cyrilzakka/clinical-trials huggingface dataset:
Collection of SPOT EGMs And inTra-Cardiac Impedance for Atrio-ventricUlar and inteR-ventricular Delays optimizatioN

The purpose of the study is to collect data from the two implanted sensors simultaneously to the surface ECG and echocardiographic measurements of electromechanical parameters, in CRT patients.

The SATURN study is a prospective, interventional, open-label, non-randomized, single-arm, acute, multicenter feasibility study.

The purpose of the study is to collect data from the two implanted sensors simultaneously to the surface ECG and echocardiographic measurements of electromechanical parameters.

The data collected will be analysed in order to explore the relevance of timings and morphological features derived from those signals in comparison with timings determined on echocardiography and electrocardiograms (ECG) in various configurations of atrioventricular (AV) and inter-ventricular (VV) delays.

A maximum of 35 subjects, implanted with a CRT-D device, will be enrolled, at approximately 6 sites in France. Each patient will participate to this study only during an echocardiographic procedure, whose duration is estimated in approximately 1.5 hour.

Eligibility Criteria:
Inclusion Criteria:

* Patient with class I or II indication for implantation of a CRT-D device according to current ESC guidelines
* Patient newly implanted with a MicroPort CRM Platinium CRT-D SonR or Platinium CRT-D device within 2 months before the Investigational Procedure
* Patient in sinus rhythm with a preserved atrio-ventricular conduction, and PR interval=220 +/- 30 ms on surface ECG
* Patient has reviewed, signed and dated the study informed consent form

Exclusion Criteria:

* Patient with permanent or persistent atrial fibrillation or atrial flutter
* Patient presenting with a permanent or frequent paroxysmal high degree atrio-ventricular block
* Device upgrade or replacement
* Minor patient (i.e. under 18 years of age), or patient under guardianship or kept in detention
* Patient unavailable for the scheduled Investigational Procedure, not able to understand the purpose of this study or refusing to cooperate
Microbiological Evaluation of Single Versus Multiple Visits Regeneration Using MALDI-TOF Mass Spectrometry

Aim of the study is to assess canal disinfection using matrix assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) in single visit and multiple visit regeneration protocols, and to assess clinical and radiographic outcomes of single visit and multiple visit regeneration protocols.

Thirty patients with necrotic immature permanent teeth showing periapical lesions will be randomly divided in two groups: group (1) single visit regeneration and group (2) multiple visits regeneration protocol, in which calcium hydroxide will be applied for one week or more according to resolution of signs and symptoms. Dentin debris collected on a file will be taken as microbiologic sample to be cultured and examined by MALDI-TOF MS. This will be performed after the access cavity preparation and after irrigation in both groups, these samples will be labelled A and B, respectively. In group (2) there will be a third sample labeled C which will be taken after the removal of the intra canal calcium hydroxide.

Eligibility Criteria:
Inclusion Criteria:

* Immature permanent upper anterior teeth.
* Necrotic teeth confirmed by sensibility test.
* Teeth with periapical lesions confirmed by periapical radiograph using paralleling device.

Exclusion Criteria:

* Teeth with orthodontic wires or brackets.
* Patient with history of allergy to any medication.
* Patient with history of bleeding disorders.
* Patient with medical illness or taking medications.
Enzastaurin as Second and Third-Line Treatment for Non-Small Cell Lung Cancer.

Enzastaurin given daily to patients with non-small cell lung cancer who have failed at least one prior therapy.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years old
* Must have been diagnosed with advanced or metastatic non-small cell lung cancer
* Must be able to visit the doctor's office every 28 days for 6 months or longer.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Have other significant medical problems as determined by your physician
* Are unable to swallow tablets
* Have a history of significant heart disease
How Well do Patients With Traumatic Brain Injury Learn New Material Using Learning Styles in Online Science Classrooms?

The purpose of this study is to determine whether learning styles are effective in the treatment of traumatic brain injury (TBI) in an educational environment.

The purpose of this study is to determine the learning outcome and effectiveness of instructional design strategy using Canfield's learning styles and Gardner's Multiple Intelligences to accommodate TBI-induced cognitive impairments in an online science learning environment.

Eligibility Criteria:
Inclusion Criteria:

1. People who have been diagnosed with Mild Traumatic Brain Injury (TBI).
2. People who are able to understand and sign an informed consent form.
3. People who have no other known neurological disorder (e.g. aphasia, stroke).
4. All participants must be 18-50 years old.
5. Be able to speak and understand English, and
6. Have use of a computer (Mac or Windows) and internet (www) access.

