cyrilzakka/clinical-trials huggingface dataset:
Development and Evaluation of AI Program for Predicting Bacterial Species From Urine Gram Stain Specimens

The purpose of this research is to develop an AI that estimates bacterial species from Gram staining images of urine specimens, and to evaluate the accuracy and labor reduction effect of Gram staining Automation system equipped with this AI.


Eligibility Criteria:
Inclusion Criteria:

* Specimens for which urine culture and urine Gram staining tests were performed for clinical purposes

Exclusion Criteria:

* Samples for which suspension of use has been requested
Blood Spot Self-administered Test and Assay

The current study will compare hormone levels of AMH, FSH and inhibin B in blood specimens collected by venipuncture and fingerstick in a sample of pre-menopausal women ages 18-45 years with normal menstrual cycles.

Recent advances in cancer diagnosis and treatment have led to greater survival rates in patients with malignancies. However, these life-saving treatments, especially alkylating agents, often lead to premature ovarian failure, infertility and related long-term health problems. It is difficult to predict whether, and the extent to which, patients will experience these problems. There are no early clinical signs of decreased fertility potential; even young women who maintain cyclic menses after therapy are at high risk of infertility, early menopause and related health problems. Preliminary studies suggest that several surrogate measures of fertility potential are different in cancer survivors compared with controls. These include follicle stimulating hormone (FSH), estradiol, anti-mullerian hormone (AMH) and inhibin B. Large longitudinal studies are needed to validate these measures with gold standard outcomes such as pregnancy rates, pregnancy outcomes and time to menopause. The main impediment to assessing the value of these markers and generating data that is useful to cancer survivors is the need for frequent and timed blood samples.

Daily or frequent trips to the clinical center are not practical and reduce the compliance of even the most motivated patients. The hypothesis that will be tested by this study is that blood spot assays can be developed that provide robust, personalized data for surrogate markers of reproductive function which can be used to assess reproductive potential in women; furthermore, bloodspots collected at home are an acceptable method for reproductive hormone measurement in women with and without a history of cancer. The current study will compare hormone levels of AMH, FSH and inhibin B in blood specimens collected by venipuncture and fingerstick in a sample of subjects.

Eligibility Criteria:
Inclusion Criteria:

* Adult females
* Age between 18-45 years
* Premenopausal (defined as menses in the past 12 months)
* Postmenarchal
* Presence of an intact uterus and two ovaries
* Ability and willingness to comply with study protocol

Exclusion Criteria:

* Pregnancy within the previous 3 months
* Lactation within the previous 3 months
Return on Investment on Lap Gastric Bypass Regarding Quality of Life

The purpose of this study is to investigate the cost of treatment and adverse efffects therof corresponds to quality of life improvements and expected wheightloss.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 35
* age 18-60 years

Exclusion Criteria:

* Prior bariatric surgery
* Prior gastric surgery
IV Lidocaine in Pediatric AIS

This study addresses the focus areas of Post-Operative Pain Management. We propose a randomized, triple-blind, placebo-controlled trial to investigate the efficacy of a systemic infusion of intravenous lidocaine as a non-opioid method of post-operative pain management following postoperative spinal fusion for adolescent idiopathic scoliosis (AIS). The outcomes assessed will be (1) the effect of intravenous lidocaine on post-operative opioid consumption, both in-hospital and at three-month follow-up, (2) the effect of intravenous lidocaine on the immunophenotype expressed following surgery, and (3) the effect of intravenous lidocaine on recovery from surgery as assessed by the Patient Reported Outcomes Measurement Information System-Computer Adaptive Tests for Pain Interference (PI) and Mobility (M) (PROMIS-CAT). Thus, we propose a study of a non-opioid method of pain control to minimize opioid consumption in-hospital and at three-months postoperatively, with primary outcomes measures that include morphine-equivalent opioid consumption and PROMIS-Mobility to assess recovery. In addition, we will test the ability of systemic lidocaine to attenuate the systemic inflammatory response to major spine surgery. The immunologic response to surgery has been associated with rehabilitation and recovery following total hip arthroplasty and this study will provide data to support further work.

