cyrilzakka/clinical-trials huggingface dataset:
Study of the Sensitivity to Change of a Bimanual 3D Analysis Protocol for the Assessment of Upper Limb Movement in Children With Cerebral Palsy Before and After Therapies

Cerebral Palsy is the most common cause of motor disability in children. It can lead to a deficit of the upper limb which alters the realization of daily activities, in particular in bimanual situations, and eventually leads to a decrease in their participation.

Three-dimensional (3D) movement analysis is a tool that provides an accurate and objective measurement of movement. This technology allows us to understand and characterize movement anomalies in order to guide and adapt therapies to the upper limb. The majority of 3D upper limb analysis protocols used to measure the effect of interventions, such as botulinum toxin injections indicated for the treatment of spasticity or other innovative rehabilitative therapies, are unimanual and do not study bimanual function, which is more representative of the actual use of the upper limbs in daily life.

Recently, a 3D bimanual analysis protocol called "Be An Airplane Pilot" (BE-API), taking place in an innovative play context, has been developed and validated in PC children. The 2nd version of the protocol (BE API 2.0) also allowed the exploration of new parameters in a bimanual situation such as the fluidity and the trajectory of the movement. In order to determine the interest of the BE API 2.0 protocol in routine clinical evaluation of the upper limbs, its sensitivity to change, i.e. its capacity to detect modifications caused by a therapy on the movements of the upper limbs is necessary (e.g.: Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT ILE), botulinum toxin injections).


Eligibility Criteria:
Inclusion Criteria:

* Child between the ages of 5 and 18,
* Child with cerebral palsy as defined by the CSEP
* Level of manipulation sufficient to perform the tasks of the 3D protocol (MACS score I to III included),
* For whom the HABIT-ILE therapeutic program and/or botulinum toxin injection is prescribed
* Affiliated via his/her parents to a social security plan,
* No opposition formulated by the holders of parental authority and the child

Exclusion Criteria:

* Child with unilateral or bilateral spastic cerebral palsy
* Cognitive deficits hindering the comprehension of instructions or visual disorders not allowing the visualization of the game board,
* Pain in the upper limb (VAS score\>3),
* Contraindications to the use of botulinum toxins and absence of indications as mentioned in the HAS 2010 recommendations
* Patients under legal protection (guardianship, curatorship, ...)
* Refusal to participate
The Efficacy and Safety of Thymosin-α1 in Patients With HBV-related ACLF

A randomized controlled trial to evaluate efficacy and safety of Thymosin-α1 administration in patients with HBV-related Acute-on-chronic liver failure.

Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease with high mortality. In this study, the investigators intend to assess the efficacy and safety of Thymosin-α1 in patients with HBV-related Acute-on-chronic liver failure.

Eligibility Criteria:
Inclusion Criteria:

* 1.Chronic hepatitis B.(Hepatitis B surface antigen positive for more than 6 months or having evidence of chronic hepatitis B virus infection).
* 2.Defined by an acute deterioration in transaminase greater than or equal to 5 times upper normal limit over14 days.
* 3.Development of jaundice (serum bilirubin greater than or equal to 10mg/dl).
* 4.Development of coagulopathy(PTA≤40% or INR≥1.5 ).
* More than one of the 5-8 criteria：
* 5.Development of hepatic encephalopathy.
* 6.Development of hepatorenal syndrome.
* 7.Hepatic narrowing progressively.
* 8.Development of massive ascites or peritonitis.
* 9. Willing to provide informed consent and comply with the test requirements

Exclusion Criteria:

* 1.Patients who have hepatocellular carcinoma confirmed by ultrasound/CT/MR.
* 2.Patients who have autoimmune disease (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, etc ) or with abnormal elevation level of autoimmune antibody.
* 3.Model for end-stage liver disease (MELD) score \<17 or \>35.
* 4.Patients with significant co-morbid illnesses such as cardiovascular or respiratory or intrinsic renal diseases which by themselves may have a bearing on the outcome.
* 5.Patients with diseases that researchers consider inappropriate to participate in the study.
* 6.Patients who have disseminated intravascular coagulation.
* 7.Drug allergy.
* 8.Patients with any other contraindications to thymosin alpha1.
* 9.Patients who participated in other clinical trials at the same time.
A Study of Acne Treatment in Children Ages 9 to 11

A study to determine if using Retin-A Micro 0.04% as facial acne treatment in patients ages 9 to 11 is safe and efficacious.

Approximately 100 female and male subjects, aged from 9 to 11 years of age, will be enrolled in this randomized, double blind, multi-center study.

