cyrilzakka/clinical-trials huggingface dataset:
Impact of Forced Expiration On Pleural Drainage Duration (KPDP)

Following thoracic surgery, pleural effusion in pleural cavity requires post-operative drainage.

Pleural effusion is responsible for pulmonary congestion, atelectasis, hypoventilation, lower efficacy of diaphragmatic curse, lower pulmonary reexpansion and vicious attitude. These complications could be avoided by respiratory physiotherapy.

Forced expiration technic in ipsilateral decubitus is one of these technics but has never been proved better than other technics regarding its efficiency.

The aim of the study is to compare the impact of such a technic on post operative thoracic drainage after pulmonary, pleural or mediastinal pediatric surgery.

Following thoracic surgery, pleural effusion in pleural cavity requires post-operative drainage, most often for few days (2 to 5 days) until fluid quantity is lower than 50 mL / 24h.

Pleural effusion may cause pulmonary congestion, atelectasis, hypoventilation, lower efficacy of diaphragmatic curse, lower pulmonary reexpansion and vicious attitude.

Respiratory physiotherapy in such situations has different aims : pulmonary decongestion and reexpansion, aid for drainage and pleural fluid reduction, avoiding complications and preventing vicious attitudes.

These aims are learned in Physiotherapy formation institutes. The forced expiration technic in ipsilateral decubitus is justified by pleural physiology and is used after pediatric surgery without any scientific evidence regarding his efficacy Using pulmonary physiotherapy after pulmonary, mediastinal or pleural surgery for children is not systematic and depends on prescriber without any professional recommendation.

Actually no scientific evidence regarding technical or postural indicates improvement of effusion drainage.

It seems to be necessary to validate efficiency of such a technic and evaluate its consequences on post-operative pain. Furthermore, this pleural drainage impacts directly the duration of hospitalization and paramedical workload

Eligibility Criteria:
Inclusion Criteria:

* Children 0-4 years
* In front have a mediastinum or lung surgery (lung segmentectomy or lobectomy or non anatomical lung resection) with pleural drainage, regardless of the type drain
* Whose parents or the holder of parental authority have signed a consent
* Whose parents or the holder of parental authority are affiliated to a social security scheme

Exclusion Criteria:

* chest trauma
* Oncology (chest tumors, lung metastases)
* Drained Pleuropneumopathies
* Spine Surgery
* Heart surgery
* Surgery for pectus excavatum
* Route of anterior surgical approach sternotomy chest kind
* Patients intubated and / or ventilated
* Patients with preoperative sepsis
Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy

The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent, postmenopausal females, histological or cytological confirmed oestrogene and/or progesterone (PgR) receptor positive breast cancer, local recurrence or metastasis

Exclusion Criteria:

* Previous systemic endocrine therapy for advanced or recurrent disease; prior fulvestrant therapy
* Premenopausal women
BCI for Hemiparetic Upper Extremities in Patients Due to Stroke

Non-invasive brain-computer interface (BCI) technology is one of the new training approaches to achieve motor restoration through a closed-loop system from brain activity through event-related desynchronization (ERD) after motor imagery (MI) or movement attempt to peripheral feedback triggered by an external hepatic device. Often, it is unclear whether the BCI intervention itself or the assistance of the external device leads to neural responses and functional gains.

This study adopts a closed-loop BCI system involving ERD induced by MI. Functional electrical stimulation (FES) and virtual reality (VR) are simultaneously delivered as feedback. The aim is to investigate the efficacy of closed-loop BCI training combined with FES and VR on the recovery of the hemiparetic upper extremity of individuals with chronic stroke.

Chronic stroke survivors are being recruited and randomly allocated into 3 groups: (1) BCI-FES-VR - participants look at an external screen displaying the VR avatar participant's arms while performing wrist dorsiflexion MI in random order (left or right). The BCI system detects the ERD of the motor area corresponding to correct MI. Then, visual feedback with the VR and motor-tactile feedback with the discharge of the FES is delivered; (2) BCI-FES - same procedure as group 1, but the difference is that the participant's hands replace the VR system; (3) BCI-VR - same procedure as group 1, but the FES is removed. Each session requires 240 MI trials with a training duration of 10 sessions in a 3-week interval.

Motor and MI assessments are being conducted at post-assessment and at a 3-week follow-up.

The findings of this study will provide significant new information regarding neurophysiological motor relearning mechanisms, which could inform the development and evaluation of BCI-based treatment for individuals with stroke and impact the field of translational neuroscience.


Eligibility Criteria:
Inclusion Criteria:

1. Have a diagnosis of ischemic or hemorrhagic stroke to unilateral hemisphere, confirmed by neuroimaging examinations, i.e., brain CT or MRI;
2. Chronic phase of stroke, i.e., time after stroke onset more than 6 months;
3. Between 18 and 64 years old;
4. With severe to moderate levels of hemiparetic upper limb impairment due to stroke, i.e., from levels 1 to 4 in the Functional Test for the Hemiplegic Upper Extremity (FTHUE)
5. Able to give informed written consent to participate in the study.

Exclusion Criteria:

1. Previous diagnosis of any neurological disease excluding stroke;
2. Presence of any sign of cognitive problems (Abbreviated Mental Test \< 6)
3. Modified Ashworth score \> 2 in wrist extensor muscle in the hemiparetic upper extremity after stroke (Bohannon and Smith, 1987) or with severe pain that hinders upper extremity movement
4. With other notable impairments of the upper extremity not caused by stroke (e.g., fracture, Rheumatoid Arthritis, or congenital deformity, etc.)
Non-interventional Study of COPD Patients With Asthma Overlap Syndrome in Viet Nam and Taiwan

The purpose of this study to determine the proportion and clinical characteristics of COPD patients with asthma symptoms (ACOS) and describe current practices in diagnosis and management in Viet Nam and Taiwan.

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity and mortality. Around 15% to 20% of COPD patients would present with features of asthma and are considered to have the overlap syndrome of COPD and asthma, commonly called asthma-COPD overlap syndrome (ACOS). In Asia, specifically Taiwan, the overall prevalence of ACOS in patients with COPD is approximately 17.4%. COPD patients with asthma symptoms represent a relevant clinical population because they have worse health-related quality of life.

Given the increased morbidity among COPD patients with asthma overlap, it is critical that these patients are properly characterized to aid the appropriate diagnosis and treatment. The Global Initiative for Asthma (GINA) and Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines have given joint recommendations on the identification, diagnosis and treatment of these patients. These recommendations have been adapted for use in the Asia Area countries. The primary objective of this study is to determine the proportion and clinical characteristics of patients with ACOS as defined by the joint GINA and GOLD recommendation amongst diagnosed COPD patients seen at the out-patient clinics.

This study is planned to determine the proportion of patients with ACOS as defined by the joint GINA and GOLD recommendation amongst diagnosed COPD patients seen at the out-patient clinics

Eligibility Criteria:
Inclusion Criteria:

* All patients with confirmed diagnosis of COPD {post-bronchodilator FEV1/FVC\<0.7 (FEV1 - forced expiratory volume at one second, FVC - forced vital capacity) based on the medical records}
* Aged \>40 years old at time of diagnosis
* Seen at out-patient clinic

Exclusion Criteria:

* Patients currently with acute exacerbation of COPD by GOLD definition (any worsening of a patient's respiratory symptoms that is beyond normal day-to-day variations and requires a change in medication)
* Patients with respiratory diseases that can show similar symptoms to chronic airway diseases such as bronchiectasis, tuberculosis (TB)-destroyed lung parenchyma, endobronchial TB, and lung cancer, or those who have history of these diseases based on physician's judgment
* Patients currently diagnosed with pneumonia and acute bronchitis
* Patients currently randomized in other clinical studies
Bolus vs. Continuous IV Lidocaine Against Post-Extubation Cough in Post-Thyroidectomy Patients

The goal of this randomized controlled trial is to compare the effect of lidocaine bolus intravenous administration to lidocaine continuous intravenous administration in post thyroidectomy patients to observe the effect against post-extubation cough. The main questions it aims to answer are:

* Cough incidence on both groups
* Which method is preferable to reduce post-extubation cough incidence


Eligibility Criteria:
Inclusion Criteria:

* ASA class 1 and 2
* Thyroidectomy patients in Hasan Sadikin Bandung Hospital

Exclusion Criteria:

* Subjects' refusal
* Had history of drug allergy, specifically lidaocaine
* Had history of asthma or other lung diseases
* Active smoker
* History of arrhythmia
* Bradycardia subjects (\<60 beats per minute)
* Pregnant people
* Perioperative upper respiratory tract infusion
* Routinely consume ACE inhibitor / bronchodilators / steroid
* Renal dysfunction
* Liver dysfunction
Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema

The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects with diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosed with type I or type II diabetes mellitus.
* Hemoglobin A1c (HBA1c) of less than or equal to (≤) 10% within 2 months prior to Day 1.
* Ability and willingness to undertake all scheduled visits and assessments.
* The study eye must meet the following requirements:

  * macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea.
  * decreased visual acuity attributable primarily to DME, the best corrected visual acuity (BCVA) 19 or more letters, 78 letters or less.

Exclusion Criteria:

* The study eye with high risk of proliferative diabetic retinopathy.
* The macular edema of the study eye is mainly caused by other diseases or factors other than DME.
* Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye.
* Administration of IVT any other anti-VEGF drugs in the study eye within 3 months and/or in the other eye within 7 days prior to Day 1.
* Any intraocular long-acting or sustained release corticosteroid treatment (e.g., dexamethasone intravitreal implant) in the study eye within 6 months prior to Day 1.
* Active intraocular or periocular infection or active intraocular inflammation in either eye.
* The study eye with poorly controlled glaucoma.
* A history of idiopathic or autoimmune related uveitis in either eye.
* History of stroke (cerebrovascular accident) or myocardial infarction within 6 months prior to Day 1.
* Uncontrolled blood pressure, defined as a systolic value greater than (\>)180 millimeters of mercury (mmHg) and/or a diastolic value \>100 mmHg while a patient is at rest.
* Currently pregnant or breastfeeding, or intend to become pregnant during the study.
* Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye.
* Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye.
* Other protocol-specified inclusion/exclusion criteria may apply.
The Effect of a New Emulsion in Dry Eye Patients on Tear Layer Aberrometry, Contrast Sensitivity, and Reading Ability

The purpose of this study is to investigate how the addition of a new emulsion artificial tear to the tear layer of dry eye and normal patients affects aberrometry, contrast sensitivity, and reading ability over time. Previous studies have indicated that daily use of artificial tears over a two week period decreases the short term affect of drop application on aberrometry and contrast sensitivity measurements. The present study will examine the effects of 4 weeks of artificial tear use to determine when the responses stabilize.

Dry eye patients experience symptoms such as; irritation, dryness, a scratchy sensation, and blur. These symptoms are the result of an insufficient tear layer. Blur can occur in dry eye patients because of an irregular tear film surface.

Artificial tears are applied to the eye to treat a variety of eye conditions. These conditions typically are associated with dry eyes and include tear film deficiency due to ocular or systemic disease, lid resurfacing problems, and contact lens wear. The artificial tears are used to alleviate the dry eye symptoms.

Dry eye is a frequently encountered ocular condition. Recent studies estimate that 7.8% of women and 4.8% of men over the age of 50 suffer from dry eye. The administration of an artificial tear to the eye can disrupt the tear layer and this disruption could then result in a change in contrast sensitivity for a few moments. Aberrometry is a technique that is able to monitor tear layer disruption and its results may correlate with contrast sensitivity changes.

Tear layer disruption results in a decrease in the modulation transfer function (MTF) for the eye. Since the tear layer is the first refracting surface of the eye, its disruption can also result in a change in contrast sensitivity, visual acuity, and aberrometry. Previous work has demonstrated that higher order aberrations increase 1.44 fold after the tear film breaks up in normal subjects. Dry eye subjects demonstrate a significant increase in higher order aberrations (i.e., total S3+4+5, spherical-like S4, and coma-like S3+5) when compared to normal subjects. This has been interpreted to be the result of increased tear irregularities in the dry eye subjects.

When an artificial tear (i.e., Vismed) was applied to the tear layer of dry eye subjects, the optical aberrations decreased. This previous study only examined the short term affect (less than 10 minutes) of a single administration of an artificial tear. In this study, we propose to examine the short and long term effects of a new emulsion on contrast sensitivity, optical aberrations, and reading ability after administration into the tear layer of normal and dry eye subjects.

Eligibility Criteria:
Inclusion Criteria:

* mild, moderate, or severe symptoms of dry eye

Exclusion Criteria:

* uncontrolled systemic disease
* contact lens wear
* participation in another clinical trial
* best corrected visual acuity poorer than 20/25
Balance, Trunk Impairment and Fear of Falling in Multiple Sclerosis Patients With Incontinence

The aim of the present study was to examine balance, trunk impairment, and fear of falling in MS patients with incontinence. Clinical symptoms of the MS patients are heterogenous, and they vary according to the lesion levels and the duration and the type of the disease. In the neurologic group,especially in MS patients, incontinence is observed even at early stages.

