cyrilzakka/clinical-trials huggingface dataset:
Self-esteem and Neuro-urological Follow-up in Patients With Spina Bifida or Spinal Cord Injury

With improved life expectancy over the last fifty years, spina bifida has become a disease of the adult. One of the major stakes for these patients is the preservation of a regular follow-up of uro-nephrologicals risk factors and of a respect for the rules of self management of their neurological bladder.

The main objective of this study is to highlight a difference in the level of global self-esteem among a population of adult patients with spina bifida and a population of adult patients with traumatic spinal cord injury gained the same level of neurological.

With improved life expectancy over the last fifty years, spina bifida has become a disease of the adult. The risk of developing a terminal renal insufficiency is eight times higher than the risk in the general population and twice as important as in acquired spinal cord injury. This risk continues to evolve with advancing age.

One of the major stakes for these patients is the preservation of a regular follow-up of uro-nephrologicals risk factors and of a respect for the rules of self management of their neurological bladder. However, some studies report that nearly two thirds of these patients are not monitored at regular neuro-urological in the adulthood. Different psychosocial determinants were analyzed as potential markers of the impact of chronic diseases from childhood to adulthood and could account for the disparity of follow-up and access to healthcare. Among these, the self-esteem is a psychological dimension of analysis particularly relevant within the framework of chronic states inherited from the childhood.

The investigators formulate the hypothesis that global self-esteem and lower perceived self-efficacy may be a causal predictive factor of a reduced access to the continence and a lower compliance monitoring in adult patients with a spina bifida.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a spina bifida aperta or an acquired traumatic spinal cord injury dating more than two years, the level of injury being below D12 and higher S1 (Score ASIA A).
* Age between 18 and 60
* Knowing how to read, write, count
* Having given their free, informed and in writing consent (an information is also given to the reliable person when it exists)
* Affiliated to the National Health Service

Exclusion Criteria:

* Psychiatric history requiring an hospitalization in a specialized unit during more than two months
* Score MMS lower than 27 ( GRECO version)
* Serious associated pathology or associated pathology which could interfer with the management of vesico-sphincteral disorders
* Neurosurgery, dating from less than one year
* Symptoms of dysfunction of ventricular bypass valve at the time of inclusion
* Clinical epileptic attack within six months prior to inclusion
* Pregnancy or breastfeeding
* Simultaneous inclusion in an another therapeutic protocol or period of exclusion from an another protocol
* Traumatic spinal cord injury acquired before age 16
Effect of Intensive Nutritional Support in Subacute Stroke Patient

Proper nutritional support during early rehabilitation may be beneficial for functional improvements in gaining functional independence and preventing complications in stroke patients. However, there was no consensus of proper amount of nutritional support in stroke patients. In this study, the investigators aimed to clarigy the effects of the intensive nutritional support during comprehensive rehabilitation during subacute phase to improve function in patients with first-ever strokes.


Eligibility Criteria:
Inclusion Criteria:

* Acute first-ever stroke patients less than 7 days after onset

  * more than 19 years old at stroke onset ③ stroke confirmed by brain CT or MRI

    * body mass index (BMI) \<25 before the comprehensive rehabilitation ⑤ Mini Nutritional Assessment \< 12 before the comprehensive rehabilitation ⑥ Fugl-Meyer assessment \< 85 at 7 days after stroke onset

Exclusion Criteria:

* Transient ischemic stroke

  * Progressive or unstable stroke

    * Pre-existing and active major neurological disease, e.g., spinal cord injury, Parkinson's disease, et al.

      * Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease or dementia ⑤ Advanced liver, kidney, cardiac, or pulmonary disease, e.g., advanced hepatocellular carcinoma, end-stage renal failure, et al.)

        * A terminal medical diagnosis consistent with survival \< 1 year

          * Diabetes mellitus, Hyperlipidemia, Metabolic syndrome, Heart failure) ⑧ Pregnant or lactating women ⑨ Prohibited from taking medication (Omapone Peri 724mL or Winuf Peri 654mL)
Sugammadex and Time to Extubation in Ophthalmic Surgery

This study is to invastigate if patients treated with sugammadex compared to neostigmine/atropine would be extubate faster upon emergence of anesthesia.

This is a retrospective case-control study including patients aged 18 years or older who underwent ophthalmic surgeries under general anesthesia with tracheal intubation between 2020 and 2022. Patients who received rocuronium as the sole neuromuscular blocking agent and were maintained with sevoflurane or desflurane and intravenous fentanyl were included. Based on the choice of reversal agent for neuromuscular blockade, patients were divided into two groups: the sugammadex group or the neostigmine group. Patients who underwent emergency surgery or combined surgeries with other specialties were excluded. Patient characteristics, including age, gender, ASA classification, weight, and height, were collected. Anesthesia-related medications were recorded. The time points of anesthesia induction, start and end of surgery, reversal agent administration, and tracheal extubation were documented.

Eligibility Criteria:
Inclusion Criteria:

aged 18 years or older ophthalmic surgeries under general anesthesia with tracheal intubation between 2020 and 2022 received rocuronium as the sole neuromuscular blocking agent maintained with sevoflurane or desflurane and intravenous fentanyl

Exclusion Criteria:

emergency surgery combined surgeries with other specialties
Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis

Chronic sinusitis is a frequent complication in cystic fibrosis. The aim of this study is to determine whether Pulmozyme(dornase alfa) would maintain sinus health (compared to placebo) in patients with cystic fibrosis who have recently undergone sinus surgery.

AIM: To evaluate the effectiveness of Pulmozyme(dornase alfa) in decreasing post-operative sinusitis symptoms in patients with cystic fibrosis (CF)

PROCEDURES: 20 patients with CF will be randomized to receive either Pulmozyme or placebo via nasal inhalation daily for 12 months. Consent will be obtained following surgery and treatment will begin 1 week post-operatively.

Monitoring will include examination and recording of adverse effects and follow up weekly for one month and then at 2.5, 6, 9 and 12 months.

Outcome measures will include ciliary function testing, pulmonary function testing, sinus questionnaires and CT scan.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and laboratory diagnosis of cystic fibrosis
* Age greater than or equal to 5 years
* Forced expiratory volume in 1 second (FEV1) greater than or equal to 40% predicted
* Sinus surgery within one week of enrollment

Exclusion Criteria:

* Pregnancy
* Intolerance of orally inhaled Pulmozyme (dornase alfa)
Cisplatin and ZD1839 + Re-Irradiation in Recurrent Squamous Cell Cancer of the Head and Neck

To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck.

To study the effects of ZD1839 combined with either cisplatin or radiotherapy on signal transduction pathway gene expression in tumor cells in patients with local-regional recurrent squamous cell cancer of the head and neck using micro array analysis from tumor samples taken at the time of relapse and during treatment.


Eligibility Criteria:
Inclusion Criteria:- Patients must have pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer primary in the upper aerodigestive tract or a second squamous cell primary (excluding nasopharynx or salivary gland tumors). Patients may have experienced more than one recurrence as long as the first recurrence occurred greater than or equal to 6 months following the end of the prior RT.

* The recurrence or second primary must have defined bi- or uni-dimensional measurements.
* Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence).
* The patient must not be a candidate for complete surgical resection. The previous irradiation must not exceed a maximum of 75 Gy.
* The entire tumor volume must be included in a treatment field that limits the total spinal cord dose to 50 Gy (prior RT and anticipated RT).
* Patients must be at least 6 months from prior radiation therapy.
* Patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease.
* Zubrod performance status 0-1.
* Granulocytes greater than or equal to 1500/mm3, platelets greater than or equal to 100,000/mm3, serum bilirubin less than or equal to 1.5 mg/dl, creatinine less than or equal to 1.5 mg/dl within 2 weeks prior to registration.
* LFT's less than or equal to 2 x normal (SGOT/SGPT/Alkaline Phosphatase). If greater than 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative for metastases, patients are eligible.
* Must be able to submit previous radiation records, including simulation and portal films, in order to assure that cord tolerance is not exceeded.
* Patients must sign a study-specific informed consent form prior to study entry. Exclusion Criteria:- Primary in the nasopharynx or the salivary gland.
* Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ZD1839 or other agents used in study.
* Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
Atezolizumab Plus Bevacizumab and Chemotherapy in First-Line Metastatic Nonsquamous NSCLC

This study aimed to explore the efficacy of Atezolizumab Plus Bevacizumab and Chemotherapy in First-Line Metastatic Non-squamous NSCLC.

This study aimed to explore the efficacy of Atezolizumab Plus Bevacizumab and Chemotherapy in First-Line Metastatic Non-squamous NSCLC.

Eligibility Criteria:
Inclusion Criteria:

18，Advanced Metastatic Non-squamous NSCLC Treatment Plan is atezolizumab-bevacizumab-carboplatin-paclitaxel

Exclusion Criteria:

Patients with contraindication of chemotherapy Pregnant or breast feeding women
Ultrasound-assisted or Landmark-based Intrathecal Administration of Nusinersen in Adult Patients With Spinal Muscular Atrophy (The EchoSpin Study)

Nusinersen (Spinraza, Biogen Inc, Boston, MA), the first treatment approved by FDA and EMA for all Spinal Muscular Atrophy (SMA) subtypes, is an antisense oligonucleotide that is administered intrathecally through a lumbar puncture. This procedure can be challenging in some adults with intermediate and late onset SMA (types II-IV) frequently presenting scoliosis secondary to neuromuscular weakness and often treated with spinal instrumentation to prevent worsening deformities.

In such patients, in order to access the intrathecal space, US guidance and/or assistance have been recently proposed as useful and successful tool. The US guidance and/or assistance have been associated to a high success rate, a reduction of number of attempts and needle passes to obtain a successful anesthesia. A reduced risk of adverse events (AEs), such as post dural puncture headache (PDPH) and low back pain (LBP), and low patient satisfaction often associated with multiple needle punctures was also reported.

Aim of this retrospective study was to report the efficacy, evaluated as rate of the successful procedures and subsequent delivery of nusinersen within the subarachnoid space, the number of attempts, the procedure time and the adverse events (AEs) of interlaminar intrathecal nusinersen administration using either ultrasound assistance or the landmark-based technique in a historical cohort of 51 adult SMA patients.


Eligibility Criteria:
Inclusion Criteria:

* A genetically confirmed diagnosis of SMA
* Treatment with nusinersen

Exclusion Criteria:

* congenital coagulopathy,
* localized infections,
* increased intracranial pressure.
Novel Influenza A (H1N1) Surveillance Registry

The demographic characteristics, clinical features, course, and outcomes of severe H1N1 influenza infection requiring intensive care have not been defined rigorously and systematically. While the majority of patients in early reports of critically ill novel influenza A (H1N1) have respiratory involvement, up to 10-20% may present with non-respiratory organ failures, such as shock, seizures, or acute renal failure. The burden of disease and resource utilization of these patients remains largely unknown. The purpose of this surveillance registry is to characterize the demographics, clinical features, outcomes, and resource utilization of patients with H1N1 influenza infection who require intensive care.


Eligibility Criteria:
Inclusion Criteria:

* Admission to an intensive care unit at a participating site with confirmed or suspected Novel H1N1 Influenza infection

Exclusion Criteria:

* Influenza-like illness due to non-influenza disease and negative testing for influenza
Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction

Rationale: Pump failure due to acute myocardial infarction (AMI) can lead to cardiogenic shock (CS): a state of low blood flow to end-organs with subsequent multi-organ failure that is associated with high mortality rated. The first line pharmacologic treatment strategy in CS is noradrenaline. This vasopressor drug is used to maintain adequate blood pressures. The assumption is that a mean arterial blood pressure (MAP) ≥ 65 mmHg will improve flow and thereby tissue perfusion of myocardium and other tissues (e.g. renal). However, there is no evidence that an increase in MAP, if achieved by noradrenaline, leads to greater end-organ blood flow and better outcomes.

Objective: With this study the investigators aim to investigate the (cost-)effectiveness of reduced noradrenaline in patients with CS by using a lower MAP target of ≥ 55 mmHg, compared to ≥ 65 mmHg. The investigators hypothesize that reduced use of noradrenaline will improve overall survival and decrease renal failure requiring renal replacement therapy.

Study design: Open label, randomized controlled multicenter trial

Study population: Adults patients with CS due to AMI

Intervention: Treatment strategy of reduced noradrenaline, by using a lower MAP target ( ≥ 55 mmHg).

Main study endpoint: composite of all-cause mortality and severe renal failure leading to renal replacement therapy within 30-days after randomization.


Eligibility Criteria:
Inclusion criteria:

1. Acute myocardial infarction, STEMI or NSTEMI
2. Early revascularization by PCI
3. Cardiogenic shock, characterized by:

I. a. Systolic blood pressure (SBP) ≤ 90 mmHg for \> 30 minutes, OR b. Use of drugs to maintain SBP \> 90 mmHg at randomization.

II. Clinical signs of impaired organ perfusion with at least one of the following criteria:

1. Altered mental status
2. Cold, clammy skin and extremities
3. Oliguria with urine output \< 30ml/hour
4. Serum lactate \> 2.0 mmol/L

III. Clinical signs of pulmonary congestion

Exclusion Criteria:

1. Resuscitation \> 30 minutes
2. Mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricular septal rupture)
3. Onset of shock \> 12 hours
4. Imminent need for mechanical circulatory support
EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent

EUS-guided biliary drainage is gaining popularity as a means of achieving endoscopic drainage in patients with failed endoscopic retrograde cholangiopancreatography (ERCP) 1. EUS-guided hepaticogastrostomy (HGS) is a type of EUS-guided biliary drainage and the procedure is employed when the ERCP fails due to a malignant bile duct obstruction but the papilla is inaccessible or if the first of the duodenum is infiltrated by tumor. Recently, a novel dedicated HGS (Niti-S, Taewoong Medical, Gyeonggi-do, Korea) has become available, the stent has a novel design to that prevents the stent from migration, further improving the safety.