Following satisfaction of entry criteria and screening procedures, subjects will receive either RETIN-A MICRO 0.04% or a color matched gel vehicle for once daily use during the 12-week treatment period. Subjects will be monitored for safety throughout the study and for signs and symptoms of local irritation at baseline, and at weeks 2, 4, 6, 8, 10 and again at study completion, week 12.

Efficacy will be assessed by facial lesion counts and by utilizing scales for Investigator's Global Evaluation of Acne Severity (IGA #1 and IGA #2) and Investigator's Global Assessment of Improvement (IGA #3). All efficacy parameters with the exception of IGA #3 will be measured at baseline and weeks 2, 4, 6, 8, 10 and 12. The Investigator's Global Assessment of Improvement (IGA #3) will be done at Week 12 only. At selected sites, photographs will be taken at Baseline and weeks 2, 4, 8 and 12.

Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant, non-nursing females, 9 to 11 years, with facial pediatric acne vulgaris
* Minimum of 20 non-inflammatory lesions (open and closed comedones)
* Minimum of 30 total facial lesions (sum of inflammatory and non-inflammatory)
* Must have at least a rating of grade 3 on the Investigator Global Assessment Scale for acne severity (IGA #1) at baseline

Exclusion Criteria:

* Known sensitivity to any of the ingredients in the study medication;
* Any nodulocystic acne lesions
* Use of acne devices or systemic therapy with antibiotics within two months prior to start and throughout the duration of the study
* Use of systemic therapy with retinoids within four months prior to study start and throughout the duration of the study
* Topical use of topical retinoids within two weeks prior to study start and throughout the duration of the study
* Topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study
* Use of an experimental drug or device within 60 days prior to study start;
* Use of hormonal therapy within 3 months prior to study start
* History of evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication
* Any significant medical conditions that could confound the interpretation of the study
* History of/or current facial skin cancer
* Inability to refrain from use of all facial products other than those supplied by the study, while participating in the study
* No use of tanning booths, sun lamps, etc.
* Subject is a family member of the employee or the investigator
Analyse of Tumour and Constitutional DNA for the Study of the Determinism in Child Neoplasia

Background. Cancer is the leading cause of death by disease in children. Most pediatric tumors differ from adult tumors in terms of biological and clinical characteristics. In children, the part of genetic determinism could be higher since the role of environmental factors may be less pronounced than in adults and that a young age at onset is a main feature of genetic cancer predisposition. Recent studies suggested that a number of genetic predisposition remains to be characterized.

Methods. Trio-Based whole exome sequencing of germline DNA from patients (children and adults diagnosed with cancers between 0 and 17 years) and parents will be performed prospectively in a multicentric study including 40 unselected cases of malignant tumor. Participating hospitals will include the CHU of Montpellier, the CHU de Nice and the AP-HP. Tumor analysis will include whole exome analysis and transcriptome for the identification of therapeutic target and contribute to confirm potential link between constitutive mutations and tumor phenotype (such as loss of expression, loss of heterozygosity).

Perspectives. This pediatric oncology study proposing a global approach integrating trio-based whole exome sequencing, somatic DNA and RNA analysis will improve the recognition of genetic predisposition and the characterization of target therapies in children with cancer.


Eligibility Criteria:
Inclusion Criteria:

* The patient has a solid or haematological malignancy, either familial forms or isolated cases diagnosed between the ages of 0 and 17 years.
* The minor patient and both biological parents are available to participate in the study OR
* The adult patient and one or both parents are available to participate in the study.
* The patient's parents must have given their free and informed consent and signed the consent for the minor's participation in the study.
* The patient's parent(s) must have given free and informed consent and the patient of legal age must have signed the consent for participation in the study.
* The patient must be affiliated or beneficiary of a Frrench social security scheme.

Exclusion Criteria:

* The patient's parents are under guardianship or trusteeship or under legal protection Yes No
* Failure to obtain written informed consent from parents (for themselves and their minor child) after a period of reflection Yes No
* No affiliation to or beneficiary of a French social security scheme (for biological parents and the patient)
Effects of Lycium Barbarum Supplements on the Progression of Senile Cataract in Hong Kong Chinese Population

With the rapid growing aging population, age-related eye diseases including cataract are becoming more prevalent. The demand for cataract surgery and post-surgical care posed enormous financial burdens to the government.

Lycium barbarum contains lutein and zeaxanthin which can filter the phototoxic blue light and neutralize the reactive oxygen species, thus provide a protective effect against cataract formation.

This study aims to determine the effects of Lycium barbarum Supplements on the progression of senile cataract in Hong Kong Chinese elderly.

Please note that a manuscript for this study is being prepared. Detailed description will be provided after we come up with the final draft.

Eligibility Criteria:
Inclusion Criteria:

* Unlikely to have cataract surgery within 3 years
* Presence of mild to moderate cataract in one or both eyes, graded by Lens Opacities Classification System III (LOCSIII).
* logMAR acuity equivalent to Snellen acuity of 20/63 or better
* no previous history and clinical signs of glaucoma by determining intraocular pressure using applanation Tonometry (no more than 22mmHg)
* no ocular anomalies: amblyopia, binocular anomalies, ocular trauma
* no history of eye surgery, laser treatment, iritis, retinal crystalline deposits, macular degeneration, or optic nerve diseases
* no extended use of systemic or ocular corticosteroid drugs
* no concurrent participation of other systemic or ocular drug intervention study

Exclusion Criteria:

* diabetes mellitus
* renal failure
* fat malabsorption syndrome
* intestinal surgery history
* chronic diarrhea
* alcoholism
* use of anticoagulants
* regular use of nutritional supplements such as multi-vitamin, mineral and other antioxidant supplements (including Omega-3)
Arrhythmia Identification in Syncope Patients: ePatch® Versus 24h Holter

This study is a Multi-center, prospective, randomized, unblinded, two-arm study to assess if 7-days of cardiac monitoring using the ePatch Holter results in identification of more clinically actionable arrythmia for patients with symptoms of syncope than standard 24 hour Holter monitoring.

This study is a multi-center, prospective, randomized, unblinded, two-arm study to assess if 7-days of cardiac monitoring using the ePatch Holter results in identification of more clinically actionable arrythmia for patients with symptoms of syncope than standard 24 hour Holter monitoring. Approximately 256 adult subjects with symptoms of syncope will be randomized 1:1 to wear either the Philips ePatch Extended Wear Holter (7 day) or Standard Wear Holter (24 hours). Randomization will be balanced for gender.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Recommended for ambulatory cardiac Holter monitoring due to symptoms of syncope
3. Able to comply with continuous ECG monitoring for up to 7 days
4. Able and willing to replace the Patch electrode at home
5. Capable of providing voluntary informed consent and mentally and physically willing and able to be compliant with the protocol, including the follow-up visit(s)

Exclusion Criteria:

1. Patient with chronic Atrial Fibrillation (AF)
2. Patient with implanted pacemaker/defibrillator
3. Patient with known allergy to adhesive materials and/or hydrogel
4. Patient with broken, damaged, or irritated skin where ECG patch will be placed
Magnetic Resonance Imaging Combined With Venous Ultrasonography of the Legs for Pulmonary Embolism

Magnetic resonance imaging (MRI) represents a promising technique but can not be used as an alternative test to multidetector CT in patients with suspicion of pulmonary embolism (PE) due to its low sensitivity and high proportion of inconclusive MRI. The purpose of this study is to evaluate diagnostic performances of MRI combined with venous ultrasonography of the legs in patients with suspicion of PE.


Eligibility Criteria:
Inclusion criteria :

* age \> or = 18 years
* clinical suspicion of PE
* Affiliate (e) to a social security
* provide written informed consent

Exclusion criteria :

* Unstable patient clinically in shock on arrival at the emergency department
* Current pregnancy
* Life expectancy less than 3 months (eg terminal cancer)
* Follow up at 3 months impossible
* Anticoagulation curative\> 48 hours prior to inclusion
* Cons-indication to spiral chest CT: allergy to contrast or creatinine clearance below 30 ml / min calculated by the Cockcroft
* Cons-indication to MRI claustrophobia, presence of intraocular metallic implant or a pacemaker, an allergy to gadolinium, morbid obesity (weight\> 130 kg, anteroposterior\> 60 cm diameter)
Ipratropium Bromide in Peri-Operative COPD

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-centre trial.The trial aims to evaluate efficacy of nebulized ipratropium bromide in Chinese peri-operative patients with COPD under general anaesthesia.


Eligibility Criteria:
Inclusion criteria:

* All patients must sign an informed consent.
* Male or female patients aged \>= 40 years and \<= 80 years
* All patients must be diagnosed with COPD and must meet the following spirometric criterion: post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 70% of forced vital capacity (FVC) at Screening Visit (Visit 1).
* All patients have relatively stable COPD (i.e. have no COPD exacerbation within 4 weeks prior to Screening Visit).
* All patients are about to receive selective surgical procedures of lobectomy or right bilobectomy or segmentectomy under general anaesthesia, whilst the estimated time of surgical procedures lasts for not less than 2 hours, and the estimated time of general anaesthesia lasts for not less than 3 hours and not longer than 5 hours.
* Patients must be able to perform all study related procedures including technically acceptable pulmonary function tests (PFTs).

Exclusion criteria:

* Patients who need maintenance treatment of bronchodilators (including anticholinergics, ß-agonists, xanthines).
* Patients with a recent history (i.e. six months or less) of myocardial infarction
* Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year
* Patients with symptomatic chronic heart failure (i.e. New York Heart Association functional class III-IV)
* Known narrow angle glaucoma
* Patients with prostatic hyperplasia or bladder neck obstruction with significant symptoms
* Patients with a history of asthma, allergic rhinitis or who have a blood eosinophil count \>= 600 / mm3 (0.6×10\^9/L). A repeat eosinophil count will not be conducted in these patients
Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB)

1. To demonstrate that colistin iv. is not inferior to meropenem in empiric treatment of VAP regarding the final point of primary efficacy: mortality in the 28 subsequent days and clinical healing in patients clinically evaluated.
2. To compare the safety of treatment with colistin vs meropenem in VAP.
3. To compare microbiological efficacy of treatment with colistin vs meropenem in VAP

Study drugs: Patients will be randomized a 1:1 rate and open label fashion to two interventions: group 1: colistin loading dose followed by colistin infusion iv/8h or group 2: meropenem 2 g/iv/ 8 h. The overall treatment time will be a minimum of 8 days.

Follow-up visits will be performed at baseline, 72 h, 8 days, the end of treatment, and 28 days from recruitment ICU discharge, hospital discharge or death.

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years with clinical and radiological criteria of VAP. The women of childbearing age (not surgically sterilized and in the period between menarche and 1 year after the menopause) must have a negative test of pregnancy in urine at the time of recruitment.

The patient or his/her legal representative must sign a document of informed consent approved by the Ethics Review Committee.

Exclusion Criteria:

Hypersensitivity to the two antimicrobials of the study (colistin/meropenem). Renal insufficiency in substitute treatment. Corporal weight \<40 kg or \>150 kg. Patients previously included in another clinical trial.
Psychosocial Treatment for Acute Low Back Pain

Acute low back pain (severe pain that comes on suddenly and lasts a relatively short time) is very common in the United States, and accounts for substantial illness, functional limitations, pain, and health care costs. This study looks at whether a program designed to improve self-efficacy (a person's belief in his or her ability to reach a goal, such as managing one's own disease) and social support improves the health status of people with acute low back pain.

Acute low back pain (ALBP) is very prevalent in the United States, accounting for substantial morbidity, functional limitations, pain, and health care costs. Psychosocial interventions that target improved symptom control and patient functioning have the potential to improve the outcomes of patients with ALBP. This study evaluates a psychosocial intervention designed to enhance self-efficacy and social support for patients with ALBP.

In this randomized, controlled trial, we will randomize eligible patients with ALBP to receive the intervention or usual care. The intervention program consists of: (1) patient education regarding ALBP; (2) explanations and rationales, in layperson's terms, of diagnostic and treatment options for ALBP; (3) discussions regarding the management of negative affect (i.e., depression, anger, fear, hostility, anxiety); (4) methods to involve social support systems; and (5) strategies to involve the primary care physician to reinforce patients' behaviors and progress. We will follow patients for 12 months and assess outcomes at 3 and 12 months.

Primary outcomes are health-related quality of life (i.e., functional status, role function, back pain symptoms) and patient satisfaction with care. Secondary outcomes include health care use, direct health care costs, self-efficacy, and social support. We will also estimate the cost-effectiveness of the intervention.

We will conduct this investigation among socioeconomically vulnerable patients with ALBP, a group that shoulders a disproportionate burden of disability and morbidity from musculoskeletal conditions and comorbid medical conditions.

Eligibility Criteria:
Inclusion Criteria:

* Acute low back pain

Exclusion Criteria:

* Chronic back pain (including surgery)
* Disability claim for back pain
* Nursing home resident
* Severe impairment in hearing, vision, or speech
* Unable to speak English
* Severe comorbidity
* Unable to contact by phone
* Excluded by primary care physician
Physical Activity in Relation to Surgical Procedures

This study will compare the outcome after surgery between a group of patients that receives instructions for prehabilitation training and one group that received standard treatment.

The aim of this study is to investigate whether a training program with intensified physical activity prior to and after a surgical procedure reduces the surgical-related postoperative recovery time, hospital stay, sick leave and complication rate.

A secondary aim is to investigate the effect of a training program with pre- and post- operative PA on the rate of resumption of QoL and normal physical function.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed colorectal cancer and a planned surgical procedure

Exclusion Criteria:

* HIPEC surgery, not able to give informed consent or understand the intervention