cyrilzakka/clinical-trials huggingface dataset:
Implementation of a Rehabilitation Technology in Orthopedic and Neurological Rehabilitation to Increase Therapy Dosage: an Exploratory Study

Rehabilitation technology is more and more implemented in conventional therapy to increase the dosage of therapy and/or increase patient's motivation towards therapy. In orthopedic as well as neurological rehabilitation it is important to exercise with enough intensity and repetitions to improve functional performance in activities of daily life, and consequently quality of life. At the moment, not all (rehabilitation) technologies are adapted towards the wishes and needs of both patients and therapists for everyday use in the clinical setting. Also, not all technologies are fit for independent use by the patients. Researcher of PXL have developed a Kinect-based system (i.e. i-ACT) for rehabilitation and performed supervised research with i-ACT in neurological and musculoskeletal rehabilitation, and older adults. Within this research, patients will exercise with i-ACT under supervision of their therapist during weekdays, but in the weekends they will be motivated by the medical staff to perform their exercises with i-ACT. The medical staff will be present for safety reasons, but the patient is asked to use and exercise with i-ACT as independent as possible. The aim of this research is to explore to which extend i-ACT is suitable for semi-independent use by patients in orthopedic or neurological rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years old
* post-operation of arthroplasty (hip or knee), or official medical diagnosis of stroke or Parkinson's disease
* understand Dutch instructions
* patient at St-Trudo ziekenhuis
* experiencing problems in functional performance

Exclusion Criteria:

* neglect
* spasticity (Brunström Fugl-Meyer \< 50)
* cognitive disfunction (Mini Mental State Examination \< 24)
* visual impairment (blind, cataract, etc.)
* persons who are not able to exit electric wheelchair
Spinal Prilocaine for Caesarian Sections

Prilocaine theoretically could provide faster onset because of its lower pKa (7,7) compared to bupivacaine (8,1). The primary objective of this prospective double blind randomized trial is to determine block onset of spinal hyperbaric prilocaine compared to bupivacaine, both with a small dose of sufentanyl as an additive.The primary hypothesis is that a significant larger amount of patients will gain surgical readiness within 8 minutes after spinal injection of prilocaine with sufentanyl compared to bupivacaine with sufentanyl. Surgical readiness is defined as a sensory block level of T5 tested by loss of cold sensation.

This study is designed as a randomised prospective double blind multi centre study.

Following approval by the Hospital Ethics committee of the University Hospital Antwerp and all participating hospitals, all-in term (37-42 weeks of gestation) pregnant women planned for a caesarean section will be asked to participate in this trial.

Patients will be randomised to receive either spinal prilocaine with sufentanyl or spinal bupivacaine with sufentanyl.The patient, the anaesthetist performing the CSE and the observer are not aware of the local anaesthetic solution administered.

Preoperative a combined spinal epidural puncture will be performed in the sitting position at the level of L2-L3 or L3-L4 . Vital parameters will be registered at regular intervals. Block characteristics ( onset, duration and intensity of the sensory block and motor block) will be measured at regular intervals.

Patients with insufficient analgesia will receive a top up dose of 5 ml lidocaine 2 % via the epidural catheter.

Time of birth, neonatal outcome (Apgar score 1 min, 5 min and 10 minutes after birth) and admission to the nicu as well as umbilicus venous and arterial blood gasses are recorded.

Patients will be discharged from the PACU when motor block reached a Bromage score 1 Time intervals of discharge to the ward will be registered.At the maternity ward the time of first contact of the baby and the mother and first breast feed (if applicable) will be registered.

One week postoperative patients will be called and asked if they experienced any postoperative symptoms like headache, micturition problems or symptoms resembling Transient Neurological Symptoms

Eligibility Criteria:
Inclusion Criteria:

* A term Pregnant women (37-42 weeks)scheduled for caesarian section

Exclusion Criteria:

* Patient refusal
* Twin or multiple pregnancy
* Preeclampsia
* Contraindication neuraxial technique
* Indication general anaesthesia
* BMI before pregnancy \>35
* Maternal height \<155 cm
The Role of Concurrent Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma(NPC) in the Era of IMRT

The purpose of this study is to verify that simultaneous integrated boost IMRT (SIB-IMRT) alone is non-inferior to SIB-IMRT combined with concurrent chemotherapy for low-risk locally advanced nasopharyngeal carcinoma.