Pelvic floor muscles contribute to continence by stabilizing the bladder neck and increasing the intraurethral pressure. Furthermore, they mechanically support the spine and the pelvis.This mechanical support is attained through an increase in sacroiliac joint stiffness and intra-abdominal pressure changes, which are important for spinal control. Along with incontinence, this mechanical support deteriorates resulting in some problems. By this way, postural function of pelvic floor muscles may alter in individuals with incontinence, and thus, lumbopelvic stabilization may be negatively affected. In addition, the activity of trunk muscles changes in individuals with incontinence, which may result in spinal movement and affect the posture. Therefore, balance disorders may develop. Postural sways caused by balance disorders and the decrease in postural corrections have been listed among risk the factors associated with falling.

When literature is examined, there exists no study examining the effects of incontinence on balance, trunk impairment, and fear of falling in MS patients. For all these reasons, investigators think that incontinence in MS patients has an effect on balance, trunk impairment, and fear of fall.

This study was aimed to investigate balance, trunk impairment, and fear of falling in MS patients with and without incontinence.

The study was conducted in 35 MS patients with an age range of 24-58 years. The patients were divided into two groups based on the occurrence of incontinence. A neurologic examination was performed using the EDSS by a neurologist.

Incontinence was measured with the Incontinence Severity Index (ISI), balance was measured with a Technobody® stabilometric platform, and fear of falling was measured with the Falls Efficacy Scale (FES).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Multiple Sclerosis Disease
* The level of disability should be between 0.5-4 according to EDSS
* having a score of 24 or more in the Mini Mental Status Test

Exclusion Criteria:

* Patients with acute attacks (six months prior to the study)
* Mini-Mental State Examination (MMSE) score of less tahn 25 points
* History of shoulder injury, surgery, medical problems or other neurological disorders in any of the participants
Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics

The role of anaerobic bacteria in the pathogenesis of palmer arsenical keratosis is not known. This can be evaluated by administering probiotics. Thirty patients from an arsenic affected area will be provided two probiotics capsules per day orally for 12 weeks and stool samples will be collected for qualitative and quantitative analysis of anaerobic bacteria. Similar number of arsenic exposed controls and healthy volunteers from the same area will be included with similar protocol for comparison. Like aerobic bacteria, anaerobic bacteria may be modulated by probiotics in arsenicosis patients.

Recent study done by our laboratory shows that there are reduction in the number of E. coli in the gut of patients with arsenical keratosis which is increase by the administration of probiotics (manuscript is preparing). However, E.coli contribute only about 0.1% of the total gut bacteria. It is not known whether anaerobic bacteria play an important role in the pathogenesis of arsenical keratosis. This can be evaluated by administering probiotics. Thirty patients of moderate arsenical palmer keratosis from an arsenic affected area will be recruited on the basis of inclusion and exclusion criteria. They will be provided two probiotics capsules per day orally for 12 weeks. Water sample will be collected before starting the study for confirming the diagnosis. Stool samples will be collected twice (before and after completion of the study) for qualitative and quantitative analysis of anaerobic bacteria. Similar number of arsenic exposed controls (30) and healthy volunteers (30) from the same area will be included in this study and they will be provided probiotics capsules with similar dosage and duration. Like aerobic bacteria, anaerobic bacteria may be modulated by probiotics in arsenicosis patients.

Eligibility Criteria:
Inclusion Criteria (Patients):

* history of taking arsenic contaminated water (\>50 ppb) for more than 6 months
* patients having moderate arsenical keratosis present on palm of the hand
* patients those voluntarily agree to participate

Inclusion Criteria (Arsenic exposed controls):

* family member of the patient
* drinking arsenic contaminated water from the same source as patient
* those voluntarily agreed to participate
* no sign/symptoms of palmer keratosis

Inclusion Criteria (Healthy volunteers):

* drinking arsenic safe water \<50 ppb)
* those voluntarily agreed to participate

Exclusion Criteria:

* pregnancy
* lactating mother
* patient receiving treatment of arsenicosis
* any other chronic disease like tuberculosis, diabetes, asthma
A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)

This is a study to assess the use of golimumab (Simponi®) in participants with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The study objective is to evaluate the clinical safety of golimumab (Simponi®) under real-life, clinical practice conditions as assessed by the incidence and type of (serious) adverse events and changes in clinical status of participants as assessed by clinical parameters.


Eligibility Criteria:
Inclusion Criteria:

* Has rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis and treatment with Simponi® by autoinjector device is to be initiated for the first time

Exclusion Criteria:

* No specific exclusion criteria