cyrilzakka/clinical-trials huggingface dataset:
The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity

The patients between the ages of 35-80 who developed spasticity in the upper extremity after stroke will be included.. Botulinum toxin(BT-A) injection will be applied to the study group(n=16) and placebo injection to the control group(n=15) in addition to conventional rehabilitation and stretching exercises. Evaluations will be made before the treatment, in the 2nd week, and in 3rd month after the treatment. Pain relief will be evaluated with the Visual Analog Scale(VAS) and spasticity assessment will be done with the Modified Ashworth Scale(MAS). The functionality will be evaluated with Fugl Meyer Assessment Scale(FMAS) and Box Block Test(BBT).


Eligibility Criteria:
Inclusion Criteria:

* hemiplegia due to a cerebrovascular accident at least 1 month ago
* cognitively competent
* have spasticity of 1 and above according to the Modified Ashworth Scale
* receive at least 3 cubes in the Box Block Test

Exclusion Criteria:

* Patients with upper extremity brachial plexus lesions,
* shoulder subluxation,
* arthritis and joint contracture,
* neglect syndrome,
* cerebellar and brain stem lesions
* those who did not accept the study
TnThs for Identification Myocardial Infarction

OBJECTIVES/BACKGROUND: We sought to determine the early diagnostic value of the new high sensitive cardiac troponin T assay (TnThs) in suspected acute coronary syndrome (ACS) and to compare it with the 4th generation cTnT assay from the same manufacturer, myoglobin and heart-type fatty acid binding protein (h-FABP).

METHODS: The study consisted of 94 patients with chest pain admitted to the chest pain unit with the diagnosis of suspected ACS without ST-Elevation. Patients were divided according to time from onset of symptoms to presentation into an early presenter group (\<4 hours) and a late presenter group (≥4 hours).

A median of 6 samples (range 2-8) were available per patient. The diagnostic performance of TnThs was assessed using ROC analysis and areas under the curve (AUC) of baseline and follow-up results of TnThs, cTnT, myoglobin, and h-FABP were compared using c-statistics.

RESULTS: The TnThs assay allows an excellent prediction of non-ST-segment-elevation myocardial infarction (non-STEMI) at presentation.A follow-up sample improves diagnostic performance in a time dependent manner. The AUC of the TnThs was superior to cTnT at all time points.

CONCLUSIONS: A baseline sample of TnThs allows an earlier prediction of non-STEMI than the less sensitive and precise 4th generation cTnT assay. The excellent performance of TnThs at baseline and follow-up might obviate the need for other early necrosis markers.


Eligibility Criteria:
Inclusion Criteria:

* consecutive patients with ACS

Exclusion Criteria:

* Patients with ST-segment elevation at presentation were excluded as were patients with muscular trauma, or severe kidney dysfunction defined as an estimated glomerular filtration rate below 60 ml/min/1.73m2.
* In addition patients who underwent percutaneous coronary intervention during follow-up sampling were also excluded
Curative Effect and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation on Non-motor Symptoms of PD

This study is a double-blind comparative study examining the curative effect and mechanism of the transcutaneous auricular vagus nerve stimulation treatment on non-motor symptoms of Parkinson's disease patients. The investigators hypothesize that treatment using transcutaneous auricular vagus nerve stimulation will improve the non-motor symptoms, such as improving sleep, and improve cortical activity simultaneously in Parkinson's disease patients.

Patients in the Experimental group underwent fourteen consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time), whereas patients in the sham stimulation group underwent fourteen consecutive daily sessions of sham taVNS. Assessments of motor and non-motor symptoms, excitability of cortex motor (using repetitive transcranial magnetic stimulation), cortical activity (using Functional near-infrared spectroscopy) and blood indicators were performed three times: at baseline, one day post intervention, fourteen days post intervention.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
* PDSS score\<82 (or a subscore\<5).
* Age between 40 and 80 years old.
* Mini-Mental State Examination score \>24.
* Right-handed patient.
* Stable medication.

Exclusion Criteria:

* Clinically diagnosed as other Parkinson's syndrome.
* Cognitive impairment (MMSE\<24), severe anxiety and depression, epilepsy history, severe diabetes, organic brain stem injury (such as stroke, tumor, demyelinating disease, etc.).
* Taking anticholinergic drugs.
* Taking antipsychotic drugs.
* There are contraindications to taVNS stimulation, such as implantation of a cardiac pacemaker after DBS operation, patients with local infection or loss of an ear, or metal implants at the stimulation site.
* There is uncontrolled hypertension, coronary heart disease, or recent acute myocardial infarction.
* Patients who cannot complete follow-up.
Continuous Blood Pressure and Waveform Measurements Comparison Between Invasive Arterial Line and PPG Sensor

The purpose of this study is to compare blood pressure values (systolic, diastolic, mean arterial pressure) and waveform as recorded by a radial arterial line catheter to the waveform and values as calculated by the Sensifree's algorithm from a PPG sensor from a variety group of patients during elective surgeries.

Before induction of anesthesia, an arterial line will be inserted to the patient radial artery using a designated short, stiff tubing kit according to catheter IFU (Instructions for Use), preferably under US guidance. Removal of air bubbles from the catheter-transducer system is mandatory prior to connecting the tubing to the catheter.

Study nurse will connect a Sensifree laptop with designated data acquisition software (Medicollector BEDSIDE) to the multi-parameter monitor communication port and start the recording of invasive blood pressure and pulse oximeter pleth (PPG sensor) per software IFU. Prior to connecting the arterial line system to the patient, a calibration (flush test) will be done and recorded. During the study, any deterioration in the waveform recorded by the intra-arterial catheter will be noted and appropriate corrective measures will be taken as soon as possible (e.g., flushing or adjusting the position of the catheter).

Preferable NIBP (Non Invasive Blood Pressure) measurement rate will be every 10 minutes, unless the medical procedure requires otherwise.

Calibration procedure will be repeated every 60 +/- 5 minutes and at the end of the surgery. Recording will take place for the duration of the surgery.

NIBP cuff will be placed over the arterial-line arm, NIBP air hose will be replaced with an air hose supplied by Sensifree and the pressure gauge in it will be connected to Sensifree laptop via analog to digital converter in order to capture the data.

Medication used during the surgery will be listed and documented in the CRF (Case Report Form) including drugs name, dose, time and method of administration.

Offline data analysis will compare the blood pressure values as calculated by the Sensifree's algorithm based on the PPG signal, to the values obtained from the arterial line. The comparison results will be measured against the accuracy performance requirements per ISO 81060-2.

Eligibility Criteria:
Inclusion Criteria:

* Signed inform consent
* Age 18-20
* Elective surgery that requires invasive BP monitoring (A-line)

Exclusion Criteria:

* Emergency surgery
* Subject has a condition that might prevent BP fluctuations
* Subject is taking medicine that might prevent BP fluctuations
* Arterial line not placed in the radial artery
* Flush test has inadequate frequency response pre-trial
* Subject's arterial line contralateral hand is not available for PPG sensor placement
* Subject has 50% or more pacemaker dependency
Two Way Bioequivalence Study Under Fed Conditions

The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions.

The purpose is to monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fed conditions.

An open-label randomized, single oral dose, two way crossover bioequivalence study to compare ondansetron Orally Dissolving FilmStrip (ODFS) 8mg with Zofran Orally Disintegrating Tablets \[ODT® (Containing Ondansetron 8 mg)\] in 48 healthy, adult, human study participants under fed conditions. Volunteers who signed the consent form and showed their willingness to participate in the study were enrolled. Volunteers who satisfied the inclusion and exclusion criteria and found to be healthy on physical examination with laboratory investigation values within reference limits were considered eligible to be admitted into the study. Study participants were fasted for 10 hours prior to dosing in both periods. Dosing was conducted as per the randomization schedule in each period under fed conditions.A washout period of 7 days was observed between the two periods.

Eligibility Criteria:
Inclusion Criteria:

* provide written informed consent.
* healthy adult within 18-45 years of age (inclusive).
* Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
* systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 90 mm Hg.
* normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period 1.
* Normal ECG, chest X-ray and vital signs.
* If study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study.

Exclusion Criteria:

* The study participants were excluded based on the following criteria:

  * incapable of understanding the informed consent.
  * history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
  * evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function
  * volunteers with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma .
  * smokes regularly more than ten cigarettes daily
  * taken over the counter or prescribed medications
  * history of any psychiatric illness, which may impair the ability to provide written, informed consent or full participation.
  * history of alcohol or substance abuse within the last 5 years.
  * clinically significant abnormal values of laboratory parameters.
  * positive urine screen for drugs of abuse at the time of admission check-in for each period.
Ancillary Study of the ULTREC Project

The ULTREC research project is designed to assess the safety of a negative strategy relying on Colour Doppler Ultrasound (CDUS) for excluding the diagnosis of a new thrombosis. The ULTREC project does not take into account the validity of the CDUS positive criteria used to confirm the diagnosis of Deep Vein Thrombosis (DVT) recurrence.

The risk of considering only the negative strategy is to ignore the possibility of having an improvement in sensitivity and negative predictive value at the expense of specificity and positive predictive value and therefore to increase the false positive rate leading to an overdiagnosis of recurrence and an overtreatment, and a potential bleeding risk.

In the ULTREC-ANCILLARY study, the research will aim at assessing the validity of baseline CDUS positive criteria for the diagnosis of DVT recurrence. As there is no diagnostic standard to which the results could be compared, it is suggested to validate these criteria based on the evolution of the thrombosis on CDUS performed at D90±5.

The hypothesis is that an unchanged appearance under anticoagulation would be in favor of sequelae and will invalidate the initial diagnosis (diagnostic failure)


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Known history of objectively documented deep vein thrombosis of the lower limb (with or without pulmonary embolism)
3. Out-patients referred for clinically suspected acute recurrent ipsilateral DVT of the lower limb
4. Patients covered by social security or an equivalent regimen
5. No objection to the use of the data
6. Inclusion in the ULTREC study

Exclusion Criteria:

1. Known current pregnancy
2. Any condition, which may prevent from performing the colour doppler ultrasound test
3. Delay from onset of symptoms to inclusion of more than 10 days
4. Therapeutic anticoagulation for more than 48 hours in the two days prior to consent to ULTREC Study
5. Presence of clinical symptoms or signs of pulmonary embolism
6. Life expectancy less than 3 months
7. Patient unable to adhere to ULTREC protocol follow-up
8. Participants under judicial protection or incapacity
Oxygen Supplementation and Ventilator Hyperinflation in the Endotracheal Suction (OSVHES)

This is a double crossover study where all patients are randomly allocated to one of two treatment sequences associated with endotracheal aspiration.The first treatment (A) uses two suctioning methods for each patient: one involving hyperoxygenation with administration of 100% oxygen 1 minute before and after suction (intervention I), and the other hyperoxygenation with oxygen supply to 20% above basal offer (Intervention II) in the same way.The second treatment (B) uses a technique of hyperinflation with the mechanical ventilator (PEEP-ZEEP) associated with hyperoxygenation. The intervention I, uses PEEP-ZEEP offering 20% above basal oxygenation and intervention II uses the PEEP-ZEEP with basal oxygen supply in the same way.

All subjects were randomly allocated using sealed envelopes to a treatment sequence A or B on Day 1. Patients received two treatments, at least four hours apart. The first treatment is in the morning and the alternate treatment is performed in the afternoon. On Day 2 the order of the treatments was reversed using the same patient position sequence.The interventions I and II are performed at least 4 hours apart to minimize any carryover effect.

Endotracheal suction must be carried out only through precise indication, because it is associated with undesirable effects on the hemodynamic parameters, ventilation, oxygenation and respiratory mechanics.

The hyperoxygenation is one of the methods of prevention of hypoxemia induced by tracheal suction procedure and have been proposed for its efficiency. Another method is the hyperinflation with the mechanical ventilator. Ventilator hyperinflation improves oxygenation, mobilizes the bronchial secretion excess and re-expand the lung collapsed areas.

The PEEP-ZEEP is a ventilator hyperinflation technique, described as a lung inflation through a positive pressure enhancement at the end of expiration (PEEP), followed by rapid lung deflation with an abrupt reduction in the PEEP to ZEEP (0 centimeters of water (cmH2O)).

Eligibility Criteria:
Inclusion Criteria:

* Mechanical ventilation for more than 12h
* Hemodynamic stability
* Presence of indication criteria of endotracheal aspiration procedure

Exclusion Criteria:

* High doses of vasopressor amines amines and/or severe arrhythmias
* Hemoglobin \< 7 g/dL
* FiO2 ≥ 0.6
* PEEP ≥ 10 cmH2O
* Conditions: rib fractures, chest drain, severe bronchospasm, pneumothorax not drained and tracheostomy
* Contraindications of ventilator hyperinflation(PEEP-ZEEP): intracranial pressure \> 10 mmHg, bleeding disorders, accented degrees of gastroesophageal reflux and bullous lung disease.
Insulin-sensitive Obesity: Lessons From Longitudinal Data

People who are overweight and/or obese are at risk of insulin resistance and type 2 diabetes. However, research has shown that some overweight and/or obese individuals remain insulin-sensitive and metabolically healthy despite their unhealthy body weight.

The investigators hypothesise that overweight and/or obese people who were deemed insulin-sensitive in previous studies will maintain their insulin sensitivity and metabolic health over time. The investigators also hypothesise that the preservation of insulin sensitivity will be accompanied by key metabolic health markers.

While obesity is a risk factor for metabolic disease, sub cohorts with obesity not complicated by the metabolic syndrome have been described. These so called "metabolically healthy obese" may have reduced risk of type 2 diabetes, cardiovascular disease and all-cause mortality compared with individuals with obesity who present with components of the metabolic syndrome.

Longitudinal studies with diabetes and cardiovascular disease risk endpoints reported that individuals with obesity who are metabolically healthy (MHO) held an intermediate health status, such that they were still worse off than the healthy normal-weight individuals. While there have been studies evaluating the stability of the MHO phenotype over time, no study has reported the durability of insulin-sensitivity per se, as measured by the gold-standard hyperinsulinaemic-euglycaemic clamp. In the present study, we aimed to trace the change in insulin resistance/sensitivity, and to uncover predictors of insulin resistance in older age. The secondary aims were to trace the change in body composition, fat distribution and metabolic markers over time in a well-phenotyped cohort studied approximately 5-6 years apart.

Eligibility Criteria:
Inclusion Criteria:

* Participation in two previous studies conducted at the Garvan Institute of Medical Research Clinical Research Facility (described in the other publications 1-3).
* Willingness to give written informed consent and willingness to participate in the study.

Exclusion Criteria:

* Pregnant and/or lactating women.
Evaluation of the Effect of Spirulina-Silicon Supplementation on the Morphological, Biomechanical and Functional Characteristics of the Arterial Wall in the Elderly

The investigators hypothesize that spirulina-silicon supplementation will lead to an improvement in vasomotor endothelial function, followed by decreased arterial wave velocity on the aorta and central arterial pressure compared to placebo subjects.


Eligibility Criteria:
Inclusion Criteria:

* The subject must have given their free and informed consent and signed the consent form
* The subject must be a member or beneficiary of a health insurance plan
* The subject is available for 6 months of follow-up
* The subject must not have any pre-existing chronic illness nor any revealed during the pre-inclusion visit, either treated or requiring treatment according to current recommendations

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Presence of a chronic cardio-vascular and/or metabolic illness, known or revealed by the pre-inclusion exam and requiring treatment in accordance to official recommendations (HAS)
* Any other chronic pathology requiring medical treatment
* History of uric acid metabolism disorders (hyperuricemia, gout, urolithiasis).
* Subject presenting a loss of limitation of autonomy
* Treated with hormone replacement therapy in females
* Active smoker or drug user
* Presence of an abnormality revealed by the pre-inclusion biological assessment of dyslipidemia justifying a prescription medication, diabetes or intolerance to glucose (insulin resistance).
* Presence of a stenosis (greater than 50% in diameter, NASCET method) or carotid occlusion revealed by the echo-Doppler screening test.
* Presence of an aneurysm (dilation\> 30 mm) of the abdominal aorta revealed by the echo-Doppler screening test.
* Arteriopathy of the lower limbs (toe systolic pressure (tsp) \<0.7) revealed by the screening test (SysToe™ device).
* Subject already taking a food supplement based on spirulina or silicon.
* History of cardio-vascular disease or heart attack
* Subject develops a chronic illness requiring medical treatment for more than 7 days or a surgical intervention leading to incapacity for more than 7 days,or a pathological event during the 14-day period before each follow-up visit, or a serious adverse event
GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study

This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.

A maximum of 636 adult subjects will be enrolled at up to 40 U.S. centers. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with an ischemic stroke presumed to be an embolic stroke of undetermined source (ESUS) verified by a neurologist within the last 365 days prior to enrollment.
* Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE) and/or transcranial Doppler (TCD), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver.
* Patient is able to tolerate antiplatelet therapy
* Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

* History of or ongoing atrial fibrillation/flutter
* Other co-morbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, cardiac prosthetics (valves), severe native valve disease (including mitral valve stenosis), severe ventricular wall motion abnormalities, aortic dissection, significant atherosclerosis, vasculitis, pre-existing non-vascular neurologic disorders, pulmonary arteriovenous malformations, prior intracranial hemorrhage, severe disability related to prior stroke, autoimmune disorders that would increase the risk of stroke or thromboembolism, or associated with increased risk of infection or procedural complications, in the opinion of the investigator, left ventricular ejection fraction of \<40%, coexistent cause or intra-cardiac shunting (e.g. VSD or ASD)
* Previous Myocardial Infarction
* Rankin Scale sore greater than or equal to 3 at the time of procedure
* Active infection that cannot be treated successfully prior to enrollment
* Neurological deficits not due to stroke that may affect the patient's neurologic assessments
* Evidence of hypercoagulable state, Uncontrolled diabetes mellitus, uncontrolled systemic hypertension or pulmonary hypertension at the time of screening or procedure
* Sensitivity or contraindication to all proposed medical treatments or any device components
* Pregnant, lactating, or intent on becoming pregnant through 24 months after enrollment.
* Indications outside the parameters accepted for placement of GSO, including extensive congenital cardiac anomalies and defect diameters considered too large for closure with the device.
* Atrial septal anatomy that is expected to necessitate placement of more than one GORE® CARDIOFORM Septal Occluder
* Need for concomitant procedure(s) that may confound detection of adverse events related to device placement
* Note: Additional Exclusion Criteria may apply