cyrilzakka/clinical-trials huggingface dataset:
Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)

The purpose of this study is to evaluate Pulmozyme® (dornase) as compared to a standard ear drop Floxin® (ofloxicin) to dissolve clogged tubes. This study will monitor the use of the new drug for any problems related to the medication. Patients are being asked to be in this study because they had tubes placed for the treatment of chronic ear infection and the tube(s) are now clogged. Clogged tubes are a common problem found in children with tubes. This problem occasionally is improved with ear drops like Floxin®. However, it is frequently not improved even after this standard ear drop treatment.

The success in treating blocked tubes may relate to the ability to dissolve the material clogging the tube as well as dealing with the thick fluid in the middle-ear. The reasoning behind this study is that the use of Pulmozyme® may be able to treat both of these problems. Pulmozyme® was approved by the FDA in 1994 for the treatment of cystic fibrosis patients. Infections present in airway (lung) secretions of cystic fibrosis patients and the material that plugs ear tubes are in some ways the same. "Off-label" use of a drug is the practice by physicians to use a FDA-approved drug in treating conditions other than what the original approval was intended for. Pulmozyme® has been used to treat other lung diseases not related to cystic fibrosis. There has been no published report on the use of Pulmozyme® to treat ear infections. This study is a clinical trial that compares two treatments and will last for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* subjects from age 1 to 18 years who have undergone tube placement in the previous 9 months.
* subjects with middle-ear fluid on entry into the study will be required to have had a prior normal hearing test.

Exclusion Criteria:

* subjects with symptoms of an acute otitis media (otalgia or otorrhea), sensorineural hearing loss,cranio-facial syndromes, cystic fibrosis, prior ear surgery except tube placement, sensitivity to fluoroquinolones and presence of granulation tissue in the lumen of the tympanostomy tubes will be excluded.
Evaluation of a Simple Pharmacokinetic Tool (myPKFiT™) to Guide Personalized Factor VIII Dosing in Patients With Hemophilia

This is an investigator-initiated, industry-funded, multi-centre, international study that will be carried out prospectively at hemophilia treatment centres across Canada, the Czech Republic and Australia with SickKids as the coordinating site. The study will use a central laboratory not directly affiliated with any of the participating sites. Enrollment target is 50 participants, both adult and pediatric with severe hemophilia A receiving Advate, who will each complete a 2-point and 6-point pharmacokinetic (PK) sampling. The main aim is to compare the results of a 2 sample PK using clinically practical time points and myPKFiT™ (a web-based, population PK Bayesian tool) to a 6 sample population PK to determine whether the results obtained are in good agreement.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Hemophilia A;
* Severe disease (FVIII \<2%);
* Receiving ADVATE for prevention of bleeding (prophylaxis) or receiving ADVATE on demand and a candidate for prophylaxis;
* Body weight ≤120 kg; and ≥12kg;

Exclusion Criteria:

* FVIII inhibitor positive (level of ≥0.6 Bethesda Units \[BU\] per mL using the Nijmegen modification of the Bethesda assay). Inhibitor status to be documented as negative prior to study enrollment according to the two most recent, consecutive inhibitor assays on record. If patients have \< 50 exposure days, an assay will be completed centrally within a reasonable timeframe (approximately 8 weeks suggested) to make sure that they are negative.
* Body weight \>120 kg or \<12kg;
* Human immunodeficiency virus (HIV) positivity with cluster of differentiation 4 (CD4) count \< 200 / microliter;
* Significant hepatic dysfunction, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5 times upper limit of normal
* History of recent events that might affect FVIII half-life (e.g., infection, surgery or an invasive procedure) within 2 weeks of blood sampling.
Effect of Neurodynamics Nerve Flossing on Femoral Neuropathy in Haemophilic Patients

To investigate the effect of Neurodynamics Nerve flossing on femoral neuropathy in patients with haemophilia

Background: heamophilia is one of the serious chronic disorders in children and adolescents which results in less physical activities and restlessness hours than their peer.

HYPOTHESES:

This study will hypnotize that:

Neurodynamics Nerve flossing will have a significant effect on femoral neuropathy in patients with haemophilia

RESEARCH QUESTION:

will the Neurodynamics Nerve flossing has an effect on femoral neuropathy in patients with haemophilia?

Haemophilic patients with Femoral Neuropathy will be randomly divided in two equal groups control group which will receive conventional selected exercise program and study group will receive the same exercise training program in addition to Neurodynamics Nerve flossing three times per week for three successive months.

The Evaluation will done pre and post interventions included:

femoral nerve motor conduction velocity, muscle test For Iliopsoas and Quadriceps muscles and Pain visual analogue scale.

Eligibility Criteria:
Inclusion Criteria:

* hemophilia A or B, all the patients
* positive femoral nerve tension test
* the Manual muscle test for iliopsoas and quadriceps muscles in all patients not less than grade 2 according to the oxford scale
* the age ranging from (12:16) years
* all the participants will be able to communicate verbally ,obey commands and instructions and co-operate with testing and training protocols

Exclusion Criteria:

* any participants have auditory, visual and sever cardiac disorders
* Patients who have mild degree of hemophilia
* Patients who have joint, muscle bleeding or pain in the lower limb in the preceding 3 weeks
* patients with any other neurological disorders or musculoskeletal disorders or deformities of the lower limb.
Exercise Rehabilitation for Children With Asthma

Asthma, a prevalent chronic condition among children and adolescents, substantially impairs their quality of life. In addressing this significant health concern, this study focuses on the potential of a customized exercise rehabilitation program tailored for this young demographic. By employing a randomized controlled trial design, the research aims to divide participants into two distinct groups: one undergoing a personalized exercise regimen and the other receiving standard medical care. The 12-week intervention for the exercise group includes a combination of aerobic activities, strength training, and targeted breathing exercises. The study's primary aim is to rigorously evaluate the impact of this specialized exercise protocol on critical health aspects such as lung function, physical endurance, frequency of asthma attacks, and overall quality of life. The anticipated findings from this research are expected to shed new light on effective asthma management strategies and offer invaluable guidance for clinical practices dedicated to improving health outcomes in young asthma patients.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with bronchial asthma;
2. No acute asthma attacks in the past three months;
3. Currently undergoing stable prophylactic treatment for asthma, with no changes in the treatment plan in the past three months.

Exclusion Criteria:

1. Suffering from other severe heart, lung, or musculoskeletal diseases;
2. Frequent acute asthma attacks or recent hospitalization records;
3. Changes in asthma medication treatment plan in the last three months;
4. Currently participating in other clinical trials that could affect the results of this study;
5. Any medical contraindications, such as severe exercise-induced asthma or other health issues affecting the ability to exercise;
6. Severe psychological or behavioral issues that may affect participation in training or adherence to the research protocol.
Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma

The purpose of the study is to determine if RAD001 treatment will shrink or slow the growth of the vestibular schwannoma(s) in Neurofibromatosis 2 (NF2) patients. Secondary objectives include determining if RAD001 treatment will improve hearing ability in NF2 patients.

RAD001 is an oral drug that is approved by Food and Drug Administration (FDA) for other types of tumors, it is not approved by the FDA for treatment of NF2 related tumors.

This protocol is a Phase II, open-label, efficacy and safety study of single-agent RAD001 in patients with NF2. During the study, subjects will receive continuous daily oral treatment with RAD001 for up to 1 year or until tumor progression.

Primary Objective: To determine whether RAD001 has an effect on the VS growth in patients with NF2 at a rate sufficient to submit the drug for further testing.

Secondary Objectives: To determine whether RAD001 has an effect on the volume of other intracranial tumors, and to assess the effect of RAD001 on hearing function in patients with NF2 (when applicable).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NF2 by National Institutes of Health (NIH) criteria
* Age ≥ 16 years
* Progressive VS growth during the previous 12 months.
* WHO performance status \> or = 2
* Adequate bone marrow, liver and renal function.
* For women of childbearing potential, no pregnancy or breast-feeding
* Willingness and ability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
* Willingness to provide informed consent

Exclusion Criteria:

* Inability to tolerate periodic MRI scans or gadolinium contrast.
* Inability to tolerate periodic audiologic testing or to understand a language with established scoring for word recognition testing.
* Inability to adequately perform volumetric measurement of at least 1 target lesionNote: Patients with cochlear or auditory brainstem implants may participate if a target lesion can be accurately assessed.
* Radiation therapy for the target lesion in the 60 months preceding inclusion in the study.
* Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug.
* Immunization with attenuated live vaccines within one week of study entry or during study period.
* Presence of a fungal infection requiring systemic antifungal treatment at enrollment
* Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
* Patients who have any severe and/or uncontrolled medical conditions.
* Patients with a known hypersensitivity to everolimus or other types of rapamycin or to its excipients.
* Patients unwilling to or unable to comply with the protocol
Endostatin Serum Levels During Bicycle Stress Test

Endostatin, a 20-kDa cleavage product of collagen XVIII, is a component of the extracellular matrix expressed in the basement membrane. As a potent inhibitor of angiogenesis, endostatin induces endothelial cell apoptosis and diminishes cell migration, adhesion and proliferation.

Endostatin may stop the progression of atherosclerosis. Atherosclerotic heart disease involves unwanted tissue growth. By cutting off the blood supply from a plaque the likelihood of plaque rupture may eventually be reduced. Recent data indicates that the loss of collagen XVIII/endostatin is related to the enhancement of neo-vascularization and vascular permeability in atherosclerosis. Plaque neo-vascularization strongly correlates with the regional content of inflammatory cells. Furthermore, increased vascular permeability enhances lipid accumulation in the vessel walls, hence increasing foam cells.

Therapeutic angiogenesis is a most promising strategy for the treatment of myocardial infarction. However, it remains unknown if and how endogenous angiogenesis inhibitors, such as endostatin, regulate angiogenesis in myocardial infarction. Rat models showed that after myocardial infarction endostatin neutralization displayed adverse left ventricular remodeling and severe heart failure compared with controls. Although angiogenesis was increased, tissue remodeling and interstitial fibrosis were further exaggerated in post-myocardial infarction hearts by endostatin neutralization.

However, several studies suggest that endostatin may locally modulate coronary collateral formation by inhibiting collateral vessel formation in patients with ischemic heart disease.

During treadmill exercise tests in healthy volunteers a significant increase in circulating endostatin levels can be observed. Exercise induces angiogenesis in cardiac and skeletal muscles by decreasing endostatin in the muscle tissues to increase blood flow to these metabolically active tissues. Thereby endostatin is released into the general circulation.

In summary, endostatin might be a new weapon to fight against atherosclerotic progression by inhibiting neo-vascularization of atherosclerotic plaques.


Eligibility Criteria:
Inclusion Criteria:

* Smoking/Non smoking
* Healthy/non healthy (if for CMP, CHD study)
* Age (depending on the group affiliation)

Exclusion Criteria:

* Suffering from grave diseases
Smoke Inhalation Injury in Patients Admitted to Intensive Care

Many Studies have shown that the smoke-inhalation injury is responsible for a high mortality mainly related to the systemic effects of carbon monoxide and cyanide. Respiratory lesions induced by smoke inhalation, is one of predictive factors of mortality.

The aim of the study is to identify the clinical and epidemiological characteristics of smoke-inhalation injury and to identify prognostic factors among these patients .

The study is a monocentric, retrospective, descriptive and analytical study , betwen december 1997 and september 2018 in intensive care unit of university of hospital.

All patients aged over 18 year and who had received a diagnosis of smoke- inhalation injury and were admitted to the ICU of Medical University Hospital , a referral center in Paris providing HBO therapy , were potentially eligible for inclusion in this investigation.

Criteria used for recommending HBO therapy to a patient with transient or prolonged unconsciousness, abnormal neurologic findings on physical examination.

Data were analyzed to identify independent factors that may influence mortality.

Eligibility Criteria:
Inclusion Criteria

* Men or women over the age of 18
* Hyperbaric oxygen therapy between 1997 and 2018

Exclusion Criteria

* Patients under 18 years old.
* Patient opposed to the use of his data
* Patients not treated with hyperbaric oxygen
Venous Congestion and Organ Dysfunction.

Venous congestion, which is a phenomenon described in cardiology and post-operative cardiac surgery, is responsible for an increase in morbidity and mortality.

Indeed, it can lead to kidney failure, liver failure, prolonged ileus, scarring complications, and neurological disorders. Clinical and ultrasound indications have been described to diagnose this condition.

To date, this phenomenon is poorly known and not described in intensive care patients outside the cardiac context. However, intensive care patients can present the risk factors associated with the occurrence of congestion: acute cardiac failure, significant water-salt overload, and/or fluid distribution anomalies. Thus, observational studies have found an association between the input-output balance, the quantity of salt-water intake, the presence of right heart dysfunction and the occurrence of acute kidney failure, digestive disorders, hypoxemia and a prolonged stay in intensive care. The presence of a congestive condition is medically treatable since diuretic decongestion is associated with improved cardiac outcomes.

It is therefore necessary, in an intensive care context, to be able to define and diagnose this state of venous congestion, to study its prevalence, and to confirm the existence of a link with organ failure in order to pave the way to known adapted treatment options.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* Patient who has expressed his or her non-opposition to the collection of data (or the health care proxy, or a close relative if the patien is unable to receive the information)
* Patient admitted to intensive care for less than 24 hours.

Exclusion Criteria:

* Person not affiliated to the national health insurance
* Minor, protected major
* Pregnant or breastfeeding women
* Anechogenicity confirmed by the operator
* Chronic atrial fibrillation
* Mechanical cardiac assistance
* Uncontrolled blood pressure (MAP \< 65 mmHg)
The Effect of Emotional Working Memory Training on Reducing Depressive Symptoms

The purpose of this study is to test whether emotional working memory training and attention bias modification training are an effective neurobehavioral therapy to improve depressive symptoms.That is whether emotional working memory training is superior to attention bias modification training or not in reducing depressive symptoms over 1 year after training.

Attentional bias has been theorized to play a critical role in the onset and maintenance of depression. Attentional bias modification training (ABMT), an experimental paradigm that uses training to induce adaptive attentional bias, was developed to test the causal model and this has therapeutic implications in depression.To test the effect of ABMT on treatment of depressive symptoms, a randomized, double-blind, placebo and blank controlled trial is conducted in college students who are experiencing mild-to-severe symptoms of depression.

Eligibility Criteria:
Inclusion Criteria:

Meet the major and mild depression disorder's criteria

Exclusion Criteria:

bipolar disorder, schizophrenia or organic mental disorder; any concurrent psychotherapy; any concurrent psychotropic medication.
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause

The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, postmenopausal women, aged 40 to 65 years
* Intact uterus
* At least 1 moderate to severe vulvar/vaginal symptom that is most bothersome

Exclusion Criteria:

* Hypersensitivity to estrogens, endometrial hyperplasia, known or suspected estrogen-dependent neoplasia
* Thrombophlebitis, thrombosis or thromboembolic disorders
* Neuro-ocular disease
Outcome of LA Versus GA for Staged CEA Prior To CABG

A retrospective analysis of all patients that underwent carotid endarterectomy (CEA) for stenotic disease - diagnosed at pre-operative investigation - prior to CABG as staged operation within 6- months.

The rate of postoperative stroke and complications was compared between CEA performed under Local anaesthetic (LA) to those performed under General anaesthetic (GA).

The primary outcome was the rate of postoperative stroke in patients that had staged CEA prior to CABG. This was defined as CEA within a period of 4 weeks prior to CABG.

We retrospectively looked at those patients that fulfilled the inclusion criteria and had CEA performed either under LA (Group A) or under GA (Group B). We measured the 30 days' postoperative stroke rate as the main outcome. We also looked at the rate of intraoperative stroke.

Additionally, we assessed the rate for developing nerve injuries and/or hematoma postoperatively. Finally, we examined the risk for developing postoperative stroke in patients with bilateral significant carotid artery disease that underwent surgery in one side.

Eligibility Criteria:
Inclusion Criteria:

- All patients that had carotid endarterectomy performed in staged fashion within 6 months before a CABG operation.

Exclusion Criteria:

* Patients diagnosed with symptomatic carotid disease
Indomethacin for Tocolysis of Preterm Labor

Indomethacin for tocolysis for 48 hours vs placebo

Background: Indomethacin is frequently used as a tocolytic, however there is currently only scant evidence to support its efficacy.

Goals: To delay preterm delivery by 48 hours and to examine longer latency periods and maternal and neonatal outcomes Methods: Randomized placebo-controlled trial of indomethacin for tocolysis. Women with a singleton pregnancy between 23w0d and 31w6d in preterm labor randomly assigned to 50mg indomethacin by mouth followed by 25mg by mouth every 6hour for 48 hours or placebo. Patients receive betamethasone for fetal lung maturity, if not previously administered, and magnesium sulfate for neuroprotection. Ultrasound performed before initiation of study drug and after completion of study medication for amniotic fluid index and fetal cardiac assessment.

Eligibility Criteria:
Inclusion Criteria:

* Preterm labor as defined by regular uterine contractions (at least 6/hour) with cervical change of at least 1 cm or cervical shortening on transvaginal ultrasound less than 25mm of functional length
* Gestational age 23w0d to 31w6d weeks
* Singleton
* ≥ 18 years old
* Able to consent in English

Exclusion Criteria:

* Major congenital anomalies associated with an increased risk of newborn death
* Multiple fetal gestation (2+)
* Known intrauterine fetal demise
* Non-reassuring fetal status requiring delivery
* Preterm premature rupture of membranes (PPROM)
* Suspected or known intrauterine infection
* Placenta previa
* Maternal allergy or contraindication to indomethacin (peptic ulcer disease, thrombocytopenia, coagulopathy, renal or hepatic dysfunction)
* Inevitable delivery (cervix ≥6cm dilated)
Comparison of the Proximal Approach and Distal Approach of Axillary Vein Catheterization Under Ultrasound Guidance

Ultrasound-guided axillary vein catheterization can be performed via the proximal or distal approach of the axillary vein. The aim of our study is to compare the first puncture success rate and safety between the two approaches of ultrasound-guided axillary vein catheterization in cardiac surgical patients with risk of bleeding.

For patients after cardiac surgery, antiplatelet drugs or anticoagulants are usually used for preventing thrombosis. Use of those drugs is associated with increased risk of bleeding. Any invasive procedures may put those patients at additional risk of bleeding. Ultrasound (US) has become widely accepted to guide safe and accurate central venous catheterization.The axillary vein in the infraclavicular area is an alternative choice for subclavian vein. Ultrasound images of the infraclavicular axillary vein differ according to its position. Proximal infraclavicular axillary vein is a direct continuation of the subclavian vein. The associated anatomy is simple and the vein is straight and thick in longitudinal axis view, which are in favor of successful puncture. Meanwhile, distal axillary vein also has anatomical advantages for safe and successful cannulations. Distal axillary vein lies further away from the artery and chest wall, and the overlap between distal axillary vein and artery gets greater on moving laterally. It is still unknow that one of the puncture approaches is superior to the other. Until now, there are no studies comparing two puncture approaches in high bleeding risk patients. The aim of the study is to compare the success rate of first puncture and safety of US-guided proximal and distal axillary venous catheterization in cardiac surgery patients with risk of bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgical patients in Cardiac Surgery Intensive Care Unit
* Axillary vein catheterization is needed according to the clinical practice
* receiving oral antiplatelet or anticoagulants at least three days

Exclusion Criteria:

* fracture of the ipsilateral clavicle or anterior proximal ribs
* subclavian and/or axillary vein thrombosis
* local infection of the puncture area
* subclavian and/or axillary veins which are not clearly visualized using ultrasound
* already presence of subclavian or axillary vein catheter
* requiring an emergency axillary vein catheterization