* There were several randomized clinical trials confirmed that concurrent chemoradiotherapy (CCRT) is superior to radiotherapy (RT)alone for locally advanced NPC, most of the patients in the trials were treated with conventional radiotherapy technique.
* As the new technique of IMRT used more and more in the clinical practice, the role of concurrent chemoradiotherapy (CCRT) seems blurred, in two of Hongkong phaseIII studies(NPC9901/9902), half of the patients were treated by 3-dimensional conformal radiotherapy (3DCRT)/IMRT,the results showed that there were no significant different in terms of overall survival between RT alone and CCRT groups. Furthermore, several large sample size retrospective studies from China, showed that there were no advantage of CCRT over RT alone when treated by SIB-IMRT.
* In an analysis of who will benefit from CCRT,( Lin, et.al, IJROBP,2004; 60:156-164), the author divided the locally advanced NPC patients into two groups, with the high-risk group defined as patients met at least one of following criteria: nodal size \>6 cm, (2) supraclavicular node metastasesN3, T4N2 and multiple neck node metastases with 1 node \>4cm.
* Based on these information, we hypothesize that, for low-risk locally advanced NPC patients, there may no need CCRT under SIB-IMRT treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histopathological proven non-keratin nasopharyngeal carcinoma
* AJCC 7th edition stage III/IVM0, without any one of following factors: node size \>6cm;supraclavicular metastasis node; T4N2; multiple neck node metastases with 1 node \>4 cm
* Life expectancy≥6 months
* Adequate renal function, defined as follows: Serum creatinine \< 2 x institutional upper limit of normal(ULN) within 2 weeks prior to registration or creatinine clearance rate (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined by 24- hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dl) x (72)\] CCr female = 0.85 x (CCrmale)
* The following assessments are required within 2 weeks prior to the start of registration: Na, K, Cl, glucose, Ca, Mg, and albumin

Exclusion Criteria:

* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated \< 3 years ago
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* Severe, active co-morbidity
* Treatment planning does not meet the requirement of prescription dose.
Forced Inspiratory Flow Volume Curve in Healthy Young Children

Spirometry testing should include both expiratory and inspiratory measurements as it may influence the expiratory flow volume curve indices. The ability to inhale medication may by judged by inspiratory flows. However, the inspiratory portion of the forced flow/volume maneuver in young healthy children has not yet been described.Objectives: To document and analyze the forced inspiratory flow volume curve indices in healthy young children.

Settings: Community kindergartens around Israel. participants; Healthy preschool children (age 2.5-6.5 years).

Methods: The teaching method included multi-target, interactive spirometry games (SpiroGame®) and accessory games for inspiration (e.g. inspiratory whistle).

Results: One hundred and fourteen of 157 children performed duplicate full adequate inspiratory maneuvers. Repeatability between two maneuvers was 5.6%, 4.0%, 5.1%, 7.3% for inspiratory capacity (IVC), forced inspiratory capacity (FIVC), peak inspiratory capacity (PIF), and mid inspiratory flow (MIF50), respectively. Inspiratory flow indices were significantly lower than the parallel expiratory flow indices and the time to reach PIF was significantly slower than the time to reach peak expiratory flow (meanSD; 22921ms vs. 92 8ms; p\<0.0001). The shape of the inspiratory curve was parabolic and did not change with age. Predicted equations that were formed were in agreement with the extrapolated prediction equation values of older children.

We found that the majority of healthy young children can produce reliable inspiratory curves. Our results provide a framework for reference equations for inspiratory flow volume curve in the young ages. The clinical applications of these equations are yet to be explored.

Study protocol: The study included healthy children (according to questionnaire) in their early childhood. Any children with previous symptoms or present treatment for asthma, respiratory symptoms (cough, post nasal drip, pneumonia, rhinitis) other respiratory diseases were excluded from the study. Forced maneuvers were measured with a commercial spirometer, ZAN100 (ZAN Messgerate, Oberthulba, Germany). The spirometer software included online analysis of inspiratory and expiratory maneuvers. The curves were monitored on the computer screen to ensure best effort. The software also included an incentive-guided spirometry game. Inspiratory indices were not part of the games, therefore efforts were continued until the child could not pass the former inspiratory attempt any further. Healthy children performed the tests in a designated room in the kindergarten. Tests were performed in a standing position without a nose-clip. Maneuvers were repeated to obtain best possible efforts on at least three technically acceptable maneuvers. Technically acceptable curves were stored and the three consecutive curves with the maximal inspiratory maneuvers were analyzed for the study.

Eligibility Criteria:
Inclusion Criteria:

* healthy children between 3-6 years old

Exclusion Criteria:

* Past or present respiratory lung disease
Dynamics of Immune Map and Outcomes After On-pump Cardiac Surgery: Protocol for a Prospective Cohort Study

Although systemic inflammatory response induced by cardiopulmonary bypass is believed as one of main reasons for these adverse events, the involved mechanism is still unclear.This cohort study would include patients undergoing on-pump valve surgery or CABG. By detecting the changes of immune cell expression profile and inflammatory related substances in blood, the spatiotemporal change curve of immune function of patients is drawn for avoiding or treating adverse events.


Eligibility Criteria:
Inclusion Criteria:

* (1) participants aged over 18 years; (2) Participants who scheduled for valve replacement or valvuloplasty, coronary artery bypass under CPB.

Exclusion Criteria:

* (1) participant with a cognitive or mental disorder who is unable to sign an informed consent form; (2) suffering from basic immune system and blood system diseases; (3) pregnancy; (4) preoperative radiotherapy and chemotherapy; (5) receive immunosuppressive drugs within six months;(6) Expected survival time less than 2 years;(7) participated in other intervention clinical trials within 30 days before operation.
Pulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial in Japan

Objective: Determine the safety and efficacy of GM-CSF inhalation in patients with aPAP.

Study Design: multi-center, randomized, double-blind, placebo- controlled, safety/efficacy study.


Eligibility Criteria:
Inclusion Criteria:

1. Age over 16 years and below 80 years (as of the date of registration).
2. Can provide signed informed consent.
3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol (including short-term hospital admission).
4. Autoimmune pulmonary alveolar proteinosis diagnosed by both HR-CT and biopsy and/or BAL as well as GM-CSF antibodies in serum positive.
5. PaO2 \< 70 mmHg after 5 minutes spine position at room air, or PaO2 \< 75 mmHg after 5 minutes spine position at room air and with symptom(s) including cough, sputum and exertional dyspnea

Exclusion Criteria:

1. Diagnosed as secondary or hereditary pulmonary alveolar proteinosis
2. WBC of 12,000/mm3 or more
3. Fever of 38 degree celsius or more
4. Severe edema
5. History of malignant disease within recent 5 years (not applied to the treated cases of uterine carcinoma in situ and local basal cell carcinoma)
6. Complication of cardiovascular diseases including congestive heart failure, angina pectoris, hemorrhagic tendency, etc with severe condition.
7. Complication of respiratory diseases such as pulmonary infectious disease(incl. pulmonary tuberculosis), bronchial asthma, lung fibrosis ,interstitial pneumonitis, or bronchiectasis, in which the evaluations of safety and efficacy of GM-CSF therapy are considered as difficult.
8. History or complication of infectious diseases which require systemic administration of antibiotics, antifungal or antiviral agents within recent 2 weeks.
9. Treatment with other cytokines
10. Pregnant or possibly pregnant women, lactating women, and women who desire to become pregnant during the study period
11. Patients who have been treated with whole-lung lavage, repeated segmental-lung lavage, or rituximab within 6 months before the start of the study (this criterion does not apply to patients for whom 6 months or more have elapsed after their last lavage or rituximab)
12. Severe liver dysfunction (AST \> 100 IU/L and/or ALT \> 100 IU/L and/or T-bil \>3.0mg/dL)
13. Severe renal dysfunction (Ccr \< 30 mL/min, calculated by Cockcroft-Gault (CG) formula)
14. Previous experience of severe and unexplained side-effects during aerosol delivery of any kind of medicinal product
15. Treatment with oral or intravenous administration or inhalation of corticosteroids.
16. Treatment with other inhaled drugs.
17. Previously treated with GM-CSF before the start of the study.
18. Demonstrate hypersensitivity to GM-CSF agent.
19. Other patients judged to be inappropriate for the study by the attending physician (e.g., patients who are unlikely to complete treatment or are uncooperative).
Skin Sympathetic Nerve Activity and Cardiac Arrhythmia

