cyrilzakka/clinical-trials huggingface dataset:
An Educational and Exercise Program as Secondary Prevention of Recurrent Lower Back Pain in Healthcare Workers

At Lyon University Medical Center, back problems are the leading cause of sick leave. The course of lower back pain is usually relatively short (recovery occurs within 4 to 6 weeks in 90% of cases). However, about 5-10% develop chronic lower back pain. Although this is a relatively small group, the economic consequences are enormous (accounting for 70 to 80% of the total cost of lower back pain).

Nowadays, some very general training sessions are offered to workers at Lyon University Medical Center, irrespective of their lower back pain status. These very general training sessions are mostly preventive and primary in nature (like back school program) despite the fact that these people already have a history of lower back pain, the main risk factor of recurrence and chronic pain.

Since the 1980, some multidisciplinary functional restoration programs have been advised as a strategy for secondary and tertiary prevention of lower back pain.

The purpose of this randomized controlled trial is to assess the effectiveness of physical exercise combined with an educational program and self-led exercise for Lyon University Medical Center workers with lower back pain. We hope this intervention will reduce the risk of recurrence and chronic lower back pain.


Eligibility Criteria:
Inclusion Criteria:

* All healthcare workers in the 4 hospital sites
* History of acute or subacute lower back pain in the 3 past years

Exclusion Criteria:

* History of surgery for spinal fractures
* History of lumbosacral arthrodesis
* History of surgical intervention or discal hernia, more than 2 levels or more than twice
* Radiculalgia with sign of motor deficit, or radiculalgia with a positive Lasègue sign
* Eligible for enrollement in a functional restoration program for lower back pain
* Ongoing low back pain (lumbago)
* Psychosocial or behavioural impairment
* Unstable cardiac disease
* Inability to fill out the questionnaires and scales (inability to understand French)
* Pregnancy
Minneapolis Children's Blood Pressure Study

To examine environmental and familial correlates of childhood blood pressure in order to predict elevated blood pressure in young adulthood. Also, to investigate the phenomena of tracking of blood pressure and obesity from childhood to young adulthood.

BACKGROUND:

Hypertension has been clearly identified as a major risk factor for coronary heart disease and stroke. Hypertension screening and intervention programs for children are based on the concept that high normal blood pressure may be the childhood antecedent of adult hypertension or that blood pressure 'tracks' through childhood, adolescence, and adulthood. Blood pressure tracking has been well established for adults and young adults but results from various studies in children are controversial. At a Symposium on High Blood Pressure in the Young in 1979, it was concluded that there was insufficient information to recommend specific interventions for prepubertal children with blood pressure levels in the upper percentiles of the blood pressure distribution. Studies of longer duration with large population sizes and repeated blood pressure measurements over time were required to determine if blood pressure levels at these young ages were predictive of adult hypertension.

DESIGN NARRATIVE:

In the Spring of 1978 a total of 10,423 children, ages 6-8 were screened. A subsample was invited to join the study of blood pressure measurement. The sample was selected as follows: all children in the top five percent of the initial systolic blood pressure distribution; all children in the bottom five percent of the initial systolic blood pressure distribution; a random sample of one in two of the remaining Black children; a random sample of one in nine of the remaining white children; and all the remaining children of other races. Included were families of about 200 Native American children. Of 2,641 selected children, 878 refused leaving a sample of 1,753. Baseline data on age, race, sex, triceps skinfold thickness, dietary history, urinary sodium and potassium excretion, physiological measures, life event changes, medical history, demographic data and body size measurements of children and their parents were collected at the first home interview conducted between 1978 and 1979. The children were followed twice per year in 1978 to 1980 and 1982 to 1985 for blood pressure and body size. Annual measurements were made of blood pressure, height, weight, skinfold thickness, and body girths. Screenings continued through early 1991 when the cohort was 19-21 years of age.

Several substudies were conducted including the relationship of red blood cell cation transport to essential hypertension, Type A behavior assessments, and familial aggregation of coronary-prone behavior.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Growth Factor Levels in the Blood of Patients Undergoing Radiation Therapy for Epithelial Cancer

RATIONALE: Measuring levels of transforming growth factor-beta (TGF-beta) in the blood of patients with epithelial cancers (head and neck, lung, breast, colorectal, and prostate) may help doctors predict how patients will respond to treatment with radiation therapy.

PURPOSE: This research study is measuring levels of TGF-beta in patients with epithelial cancers who are undergoing radiation therapy.

OBJECTIVES:

* To determine whether there is a dose-dependent increase in TGF-beta following radiotherapy in patients with epithelial cancers.

OUTLINE: Patients undergo blood sample collection prior to treatment, 24-72 hours after the first fraction of radiotherapy, and at the end of radiotherapy. Patients will also be asked for a weekly blood sample, but this is optional. Samples are analyzed to compare pre- and post-treatment TGF-beta levels.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Known diagnosis of an epithelial cancer, including any of the following:

  * Head and neck
  * Lung
  * Breast
  * Colorectal
  * Prostate
* Radiotherapy must be a component of planned treatment therapy

PATIENT CHARACTERISTICS:

* No serious medical or psychiatric illnesses which would prevent informed consent
Development of a Partograph E-learning Tool and Evaluation of Its Efficiency in Student Midwives

A randomized control trial was made to develop a partograph e-learning tool and evaluate its effectiveness in student midwives in Turkey.

With the use of a partograph, complications are detected and intervened promptly, and unnecessary applications are avoided. Therefore, it has become an integral part of the practices of midwives who manage normal births under their responsibility to reduce maternal and neonatal morbidity and mortality. One of the intrapartum care services of midwives is to detect prolonged labor, especially with the use of a partograph, and to apply quick and accurate intervention. However, the partograph is not widely used all over the world at the desired level.

Recently, the use of the e-learning system, which is recommended as a method of obtaining and perceiving information easily, has increased considerably. Although this is a new concept in our country, it has started to be adopted rapidly.

In our country, there is no study on the use of e-learning in midwifery practices. However, in many international studies, it is stated that e-learning is acceptable and more practical and effective than classical methods in midwifery education and practices. This research was designed as a randomized controlled experimental study to develop an e-learning tool that could be an alternative to midwifery students' learning of the use of a partograph and to evaluate its effectiveness.

The hypothesis was tested that there is a significant difference between the students who received and did not receive training with the partograph e-learning tool in terms of post-test education achievement scores. In addition, it was found that there is a significant difference between the pre-test and post-test education achievement scores of the students who received training with the partograph e-learning tool.

Eligibility Criteria:
Inclusion Criteria:

* Studying in the 3rd year of the midwifery undergraduate program
* Those who took the Childbirth and Postpartum Period Lecture and enrolled in the Childbirth and Postpartum Period At Risk Lecture
* Able to use the internet and computer
* Having an e-mail address with which he can communicate over the internet
* Students with internet access

Exclusion Criteria:

* Students who could not continue their education due to reasons (Registration freeze, lateral transfer, health problems, etc.) were excluded from the research.
Evaluation of the Impact of Nurse-led Telephone on Treatment Compliance

The study will take place over a period of 27 months. The recruitment phase will last approximately 24 months and each patient will participate for approximately 3 months.

At the inclusion visit (D0), the investigator will ask the patient whether he would like to participate in the study and will obtain his written consent.

Patients agreeing to participate will be randomised (3:1 ratio) and included in one of the following 2 groups:

Group without 'remote additional personalised nurse-led follow-up: patients will receive the healthcare given routinely by their medical team (100 patients).

Group with 'remote additional personalised nurse-led follow-up: patients will receive telephone calls from a nurse in addition to the healthcare given routinely by their medical team (300 patients).

All the patients will be seen according to normal practice by the study medical team.

Patients in the group with 'remote additional personalised nurse-led follow-up will be contacted 8 times during the study (at D1, D7, D14, D21, D28, D44, D59 and D89). The nurse will make sure that the treatment takes place in good conditions; she cannot intervene in the medical care of the patient, nor give answer to the questions relative to the disease or to the treatment of the patient. The medical team remains the privileged contact of the patient.

Purpose:

Study Design:

Eligibility Criteria:
Inclusion criteria:

Male or female patient older than 18 years. Adult patient diagnosed with stage IIIb/IV NSCLC locally advanced or metastatic, with activating mutation(s) of EGFR and who is EGFR-TKI naïve.

Patient for whom a decision of treatment with afatinib monotherapy has been taken in the frame of its marketing authorization.

Out-patient. Patient having given written consent for participation in the study. Patient who is able to participate in the investigator's opinion. Patient affiliated with the French social security.

Exclusion criteria:

Patients participating in an interventional clinical study. Patients for whom a participation in an interventional clinical study is foreseen within 3 months following the study inclusion.

Patients participating in a therapeutic education program.
CD155 in Bladder Cancer

This research is designed to investigate the prognostic and predictive value of CD155 in muscle invasive bladder cancer.


Eligibility Criteria:
Inclusion Criteria:

* patients with non-metastatic muscle invasive bladder cancer
* pathology confirmed urothelial carcinoma
* underwent cystectomy and pelvic lymph node dissection

Exclusion Criteria:

* not enough tissue for immunohistochemistry
* patients with a second neoplasm
Mucin in Sputum of CF During Pulmonary Exacerbation

The purpose of this study is to determine whether mucin is increased during pulmonay exacerbations in adult patients with cystic fibrosis (CF).

CF is typically associated with mucus hypersecretion in the airways. In health, mucin is the major macromolecular component and is responsible for the protective and clearance properties of the mucus gel. In a recent study we found that mucins are decreased in the sputum of adult CF patients.

In this study we want to investigate the differences on the mucin and DNA quantity and quality of airway secretions in during pulmoanry exacerbation.We hypothesize that during an exacerbation the mucin and DNA amount is increasing.

The aim of this study is to evaluate the molecular (mucins) and structure properties (mucin-DNA-network) of the airway secretions in CF related to the severity of the disease.

We characterize sputum composition of patients with pulmonary exacerbations. Using gel electrophoresis and dot-blot with specific antibodies we will analyze MUC5AC and MUC5B mucins. DNA amount will be measured by microfluorimetry. With the laser scanning confocal microscopy the mucin-DNA-network will be evaluated.

The significance of these studies is that they will give us novel information about the pathogenesis of chronic inflammatory airway diseases, provide tools for assessing the progression of lung disease, and most critically, will identify novel opportunities and targets for therapeutic intervention.

Eligibility Criteria:
Inclusion Criteria:

* cystic fibrosis
* chronic pseudomonas aeruginosa inflammation
* pulmonary exacerbation

Exclusion Criteria:

-
Chinese TaTME Registry Collaborative

Total mesorectal excision (TME) is the gold standard procedure for treating rectal cancer. However, in patients with obesity, prostate hypertrophy, low located tumor or/and pelvic stenosis, the traditional laparoscopic or open surgery is not easy to conduct. Transanal total mesorectal excision (TaTME) might serve as a better procedure for these patients, for it might ease the dissection of the low mesorectum. So far, several studies have showed the promising results of TaTME, but the multi-center data in China is still lacking. This nationwide registry study included more than 30 Chinese hospitals, aiming at obtaining data on the safety and efficacy of this procedure in Chinese patients with rectal cancer and encouraging future research in this field.