The aim of the current study is to evaluate the feasibility and outcomes of the novel lumen apposing stent for EUS-guided HGS. The hypothesis is that the device is safe and effective.

This is a prospective feasibility study enrolling patients suffering from malignant biliary obstruction with failed or anticipated difficult ERCP. Consecutive patients satisfying the inclusion criteria would be recruited.

EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent. The MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea) is a novel device designed for hepaticogastrostomy. The stent is a partially covered metal stent made by nitinol covered with silicone. One end of the stent is uncovered and designed for placement in the intrahepatic ducts. The other end has a self-folding design that creates a flange and prevents migration of the stent outside the stomach. The stent diameter is either 8 or 10mm and the length can be 6,8,10 or 12cm long.

Outcome parameters include safety, technical and clinical success

Eligibility Criteria:
Inclusion Criteria:

1. \>= 18 years of age
2. Anatomically feasible for EUS-guided hepatico-gastrostomy
3. Patients with clinical symptoms and/or signs of extrahepatic biliary obstruction (jaundice, biliary-type pain, cholangitis)
4. Patients with unsuccessful ERCP (failed ERCP, anticipated difficult ERCP or high risk for pancreatitis)
5. Written informed consent (and assent when applicable) obtained from subject.

Exclusion Criteria:

1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
2. Coagulopathic patients (INR\>1.5, platelets \<50,000)
Effects of Motor Cognitive Training on Functional Loss After Osteoporotic Wrist Fractures

The therapy results after distal radius fracture especially of elderly patients are often suboptimal. The central problem results from the inevitable, 3-6-weeks immobilization, which leads to reduction in ROM of the wrist, deterioration of muscle strength as well as malfunction of fine motor skills and coordination. Currently, there are no adequate proactive strategies to counteract these immobilisation problems. Hence the overall aim of our research project is to investigate the therapeutic potential of a motor-cognitive therapy on hand function after distal radius fracture. On the one hand the pilot study should provide information about the level of recruitment rate necessitated for an adequate sample size which allows reliable evidence for the therapy effects. On the other hand we want to evaluate the sensitivity and adequacy of the assessment instruments.

The pilot is conceived as a controlled, randomised, longitudinal intervention study over 6 weeks with 3 groups. One experimental group imagine movements and actions without executing them. A second experimental group performs mirror training, in which visual feedback through a mirror activates additionally the contralateral hemisphere. The control group receives therapy as usual. There are three key domains to be analysed: function (PRWE), impairment (ROM, strength) and participation in social life/life quality (DASH, EQ5D).


Eligibility Criteria:
Inclusion Criteria:

* wrist fracture
* age 65 and older

Exclusion Criteria:

* unstable medical conditions which preclude surgical intervention (ASA 5)
* Patients who do not live independently (nursing home)
* Patients with an open fracture
* Associated soft tissue or skeletal injury to the same limb
* Cognitive impairment (6CIT \< 10)
Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects

This study to determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males or females, 18 to 55 years of age (both inclusive) at the time of screening.
* Medical history without any major pathology as judged by the Principal Investigator.

Exclusion Criteria:

* History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* Positive urine drug/alcohol testing at screening or confinement.
* Positive testing for HIV, Hepatitis B or Hepatitis C.
* History or presence of alcohol or drug abuse within the 2 years prior to screening.
* Excessive intake of alcohol, defined as an average daily intake of greater than three units, or an average weekly intake of greater than 21 units (one unit is equivalent to 1 can or bottle (12 oz) of beer, or 1 measure (1.5 oz) of spirits, or 1 glass (5 oz) of wine) in the last 6 months prior to screening.
* Known hypersensitivity to quinolones/fluoroquinolones.
* History of allergic or other serious adverse reactions to benzodiazepines or lidocaine.
Vaping Adverse Lung and Heart Events Cohort

This prospective study assesses the pulmonary and cardiovascular effets of vaping in adult electronic cigarette users with biannual visits and a 5-year follow-up.

Daily vaping device users will be recruited in the Quebec City metropolitan area. Subjects will be asked to perform pulmonary function tests (spirometry, oscillometry, plethysmography, methacholine provocation) every 6 months for a 5-year follow up. Subjects will also answer a questionnaire assessing their vaping, tobacco and cannabis smoking habits, as well as their perceived respiratory symptoms. Blood draws and sputum inductions will be performed for cell counts and to measure inflammation markers.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Daily electronic cigarette user
* No respiratory infection in the 4 weeks before a visit

Exclusion Criteria:

* Women who are pregnant or breast-feeding.