cyrilzakka/clinical-trials huggingface dataset:
Asthma Inpatient Research on Education

Children with asthma are admitted for asthma attacks very frequently in the U.S. The families and children are given basic education about asthma but studies are needed to improve this education so that it makes a meaningful difference in health outcomes and asthma care. This study compares two inpatient education models for children hospitalized with asthma.

The current standard is to review an asthma action plan with families and to review inhaler medication administration. In this study, investigators will be assigning families to either a control (current standard education) or and intervention group. In the intervention group, participants will receive interactive education based on learning theories that are thought to enhance long term memory. Participants in the interactive group will build their own action plan using colored templates and pictures. Participants will also learn to use their inhaler using teach-back methodologies. Investigators will then compare the two groups in terms of ER visits, hospitalizations, family confidence in managing asthma, asthma knowledge, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma

Exclusion Criteria:

* Active Cardiac Disease
* Speaks language other than English or Spanish
Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Surgery Reduce Postoperative Haemarthrosis

To find superiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss, haemarthrosis prevalence and improvement functional prognosis in anterior cruciate ligament arthroscopy.

Tranexamic acid is an anti-fibrinolytic drug, recommended in total hip arthroplasty to reduce peroperative and postoperative hemorrhagic complications. The original character of our study lies in the serum dosage of tranexamic acid, allowing to correlate the primary objective (blood loss) with this one. The investigators will focus on the reduction of the risks associated with the administration of intravenous medicines, the economic aspect and the ease of use.

Eligibility Criteria:
Inclusion Criteria:

* Primary arthroscopic surgery for anterior cruciate ligament reconstruction

Exclusion Criteria:

* Renal failure with serum creatinine level higher than 1,40 mg/dL
* Thromboembolic events in last 12 months before surgery
* Pregnancy
* Congenital or acquired coagulation diseases
* History of gastric surgery that could lead to malabsorption
* Diabetic gastro-paresis
Ultrasound-guided Adductor Canal Block for Total Knee Replacement

Total knee arthroplasty is associated with intense early postoperative pain. Fast track recovery programs including early therapy protocols and early hospital discharge are being implemented at various hospitals. The postoperative analgesic pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. Adductor canal blockade is commonly used to provide postoperative analgesia for total knee arthroplasty (TKA) surgery. The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.

The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.

Eligibility Criteria:
Inclusion Criteria:

* Participants 40 to 75 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia

Exclusion Criteria:

* Patient refusal
* American Society of Anesthesiologists physical status classification of 4 or higher
* Pre-existing neuropathy in the femoral or sciatic distribution
* Coagulopathy
* Infection at the site
* Chronic opioid use (greater than 3 months)
* Pregnancy
* Medical conditions limiting physical therapy participation
* Any other contra-indication to regional anesthesia
Advanced MR Techniques for Breast Cancer Detection

Evaluation of advanced MRI acquisition techniques (perfusion and diffusion) to detect breast cancer. Two MR advanced sequences will be added to a standard breast MRI protocol for evaluation purpose.

This is a prospective monocentric longitudinal study on a consecutive population of patients who require breast MRI as part of their course of care in the radiology department of the Tenon Hospital (3T MRI).

The standard protocol for breast MRI routinely performed in Tenon hospital consists of a set of MR acquisitions performed with contrast agent injection. The research consists of adding perfusion and diffusion sequences to the regular MR protocol. The addition of these sequences does not require a new injection of contrast medium.

Diagnosis of lesions after the breast MR exam will be performed using standard MR sequences as usual. According to the recommendations of SIFEM, the final diagnosis of the lesions will be made either by histological analysis of a biopsy performed as part of the patient's standard care pathway, or during patient's follow-up if a biopsy is not indicated (up to two years after breast MR exam).

The research will focus on evaluating the sensitivity and specificity of perfusion MRI sequence with or without diffusion MRI sequence compared to the sensitivity and specificity of the standard protocol.

For the perfusion sequence, the following data will be extracted: qualitative (shape of the contrast curve), semi-quantitative (elevation slope and asymptote of the curve) and quantitative by compartmental modeling (tissue perfusion, blood volume fraction, surface capillary permeability).

For the diffusion MRI, the extraction of quantitative data such as CDA, IVIM and Kurtosis will be performed and parametric maps, cellularity maps and an assessment of lesion heterogeneity will be calculated.

A correlation will be made with histological, immunohistochemical and molecular results of cancers following biopsy

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Patient who has signed a consent form to participate in the study
* Affiliated patient or beneficiary of a social security scheme
* Patient with an injected breast MR exam planned as part of her care pathway.

Exclusion Criteria:

* Patients under guardianship or curatorship
* Pregnant or breastfeeding patients
* Patients with contraindications to realization of an MR exam and an injected MR exam
Potential Use Of Brain Network Activation Analysis to Diagnose Major Depression

The investigators are doing this study to find out if they can use electroencephalographic (EEG) recordings, which measure brain waves, to predict response to antidepressant treatments, as well as to distinguish patients who have depression from those who do not. In particular the investigators want to test the usefulness of a new type of analysis of EEG recordings called brain network activation or BNA. BNA allows to identify patterns of activation in brain networks and to track their changes over time.


Eligibility Criteria:
For Patients with Major Depressive Disorder

Inclusion Criteria:

* • Male and female outpatients, aged 18-55 years

  * Subjects meeting full criteria for the diagnosis of current Major Depressive Disorder (MDD) without psychotic features, as determined by clinical evaluation and Mood Module of structured diagnostic interview (SCID), completed by the study clinician.
  * HAM-D17 score of 14 or higher
  * Able to provide informed consent
  * Right handed, normal (corrected) vision and normal hearing

Exclusion Criteria:

* • Other primary diagnoses including major depressive disorder with psychotic features, bipolar disorder, schizoaffective disorder, schizophrenia, dementia, attention deficit hyperactivity disorder (ADHD).

  * Substance use disorder (abuse or dependence with active use within the last 6 months).
  * Significant sensory deficits such as deafness or blindness.
  * Severe or unstable medical illness, including history of closed head injury resulting in loss of consciousness, seizure disorder; history of neurological disorders.
  * Pregnant or nursing females who are not using an accepted method of contraception (birth control pill, IUD, combination of barrier methods)
  * Clinically significant abnormal laboratory values or electrocardiogram For Healthy Controls

Inclusion Criteria:

* Males and females, aged 18-55 years
* Subjects who do not meet full criteria for any of the major psychiatric diagnosis including MDD, bipolar disorder, schizophrenia, substance abuse/dependence, attention deficit hyperactivity disorder (ADHD), as determined by clinical evaluation and structured diagnostic interview, completed by the study clinician.
* Right handed, normal (corrected) vision and normal hearing

Exclusion Criteria:

* Any current primary psychiatric, or medical condition determined to be clinically significant.
* Current use of psychotropics or any medication with clinically significant central nervous system effects.
Evaluation of Safety and Parameters of Application Technique

This study is conducted in Europe. The aim of the study is to monitor patients changing therapy from syringe to insulin delivery system as prescribed by the treating physician in Slovakia.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus (type 1 or type 2)
* Treated with insulin
A T Drain Approach Treating Anastomotic Leaks After Gastrointestinal Surgery

Assessing the use of a T drain approach for an anastomotic leak after gastrointestinal surgery. The study's aim is to retrospectively assess the safety and benefits of this approach.

Assessing the use of a T drain approach for an anastomotic leak after gastrointestinal surgery. The T drain approach is inserting a latex t tube drain into the leak site of the anastomosed bowel and diverting the fecal matter. The study's aim is to retrospectively assess the safety and benefits of this approach.

Eligibility Criteria:
Inclusion Criteria:

* Patients after elective or emergent gastrointestinal surgery with a leak in their GI anastomosis

Exclusion Criteria:

* under 18 years of age
* Pregnancy
Use of a Compliant Balloon for Large Bore Catheter Navigation in Mechanical Thrombectomy for Stroke: a Retrospective Study

The superiority of mechanical thrombectomy (MT) in patients with acute ischemic stroke from large vessel occlusion compared to standard medical therapy alone has been demonstrated by several randomized clinical trials and become the standard of care for these patients. A direct aspiration first pass technique (ADAPT) for the endovascular treatment of stroke using a large-bore catheter has been reported to be an effective method of achieving MT. Recent studies reported that ADAPT is as efficient and safe as stent retrievers, with a similar successful recanalization rate, but may have better functional outcomes, fewer procedure related-adverse events, and a tendency for faster revascularization compared to the stent-retriever thrombectomy.

However, navigation of a large-bore aspiration catheter is not always possible due to unsuccessful passage of the ophthalmic artery origin ("ledge effect") or tortuous vascular anatomy. The coaxial technique comprises guiding the large-bore catheter with a smaller inner catheter and can facilitate distal access. However, there is a gap between the inner catheter and the distal tip of the large-bore outer catheter that creates a risk of damaging the vessel wall and causing dissection or subarachnoid hemorrhage. Even with this coaxial technique, it is not always possible to reach the clot site with the large-bore catheter. To decrease the gap between the two catheters, several authors have used, in place of the inner microcatheter, a compliant balloon catheter positioned and inflated at the distal tip of the large-bore catheter. The aim of the present study was to evaluate the safety and efficacy of ADAPT assisted by a compliant balloon (ADAPT-AB) when ADAPT using the coaxial technique fails to reach the clot site.


Eligibility Criteria:
Inclusion Criteria:

* Endovascular therapy were large arterial occlusions proven by MR angiography,
* Alberta Stroke Program Early CT Score (ASPECTS) \>5 on MRI,
* Baseline National Institutes of Health Stroke Scale (NIHSS) score \>5.

If eligible, patients received intravenous thrombolysis (IVT).

Exclusion criteria:

- Vertebro-basilar occlusion
Study of the Analytical Performance of Different Salivary Self-collection Methods for the Detection of COVID-19

Since March 2020, the SARS-CoV type coronavirus infection (SARS-CoV-2; nCoV19; COVID-19) is considered pandemic. As early as April 2020, the World Health Organization recommended the implementation of mass screening of populations, with the aim of identifying cases and contacts and controlling viral spread. Since the end of lock-down on May 11, 2020,the screening policy has been intensified to fight against COVID-19. Virological tests by RT-PCR are thus accessible to all, without a prescription and reimbursed by health insurance. The French government has also set a quantitative target of 1 million tests per week. In order to meet this target, the number of sampling centers has been increased (mobile structures, etc.).

Screening tests are currently carried out using a nasopharyngeal swab analyzed by RT-PCR for the detection of viral RNA. This type of sample has several technical and logistic constraints. It must be carried out by personnel who are authorized and trained in this procedure and in appropriate hospital hygiene practices. It exposes the sampling personnel to possible contamination through nasopharyngeal secretions or coughing that may occur during sampling. With the increase in screening, there are sometimes insufficient numbers of sampling personnel and there is significant market pressure for swabs and virological transport media.

In addition, these swabs are uncomfortable or even painful for the patient, which could imply a reluctance to be screened. They are also complicated in children, whether they are rhino- or oropharyngeal.

An alternative to the nasopharyngeal swab, which is the subject of this project, would be to have one or more reliable sampling methods that are less restrictive than the nasopharyngeal swab ("gold standard"). Thus, we propose to test and compare the results obtained by molecular biology techniques on nasopharyngeal, salivary and buccal swabs.


Eligibility Criteria:
Inclusion Criteria:

* To be at least 18 years of age
* To come at hospital for SARS-CoV-2 screening
* To be able to receive a nasopharyngeal swab

Exclusion Criteria:

* People under 18 years of age
* Inpatient in intensive care
* Pregnant or breastfeeding woman
* Individual with dry syndrome (Gougerot-Sjögren syndrome)
* Taking treatments that reduce salivary volume (anticholinergic activity)
* People with a COVID-19 diagnosis confirmed by a molecular biology method \>7 days ago
* Contraindication to oral swabbing
Probiotics in Mild Alzheimer's Disease

The main objective is to investigate whether administration of probiotics to patients with mild Alzheimer's Disease (AD) reduces neuroinflammation, improves cognitive function and modifies neurophysiological measures, compared to a patient group that receives placebo (no active probiotics).

We will measure specific blood inflammatory markers (primary outcome), neurophysiological activity, cognitive test scores, microbiome composition and dietary habits of participants in the probiotics and placebo group.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥65 years, able to give consent
* Mini-Mental State Examination (MMSE) scores 19-23 (mild AD)
* approximately equal male:female ratio

Exclusion Criteria:

* Inability to give consent
* other neurological disease
* relevant psychiatric disorders (e.g. major depression)
* gastrointestinal/metabolic conditions
* history of alcohol/substance dependence
* use of systemic antibiotics in the previous 6 months
* corticosteroid use
* immune stimulating medications
* immunosuppressive agents
* probiotics consumption in the previous 6 months.
* immunosuppression
* structural heart disease
* neutropenia
* radiation
* active intestinal disease
A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165)

A 53-week study to determine the effect of montelukast sodium when given to children (with infrequent episodic asthma) at the earliest symptoms of an acute episode of asthma.


Eligibility Criteria:
Inclusion Criteria:

* Males or females between the ages of 2 and 14 who have infrequent episodic asthma.
Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors

Open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study.

This is a study of PEGPH20 in human subjects and is designed to evaluate the safety of PEGPH20 and to determine the maximum tolerated dose of PEGPH20. All patients will receive PEGPH20. Each group of patients will receive a higher dose than the previous group. This will continue until the group with the highest planned dose completes the study or until a group has major side effects from their assigned dose.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic (histologic or cytologic) confirmation of metastatic or locally advanced solid tumor.
* Patients who have experienced disease progression after receiving appropriate standard / approved chemotherapy and for whom no further standard or palliative treatment measures exist, or who have chosen to decline standard or palliative treatment.
* One or more tumors measurable by RECIST criteria.
* Karnofsky performance status ≥ 70%.
* Recovery from any toxic or other effects of all previous therapy, including radiation, chemotherapy and surgery.
* Negative serum or urine pregnancy test result in women of childbearing potential.
* For men and women of child-producing potential, agreement to use effective contraception (hormonal or barrier birth control or abstinence) from the time of screening before study entry and throughout study participation.

Exclusion Criteria:

* Brain metastasis.
* New York Heart Association Class III or IV cardiac disease, myocardial infarction, or cardiac arrhythmia requiring medical therapy.
* Known allergy to hyaluronidase.
* Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions including psychiatric illness) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
* Women currently breast feeding.
* Concurrent participation in any other interventional therapeutic study.
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia

This study is a 12-week randomized-controlled clinical trial. It will be planned to conduct in a total of 120 male and female subjects from the Department of Psychiatry at Kaohsiung Chang Gung Memorial Hospital. Eligible subjects will be psychiatric patients, aged between 20-65 years old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion and exclusion criteria. The intervention with aerobic walking programs will be initiated after randomization for patients who continue their usual treatment. Subjects will be enrolled for 12 weeks aerobic walking treatment and randomly assigned to (1) treatment-as-usual, (2) treatment-as-usual plus aerobic walking. We will measure the treatment response to clarify the effect of aerobic walking in patients with schizophrenia. This study is being performed to investigate the possibly beneficial effects of aerobic walking on cognitive function and energy metabolites in schizophrenia.

This 12-week randomized-controlled clinical trial will be planned to conduct in a total of 120 male and female subjects from the Department of Psychiatry at Kaohsiung Chang Gung Memorial Hospital. Eligible subjects will be psychiatric patients, aged between 20-65 years old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion and exclusion criteria. The intervention with aerobic walking programs will be initiated after randomization for patients who continue their usual treatment. Subjects will be enrolled for 12 weeks aerobic walking treatment and randomly assigned to (1) treatment-as-usual, (2) treatment-as-usual plus aerobic walking. The wearable watch will be used during the participants join the walking programs. We will measure the treatment response to investigate the effect of aerobic walking in patients with schizophrenia. This study is being performed to investigate the possibly beneficial effects of aerobic walking on cognitive function in schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

1. The patient has been diagnosed of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria (DSM-5) criteria
2. The patient has the ability to complete the written informed consent

Exclusion Criteria:

1. The patient has been diagnosed with organic mental disorders, intelligence disability, dementia, major depressive disorder, bipolar affective disorder, and alcohol or substance use disorder
2. The patient has major systemic physical diseases, including cardiovascular diseases, uncontrollable arrhythmia, renal diseases, liver diseases or thyroid diseases
3. The patient has certified as physical disability
4. The patient is pregnant or has genetic diseases or infectious conditions