louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06304727: Evaluation of Short Enteral Nutrition in the Emergency Room for Bronchiolitis With Main Nutritional Impairment
Official title: Evaluation of Short Enteral Nutrition and Monitoring in the Emergency Room for Infants Under 1 Year of Age With Bronchiolitis With Main Nutritional Impairment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchiolitis
Keywords: infant
bronchiolitis
enteral feeding
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion of all infants under one year old presenting a bronchiolitis with exclusive nutritional impairment and treated in the emergency room of the Hôpital Femme Mère Enfant according to the Protocole de prise en charge de la bronchiolite avec forme digestive prédominante à l'accueil des urgences de l'HFME (Protocol for the management of bronchiolitis with a predominantly digestive form at the HFME emergency department)- ZSBCD. This population will constitute a restrospective cohort in a pediatric tertiary care hospital during the 2022-2023 bronchiolitis season.

Brief summary: The winter epidemic of bronchiolitis in infants poses insurmountable difficulties for the hospital system for the 2022-2023 season globally. These difficulties are linked to the combination of an unusual epidemic intensity and the loss of medical and paramedical caregivers in the hospital leading to the closure of beds since the Covid-19 pandemic. Bronchiolitis in youngest and most vulnerable infants can lead to severe clinical pictures requiring hospitalization. Among them, some infants present exclusively with inability to eat and only require continuous enteral nutrition during their hospitalization.

A service protocol has been put in place in the pediatric emergency room of the Hôpital Femme Mère Enfant for the 2022-2023 season to carry out short enteral nutrition and monitoring before returning home. This outpatient care would aim to reduce the effect of hospital saturation during the winter epidemic of bronchiolitis, increase the comfort and satisfaction of families by allowing less disruption of family life and prevent nosocomial infections.

A retrospective evaluation of the feasibility and effectiveness of this protocol is necessary to rely on this first experience of outpatient management.


Eligibility criteria: Inclusion Criteria:

* Children being treated according to our Short-Term Enteral Nutrition Protocol

Exclusion Criteria:

* Parents refusal

Primary outcomes:
measure: Feasibility of the short enteral feeding protocol
timeFrame: From day1 of protocol inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Femme Mere Enfant
Study officials:
References:
Clinical trial NCT05754827: RDW to Platlet Count Ratio in CKD Patients
Official title: Red Blood Cell Distribution Width to Platelet Count Ratio as a Predictor of Cardiovascular Complications in CKD Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Complication
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CKD Patients and patients receive dialysis admitted to Sohag University hospital at period of admission 18 years or older.

Brief summary: The aim of the study is to determine Red blood cell distribution width to platelet count ratio as a predictor of cardiovascular complications in CKD patients

Detailed description: comparative study between RDW to Platlet count ratio in CKD patients without cardiovascular complications and CKD patients with cardiovascular complications

Eligibility criteria: * Inclusion Criteria:

  * CKD Patients and patients receive dialysis \>18 years old
* Exclusion Criteria:

  * Serious complications of any other organs
  * patients who had previously undergone kidney transplantation .
  * CKD patients with history of previous CVD
  * patients with an infection, blood transfusion or receiving immunosuppressive drugs, as this may have affected the inflammatory response within the 3 months
  * patients who were pregnant
  * patients with chronic hematological disease
  * patient\<18 years

Primary outcomes:
measure: Comparison of results of RDW to platlet ratio in CKD patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Jankowski J, Floege J, Fliser D, Bohm M, Marx N. Cardiovascular Disease in Chronic Kidney Disease: Pathophysiological Insights and Therapeutic Options. Circulation. 2021 Mar 16;143(11):1157-1172. doi: 10.1161/CIRCULATIONAHA.120.050686. Epub 2021 Mar 15.
Clinical trial NCT02454127: Effectiveness of Four Popular Diet Strategies for Weight Loss and Cardiac Risk Reduction
Official title: Effectiveness of Four Dietary Treatment Strategies for Metabolic Syndrome: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Disease
Metabolic Syndrome
Keywords: nutrition
popular diets
weight loss
lifestyle
counseling
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A single-center randomized trial at an academic medical center in Boston, Mass, of overweight or obese adults with known hypertension, dyslipidemia, or fasting hyperglycemia. Participants were enrolled starting July 18, 2000, and randomized to 4 popular diet groups until January 24, 2002.

Detailed description: Objective: To assess adherence rates and the effectiveness of 4 popular diets (Atkins, Zone, Weight Watchers, and Ornish) for weight loss and cardiac risk factor reduction.

Design, Setting, and Participants: A single-center randomized trial at an academic medical center in Boston, Mass, of overweight or obese adults with known hypertension, dyslipidemia, or fasting hyperglycemia. Participants were enrolled starting July 18, 2000, and randomized to 4 popular diet groups until January 24, 2002.

Intervention: A total of 160 participants were randomly assigned to either Atkins (carbohydrate restriction, n=40), Zone (macronutrient balance, n=40), Weight Watchers (calorie restriction, n=40), or Ornish (fat restriction, n=40) diet groups. After 2 months of maximum effort, participants selected their own levels of dietary adherence.

Main Outcome Measures: One-year changes in baseline weight and cardiac risk factors, and self-selected dietary adherence rates per self-report. Outcome measures included body weight, total cholesterol, LDL-C, HDL-C, triglycerides, hsCRP, insulin, glucose.

Eligibility criteria: Inclusion Criteria:

* BMI 27-42;
* At least one metabolic cardiac risk factor

Exclusion Criteria:

* Age under 18 years;
* Insulin therapy;
* Unstable chronic illness;
* Unwilling to follow dietary advice

Primary outcomes:
measure: Weight Loss
timeFrame: 1 year
Secondary outcomes:
measure: Total Cholesterol
timeFrame: 1 year
measure: LDL Cholesterol
timeFrame: 1 year
measure: HDL Cholesterol
timeFrame: 1 year
measure: Triglycerides
timeFrame: 1 year
measure: Glucose
timeFrame: 1 year
measure: Insulin
timeFrame: 1 year
measure: C-reactive Protein
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Tufts Medical Center
name: Michael L Dansinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dansinger ML, Gleason JA, Griffith JL, Selker HP, Schaefer EJ. Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: a randomized trial. JAMA. 2005 Jan 5;293(1):43-53. doi: 10.1001/jama.293.1.43.
Clinical trial NCT06421727: Rehabilitation Of Balance Function In Patients With Persistent Postural Perceptual Dizziness.
Official title: Rehabilitation Of Balance Function In Patients With Persistent Postural Perceptual Dizziness: A Longitudinal Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Persistent Postural Perceptual Dizziness
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: combined vestibular rehabilitation incorporating optokinetic stimulation and virtual reality exercises on persistent postural perceptual dizziness patients.
Primary purpose: TREATMENT

Brief summary: Rehabilitation Of Balance Function In Patients With Persistent Postural Perceptual Dizziness: A longitudinal Study

Detailed description: this study will be conducted to show the long term effect of combined vestibular rehabilitation incorporating optokinetic stimulation and virtual reality exercises on persistent postural perceptual dizziness patients.

Aim:1.Evaluate the balance control function in patients with persistent postural perceptual dizziness using computerized dynamic posturography.

2.To study effect of rehabilitation using optokinetic stimulation and virtual reality on persistent postural perceptual dizziness patients.

3.To follow up patients after the vestibular rehabilitation therapy to study the persistence of improvement" if any" in patients with persistent postural perceptual dizziness .

Type of the study : prospective cohort and longitudinal study. Sources of data : Audio-vestibular medicine unit , Sohag University Hospital. Study group : consists of 36 patients age ranged from 18-65 years suffering from symptoms of persistent postural perceptual vertigo.

All subjects will be submitted to:

A- Detailed medical history, full history of dizziness. B-Acoustic impedance test. C-Basic audiological evaluation. D- Vestibular assessment.

Eligibility criteria: Inclusion Criteria:

* Age: from 18 years to 65 years old.
* Gender: males and females.
* Can withstand and willing to undergo repeated vestibular rehabilitation therapy .\*No history of any disease required to give treatment that could affect results.

Exclusion Criteria:

* Neurological disorders, paresis, paralysis, motor disorder, ataxia, brain mass, multiple sclerosis and stroke with grade 4 muscle power or below.
* Otological disorders e.g. middle ear pathology (chronic suppurative otitis media, Tumor).
* Psychiatric disorders e.g. Schizophrenia and endogenous depression.
* Severely ill patients who would not tolerate vestibular rehabilitation therapy .

Primary outcomes:
measure: Rehabilitation Of Balance Function In Patients With Persistent Postural Perceptual Dizziness : A longitudinal Study
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sohag University
name: Maha Ahmed
role: STUDY_CHAIR
References:
Clinical trial NCT05462327: Low Fresh Gas Flow in Prone Position
Official title: Low Fresh Gas Flow and Normal Gas Flow Anesthesia in Patients Undergoing Surgery in Prone Position: Impact on Hemodynamics and Regional Cerebral Oxygenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Hemodynamics
Low Flow Anesthesia
Near Infrared Spectroscopy
Prone Positioning
Regional Cerebral Oxygenation
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Low flow anesthesia in the prone position was safe in terms of systemic hemodynamics and did not reduce cerebral oxygenation compared to normal flow.

Detailed description: Patients were randomly allocated to either low fresh gas flow(LF, 0,5 L/min during maintenance) or normal flow (NF, 2 L/min)) general anesthesia. In both groups, participants were first administered with 100% oxygen at a 4 L/min flow rate. Propofol 2-2,5 mg/kg, rocuronium bromide 0,6 mg/kg, and fentanyl 1 mcg/kg IV were used for anesthesia induction.In the operating room, pulse rate, mean arterial pressure (MAP), peripheral hemoglobin oxygen saturation (spO2), and right and left side regional cerebral oxygen saturation (Masimo's O3 regional oximetry device) were measured before premedication and anesthesia induction, at 10 minutes after endotracheal intubation, at 10 minutes after prone positioning, at 1st, 2nd, 3rd, 4th and 5th hours of operation, before repositioning to supine, after the resumption of supine position and at 5 minutes after extubation. In conclusion, low flow anesthesia in patients undergoing surgery in the prone position did not cause a reduction in cerebral oxygenation compared to normal flow.

Eligibility criteria: Inclusion Criteria:

* undergoing surgery in the prone position
* having an American Society of Anesthesiologists (ASA) physical status I to III
* willingness to participate in the study

Exclusion Criteria:

* having a Glasgow coma scale (GSC) score ≤ 12
* previous history of cranial surgery
* advanced cardiovascular and/or pulmonary disease
* mental retardation
* neurological disease

Primary outcomes:
measure: Low and Normal Fresh Gas Flow Difference in Prone Position
timeFrame: Systemic and cerebral oxygenation values were measured 10 minutes after induction to general anesthesia and followed up to 10 minutes were left to completion of the surgery for about 5 hours, which may vary according to the duration of the surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Tascioglu City Hospital
state: Sisli
Study officials:
References:
Clinical trial NCT06443827: Effect of Intravenous Amantadine Sulphate on Disorders of Consciousness
Official title: Effects of Intravenous Amantadine Sulphate on Brain Dynamics and Neurobehavioral Status in Patients With Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Amantadine
Consciousness Disorders
Electroencephalography
Keywords: DoC = Disorders of Consciousness
PSD = Power Spectral Density
Amantadine sulphate
EEG
Lead sponsor: Azienda Sanitaria dell'Alto Adige
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Double-blind, placebo-controlled, crossover ("within subjects") study with an A-B-A-B treatment scheme, in which "placebo" (A) and "amantadine sulphate" (B) intervention sessions alternated weekly in the same patient for a total of four weeks (A1-B1-A2-B2).
Primary purpose: TREATMENT

Brief summary: Double-blind, placebo-controlled, crossover ("within subjects") study with an A-B-A-B treatment scheme to investigate the neuromodulatory effects of intravenous amantadine sulphate at a single daily dose of 200 mg in patients with disorders of consciousness (unresponsive wakefulness syndrome and minimally conscious state) by integrating traditional neurobehavioral assessment with spectral analysis of electrocortical activity derived from 64-channel electroencephalography (EEG) recordings.

Detailed description: Research hypothesis Intravenous amantadine sulphate treatment (200 mg) over five days improves consciousness, defined as an increase in CRS-r score of at least 3 points, and changes the band powers of the EEG in patients with disorder of consciousness admitted in a Neurorehabilitation Department.

Eligibility criteria: Inclusion Criteria:

Adults with disorders of consciousness due to acquired brain injury classified according to international guidelines based on CRS-R evaluation as unresponsive wakefulness syndrome/vegetative state (UWS/VS) or minimally conscious state (MCS) either in the subacute or chronic stage

Exclusion Criteria:

* Age \< 18 years
* History of epileptic seizures/status epilepticus
* Scalp defects
* pregnancy
* Severe uncompensated heart failure (NYHA IV)
* Atrioventricular block (AV block) second-degree and third-degree
* Known bradycardia (below 55 beats/minute)
* Known long QT interval (QTc according to Bazett \> 420 ms
* History of serious ventricular arrhythmias
* Hypokalemia or hypomagnesemia
* Impaired renal function

Primary outcomes:
measure: Coma Recovery Scale-Revised (CRS-R)
timeFrame: days 14 and 28
measure: EEG band power alpha, beta, theta, delta
timeFrame: days 14 and 28
Secondary outcomes:
measure: "periodic" and "aperiodic" exponents of the average power spectral density
timeFrame: days 14 and 28
Other outcomes:
Locations:
city: Vipiteno
country: Italy
facility: Hospital of Vipiteno
state: Bolzano
Study officials:
affiliation: hospital of Vipiteno
name: Viviana Versace, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02069327: The Role of Fat Emboli in the Trauma Inflammatory Response
Official title: The Role of Fat Emboli in the Trauma Inflammatory Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Fracture
Keywords: Femur
Fat
Emboli
Bone
Marrow
proteomic
proteomics
metabolomics
metabolomic
inflammatory
cytokine
chemokine
anaphlylatoxin
Thromboelastography
Medical Center of the Rockies
Fat Embolism Syndrome
Injury
Fracture
Metabolite
MCR
TEG
FES
Lead sponsor: Poudre Valley Health System
Sponsor class: OTHER
Collaborators: name: Colorado State University
First posted: 2014-02-24
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing a tibial or femoral fracture procedure in the operating room.

Brief summary: This is an observational study designed to investigate the role of fat emboli in patients who are undergoing a tibial or femoral fracture procedure in the operating room. The purpose of this study is to obtain samples of bone marrow and blood during tibial or femoral fracture procedures to understand the inflammatory response.

Detailed description: Bone marrow is routinely removed during a tibial or femoral fracture procedure; researchers will take samples for this study from bone marrow that has already been removed as part of this procedure. No additional marrow samples will be taken as part of this research study. Also, researchers will collect blood (about 4 teaspoons) for testing inflammatory response and coagulation. Researchers may need to insert an additional line to collect your blood.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing a tibial or femoral fracture procedure in the operating room.

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Inflammatory Response
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
Study officials:
affiliation: Poudre Valley Health System
name: Julie Dunn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01494727: Phase I Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg
Official title: A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet After a Single Oral Administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Pharmacokinetics
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2011-12-19
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objectives of this study are:

* To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers
* To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers


Eligibility criteria: Inclusion Criteria:

* Male volunteers in the age between 20 and 45 years old
* Body Mass Index (BMI) in the range of 19 to 27 kg/m2

Exclusion Criteria:

* History of allergy or sensitivity to any drug, including amlodipine or valsartan
* History of clinically significant hepatic, renal, gastrointestinal, neurology, pulmonary, endocrine, musculoskeletal, hematologic, oncologic, psychiatric, especially cardiovascular disease
* History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
* Hypotension (Systolic Blood Pressure(SBP) ≤ 100 mmHg or Diastolic Blood Pressure(DBP) ≤ 65 mmHg)
* Hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg)
* Clinical laboratory test values are outside the accepted normal range

  * Aspartate Transaminase(AST) or Alanine Transaminase(ALT) \> 1.25 times to normal range
  * Total bilirubin \> 1.25 times to normal range
* Positive for Hepatitis B Virus surface Antigen(HBsAg), Hepatitis C Virus Antibody(HCVAb) or Human Immunodeficiency Virus Antibody(HIVAb)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: