cyrilzakka/clinical-trials huggingface dataset:
Thoracic Epidural Depth in Children Using Magnetic Resonance Imaging.Magnetic Resonance Imaging

The purpose of this study is to evaluate the thoracic skin to epidural space depth in children and define the ratio between the straight and inclined thoracic skin to epidural depth.

Thoracic epidural in children confers clinical benefits but are technically challenging. The prediction of thoracic skin epidural depth (SED) might increase the success rate and decrease complications. Magnetic resonance imaging (MRI) is the most comprehensive imaging modality of the spine, and the measurements derived can be more accurate.

The present study is based on Magnetic Resonance Imaging (MRI)-based measurements to evaluate the thoracic SED and define the ratio between the straight and inclined SED at the two thoracic levels (T6-7 and T9-10) in children.

Eligibility Criteria:
Inclusion Criteria:

Children aged 1 month to 8 years undergoing Magnetic Resonance Imaging evaluation

Exclusion Criteria:

Patients with scoliosis, myelomeningocele, tumors of the spinal cord or vertebral bodies, spina bifida, tethered cord, spinal metastasis
Left Atrial Appendage Closure Registry of Henri Mondor Hospital

Intro: Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to strokes or systemic embolisms. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is an interventional cardiology technique for patients at high risk of stroke related to atrial fibrillation in whom long term anticoagulation therapy cannot be conducted. This procedure involves implantation of an occlusion device into the left atrial appendage to close it and prevent migration of thrombotic material that could otherwise cause distant embolism. Closure of the left atrial appendage avoids long-term prescription of anticoagulants while protecting patients against the risk of systemic embolism and stroke.

Hypothesis/Objective: the main objective of this study is to assess the long term efficacy of left atrial closure, 5 years after the procedure Method: 150 patients will be included prospectively. We will also include restropectively100 other patients, previously treated by left atrial appendage closure at Henri Mondor hospital. Demographic, clinical, echocardiographic, and computed tomography data will be obtained by physical examination or medical records.

Conclusion: this study will allow to assess the long term efficacy of left atrial closure in atrial fibrillation patients.


Eligibility Criteria:
Inclusion Criteria:

* Any patient for whom an indication has been made for implantation of a device for the closure of the left atrial appendage without restriction of indication and regardless of the outcome of the procedure (implantation success or not)

Exclusion Criteria:

* Refusal of the patient to participate in this study
* Minor patient
* Patient not affiliated to the French social security system
Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures

The purpose of this study is to compare two methods that are currently used at the end of a CT guided lung biopsy to close the hole on the surface of the lung in order to minimize the chance of air leaking out of the hole. The two techniques consist of either injecting a very small amount of your the blood called a blood patch into the biopsy hole or injecting a gel-based FDA approved artificial plug called BioSentry that will eventually get absorbed into the body.

This study will determine the rate of all pneumothoraces and those pneumothoraces requiring treatment following percutaneous lung biopsy in patients who have received ABPI or BioSentry at the end of the biopsy procedure. The data collected will be used to determine if there is equal effectiveness in the reduction of pneumothorax rates from both interventions.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Referred for CT guided biopsy of lung lesion
* Target lesion of any size
* Target lesion located 1.5 cm or more away from visceral pleura based on the needle path
* Skin thickness ≤7 cm (from skin to pleura)
* Needle path without transgression of pleural fissure bleb, or bulla is possible
* Coaxial biopsy technique using Angiotech 19-Gauge introducer needle
* Needle length ≤15

Exclusion Criteria:

* Passage through non-aerated lung or tissue
* More than 1 biopsy on the same side requiring more than 1 pleural puncture
* History of prior ipsilateral lung interventions including:
* Chest tube placement
* Surgery
* Pleurodesis
* Radiation treatment
Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery

The purpose of this study is to look at whether the use of a simple technique before surgery, which involves inflating a blood pressure cuff on the infant's leg, can improve development of language, motor and thinking skills at 12 months of age. Some research has found that a brief shortage of blood supply to an organ (such as a leg) at level that does not cause harm may help the body to tolerate a longer and more severe shortage of blood (for example, during surgery).

The purpose of this study is to look at whether the use of a simple technique before surgery, which involves inflating a blood pressure cuff on the infant's leg, can improve development of language, motor and thinking skills at 12 months of age. Some research has found that a brief shortage of blood supply to an organ (such as a leg) at level that does not cause harm may help the body to tolerate a longer and more severe shortage of blood (for example, during surgery).

Neurodevelopmental Assessment:

The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)9 assesses the developmental functioning of infants and young children between the ages of 1 month and 42 months. Cognitive, language, and motor development are assessed through structured play activities. Social-emotional and adaptive functioning are assessed through parent questionnaires. Administration time is 45 - 60 minutes, depending on the child's performance and behavior. Psychometric properties are well defined and acceptable. Composite scores for cognitive, language, motor, social-emotional, and adaptive behavior are standardized with a mean of 100 and a standard deviation of 15.

The Infant Development Inventory (IDI)10 will also be used to assess neurodevelopmental functioning, based on parent report. Parents are asked to rate their child's developmental skills in five domains: social, self help, gross motor, fine motor and language. Administration time is approximately 10 minutes. Infants are categorized as delayed or not delayed for each of the five domains.

Eligibility Criteria:
Inclusion Criteria:

* Infants \<7 months of age
* Undergoing open heart surgery
* Written informed consent

Exclusion Criteria:

* Presence of known gross neurologic abnormality preoperatively
* History of birth asphyxia
* Non-English speaking family
Study to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in the Elderly Population

As the licensed pneumococcal vaccine is not always satisfactory in elderly, new investigational pneumococcal vaccines are evaluated in the healthy elderly population. Note: The study consists of the primary phase (106068): vaccination and follow-up and the extension (106072) of the primary phase: 1 year follow-up.

This protocol posting details the procedures of both the primary \& extension phase.

No new subjects will be enrolled in the Extension Phase of the study. All outcome measures at Month 12 will only be evaluated in the subjects in the Belgian site.

Upon request, volunteers will receive flu vaccination free of charge. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* A male or female between 65 and 85 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject.

Exclusion Criteria:

* Previous vaccination against Streptococcus pneumoniae.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
* Acute disease at the time of enrolment.
* History of documented radiologically confirmed pneumonia within 3 years prior to first vaccination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
* Current or history of Parkinson disease, Alzheimer disease, stroke, dementia or any serious neurologic or mental disorders.
* All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
* Subjects with documented anaemia or iron-deficiency.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccine(s) with the exception of a Flu vaccine which can be administered at least 1 week preceding the first dose of vaccine(s) or 1 month after the first dose of the vaccine(s).
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Administration of immunoglobulins and/or any blood products within three months preceding the first dose of study vaccine or planned administration during the study period.
* History of administration of an experimental/licensed vaccine containing MPL or QS21.
* History of chronic alcohol consumption and/or drug abuse.
European Study of Opioid Induced Constipation

Constipation is common (40-90%) in advanced cancer patients , and has a significant negative impact on quality of life. The aetiology of constipation is often multifactorial in advanced cancer patients. However, it is well recognised that opioid analgesics are a common cause of constipation in this group. The prevalence of opioid-induced constipation (OIC) is stated to be 40-70%, although a recent large study reported an even higher figure.

OIC has been reported to exceed pain in terms of distress caused, and studies have found that some patients choose to reduce or discontinue opioid medication in order to attempt to better control constipation. Moreover, OIC is associated with a variety of physical (gastrointestinal, systemic), psychological and social problems.

This European study follows on from a United Kingdom study, and aims to confirm findings of the previous study in a larger, more heterogeneous sample: it also aims to explore additional strategies to manage OIC. Moreover, the study aims to identify differences in perception of normal bowel habit / constipation, and differences in OIC management in the different European countries. Previous studies suggest that there are cultural differences in people's beliefs about constipation / normal bowel function. The aim of the project is to investigate OIC in a real world / heterogenous group of European patients with cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or over
* Diagnosis of cancer
* Diagnosis of cancer pain or cancer treatment-related pain
* Taking regular opioids for at least one week (i.e. opioid for mild to moderate pain / "weak" opioid; or opioid for moderate to severe pain / "strong" opioid)

Exclusion Criteria:

* Unable to provide consent
* Unable to complete questionnaire
Organoid-driven Chemotherapy Choice in Metastatic Pancreatic Cancer Patients.

Pancreatic cancer is burdened by an extremely low survival rate. Survival chances reduce even further when the tumor spreads to other organs such as lymphnodes, liver or lungs. When the tumor cannot be surgically resected, the only valid curative option is represented by chemotherapy. However, therapies available to date have limited efficacy and they do not specifically target the biological characteristics of the tumor. The aim of the project is to validate a new technology called \&amp;#34;patient-derived organoids\&amp;#34; (PDOs) in predicting the best drugs for the treatment of pancreatic cancer based on the tumoral characteristics and behavior.

In order to generate PDOs a sample of tumoral tissue will be collected during a small surgical procedure, called laparoscopy. PDOs represent mini, three-dimensional copies of the original tumor, of which they maintain its behavior and aggressiveness. Through the DNA and RNA analysis of the tumor, the aim is to predict the best available drug by screening thousands of potentially effective compounds. Once identified, drugs will be tested in vitro on PDOs and the most efficient drug in controlling the tumor will be administered to the patient, once the present standard-of-care treatments fail.

Multiple benefits are expected from this trial. First of all, the most effective drug against their tumor based on an objective in vitro response will be provided. This might reflect in a better control of the disease and in a longer survival. Targeting the chemotherapy will also imply less side-effects due to unnecessary elevated chemotherapeutic dosages, which in turn will lead to a better compliance with the therapy. Eventually, all these aspects will reflect into a better quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Patients older than 18 years
* Patients with metastatic pancreatic ductal adenocarcinoma
* At least one lesion amenable for surgical excisional biopsy
* ECOG Performance status 0-2
* Radiologically measurable disease
* Life expectancy \&gt; 3 months
* Absolute leucocyte count \&gt;1.5 G/l, platelets \&gt;100 G/l
* Serum creatinine \&lt;1.5 times of the upper limit of normal or Clearance \&gt;50ml/min (according to the CKD-EPI formula)

Exclusion Criteria:

* Known allergies or intolerance to one or more compounds present in one of the 3 first line regimens approved for the trial
* Concomitant need for full anticoagulation that cannot be interrupted or bridged prior to tissue biopsy
* ECOG PS \&gt;2
* Heart failure (NYHA class III-IV)
* Severe or uncontrolled concurrent illness
* Active viral infection from HIV, HBV or HCV, even if under antiretroviral treatment
* Myocardial infarction within the previous 6 months
* Patients who are pregnant or breastfeeding
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Locally-advanced or metastatic solid tumor with KRAS G12D mutation
* For Part 1 and Part 2 Combination Groups 1 and 2: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment to improve the disease outcome
* For Part 2 Combination Groups 3 and 4: No more than 1 prior standard treatment
* Cohort specific requirements as follows:

  * Parts 1A and 1D: Histologically or cytologically confirmed malignant solid tumor of any tissue origin
  * Part 1B

    * Disease group 1: diagnosis of PDAC and ≤ 2 prior standard systemic regimens for pancreatic cancer
    * Disease group 2: diagnosis of CRC
    * Disease group 3: diagnosis of NSCLC
    * Disease group 4: diagnosis of other advanced solid tumor and not part of Disease groups 1, 2 or 3
  * Part 1c: Confirmed diagnosis of PDAC, CRC, or NSCLC
  * Parts 2A and 2B

    * Combination 1: Diagnosis of PDAC or Diagnosis of CRC and

      * Prior treatment in the advanced setting with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan and
      * In Part 2a: ≤ 3 prior standard regimens
      * In Part 2b: ≤ 2 prior standard regimens
    * Combination 2: Diagnoses of PDAC, CRC or NSCLC
    * Combination Group 3 (INCB161734 in combination with GEMNabP) and Combination Group 4 (INCB161734 in combination with mFOLFIRINOX):

      * Diagnosis of PDAC
      * ≤ 1 prior standard systemic regimen for pancreatic cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Prior treatment with any KRAS G12D inhibitor
* Known additional invasive malignancy within 1 year of the first dose of study drug
* History of organ transplant, including allogeneic stem cell transplantation
* Significant, uncontrolled medical condition
* History or presence of an ECG abnormality
* Inadequate organ function

Other protocol-defined Inclusion/Exclusion Criteria may apply
The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure

The aim of this study will be to determine the effects of pilocarpine as an adjunct medication to latanoprost monotherapy at multiple intervals throughout a 24-hour period and compare these effects to latanoprost alone.

This study plans to learn more about the effect of pilocarpine on intraocular pressure and ocular perfusion pressure for a full twenty-four hour period.

In this study, the investigators seek to better characterize the knowledge base of the intraocular pressure (IOP) lowering effects of pilocarpine in patients with open angle glaucoma or ocular hypertension who are currently taking latanoprost. The goal is to define the potential additive effect of pilocarpine throughout a 24-hour period, not only for IOP, but for ocular perfusion pressure (defined as 2/3\[diastolicBP + 1/3(systolicBP - diastolicBP)\] - IOP). These data will allow to expand current knowledge of the effects of pilocarpine and help determine if this medication has a useful role as an adjunctive treatment in glaucoma.

Eligibility Criteria:
Inclusion Criteria:

* Current confirmed diagnosis of:

  * open angle glaucoma, or
  * ocular hypertension including pigment dispersion glaucoma, and
  * pseudoexfoliation glaucoma.
* Current use of topical latanoprost once a day in both eyes for at least 6 weeks
* any race/ethnicity

Exclusion Criteria:

* Females who are currently pregnant or planning to become pregnant during the study period
* Diagnosis of any other form of glaucoma other than open-angle
* Intraocular pressure readings of \<14mmHg in either eye when measured during routine office visit in the past 12 months.
* Schaffer angle grade \< 2 in either eye by gonioscopy
* Intraocular surgery within 6 months or laser within 3 months
* History of retinal tear or detachment in either eye
* Active iritis in either eye as determined by most recent eye examination
* Patients who smoke or have irregular daily sleep patterns
* Patients who have started or changed glucocorticoids therapy in the last 3 months
* Patients who are currently using medical or recreational marijuana
* Any use of a non-FDA approved medication for glaucoma in the last 3 months
The Influences of Dry Eye Disease on Optical Quality

DED could result in visual disturbance and damage optical quality. We aimed to evaluate the influences of dry eye disease (DED) on optical quality and their correlations.

This study is aimed at evaluating changes of optical quality in dry eye patients with superficial punctate keratopathy after being treated by artificial lubricant and anti-inflammatory eye drops.

Eligibility Criteria:
Inclusion Criteria:

1. patients were diagnosed as dry eye according to the criteria provided by the Dry Eye Workshop (DEWS)
2. positive corneal fluorescein staining (CFS)
3. best-corrected distance visual acuity better than 20/20.

Exclusion Criteria:

History of ocular surgeries, contact lens wear, meibomian gland dysfunction, and any type of corneal scarring such as dystrophies or infections.
The Influence of Rapid Recovery on Sleep Quality Following Total Knee Replacement Surgery

The purpose of this study is to evaluate the influence of rapid recovery on sleep quality following total knee replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Primary unilateral total knee artropasty;
2. Patients with Knee osteoartritis or Rheumatoid arthritis;
3. Able and willing to provide signed informed consent.

Exclusion Criteria:

1. Simultaneously bilateral total knee artropasty or revision case;
2. Surgical History of the knee joint;
3. Knee joint cavity paracentesis in recent 3 months;
4. Stiffness with knee;
5. Blood coagulation disorders;
6. History of deep venous thrombosis;
7. Concomitant medical problems such as uncontrolled hypertention, severe cardiovascular disorder, chronic obstructive pulmonary disease, liver or renal failure
8. allergic to NSAIDs, opioid analgesics, zolpidem
9. sleep apnea, Parkinson disease, dementia, depression
10. use of sedatives or hypnotics
11. inability to comply with polysomnographic measurement
Role of Individualized PEEP Vs Fixed PEEP in Mechanical Ventilation During Laparoscopic Surgeries

To compare the effects of Individualized positive end-expiratory pressure with recruitment maneuver on respiratory parameters and oxygenation in mechanical ventilation during laparoscopic surgeries with the fixed positive end-expiratory pressure and conventional mechanical ventilation without positive end-expiratory pressure.

Thus study will compare the effects different methods of positive end-expiratory pressure administration in mechanical ventilation on respiratory parameters and oxygenation of the patients undergoing laparoscopic surgeries. There will be three groups of patients which will be as follows: Individualized positive end-expiratory pressure with recruitment maneuver group, fixed positive end-expiratory pressure group and conventional mechanical ventilation. Respiratory parameters; dynamic compliance, driving pressure and ratio of partial pressure of oxygen to fractional inspiration of oxygen will be measured. Mechanical ventilation respiratory parameters i .e. peak pressure, plateu pressure , dynamic compliance and driving pressure will be measured from ventilator machine. P/F ratio( Ratio of partial pressure of oxygen to inspiratory fraction of oxygen) will be measured by taking blood samples for arterial blood gas analysis.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age Limit : 25 years to 65 years

  2. Patients undergoing laparoscopic suregeries

  3. ASA 1-3

Exclusion Criteria:

* 1. Hemodynamic instability 2. Bronchospam 3. Patients having COPD 4. History of pulmonary bulla 5. Patients having history of pneumothora