cyrilzakka/clinical-trials huggingface dataset:
Motivational Interviewing and Practice of Physical Activity in Patients With ALD

Since 2017, ALD patients can be prescribed Adapted Physical Activity (APA) on prescription. However, this possibility of prescription remains relatively unknown and little used by doctors, while the benefits of APA in particular in chronic diseases are well established and 30% of adults in France do not reach the recommendations of WHO on physical activity. These obstacles to prescription are well known thanks to studies on the subject (lack of information on Sport-Health networks, lack of training in APA prescription, poor financial support, lack of support for deliver to patients).

To overcome this lack of implementation, the city of Amiens, via the Office des Sports d'Amiens Métropole (OSAM), has implemented since September 2022 tools to help prescribe APA: blocks pre- filled certificates of absence of contraindication and prescription of adapted physical activity.

In other areas of health, such as breastfeeding, performing motivational interviewing has improved patient compliance. Patients with chronical disease consult a doctor from the Amiens metropolitan area recruited beforehand who informs them of the existence of the physical activity promotion program of Amiens Métropole. After obtaining their consent and establishing a certificate of no contraindication, the patients will be randomized by a random draw into two groups: motivational interviewing (ME) and control group (GT). Upon entry into the program, all patients will be seen for an assessment of their physical condition at the premises of Amiens Métropole by a teacher in adapted physical activity (APA) in order to be assessed and directed to a club or a approved associations. The EM group will also benefit from a motivational interview at 0 and 3 months by a doctor trained in the technique. The entire cohort will complete the SF12 (perception of quality of life) and IPAQ (current level of physical activity) questionnaires at 0 and 6 months during the usual appointments with the APA teacher.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic disease (ALD)
* aged 18 and over, autonomous in their ability to move
* living in the metropolis of Amiens

Exclusion Criteria:

* contraindication to the practice of physical activity;
* patient under guardianship, curators,
* safeguard of justice ;
* patient deprived of liberty ;
* pregnant woman ;
* patient who not benefiting from a social security scheme
Human-Prosthetic Interaction: Brain & Technology After Lower-Limb Loss

This study evaluates brain neuroplasticity and functional performance in people with unilateral lower limb amputation.

The researchers will investigate the beneficial effect of a passive prosthetic ankle (Lunaris®) on functional physical performance, brain neuroplasticity and movement patterns compared to conventional prosthetic feet and able-bodied individuals.

The clinical trial will comprise four test days for participants with a lower limb amputation and two days for the control group of able-bodied individuals.

The able-bodied individuals will undergo an MRI scan at the University Hospital Brussels (dpt. Radiology and Magnetic Resonance) and perform functional performance tests.

Participants with a lower limb amputation will start the clinical trial upon the start of their rehabilitation. At week 0, when initiating the rehabilitation, participants will undergo a baseline MRI scan at the University Hospital Brussels (dpt. Radiology and Magnetic Resonance). Then, they will be allocated to the intervention arms (Lunaris® or the SACH foot®) and will conduct their rehabilitation to learn to walk with a prosthesis. At the end of the rehabilitation, after 12 weeks, participants will perform baseline functional performance tests, fill out the prosthetic evaluation questionnaire (PEQ) measuring the quality of life. Between weeks 12 and 24 of the clinical trial (i.e. intervention period), participants will perform their daily activities with the allocated prosthesis. During weeks 12 - 24, trying out new prosthetic devices will be allowed within the group of individuals wearing the SACH foot® as this is considered the usual care. At the end of this period (after week 24), the post-test assessment will take place and participants will undergo the same MRI and functional performance tests and fill out the PEQ as during the baseline assessments to evaluate the changes that occurred. Additionally, participants will be asked to fill out the Quebec User Evaluation of Satisfaction with Assistive Technology. The 12-week intervention period is chosen based on a study examining the effect of 12 weeks of balance training in healthy and older adults on neuroplasticity and the accommodation time to walking with a new prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral transtibial (below knee) amputation
* Healthy subject
* Medicare Functional Classification Level: K3-4

Exclusion Criteria:

* Any neurological disease
* Upper limb or bilateral amputation
* Osso-integration
* Metal implants
* Diabetes
Host-pathogen Interaction in Otitis Media

Otitis Media (OM) is one of the most frequent diseases in childhood and the primary reason for children to visit a physician. In many countries it is the most common reason to prescribe antibiotics leading to increased drug-resistance of the causative agents, or to undergo surgery. Costs for general health care are expanding, and are estimated to be 3-5 billion dollar annually in the United States. Prevention is suspected to be an important solution to this problem.

Although OM management has no universal standard yet, it may imply watchful waiting, antibiotic treatment, adenoidectomy, insertion of tympanostomy tubes and (future) vaccination. Approximately 80% of the acute otitis media (AOM) cases is self-limiting within 2-14 days and also otitis media with effusion (OME) resolves spontaneously: 60% of newly detected OME resolves within 3 months. However, in a significant part of the OM population persistent or recurrent episodes of OM are responsible for a significant morbidity for both children and parents, despite variable treatment options.

Through the set up of a new prospective cohort in a clinical setting, relevant patient characteristics, the role of bacterial and viral pathogens, the role of recurrent infection in relation to biofilm formation, and the host response at protein level will be studied in detail. This project is expected to increase the understanding of the underlying mechanisms of OM disease, which will support future treatment and prevention strategies. Better understanding in OM pathogenesis is warranted in order to develop these novel preventive strategies.


Eligibility Criteria:
Inclusion Criteria:

* children up to 5 years of age
* suffering from rAOM, COME or CSOM
* waiting for tympanostomy tube insertion
* informed consent

Exclusion Criteria:

* No informed consent
* The child has a malignancy, or organ transplantation, or immune deficiency in the medical history
* The child had recent elective ear surgery (i.e. mastoidectomy, implants \<2 weeks ago)
* The child suffers from systemic infectious diseases (i.e. hepatitis, chickenpox)
Study of AMD3100 (Plerixafor) and Rituximab in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

The purpose of this research study is to determine if plerixafor can make CLL/SLL (Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma) cells more sensitive to being killed by rituximab, an anti-cancer drug that is commonly used in treating CLL and SLL. In this study, plerixafor will be added to standard treatment with rituximab. Subjects will be monitored to see how well they tolerate the use of these drugs together and how well they work to treat the leukemia.

The primary objective is to determine the maximum tolerated dose (MTD) of plerixafor when combined with rituximab as treatment for previously treated patients with CLL or SLL.


Eligibility Criteria:
Inclusion Criteria:

* Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period or be surgically sterile. Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during treatment and for 3 months after the treatment period or be surgically sterile.
* Diagnosis of CLL or SLL, relapsed from at least one prior therapy.
* CLL/SLL cells expressing CD20 documented during screening.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
* Life expectancy of at least 12 weeks.
* Serum creatinine ≤2.0 mg/dL.
* Total bilirubin ≤2.0 mg/dL.
* ALT (alanine aminotransferase) and AST (aspartate aminotransaminase) ≤2 times the upper limit of normal (ULN); for patients with liver involvement of CLL/SLL disease, this limit is increased to ≤5 times the ULN.
* At the time of enrollment, patients must be \>4 weeks since major surgery, radiotherapy, chemotherapy (\>6 weeks for some chemotherapies), immunotherapy, biotherapy/targeted or investigational therapies and recovered from the toxicity of prior treatment to ≤ grade 1.

Exclusion Criteria:

* White Blood Cells (WBC) \>250 x 10\^9 cells/L.
* Disease refractory to rituximab therapy- defined as a failure to respond to prior rituximab-containing regimen.
* Women who are breastfeeding.
* Active viral hepatitis.
* Active infection or treatment with antimicrobial or antiviral therapy within 1 week of enrollment with the exception of prophylactic therapy.
* History of prior allergic reaction to plerixafor or rituximab.
* Significant lung disease.
* Serious cardiac disease such as a history of sustained ventricular arrhythmia, uncontrolled and serious congestive heart failure (CHF), angina, acute coronary syndrome, or myocardial infarction within 6 months of enrollment or other significant medical or psychosocial conditions that warrants exclusion.
Varian ProBeam360° Proton Therapy System China Clinical Trial (Wuhan)

This study is a clinical trial of prospective, single-center, single-arm objective performance criteria. This trial will be conducted with a total of 47 participants enrolled. All participants will be treated with radiation therapy using the medical device of Varian ProBeam360° Proton Therapy System (ProBeam360°), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration.

Tumors sites include Intracranial, head and neck, chest, abdomen, spine, pelvic cavity, extremity and other sites. The screening period from informed consent to enrollment is expected to be 4 weeks, while the treatment period is 1 to 8 weeks. The period after the last treatment is divided into short-term follow-up which is 3 months after treatment completion and long-term follow-up which is 5 years after treatment completion. The clinical trial with short-term follow-up fulfills the requirements for NMPA regulatory registration. All the end points claimed will be achieved in the short-term follow-up stage. The trial is defined as completion once short-term follow-up is finished.

And long-term follow-up report will be submitted for future post market evaluation when requested by NMPA.

Eligibility Criteria:
Inclusion Criteria (Major Criteria):

* Confirmed by cellular or histopathological diagnosis and/or evidence of imaging or laboratory tests, with a clinical diagnosis of benign, Patients with malignant intracranial tumors, as well as malignant solid tumors of the head and neck, chest, abdomen, spine, pelvis, and extremity;
* The target lesion is a measurable solid tumor, and the longest diameter of the lesion should be ≥10mm;
* Those who have an expected survival time of more than 6 months;
* Eastern Cooperative Oncology Group (ECOG) physical status is graded as 0\~2;
* Females of childbearing potential with a negative blood or urine pregnancy test result within 7 days prior to the first treatment;

Exclusion Criteria (Major Criteria):

* Patients with contraindications to radiation therapy, including those with a known genetic predisposition to enhance the sensitivity of normal tissue radiotherapy or concomitant conditions leading to hypersensitivity to radiotherapy
* Patients with uncontrolled tumors other than the tumors to be treated, or patients with extensive metastases based on medical history or as judged by the investigator
* Proton radiation therapy area includes implanted pacemakers, defibrillators, cochlear implants, drug infusion pumps, other nerve stimulators, etc. (whether turned on or not); or passive implants that affect radiotherapy
* Tumor interventional treatment for the same lesion within 30 days prior to screening, such as transarterial chemoembolization (TACE), thermal ablation, etc.;
Treatment of Hemorrhoid With 1940nm Laser Procedure

Patients with hemorrhoids 2-3 st will be treated with laser 1940nm or sclerothearapy with Aethoxysklerol

Prospective randomized, control study. Patients with hemorrhoids 2-3 will be randomized in two groups. 100 patient in each. Patients will be treated with laser 1940nm or sclerothearapy with Aethoxysklerol.

Follow up for one year. Primary end point - recurrence of hemorrhoids desease.

Eligibility Criteria:
Inclusion Criteria:

hemorrhoids 2-3st

Exclusion Criteria:

Acute hemorrhoids IBD psychosomatic diseases previous surgical interventions
Comparison of Monodose and Multidose Presentations of GSK Biologicals' Hepatitis B Vaccine in Terms of Immune Response

GSK Biologicals' currently licensed multidose hepatitis B vaccine will be compared to the currently licensed monodose hepatitis B vaccine in a population with well documented hepatitis B immunological response to the vaccine (Belgium).

Randomized study with two groups. One group will receive GSK's multidose hepatitis B vaccine and the other group will receive GSK's monodose hepatitis B vaccine

Eligibility Criteria:
Inclusion criteria:

* A male or female \>= 18 years of age
* Written informed consent obtained from the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
* Previous vaccination against hepatitis B
* History of hepatitis B infection
* Known exposure to hepatitis B within the previous 6 weeks
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
* Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature \< 37.5°C (99.5°F) / Axillary temperature \<37.5°C (99.5°F).
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions during the study period.
THE PHYSIOLOGICAL EFFECTS OF ELECTROMAGNETIC EMISSIONS ON THE GENERAL CONDITION OF THE PATIENT

Hospital patients usually experience anxiety caused by physiological, psychological and environmental stimuli. This emotional state corresponds to the psychophysiological response to a perceived threat.

The investigator's goal is to use a non-drug approach to these problems which would help improve the quality of life of patients, prevent the consumption of anti-anxiety drugs / antidepressants; and thus to reduce the direct cost in terms of treatment, but also to reduce the indirect costs linked to work stoppages and the consumption of the care offer.

Working hypothesis: Local magnetic muscle stimulation improves people's well-being and relaxation

Primary objective :

Describe the effect of the intervention on the level of anxiety / depression in patients with anxious and / or depressive characteristics

Secondary objectives:

* Describe the variation in the quality of life of patients before and after the intervention
* Describe the variation in drug consumption
* Describe the use of post intervention hospitalization
* Describe the variation in the quality of sleep before and after the intervention
* Describe the timeframe for returning patients to professional activity

Eligibility Criteria:
Inclusion Criteria:

* Major patient hospitalized for the management of a chronic pathology and / or its complications;
* Patient with a Hospital Anxiety and Depression scale score (HAD) ≥ 8 for items assessing anxiety disorders; AND a HAD score ≥ 8 for the items assessing depressive disorders.
* Subject affiliated to a social security scheme or beneficiary of such a scheme
* No participation in another clinical study

Exclusion Criteria:

* Minor patient
* Pregnant and breastfeeding women
* HAD score \<8 for items evaluating anxiety disorders OR a HAD score \<8 for items evaluating depressive disorders
* Major subject protected by law, under curatorship or tutorship
Safety and Efficacy of ALC in Breast Cancer in Subjects With Fatigue

The objective of this study is to evaluate the efficacy and safety of ALC in the treatment of non-anemic, breast cancer subjects who develop moderate or severe fatigue during adjuvant radiotherapy.

The objective of this study is to evaluate the efficacy and safety of ALC in the treatment of non-anemic, breast cancer subjects who develop moderate or severe fatigue during adjuvant radiotherapy

Eligibility Criteria:
Inclusion Criteria:

* Stage 0-III breast cancer in which adjuvant radiation is indicated;
* Qualifying Brief Fatigue Inventory (BFI) score 6. -

Exclusion Criteria:

* Medication to treat or manage fatigue and pain
* Use of erythropoietin to control anemia
* Clinical evidence of hypothyroidism or hyperthyroidism
Take-Care Program: Effectiveness of a Physical Therapy Program on Cancer Related Symptoms

Effectiveness of a physical therapy program focussed on core stability exercise and massage as a recovery method in breast cancer survivors after oncology treatment.

Eligibility Criteria

1, had a diagnosis of breast cancer (stage I-IIIA); 2, between 25-65 years; 3, finished co-adjuvant treatment except hormone-therapy; 4, not having active cancer; 5, interest to improve their lifestyle increasing physical activity; and, 6, present 3 to 5 of the following physical findings, judged by the oncologist who referred the patient: neck or shoulder pain symptoms, reduced range of motion in neck- shoulder area, reduced physical capacity, any psychological problem, increased fatigue, sleep disturbances, or any problem in coping with reduced physical and psychosocial functioning.

Principal Outcomes Fatigue Score: Piper Fatigue Scale Mood State:Profile of Mood State Quality of Life: QLQ-BR23

Eligibility Criteria:
Inclusion Criteria:

* Finished oncology treatment (chemotherapy, radiation, surgery)

Exclusion Criteria:

* Other musculoskeletal conditions.
Investigating the Clinical Features and Prognosis of Bronchiectasis Adult Patients

Bronchiectasis is a chronic respiratory disease characterized by permanent bronchiectasis.The incidence and prevalence of bronchiectasis have assumed continuously grows in global. Different from overseas, bronchiectasis is common disease in China. This study will collect data from the real-world bronchiectasis database and follow up for one year, describe the bronchiectasis exacerbation rate and proportions for frequent exacerbation, clinical features and prognosis of bronchiectasis exacerbation, the treatment pattern (when clinically stable) during follow-up period; and describe characteristics of bronchiectasis at baseline. This study will also explore potential baseline risk factors for bronchiectasis exacerbation during follow-up period.

Bronchiectasis is a chronic respiratory disease characterized by permanent bronchiectasis, its main clinical symptoms are cough, dyspnea, hemoptysis and recurrent respiratory tract infections. The incidence and prevalence of bronchiectasis have assumed continuously grows in global. Different from overseas, bronchiectasis is common disease in China. In 2013, the prevalence rate of bronchiectasis in Chinese residents over 40 years old was 1,200/100,000. As lack of large epidemiological data in China, the prevalence rate may still be underestimated, which needs more attention and research.

Bronchiectasis has heavy disease burden, characterized by recurrent acute exacerbations, high mortality, poor prognosis and heavy economic burden. The key points of bronchiectasis treatment strategy include exacerbation prevention, number of exacerbations reduction, prognosis improvement and then the quality of patients' life improvement. Therefore, it is important to describe the clinical features and prognosis of bronchiectasis (especially the incidence of acute exacerbations and the proportion of frequent exacerbations), and it would be helpful to understand the characteristics of bronchiectasis and standardize related diagnosis and treatment strategy.

This study will collect data from the real-world bronchiectasis database and follow up for one year, describe the bronchiectasis exacerbation rate and proportions for frequent exacerbation, clinical features and prognosis of bronchiectasis exacerbation, the treatment pattern (when clinically stable) during follow-up period; and describe characteristics of bronchiectasis at baseline. This study will also explore potential baseline risk factors for bronchiectasis exacerbation during follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with bronchiectasis (according to the Chinese consensus, patient's previous chest CT examination must show bronchiectasis).
* Patients with age ≥18 years old.

Exclusion Criteria:

* Bronchiectasis due to known cystic fibrosis.
* With acute bronchiectasis exacerbation within 4 weeks before enrolment.
* Participated in any interventional clinical trial within 6 months before enrolment.
* Patients who are unable or unwilling to provide informed consent.