a Phase IV, randomized, triple-blind, placebo-controlled trial with two study groups: postoperative standard of care with opioid patient controlled analgesia (PCA) and IV lidocaine infusion versus postoperative standard of care plus normal saline placebo. Block randomization into one of the two groups will be based on a random table generated using an R-program. Group 1 (Study) will receive intravenous lidocaine during and after posterior spinal fusion for AIS. Group 2 (Control) will receive saline placebo during and after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Adolescent idiopathic scoliosis indicated for posterior spinal fusion.
2. Ages between 12 and 18 years of age.
3. Parent/Guardian capable of providing informed consent for study participation

Exclusion Criteria:

1. Age \< 12 or \> 18 years old.
2. Unable to obtain consent for the surgical intervention or study, or if mental capacity prohibits the ability to provide consent and complete patient-reported outcomes tools.
3. Diagnosis of sepsis or infection
4. Diagnosis of primary or metastatic malignancy.
5. Participation in another clinical trial.
6. Past or current diagnoses of a cardiac arrhythmia or first/second degree heart block.
7. Past or current seizure disorders.
8. Allergy to bupivacaine.
9. Planned anterior approaches for treatment of scoliosis deformity.
10. Limited English proficiency (e.g. unable to obtain informed consent for surgery without a translator)
11. Ward of the State children
A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)

This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme. Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks (placebo group). Patients must have had stable CF symptoms without any change in therapy for 2 weeks prior to enrollment in order to participate.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form and, if applicable, Assent Form
* Age ≥ 14 years old at screening
* Proven diagnosis of CF
* Ability to perform acceptable and reproducible spirometry maneuvers at screening
* FVC ≤ 45% predicted for race, height, age, and sex at screening
* Chronic use of Pulmozyme for at least 3 months in the last year and daily or twice daily use during the 14 days prior to screening
* Stable regimen of chest physiotherapy (CPT) for at least 14 days prior to screening
* Ability to complete the 6-minute walk test at screening
* Ability to complete the 6-minute walk test and spirometry at Visit 2
* If on routine tobramycin solution for inhalation (i.e., TOBI®) or other cycled antibiotic therapy, intention to either start or stop therapy at the time of Visit 2 (based on routine therapy cycle; no other planned change in this antibiotic regimen for 28 days before or 28 days after Visit 2)
* Clinically stable with no change in medications during the 14 days prior to screening

Exclusion Criteria:

* Use of an investigational drug or device within 28 days prior to screening
* Previous episode of acute respiratory failure requiring assisted ventilation within 2 years prior to screening
* Previous lung transplant
* Any cardiac disease that would contraindicate performing the 6-minute walk test
* Pregnancy or nursing
* Known hypersensitivity or other contraindication to the use of Pulmozyme
* Previous completion or premature discontinuation of study drug or withdrawal from this study
* More than one prior screening failure for this study at any time or any prior screening failure for this study within the last 28 days
Performance of Two Different ke0s in the Same Pharmacokinetic Propofol Model

The aim of this study was to assess the clinical performance of two different ke0s (fast and slow) in terms of propofol effect-site concentration (Ce) during the loss and recovery of consciousness, using Marsh's pharmacokinetic model.The hypothesis to be tested was that the Ce of propofol predicted by the slow ke0 in the loss and recovery of consciousness is similar, differently from the fast ke0.

Introduction: The ke0 can be defined as the proportional variation of the gradient of concentration between the plasma and the effect-site in relation to the unit of time. Theoretically, the higher the value of the ke0, the faster the drug enters the effect-site. Therefore, drugs with short T½ke0 have high ke0s and fast onset of action. The aim of this study was to assess the clinical performance of two different ke0s (fast and slow) in terms of propofol effect-site concentration (Ce) during the loss and recovery of consciousness, using Marsh's pharmacokinetic model. Method: Twenty healthy male adult volunteers participated in this study. Propofol was first administered to the individual volunteer using Marsh's pharmacokinetic target-controlled infusion model with ke0 of 1.21 min-1 and, on another opportunity, with the same pharmacokinetic model but ke0 of 0.26 min-1. Propofol was infused in plasma target-concentration of 3.0 µg.mL-1. Loss and recovery of consciousness was defined as response of the volunteer to verbal stimulus. The Ce was registered at the moments of loss and recovery of consciousness. Results: At loss and recovery of consciousness, propofol Ce means predicted by the fast ke0 were different (3.64 ± 0.78 and 1.47 ± 0.29 µg.mL-1, respectively, p \< 0.0001), whereas with the slow ke0 the predicted Ce means were similar (2.20 ± 0.70 and 2.13 ± 0.43 µg.mL-1, respectively, p = 0.5425). Conclusion: It can be concluded that slow ke0 (0.26 min-1) incorporated into Marsh's pharmacokinetic model showed better clinical performance than fast ke0 (1.21 min-1), since the predicted effect-site concentrations of propofol at loss and recovery of consciousness were similar.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* male
* adult between 20 and 45 years old

Exclusion Criteria:

* use of alcohol or illicit drugs
* chronic use of H2 inhibitors and tricyclic antidepressants of calcium channel blockers
* hypersensitivity to the drugs used in the experimental protocol.
The Effect of Intensive Insulin Therapy

Aim. To determine whether the maintenance of normoglycemia decreases the incidence of ventilator associated pneumonia (VAP), reduces its treatment period and the length of stay in the intensive care unit.

Methods. Prospective, randomized, controlled trial. We enrolled 117 mechanically ventilated trauma (71) and abdominal (46) surgical patients, older than 18, of both sex. In 57 patients (strict glucose control group) we aimed to maintain the blood glucose level between 4.4 and 6. 1 mmol/L, while in 60 patients (standard glucose control group) it was maintained between 7.8 and 10.0 mmol/L, with the use of continues insulin infusion. Insulin dose adjustments were based on measurements of glucose in capillary blood sample.

Key words: surgical patients; mechanical ventilation; pneumonia; blood glucose; insulin infusion; hospital stay

see brief summary

Eligibility Criteria:
Inclusion Criteria:

* surgical patients
* mechanical ventilated
* both sex
* older than 18

Exclusion Criteria:

* non-surgical patients
* non mechanical ventilated
* younger than 18
* pregnant women
Thrombelastogram in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery

Study Objective is to correlate the results of preoperative platelet mapping derived from modified TEG with clinically significant postoperative bleeding and consumption of blood products.

Study Design:

Prospective observational study with blinded assessment of study endpoint variables. Collection of information concerning study endpoints will be performed by the investigator blinded to the results of preoperative testing of platelet function. The information will be collected from 60 patients undergoing cardiac surgery in the Department of Cardiac Surgery of Sheba Medical Center.

Study endpoints

1. Primary endpoint- resternotomy for bleeding after the surgery.
2. Secondary endpoints- chest tube output during first 24 hours after the surgery; consumption of blood products during first 3 postoperative days.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery with the history of aspirin and/or ADP receptor antagonist for at least 7 days prior the surgery

Exclusion Criteria:

* Emergent surgery
* Heart transplant surgery
* Implantation of ventricular assist devices
* Enrollment into conflicting study
Role of Flavanols in Exercise and Aging

It has well known that diets rich in fruits, vegetables and cocoa products are associated with positive health benefits and these positive effects have been shown to be due to compounds they contain called flavanols. Flavanols have been shown to exert their positive effects by indirectly increasing nitric oxide (NO) bioavailability. NO is a potent vasodilator that is believed to play a role in increasing blood flow to active muscle during exercise. This regulatory process is impaired with healthy aging. The underlying premise to this study is that if NO bioavailability can be increased following flavanol ingestion, will there be a restoration of blood flow during exercise in older individuals? Accordingly, the first part of this research project will compare the acute vascular effects of flavanol ingestion between a young and old group. The investigators have hypothesized that both groups will show an improvement in blood flow to active muscle during exercise, though the magnitude of the change will be greater in the older group. The second part of this project will look at the effects of 4 weeks of daily flavanol ingestion in the old group. The investigators hypothesize that subjects will demonstrate an improvement in blood flow to active muscle during exercise after the 4 week intervention and that the magnitude of the change will be greater than the acute effects. Findings from this proposal will provide evidence for the efficacy of flavanols to be used (as a simple and safe lifestyle intervention) to reverse or combat impaired blood flow regulation in older individuals.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females between 18 - 30 years old
* Males and Females between 60 - 80 years old

Exclusion Criteria:

* cardiovascular and/or microvascular disease
* blood clotting disorder
* pregnant lady
* current smoker (or regularly smoked within last year)
* a history of an adverse reaction to cold
* taking medications known to effect the autonomic nervous system
Continuous And Pulsed Ultrasound Treatments On Carpal Tunnel Syndrome

The aim of this placebo-controlled study was to evaluate the effects of pulsed and continuous ultrasound treatments combined with splint therapy on patients with mild and moderate idiopathic carpal tunnel syndrome

The study included 36 carpal tunnel syndrome patients who were randomly divided into 3 groups.The first group received 0 W/cm2 placebo ultrasound treatment. second group received 1.0 W/cm2 continuous ultrasound treatment and the third group received 1.0 W/cm2 1:4 pulsed ultrasound treatment 5 days a week for a total of 15 sessions. All patients were also treated with night splints during the treatment. Pretreatment and posttreatment Visual Analogue Scale scores, Symptom Severity Scale scores, Functional Status Scale scores, median nerve motor conduction velocity. and distal latency and sensory conduction velocity of median nerve in the 2nd finger and palm were compared.

Eligibility Criteria:
Inclusion Criteria:

* Mild or moderate idiopathic carpal tunnel syndrome (without thenar atrophy or spontaneous activity on electrophysiological examination of the abductor pollicis brevis (APB) muscle)

Exclusion Criteria:

* Secondary entrapment neuropathies
* Cervical radiculopathy
* Systemic diseases with increased risk of the carpal tunnel syndrome
* Gained surgical relief of the syndrome
* Treated with ultrasound for the syndrome
* A history of steroid injections into the carpal tunnel and of physical therapy within the last 3 months
* Patients with either thenar atrophy or spontaneous activity (fibrillation potentials and positive sharp waves) on electrophysiological examination
Theta Burst Stimulation With an 8-Coil Versus H1-Coil for Resistant Depression

The goal of this clinical trial is to compare response rates after treatment with Figure Eight-Coil TMS versus H-Coil TMS on the prefrontal cortex left dorsolateral, in patients suffering from depression resistant. The main question it aims to answer is:

rTBS (accelerated neuronavigated intermittent Theta Burst Stimulation) is more effective than hTBS (accelerated deep intermittent Theta Burst Stimulation) in the treatment of resistant depression in terms of response rate.?

Researchers will compare Figure Eight-Coil TMS (rTBS) versus H-Coil TMS (hTBS) to see if rTBS is more effective than hTBS.

Participants will:

* Receive, for each stimulation method, 8 sessions per day spaced 50 minutes apart, over 5 days.
* Have visit all day of stimulation for checkups and tests.
* Have a a research MRI before and after treatment.
* Have follow-up visits at 1 month, 2 months, 3 months, 6 months, and 12 months post-treatment, via teleconsultation.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Presenting a major depressive episode according to the DSM-5-TR criteria, occurring as part of major depressive disorder (unipolar depression)
* The major depressive episode must meet the criteria for treatment resistance, defined by a lack of response to at least two different antidepressant treatments prescribed at an effective dose for a duration of 6 weeks or more
* Stable treatment for at least 6 weeks
* Affiliation with a social security system or State Medical Assistance (Aide Médicale d'État)
* Patient agrees to participate in the study and has signed an informed consent form

Exclusion Criteria:

* Presence of a contraindication to TMS: epilepsy, intracranial foreign body, cochlear implant, retinal implant, pacemaker
* Presence of a bipolar disorder according to DSM-5-TR criteria
* Presence of catatonic or psychotic features during the current episode
* Presence of severe psychiatric disorders other than a major depressive episode
* Presence of neurological disorders
* Unstable epilepsy
* Current moderate to severe addiction disorders other than caffeine and/or tobacco
* Current suicidal ideation
* Use of any brain stimulation treatment (ECT, rTMS, tDCS) for the current episode
* Pregnancy or breastfeeding
* Women of childbearing potential without effective contraception
* Persons under guardianship or legal protection
PRevalence Of Transient Global Amnesia in Obstructive Sleep Apnea Syndrome

Amnesic stroke is an amnestic syndrome lasting less than 24 hours characterized by the occurrence of anterograde amnesia often associated with retrograde amnesia, the pathophysiology of which is still poorly understood at present. A recent study on a small sample size (N=29) highlighted an association between obstructive sleep apnea syndrome and amnesic stroke. Our study seeks to confirm or refute these results on a larger cohort (N=200-250). A better understanding of the pathophysiological processes involved would open up new therapeutic avenues.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients seen for consultation in the Neuropsychology Department of Strasbourg University Hospital between March 1, 2015 and December 31, 2021 following an episode of amnestic stroke meeting the Hodges and Warlow criteria:
* The stroke must have been documented and reported by a competent witness present during the stroke.
* Anterograde amnesia during the stroke.
* Absence of vigilance, personality, and cognitive disorders other than memory disorders (aphasia, apraxia, etc.).
* Absence of focal neurological symptoms during the episode and its aftermath.
* Absence of epileptic manifestations.
* Resolution of the episode in less than 24 hours.
* Exclusion of patients with a history of recent head trauma or active epilepsy (undergoing regular treatment or having experienced a seizure in the last 2 years).
* Subjects who have not expressed opposition to the reuse of their data for scientific research purposes.

Exclusion Criteria:

* Patients who have expressed opposition to the retrospective reuse of their data for scientific research purposes.
* Patients with active epilepsy
* Patients with recent head trauma
* Patients with an MMS \< or equal to 25
* Subject under guardianship or curatorship
* Subject under judicial protection
Remediation of Impaired Self-Regulation in Patients With Mild TBI

The ability to regulate impulses enables us to plan for the future, to maintain focus in the face of distractions (i.e. to encode memories), and to manage emotions. This self regulation can be compromised in individuals who have a history of mild traumatic brain injury and co-occurring disorders. In this study the investigators are using functional MRI scanning to understand how memory and self regulation are expressed in the brains of people with a history of mild traumatic brain injury. The investigators are also testing whether the medication tolcapone may improve memory and self regulation.

In this randomized, double-blind, placebo-controlled, crossover cognitive neuroscience study, the investigators are evaluating whether the COMT inhibitor tolcapone impacts memory and self regulation, as measured both behaviorally (via cognitive testing) and neurophysiologically (via functional MRI). A new study arm that does not include use of tolcapone, nominally equivalent to the placebo arm only, is now also included to address performance on cognitive testing alone.

Eligibility Criteria:
Inclusion Criteria:

* Veteran ages 18-50 and in general good health;
* Able to read English at a 6th grade level;
* Able to provide written informed consent;
* Normal or corrected to normal visual acuity;
* Stable doses of all medications (2 weeks or greater);
* History of mild traumatic brain injury greater than 6 months prior to participation

Exclusion Criteria:

* Contraindications to MRI scanning;
* Inability to complete basic fMRI requirements;
* History of brain surgery or penetrating brain injury;
* Uncontrolled blood pressure (low or high);
* Contraindications to tolcapone use (not required for subjects who participate only in the study arm that does not include study medication);
* Use of medications or drugs with dopamine-related actions within 30 days;
* Active substance abuse or dependence;
* Clinically severe medical illness requiring treatment;
* History of psychiatric hospitalization (past 1 year) or suicide attempt (past 5 years);
* Seizures greater than 4 weeks after TBI event or seizures requiring active treatment;
* History of brain tumor, stroke, Alzheimer's disease, aneurysm rupture, or multiple sclerosis;
* History of schizophrenia, ADHD or psychiatric diagnosis EXCEPT depression or PTSD