louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06923267: Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials
Official title: Ultrasound Evaluation of Cardiac Function During Three Spontaneous Breathing Trials in Intensive Care Unit : A Prospective Interventional Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Weaning Invasive Mechanical Ventilation
Weaning-induced Pulmonary Edema
Weaning Failure of Mechanical Ventilation
Spontaneous Breathing Test
Intensive Care Units (ICUs)
Keywords: Humidified high flow
Cardiac ultrasound
Spontaneous breathing trial
T-Piece
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to evaluate the evolution of a cardiac ultrasound index (E/E') during 3 spontaneous breathing trials in Intensive Care Unit (ICU) adults (over 18 years) patients at risk for weaning failure. The main objective is to find out which spontaneous breathing trial is the least demanding in terms of heart work.

Investigators will compare 3 consecutive spontaneous breathing trials in a random order to see if one is superior to the others.

Participants will not have to perform any specific procedure apart from breathing without respiratory support during the spontaneous breathing trial. During these trials, the investigator will perform cardiac ultrasound measurements.


Eligibility criteria: Inclusion Criteria:

* Intubated patient undergoing invasive mechanical ventilation for at least 24 hours and scheduled for a spontaneous breathing trial
* Richmond Agitation Sedation Scale (RASS) between -1 and +1
* Patient at high risk of re-intubation with at least one of the following criteria:

  * Underlying cardiac disease (left ventricular dysfunction with left ventricular ejection fraction ≤ 45%, documented ischemic heart disease, chronic atrial fibrillation, known history of cardiogenic pulmonary edema)
  * Underlying respiratory disease (COPD, Emphysema, bronchial dilatation, asthma, obesity/hypoventilation syndrome, restrictive lung disease)

Exclusion Criteria:

* Neuromuscular pathology (myasthenia type) preceding hospitalization
* Pregnant or breast-feeding women
* Patient already included in the study
* Protected person (under guardianship or curatorship)
* Person under court protection
* Person not affiliated to a social security scheme

Primary outcomes:
measure: Ultrasonographic evaluation of cardio E/E' index during 3 randomly assigned cross-over spontaneous breathing trials.
timeFrame: At the 5th minute from beginning of each spontaneous breathing trial (each breathing trial is 15 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Orleans
country: France
facility: Chu Orleans
Study officials:
References:
Clinical trial NCT02071667: Association of Periostin Levels and Chronic Sinusitis
Official title: Association of Periostin Levels and Chronic Sinusitis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sinusitis
Nasal Polyps
Keywords: Chronic sinusitis
Nasal Polyps
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are recommended for sinus surgery as part of their care who self report no asthma.

Brief summary: The purpose of this study is to see if a protein in blood, called periostin, can determine if patients have chronic sinusitis. This protein is in everyone's body, but the level of the protein may indicate certain conditions such as chronic sinusitis. The investigators are interested in testing levels of periostin to see if they are higher or lower than patients without chronic sinusitis, just as periostin is higher in patients with asthma. All patients enrolled in this study will have chronic sinusitis without asthma.


Eligibility criteria: Inclusion Criteria:

* Patients with sinus disease which requires surgical intervention
* Ability to understand and give informed consent

Exclusion Criteria:

* Previous diagnosis of asthma
* Positive methacholine challenge at screening
* Diagnosis of cystic fibrosis
* Concomitant use of systemic corticosteroids (except for those prescribed as part of standard pre-surgical treatment)

Primary outcomes:
measure: Difference in circulating serum periostin levels pre and post sinus surgery
timeFrame: 10-15 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
Clinical trial NCT01023867: Clinical Trial of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
Official title: Comparative Assessment of Clinical Efficacy of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Dementia
Keywords: Alzheimer's disease
Mixed Dementia
Donepezil
Efficacy
Adverse Event
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Eisai Korea Inc.
First posted: 2009-12-02
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia.

Detailed description: The purposes of this study are:

1. to compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia
2. to help to clinicians in choosing the best treatment for patients with mixed dementia

Eligibility criteria: Inclusion Criteria:

1. A diagnosis of probable AD and Mixed Dementia according to the criteria of the NINCDS-ADRDA
2. Korean version Mini-Mental State Examination scores between 10 and 26
3. History of cognitive decline that had been gradual in onset and progressive over at least 6 months
4. A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.

Exclusion Criteria:

1. they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
2. Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
3. Cerebral injuries induced by trauma, hypoxia, and/or ischemia
4. Clinically active cerebrovascular disease; History of seizure disorder
5. Other physical conditions that required acute treatment.

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)
timeFrame: 13 weeks, 26 weeks, 39 weeks, 52 weeks
Secondary outcomes:
measure: Seoul Activities of Daily Living (S-ADL)
timeFrame: 13 weeks, 26 weeks, 39 weeks, 52 weeks
measure: Seoul-Instrumental Activities of Daily Living (S-IADL)
timeFrame: 13 weeks, 26 weeks, 39 weeks, 52 weeks
measure: Korean Neuropsychiatric Inventory (K-NPI)
timeFrame: 13 weeks, 26 weeks, 39 weeks, 52 weeks
Other outcomes:
Locations:
city: Seoul City
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Doh Kwan Kim, PhD, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03629067: Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects
Official title: A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between BR1010 and Co-administration of BR1010-1 and BR1010-2 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: Hypertension
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Pharmacokinetics and safety/tolerability between Fimasartan/Amlodipine/Hydrochlorothiazide and co administration of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* A healthy adults aged 19-50 years

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease
* Hypersensitivity to ingredient of IP and other medication, food
* Participation in any other study within 3months
* History of whole blood donation within 2months and Apheresis 1month

Primary outcomes:
measure: Cmax
timeFrame: 0~144hours after Medication
Secondary outcomes:
measure: AUCinf
timeFrame: 0~144hours after medication
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-sang Yu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01122667: Pharmacokinetics of Anacetrapib (MK0859) in Subjects With Impaired Renal Function (MK-0859-038)
Official title: A Single-Dose Study to Investigate the Pharmacokinetics of MK0859 in Subjects With Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Keywords: Renal Insufficiency
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-05-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib in subjects with impaired renal function and healthy matched control subjects.


Eligibility criteria: Inclusion Criteria:

* Female subjects of reproductive potential test negative for pregnancy and agree to use two acceptable methods of birth control throughout the study
* Subject is in good health
* If Subject is a smoker, smoking is limited to no more than 10 cigarettes per day

Exclusion Criteria:

* Subject has a history of stroke, chronic seizures or major neurological disorder
* Subject has a history of cancer
* Subject is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study
* Subject consumes excessive amounts of alcohol or caffeine
* Subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks
* Subject is a nursing mother
* Subject has had a kidney removed or has a functioning renal transplant

Primary outcomes:
measure: Area Under the Curve (AUC(0 to infinity)) of anacetrapib
timeFrame: through 168 hours post dose
Secondary outcomes:
measure: Safety and tolerability of a single dose administration of 100mg anacetrapib, measured by the number of clinical and laboratory adverse events
timeFrame: through 14 days post dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lauring B, Li XS, Liu Y, Corr C, Lazarus N, Cote J, Larson P, Levonas AO, Lasseter KC, Preston RA, Smith WB, Lai E, Wagner JA. Influence of renal and hepatic impairment on the pharmacokinetics of anacetrapib. J Clin Pharmacol. 2014 Nov;54(11):1247-55. doi: 10.1002/jcph.320. Epub 2014 Jun 6.
Clinical trial NCT04177667: Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality
Official title: Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality: Post-hoc Analyses From a Double-blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Infertility
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 104
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spermatozoa are vulnerable to lack of energy and oxidative stress as a result of elevated levels of reactive oxygen species. Therefore, it is essential that appropriate nutrients are available during maturation.

This randomized, double-blind, placebo-controlled trial investigated the effect of 6 months supplementation with carnitines and other micronutrients on sperm quality in 104 subjects with oligo- and/or astheno- and/or teratozoospermia with or without varicocele. Semen analyses were done at the beginning and end of the treatment. In addition to main analyses, post-hoc analyses for age and body mass index (BMI) were carried out. Results were interpreted by dividing the population into two age and BMI classes.


Eligibility criteria: Inclusion Criteria:

* men with oligo- and/or astheno- and/or terato-zoospermia
* with or without varicocele
* men aged between 18 and 50 years
* men from couples with history of difficulty conceiving for more than 12 months

Exclusion Criteria:

* subjects with known hypersensitivity to any of the treatment compound
* history of undescended testes or cancer
* endocrine disorders
* history of post-pubertal mumps
* genitourinary surgery
* obstructive azoospermia or obstructive pathology of the urogenital system
* autoimmune disease
* cystic fibrosis
* history of taking any therapy affecting fertility within last 3 months
* excessive consumption of alcohol or regular use of illicit or "recreational" drugs
* positive serology for HIV
* subjects following any special diet
* any condition which in the opinion of the investigator might put the subject at risk by participation in this study and subjects involved in any other clinical trials

Primary outcomes:
measure: Evaluation of sperm concentration (millions/ml) on spermogram of infertile men
timeFrame: 6 months
measure: Evaluation of sperm motility (%) on spermogram of infertile men
timeFrame: 6 months
measure: Evaluation of sperm normal morphology (%) on spermogram of infertile men
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of pregnancy rate (number)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02773667: Renal Tracer Elimination in Thyroid Cancer Patients Treated With 131-Iodine
Official title: Relationship Between Estimated Glomerular Filtration Rate and Biological Half-life of 131I. Prospective Analysis in Patients With Differentiated Thyroid Carcinoma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Carcinoma
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histological secured differentiated thyroid cancer stationary for treatment or diagnostic with radioiodine

Brief summary: Correlation analysis between estimated renal function and biological half life of 131-I during radioiodine treatment of patients with differentiated thyroid cancer.

Detailed description: 131-I during radioiodine treatment of patients with differentiated thyroid cancer is mainly renally excreted. It is advised in the clinical guidelines that serum creatinine should be determined before applying 131-I and if necessary the administered dose should be reduced. Nevertheless no guideline gives advice in what extent the dose should be decreased. The adjustment is at the discretion of the attending physician.

Aim of this prospective study is to correlate the biological half life of 131-I with the renal function to give objective recommendations concerning the reduction of the applied dose in patients with limited renal function.

Eligibility criteria: Inclusion Criteria:

* patients with differentiated thyroid carcinoma
* stationary for treatment or diagnostic with radioiodine
* state after thyroidectomy
* written consent of the patient
* minimum age 18 years

Exclusion Criteria:

* no written consent of the patient
* patients with large residual thyroid tissue (iodine uptake \> 10%)
* children under 18 years of age
* inclusion in concurrent interventional studies
* patients without TSH-stimulation by rhTSH

Primary outcomes:
measure: Correlation between estimated renal function and biological half life of 131-I
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: University Hospital Jena
state: Thüringen
Study officials:
affiliation: Study Principal Investigator
name: Martin Freesmeyer, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00945867: Cytochrome P450 2D6 (CYP 450 2D6) Genotype and Flecainide Efficacy
Official title: The Use of CYP 450 2D6 Genotype as a Predictor of Flecainide Efficacy in the Treatment of Patients With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: flecainide
pharmacogenetics
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-07-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with atrial fibrillation and a normal heart.

Brief summary: The determination of the 2D6 genotype will enable us to determine the way flecainide is metabolized by the liver. Some individuals are poor metabolizers and some individuals are extensive metabolizers of the drug. This will also determine which patients will benefit from the drug.

Detailed description: Pharmacogenetics is the study of genetic variations on drug metabolizing enzymes and transporters. Pharmacogenetics is one of the first clinical applications of the Human Genome Project. Pharmacogenomics is the study of the role of interindividual genomics variability on drug response, efficacy, and metabolism. It correlates the effects of the entire expressed genome to the clinical usefulness and toxicity of a drug. Pharmacogenomics has the potential to change the way patients' therapy is optimized, allowing an era of "personalized medicine" in which patients will be divided into groups based on genetic markers that treatment outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients with recurrent AF
* Patients with a structurally normal heart
* Patients \> 18 YO
* Patients who signed an informed consent

Exclusion Criteria:

* Renal failure with creatinine clearance less than 40
* Elevated liver enzymes 3 times the normal range, or causing coagulation test abnormality
* Pregnant patients
* Patients treated with psychiatric agents

Primary outcomes:
measure: no recurrence of atrial fibrillation
timeFrame: 3 months
Secondary outcomes:
measure: the dose of flecainide used
timeFrame: 6 months
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Moshe Sharist, MD
role: STUDY_CHAIR
affiliation: Assaf-Harofeh Medical Center
name: Shmuel Bar-Haim, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03922867: Web-based CBT for Insomnia Patients With Fibromyalgia
Official title: Comparison of Feasibility and Efficacy of a Web-based Cognitive Behavioral Therapy Versus Usual Care for Management of Insomnia in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Fibromyalgia
Keywords: insomnia
fibromyalgia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Researchers are evaluating if cognitive behavioral therapy for insomnia delivered over the internet will help with fibromyalgia symptoms.

Detailed description: The investigators are studying the effect of an internet-based cognitive behavioral therapy for insomnia, compared with usual care in fibromyalgia patients. Fibromyalgia patients will consent to study, and a determination made if the patients meet criteria. If eligible, qualifying patients will be randomized, and begin participation in randomized intervention. During participation on the study subjects will complete surveys at set intervals.

Eligibility criteria: Inclusion Criteria:

* Meets diagnostic criteria for fibromyalgia
* Has insomnia
* Have internet access and a device that can access the web-based program.

Exclusion Criteria:

* Active sleep disorder which is not treated (obstructive sleep apnea, obesity hypoventilation syndrome)
* Active psychiatric disorder (Bipolar affective disorder, anxiety, depression, schizophrenia) which is not optimally managed.
* Chronic fatigue syndrome
* Morbid obesity

Primary outcomes:
measure: Change in insomnia severity
timeFrame: through study completion, an average of 12 weeks
measure: Change in attitude towards sleep
timeFrame: through study completion, an average of 12 weeks
Secondary outcomes:
measure: Change in fibromyalgia symptoms
timeFrame: through study completion, an average of 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ravindra Ganesh, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Sanjeev Nanda, MD
role: STUDY_CHAIR
References: