louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06200870: ID as a Promoter of IH-induced CAVD
Official title: Iron Deficiency as a Promoter of Intra-leaflet Haemorrhage-induced Aortic Valve Calcification
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Iron Deficiencies
Calcified Aortic Valve
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at the outpatient clinic or inpatient department, Qilu hospital of Shandong University, Jinan, were recruited during the period from January 2018 to March 2023.

Brief summary: Calcific aortic valve disease (CAVD) is a highly prevalent, disabling and costly disorder with generally poor long-time outcomes once critical stenosis presents with symptoms. Elucidating viable therapeutic strategies for CAVD is pressing. Valvular interstitial cells (VICs) control the structure and function of aortic valve. Intra-leaflet haemorrhage (IH), commonly occurring in histologically stenotic aortic valves, while, in 2019, researchers pointed that iron deposits also presented obviously healthy valves. In line with this, later exploration from vitro showed that iron stimulation alone could not promote VICs calcification. Iron deficiency (ID) is a frequent co-morbidity in multiple chronic cardiovascular diseases such as CAVD; up to 50% of patients with severe aortic stenosis present ID. Data from a small clinical study in patients undergoing TAVI showed those in ID status appeared much higher mean transaortic gradient; whereas no studies have assessed the correlation between ID and aortic valve remodelling and dysfunction progress itself. Here, the investigators aim to investigate for a tentative correlation between ID and human aortic valve remodeling and dysfunction.


Eligibility criteria: Inclusion Criteria:

* if performed with both color doppler echocardiography and anemia profile on admission as part of routine checkup.

Exclusion Criteria:

* if younger than the age of 18;
* if no anemia profile or doppler echocardiography was measured;
* if anemia profile or doppler echocardiography was analyzed in external laboratories;
* if had a history of rheumatic heart disease, infective endocarditis or any other congenital disorders that may implicate aortic valve structures, such as bicuspid aortic valve morphology, Marfan syndrome, and so on.

Primary outcomes:
measure: Serum iron
timeFrame: within 24 hours of admission
measure: Total iron binding capacity
timeFrame: within 24 hours of admission
measure: Serum transferrin receptor
timeFrame: within 24 hours of admission
measure: Unsaturated iron-binding capacity
timeFrame: within 24 hours of admission
measure: Serum transferrin
timeFrame: within 24 hours of admission
measure: Transferrin saturation
timeFrame: within 24 hours of admission
measure: Soluble transferrin index
timeFrame: within 24 hours of admission
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05991570: Thoracoscopic Exploration in Comparison to Exploratory Thoracotomy in Chest Trauma
Official title: Uni-portal Thoracoscopic Exploration in Comparison to Exploratory Thoracotomy in Hemodynamically Stable Thoracic Trauma Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thoracic Injury
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cohort study
Primary purpose: DIAGNOSTIC

Brief summary: Video-assisted thoracic surgery has a standard role in diagnosis and therapy in thoracic surgery, In the past, most patients necessitating surgical treatment secondary to chest trauma was exposed to open thoracotomy, which was the most morbid of surgical incisions

Detailed description: Video-assisted thoracoscopic surgery has become a popular and acceptable method for diagnosis of intra-thoracic lesions since 1990s with the developments in surgical techniques. It is also used for treatment of retained pleural collections, it is a simple alternative to open thoracotomy. Although it's multiple advantages, timing of surgery and its effects on patients' results are not well elucidated. Multiple studies report that prognosis of patients is better with the earlier interventions in injured chest. However, there is so many differences for the optimal time for surgery in these studies .

Indications of VATS have been extended for management of diagnosis and treatment of chest trauma since 1990. This approach has multiple advantages as chest tube setting, minimally invasive surgery, less postoperative pain, and chest exploration. Today, VATS is used for empyema, persistent pneumothorax, retained haemothorax, mediastinal and diaphragmatic exploration, pleuro-pericardial ruptures, surgery for thoracic duct injury and aspiration of symptomatic foreign bodies.

Eligibility criteria: Inclusion Criteria:

1. patient aged more than 13 yards old
2. Hemo-dynamically stable patients with chest trauma
3. Willing and able to provide written informed consent and comply with study requirements.

Exclusion Criteria:

1. patient aged less than 13 yards old.
2. Hemo-dynamically instable patients
3. Head trauma patients.
4. missing informed consent
5. Participation in another clinical research.

Primary outcomes:
measure: Duration of airleak, lung expansion and post operative bleeding.
timeFrame: 2 weaks postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01609270: CardioRoot Post-Marketing Surveillance Registry
Official title: CardioRoot Post-Marketing Surveillance Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Surgical Procedure
Lead sponsor: Maquet Cardiovascular
Sponsor class: INDUSTRY
First posted: 2012-05-31
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with aneurysmal and occlusive disease of the thoracic aorta treated with a CARDIOROOT vascular graft.

Brief summary: Post-marketing surveillance registry of the CardioRoot graft.

Detailed description: Study objective is to monitor the performance and safety of CardioRoot vascular grafts implanted in a thoracic position. Patient survival rates will be monitored as well as immediate and long-term complications.

Eligibility criteria: Inclusion Criteria:

* patients requiring a CardioRoot graft as per the CardioRoot Instructions for Use (IFU)

Exclusion Criteria:

* patients with contra-indications per CardioRoot IFU
* patients requiring consecutive aortic surgery
* patients with coronary artery disease
* patients who require urgent or emergent surgery

Primary outcomes:
measure: Graft complications
timeFrame: 30 days
measure: Graft complications
timeFrame: 1 year
Secondary outcomes:
measure: Subject mortality rate
timeFrame: 30 days, 1 year
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Prague
country: Czechia
facility: General University Hospital
city: Prague
country: Czechia
facility: University Hospital Motol
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire (CHU) de Bordeaux
city: Lecco
country: Italy
facility: Ospedale Manzoni di Lecco
city: Milano
country: Italy
facility: Ospedale Luigi Sacco
Study officials:
References:
citation: Tasca G, Lindner J, Barandon L, Santavy P, Antona C, Burkert J, Gamba A. Aortic root surgery with the CARDIOROOT vascular graft: results of a prospective multicenter post-market surveillance study. J Cardiothorac Surg. 2019 May 21;14(1):94. doi: 10.1186/s13019-019-0914-y.
Clinical trial NCT06152770: Comparison of Turkish Children's Actual Weights With Which Predicted Weights by Estimation Methods
Official title: Comparison of Turkish Children's Actual Weights With Predicted Weights Values by APLS, Luscombe and Owens, Best Guess, Nelson Formulas and Broselow Band Methods
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pediatric Hernia
Lead sponsor: Bozok University
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 2600
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients between the ages of 0-18 who applied to the pediatric surgery outpatient clinic

Brief summary: The goal of this observational study is to compare body weigth with the prediceted weigth values abtracted by weigth estimation methods in Turkish Children.

The main question it aims to answer is: to evaluate the suitability of APLS, Luscombe \& Owens, Best Guess, Nelson Formula and Broselow Band methods in estimating actual measurements in patients coming to the surgery outpatient clinic of our hospital


Eligibility criteria: Inclusion Criteria:admitted to the pediatric surgery clinic 0-18 years old patients will be included

Exclusion Criteria:Those who have a disease that will cause severe developmental growth retardation will be excluded

Primary outcomes:
measure: Comparison of actual weigth with predicted weigth
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00915070: Role of Endothelin-1 in Optic Nerve Head Blood Flow Regulation During Isometric Exercise in Healthy Humans
Official title: Role of Endothelin-1 in Optic Nerve Head Blood Flow Regulation During Isometric Exercise in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: BQ-123
Optic Nerve Head Blood Flow
Intraocular Pressure
Regional Blood Flow
Ocular Physiology
Optic Disk
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-06-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance to changes in perfusion pressure. In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. The investigators could recently show that Endothelin-1 is a key metabolite in the regulation of vascular tone in the eye and plays an important role in the blood flow autoregulation of the choroidal circulation. However, no data is yet available for the optic nerve head. Thus, the present study is designed to test the hypothesis that Endothelin-1 plays also a role in optic nerve head blood flow autoregulation.

Therefore, subjects will perform squatting to increase systemic perfusion pressure during administration of either an endothelin A-receptor blocker (BQ-123) or placebo. Optic nerve head blood flow will be continuously measured during the procedure to investigate optic nerve head autoregulation.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 18 and 35 years, nonsmokers
* Men and women will be included in equal parts
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal findings in the laboratory testings unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia less than 3 diopters

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug (except intake of oral contraceptives)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
* Pregnancy

Primary outcomes:
measure: Optic nerve head pressure-flow relationship
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Gabriele Fuchsjaeger-Mayrl, MD, Univ.Doz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00527670: Pilot Study to Identify the Influence of Genetic Profile Aberrations on Patients With Recurrent Hernias
Official title: Pilot Study to Identify the Influence of Genetic Profile Aberrations on Patients With Recurrent Hernias
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pathological Processes
Keywords: Genomics
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2007-09-11
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical patients at the University of Missouri Healthcare system.

Brief summary: The aim of this study is to compare collagen composition in the skin and fascia of patients with recurrent or incisional hernias versus normal controls. We will identify potential genes responsible for genetic alterations in collagen deposition by using gene chip analysis of the tissue obtained and comparing the hernia group versus controls. The ultimate goal of this study is to identify target genes which may help us eventually predict which patients are at risk for developing post-operative hernias.

Detailed description: This is a prospective, case control pilot study with the aim of identifying potential genetic influences on recurrent hernia formation. Patients with recurrent abdominal hernias will be compared with normal control subjects. The study endpoints will compare tissue collagen I/III ratios between the groups. It will also use gene chip technology to identify potential differences in gene expression between the two groups, followed by confirmation of the differential expression using RT-PCR.

