severe amblyopia.
* Suffering from other psychological or physical disorders.
* Parents did not agree to sign the informed consent form or the child was not willing to participate in this experiment.
Hyaluronic Acid and Polynucleotides for Supra-bony Defects

The goal of this pilot study is to describe the early wound healing molecular events and the vascularization pattern associated with the treatment of supra-bony defects with access flap alone or in association with a combined formulation of hyaluronic acid and polydeoxyribonucleotides gel.

This is a parallel-group, pilot study aiming that consists of 7 visits over a minimum period of 4 months. Up to 24 periodontitis patients presenting with supra-bony defects will be recruited at the Centre for Oral Clinical Research (COCR) at the Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, United Kingdom.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy males and females ≥18 years old
* Stage III or IV periodontitis (Papapanou, Sanz et al. 2018)
* Presence of supra-bony periodontal defects (i.e., defects where the base of the pocket is located coronal to the alveolar crest and characterized by a predominantly horizontal pattern of tissue destruction) confirmed clinically and radiographically at a minimum of two and a maximum of four adjacent teeth and with a probing pocket depth (PPD) \> 5 mm, following non-surgical periodontal therapy (NSPT). If \>4 adjacent teeth exhibited the above clinical and radiographic conditions, the four adjacent teeth showing the greatest overall loss of periodontal attachment were included. Wisdom teeth and second molars will not be considered for the study.

If defect presents with an intrabony component, this should be ≤2 mm.

* Non-surgical periodontal treatment (step 1 and 2) completed within the previous 4 months
* Full-mouth bleeding score (FMBS) and full-mouth plaque score (FMPS) ≤20%

Exclusion Criteria:

* Teeth with degree III mobility
* Multi-rooted teeth with grade ≥2 furcation involvement
* Heavy smokers (≥10 cigarettes a day)
* Untreated caries or endodontic lesions or abscesses on the teeth involved in the surgery
* Previous periodontal surgery in the area selected for the study
* History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures (e.g., mitral valve prolapse, artificial heart)
* Antibiotic or anticoagulant therapy during the month preceding the baseline exam.
* History of alcohol or drug abuse
* Medical history that includes uncontrolled diabetes or hepatic or renal diseases, or other serious medical conditions that can have a negative impact on the periodontal condition
* In treatment with medications that can severely affect bone metabolism and blood clot formation (e.g., anticoagulants, long-term corticosteroids, bisphosphonates, immunosuppressants)
* Self-reported pregnancy or lactation.
A CpG-methylation-based Assay for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Treatment

Whether patients with stage III clear cell renal cell carcinoma(ccRCC) should receive adjuvant targeted therapy or not is still on debate. The investigators invented a assay consisting of 5 CpGs: cg00396667（PITX1）, cg18815943 （FOXE3）, cg03890877（TWF2）, cg07611000 （EHBP1L1）and cg14391855（RIN1）that was successfully categorise patients with stage III clear cell renal cell carcinoma into high-risk and low-risk groups with Harzard Ratio(HR) of 4.93. Here the investigators randomly assign assay-defined high risk patients of locally advanced ccRCC into adjuvant targeted therapy group and observation group.Disease free survival and overall survival are the end points of observation.

The investigators' CpG-methylation-based assay contains 5 CpGs: cg00396667（PITX1）, cg18815943 （FOXE3）, cg03890877（TWF2）, cg07611000 （EHBP1L1）and cg14391855（RIN1）. The investigators evaluate the CpG methylation status of surgical specimens using pyrosequencing and calculate their risk score\[risk score=(0.0066×PITX1)+(0.0034×FOXE3)-(0.027×TWF2) -(0.018×EHBP1L1)-(0.03×RIN1)\], risk score ≥-0.1 as assay-defined high risk status and risk score\<-0.1 as assay-defined low risk status. The investigators randomly assign assay-defined high risk patients of stage III ccRCC into intervention group and control group. The intervention group should receive adjuvant targeted therapy while the control group deserve observation. Primary endpoint is the disease free survival and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* The informed consent has been obtained from the patient.
* With confirmed diagnosis of stage III clear cell renal cell carcinoma
* With moderate/good ECOG health rating (PS): 0-1 score.
* The patient receive no anti-cancer treatment before primary surgery.
* The patient receive radical operation for renal cancer with negative margin.

Exclusion Criteria:

* With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
* With bad compliance or contraindication to enrollment.
* Pregnant woman or lactating woman.
* With contraindication to receive adjuvant targeted therapy.