louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05159063: Bedside Ultrasound for Fluid Estimation
Official title: Correlation of Internal Jugular and Inferior Vena Cava Diameter Variation on Bedside Ultrasound With Invasive Right Heart Catheterization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Catheterization
Keywords: Internal jugular vein
Inferior vena cava
Right heart catheterization
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adult patients scheduled to undergo right heart catheterization.

Brief summary: The study aims to standardize patient positioning during bedside ultrasound assessment of internal jugular vein (IJV) and correlate the results with invasive hemodynamics obtained immediately after. The study hypothesizes that the respiratory variation in the size of IJV, as estimated through ultrasound at bedside, is an accurate estimation of the patient's actual right atrial pressure estimated through right heart catheterization.


Eligibility criteria: Inclusion Criteria:

* Undergoing right heart catheterization

Exclusion Criteria:

* Superior vena cava obstruction or compression
* Severe tricuspid regurgitation
* Mechanically ventilated patients

Primary outcomes:
measure: Cross-sectional diameters of the internal jugular vein (IJV)
timeFrame: 5 minutes
measure: Cross-sectional diameters of the internal jugular vein (IJV)
timeFrame: 5 minutes
measure: Sniff collapsibility of IJV
timeFrame: 10 minutes
measure: Cross-sectional diameters of the inferior vena cava (IVC)
timeFrame: 5 minutes
measure: Cross-sectional diameters of the inferior vena cava (IVC)
timeFrame: 5 minutes
measure: Cross-sectional diameters of the inferior vena cava (IVC)
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Gaurang Vaidya, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaidya GN, Kolodziej A, Stoner B, Galaviz JV, Cao X, Heier K, Thompson M, Birks E, Campbell K. Bedside ultrasound of the internal jugular vein to assess fluid status and right ventricular function: The POCUS-JVD study. Am J Emerg Med. 2023 Aug;70:151-156. doi: 10.1016/j.ajem.2023.05.042. Epub 2023 Jun 6.
Clinical trial NCT02180763: Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps
Official title: A Randomized, Cross-over Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL According to the Delivery Device: Injections Using Pump or Rapid Push.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Immunodeficiency (PID)
Keywords: Primary Immunodeficiency, PID
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2014-07-03
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL according to the delivery device.


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥ 18 years)
* Presenting with primary immunodeficiency
* Having received subcutaneous injections of immunoglobulin at home using an automatic pump for at least 1 month at the time of inclusion
* For whom the investigator decides to maintain immunoglobulin replacement therapy with subcutaneous injections of Gammanorm® 165 mg/mL at home
* Having signed an informed consent form

Exclusion Criteria:

* Patient currently participating in another interventional study at the time of inclusion

Primary outcomes:
measure: "Life Quality Index" (LQI) score (factor I: treatment interference)
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Haut-Leveque Hospital
city: Caen
country: France
facility: University Hospital of Caen
city: Lille
country: France
facility: University Hospital of Lille
city: Limoges
country: France
facility: Hospital Dupuytren
city: Lyon
country: France
facility: Clinique Mutualiste
city: Reims
country: France
facility: University Hospital of Reims
city: Toulouse
country: France
facility: University Hospital of Toulouse
city: Tours
country: France
facility: University Hospital of Tours
Study officials:
affiliation: Universtiy Hospital of Caen
name: Boris Bienvenu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bienvenu B, Cozon G, Mataix Y, Lachaud D, Alix A, Hoarau C, Antier D, Hachulla E, Brice S, Viallard JF, Tamisier S, Fauchais AL, Renon-Carron F, Clerson P, Fardini Y, Crave JC, Miossec P. Rapid Push vs Pump-Infused Subcutaneous Immunoglobulin Treatment: a Randomized Crossover Study of Quality of Life in Primary Immunodeficiency Patients. J Clin Immunol. 2018 May;38(4):503-512. doi: 10.1007/s10875-018-0507-x. Epub 2018 May 31.
Clinical trial NCT01885663: UCB Therapy in Acquired Brain Injury
Official title: Umbilical Cord Blood Therapy for Patients With Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acquired Brain Injury
Keywords: Umbilical cord blood
Acquired brain injury
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 3
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: UCB therapy for TBI patient
Primary purpose: TREATMENT

Brief summary: This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood (UCB) therapy for patients with acquired brain injury.

