cyrilzakka/clinical-trials huggingface dataset:
Guided Self-determination in the Treatment of Chronic Pain to Promote the Life Skills of the Patient

The purpose of this randomized study is to find out whether using the Danish-developed nursing intervention guided self-determination (GSD) can improve life skills of the chronic pain patient.

The hypothesis is "using guided self-determination in the treatment of chronic pain patients will increase the life skills of the patients and thus their life quality in spite of pain".

Twenty percent of the Danish population suffer from chronic pain, which leads to the second highest financial expense following psychiatric diseases. In treating chronic pain, the main focus is often on diagnosis and treatment rather than life quality and everyday life. Several studies point to the fact that the interaction between the health professional and the patient can be improved by the individual patient being educated in taking responsibility for his/her own illness, and by involving the patient in decision making through training communication.

GSD is an educational method, comprising 32 semi-structured reflection sheets inviting the patients in groups of 4 through 8 sessions of 150 minutes' duration to reflect on the patient's own situation and to be active in co-operation with the nurses.

A total of 192 patients will be included and randomized in either an intervention or in a control group. The difference between the two groups is measured by means of three questionnaires, SF-36, PAM and SOC, which are answered before and after the intervention as well as 6 months later.

The hypothesis is "using guided self-determination in the treatment of chronic pain patients will increase the life skills of the patients and thus their life quality in spite of pain".

An alliance is established between The Multidisciplinary Pain Clinic at Herlev Hospital and The Pain Clinic at Naestved Hospital as well as The Regional Pain Clinic at Koege Hospital to conduct this intervention and thus make the best possible use of interrelated knowledge within the issue.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older, diagnosed with nonmalignant chronic pain

Exclusion Criteria:

* patients who do not read, write and understand the Danish language
* patients with a known medical abuse
* patients needing special psychological and/or psychiatric intervention
* patients with health-related problems preventing them from participating in a group
VIDAS® TBI Real Life Performance in Subjects with Mild Traumatic Brain Injury (mTBI)

Decision Rules for an initial CT-scan in patients arriving to Emergency Department (ED) and presenting a mild traumatic brain injury could be optimized by the use of an objective parameter easily and rapidly measured. This may be the place for serum biomarkers providing a quick and accurate assessment. BioMérieux has now developed an automated assay for the measurement of serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase (UCH-L1), the VIDAS® TBI assay to fill out this unmet needs. The goal of the herein study is to generate real-world data and evidences to support the VIDAS® TBI performances.

The assessment of severity of TBI patients is based on the Glasgow Coma Scale (GCS) and the initial management in the ED includes performing a non-contrast brain Computed Tomography (CT) scan if the patient meets specific conditions. To date, real world data show that EDs would actually not follow guideline recommendations and a substantial CT overuse is observed. Management strategies are becoming more and more focused on selective CT use to effectively manage health care resources. Efforts have been made to optimize the indications for brain CT scan after mTBI. Although brain CT scan plays a central role after mTBI, there is an unmet clinical need for an objective tool to optimize indications for CT scan, reduce patient radiation exposure, and possibly predict patient outcome. Clinical Decision Rules for an initial CT-scan could be optimized by the use of an objective parameter easily and rapidly measured. This may be the place for serum biomarkers providing a quick and accurate assessment. BioMérieux has now developed an automated assay for the measurement of serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase (UCH-L1), the VIDAS® TBI assay to fill out this unmet needs. The goal of the herein study is to generate real-world data and evidences to support the VIDAS® TBI performances.

Eligibility Criteria:
Inclusion Criteria:

* Adult subject ≥ 18 years old
* Subject with a Glasgow Coma Scale (GCS) score between 13-15 on admission
* Subject presenting to the Emergency Department for suspected mild Traumatic Brain Injury
* Subject with a non-contrast head Computed Tomography (CT) scan ordered per the clinical site's care usual care
* Blood sampling possible within 12 hours of injury (1 tube of 4-5 mL of blood)
* Subject expected to stay at least 2 hours in the ED or in a ward
* Subject with signed Informed Consent Form (ICF)

Exclusion Criteria:

* Time of injury unknown
* Subject with non-traumatic neurological disorders (e.g, dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors, spontaneous intracranial haematoma)
* Neurosurgery, stroke or transient ischemic attack within the last 30 days
* Subject with an active cancer
* Subject with penetrating head injury
* Special populations, including women with known pregnancy, prisoners, or institutionalized individuals
The Effect of Hippotherapy Simulator in Cerebral Palsy

Hippotherapy simulators imitate the passive movements of the horse, producing simple movements similar to those of the horse. Hippotherapy simulators are intended to improve sitting balance, postural control and trunk balance.

The aim of this study was to research the therapeutic effects of hippotherapy simulator on sitting balance, trunk control and upper extremity skills in individuals with Cerebral Palsy (CP).

Spastic CP will be participate the study between the ages of 4 and 18 years. Children's classified with GMFCS and MACS.

The eligible participants will be allocated two groups, including hippotherapy simulator training group and traditional physiotherapy control group. All the assessments will be performed before and after the training in the 8-week training groups.

The control group individuals will be given a traditional physiotherapy two days per week for a total of 8 weeks (traditional physiotherapy session will last 45 minutes). Hippotherapy simulator training group will receive a traditional physiotherapy and hippotherapy simulator training, two days a week for a total of 8 weeks (30 minutes traditional physiotherapy session+15 minutes hippotherapy simulator training). All sessions will be performed in the clinic with the specialist physiotherapist.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Spastic Cerebral Palsy voluntary participation
* Age between 4-18 years,
* GMFCS Level I-II-III
* MACS Level I-II-III
* Have the ability to sit upright with support

Exclusion Criteria:

* Not voluntary to participate in the research,
* Botox in the last 6 months
* Hip or spine surgeries in the last 6 months
Telerehabilitation in Severe Acquired Brain Injury

We will investigate the use of TR, based on advanced Information and Communication Technology (ICT) solutions, taking into account that the supervision of rehabilitation at home will be enriched with the counselling and vital parameters monitoring. The aim of the study is to evaluate that TR is at least non-inferior in comparison with the same amount of usual territorial rehabilitative physical treatments (UTRT), taking into account patients' functional recovery, psychological well-being, caregiver burden, and healthcare costs. The enrolled patients will be balanced for pathology and randomized in two groups, performing TR (G1) or standard rehabilitation training (G2), respectively, according to a pc-generated random assignment.TR will be delivered by means of an advanced video-conferencing system, whereas the patient will be provided with low-cost monitoring devices, able to collect data about his/her health status and QoL. In both the groups each treatment (either cognitive or motor, or both as per patient functional status) will last about one hour a day, five days/week, for 12 weeks. Two structured telephone interviews will be administered to the patients (when possible) and/or their caregivers, and to all the healthcare professionals involved in the patient management, one week after the beginning and at the end of the TR.


Eligibility Criteria:
Inclusion Criteria:age range 18 to 65 years; diagnosis of SABI; availability at home internet connection.

Exclusion Criteria: severe cognitive and behavioral impairments, cardio-respiratory instability or other medical illness potentially interfering with the treatment, severe limb spasticity, high-risk of spontaneous fracture, substance abuse.
Randomized Trial of Coronary Angioplasty for de Novo Lesions in sMall vesSElS With Drug Eluting Balloon.

Significant lesions in small coronary arteries are frequently found (35%-50%) in patients with coronary artery disease. Independently of the type of coronary angioplasty the restenosis and the need for repeat revascularization remains the main limitation, representing a challenging problem even in the DES (drug eluting stent) era. Recently has been developed drug eluting balloons (DEBs), which have been successfully tested in small series on in-stent restenosis, but few evidence is available in the context of small vessels disease.

The current study has been designed to know, in one hand, the clinical efficacy of the Drug elluting balloon IN.PACT FALCON and, in other hand, the effectiveness, and the cost-effectiveness incremental analysis of DEBs (IN.PACT FALCON vs. DES ( RESOLUTE INTEGRITY) in patients with de novo lesions in small vessels.

Recent studies have reported the efficacy of the local application of paclitaxel ® inhibiting neointimal proliferation, and thus the limitation of restenosis, which has led to the conception and development of drug-coated balloon or "Drug Eluting Balloons" (DEB), releasing the antiproliferative drug at the time of expansion. Initially they were applied in the treatment of in-stent restenosis. However, DEB may represent a therapeutic alternative in other contexts where anatomo-clinical uses are not always therapeutic percutaneous coronary revascularization with stent implantation, as is the case of coronary lesions located in small vessels.

Eligibility Criteria:
Inclusion Criteria:

1. Older than 18, informed consent.
2. Evidence of CAD with severe de novo lesion in the native coronary arteries ( ≥70% stenosis by visual estimation or \>50% by CT scan); affecting
3. Vessels between 2,25 and 2,75 mm diameter and
4. The length of the coronary stenosis ≤25 mm
5. Patient informed consent form signed.

Exclusion Criteria:

1. Lesion in coronary left main ,
2. Chronic total occlusions,
3. Lesions at bifurcation,
4. Severe calcified lesions,
5. Lesions in aorto-coronary saphenous veins or arterial grafts,
6. Acute Myocardial Infarction during 48 hours before the procedure,
7. Severe renal dysfunction,
8. Hypersensibility, allergy or contraindication of medication: acetylsalicylic acid, clopidogrel, ticlopidine, heparin, paclitaxel,
9. Allergy to contrast media,
10. Life expectancy less than 1 year,
11. 1 year FU not guaranteed,
12. Being participating in another study.
An Expanded Access Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer Who Have Completed Clinical Study COU-AA-001

The purpose of this study is to provide access to abiraterone acetate for patients who have completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and continue to receive clinical benefit from this treatment.

This is an open-label (identity of study drug will be known) extended access study to evaluate the safety and efficacy of continued administration of abiraterone acetate in patients who have completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and continue to receive clinical benefit from this treatment. Patients will continue with the same dose regimen administered at the end of Study COU-AA-001 and will receive a low-dose glucocorticoid daily. Patients will be followed every 3 months for disease progression and survival for up to 3 years following study entry. Safety will be monitored throughout the study up to 30 days after the last dose of study medication.

Eligibility Criteria:
Inclusion Criteria:

* Completed 12 cycles of abiraterone acetate under study COU-AA-001
* Last dose of abiraterone acetate within 14 days prior to treatment in this study
* Demonstrates potential to gain clinical benefit with continued abiraterone acetate treatment
* Serum potassium level \>=3.5 mmol/L
* Eastern Cooperative Oncology Group Performance Status of \<3 (Karnofsky Performance Status \>=30%)
* Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

* Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
* Uncontrolled hypertension
* Abnormal liver function
* Clinically significant heart disease as evidenced by a myocardial infarction in the past 12 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease (patients with a history of atherosclerotic vascular disease requiring coronary or peripheral artery bypass surgery may be enrolled provided the surgery occurred at least 2 years prior to enrollment and after consultation with a cardiologist to insure that the disease is stable)
* Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
Clinical Wound Healing After Lower 3rd Molar Fully-impacted Surgery With 2 Types of Flap

The dehiscence distal to the second molar after lower third molar extraction is very common because the access flap for surgical extraction cannot be repositioned on a portion of healthy bone to guarantee suture support. The healing process is therefore delayed and the possible accumulation of food and debris is often responsible for bad smell and pain with the consequent occurrence of an overlapping infection.

The main aim of the study is to evaluate whether healing is significantly different using two different flaps for surgical access. Clinical assessment and a quality of life questionnaire are used for the evaluation.


Eligibility Criteria:
Inclusion Criteria:

* fully-impacted lower third molar
* patients aged between 18 and 35

Exclusion Criteria:

* patients undergoing drug treatment for systemic diseases that can influenced the healing process,
* pregnant women,
* smoking habits
* patients with disabilities
* all interventions in which intraoperative accidents involving the soft tissues occurred (laceration of the mucosa / flap).
Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2008/2009

Annual trial for registration influenza vaccine with the strain composition for season 2008/2009


Eligibility Criteria:
Inclusion Criteria:

* Subjects eligible for enrollment into this study are male and female adults who are:

  1. ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
  2. able to comply with all study requirements
  3. in good health as determined by:
* medical history
* physical examination
* clinical judgment of the investigator

Exclusion Criteria:

* They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to:

  1. Cancer, except for localized skin cancer;
  2. Advanced congestive heart failure;
  3. Chronic obstructive pulmonary disease (COPD);
  4. Autoimmune disease (including rheumatoid arthritis);
  5. Acute or progressive hepatic disease;
  6. Acute or progressive renal disease;
  7. Severe neurological or psychiatric disorder;
  8. Severe asthma.
* They have history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate);
* They have a known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:
* receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study;
* receipt of immunostimulants;
* receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;
* suspected or known HIV infection or HIV-related disease;
* They have a known or suspected history of drug or alcohol abuse;
* They have a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
* Women who are pregnant, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days);
* Within the past 12 months, they have:
* received more than one injection of influenza vaccine
* Within the past 6 months, they have:
* had laboratory confirmed influenza disease;
* received influenza vaccine;
* Within the past 4 weeks they have received:
* another vaccine;
* any investigational agent;
* They have any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days; 1 - They have experienced an acute exacerbation of a COPD within the past 14 days
Understanding the Determinants of Physical Activity Levels in Persons With Chronic Pain

The proposed research topic will investigate the determinants of physical activity (PA) levels in patients with chronic pain. The aim of the research project is to quantify the self-reported and free-living physical activity levels in people with chronic pain. Describe and explore the characteristics and relationships of these participants in terms of pain severity, fear of movement, patterns of activity, anxiety and depression, and number and differing types of long term conditions and how these all correlate with PA levels. Explore PA levels of chronic pain patients and the correlation of psychosocial factors.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with pain lasting more than 12 weeks (chronic pain)
* 16 years or older

Exclusion Criteria:

* None
Biodiversity in the Diet in Vietnam

Agricultural biodiversity can have an important role in improving diet diversity, quality and nutrition and can be seen as the foundation of the food and nutrition value chain. Increasing the availability and access to local agricultural and/or wild biodiversity genetic resources has the potential to increase production, making more food available for consumption as long as entitlements to access it exist. However, as the history of food security interventions has shown, increasing the production and supply of staple crops alone is not enough to improve food security or nutritional status. However, while agricultural diversification is an important component, it is not alone sufficient to improve diet diversity. Other system elements including women's education and knowledge, intra-household dynamics and women's status and cultural beliefs and practices that improves children's health and nutrition are important to ensure biodiversity has a successful role in improving dietary diversity and quality.


Eligibility Criteria:
Inclusion Criteria:

* villages: Characterized as Thai village. Only Thai villages will be selected for the study as agriculture practices, diets, food preferences, language and cultures can change drastically between ethnic groups.
* participants: i) Woman of reproductive age (between 15-49 years) who are the mother or primary caregiver of a child between 12 and 23 months of age. This age group is part of the critical 1000 day window for child development and marks the time when young children can potentially consume all foods from the household pot and consume a more diverse diet. As such, it is from this age group that biodiversity can have an effect on children's diets.

ii) Both the woman and the child should be permanent residents in the village selected and do not temporarily migrate outside the village cluster during the year.

Exclusion Criteria:

* villages: Urban center of commune/province as these villages/cities do not have agriculture or home garden opportunities
* participants: currently engaged in other agriculture or nutrition programme or intervention apart from what is offered by government extension workers
redoPOEM : Failure of a First POEM

observational study, measurement of efficacy in the cohort.

Achalasia is a motor disorder of the esophagus with a prevalence of 1/10000. Multiple treatments have been proposed, including endoscopic dilation, botulinum toxin injection and surgery using the Heller myotomy technique. These techniques are moderately effective and/or carry the risk of per- and post-procedural complications. POEM has been available since 2008, with 80-90% efficacy and 90% safety, and no serious complications have been reported. In the event of failure of a first POEM, a second POEM, known as "redoPOEM", can be proposed. Several studies show efficacy of between 76% and 96% and a safety of between 80% and 86%, with only one serious adverse event reported, and no deaths. However, the studies carried out involved small numbers of patients, generally around 50, the vast majority in Asian countries. The aim of this study was therefore to evaluate the efficacy and safety of redoPOEM reported in patients from several expert centers in Europe.

Eligibility Criteria:
Inclusion Criteria:

* adult patient
* diagnosis of achalasia based on clinical criteria according to Eckardt score, manometry, and radiology when available.
* failure after POEM (Eckardt score \> or equal to 4 in consultation) treated with a new POEM.
* no active digestive neoplasia.

Exclusion Criteria:

* Technical failure of redoPOEM
* Person not affiliated to a Social Security scheme
* Language barrier preventing fair collection of non-opposition.
Dose Finding Study In Subjects With Crow's Feet

The purpose of this study is to establish the therapeutic range of ANT-1401 in the treatment of Crow's Feet.


Eligibility Criteria:
Inclusion Criteria:

* 30 - 60 years of age
* mild to moderate Crow's Feet wrinkles at rest
* moderate to severe Crow's Feet wrinkles on contraction
* willingness to refrain from any product affecting skin remodeling
* female subjects must be not pregnant and non-lactating

Exclusion Criteria:

* history of peri-ocular surgery, brow lift or related procedures
* procedures affecting the lateral canthal region in the prior 12 months
* application of topical prescription medication to the treatment area
* female subjects who are pregnant or are nursing a child