cyrilzakka/clinical-trials huggingface dataset:
Intracoronary Infusion of BM-Derived Mononuclear Cells in Patients With Large Acute Myocardial Infarction

Large acute myocardial infarctions are the most frequent cause of subsequent systolic heart failure. Some evidence exists on the improvement after intracoronary administration of bone marrow cells in patients with a recente acute myocardial infarction. Although subgroup analyses suggest that patients with the largest myocardial infarctions have the largest increase in ejection fraction after intracoronary bone marrow administration, there is no published trial including only large myocardial infarctions. Therefor we sought to confirm the subgroup analyses by conducting a trial in only large first acute myocardial infarction patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥20 and \<80 years old
* Acute myocardial infarction \>2 and \<96 hours from start to reperfusion
* Cumulative ST-segment elevation \>6 mm on 12 lead ECG
* No functional myocardial impairment outside the myocardial infarction region
* Succesful PCI of infarct related coronary artery
* Left ventricular ejection fraction \<50% on ventriculography, echo or MRI
* Accepted anticonceptive use during the study for women of childbearing potential
* Written and signed informed consent

Exclusion Criteria:

* CPR \> 10 minuts or persistent cardiogenic shock
* complete left bundle branch block without concordant ST-segment elevation
* Need foor cardiac surgery (valvular, coronary or other)
* Trombocytopenia, coagulation disorders or hematological disease
* History or active malignancy
* Life expectancy (apart from acute myocardial infarction) \<5 years
* Dialysis or severe kidney insufficiency (creatinin clearance \<30ml/')
* Severe liver insufficiency
* Severe respiratory disease
* Systemic inflammatory pathology (acute or chronic, apart from inflammation associated with myocardial infarction)
* Symptomatic cerebral or periferal vascular disease
* Prior myocardial infarction or prior myocardial dysfunction
* Prior CABG or heart valve surgery
* Pregnancy, pregnancy wish or lactation \<1 month
* Psychiatrical illness
* Physical or psychological inability to adhere to the protocol
* Participation in other not yet completed study
Emergency/Compassionate Use PFO Occluder

Emergency/compassionate use for the AMPLATZER PFO Occluder


Eligibility Criteria:
Inclusion Criteria:

* Emergency/compassionate use for patients not meeting the inclusion criteria for the AMPLATZER PFO Access Registry.
Journey II BCS EU Observational Trial

Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.

Multicenter, prospective, observational study to collect relevant clinical data from 167 subjects implanted with the Journey II BCS Knee System. Data from eligible subjects, who have provided written informed consent for the collection of their coded data will be recorded from the patient's medical file on specially designed case report forms (CRF's).

Total study duration for participants will be 10 years with follow-up visits planned at 3 months, 1 year, 2 years, 5 years and 10 years post-surgery. An interim analysis describing the clinical outcome is planned after 5 years.

Eligibility Criteria:
Inclusion Criteria

* subject requires primary total knee arthroplasty with the Journey II BCS Total Knee System, including patella resurfacing
* subject requires primary total knee arthroplasty due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis)
* subject is of legal age to consent, agrees to consent to and to follow the study visit schedule, by signing the EC approved informed consent form

Exclusion Criteria:

* age \> 75 years
* conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
* subject has inadequate bone stock to support the device
Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever

This study is focused on investigating the efficacy and safety of the FlowTriever device to treat low-risk submassive pulmonary embolism.

In this study, patients that present with low-risk submassive pulmonary embolism with hemodynamic stability and with either positivity of cardiac biomarkers, or radiographic or echocardiographic evidence of right ventricular strain will be assigned to be treated with mechanical thrombectomy, which includes conscious sedation, via FlowTriever.

Eligibility Criteria:
INCLUSION CRITERIA

I1. ≥ 18 years of age

I2. Clinical signs and symptoms of low-risk Intermediate pulmonary embolism defined per 2019 ESC Guidelines:

Only one of the following:

* Presence of either RV strain or RV dilation on CT scan or Echo TTE
* 4th generation Troponin T \> 0.01 ng/mL or 5th generation Troponin T \>14 ng/L

Troponin I \> 51.4 ng/L (Northwell reference laboratory)

I3. sPESI score 0 or \>1\*

\*Signs of RV dysfunction on Echo TTE or CTPA or elevated cardiac biomarker levels may be present, despite a calculation of sPESI 0.

I4. Echocardiogram, Computed Tomography Pulmonary Angiogram, or pulmonary angiographic evidence of proximal filing defect in at least one main, lobar, or segmental pulmonary artery with or without pulmonary infarction

I5. Hemodynamically stable

EXCLUSION CRITERIA

E1. Patients with active and severe COVID-19 infection (e.g. using ventilator, requiring hemodynamic support)

E2. Unable to anti-coagulate with heparin or alternative

E3. Known sensitivity to radiographic contrast agents that cannot be pre-treated

E4. Life expectancy \< 6 months

E5. Current participation in another study that may interfere with the patient's participation in this study.

E6. Inability to consent

E7. Patient is pregnant or plans to become pregnant within the next 6 months and/or currently breastfeeding.

E8. Subsegmental pulmonary embolism only
Apneic Oxygénation by Nasal Canula During Infants Airway Management Study

This is a randomized clinical trial investigating the utility of apneic oxygenation via high flow nasal cannulae during airway management for infants general anaesthesia. Three groups will be compared, a control group at 0 L/min, a 0,2L/Kg/min and a 1L/Kg/min group. The primary outcome will be the time (in seconds) between onset of apnea and one of theses end-points : desaturation (SPO2 \<95%) or Airway management completed.

Airway management can be a life saving therapy. One major complication that may occur during airway management is a lack of oxygen in the blood, especially in peadiatric population, due to anatomical and physiological considerations. If severe or prolonged, this lack of oxygen can result in permanent brain damage, damage to other vital organs or even death. Pre-oxygenation prior to induction of anaesthesia is standard practice to prevent desaturation and hypoxemia. Apnoeic oxygenation in adults is effective and prolongs the time to desaturation. Apneic oxygenation is a novel method of delivering oxygen to a patient despite a lack of active respiration (i.e. the patient is not breathing on their own and the investigators are not providing the patient an artificial breath). The simplest and least invasive method to provide apneic oxygenation is the application of oxygen through nasal cannula during airway management. The effectiveness of apnoeic oxygenation in the adult is well document, especially in bariatric population or ICU, however only few study are interesting about pediatric population. Recent studies suggest that high flow is similar to low flow oxygenotherapy. Therefore, the aim of this study was to investigate the effectiveness of apnoeic oxygenation during airway management in infants.

This is a randomized clinical trial investigating the utility of apneic oxygenation via high flow nasal cannula during airway management for infant's general anesthesia. Three groups will be compared, a control group at 0 L/min, a 0,2L/Kg/min and a 1L/Kg/min group. The primary outcome will be the time (in seconds) between onset of apnea and one of these end-points : desaturation (SPO2 \<95%) or Airway management completed.

All infants included will receive french actual standard of care concerning general anesthesia and peri-operative medicine.

Eligibility Criteria:
Inclusion Criteria:

* Infants Between 0 (post-conceptionnal age \>41 weeks post Amenorrhea) and 24 months of life
* Scheduled for elective surgery under general anesthesia
* Need of orotracheal Intubation by direct laryngoscopy or Video-laryngoscopy

Exclusion Criteria:

* Emergency surgery
* Crush Induction needed
* High clinical risk of difficult airway management
* Premature before 1 month of life
A Phase 2 Trial of OPC-64005 for Major Depressive Disorder

The objective of the trial is to compare the efficacy of OPC-64005 at 20 mg vs placebo and to assess the safety and pharmacokinetics of OPC-64005 at 10 and 20 mg in patients with major depressive disorder (MDD).The primary endpoint is the mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 of the double-blind treatment period in the OPC-64005 20-mg group compared with the placebo group


Eligibility Criteria:
Inclusion Criteria:

* Patients with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode" with the current episode persisting for ≥4 weeks to ≤1 year
* Patients with a total score of ≥18 on the 17-item Hamilton Rating Scale for Depression (HAM-D)

Exclusion Criteria:

* Patients with a diagnosis of any of the following diseases according to DSM-5 Neurocognitive disorders, history or complication of schizophrenia spectrum or other psychotic disorder, history or complication of bipolar and related disorders, feeding and eating disorders, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, personality disorders, neurodevelopmental disorders, substance-related and addictive disorders (within 180 days prior to informed consent)
* Patients exhibiting mood-incongruent psychotic features in the current major depressive episode
* Patients who, in the opinion of the investigator or subinvestigator, are judged to have treatment-resistant depression, ie, a certain degree of therapeutic effect is not obtained by administration of 2 or more antidepressants having different mechanisms of action at sufficient doses for at least 6 weeks for the current major depressive episode
* Patients receiving augmentation treatment, such as antipsychotics, for the current major depressive episode (excluding the use of sulpiride for depression/depressive state or gastric/duodenal ulcer)
Birth & Breastfeeding Support Study

The goal of this observational study is to learn about the effects of birth practices such as cesarean section and vacuum assisted birth and diseases such as gestational diabetes and preeclampsia on exclusive breastfeeding. The main question it aims to answer is:

• Does cesarean section, vacuum assisted birth, gestational diabetes and preeclampsia affect exclusive breastfeeding three months after birth? Participants answer eight online survey questions. One survey is distributed before birth and the remaining seven surveys are distributed after birth at three, seven and four-teen days, as well as one, three, six and twelve months after birth.


Eligibility Criteria:
Inclusion Criteria: 18 years, intention to breastfeed, single gestation, reads and understands Danish -

Exclusion Criteria: Twin gestation, less than 18 years, no intention to breastfeed, does not read and understand Danish

-
Broader Implementation of a Successful Dual-Generation Intervention in Partnership With Head Start of Lane County

This project involves the development of a scaled-up model of a successful dual-generation intervention targeting attention, stress, and self-regulation in families attending Head Start, and improvements of outcome assessments of the intervention. The investigators hypothesize that families randomly assigned to receive the intervention, compared to families not receiving the intervention, will show improved brain function for attention and self-regulation and improved physiological function for stress regulation in both children and their parents, improvements in child school performance and cognition, and improvements in assessments of parent/family well being.

Based on basic research on the neuroplasticity of attention, stress, and family dynamics, the investigators developed a successful dual-generation intervention that targets attention, stress, and self-regulation. The intervention has been shown to improve brain function for attention, cognition, and behavior in preschool children in Head Start (HS) and also improves communication skills and reduces stress in parents. This project involves the development of a scaled-up model of this intervention working with with Head Start of Lane County (HSOLC).

Goal 1: In partnership with HSOLC, the investigators have developed a scaled-up model of the intervention that is delivered by HS specialists and sustainable and replicable by other HS programs. This intervention is called Creating Connections: Strong Families, Strong Brains (CC).

Goal 2: To characterize the degree to which CC improves distal outcomes related to parent/family well-being by assessing health and safety outcomes in parents and children, parental education, financial literacy and decision making, household chaos, and biomarkers of allostatic load related to health outcomes.

Goal 3: To evaluate hypothesized mediating factors related to changes in family well-being, specifically changes in foundational systems (stress and self-regulation) by refining measures of family stress and self-regulation by assessing heart rate variability in parents and children and neurophysiological measures of self-regulation in parents.

Children and parents at randomly assigned HSOLC sites will receive CC, and other HSOLC sites will deliver the regular HS curriculum. The investigators hypothesize that participation in CC will result in improved brain function for attention and self-regulation as well as improved physiological function for stress regulation in both children and their parents compared to families not receiving the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Student at Head Start of Lane County (child); parent of student at HSOLC (parent)

Exclusion Criteria:

* Not a native speaker of English or Spanish
* does not have normal hearing, vision, physical, motor, and emotional development
* has history of brain injury or disorder
* currently taking medications that affect brain function
The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis

The purpose of the study is to evaluate the effect of ruxolitinib cream on itch in participants with Atopic Dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Participant has clinically confirmed diagnosis of active AD for at least a 6-months.
* Participant has chronic pruritus related to AD for at least 3 months .
* Participant has an overall BSA (excluding palms, soles, scalp, genitals, and folds) affected by AD of 1%-20% on Day 1.
* Participant has an IGA score of at least 2 on Day 1.
* Participant has a single PP-NRS score ≥ 4 in the 24-hour period prior to the screening visit.
* Willingness to avoid pregnancy or fathering children.
* Participant must be willing to comply with all study procedures and restrictions including discontinuation of all current therapies for AD and pruritus (unless otherwise specified), and must be available for the duration of the study.

Exclusion Criteria:

* Female participnat who is breastfeeding, pregnant, or planning to become pregnant during the study.

Participant had significant flares or unstable course in AD.

* Participant has clinically infected AD or has used antibiotics (systemic or topical) for their infected AD within 2 weeks prior to the run-in period.
* Participant has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
* Participant has any clinically significant medical condition or physical/laboratory/vital sign abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.
* Participant has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the run-in period.
* Participant is unlikely, in the opinion of the investigator, to be compliant with study procedures and requirements.
Blood Levels of Ketamine in Patients Using Topical Application of 10% Ketamine Gel for Neuropathic Pain

The purpose of this research study is to measure how much, if any, ketamine is absorbed into the blood stream after ketamine gel is applied to the skin. The investigators expect that the topical administration will provide pain relief locally, at the site of pain, but not be absorbed into the bloodstream and thus not cause side effects. This research will help assess the safety of this drug by measuring the blood concentrations of the drug.

Ketamine is a general anesthetic drug but also has excellent pain relieving qualities. It has been used to relieve chronic pain by administering intravenously, by mouth, or as an injection beneath the skin. When given these ways ketamine can occasionally cause side effects like dizziness, nausea, nightmares, agitation, hallucinations. Recently it has been used topically for patients with neuropathic pain in order to avoid the dizziness and nausea side effects.

Neuropathic Pain can be partially caused by the misfiring of small nerve fibers close to the area of pain. By applying it on the skin, it is expected the drug can penetrate the skin and act directly on the small nerve fibers. The advantage is that less drug will get into the blood circulation. Up to now, it has not been carefully studied how much of the drug appears in the circulation after application on the skin.


Eligibility Criteria:
Inclusion Criteria:

* Patients with peripheral, focal neuropathic pain such as or complex regional pain syndrome following surgery, bony, soft tissue trauma or nerve trauma, associated with significant allodynia and hyperalgesia who score equal to or greater than 4 in the DN4 questionnaire.
* Duration of pain more than 3 months.
* Ability to speak English adequately to consent to and participate in the study

Exclusion Criteria:

* Allergy to ketamine
* Severe medical illnesses like, e.g. unstable angina, tachyarryhthmias, renal or hepatic failure
* History of psychosis.
* Patients who are already on oral ketamine treatment.
* Patients who are taking HIV Antiretrovirals: (indinavir, nelfinavir, ritonavir saquinavir); Antibiotics: (clairithromycin, itraconazole, ketoconazole, telithromycin,fluconazole, erythromycin); Calcium Channel Blockers (verapamil, diltiazem),Amiodarone, Ciprofloxacin. (These drugs inhibit CYP 3A4 enzyme which metabolises ketamine)
Growth Hormone Study in Adults With Prader-Willi Syndrome

The overall objective of this study is to measure the effect of growth hormone (GH) treatment on physical and psychosocial health in adults with Prader-Willi syndrome. Adults with PWS who have not been treated with GH during the past three years and who will start with GH treatment as part of regular patient care will be asked for informed consent to participate in this open-label prospective cohort study. We hypothesize that growth hormone treatment will improve the physical and psychosocial health.

OBJECTIVES:

To measure the effect of GHt on physical and psychosocial health in adults with PWS.

The primary endpoint is change in lean body mass (LBM (kg)) as assessed by Dual Energy X-ray Absorptiometry (DEXA) scan. Secondary endpoints are total fat mass, bone density, physical health and psychosocial health. Also the occurrence of side-effects will be assessed. Only data that are collected as part of regular patient care will be used.

STUDY DESIGN:

Open-label prospective cohort study.

STUDY POPULATION:

Adults with PWS who have not been treated with GH during the past three years and who will start with GHt as part of regular patient care.

Eligibility Criteria:
Inclusion Criteria:

* The patient is diagnosed with Prader-Willi syndrome (genetically confirmed)

Exclusion Criteria:

* Non cooperative behaviour
* Pregnancy
* Known malignancies
* Poorly controlled diabetes (HbA1c \> 64 mmol/mol (8%))
* Untreated obstructive sleep apnea (apnea-hypopnea index \> 5)
* Body mass index above 40 kg/m2
* Upper-airway obstruction of any cause
Whole Eye Optical Coherence Tomography (OCT) to Improve Refractive Surgery and Eye Care

The overall objective is to develop the hardware systems and software algorithms necessary to make accurate measurements of the whole eye with optical coherence tomography (OCT).

The research procedure that each subject will undergo is imaging with the OCT system. Three populations will be included: 1. Normals to ensure the imaging range of the system, 2. Patients with previous LASIK who will be undergoing cataract surgery, and 3. Patients with a history of cataract surgery or high myopia. The third group will also undergo MRI imaging for comparison.

There are no known risks to the subject from imaging with optical coherence tomography beyond what is normal for standard ocular photographic procedures. Light exposure is below ANSI limits. In groups 2 and 3, clinical parameters drawn from the OCT images will be compared to standard of care imaging.


Eligibility Criteria:
Inclusion Criteria:

* 21 years or older.
* Pseudophakic group: has had prior uncomplicated cataract surgery with a monofocal or toric intraocular lens, able to undergo head MRI
* High myopia group: refraction equal to or stronger than -6 D spherical equivalent, able to undergo head MRI

Exclusion Criteria:

* under 21 years of age, unable or unwilling to give consent.
* Pseudophakic group: complications with cataract surgery or insertion of a multifocal intraocular lens, failure to pass MRI pre-screening (e.g. prior metallic implants, claustrophobic), unable to fixate.
* High myopia group: failure to pass MRI pre-screening, unable to fixate.