cyrilzakka/clinical-trials huggingface dataset:
Identification of Risk Factors for Recurrence of Low Back Pain and Occupational Repercussions

Low back pain (LBP) is the leading cause of disability and one of the most common reasons for physician visits in primary care, with a 33 % rate of recurrence during the first year, converting LBP into a chronic condition.

The french High healthy authority recommend early occupational oriented intervention associated with a multidisciplinary rehabilitation program.

However even if these recommendations are taken into appropriate account, risk for recurrence of Low back pain and occupational repercussions often occured.

This study aims to identify the risk factor(s) of sick leave after a rehabilitation stay in outpatients and thus adapt cares provided to the patients in respect of their needs and expectations.


Eligibility Criteria:
Inclusion Criteria:

* men and women over 18 years old
* able to understand and respect the protocol requirement
* who signed the consent prior to any other procedure protocol
* patients suffering from chronic lower back or lumbo-radicular pain since more than 3 months
* employee bellow 3 years before retirement
* patients included in a multidisciplinary rehabilitation program and occupational medicine

Exclusion Criteria:

* major patients under guardianship/curator/legal protection
* pregnant patients
* obese patients with BMI (body mass index) \> 35 (grade 2)
* patients suffering from neurological pathology
* patients suffering from chronic lower back or lumbo-radicular pain since less than 3 months
* patients suffering from chronic lower back pain with inflammatory or tumoral or infectious ethiology
Mobile Phone-Based Smoking-Cessation Intervention for Smoking Parents

This study aims to explore the feasibility and preliminary effectiveness of a mobile phone-based intervention tailored specifically for smoking parents.

Parental smoking is associated with numerous adverse outcomes, including exposure to secondhand smoke, heightened risk of respiratory illnesses in children, and an increased likelihood that children will adopt smoking behaviors themselves. Despite awareness of these risks, many parents find it challenging to quit smoking due to stress, lack of support, and time constraints.

This randomized controlled trial (RCT) investigates the effectiveness of a mobile phone-based intervention tailored specifically for smoking parents. The intervention group will receive AI-powered chatbot cessation support, while the control group will be provided with brief cessation advice. The study aims to determine whether the AI-driven intervention is more effective in helping parents quit smoking compared to traditional brief advice.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18 and above, reside in Zhuhai for the next 6 months
2. smoke at least 1 cigarette or use e-cigarettes daily
3. have a smartphone and a WeChat account, able to use WeChat skillfully

Exclusion Criteria:

1. Smokers who have communication barrier (either physically or cognitively)
2. Smokers who are currently participating in other SC programmes or services
MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis

Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Decreased efficacy, intolerance and high treatment burden with currently available therapies indicate a need for additional therapies. MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery. Preclinical and clinical studies conducted to date show that aerosol doses of MP-376 are safe and well tolerated, exert an antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal antibiotics. High concentrations of levofloxacin in the lung delivered as MP-376 are active against CF pathogens including those with high minimum inhibitory concentration (MIC) levels to aminoglycosides such as tobramycin (TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered rapidly and efficiently using a customized PARI investigational configuration of the eFlow® nebulizer system.

This trial will be a double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin administered as MP-376 given for 28 days by the aerosol route to CF patients.

Study with completed results acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria (selected):

* \>/= 12 years of age
* Confirmed Diagnosis of Cystic Fibrosis
* Positive sputum culture for P. aeruginosa at screening and within the past 12 months
* Patients are able to elicit an FEV1 \>/= 25% but \</= 85% of predicted value at screening
* Have received at least 3 courses of inhaled antimicrobials over the preceding 12 months
* Clinically stable with no changes in health status within the last 28 days
* Able to reproducibly produce sputum and perform spirometry

Exclusion Criteria (selected):

* Use of any nebulized or systemic antibiotics within 28 days prior to baseline
* History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
* Evidence of respiratory infections within 14 days prior to dosing
* CrCl \< 20ml/min or \< 20ml/min/1.73 m2 at Screening
An Open-Label Study of Azetukalner in Major Depressive Disorder

X-NOVA-OLE is a multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner as a monotherapy in adult participants who successfully completed an antecedent Phase 3 study of azetukalner in Major Depressive Disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* Participant successfully completed the treatment period of an antecedent azetukalner Phase 3 study in MDD.
* Participant provides written informed consent to participate in the study, is able to understand the procedures and study requirements, and agrees to abide by them.
* Participant is willing to comply with the contraception requirements.
* Male participants must agree not to donate sperm until 3 months after the last dose of study drug. Female participants must agree not to donate ova until 3 months after the last dose of study drug.

Exclusion Criteria:

* Participant met any of the withdrawal criteria, or discontinued study drug early, or was terminated early from an antecedent study.
* Participant had any protocol deviations in an antecedent azetukalner study that, in the opinion of the investigator, would preclude participation in this study.
* Participant is unable to comply with study procedures or is inappropriate for the study, as judged by the investigator.
* Participant has any medical condition, personal circumstance, or ongoing AE (from an antecedent study) that, in the opinion of the investigator, exposes the participant to unacceptable risk by participating in the study or prevents adherence to the protocol.
* Female participant who is pregnant, breastfeeding, or planning to become pregnant within 3 months after the last dose of study drug.
* Participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of any medical condition during the study or within 28 days after completion of this study.
* Participant is judged to have a significant risk for self-harm or suicidal behavior or is considered to be an imminent danger to themself or others, as determined by the C-SSRS or in the opinion of the investigator.
Beta-Blocker in Chronic Obstructive Pulmonary Disease (COPD) Study

Smoking causes both smoking related lung disease (COPD) and ischaemic heart disease. These are very common conditions and many patients have both diseases. Beta-blocker drugs are extensively used in the treatment of angina, high blood pressure and after heart attacks to decrease symptoms and prolong life. Beta-agonists are used in COPD to decrease breathlessness and improve exercise tolerance. It used to be thought that beta-blockers cannot be used in COPD patients as they may make the breathlessness worse, but it has now been established that they can be used safely. Beta-blocker drugs and beta-agonists have 'opposite' effects on the body and the investigators do not know if they can work together or if they would cancel each other out. The investigators also do not know which of the different types of beta-blockers now available are better for COPD patients. This study will investigate what happens to the airways of people taking both of these drugs.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD
* \> 40 years of age
* \> 15 pack year smoking history

Exclusion Criteria:

* Contra-indication to beta-blocker use
* Severe COPD FEV1 \< 30% or 1 L
* Not responsive the methacholine
VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

The purpose of this protocol is to prove the efficacy of vertebroplasty in patients suffering from acute non osteoporotic vertebral compression fracture.

Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse.

Our study will compare vertebroplasty versus conservative therapy (brace).

The study is a prospective, randomized trial comparing conservative treatment (brace) and vertebroplasty in acute (less than 15 days after trauma) traumatic vertebral compression fracture (VCF) type A according Magerl classification

Eligibility Criteria:
Inclusion Criteria:

* 18 - 70 year old
* volunteers
* Vertebral compression fractures Magerl type A
* Acute Trauma (less than 15 days)
* Between T5 and L5
* Patient able to undergo both vertebroplasty and conservative treatment
* Consent form obtained

Exclusion Criteria:

* Neural arch fracture
* C1 to T4 fracture
* Neurologic symptoms caused by the fracture
* Encephalic trauma with Glasgow Coma Scale less than 15
* Ongoing cancer
* Routine painkillers intake
* Local or systemic infection
* Coagulation's disorder
* Pregnancy
* Involvement in an another clinical trial
Full-Thickness-Gastroplication For The Treatment Of Gastroesophageal Reflux Disease GERD

This is a prospective study to extensively evaluate subjective patient parameters on quality of life, reflux-symptoms, side effects, medication-use and measurements of esophageal manometry and Impedance-pH-Monitoring after Full-Thickness-Gastroplication.


Eligibility Criteria:
Inclusion Criteria:

* persistent or recurrent symptoms despite continuous medical treatment, at least one typical reflux symptom (heartburn/ regurgitation/dysphagia/epigastric pain) and/or at least one atypical reflux symptom (cough/ asthma/hoarseness/distortion of taste), pathologic esophageal acid exposure as documented by a reflux-related DeMeester score ≥14.7, and symptom correlation ≥50%, and/or reflux episodes \>73.

Exclusion Criteria:

* any distinct hiatal hernia detectable by gastroscopy or barium radiography, dysphagia, esophageal strictures, poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.
Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia

The objective of this study is to explore the neurocognitive efficacy of Sertindole versus comparator in patients with schizophrenia using the MCCB.

Sertindole is an atypical antipsychotic approved in the European Union (EU) for use in patients with schizophrenia who are intolerant to at least one other antipsychotic agent. During clinical development sertindole was found to be as effective in the treatment of schizophrenia as the first-generation antipsychotic haloperidol and as the second-generation antipsychotic risperidone.

Sertindole is generally well tolerated and has a benign side-effect profile, including an absence of sedation, no effect on plasma prolactin levels, moderate weight gain, no anticholinergic-mediated cognitive impairment and a low rate of extrapyramidal symptoms (EPS). Sertindole has been shown to prolong the QT interval and is contraindicated in patients with prolonged QT interval and in patients receiving drugs known to significantly prolong the QT interval.

The study is designed to provide data on the neurocognitive properties of sertindole versus quetiapine in patients with schizophrenia. Efficacy for cognitive impairment is assessed in patients who are in a stable phase of their illness, with a predefined maximum level of symptoms that will allow them to be included in the study. Prior antipsychotic medication will be withdrawn (down-tapered) and patients will be randomly assigned to one of the study drugs.

Cognitive deficiencies are an important feature of schizophrenia and correlate strongly with functional impairment. Improving functional outcomes in schizophrenia has a high priority and has resulted in the initiation of a program called Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) leading to the development of a neuropsychological test battery, the MCCB which is used in this study.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of schizophrenia
* Man or woman, aged between 18 and 55 years

Exclusion Criteria:

* Current Axis I primary psychiatric diagnosis other than schizophrenia
* Not previously received antipsychotic drugs for schizophrenia
* Acute exacerbation requiring hospitalisation within the last 3 months
* Clinically significant extrapyramidal symptoms
* Clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia
* Congenital long QT syndrome or a family history of this disease, or known acquired QT interval prolongation
* Significant ECG abnormalities
* Hypokalaemia or hypomagnesaemia
* In concurrent treatment with drugs inhibiting the P450 enzymes system CYP3A
Effect of Age on Propofol-BIS Response

Recently, reports appeared of an 88-yr-old octogenarian exhibiting bispectral index (BIS) value of 46 before anaesthesia induction, and a 91-yr-old nonagenarian fully conscious at BIS value of 52 after propofol anaesthesia recovery. BIS algorithm was heuristically derived from a database of mostly "relatively fit, young healthy" volunteers. To date there are no studies precisely quantifying BIS response to propofol concentrations among different age groups

Objective: Recently, reports appeared of an 88-yr-old octogenarian exhibiting bispectral index (BIS) value of 46 before anesthesia induction, and a 91-yr-old nonagenarian fully conscious at BIS value of 52 after propofol anesthesia recovery. BIS algorithm was heuristically derived from a database of mostly "relatively fit, young healthy" volunteers. To date there are no studies precisely quantifying BIS response to propofol concentrations among different age groups.

Methods: Investigators set Propofol estimated plasma concentrations (Cp) to gradually reach 3.5 microg·mL-1 over 3.5 min in 80 patients, five male and five female, divided by age decades from vicenarian (20-29 yr) to nonagenarians (90-99 yr). BIS values were fitted against Cp in our newly devised logistic model and traditional sigmoid Emax model. Raw BIS electroencephalography and measured propofol arterial samples determined whether changes are pharmacodynamic or pharmacokinetic asserted.

Propofol link to FDA site at FDA's Drugs@FDA web site. https://www.accessdata.fda.gov/scripts/cder/drugsatfda: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Eligibility Criteria:
Inclusion Criteria:

80 patients, five male and five female, divided by age decades from vicenarian (20-29 yr) to nonagenarians (90-99 yr)

Exclusion Criteria:

Patients with liver disease
Investigating the Adhesion of New Adhesive to the Skin

The adhesion of the new adhesive strips is investigated on healthy volunteers

Inclusion visit:

* Introduction to the study
* Inclusion in study
* Baseline information is obtained
* Instruct subject to pre-strip of abdominal skin

Test visits 1-25 (up to maximum 25 visits per subject. (1-3 days after pre-stripping the abdominal skin):

* Baseline measurements are conducted on both sides of the stomach (TEWL, hydration, erythema, pH - 3 repeated measurements under each adhesive strip area (upper, middle and bottom of adhesive strip)
* Potential wetting of skin - shower/bicycle exercise (max 60 minutes) and after-wetting baseline measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
* Adhesive strips are weighted and applied
* Potential shower/bicycle exercise (max 60 minutes)
* Adhesive strips are removed at pre-defined timeslots (peel force measured)
* Discomfort when strip was peeled of is evaluated by subject (VAS)
* Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
* Acclimatization ½
* Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
* Adhesive strips are weighed
* Photo of adhesive strips

The subjects can be asked to apply and change strips every 24 hours between two test visits but for a maximum of 10 days between two visits. The strips should be applied at the same place every time.

Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have intact skin on the area used in the investigation

Exclusion Criteria:

1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy
2. Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Have dermatological problems in the abdominal area (assessed by investigator)
Effect of Home Based Swallowing Exercise in Stroke Patients With Dysphagia

Dysphagia is a common problem in post-stroke patients and greatly impaired quality of life. Among them, the strength of tongue and lip muscles played a key role in the oral phase of swallowing and many stroke survivors suffered from these muscles weakness. Iowa oral performance instrument (IOPI) is a standardized portable device that can be used to quantify tongue muscle strength, thus allowing the clinician to set the level of resistance necessary to achieve optimal gains in strength, and also providing visual feedback of performance to the patients to guide training. In this study, we use Videofluoroscopic Swallowing Study (VFSS) to screen for the stroke patient suffering from dysphagia and recruited them into the trial. They then participated in a home based resistance-training program using the tongue depressor, 1 time everyday and each time consisted of 30 repetitions, totally 4 weeks. Various tongue strength variables and subjective scale were obtained before and after the intervention. The purpose of the study was to evaluate the effect of the home based swallowing therapy in the post stroke dysphagia patients.


Eligibility Criteria:
Inclusion Criteria:

* Acute stroke within 1 year, videofluoroscopic swallow study revealed abnormalities
* Mini-Mental Status Examination \>20, could cooperate swallow therapy

Exclusion Criteria:

* Already known dysphagia before stroke event
* Malocclusion or severe facial palsy
* Localized oral lesion interfering swallowing
Dynamic Changes of the Human Microbiome Predict the Risk of Poor Prognosis in Patients With Acute Ischemic Stroke: a Multi-center Study

Recent studies have found a close relationship between acute ischemic stroke(AIS) and gut microbiota, but whether the dynamic changes in human microbiome after stroke can predict poor prognosis of stroke remains unclear. Therefore, we planned to explore the predictive value of human microbiome and its metabolites in stroke prognosis through a multicenter cohort study

This study was designed as a prospective, observational, multicenter cohort study. 2000 patients with AIS will be enrolled continuously through multiple centers. Oral swabs, feces (the day after admission, 1 month, 3 months after the onset of disease) and blood samples (the day after admission, 3 months after the onset of disease) will be collected. After the onset of the disease (1 month, 3 months, 6 months and 12 months), outpatient/telephone follow-up will be conducted to evaluate the neurological function scores of the patients, and the recurrence of stroke and other cardio-cerebrovascular events will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Meet the AIS diagnostic criteria;
* Age 18-80;
* Within 7 days of the onset;
* Signing the informed consent, providing relevant medical history and biological specimens.

Exclusion Criteria:

* mRS \> score 2 before onset;
* Serious systemic diseases including malignant tumors;
* Hematological diseases and autoimmune diseases;
* ALT or AST \> 2 times the upper limit of normal value or severe liver disease;
* Serum creatinine \> 1.5 times the upper normal limit or severe nephropathy;
* History of alcoholism, drug abuse, and chemical poisoning (e.g. pesticide poisoning);
* History of intestinal tumor, irritable bowel syndrome or inflammatory bowel disease or confirmed in hospital;
* Antibiotic use within 1 month before admission;
* Fece cannot be obtained within 4 days after admission.
Acceptance of Hepatitis C Screening by Self-testing in High Risk and General Population

The main purpose of the study is to evaluate the acceptance and viability of self-testing using dried blood spot (DBS) testing assisted by center of origin or referral hospital, as a strategy for screening for hepatitis C virus (HCV) in high risk population (ex-users of drug dependence centers) compared to the general population assisted by primary care centers.

This is a randomized clinical trial involving patients who between 2013 and 2017 have contacted the drug dependence center and patients from general population.

After selecting those who do not meet any exclusion criteria, a letter will be sent to them inviting them to participate in this study. This letter will contain the study information sheet and informed consent, and a self-testing kit with an explanatory leaflet so that each person can carry out the test in a simple and easy way.

The main purpose of the study is to evaluate the acceptance and viability of self-testing using dried blood spot (DBS) testing, to study whether support improves participation and to identify predictors of participation.

For the present study, assuming an increase of 18% participation (from 18% to 28% offering support by the patient's referral center, and based on a previous study in our environment of self-testing in the general population), taking into account a power of 80%, alpha error of 5%, and losses of 20%, will require 346 patients per group.

Eligibility Criteria:
Inclusion criteria:

* All subjects who have contacted a drug dependence center between 2013 and 2017, as well as patients from a group of a primary care center.
* Signed informed consent.

Exclusion criteria:

* Patient's refusal to participate in the study.
* Negative HCV serology or viral load in the last year.
* Death.
* Belonging to another health area
* Not having the patient's address in the hospital's computer system.