cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease

This is a single-center, open label study evaluating the acute effect of caloric vestibular stimulation on UPDRS motor scores in Parkinson's Disease patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient should have a UPDRS motor score of 14 (off medication) or higher (mild to moderate)
* Patient should have a Hoehn \& Yahr staging of 1 to 3 (mild to moderate)
* Patient must be an adult (18 years of age or older)

Exclusion Criteria:

* Women who are pregnant or nursing
* have a history of significant cardiovascular disease (no pacemakers)
* have a history of unstable mood disorder or unstable anxiety disorder or psychosis
* use a hearing aid
* have a cochlear implant
* have been diagnosed with neurological disease other than Parkinson's disease. No atypical parkinsonism.
* have a diagnosed vestibular dysfunction
* abuse alcohol or other drugs
* have had eye surgery within the previous three months or ear surgery within the previous six months
* have active ear infections or a perforated tympanic membrane
* have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial
The Effect of Age on the Hemodynamic Response During Rest and Exercise in Healthy Humans

Primary: To observe how hemodynamic parameters are affected by age during rest and exercise in healthy humans. Furthermore, how an acute fluid challenge changes hemodynamic parameters.

Secondary: To thoroughly examine this population with regard to cardiac performance and function, anthropometrics, metabolic status, exercise capability, constitution, pulmonary status, and humoral markers of organ functions. This population will serve as a healthy control group, to which different populations can be compared, hence the need for a comprehensive characterization.

Hypotheses:

Diastolic function and parameters associated with diastolic function gradually deteriorate with increasing age. The gradual deterioration is unmasked at an earlier age during exercise and fluid challenge, compared to measurements made at rest.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* No acute or chronic diseases that can influence hemodynamics
* Pause in medication with effect on hemodynamics 24h before experimental day
* Echocardiography, with no structural abnormalities with an impact on hemodynamics.
* ECG without any pathological findings, including arrhythmia
* Normal red and white blood count, normal renal, liver, thyroid, immune, and hematological function as well as normal electrolytes, HbA1c and natriuretic peptides
* Ability to perform graded bicycle exercise testing
* BMI in the range of 20-30 kg/m2
* Height within population mean ±2 standard deviations
* VO2-max within population mean ±2 standard deviations (age corrected)
* Acceptable sonographic conditions
* Informed consent

Exclusion Criteria:

* History of heart failure (verified or suspected), or heart failure verified by pathological left and right systolic and diastolic measurements of the heart
* Hypotension (systolic blood pressure \< 100 mmHg)
* Inability to participate
* Pregnant women
* Diabetes
Aerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii in Neonates

This study is planned to compare the clinical efficacy and safety of aerosolized plus intravenous colistin vs. intravenous colistin as adjunctive therapy for the treatment of ventilator-associated pneumonia (VAP) due to pandrugs-resistant (PDR) Acinetobacter baumannii in the neonates.

This study will evaluate the neonates with VAP due to PDR-Acinetobacter baumannii who receive aerosolized plus intravenous colistin compare with intravenous colistin as adjunctive therapy. The efficacy and safety after study will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Neonates who are admitted to the neonatal intensive care unit, Hat Yai Hospital during the study period.
* Neonates who were complicated with VAP due to PDR-Acinetobacter baumannii susceptible to colistin (by minimal inhibitory concentration (MIC) \< 2 mcg/dL).

Exclusion Criteria:

* Neonates who have a major anomaly or chromosomal abnormality.
* Neonates who receive colistin prior 7 days prior to study.
* Neonates who have a significant renal dysfunction defined as a serum creatinine (SCr) \>1.5 mg/dL or a decrease in urine output to \< 1 mL/kg/h;
cPSTA System CADLAD Study

This study is primarily designed to collect resting phase signals from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography to machine learn and test an algorithm for detecting the presence of significant coronary artery disease in symptomatic adult patient.

This clinical protocol is primarily designed to collect resting phase signals from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography to machine learn and test an algorithm for detecting the presence of significant coronary artery disease in symptomatic adult patient. In addition to this primary objective, machine-learned algorithms will be developed and tested to report the left ventricular ejection fraction and to identify the location of significant coronary artery disease. The performance of the machine-learned algorithm will be evaluated using a comparative paired trial design. In this study, the physician will not be provided the results of analysis performed and, accordingly, the results of the analyses will not be used to guide treatment decisions for the patient.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥21 years of age at the time of screening
2. Meets criteria for coronary angiography
3. Scheduled to undergo cardiac catheterization with coronary angiography
4. Ability to understand the requirements of the study and to provide written informed consent

Exclusion Criteria:

1. Prior documented myocardial infarction (MI)
2. Prior coronary artery bypass grafting (CABG) or previous coronary interventions (PCI)
3. Indication for invasive coronary angiography other than to assess for obstructive CAD (e.g., arrhythmia, cardiomyopathy, valvular abnormality)
4. Previous heart valve replacement
5. Previous sustained or paroxysmal atrial or ventricular arrhythmia
6. Infiltrative myocardial disease (Amyloid, Sarcoid, Right ventricular dysplasia)
7. Presence of cardiac implantable electronic device (CIED), including implantable cardioverter defibrillator (ICD), pacemaker (PM), implantable loop recorders and other monitors
8. Implantable Neuro-stimulators
9. Congenital Heart Disease
10. Pregnancy (breast feeding)
11. Currently taking any Type IA, IC or III antiarrhythmic
12. Any history of Amiodarone therapy
13. Clinically significant chest deformity (e.g., pectus excavatum or pectus carnitatum)
14. Breast implants
15. Neuromuscular Disease if the condition results in tremor or muscle fasciculations
Safety Study of Flavocoxid in Duchenne Muscular Dystrophy

Objective of this study is to evaluate safety and tolerability of flavocoxid administered at the daily oral dose of 500 or 1000 mg/die for one year in DMD patients, alone or in association with steroids (deflazacort on alternate days) started at least one year before. The investigators will also perform a multidimensional clinical evaluation covering functional and muscle strength and quality of life (QoL)assessments.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of DMD, confirmed by muscle biopsy and molecular analysis by MPLA;
* range of age between 4 -16 years;
* unaided ambulation for at least 75 meters, unassisted during the Screening 6MWT. Other personal assistance or use of assistive devices for ambulation (eg, short leg braces, long leg braces or walkers) is not permitted.
* follow-up of at least 1 year before baseline with the selected motor outcome measures;
* patients able to perform evaluation tests;
* patient legally authorized representative (LAR) able to understand and give the informed consent;
* absence of contra-indications to the use of flavocoxid (see below);
* written informed consent signed by LAR.

Exclusion Criteria:

* treatment with other drugs analogue, similar or interacting with flavocoxid or immunosuppressive therapy (other than corticosteroids) within 3 months prior to start of study treatment;
* exposure to another investigational drug or supplements within 2 months prior to start of study treatment;
* presence of cognitive impairment that could influence the performance of the evaluation tests;
* history of major surgical procedure within 30 days prior to start of study treatment;
* expectation of major surgical procedure (eg, scoliosis surgery) during the 12-month treatment period of the study;
* ongoing participation in any other therapeutic clinical study;
* expectation of recruitment in the forthcoming exon-51 trial;
* requirement for daytime ventilator assistance;
* presence of liver-diseases or assumption of any hepatotoxic agent;
* screening laboratory values out of the laboratory ranges if clinically meaningful;
* prior or ongoing medical condition (eg, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
Improving Patient and Caregiver Engagement by Sharing Annotated Audio-recorded Clinic Visits

In this project, the investigators will conduct a three-arm patient-randomized pilot trial in older adults with multimorbidity in ambulatory care settings to determine the feasibility, usability, and acceptability of an audio-based PHL developed with older adults and caregivers, HealthPAL.

Providing digital recordings of clinical visits to patients has emerged as a new strategy to promote patient and family engagement in care. With advances in natural language processing, an opportunity exists to maximize the value of visit recordings for patients by automatically annotate key visit information (e.g., medications, tests \& imaging) with linkages to trustworthy online resources. These resources can be curated in an audio-based personal health library (PHL). In this project, the investigators will conduct a three-arm patient-randomized pilot trial in older adults with multimorbidity in ambulatory care settings to determine the feasibility, usability, and acceptability of an audio-based PHL developed with older adults and caregivers, HealthPAL. Participants in the intervention arms will receive access to an audio-based PHL with either 1) a clinic visit recording where key information is annotated and hyperlinks to trustworthy health information are provided (HealthPAL), 2) a clinic visit recording without annotations or hyperlinks, or 3) the third group of participants will receive usual care (control) with no recordings. Usability metrics and satisfaction will be assessed at two weeks. Preliminary data on the impact of HealthPAL on patient ability to seek, find and use health information with high confidence and patient activation, as well caregiver preparedness will also be gathered.

Eligibility Criteria:
Inclusion Criteria:

* (1) ≥ 65 years
* (2) with multimorbidity
* (3) plan on receiving ongoing care at the clinic for the subsequent month
* (4) access to internet.

The investigators will only include patients of clinicians (MDs, NPs) who (1) are based at the study clinic; (2) who treat adult patients.

Exclusion Criteria:

* (1) who have a six-item screener (SIS) of cognitive function score ≤ 4 and/or for those with a defined caregiver, whose proxy has not provided consent for the patient's participation
* (2) with schizophrenia, or other psychotic disorders, substance-abuse disorders, and with uncorrectable vision or hearing impairment
* (3) who reside in nursing homes, long-term care, skilled nursing, or hospice.

The investigators will exclude clinicians who (1) are trainees, e.g., medical students or residents; or (2) commonly audio or video record clinic visits for patient's personal use.
Randomized Controlled Trial on the Use of Flammacerium in Necrotic Arterial Wounds of the Lower Limb Versus Standard Treatment

Ischemia of an area may lead to a necrotic wound. In lower limb, it especially happens in diabetic or artheriopatic patients. It can lead to an amputation need. Revascularization procedure cannot be provide in all cases. Flammacerium, by a crust training and its anti-inflammatory effect, could stabilize necrosis extension, avoid bacterial contamination and then improve some incapacitating symptoms like odor or pain. This product may allow to delay amputation ruling for patients on who this procedure is unsafe. During 6 months, the investigators evaluate Flammacerium against standard dressing procedure in necrotic wound of the lower limb in patients where no revascularization can be provide. The investigators observed its effect on amputation need, symptoms as pain, infection, wound aspect evolution, wound size decrease.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic wound of the lower limb
* Minimum 50% necrosis
* Arteriopathy with ABI\<0.7 or \>1.3 with radiographic examinations
* No revascularisation procedure possible for any reasons
* No urgent amputation need
* Amputation considered in a short term
* Non life-threatened patients

Exclusion Criteria:

* Sulphonamide hypersensibility
* Propyleneglycols hypersensibility
* Enzyme glucose deshydrogenase deficiencies
* Others studies participation
* Tutorship or curatoship
Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study

The purpose of this study is to test the feasibility and efficacy of intervening with 2-year-old children with elevated temperamental Fear and/or Shyness or 3-year-old children with elevated anxiety and their parents, using a parent-child Cognitive Behavioral Therapy (CBT) protocol to reduce anxiety disorders and maintain reduced anxiety at one-year follow-up. Before the COVID-19 pandemic, study visits and treatment sessions were conducted in office. Now all visits and treatment sessions are conducted remotely.


Eligibility Criteria:
Inclusion Criteria:

* The child scores \>1 Standard Deviation (SD) above reported means for the Fear or Shyness scales on the Early Childhood Behavior Questionnaire (ECBQ) (if child is 21-35 months) or the child scores \>1SD above reported means for the Total Anxiety, Generalized Anxiety, Social Anxiety, Physical Injury Fears, or Separation Anxiety scales on the Preschool Anxiety Scale (PAS) (if child is 36-47 months) as completed by a parent
* The parents are able to speak, understand, and read English
* The child must have a working knowledge of English.

Exclusion Criteria:

* Autism Spectrum Disorder (ASD) or global developmental delay in the child
* The child has disruptive behavior so severe as to interfere with participation in intervention sessions
* The child has a different primary disorder for which CBT for anxiety is inappropriate (e.g. severe depression, depression in the mother, significant medical disorder).
Mutual Interactions Between Absence Epilepsy Seizures and the Integration of Sensory Stimuli

Epileptic seizures arise from neuronal defects that often alter the capacity of the brain to process sensory information. During absence seizures, a frequent epileptic syndrome in children, the normal conscious and perceptual processes are temporarily interrupted. This is the result of abnormal synchronized neural activities in the thalamo-cortical loops, leading to bilateral spike-and-wave discharges (SWDs) in the cortical electroencephalograms (EEGs). The brain mechanisms underlying the lack of sensory experience during absence seizures are disputed. Based on preliminary data, the investigators hypothesize that the alternation of 'spike' and 'wave' patterns during seizure could cause a time-to-time inconstancy in cortical responsiveness, preventing conscious perception. Using a real-time closed-loop stimulation system, the investigators will research how the S- and W-patterns specifically alter the sensory-evoked responses in the EEG. During a standard EEG, visual stimulations will be applied between and during absence seizures to test the hypothesis that repeated sensory stimuli, applied with an appropriate timing relative to the seizure-related oscillatory cycle, could negatively interfere with the regenerative network mechanisms involved in the occurrence of SWDs. The completion of this project should permit to unveil a new neuronal mechanism supporting the lack of conscious experience during absences and pave the way for new clinical non-invasive strategies to interrupt ongoing seizure activity.


Eligibility Criteria:
Inclusion criteria :

* Age 2-20 years
* childhood or juvenile absence epilepsy defined by International Ligue Against Epilepsy (ILAE)
* Electroencephalogram (EEG) indicated for clinical follow-up

Non inclusion criteria:

* Visual deficit
* Abnormal Magnetic Resonance Imaging (MRI)
* Medical history of photosensitive epileptic seizures
Hand Hygiene Practices and Microbial Contamination on Feeding Tubes and Other Components of Feeding Systems

Enteral feeding tube (EFT) and component of feeding systems can serve as a reservoir of microorganisms, and the main reason is inappropriate hand hygiene practices. The aim of the project is to determine colonization of microorganisms on the EFT and other components and assess the relation between colonization and adherence to hand hygiene practices by healthcare workers in the intensive care unit.