Sympathetic tone is important in cardiac arrhythmogenesis. The simultaneous recording of sympathetic nerve activity (SNA) and electrocardiogram (ECG) was obtained by invasive method. The purpose of this protocol is to further develop this recording method to turn it into a new non-invasive tool for arrhythmia prediction and detection. This method may also be useful in validating the results of surgical procedures aimed at sympathetic denervation


Eligibility Criteria:
Inclusion Criteria:

- patient hospitalized at Bordeaux University Hospital for sudden death, ventricular tachycardia, persistent or paroxysmal atrial fibrillation treated by ablation and/or vein of Marshall ethanol infusion

Exclusion Criteria:

* pregnancy,
* patient under 18 year old,
* patient with a cardiac stimulation device
Acupuncture for Rhinitis Complicated With Asthma

This randomized controlled study aimed to evaluate the efficacy and safety of acupuncture therapy on persistent allergic rhinitis patients complicated with asthma.


Eligibility Criteria:
Inclusion Criteria:

1. Suffering from persistent Allergic rhinitis (PAR; nasal obstruction, rhinorrhoea, sneezing and nasal itching) symptoms for more than 4 days/week, and greater than 4 consecutive weeks.
2. Moderate-severe symptoms according to Allergic rhinitis and its impact on asthma (ARIA) criteria.
3. Positive reaction for more than or equal to one respiratory allergen (SPT or MAST)
4. Stable asthma symptoms with diagnosis of Asthma by respiratory or allergic disease specialist.
5. No changes in asthma or allergic rhinitis drugs for the past month
6. Aged greater than or equal to 18 years, either sex.
7. No problem with expression of opinion
8. Provided with written consent
9. No other disease except allergic rhinitis or asthma which could affect the disease.

Exclusion Criteria:

1. Having experience using ventilator due to exacerbation of asthma symptoms within six months.
2. Experience of acute respiratory tract infection treated with antibiotics within 14 days
3. Having anatomical occlusion or deformation in nasal cavity.
4. Signs of infection in chest X-ray or having active respiratory disease except asthma
5. Below or equal to 4 on Total nasal symptom score (TNSS) in the latest week.
6. Received drugs affecting directly to allergic rhinitis such as H1-antihistamines, decongestants (nasal, oral or ocular), corticosteroids within 14 days.
7. Received following treatments for allergic rhinitis or asthma within six months ; Traditional Korean medicine interventions such as acupuncture, moxibustion, cupping therapy and herbal medication inhalation or CAM including homeopathy.
8. Received herbal medication for allergic rhinitis or asthma within 14 days.
9. Pregnant, planning the pregnancy or breast-feeding
10. Tuberculosis, hepatitis or more than 2 x normal limit of serum creatinine, aspartate aminotransferase/alanine aminotransferase (AST/ALT).
11. Skin lesion on acupoint or other systemic disease insufficient for acupuncture.
12. Night-shift workers staying up all night
13. Who cannot participate clinical trial properly.
Staphylococcus Aureus Nasal Carriage

The repeated exposition to S. aureus is considered as a determining factor of acquisition of the nasal colonization. The healthcare professionals are regularly in touch with this pathogenic bacterium. Prevalence of the nasal carriage of S. aureus in this population was the object of several studies but little took into account the respect for the rules of good hygienic practice. The results of our previous study carried out during the international congress of staphylococci (ISSSI, Lyon in August 26-30th, 2012) showed an association between the work in a hospital environment and the increase of the risk of nasal carriage. On the contrary, the use of the hydro-alcoholic solutions had a protective effect against this carriage. However, sized of the health care population of our study was limited.

The goal of this study is to confirm our previous results on a larger cohort of healthcare professionals. The main objective is to estimate the prevalence of nasal carriage according to the professional category and by taking into account the degree of conformity with good hygiene practices including the use of hydro-alcoholic solutions.


Eligibility Criteria:
Inclusion Criteria:

- Employees with Consent.

Exclusion Criteria:

- Presence of contraindicating medical conditions preventing nasal swabing
Electroacupuncture for Patients With Chronic Urinary Retention Secondary to Lower Motor Neuron Lesion

Chronic Urinary Retention (CUR) is defined as a non-painful bladder which remains palpable or percussible after the patient has passed urine by International Continence Society. Postvoid residual urine volume ≥300 mL seems to be widely accepted.

CUR may be caused by a variety of diseases and events including injury of sacral plexus, cauda equina and sacral spinal cord, pelvic floor nerve lesion after pelvic surgery and peripheral neuropathy due to diabetes, etc.. Aforementioned injuries generally affect lower motor neuron causing detrusor underactivity, acontractile detrusor or detrusor areflexia. The prevalence varies by different causes of lower motor neuron lesion. The symptoms of patients are voiding difficulty, bladder distention, bladder without sensation and overflow incontinence.

A multi-center randomized sham-controlled trial will be conducted. The aim of this study is to assess the efficacy and safety of electroacupuncture for urinary function of patients with CUR caused by lower motor neuron lesion.


Eligibility Criteria:
Inclusion Criteria:

* Have chronic urinary retention caused by lower motor neuron damage.
* Age 18 to 75 years.
* Have chronic urinary retention caused by injury of sacral plexus, cauda equina and sacral spinal cord, pelvic floor nerve lesion after pelvic surgery and peripheral neuropathy due to diabetes.
* Have postvoid residual urine volume 300 mL or more and sensation of bladder.
* Bladder contractile index is more than 100 or more.
* Duration of disease is more than 3 months.
* Intermittent clean catheterization or indwelling catheterization.
* Sign informed consent and participate in the study voluntarily.
* Exclusion Criteria:
* Have urinary retention due to bladder outlet obstruction (bladder neck contracture, urethral stricture, prostate cancer, prostatic hyperplasia, etc.)
* Have urinary system tumors or stones.
* Have detrusor underactivity due to other non-lower motor neurogenic disease.
* Have bowel and urinary disorder due to lesions or injuries of thoracic spinal cord, cervical spinal cord and brain.
* After suprapubic cystostomy.
* Have heart, liver, kidney, mental disorders or coagulation disorders.
* Have been implanted a cardiac pacemaker, sacral nerve stimulation electrode, pudendal nerve stimulation electrode, or bladder stimulation electrode.
* During pregnancy or in lactation.
Safety and Efficacy of SPD465 in Adults With ADHD

The purpose of the study is to evaluate how safe and how well SPD465 works compared to placebo in adults with ADHD. It is hypothesized that SPD465 will achieve an extended duration of clinical benefit.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of ADHD using DSM-IV-TR criteria (at least 6 of the 9 subtype criteria met)
* Baseline ADHD-RS-IV score =\>24
* IQ score of =\> 80 (using Kaufman Brief Intelligence Test)

Exclusion Criteria:

* BMI \< 18.5 or \> 30 kg/m2
* Diagnosis of Post Traumatic Stress Disorder, psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
* History of seizure disorder or a lifetime history of any seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder
* History of uncontrolled hypertension or currently hypertensive
* Subjects who have taken atomoxetine (STRATTERA) within 30 days prior to screening
* Current (or history within the last 12 months) of drug dependence or substance abuse disorder according to DSM-IV-TR criteria (excluding nicotine)
* Female subject is pregnant or lactating, less than 3 months post partum