Detailed description: Acquired brain injury (ABI) means brain damage caused by events after birth, rather than as part of a genetic or congenital disorders. Those with ABI suffer from cognitive, physical, or behavioral impairments limiting their activity and participation in society. ABI results from traumatic or non-traumatic brain injury due to internal or external source (e.g. infection, brain tumor, hypoxia). Preclinical studies regarding cell therapy in animal models of ABI showed improvements of neurological dysfunction. UCB possess various stem or progenitor cells and is known to secrete neurotrophic factors to repair injured brain. This clinical research aims to determine the safety and efficacy of allogeneic UCB for patients with ABI.

Eligibility criteria: Inclusion Criteria:

* Acquired brain injury
* Duration: over 12 months
* Willing to comply with all study procedure

Exclusion Criteria:

* Medical instability including pneumonia or renal function at enrollment
* Uncontrolled persistent epilepsy
* Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
* Not eligible according to the principal investigator

Primary outcomes:
measure: Monitoring adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Changes in standardized gross motor function
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in motor performance
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in cognitive neurodevelopmental outcome
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in motor neurodevelopmental outcome
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in functional performance in daily activities
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in brain glucose metabolism
timeFrame: Baseline - 12 months
measure: Changes in brain white matter integrity
timeFrame: Baseline - 12 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
Study officials:
affiliation: CHA University
name: MinYoung Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03930563: Inorganic Nitrate and OSA
Official title: Acute Beetroot Juice Supplementation and Peripheral Chemoreflex Sensitivity in Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: inorganic nitrate
blood flow
Peripheral chemoreflex
Common carotid artery
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 21
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to determine if acute beetroot juice supplementation reduces peripheral chemoreflex sensitivity in patients with obstructive sleep apnea. All subjects will consume low-dose (BRL), higher-dose (BRH), and placebo (BRP) beetroot juice randomly on three independent study visits. Beetroot juice also improves blood flow thus, the investigators will also measure blood flow to the carotid chemoreceptors.

Detailed description: Four-weeks of daily beetroot juice supplementation reduces peripheral chemoreflex sensitivity in healthy older adults who have 'normal' responses to acute hypoxia. Patients with obstructive sleep apnea have exaggerated peripheral chemoreflex sensitivity. It remains unknown if beetroot juice supplementation reduces peripheral chemoreflex sensitivity in patients with obstructive sleep apnea. Additionally, increasing blood flow to the peripheral chemoreceptors reduces sensitivity. Given that beetroot juice improves blood flow, the investigators will also measure common carotid artery blood flow at rest and during hypoxia.

Eligibility criteria: Inclusion Criteria:

* OSA group: patients recently diagnosed with mild-to-moderate OSA
* Control group: healthy individuals

Exclusion Criteria:

* Diagnosis of heart disease
* Diagnosis of diabetes
* Diagnosis of any autonomic disorders
* Diagnosis of kidney disease
* Diagnosis of central sleep apnea
* Regular physical activity exceeding 30 minutes 3 days/week
* A body mass index ≥40 kg/m2
* Current or former use of a continuous positive airway pressure machine
* Current tobacco use
* Currently prescribed hormone replacement therapy

Primary outcomes:
measure: Changes in peripheral chemoreflex sensitivity
timeFrame: Before and after consuming all supplements (within three hours)
Secondary outcomes:
measure: Changes in common carotid artery blood flow
timeFrame: Before and after consuming all supplements (within three hours)
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Medical Education Building
state: Iowa
Study officials:
affiliation: University of Iowa
name: Darren P Casey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03388463: Single Dose Omeprazole Versus High Dose in High-risk Critically Ill Patients.
Official title: The Effectiveness of Standard Single Dose Omeprazole Versus High Dose Continuous Infusion in High-risk Critically Ill Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Upper gastrointestinal (GIT) bleeding is common in high risk critically ill patients. Hyperacidity has been identified as one of the main reasons for bleeding.1 2 Antacids with different treatment modalities have been studied to establish the best regimen for prophylaxis against bleeding.3 4 Proton pump inhibitors (PPI) are the most common drugs used in the medical field as antacids. The present study was carried out to investigate the beneficial effects of high dose omeprazole versus standard low dose as a prophylaxis against upper GIT bleeding in high risk critically ill patients.

Detailed description: A hundred and ten high risk critically ill patients were divided into two groups, fify five patients each. Group A received intravenous (IV) omeprazole 40mg bolus dose once daily followed by normal saline infusion. Group B received IV bolus of 80 mg omeprazole followed by 8mg/h infusion. The treatment was for the whole period of ICU stay. Gastric pH, residual gastric volume, signs of significant upper GIT bleeding, ICU stay Hb, number of ventilator free days, ICU stay haemoglobin (Hb), number of red cell units transfused in ICU, ICU stay, and numbers of ICU survivors were recorded.

Eligibility criteria: Inclusion Criteria:

* Mechanically ventilated patients were identified as high risk patients. Patients with nasogastric tube inserted as part of their medical care were included in the study.

Exclusion Criteria:

* Patients admitted because of upper gastrointestinal bleeding, patients who were not scheduled for early enteral nutrition during the first 24 hours of intensive care unit (ICU) admission, patients with bleeding disorders, renal replacement therapy, history of gastric ulcer, gastric surgery, and the use of gastric antacids before ICU admission.

Primary outcomes:
measure: Significant upper gastrointestinal bleeding
timeFrame: 20 days during ICU stay.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03342963: Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults
Official title: A Single-center, Open-label, Randomized, Two-treatment, Two-period Crossover Trial to Investigate Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Adults
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 74
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the bioequivalence of aripiprazole between administration of one ASC-01 tablet (aripiprazole 3 mg/sertraline 100 mg combination drug) and concomitant administration of one aripiprazole 3-mg tablet and two sertraline 50-mg tablets (Cohort 1).

To investigate food effect on plasma pharmacokinetics of aripiprazole and sertraline by single oral administration of ASC-01 under a fasting or fed condition (Cohort 2).


Eligibility criteria: Inclusion Criteria:

* Healthy male subject at the age between 20 and 40 at the time of informed consent
* Subject has a body mass index (BMI = body weight \[kg\]/height \[m\]2) of ≥18.5 and \<25.0 kg/m2 at screening
* Subject is providing consent for participation in this trial in writing prior to the start of the procedures related to this trial, and judged by the investigator or subinvestigator to be capable of observing procedures in this trial.

Exclusion Criteria:

* Subject has a clinically significant abnormality in physical findings at screening or in medical history that in the investigator's or subinvestigator's opinion may place the subject at risk or interfere with outcome variables including drug absorption, distribution, metabolism, and excretion.
* Subject is judged by the investigator or subinvestigator to be inappropriate for participation in this trial.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) of Aripiprazole in Cohort 1
timeFrame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing
measure: Area Under the Plasma Concentration Versus Time Curve 168h (AUC168h) of Aripiprazole in Cohort 1
timeFrame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing
measure: Cmax of Aripiprazole and Sertraline in Cohort 2
timeFrame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing
measure: AUC168h of Aripiprazole and Sertraline in Cohort 2
timeFrame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Clinic of Kyusyu Region
Study officials:
References:
Clinical trial NCT02227563: tDCS & Auditory Hallucinations in Schizophrenia
Official title: tDCS & Auditory Hallucinations in Schizophrenia (AVH-SZ)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Keywords: dorsolateral prefrontal cortex
left superior temporal gyrus
auditory hallucinations
transcranial direct current stimulation (tDCS)
Lead sponsor: Herzog Hospital
Sponsor class: OTHER
First posted: 2014-08-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate tDCS effects on schizophrenia symptoms, particularly on auditory verbal hallucinations. tDCS applied with cathodal (inhibitory) electrode over the left temporal parietal junction and anodal (excitatory) electrode over the left dorsolateral prefrontal cortex.


Eligibility criteria: Inclusion Criteria:

* Ages 18-60
* Primary diagnosis of Diagnostic and Statistical Manual, fifth edition, schizophrenia
* Persistent auditory verbal hallucinations
* Right handed
* Under stable doses of antipsychotic medication for ≥4 weeks
* Normal hearing by self-report and physical exam
* Use of effective method of birth control for women of childbearing capacity
* Capable to provide informed consent. For patients judged to be incapable to provide informed consent the legal guardian of the patient must agree to participation in the study and provide signed informed consent

Exclusion Criteria:

* Current or past history of substance dependence or abuse (excluding nicotine)
* Other current Axis I disorders
* History of seizure, epilepsy in self or first degree relatives, stoke, brain surgery, head injury, intracranial metal implants, known structural brain lesion, devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
* Frequent and persistent migraines
* History of adverse reaction to neurostimulation
* Participation in study of investigational medication within 6 weeks
* Pregnancy
* Women who are breast-feeding
* Current significant laboratory abnormality

Primary outcomes:
measure: change from baseline in auditory hallucination rating scale
timeFrame: 1 week post-treatment
Secondary outcomes:
measure: change in self-report quality of life scale from baseline
timeFrame: 1 week post treatment
Other outcomes:
measure: change from baseline in auditory event related potentials (ERP)
timeFrame: change in auditory ERP from baseline at 1 week
Locations:
city: Jerusalem
country: Israel
facility: Herzog Hospital
Study officials:
affiliation: Sarah Herzog Memorial Hospital
name: Oded Meiron, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091.
Clinical trial NCT00681135: Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients
Official title: Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients: Comparison of Different Toothbrushing Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Gingivitis
Keywords: orthodontics
toothbrush
interdental brush
oral hygiene
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2008-05-21
Enrollment: 118
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the use of a sonic toothbrush alone is more effective than two other toothbrushing protocols on dental plaque elimination in patients with fixed orthodontic appliances.


Eligibility criteria: Inclusion Criteria:

* no systemic diseases
* orthodontic appliance (min. 10 completely erupted permanent teeth with brackets/bands)
* informed consent

Exclusion Criteria:

* presence of caries lesion
* antibiotic therapy within the previous 6 months
* diagnosis of early onset periodontitis

Primary outcomes:
measure: Plaque Indices
timeFrame: every 4 weeks for 3 months
measure: Gingival Indices
timeFrame: every 4 weeks for 3 months
Secondary outcomes:
measure: Periodontal parameters
timeFrame: every 4 weeks
measure: Microbiological parameters
timeFrame: every 4 weeks
measure: Molecularbiological parameters
timeFrame: every 4 weeks
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Orthodontics
state: Baden-Württemberg
Study officials:
affiliation: Department of Orthodontics, University of Heidelberg
name: Christopher J. Lux, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT03629535: Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband
Official title: Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Hypertension
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of the present investigation is to determine the accuracy of a non-invasive non-oscillometric blood pressure wristband device when compared to invasive intra-arterial blood pressure monitors. In an intensive care unit patients who already have an intra-arterial blood pressure monitor in place, this wristband device will be applied and blood pressure readings compared for approximately 15 minutes. Blood pressure readings will be gathered and compared.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the Surgical Intensive Care Unit who are already fitted with an invasive Arterial Line (A- Line) are eligible for the trial, and no volunteers candidates for an A Line are requested.

Exclusion Criteria:

* Within the candidate group of individuals whose procedure in the hospital requires an A-Line, the wristband may not, for various reasons, produce a clean signal. This is immediately determined after wearing the band (and may be related to the size of the wrist of the subject, among other things). Such candidates will be excluded from admission to the study.
* All data from a subject shall be excluded if the invasive reference systolic blood range is greater than 20 mmHg (2, 67 kPa) or if the invasive reference diastolic range is more than 12 mmHg (1, 6 kPa) in any single determination.

Primary outcomes:
measure: Average Error in Blood Pressure Readings
timeFrame: during intervention for 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Greta Piper
role: PRINCIPAL_INVESTIGATOR
References: