cyrilzakka/clinical-trials huggingface dataset:
Beta Agonist Nebulization in Non Invasively Ventilated COPD Patients: Safety, and Therapeutic Efficacy Range.

randomized double-blind controlled study in parallel groups

Salbutamol is a β2 mimetic short-acting to be administered by nebulization in this study.

During this administration, non invasive ventilation for the patient will be continued.

Randomization will focus on the treatment administered (placebo or salbutamol ).

After the first phase , a switch will be set up for each patient , retaining the blind it will be administered salbutamol (for those who received placebo in the first phase ) or placebo (for those receiving salbutamol ) .

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient with BPCO, defined:

  * by an irreversible obstructive syndrome
  * and\\or by different arguments (histories, symptoms, physical examination, thoracic radiography, gas of the blood)
* Decompensation of this BPCO in the form of acute respiratory failure
* No argument for a dominant acute left cardiac insufficiency
* Consent signed by the patient
* Patient with national health assurance

Exclusion Criteria:

* Contraindications in the not invasive ventilation
* Patient not volunteer for the realization of the spirometry
* Precautions for use of ß2 mimetic (engrave hyperthyroidism)
* Under guardianship patient or protection of justice
* Pregnant patient
Specified Drug-use Survey on Abilify Prolonged Release Aqueous Suspension for IM Injection (Prevention of Relapse of Mood Episodes in BP)

To investigate the safety for an observation period of 52 weeks with use of Abilify prolonged release aqueous suspension for intramuscular (IM) injection in patients with bipolar I disorder for prevention of recurrence/relapse of mood episodes in the routine clinical setting. The early stage safety after the switching from oral aripiprazole to this IM injection is investigated including extrapyramidal syndrome and malignant syndrome. Information regarding efficacy is collected as well.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* patients with a known hypersensitivity to aripiprazole
TARGET Post-Approval Study

The purpose of this prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium and Proclaim Neurostimulator System for dorsal root ganglion (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for permanent implants.

A maximum of 426 adult subjects with moderate to severe chronic, intractable, pain of the lower limbs due to CRPS types I and II will undergo a trial of the Axium or Proclaim Neurostimulator System across up to 45 study sites in the United States. Only subjects who report a 50% or greater reduction in overall pain intensity through direct patient-reported percentage of pain relief will receive the permanent implant. Subjects will then return to the office for follow-up at 1, 3, 6 and 12 months post-permanent implant.

Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female between ≥ 22 and ≤ 75 years of age.
* Subject has moderate to severe chronic intractable pain of the lower limbs resulting from Complex Regional Pain Syndrome (CRPS) types I or II.
* Subject has a baseline Visual Analogue Scale (VAS) of ≥ 60 mm for overall pain at the time of the baseline assessment.
* Subject is willing and able to comply with the study requirements.
* Subject is able to provide written informed consent.

Exclusion Criteria:

* Subject has an active implantable medical device including but not limited to cardiac pacemakers and cardiac defibrillators.
* Subject is currently involved in medically related litigation, including workers compensation.
* Subject has a life expectancy of less than one year.
* Subject is pregnant or of child bearing potential and not using adequate contraception as determined by the investigator.
* Subject has, or plans to have, a spinal cord stimulation system or infusion pump system implanted.
* Subject has, or plans to have, a peripheral nerve stimulation system (PNS) or peripheral nerve field stimulation system (PNfS) implanted.
* Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the implant procedure and/or recovery from the implant procedure or could complicate the required procedures and evaluations of the study in the judgment of the investigator.
Assessing the Role of Exercise Intensity in Slowing Disease Progression in Early Parkinson's Disease

Participants will complete a self-selected intensity of exercising over a 6 month period, with detailed clinical assessments at commencement and completion to determine the rate of progression of parkinsonism and gait abnormalities