Exclusion Criteria:

1. Don't meet the inclusion Criteria
2. Other known neurological disorder (e.g. aphasia, stroke).
"Becoming Parents": A Hospital-community Partnership

The proposed of this study is to determine if an intervention, known as the "Becoming Parents" programme, is more effective in improving the mental health, marital relationship and parental competence of expectant couples in a Chinese community.

Transition to parenthood is potentially a stressful life event for many new parents, which, if not properly managed, could have adverse effects on their mental health, marital satisfaction, and parent-child relationships. The proposed programme, "Becoming Parents", aims to turn the challenges of the transition into opportunities of learning and support for these parents. Building on our experience of instituting a pioneering programme to support new fathers prenatally, "Becoming Parents" has an extra component of support for new parents in the postnatal period using trained volunteers from the community networks. Through "Becoming Parents", seamless antenatal-postnatal care based on a hospital-community partnership will be provided to 125 expectant couples in a target community which is known for its high risks for postnatal depression, child abuse and intimate partner violence. In addition to addressing the health promotional needs of the target community, "Becoming Parents" will also illustrate how a community's capacity for health promotion can be maximized through the collaboration of healthcare providers and network of community partners in helping couples function more optimally during their transition to parenthood.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Expectant couples with the pregnant women attending antenatal clinic in Princess Margaret Hospital before 20 weeks of gestation.

Exclusion Criteria:

1. Expected couples who are unable to communicate in Cantonese, Putonghua or English.
2. Multiple pregnancy
Validation of Active-Insights Device to Measure Crying Time

To assess the ability of a machine learning algorithm to accurately detect fussing and crying time in infants using accelerometery data collected from a wearable device, compared to the Barr's parent-/caregiver-completed behaviour diary.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 4-12 weeks at screening.
2. Gestational age 37 weeks - 41 weeks at birth.
3. Birth weight appropriate for gestational age (AGA - weight between 10th and 90th percentile) or Large for Gestational Age (LGA - weight above the 90th percentile) determined using WHO Weight-for Age percentile guides.
4. Infant has excessive crying, defined as 3 or more hours per day, during 3 or more days in the preceding week.
5. No birth trauma and nonsyndromic.
6. Readiness and the opportunity for parents/caregivers to fill out a study diary, questionnaires and for infant to wear device.
7. Parent/caregiver with ability to understand and comply with the requirements of the study, as judged by the Investigator.
8. Parent/caregiver willing and able to give informed consent for their and their infant's participation in the study.
9. Infant is considered healthy, following physical exam.

Exclusion Criteria:

1. Infants with failure to thrive, intrauterine growth retardation, haematochezia (blood in the stools), diarrhoea (watery stools that takes the shape of a container \> 12x in breastfed and \>5 in partially breastfed infants daily), or fever (38.0 degrees).
2. Premature infants (\<35 weeks gestation at birth).
3. Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, formula-fed infants, and those with liver disease.
Investigating HD-tDCS in Improving Word Finding and Memory Retrieval in Individuals With MCI

This study is attempting to improve word finding and memory retrieval problems persons with mild cognitive impairment (MCI) may have.

This study attempts to improve word finding and memory retrieval problems in persons with mild cognitive impairment (MCI). To remember and find words, the brain has to search for the correct memory and MCI can negatively affect this search. Studies have suggested that low level electrical stimulation of the memory retrieval circuit can improve memory recall. The purpose of this study is to find the exact influence of multi-electrode or High Definition transcranial Direct Current Stimulation (HD-tDCS) by targeting a frontal and a parietal brain area, and their roles in memory retrieval/word finding in MCI. By modulating ongoing activity in 6 sessions of HD-tDCS the study investigates whether HD-tDCS may be used as a way to improve memory retrieval/word finding evaluated by cognitive measures and electroencephalography (EEG) measures before the first session and after the last session of HD-tDCS with a follow-up session 1-month after the stimulation procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 40 and 90
2. Capable of understanding and signing an informed consent
3. Experiencing severe memory problems

Exclusion Criteria:

1. Severe organic co-morbidity
2. Pace maker / defibrillator
3. Pregnancy
Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis

The purpose of the study is to determine whether topical ocular administration of LME636 60 mg/mL is efficacious in resolving the ocular inflammation in the anterior chamber (AC) associated with acute anterior uveitis (AAU).

Eligible subjects will be randomized to LME636 or Dexamethasone in a 3:1 ratio at the time they present to the trial site with the AAU flare and will enter treatment for 28 full days. Subjects with worsening disease from Visit 2/Day 4 onward or subjects without improvement after 14 days of treatment will be discontinued from treatment, unmasked and treated with a rescue regimen at the discretion of the investigator.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent.
* Diagnosis of non-infectious AAU in at least 1 eye.
* Anterior chamber cell score of 2+ or 3+ as per Standardization of Uveitis Nomenclature (SUN) in at least one eye.
* Able to communicate well with the Investigator, to understand and comply with the requirements of the study.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of child-bearing potential unwilling to use effective contraception methods as defined in the protocol.
* AC cell score of 4+ (SUN) or hypopyon.
* Onset of anterior uveitis more than 2 weeks prior to enrollment in the study.
* Presence of intermediate-, posterior-, or panuveitis in either eye.
* Administration of stable doses \>10 mg daily systemic prednisone or corticosteroids as described in the protocol.
* Recurrent corneal abrasion or ulceration in either eye (past or present).
* Tuberculosis (past or present).
* Other protocol-specified exclusion criteria may apply.
Magnetic Resonance Guided High Intensity Focused Ultrasound in Advanced Pancreatic Adenocarcinoma Treatment

The primary purpose of this protocol is to assess the ExAblate 2100 MR guided high intensity focused ultrasound device as an intervention for treatment of advanced stage pancreatic adenocarcinoma.

Primary Objective: The primary endpoints for this study will be 1) feasibility of ablation and 2) safety of ablation.

Secondary Objective: 1.)Pain reduction after ablation. 2.) Evidence of inflammation at ablation site based on histology, or in blood after ablation

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age
* Patients willing to sign a written informed consent document
* Patients with unresectable, locally advanced or metastatic pancreatic adenocarcinoma
* Patients with upper abdominal pain rating at least 4 out of 10 in severity on BPI
* Tumor must be visualized on CT or MRI, obtained within 30 days of enrollment
* Tumor must be accessible to the ExAblate MRgFUS device
* Life expectancy ≥ 3 months, as determined by oncologist and documented in chart
* ECOG performance status of 0, 1, or 2
* INR \< 1.6, platelet count \> 50,000 microL
* Serum urate, calcium, potassium, phosphate, creatinine \< 1.5x upper limit of normal
* Patients can receive general anesthesia, as determined by anesthesiologist

Exclusion Criteria:

* Previous pancreatic surgery
* Patients with contraindication for MR imaging such as implanted metallic devices that are not MRI-safe, size limitations, claustrophobia, etc.
* Patients with known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease (GFR \<30 mL/min/1.73 m2) or on dialysis
* Pregnant and nursing patients will be excluded from the study because of a contraindication to administering MRI contrast agents to these patients
* Patients unable to receive general anesthesia
* Target is:

  1. NOT visible by non-contrast MRI, OR
  2. NOT accessible to ExAblate device
* Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 6 hrs of total table time)
* Patients with acute medical condition (e.g. pneumonia, sepsis) that is expected to hinder them from completing this study
* Patients with unstable cardiac status including:

  1. Unstable angina pectoris on medication
  2. Patients with documented myocardial infarction within six months of protocol entry
  3. Congestive heart failure requiring medication (other than diuretic)
  4. Patients on anti-arrhythmic drugs
  5. Patients with severe hypertension (diastolic BP \> 100 on medication)
  6. Patients with severe hematologic, neurologic, or other uncontrolled disease (e.g. platelets \< 50,000/microL, INR \> 1.5)
* Patients who are taking anti-thrombotic medication
* Severe cerebrovascular disease (multiple CVAs or CVA within 6 months)
Small-fiber Neuropathy in Chronic Kidney Disease

Neurological dysfunction is a common complication of late stage chronic kidney disease (CKD) and peripheral nerve system is often involved in such complication. Sensory disturbances such as paresthesia and hypoesthesia are the predominant symptoms in uremic polyneuropathy and it is traditionally thought the uremic polyneuropathy mainly involve large-diameter sensory nerves. However in uremic patients the abnormal thermal thresholds, the sensory symptoms like numbness, burning, paradoxical heat, cold or freezing, and pain, and the frequent symptoms of autonomic dysfunction suggest that small-fiber neuropathy should be a clinical entity in patients of CKD. But there are still few investigations with emphasis on the changes of small-fiber nerves in CKD, and little is known about the characteristics and mechanism of small-fiber neuropathy in CKD. Skin biopsy with evaluation of epidermal nerve density and the morphology of epidermal nerves and the subepidermal nerve plexus is an effective and minimally invasive test for assessment of small-fiber neuropathy. Contact heat evoked potential (CHEP) recording the brain responses evoked by contact heat stimuli on the skin is a non-invasive technique to investigate the thermo-nociceptive pathways mediated by small-fiber nerves. In the current study, we will use an integrated approach by combining the skin biopsy, quantitative sensory testing, autonomic function tests, and CHEP to investigate the pathological, psychophysical and physiological aspects of small-fiber neuropathy in patients of CKD. The aims of the current study is to address the following issues: (1) the changes of small fiber nerves in uremia and CKD of different stage; (2) the correlation of skin innervation with clinical manifestations, thermal thresholds, and autonomic function; (3) the influence of dialysis therapy, the type of dialysis therapy, or renal transplantation on the small fiber neuropathy in uremia; (4) the roles of blood chemical substances, metals, and endocrine profiles on the development of small-fiber neuropathy; (5) the relationship between the small-fiber neuropathy and pruritus or restless leg syndrome; and (6) the pathological and physiological correlates of painful symptoms by skin biopsy and CHEP in CKD related neuropathy. The results of the study will provide important insights in the understanding of the pathogenesis, and the prevention and new treatments of small-fiber neuropathy in CKD.


Eligibility Criteria:
Inclusion Criteria:

* The patients should fulfill the criteria of CKD according to renal function study and the patients of end-stage renal disease should receive regular dialysis therapy and follow-up at outpatient clinics.
* For disease comparison, patients with peripheral neuropathy of variable etiologies will also be recruited.

Exclusion Criteria:

* Poor control DM,
* Severe heart failure,
* Bleeding tendency,
* Severe lung disease with respiratory distress,
* Severe infection,
* Alcoholism,
* Amyloidosis,
* Poor wound healing history.
Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis

There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Cefiderocol is a newly approved broad spectrum intravenous siderophore cephalosporin antibiotic, which has potent in vitro activity against multidrug resistant Pseudomonas aeruginosa, Burkholderia cepacia complex, Achromobacter species, and Stenotrophomonas maltophilia, all pathogens implicated in CF pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of cefiderocol in 12 adult CF patients admitted for a pulmonary exacerbation at one of 4 participating hospitals in the US. Patients will remain on standard of care IV antibiotics and receive 4-6 doses of cefiderocol 2 grams infused over 3 hours every 6-8 hours, depending on kidney function. Blood will be sampled after the final dose to determine concentrations and pharmacokinetics of cefiderocol. Safety and tolerability will be assessed throughout the 2 day study.

Participants will receive 4-6 doses of cefiderocol 2 grams every 6-8 hours, in addition to standard intravenous antibiotic therapy selected by the site. Just prior and then after the final dose, a total of nine blood samples will be collected to measure cefiderocol concentrations. Data will be fit to a population pharmacokinetic model. The final model will be utilized in a Monte Carlo simulation to determine the probability of several different dosing regimens retaining concentrations above the minimum inhibitory concentration (MIC) for at least 75% of the dosing interval. These data will be utilized to determine an optimized dosing regimen for adults with CF.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of CF
* Acute pulmonary exacerbation as the primary reason for admission to the hospital with requirement to receive systemic antibiotic treatment

Exclusion Criteria:

* Females that are pregnant and/or breastfeeding
* History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic (a history of mild rash to a cephalosporin followed by uneventful re-exposure is not a contraindication)
* History of a lung transplant at any time in the past or any other organ transplantation (e.g., liver) within the last 6 months
* Moderate to severe renal dysfunction defined as a creatinine clearance \< 60 mL/min (as calculated by the Cockcroft-Gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis
* A hemoglobin less than 8 gm/dL at baseline
* Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)

Prospective, multicenter registry in patients undergoing commercially available balloon expandable valve implantation. The registry will consist of 3 phases:

Prospective determination of baseline Status Quo (3 months):

Documentation of treatment pathways and endpoints of "routine" patients without educational program

Dedicated reflection and training (1 day):

One training session after the observational period to reflect on treatment pathways, exchange between valve coordinators involved, and develop improvements.

Implementation of tailored changes (2 months):

Implementation of the changes developed in the training.

Determination of the effect (3 months):

Coordinator measures optimization changes and determines effects.

Along the severe aortic stenosis (sAS) treatment pathway there are delays that may impact quality management and hospital efficiency. A dedicated valve coordinator, interfering with all stages of patient handling throughout the hospital may increase the efficiency of the sAS patient flow, accelerate decision making and clinical outcomes while at the same time decreasing resource consumption.

The hypothesis is that the implementation of a dedicated valve coordinator will improve the patient flow of sAS patients scheduled to undergo TAVI, their outcome, patient and physician satisfaction and will optimize costs.

In total, three centers across Germany (Munich, Düsseldorf, Bad Bevensen) will participate.

Eligibility Criteria:
Inclusion Criteria:

* elective patients with a diagnosis of severe symptomatic aortic stenosis and admitted for TAVI

Exclusion Criteria:

* patients not providing written informed consent