cyrilzakka/clinical-trials huggingface dataset:
Ultra-low-dose Whole-body CT Using AI-based CT Reconstruction in Patients With Multiple Myeloma

This prospective study aims to perform intra-individual comparison of the image quality between ultra-low-dose whole-body CT with deep learning reconstruction and conventional low-dose whole-body CT with iterative reconstruction in patients with suspected multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* patients with suspected multiple myeloma and scheduled for noncontrast-enhanced low-dose whole-body CT
* patients who have no previous history of chemotherapy for multiple myeloma

Exclusion Criteria:

* patients who do not agree to the protocol
* non-Korean patients
* pregnancy
Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility

Several data emphasize the relation between tachycardia (\>90/min) and high mortality during septic shock. The investigators previously demonstrated the high mortality associated with hypercontractility, tachycardia and the presence of a left ventricular obstruction. A severe hypovolemia, a hyper adrenergic stimulation or a severe vasoplegia can all explain this relation between tachycardia, hypercontractility and the mortality during septic shock.

Landiolol is another short-term acting beta-blocker with a half-life of 4 minutes without any beta 2 activity or membrane stabilizing effect. The landiolol has been used in critically ill patients to control supraventricular tachycardia but not in this context of tachycardia and septic shock. The investigators hypothesize that landiolol by reducing the heart rate may improve the survival of patients treated for a septic shock and presenting with an hypercontractility state.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Patient admitted for a septic shock (according to the SEPSIS3 definition: sepsis with persisting hypotension (MAP\<65mmHg or SAP \<90mmHg) requiring vasopressors to maintain MAP\>65mmHg and having a serum lactate level \>2 mmol/L
* Patient who received at least 30ml/kg of fluid and absence of fluid responsiveness
* Left ventricular ejection fraction \>65% (visual or Simpson method using echocardiography)
* Tachycardia \>100 bpm in sinus rhythm with a MAP 65mmHg for more than 1 hour
* Patient receiving invasive mechanical ventilation
* Patients adapted to the ventilator under sedation and analgesia
* Written informed consent
* Patient covered by French national health insurance

Exclusion Criteria:

* Patients with inclusion criteria already present for more than 36 hours
* Patient treated with Dobutamine, adrenaline or isoprenaline
* Patient currently treated with beta blockers (previous home betablocker treatment is not an exclusion criteria)
* Supra ventricular (atrial fibrillation or flutter) or ventricular arrhythmias
* Patients with any form of cardiac pacing
* Sick sinus syndrome
* Severe atrioventricular (AV) nodal conductance disorders (without pacemaker): 2nd or 3rd degree AV block
* Known pulmonary hypertension
* ScVO2 \<70%
* Moribund
* Cardiac arrest
* Non-treated phaeochromocytoma
* Acute asthmatic attack
* Pregnant or breastfeeding woman
* Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision),
* Age \<18 years
* Hypersensitivity to the active substance or to any of the excipients
* Severe bradycardia (less than 50 beats per minute)
* Cardiogenic shock
* Severe hypotension
* Decompensated heart failure when considered not related to the arrhythmia
* Severe, uncorrectable metabolic acidosis
* Presence of significant bleeding, or
* Acute respiratory distress defined by increased oxygen dependency, polypnea \> 30 /min, signs of struggle (pulling, thoraco-abdominal sway) if the patient is not intubated and ventilated.
DBS TaT in Peer-assisted Telemedicine for Hepatitis C

The purpose of this study is to compare the rate of treatment initiation achieved by peer-assisted telemedicine contingent on phlebotomy (usual care) versus that achieved with a new protocol, called Dried Blood Spot Test and Treat (DBS TaT). DBS TaT includes DBS testing to diagnose hepatitis C (HCV), utilizes a novel clinical decision aid that identifies patients who are low risk for hepatic (liver) fibrosis, and directs those patients to HCV treatment initiation prior to routine hepatic fibrosis assessment.

The investigators hypothesize that DBS TaT will increase the rate of HCV treatment initiation compared to peer-assisted telemedicine contingent on phlebotomy (usual care).