Participants will complete a self-selected intensity of exercising over a 6 month period - including jogging, swimming and circuit training, with detailed clinical assessments at commencement and completion (including UPDRS, gaitrite lab study) to determine the rate of progression of parkinsonism and gait abnormalities

Eligibility Criteria:
Inclusion Criteria:

* Early Parkinson's Disease,
* Able to provide informed consent,
* able to complete exercise diaries for 6 months,
* no medications or on levo-dopa

Exclusion Criteria:

* Not on dopamine agonists,
Study of Genic Expression Profiles of the Epithelium of the Nose and Bronchi in Healthy and Allergic Subjects

The respiratory epithelium plays a leading role in the development of allergic respiratory disease with barrier function alteration, its repair mechanisms, of anti-viral fight and the ability to induce by itself Th2 responses. The majority of allergic asthmatic patients have reached concomitant ENT: the concept of "one airway, one disease." Access to this material of epithelial study in the different phenotypes of the disease appears to be crucial. Nasal and bronchial epithelial tissues reveal essential differences in particular related to their environment (remodeling less intense and a lower sensitivity to the virus in the nose), but they nevertheless share many common cellular characteristics.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years and \<30 years
* isolated allergic rhinitis according to clinical criteria ARIA
* absence of asthma whose diagnosis is made based on clinical criteria or mild to moderate persistent asthma controlled with a diagnosis is made based on clinical criteria

Exclusion Criteria:

* recent rhino-bronchial infection (\<6 weeks)
* asthma exacerbation in the previous 6 weeks
* Chronic disease may in the opinion of the investigators interfere with the results of the study or expose them to additional risk.
* Treatment with nasal corticosteroids, inhaled or systemic in the past 6 weeks
* Current smoking no history of smoking or not smoking for at least 12 months and weaned smoking history \<5 pack-years)
* Special Needs
Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy

To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients who progressed after gefitinib therapy.

This single center, single arm open label study is designed to assess the safety and efficacy of using high dose of Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that progressed after routine gefitinib therapy by progression-free survival, as well as overall survival and disease control rate. The adverse events and adverse reaction are evaluated as well.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed local advanced or metastatic stage IIIB/IV NSCLC.
* Have been treated with gefitinib and achieved completed response, partial remission, or stable disease within 3 months after first dose of gefitinib.
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors.
* Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

* Allergic to icotinib.
* Gefitinib excepted, experience of Anti-tumor Monoclonal Antibody or small molecular compounds therapy such as erlotinib or Cetuximab.
* Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Evaluation of a Novel Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth in Women Presenting With Signs and Symptoms of Preterm Labor

Currently, the American College of Obstetricians and Gynecologists (ACOG) indicate in their most recent Practice Bulletin on the Management of Preterm Labor that many tests to identify women at risk of preterm birth have been proposed and evaluated; however, only ultrasonography and fetal fibronectin testing have been shown to have benefit. Ultrasonography to determine cervical length, fetal fibronectin testing, or a combination of both may be useful in determining which women are at high risk for preterm delivery. However, their clinical usefulness may rest primarily with their ability to identify women who are least likely to deliver (i.e. their negative predictive value). Therefore, there is an urgent need for a test with a high positive predictive value in order to accurately predict imminent delivery to allow for salutary intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for emergency obstetrical care at an emergency room or labor \& delivery unit with signs, symptoms or complaints suggestive of preterm labor (PTL)

  * Uterine contractions, with or without pain
  * Intermittent lower abdominal pain
  * Dull backache
  * Pelvic pressure
  * Bleeding during the second or third trimester
  * Menstrual-like or intestinal cramping, with or without diarrhea
  * Patient is not "feeling right"
* Gestational age between 200/7 and 366/7
* Consenting to be part of the trial

Exclusion Criteria:

* Presented for regularly scheduled obstetrical care with symptoms
* \< 18 years old and not emancipated consenting minor
* \< 200/7 weeks of gestation or ≥ 37 weeks of gestation cervix length \> 30 mm
* cervical dilatation \> 3 centimeters
* overt rupture of the fetal membranes (ROM) as indicated by visualized leakage of fluid from the cervical os
* heavy vaginal bleeding
* received tocolytic medications for treatment of threatened preterm delivery prior to collection of the cervicovaginal specimens or cervical length measurements
* suspected placenta previa
* cervical cerclage in place
* a symptom not associated with idiopathic threatened preterm delivery (e.g. trauma)
* digital exam prior to specimen collection
Efficacy of a Foot Strengthening Protocol on Sport Performance Kinetics

This randomized controlled trial aims to explore the effect of a foot strengthening protocol on toe flexion strength, foot deformation and morphology as well as kinetics during sprinting, cutting and jumping in healthy athletes (18-40 completed years). The study consists of a 4 weeks control period, followed by 8 weeks intervention period and 4 weeks follow up

During the first period participants are unaware of their allocation, while in the intervention period they will be allocated to a train intervention or a control group (habits maintenance). The primary outcome is the toes maximal voluntary isometric plantarflexion. The treatment effectiveness estimand is the same as in a pretest-posttest case control study, considering the end of the control period as pre-point. An estimation of the individual variability in response to the treatment will be provided.

Eligibility Criteria:
Inclusion criteria :

* To be affiliated in the federation of one of the following sports : soccer, handball, rugby, basketball or track and field;
* To practice their respective sport more than two times per week;
* Be affiliated or beneficiary of a social security insurance;
* Having freely given their written consent after having been informed of the purpose, the procedure and the potential risks involved.
* Licensed in a tennis club (FFT) and in a volleyball club (FFVolley)

Exclusion criteria :

* Use of pharmacological therapy to match gander identity;
* Have an abnormal range of motion of the toes and/or ankle;
* Have any kind of ankle or foot pain (self-defined and self-reported by the FAAM questionnaire) in the previous 6 months;
* Have a previous injury or surgery of the lower limb in the previous 6 months;
* Have a neurological or vestibular deficit that may affect walking or balance (lumbar-sacral radiculopathy, peripheral nerve pathology, Marfan or Eehlers-Danlos syndrome, etc.);
* Have contraindication to neuromuscular electrical stimulation (pacemaker, seizure disorders, pregnancy);
* Have a previous foot strengthening experience in the past 6 months for at least 2 weeks and more than one session per week;
* Participate at the same time in another medical interventional experiment or have participated in such a study in the 30 days preceding this study;
* Being unable to understand the purpose and conditions of the study, and to give consent;
* Being deprived of liberty or under guardianship.
Prospective Evaluation of the Impact on Patients' Quality of Life of a 12-Week Adapted Physical Activity Program (APA)

The objective of this study is to evaluate the effects of regular physical practice on fatigue, quality of life and kinesiophobia in patients treated at the ICO in Angers, regardless of the type of cancer and the type of treatment.

The objective of this study is to evaluate the effects of regular physical practice on fatigue, quality of life and kinesiophobia in patients treated at the ICO in Angers, regardless of the type of cancer and the type of treatment.

A 12-week Adapted Physical Activity program (APA) is proposed to patients included in the study with an assessment of fatigue, quality of life, level of physical activity and kinesiophobia (fear of movement) at the beginning of the study.

A second assessment of fatigue and quality of life will be done during the 6-week management.

At the end of the program, a final evaluation of fatigue, quality of life and kinesiophobia will be done.

Eligibility Criteria:
Inclusion Criteria:

1. Oncological care at the ICO
2. All types of cancer
3. Regardless of the type of treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy)
4. Age \> 18 years old
5. Follow the APA program at the ICO
6. Subject informed of the study

Exclusion Criteria:

1. Contraindication to the practice of sport
2. APA Program outside the ICO
3. Subject opposing the use of his data
4. Minor or adult patient under guardianship or curatorship
5. Pregnant woman
6. Altered general condition
Single Cutting Guides System for the Installation of a Total Knee Replacement

The knee prosthesis is a validated treatment for end-stage of knee osteoarthritis, and this intervention usually provides a significant improvement in the quality of life of patients. However, a significant percentage of patients (up to 30%) are disappointed with the outcome of the intervention. One hypothesis that could explain these poor results might be the poor positioning of implants. Individual cutting guides are produced after a CT scan response planning carried out according to the CT scan anatomy of each patient, and subsequently adapted to its real anatomy during surgery, thus theoretically better accuracy of the implementation over conventional techniques. It has been shown in the past that the navigation has been the gold standard in measuring the three-dimensional orientation of the implants during surgery, and this system is systematically used in the service for over 10 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total knee prosthesis.

Exclusion Criteria:

* Patients under 18 years
Comparison of Different Locations for Pulse Oximetry Probes in Cardiovascular (CV) Patients With Poor Peripheral Perfusion

The purpose of this study is to determine if the forehand location for sensor placement has less episodes of signal dropout than the finger sensor location. In addition, this study will evaluate two finger sensors, which utilize different technology to compare signal quality.

A comparison study design will be used to evaluate the signal quality of pulse oximetry sensors placed in two locations: forehand and finger. Each subject will serve as their own control, with measurements of signal quality evaluated at 2 second intervals over a period of one hour. The measurements will be recorded simultaneously with a computer program and laptop computer. Finger and forehand sensors will be applied according to manufacturer's guidelines. An output connection will be made from each pulse oximeter computer unit to a password protected, laptop computer for data downloading. Data will be collected for a 1 hour period at 2 second increments and stored in the hard drive of the laptop. Following completion of data collection, the study sensors will be removed.

Eligibility Criteria:
Inclusion Criteria:

* CICU patients with a new diagnosis or history of CHF or cardiomyopathy
* Patients with a medical order for pulse oximetry monitoring
* Age greater than or equal to 18 years of age
* English speaking
* Signs of hypoperfusion

Exclusion Criteria:

* CICU patients with an impediment to sensor application
* CICU patients with excessive facial edema
* CICU patients with mechanical ventilation
* CICU patients with intra-aortic balloon pump therapy
* CICU patients with intravenous vasopressor drug administration
Interdisciplinary Study Group of Lupus Erythematosus (ISGLE)

Cutaneous lupus erythematosus (CLE) is a disease with a wide spectrum of clinical manifestations and a variable prognosis. The aim of this study is to create a standardized evaluation of the different subtypes of this disease in order to receive an overview of the spectrum of clinical and laboratory features as well as the therapeutic strategies for patients with CLE.

Methods: A core set questionnaire has been developed in the course of the "European Society of Cutaneous Lupus Erythematosus (EUSCLE)", and a total of 40 patients (32 females, 8 males) in two centres, Germany and Sweden, were included in this study. Results: CLE was diagnosed in 39 individuals (5 with acute CLE, 10 with subacute CLE, 13 with chronic CLE, and 18 with intermittent CLE) and one individual presented with a systemic manifestation of the disease. Furthermore, disease onset and duration as well as activity and damage of skin lesions using a modified CLASI were examined. Interestingly, 75% of the patients with CLE showed a positive history of photosensitivity, but only 62.5% exhibited characteristic lesions after standardized phototesting. Laboratory analysis revealed positive antinuclear antibodies in 50% of the patients, positive anti-Ro/SSA in 12 and positive anti-La/SSB antibodies in 8 cases. The predominantly used treatments included sunscreens (38 patients), topical steroids (31 patients), topical calcineurin inhibitors (12 patients), chloroquine (19 patients), hydroxychloroquine (11 patients), and systemic steroids (12 patients). Conclusions: The new core set questionnaire enables the clinician to characterize the different skin manifestations involved in CLE and to evaluate disease activity and reasonable treatment modalities. Furthermore, epidemiological data and laboratory features can be assessed for the various subtypes. In the future, this standardized evaluation might lead to the development of diagnostic guidelines and evidence based therapeutic strategies thus improving quality of care for patients with CLE.

Eligibility Criteria:
Inclusion Criteria:

* cutaneous lupus erythematosus confirmed by histological analysis
* photoprovocation-test performed in advance
* written informed consent available prior to any procedures

Exclusion Criteria:

* patients with conditions that are contrary to the above mentioned criteria
The Effect Of Tramadol, Metamizol and Dexketoprofen Combination On Chronic Pain Development After Heart Surgery

Non Coronary Heart Surgery scheduled for the study , in patients with acute postoperative period Use of tramadol retard, metamizol and dekxketoprofen the effects on pain and character has been seen in the chronic phase targeted.

This prospective study analyzed surgical thoracotomy and sternotomy patients treated with analgesic drug when higher than 4 regularly. Clinical parameters include general demographics, preoperative and postoperative clinical examination status, pain scores, neuropathic pain scores, medication side effects, additional analgesic, antiemetic and lacsatif needs, vital functions, chest drains, blood transfusion needs, duration of cardiopulmonary bypass, cross clamp time and anaesthesia time. The screening tests for neuropathic pain is the Douleur Neuropathique 4. Using at postopertative 3.month DN4 questionnaires predict persistent postoperative neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients included between 20-70 years
* ASA 1-4
* Euroscore value lower than 7
* Undergoned non coronary heart surgery (minithoracotomy and sternotomy)
* Intensive care has been discharged from the service in 24 hours , with patients given tramadol retard , metamizol, Dexketoprofen on postoperatif first day to discharged from the hospital.

Exclusion Criteria:

* Diabetes mellitus
* Chronic renal failure
* COPD
* Uncontrolled hypertension
* Epilepsy
* Psychiatric disease
* Malignancy
* Patients with a history of cerebrovascular disease
* Patients with ischemia
* Patients suffering from chronic pain and analgesic use
* Patients taking antidepressants and antiepileptic drug
* Off-pump technique used or redo undergo cases
* Ongoing postoperative time thoracic or mediastinal drains more than 48 hours remaining patients, bleeding or patients who received repeated revisions due to infection
* More than 24 hours remaining in intensive care patients
* Patients with long discharge duration 1 week
* Patients who discontinued due to side effects of tramadol may begin after medicines.
* Postoperative wound infection.
Esophageal Hypersensitivity Study in Healthy Volunteers

The purpose of the study is to compare sensitivity and sensitization of visceral pain in the esophagus using different pain stimuli


Eligibility Criteria:
Inclusion Criteria:

* Provision of written consent
* Clinically normal physical findings
* Sensitization potential

Exclusion Criteria:

* Clinically significant illness within 2 weeks prior to the first dose of investigational product
* History of clinically significant disease
* Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
Xishui Project for IDM of COPD and Comorbidities

Study Population: 4000 stable COPD patients, and among them approximately 2000 subjects with hypertension and/or type 2 diabetes complications.

Design: Cohort Study Primary Objectives: The primary objective of this study is to access the effectiveness of IDM on changes in FEV1 from baseline to the 24th week visit in patients with COPD.

Statistical Analysis: We plan to compare demographic differences between groups based on whether the data conformed to normal distribution and satisfied variance chi-square, and proposed to calculate p-values using the t-test or non-parametric test for continuous data and Person's χ² or non-parametric test for categorical data. A two-sided p-value \< 0.05 is considered statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥40 years;
* Stable COPD patients with post-bronchodilator FEV1/FVC \<70% or previously diagnosed of COPD by physicians and confirmed by PFT;
* With/without diabetes and/or hypertension;
* Permanent resident of Xishui (not expected to leave the area within 1 year).

Exclusion Criteria:

* Suffering from severe cognitive disorders or total loss of ability of daily living.
* Death.