Eligibility Criteria:
Inclusion Criteria:

* malignant or benign neoplasms of the rectum
* the lower edge of the tumor from the anal margin less than 10cm according to MRI or rigid endoscopy
* tolerable to surgery
* be able to understand and willing to participate in this registry with signature

Exclusion Criteria:

* patients requiring emergency surgery such as obstruction，perforation and bleeding
* tumor involving adjacent organs, anal sphincter, or levator ani muscle
* muti-focal colorectal cancer
* preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence
* history of inflammatory bowel disease or familial adenomatous polyposis
* can not tolerate the surgery
* history of serious mental illness
* pregnancy or lactating women
* preoperative uncontrolled infection
* the researchers believe the patients should not enrolled in
Plasma Dosage of Venetoclax in the Fup of AML Patients Treated With Aza + Ven

The study proposes to correlate the plasma dosage of VEN with the inhibition of its Bcl-2 target during the first treatment cycle. VEN will be measured sequentially during the first treatment cycle and assess inhibition of its target by measuring the level of phosphorylation of Bcl-2 serine 70. In parallel, BH3 profiling will be evaluated sequentially. All these analyses will be correlated with treatment toxicity, response rate and overall patient survival. This pilot study will highlight the inter-individual variability of this AZA + VEN combination, and enable to launch a national study via the national cooperative groups to validate the results and thus ultimately propose a personalized treatment for patients benefiting from this combination.


Eligibility Criteria:
Inclusion criteria :

* Patient with acute myeloid leukemia (AML) not eligible for intensive chemotherapy
* Patients aged 18 or over
* Patient treated with the combination azacitidine (AZA) + venetoclax (VEN)
* Patient having signed the study informed consent form
* Patient with social security coverage

Exclusion criteria :

* Patients receiving treatment inhibiting or inducing Cytochrome CYP3A4
* Presence of an active, uncontrolled infection
* Patient participating or having participated in a clinical drug trial in the month prior to inclusion.
* Vulnerable persons
A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula

The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUMA® XC injectable gel using cannula in participants seeking correction of age-related volume deficit in the mid-face.


Eligibility Criteria:
Inclusion Criteria:

Male or female aged 35 to 65 (inclusive) years of age with overall mid-face severity of Moderate, Significant, or Severe for both cheeks on the Mid-Face Volume Deficit Scale (MFVDS);

Exclusion criteria:

* Has any facial procedures or trauma that may interfere with the study procedures and results;
* Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo allergen desensitization therapy during the term of the study;
* Has active autoimmune disease;
* Has current cutaneous or mucosal inflammatory or infectious processes.
"Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder (ILR)"

STUDY TYPE:

Prospective, national , multicenter, and observational study.

OBJECTIVE:

To assess the incidence of AF in patients with cryptogenic stroke who have implanted an AF detection device during a period of 2 years.

DEVICE:

Reveal XT 9529 (SQDM)

SAMPLE SIZE AND STUDY DURATION:

100 patients enrolled which will be followed during a period of 2 years.

Observational study in patients with cryptogenic stroke (TOAST criteria) and with an implanted EKG loop recorder, with the primary objective of knowing the atrial fibrillation incidence in this population

Eligibility Criteria:
Inclusion Criteria:

* All patients included must meet one of these two conditions:

  * Patient presenting with an episode of transient ischemic attack (TIA) of cryptogenic origin with neurological symptoms of less than 24h of evolution and negative neuroimaging.
  * First episode of ischaemic stroke with cryptogenic etiology following TOAST criteria
* All patients must meet all of the following:

  * The patient has been implanted an ILR within 30 days after qualifying event
  * Age between 45-85 years
  * No stenosis \>50% in any arterial vessel corresponding to the affected territory
  * Normal Echocardiography
  * Normal 24 hours EKG Holter recording
  * Absence of Patent Foramen Ovale through transcranial doppler (or transesophageal echocardiography)
  * Acceptance and signature of Patient Informed Consent.

Exclusion Criteria:

* All patients included cannot meet any of the following conditions:

  * Recurrent stroke or TIA
  * Stroke or TIA with determined etiology according to TOAST criteria.
  * Anticoagulation indication at the time of enrollment in the study.
  * Total contraindication for anticoagulation therapy
  * Atrial fibrillation detection prior to enrollment
  * Severe cognitive impairment or dementia
  * Patient unable to be followed up
  * Patients enrolled in another clinical trial
  * Patients with life expectancy of less than 1 year
  * Pregnancy
Studying Biomarkers in Samples From Young Patients With Rhabdoid Tumors

RATIONALE: Studying samples of tissue from patients with rhabdoid tumors in the laboratory may help doctor learn more about changes that occur in DNA and identify genes related to cancer.

PURPOSE: This research trial studies biomarkers in samples from young patients with rhabdoid tumors.

OBJECTIVES:

* To investigate the expression and function of transposons in 50 primary rhabdoid tumors.

OUTLINE: Freshly frozen rhabdoid tumors will be studied using fluorescence in situ hybridization (FISH) and polymerase chain reaction (PCR) to establish the genomic location of transposons. Protein expression in rhabdoid tumor tissue microarrays is also analyzed.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Freshly frozen rhabdoid tumors from either renal or extra-renal sites from children younger than 2 years of age
* Clinical patient information (age, gender, comorbidities, tumor stage, size, pathology, therapy, outcome) available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem Cells

This is a single center, single arm and open-label study to investigate the safety and efficacy of iPS-NCS with Parkinson's Disease


Eligibility Criteria:
Inclusion Criteria:

1. The subject is able to understand the research requirements, provide written informed consent, and complete the study in accordance with the procedures;
2. The subject is clearly diagnosed with Parkinson's;
3. Recorded disease progression over the past 6 months;
4. Vital organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥ 50%, no obvious abnormality in ECG; blood oxygen saturation ≥ 90%; creatinine clearance calculated by Cockcroft-Gault formula ≥ 40ml/min; ALT and AST ≤ 3 times the normal range, total bilirubin ≤ 2.0 mg/dl;
5. Blood routine: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×10/L;

Exclusion Criteria:

1. Mental illness or a neurological disease not associated with Parkinson's disease;
2. Serious other concomitant diseases (tumor, organ failure, etc.);
3. Subjects used a large amount of corticosteroids, immunoglobulins, immunosuppressants before entering the study;
4. Participated in other clinical trials of cell preparations and participated in other clinical trials within 3 months;
5. There are already cognitive impairments or depressions, etc., and the research cannot be completed well;
6. Female subjects who are breast-feeding or have a pregnancy plan recently.
Maturation of Auditory Processing in Children With Dyslexia Compared to Average-reading Children

The hypothesis of central auditory processing disorders has been advanced to explain the anomalies of the grapheme/phoneme combination in some dyslexia. These phonological disorders may be linked to abnormalities of the efferent (medial olivocochlear) system modulation and of cortical asymmetry. Indeed, the efferent system has an asymmetry in relation to handedness. Thus, in right-handed subject, it is predominant on the right side. In contrast, in the subject-handed dyslexic, the efferent system tends to be right-lateralized or non-lateralized. However, after an audio-visual training, normal lateralization can appear. This maturation of the efferent system lateralization during reading acquisition seems to have a particular profile in dyslexics with phonological disorder, especially if it is persistent. This finding allows to consider new prognostic evaluation and speech therapy rehabilitation in the dyslexic child.


Eligibility Criteria:
Common inclusion criteria

* Native French speaker and french education
* No medical treatment for behavior or neurological disorders (as epilepsy)
* Normal or corrected vision
* Right-handed children (Edinburgh tets (Oldfield, 1971): \>+50%)
* Normal ORL examination
* No hearing loss : hearing thresholds not above 15 dB between 250 and 4 000 Hz
* Presence of Otoacoustic Emissions (Total amplitude \< 5 dB or SNR \> 3dB for at least 3 frequency bands between 1 and 4 kHz)
* Normal level of intellectual development
* Regular school attendance

For the normal reading children

* Aged from 6 to less than 11
* Normal reading level

For the dyslexic children

* Aged from 8 to less than 11
* Diagnostic of dyslexia made by a complet check-up during the 6 last months before the inclusion

Exclusion Criteria

* Neurological or psychiatric disease incompatible with the testing procedure
* Ear disease during more than 6 months
* Normal reading children who have repeat a year
* Previous speech therapy for normal reading children
* Not corrected visual acuteness
* Schooling in a foreign language
* Foreign language spoken at home with both parents
* Known hearing deficit
* Invalid social security