This prospective, observational and semi-experimental study will be conducted in one year. The project will be completed with healthcare workers and 51 patients who are feeding enteral route via nasogastric tube at least for three days. The researchers will provide training to healthcare workers in accordance with the World Health Organization (WHO) Hand Hygiene Guidelines. Hand hygiene behaviors of the participants will be observed and the question forms will be filled before and after training by researchers. The samples for microbial analysis will be collected from the EFT by sterile swaps.

Enteral Feeding Tube (EFT) such as Nasogastric Tube (NGT), Duodenal/Jejunal Tube and Gastrostomy Tube are frequently used in Intensive Care Unit (ICU). However, EFT is generally an omitted/neglected source of contamination. EFT can serve as a reservoir of Methicillin Resistant Staphylococcus Aureus (MRSA), which multiplies the risk of mortality by 2-2.5 times, for microorganism transmission. As a consequence of contamination of EFT, microorganisms, that may be manifest with the symptoms such as abdominal pain, distention, nausea, vomiting, diarrhea, may reproduce and progress to bacteremia, septicemia and even to death. In some studies, it is observed that there is a relation between the contamination on the external surface of EFT and contamination on the entry of EFT (hub), and it is also reported that the rate of contamination on the hub of the EFT and the environment of the patient is quite high. ICU nurses are responsible for sustaining safe and secure feeding, medication and fluid replacement of patients. Also, they provide enteral feeding products to patients as they are prescribed. Personnel training, proper processing procedures and developed enteral feeding protocols are shown to decrease the incidence of bacterial contamination on the enteral feeding tube

Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 years old or older
* Being enteral fed via nasogastric tube at least for three days
* Patients' relatives approve to be enrolled are going to be included in the study
* Nurses and other healthcare providers who work in the ICU

Exclusion Criteria:

* Patients who are being under respiratory, contact or droplet isolation according to definitions of Centers for Disease Control and Prevention
* Patients' relatives do not approve enrollment
Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy

This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2 or placebo for 4-weeks.


Eligibility Criteria:
Key Inclusion Criteria:

* Males and females between 18 and 65 years of age, inclusive
* Diagnosis of narcolepsy according to ICSD-3 (International Classification of Sleep Disorders, 3rd Edition) or Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
* Body mass index from 18 to 40 kg/m2, inclusive
* Consent to use a medically acceptable method of contraception
* Willing and able to provide written informed consent

Key Exclusion Criteria:

* Female subjects who are pregnant, nursing, or lactating
* Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
* History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
* Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
* Use of any medications that could affect the evaluation of cataplexy
* Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
Risk Factors for Postoperative Complications in Major Non-cardiac Surgery: Post-hoc Analysis of the OPHIQUE Multicentre Study

Post-operative morbidity and mortality is related to many factors related to the patient's condition, the intra-operative period and the optimisation of intra-operative haemodynamic and respiratory parameters. Many studies have looked at the determinants and factors that increase postoperative complications. However, these have been randomised studies looking at one parameter in particular.

This analysis would be the first to investigate the determinants of postoperative complications in a large population of patients undergoing major non-cardiac surgery. This is a post-hoc analysis of patients included in the OPHIQUE study, whose main objective was to evaluate intraoperative haemodynamic management guided by a marker of tissue hypoperfusion (the respiratory quotient).


Eligibility Criteria:
Inclusion Criteria:

* Abdominal, orthopaedic or vascular surgery under general anaesthesia and with an estimated duration of surgery \> 2 hours
* Adult patients (age ≥ 18 years)
* ASA score ≥ II
* Patient with at least two of the following comorbidities: age \> 50 years, high blood pressure (HTA), heart failure, ECG abnormality, smoking, stroke, transient ischemic attack (TIA), peripheral arterial disease (PAD), insulin-dependent or non-insulin-dependent diabetes mellitus (NIDDM), ascites, chronic renal failure (CRF)
* Signature of the consent form
* Affiliation to a social security scheme

Exclusion Criteria:

* Severe untreated or unbalanced hypertension
* Preoperative renal failure on dialysis
* Acute heart failure
* Acute coronary insufficiency
* Vascular surgery with renal plasty
* Cardiac surgery
* Permanent laparoscopy
* Chronic respiratory failure with home oxygen therapy
* Acute respiratory distress syndrome with FiO2\>60%.
* Preoperative shock
* Surgery under spinal anaesthesia and epidural only
* Refusal to participate by the patient
* Pregnant, parturient or breastfeeding women
* Patients under guardianship or curators, under court protection or deprived of public rights
* The patient already included in another therapeutic trial with an experimental molecule
* Emergency surgery
* Patients who do not want their personal data to be used in the framework of the research