Oregon has the fourth highest prevalence of hepatitis C (HCV) and third highest HCV-related mortality in the nation and it predominantly effects people who use drugs (PWUD). To respond to this, Peer Assisted Telemedicine for Hepatitis C (PATHS), a Substance Abuse and Mental Health Services Administration supported telemedicine-based HCV treatment program that serve PWUD in predominantly rural areas of Oregon was created. PATHS partners with "peers," people with lived experience of substance use, who work for community-based organizations serving PWUD in high-needs rural counties. Patients are referred to PATHS from opiate treatment programs and community-based organizations throughout the state, which are PATHS' "sites."

The leading barrier to HCV treatment initiation within PATHS is the requirement for participants to complete phlebotomy prior to treatment. To address this problem, PATHS is piloting the use of commercially available, laboratory-validated dried blood spot (DBS) tests to confirm active HCV, but patients who complete DBS must still undergo either phlebotomy or transient elastography (TEG) to complete guideline-recommended hepatic fibrosis staging before HCV treatment. Transient elastography is a validated, non-invasive, clinical standard of hepatic fibrosis assessment covered by Oregon Medicaid, but it is inconvenient to access in rural areas.

This study aims to determine the impact of Dried Blood Spot Test and Treat (DBS TaT) compared to phlebotomy-contingent treatment (usual care) in a cluster randomized controlled trial performed within Peer Assisted Telemedicine for Hepatitis C (PATHS). The primary outcome is the rate of treatment initiation in PATHS sites utilizing DBS TaT versus PATHS sites utilizing usual care. 18 PATHS sites are randomized to DBS TaT implementation or ongoing usual care. Within DBS TaT, participants with low risk for hepatic fibrosis will be offered HCV treatment without phlebotomy but will still undergo imaging-based hepatic fibrosis assessment to ensure safety.

Eligibility Criteria:
Inclusion Criteria:

* Active hepatitis C infection
* Willing to engaged with the PATHS program for clinical care

Exclusion Criteria:

• Currently pregnant
Cortical Plasticity After Motor Cortex Stimulation in Healthy Subject and Chronic Pain Patients

The primary aim of this study is to evaluate the induction of sensory-motor cortex plasticity after motor cortex stimulation in healthy subjects, using laser-evoked nociceptive cortical potentials, and in chronic neuropathic pain patients using functional MRI. As a secondary goal, the project will analyse possible correlations between the magnitude of cortical plasticity and that of the pain-relieving effect.

In healthy subjects, cortical plasticity is evaluated by the comparison of somatosensory cortical maps before and after two isolated sessions of 20 Hz and theta-burst rTMS, in a cross-over randomized study.

Two sessions of 5 consecutive days of rTMS are proposed to the patients with a minimum of 4 weeks between the two sessions, defined by 20 Hz and theta-burst stimulation in a cross-over randomized order. Cortical plasticity of the motor cortex is evaluated via functional MRI (motor activation) performed before the first rTMS session and the last day of each session of rTMS.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects aged from 18 to 70 years, male or female, with social protection, fully informed and having given their written consent.
* patients :

  * aged from 18 to 80 years, male or female, with social protection , fully informed and having given their written consent.
  * unilateral pharmacoresistant neuropathic pain during at least one year,
  * without any change of the pharmacological treatment since at least one month

Exclusion Criteria:

* for healthy subjects only:
* history of chronic pain
* analgesic medication within 24h before stimulation

For patients only: new analgesic treatment within 1 month before consent

for both:

* drug addiction, headache, epilepsy history
* ferromagnetic intracranial device
* implanted stimulator
* absence of contraceptive method for women of childbearing age
Integral Management of Healthcare Problems Related With Drugs in Polimedicated Patients: Medication Code

Background:

Although Drug- related Problems (DRPs) in polimedicated patients are a major public health problem in western countries and many of them have been considered avoidable, secondary and primary prevention policies have not been systematized, beyond pharmaceutical care programs in certain settings and on specific patients.

Objectives:

The main objective of this study is to evaluate the impact of implementing the Medication Code (CM) on patients who consult the emergency department for a DRP (secondary prevention of DRP). It is also intended to draw conclusions, based on the knowledge obtained in terms of DRP that will allow the establishment of future actions to reduce its prevalence (primary prevention actions).

Method:

A single-centre clinical trial is proposed in which adult patients will be selected to consult the Hospital Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCSP) for a primary or secondary diagnosis of DRP and will be randomised with a 1:1 distribution to be included in the medication code (intervention group) or to receive usual care (control group). The intervention will be evaluated in terms of health outcomes (ED consultations and hospital readmission).

A single-centre clinical trial is proposed in which adult patients will be selected to consult the Hospital Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCSP) for a primary or secondary diagnosis of DRP and will be randomised with a 1:1 distribution to be included in the medication code (intervention group) or to receive usual care (control group). The intervention will be evaluated in terms of health outcomes (ED consultations and hospital readmission).

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Drug Related Problems (DRP) related to drugs from Anatomical Therapeutic Chemical (ATC) groups A, B and C

Exclusion Criteria:

* DRP due to autolytic attempt or final phase of life.
* Denied informed consent
Telehealth Follow-up in Patients With Rheumatoid Arthritis

The main objective of the present project is to test the effect of a customized Patient-Reported-Outcome (PRO)-based telehealth follow-up compared to a conventional pre-scheduled outpatient follow-up to monitor disease activity and expenses associated with the follow-up in patients with RA

Rheumatoid arthritis (RA) is a chronic inflammatory joint disease with a high burden both for the patient and society. Outcomes for the individuals living with RA have been improved and the majority of RA patients are now in remission or low disease activity status. RA patients continue to be followed up by pre-scheduled visits, which may compromise accessibility for the sickest and thus, quality of care. The introduction of patient-initiated follow-up leads to a reduction in the use of outpatient clinic services without compromising outcomes. Self-monitoring and remote patient monitoring are facilitated by electronic innovative health tools. Among RA patients with low disease activity or remission, a Patient-Reported Outcome-based telehealth follow-up for tight control of disease activity in RA can achieve similar disease control as conventional outpatient follow-up and is likely to reduce the costs. Thus, the main objective of the present project is to test the effect of a customized PRO-based telehealth follow-up compared to a conventional prescheduled outpatient follow-up to monitor disease activity and expenses associated with the follow-up in Norwegian RA patients.

Eligibility Criteria:
Inclusion Criteria:

1. \>18 years
2. Fulfilling the European League against Rheumatism (EULAR) / American College of Rheumatology (ACR) 2010 classification criteria for RA
3. Being in remission (RAPID 3 score \<=3)
4. Able to use the electronic app
5. Able to give informed consent

Exclusion Criteria:

1. \<18 years
2. Severe cognitive failure
Tube Feeding Tolerance After Switch to Peptide Based Formula in Children With Developmental Delay

A retrospective chart review to assess feeding tolerance in children who had been switched from an intact protein formula to a Peptide based formula due to feeding intolerance in a pediatric facility for the developmentally delayed.

Medical records of pediatric patients with enteral feeding intolerance on standard polymeric formulas that were switched to a peptide based formula will be retrospectively analyzed. Data will be collected on caloric intake, ability to meet enteral nutrition goals, incidence of intolerance, and the use of medications to control gastrointestinal symptoms.

Eligibility Criteria:
Inclusion Criteria:

* 13 months to \< 18 years of age on admission to facility
* Required enteral nutrition to meet 90% or more of their energy needs prior to switch to a Peptide based formula
* Received enteral nutrition with an intact protein formula for a minimum of two weeks prior to a switch to a Peptide based formula
* Have documentation of intolerance to an intact protein formula, followed by a switch in formula received to a Peptide based formula
* Have documentation of an assessment of feeding tolerance following the switch to a Peptide based formula
* Formulas received must be indicated for use in children or adults (not infant formulas).

Exclusion Criteria:

* Recent abdominal surgery, change in tube position/placement (within past 30 days)
* Cow's milk protein allergy
* Any current infections including upper respiratory, viral, gastroenteritis, wound infection.
Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops in Parkinson's Disease

Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is abnormally synchronised and rhythmic. The oscillatory activity prevails at 8-30 Hz in untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels inversely correlates with motor impairment. Moreover, these different levels in BG-cortical loops are coherent in this frequency band. The 8-30 Hz activity is suppressed by treatment following treatment with dopaminergic drugs and is partially suppressed prior to and during voluntary movements. An unanswered question is how do BG-cortical loops become so prominently engaged in this oscillatory activity? One possible explanation is that the resonance frequencies of the loops fall in the 8-30 Hz band in the untreated state, so that oscillations in this band are transmitted particularly well. This hypothesis was confirmed in a previous series of experiments.The aim is to determine whether the resonance frequency within BG-cortical loops is correlated to the BG-cortical coherence frequency (with 20 subjets during 24 months).

Methods: Record STN-cortex LFP coherence pattern and then stimulate STN (at 0, 5, 10, 15, 20, 25, 30 Hz) in newly implanted patients at rest and during simple and complex motor tasks while recording the steady state evoked potential over the cortex using EEG. The resonance frequency will be calculated as previously (Eusebio et al, Brain 2009). Experiments will be carried out both in the OFF medication and ON medication condition.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease idiopathique evolving for more than 5 years
* Dopa-Sensibility superior to 50 %
* Electrodes of stimulation implanted in 2 NST at Timone (Pr PERAGUT)

Exclusion Criteria:

* Bad tolerance of the condition OFF Dopa and\\or OFF stimulation
Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe

This Phase 1, single-center study will be conducted in an open-label, randomized, parallel design. Healthy male and female participants aged 18 to 65 years will receive a single dose of itepekimab subcutaneous (SC) administered by either a prefilled syringe (PFS) or an autoinjector (AI). Itepekimab will be administered by a trained healthcare professional (HCP).

Female and male participants will have a body weight between 50.0 and 100.0 kg and body mass index (BMI) \>18.5 and ≤30 kg/m2.

Participants who satisfy the inclusion criteria will be randomized to one of the 2 study intervention groups:

* Itepekimab administered via AI (test)
* Itepekimab administered via PFS (reference) The randomization will be stratified by weight category (\<70 kg, ≥70 to \<80 kg and ≥80 kg) and injection site (abdomen, thigh, and arm).

Study duration for each participant is up to approximately 162 days, including:

* Screening period: up to 21 days
* Institutionalization: 2 days including 1 treatment day (Day 1)
* Follow-up period: 140 days (±5 days)
* End of study (EOS): Day 141 (± 5 days)


Eligibility Criteria:
Inclusion Criteria:

• Having given written informed consent prior to undertaking any study-related procedure.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

• Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Outcomes of Neonatal Acute Kidney Injury In Premature Infants

The objective of this protocol is to investigate the impact of prematurity, with or without associated acute kidney injury (AKI), on the future risk of chronic kidney disease (CKD) by establishing a patient registry and biorepository. Serum and urine samples will be collected serially from premature infants admitted to the neonatal intensive care unit (NICU) at Albert Einstein College of Medicine/Weiler Hospital and subsequently followed in the NICU follow-up and pediatric nephrology ambulatory subspecialty clinics. The biorepository will be linked to a comprehensive clinical database.

This is an observational pilot study to enhance understanding of the pathophysiology and epidemiology associated with effects of AKI in premature infants and the role that neonatal AKI plays in future development of CKD. In eligible preterm infants, blood and urine samples will be collected at pre-specified time points during hospitalization and at outpatient follow-up appointments at 6 months, 1 year, 2 years, and 5 years of age and stored in the biorepository. Blood pressure will be measured and recorded at NICU discharge and at all follow-up visits. A renal ultrasound will be performed to monitor renal growth at 2 and 5 years of age. All data will be entered into a comprehensive clinical database, including laboratory results.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants less than 32 weeks/ gestational age admitted to the Neonatal Intensive Care Unit at Weiler Hospital (The Children's Hospital at Montefiore).

Exclusion Criteria:

* Known major congenital anomalies of the kidney and urinary tract (CAKUT) including solitary kidney, cystic dysplasia, multicystic dysplastic kidney, renal hypoplasia, obstructive uropathy
* Other genetic syndromes or medical conditions that preclude enrollment per judgment of the attending neonatologist
Ethanol Induces Skeletal Muscle Autophagy

In this study we plan to demonstrate that ethanol induces skeletal muscle autophagy to degrade MAA adducts.

Hypothesis: Ethanol mediated modification of skeletal muscle proteins to form MAA adducts that in turn induce skeletal muscle autophagy.

Patients with alcoholic steatosis, hepatitis and cirrhosis (n=10 each) will be recruited from the liver transplant nutrition clinic or the hepatology inpatient service and their body composition quantified using anthropometry, bioelectrical impedance analysis, CT image analysis and DEXA if available.

Control Subjects. Controls will be recruited by advertisement. All control subjects will have a normal clinical history, physical examination, and screening chemistries. They will not have any significant medical conditions requiring the use of medications. Their nutritional status within 20% of normal as defined by ideal body weight.

Eligibility Criteria:
Inclusion Criteria:

Alcoholic liver disease:

* clinical, biochemical, imaging criteria and liver biopsy where available
* Age 18 - 65 years old

Controls:

* Serum liver transaminases (i.e. ALT and AST) 40 IU/L
* Normal liver ultrasound
* Age 18 - 65 years old

Exclusion Criteria:

For both groups - alcoholic liver disease and controls:

* Poorly controlled diabetes mellitus (HbA1C\>9.5 g/dl)
* Untreated Hyper- / hypo- thyroidism
* Patients on dialysis, renal disease with serum creatinine 1.5 mg/dL
* Active intravenous drug use
* History of bowel surgery or gastric bypass surgery
* Medications known to alter muscle protein metabolism (i.e. corticosteroids, tamoxifen, high-dose estrogen, testosterone or anabolic steroids)
* Metastatic disease, Advanced cardiac or pulmonary disease
* Pregnancy
* Coagulopathy- INR \>1.4 and platelet count \<80,000/ml.
Reducing Nephrotoxicity of Vancomycin: A Prospective Study of Continuous Versus Intermittent Infusion of Vancomycin

This study is being carried out to find out whether there is reduction in vancomycin-induced kidney injury (nephrotoxicity) when vancomycin is given as intermittent versus continuous infusion.

This study will recruit 220 subjects from 2 hospitals over a period of 3 years.

Participants are invited if they have an infection that requires prolonged vancomycin therapy (\> more than 10 days).


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 21-80 years
* Documented infection requiring prolonged (\> 10 days) of vancomycin therapy
* Creatinine clearance \> 50 ml/min (using Cockroft-Gault equation)

Exclusion Criteria:

* Patient already received 7 days or more of vancomycin therapy
* Pregnancy
* Severe burns \> 40% body surface area
* Spinal cord injuries
* Participation in another interventional trial in previous 30 days
* Inability to obtain informed consent
Digital Analysis of Primary Teeth Crown Dimensions and Clinical Evaluation in a Sample of Egyptian Children

The aim of this study will be conducted to:

1. Digitally determine crown dimensions of primary teeth in a sample of Egyptian children.
2. Clinical evaluation of prefabricated zirconia crowns according to the Egyptian sizes compared with the international standard zirconia crowns sizes for primary upper central incisors

Currently, there is limited availability of primary tooth crown measurement for Egyptian children. SO, this study aims to digitally determine tooth crown dimensions of primary teeth in a group of Egyptian children and compare prefabricated zirconia crowns according to the Egyptian crown sizes with the international standard zirconia crowns sizes for primary upper central incisors.

Eligibility Criteria:
Inclusion Criteria:

* Children having normal fully erupted primary teeth and with no morphological variations.
* Children with no history of orthodontic or prosthodontic treatment.
* Children with normal overjet and overbite.
* Sound interproximal \& buccal / lingual walls with or without minimal occlusal pits \& fissure incipient caries.
* No previous interproximal \& buccal / lingual restorations.
* Intact mesial and distal marginal ridge.

Exclusion Criteria:

* Children with gross carious lesions.
* Children with hypo-mineralization, hypoplasia and fracture primary teeth.
* Children with medical disabilities