louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01606839: Noninvasive Measurement of Cardiac Output in Pulmonary Hypertension Using Inert Gas Rebreathing
Official title: Noninvasive Measurement of Cardiac Output in Pulmonary Hypertension Using Inert Gas Rebreathing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Ludwig Boltzmann Gesellschaft
First posted: 2012-05-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients undergoing diagnostic or follow-up right heart cathereization.

Brief summary: The study hypothesis is that accuracy of CO measurement by IGR does not differ from classical CO measurement methods such as thermodilution or direct Fick method. This is why the study aims to determine whether non invasive cardiac output (CO) measurement using inert gas rebreathing (IGR)is a suitable method in patients with pulmonary hypertension. In order to examine this, the IGR method will be used in patients undergoing diagnostic or follow-up right heart catheterization.

Detailed description: Inert Gas Rebreathing method enables non invasive measurement of cardiac output (CO) using the single rebreathing method. A mixture of blood soluble (N2O) and blood insoluble gas (SF6) and environmental air is inhaled and the amount of N2O, SF6, O2 and CO2 is measured by a photoacoustic analysator. The length of a measurement is about 1 minute.

As the gold standard measurement of CO is performed invasively, there is an urgent need for the development of non-invasive tools like IGR.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Patients who undergo right heart catheterization

Exclusion Criteria:

* Missing written informed consent

Primary outcomes:
measure: Cardiac output
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Ludwig Boltzmann Institute for Lung Vascular Research
Study officials:
affiliation: Medical University of Graz
name: Horst Olschewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04210739: Chronic Non Bacterial Prostatitis: a Trial of TRUS Guided Injection of Betamethason
Official title: Managment of Refractory Cases of Chronic Non Bacterial Prostatitis by TRUS Guided Injection of Betamethason
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Chronic Non Bacterial Prostatitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: chronic non bacterial prostatitis
Primary purpose: TREATMENT

Brief summary: TRUS guided injection of long acting corticosteroids in chronic non bacterial prostatitis patients who failed to response to medical treamtment

Detailed description: chronic non bacterial prostatitis is usually due to congestion combined with severe inflammatory process of the prostate, it is usually a recurrent bothersome problem, so patients who fail to response to classic medical treatment are expected to benefit from a strong anti inflammatory injection like betamethasone, which has strong anti inflammatory plus anti oedematous properties so limitation of this inflammatory process across the prostate is expected to relieve the patients symptoms

Eligibility criteria: Inclusion Criteria:

* chronic non bacterial prostatitis who failed medical treatment

Exclusion Criteria:

* chronic bacterial prostatitis patients

Primary outcomes:
measure: Comparing IPSS before and after injection.
timeFrame: evaluation over 3 months after injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02766439: Rhupus Syndrome and Efficacy of Etanercept Treatment
Official title: the First People's Hospital of Chenzhou
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhupus Syndrome, Etanercept
Lead sponsor: First People's Hospital of Chenzhou
Sponsor class: OTHER
First posted: 2016-05-09
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who were unresponsive to therapy with corticosteroid and disease-modifying antirheumatic drugs (DMARDs), with a Disease Activity Score in 28 Joints (DAS28) \>5.1 were enrolled

Brief summary: between March 2013 and March 2014, Rhupus patients were enrolled to receive a 25-mg etanercept injection subcutaneously twice a week. The follow-up time of the study was 24 weeks.

Detailed description: between March 2013 and March 2014, patients who were unresponsive to therapy with corticosteroid and disease-modifying antirheumatic drugs (DMARDs), with a Disease Activity Score in 28 Joints (DAS28) \>5.1 were enrolled to receive a 25-mg etanercept injection subcutaneously twice a week. The follow-up time of the study was 24 weeks.

Eligibility criteria: Inclusion Criteria:

- Rhupus patients who were unresponsive to therapy with corticosteroid and disease-modifying antirheumatic drugs (DMARDs), with a Disease Activity Score in 28 Joints (DAS28) \>5.1

Exclusion Criteria:

- those who had participated in other studies

Primary outcomes:
measure: Disease Activity Score in 28 Joints (DAS28)
timeFrame: 24 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05578339: Predicting the Lens Capsular Bag Size Using Pre-operative Biometry
Official title: Predicting the Lens Capsular Bag Size Using Pre-operative Biometry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Senile
Keywords: capsular bag
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Aim of this study is to assess whether a high-resolution scan of the crystalline lens before surgery may be helpful in predicting post-operative capsule bag diameter.

Detailed description: Most of the measurement procedures used in this study are non-invasive and all are used in standard routine clinical practice, the benefit/risk ratio appears acceptable.

However, a capsule tension ring will be used. A CTR is not used routinely, usually only in cataract operations in which the lens capsule is not stable enough - in other words, for stabilization. The insertion of the CTR is problem-free in most cases. In extremely rare cases, however, the lens capsule may be injured. And document complications will be collected, report them in a final paper. The CTR used in the study is a standard device and CE-marked device. Studies using CTR showed that it is beneficial in difficult cases.

Gonioscopy after cataract surgery will be performed after 1 week. At this time point the wound is already sealed and there appears to be no increased risk to the patient. In the first study performed in a similar fashion in 1999 gonioscopy was performed one day after surgery.

Aim of this study is to predict the diameter of the capsular bag using pre-operative optical biometry findings.

This is a prospective, observer-blind and monocentric study that includes patients scheduled for cataract surgery. Recruitment will take part on the day of pre-assessment. For each patient only one eye will be included.

In total 50 eyes of 50 patients will be included, of which at least 5 eyes with an axial eye length below 22.5mm and 5 eyes with an axial eye length above 25.0mm.

Eligibility criteria: Inclusion Criteria:

* Patient scheduled for cataract surgery
* Well dilated pupil at the pre-assessment visit (dilated pupil size at least 6.0mm)
* Age 21 and older
* Pre-operative visual acuity of at least 0.25 Snellen

Exclusion Criteria:

* Parameters that influence the capsular bag stability (pseudoexfoliation syndrome, St. p. severe eye trauma, Phakodonesis)
* In women of childbearing age, a pregnancy test will be performed before inclusion into the study.

Primary outcomes:
measure: Capsular bag size
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Hanusch Hospital, Department of Ophthalmology
Study officials:
References:
Clinical trial NCT00302939: Etiology of Anemia
Official title: Studies in the Etiology of Anemia in an Unselected Sequential Referral Population
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anemia
Keywords: Aging
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-03-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community

Brief summary: This study looks at the causes of anemia in adults of all ages who are referred by their primary care physician.

Detailed description: This study is being done to determine if the range of causes of anemia changes with advancing age. The goal of this study is to apply research methods to see if causes of anemia can be determined in patients where a clear cause is not found with routine clinical testing available to all patients in physician offices.

Participants in this study will be evaluated at the NIA-ASTRA unit at Harbor Hospital in Baltimore. Testing will consist of both diagnostic and research blood and urine testing along with history and physical exam. An optional bone marrow aspirate or aspirate and biopsy may be performed if the patient permits and it is indicated for either research or clinical diagnostic purposes. All study information supporting a specific diagnosis will be provided to the patient and, at their request, to their primary care physician if specific treatment is indicated.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Hemoglobin (Hgb) less than 13 in males and females

Exclusion Criteria:

* Pregnant or nursing women
* Participation within the past six weeks in another research study which the Principal Investigator believes is incompatible with this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: National Institute on Aging
state: Maryland
Study officials:
affiliation: NIA/NIH
name: William Ershler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guralnik JM, Eisenstaedt RS, Ferrucci L, Klein HG, Woodman RC. Prevalence of anemia in persons 65 years and older in the United States: evidence for a high rate of unexplained anemia. Blood. 2004 Oct 15;104(8):2263-8. doi: 10.1182/blood-2004-05-1812. Epub 2004 Jul 6.
citation: Artz AS, Fergusson D, Drinka PJ, Gerald M, Bidenbender R, Lechich A, Silverstone F, McCamish MA, Dai J, Keller E, Ershler WB. Mechanisms of unexplained anemia in the nursing home. J Am Geriatr Soc. 2004 Mar;52(3):423-7. doi: 10.1111/j.1532-5415.2004.52116.x.
Clinical trial NCT04191239: Comparing Two Different Modes of Ventilation in Pretem Neonates Bilevel VG and PRVC
Official title: Two Different Types of Ventilation in Preterm Neonates; Bilevel Volume Guarantee and Pressure Regulated Volume Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Newborn Morbidity
Respiratory Failure
Bronchopulmonary Dysplasia
Mechanical Ventilation Complication
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All preterms under 32 weeks and between 800-1200 grams, intubated and ventilated in neonatal intensvie care unit

Brief summary: Intubated preterm infants between 800-1200 grams and under 32 weeks of gestational age will start with PRVC ventilation mode, basal blood gases and work of breathing will measured. After that mode will shift to Bilevel Volume Guarantee mode for two hours than clinical and other parameters will be checked again. After this intervention, patients will allocated to PRVC or Bilevel VG group for remaining time.


Eligibility criteria: Inclusion Criteria:

* Need for mechanical ventilation
* 800-1200 grams of birthweight
* Surfactant received
* under 32 weeks of gestational age

Exclusion Criteria:

No need to intubation Congenital anomalies

-

Primary outcomes:
measure: Intubation time
timeFrame: 8 weeks
Secondary outcomes:
measure: Oxygen dependency
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
References:
Clinical trial NCT01781039: Investigation of Anatomical Correlates of Speech Discrimination
Official title: Investigation of Anatomical Correlates of Speech Discrimination
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sensorineural Hearing Loss
Keywords: "hair cell"
"hearing aid"
"hearing loss"
"auditory nerve"
synaptopathy
"Outer hair cell"
"Otoacoustic emission"
Lead sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 1652
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients referred from the St. Elizabeth's Department of Otolaryngology and self-referred patients to the Audiology Clinic.

Brief summary: Understanding speech is essential for good communication. Individuals with hearing loss and poor speech discrimination often have little success with hearing aids because amplifying sound improves audibility, but not clarity of the speech signal. The purpose of this study is to determine the relative importance of the sensory cells of the inner ear and auditory neurons on speech discrimination performance in quiet and in noise. This information may be used as a predictor of hearing aid benefit. The investigators expect to find decreased speech understanding ability resulting from both loss of sensory cells and the loss of auditory neurons.


Eligibility criteria: Inclusion Criteria:

* Normal hearing to moderate sensorineural hearing loss
* Sufficient English proficiency to complete speech discrimination testing in English

Exclusion Criteria:

* Hearing loss less than a 45 dB HL pure tone average (average hearing thresholds at 500, 1000 and 2000 Hz)
* Conductive hearing loss
* Neurodegenerative disease

Primary outcomes:
measure: Regression analysis
timeFrame: June 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Brighton
country: United States
facility: Steward St. Elizabeth's Medical Center
state: Massachusetts
Study officials:
affiliation: Steward St. Elizabeth's Medical Center
name: Mark Parker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bramhall N, Ong B, Ko J, Parker M. Speech Perception Ability in Noise is Correlated with Auditory Brainstem Response Wave I Amplitude. J Am Acad Audiol. 2015 May;26(5):509-517. doi: 10.3766/jaaa.14100.
citation: Hoben R, Easow G, Pevzner S, Parker MA. Outer Hair Cell and Auditory Nerve Function in Speech Recognition in Quiet and in Background Noise. Front Neurosci. 2017 Apr 7;11:157. doi: 10.3389/fnins.2017.00157. eCollection 2017.
citation: Parker MA. Identifying three otopathologies in humans. Hear Res. 2020 Dec;398:108079. doi: 10.1016/j.heares.2020.108079. Epub 2020 Sep 24.
Clinical trial NCT00754039: Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol
Official title: The Effects of the Combination of Welchol and Tricor Compared to TriCor Alone in Patients With Mixed Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Hyperlipidemia, Familial Combined
Keywords: Mixed hyperlipidemia
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-09-17
Enrollment: 129
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.


Eligibility criteria: Inclusion Criteria:

* 30-70 years of age
* History of mixed hyperlipidemia
* Prescribed a Step 1 diet at least 30 days prior to screening
* Women were not pregnant, breast-feeding, or plan to become pregnant during the study
* Women had a hysterectomy or tubal ligation, were post-menopausal, or practiced reliable birth control procedures
* Serum LDL-C \>/= 115 mg/dL; Serum TG \>/= 150 \& \< 750 mg/dL

Exclusion Criteria:

* BMI \>40
* HbA1C \> 10%
* Type 1 diabetes
* Intolerance to fibrates
* History of intolerance to colesevelam HCl
* History of swallowing disorders or intestinal motility disorders
* Any other disorder that might interfere with the conduct of the study
* History of drug or alcohol abuse
* Recent (within 28 days) history of cardiac disease (MI, CHF, CABG, etc.)

Primary outcomes:
measure: % change in LDL-C from baseline
timeFrame: 6 weeks
Secondary outcomes:
measure: The absolute change in LDL-C from baseline
timeFrame: 6 weeks
measure: The absolute change and % change in LDL-C from week -8 (untreated)
timeFrame: 14 weeks
measure: The percentage of patients who achieved target LDL-C
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Longwood
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Winterpark
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Lombard
country: United States
state: Illinois
city: Overland Park
country: United States
state: Kansas
city: Stateville
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
Study officials:
References:
Clinical trial NCT01705639: Melatonin and Glucose Tolerance Among Individuals With a Variant of the MTNR1B Gene
Official title: Does Melatonin Treatment Affect Glucose Tolerance Among Individuals With a Variant (rs10830963) of the Melatonin Receptor 1B (MTNR1B) Gene?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Glucose Tolerance
Keywords: diabetes
melatonin
glucose tolerance
sleep
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Lund University
name: Folkhalsan Research Center
First posted: 2012-10-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The effect of 3 months of melatonin 4mg treatment on glucose tolerance in different variants of the melatonin receptor 1B gene will be evaluated. The following will be done at 0 and 3 months:

* OGTT
* questionnaires about sleep and activity
* Actigraph
* Anthropometry
* Blood pressure

Detailed description: http://www.sciencedirect.com/science/article/pii/S1550413116301607

Eligibility criteria: Inclusion Criteria:

* signed informed concent
* Known genotype for MTNR1B from the Botnia-ppp study
* Age 18-75 years

Exclusion Criteria:

* Diabetes
* Positive GAD-ab
* Sever dysregulated hypertension
* glaucoma
* severe coronary heart disease or arrythmias
* previous or ongoing severe ventricle or duodenal ulcer
* psychosis or anxiety disorder
* regular use of sleep pills, antidepressants or neuroleptics
* creatinine \> 130 µmol/L
* elevated liver enzymes (ASAT, ALAT, ALP, GT, bilirubin) \> 3 times reference value
* inability to sign informed concent
* other factor with according to the physician may affect treatment or results.
* participation in other clinical study
* allergy to melatonin or other substance in the capsule
* hereditary galactose intolerance or glucose/galactose malabsorption
* intention to become pregnant

Primary outcomes:
measure: Glucose tolerance
timeFrame: 3 months
Secondary outcomes:
measure: sleep
timeFrame: 3 months
measure: Activity
timeFrame: 3 months
Other outcomes:
Locations:
city: Jakobstad
country: Finland
facility: Botniacentret Jakobstad
city: Vasa
country: Finland
facility: Vasa health care centre
Study officials:
affiliation: University of Lund, University of Helsinki
name: Leif Groop, Prof.
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Tiinamaija Tuomi, Docent
role: STUDY_DIRECTOR
affiliation: Folkhalsan
name: Bo Isomaa, Docent
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tuomi T, Nagorny CLF, Singh P, Bennet H, Yu Q, Alenkvist I, Isomaa B, Ostman B, Soderstrom J, Pesonen AK, Martikainen S, Raikkonen K, Forsen T, Hakaste L, Almgren P, Storm P, Asplund O, Shcherbina L, Fex M, Fadista J, Tengholm A, Wierup N, Groop L, Mulder H. Increased Melatonin Signaling Is a Risk Factor for Type 2 Diabetes. Cell Metab. 2016 Jun 14;23(6):1067-1077. doi: 10.1016/j.cmet.2016.04.009. Epub 2016 May 12.