Patients will be enrolled from the surgical clinic population. If they consent to the study, both the hernia group and the control group will have 0.5 x 0.5 x 0.1 cm3 pieces of skin and fascia collected at the time of their surgery. A small piece of tissue will be used for immunofluorescene to study collagen I/III ratios. RNA will be extracted from the rest of the tissue for the genetic studies.

Eligibility criteria: Inclusion Criteria:

* Hernia Group: Diagnosis of ventral or incisional hernia.
* Control Group: appendicitis, symptomatic cholelithiasis or cholecystitis, adrenal disease necessitating adrenalectomy.
* Scheduled for an appropriate laparoscopic repair of above diagnosis.
* Females only: Not pregnant.

Exclusion Criteria:

* Steroid use
* Severe COPD or pulmonary disorders
* History of a connective tissue disorder
* Presentation for surgery with a diagnosis other than those listed above in inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Hospital and Clinics
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Bruce Ramshaw, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04766970: Telehealth Autism Assessment for Adults
Official title: Telehealth Autism Assessment for Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: The study aims to investigate the reliability and validity of an adapted Autism Spectrum Disorder assessment measure for use in a telehealth visit.


Eligibility criteria: Inclusion Criteria:

* Age 18-60 years old
* Access to personal computer with video, microphone, and speaker
* English literate
* Fluent English speaker

Exclusion Criteria:

* Non-fluent English speaker
* Not English literate

Primary outcomes:
measure: Concurrent validity
timeFrame: Immediately after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Brianna Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03694470: Characteristics of Patients With Type 2 Diabetes Mellitus (CVD-RNDR)
Official title: Retrospective Study to Describe Characteristics of Patients With Type 2 Diabetes Mellitus Who Were Initiating Use or Treatment With Sodium-glucose Co-transporter-2 Inhibitors and Other Diabetes Medications (Other Glucose Lowering Drugs) in 2015-17 Based on National Russian Diabetes Registry Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-10-03
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Data of T2DM patients consecutively included in the RNDR from January 2015 to October 2017 will be included in this retrospective analysis. New users will be defined as individuals with T2DM either receiving a prescription of a SGLT-2 inhibitor or other GLD during the study period. Individuals with a previous issued/dispensed prescription of that medicine class during the preceding 1 year are not defined as new users. The year of the first issued prescription of the included medication classes during the study period will be denoted the index year. The group of other GLD will include all diabetes medicines, allowing combinations and monotherapy use except use of SGLT-2 inhibitors. The class SGLT-2 inhibitors include mainly dapagliflozin, empagliflozin and canagliflozin.

Since SGLT-2 inhibitors are relatively recently introduced on the market the population size and follow-up time is limited. Approximately 22,000 patients registered in RNDR will be included.

Brief summary: This observational retrospective study will describe characteristics of patients with type 2 diabetes mellitus (T2DM) who were initiating use or treatment with sodium-glucose co-transporter-2 (SGLT-2) inhibitors and other diabetes medications (other glucose lowering drugs) in 2015-17 based on National Russian Diabetes Registry data.


Eligibility criteria: Inclusion criteria are:

* New user receiving or dispensed prescription of SGLT-2 inhibitor medication or other GLD treatments oral as well as injectable, including fixed-dose combination (FDC) products containing these medication groups;
* T2DM diagnosis on or prior to the index year;
* ≥ 18 years old at index year.

Exclusion criteria are:

* Patients with a T1DM diagnosis on or prior to index year and only insulin use in the year prior to index;
* Patients with a gestational diabetes in the index year or 1 year prior to index.

Primary outcomes:
measure: The proportion of patients who were new users of SGLT-2 inhibitors in 2015, 2016, 2017
timeFrame: 2015-2017
Secondary outcomes:
measure: Number of participants with abdominal laboratory values
timeFrame: 2015-2017
measure: Number of participants with co-morbidities
timeFrame: 2015-2017
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Research site
Study officials:
References:
Clinical trial NCT04890470: Effects of Oxytocin and Vasopressin on Moral Decision Making
Official title: Effects of Oxytocin and Vasopressin on Moral Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: moral decision making
oxytocin
vasopressin
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To determine whether the neuropeptide oxytocin (OXT) and vassopressin (AVP) influence moral decision making

Detailed description: In a double-blind, between- subject placebo (PLC) controlled design, subjects will first complete a series of questionnaires in terms of mood, clinical symptoms, and traits. After that their moral judgment and emotion towards both verbal descriptions of moral dilemma scenarios and pictures of specific interpersonal ones will be assessed and the effect of intranasal OXT and AVP between both male and female healthy subjects will be investigated.

Eligibility criteria: Inclusion Criteria:

* healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Effect of OXT and AVP on behavioral index of moral decision task
timeFrame: 45 mins - 105 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Sichuan
country: China
facility: Xiaoxiao Zheng
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Keith M. Kendrick
role: PRINCIPAL_INVESTIGATOR
References: