louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03999073: Carotid Atherosclerosis in Patients With Aortic Coarctation
Official title: Carotid Atherosclerosis in Patients With Aortic Coarctation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Aortic Coarctation
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with aortic coarctation

Brief summary: Despite aortic coarctation (CoA) repair these patients have cardiovascular complications and coronary artery disease is the most common cause of death.

Detailed description: The aim with this study was to measure intima-media thickness (IMT) and plaques in arteries compared to cardiovascular markers in controls and patients with CoA.

Eligibility criteria: Inclusion Criteria:

* sex and age-matched controls

Exclusion Criteria:

* acute and chronic inflammation disease, underlying malignancies and diabetes mellitus.

Primary outcomes:
measure: Intima-media thickness
timeFrame: Intima-media thickness will be measured at one time point namely at inclusion. Data will be reported when study is completed, an average of 2 year.
Secondary outcomes:
measure: Cardiovascular markers
timeFrame: Blood samples will be taken at one time point namely at inclusion. Then biomarkers will be analysed when study is completed. Data will be reported when study is completed, an average of 2 year.
Other outcomes:
Locations:
Study officials:
References:
citation: Hlebowicz J, Holm J, Lindstedt S, Goncalves I, Nilsson J. Carotid atherosclerosis, changes in tissue remodeling and repair in patients with aortic coarctation. Atherosclerosis. 2021 Oct;335:47-52. doi: 10.1016/j.atherosclerosis.2021.09.016. Epub 2021 Sep 21.
Clinical trial NCT00355173: Pilot Study to Assess the Efficacy and Safety of the Lubo Cervical Collar
Official title: Pilot Study to Assess the Efficacy and Safety of the Lubo Cervical Collar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Elective Surgical Procedure
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-07-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Lubo cervical collar is a device that simultaneously maintains cervical spine control and keeps an open airway in a non-invasive manner. The purpose of the device is to manage cervical spine control and airway protection in the trauma patient.

Detailed description: Cervical spine stabilization is usually achieved by a semi-rigid collar. While these collars achieve the goal of supporting the cervical spine, they limit the possibilities for jaw thrust or other airway manipulations. Definitive airway protection usually must be achieved by orotracheal intubation. Thee Lubo collar is a device that simultaneously maintains cervical spine control and keeps an open airway in a non-invasive manner that is simple to operate. The objective of the study is to test the safety of the collar volunteers. The study is composed of two stages:1.healthy volunteers that will not undergo any intervention except testing the LCC.2. second group of patients scheduled to undergo an operation under general anesthesia with endotracheal intubation or laryngeal mask airway.

Eligibility criteria: Inclusion criteria

1. Males or females.
2. Age 18-60.
3. Normal airway anatomy, with expected easy ventilation and intubation.
4. Anesthetic risk- class 1or 2 by the American Society of Anesthesiologists (ASA) criteria.
5. Patients scheduled for an elective operation at the lower part of the body in supine position not supposed to last more then 2 hours.
6. Anesthetic plan- general anesthesia

Exclusion criteria

1. Known problems of the cervical spine.
2. Known problems of the temporomandibular joint.
3. Suspected difficult intubation or difficult mask ventilation.
4. High risk of gastric content aspiration.
5. Morbid obesity (BMI \>32).
6. Pregnancy
7. Psycho- social problems
8. Any cerebrovascular or cardiovascular disease
9. Known hypersensitivity reactions to fabrics or plastics
10. Any rash, eruption, wounds or sores at the upper torso, the neck and the head.
11. No participation in other clinical trail at the time of the trail

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Omri Lubovsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lubovsky O, Liebergall M, Weissman C, Yuval M. A new external upper airway opening device combined with a cervical collar. Resuscitation. 2010 Jul;81(7):817-21. doi: 10.1016/j.resuscitation.2010.02.013. Epub 2010 Apr 20.
Clinical trial NCT02835573: Potential Diagnostic and Prognostic Value of microRNAs for the Patients of Sepsis-induced Myocardial Injury
Official title: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis-induced Myocardial Injury
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-07-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of sepsis-induced myocardial injury

Brief summary: The purpose of this study is to evaluate the potential diagnostic and prognosis value of circulating microRNAs compared with cTnI for the patients of sepsis-induced myocardial injury at the emergency department (ED) and intensive care unit (ICU).


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of sepsis:SOFA score increase \>=2 at baseline level induced by infection.
2. Suspected myocardial injury,including 1 as follows at least:Low blood pressure or using vasoactive drugs; ECG changes(ST segment changes or pathological Q wave); Troponin elevation(\> 0.5 μg/L); BNP elevation(\> 4670pg/ml); Echocardiography: cardiac function decline(EF\<50%).

Exclusion Criteria:

1. Skeletal muscle damage (induced by orthopedics, vascular surgery or trauma surgical disease, surgery);
2. Pregnant and lactating women;
3. Patients with mental disorders;
4. Patients are using other experimental drugs;
5. Refusal to provide informed consent

Primary outcomes:
measure: Diagnostic value of microRNAs evaluate by qPCR in patients of sepsis-induced myocardial injury
timeFrame: Day 7
Secondary outcomes:
measure: Prognostic value of microRNAs in patients of sepsis-induced myocardial injury
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ethics Committee of Xinhua Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT05226273: Occupational Exposure to Dust and the Relationship With the Respiratory Symptoms, Lung Function Among Construction Workers of the University of Malaysia Sabah (UMS)
Official title: Occupational Exposure to Dust and the Relationship With the Respiratory Symptoms, Lung Function Among Construction Workers of the University of Malaysia Sabah (UMS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Occupational Exposure
Keywords: Occupational exposure, Air pollution, Lung function
Lead sponsor: Universiti Malaysia Sabah
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: construction workers who work at the construction site

Brief summary: Background The respiratory tract often becomes the site of injury from occupational exposure. All construction sites generate high levels of dust, typically from concrete, silica, asbestos, cement, wood, stone, sand and therefore, the workers are exposed to this airborne dust and increased their risk of developing respiratory disorders. Limited studies have been conducted to assess the relationship between respiratory symptoms, lung function and occupational dust exposure among construction workers in Sabah. The objectives of this study are to determine the occupational exposure to dust and the relationship with the respiratory symptoms as well as lung function among construction workers in UMS Teaching Hospital.

Materials and methods This cross-sectional study consisted of construction workers working in all sections in the development of UMS Teaching Hospital. A standard respiratory questionnaire was distributed to construction workers and lung function measurement was performed using Spirometry and the results of their respiratory status were compared between workers who were exposed and unexposed to dust. Occupational dust exposure was determined by the gravimetric method using an air sampler. The total duration of the collection was 8 hours and the filters with the dust samples were analyzed in the laboratory.


Eligibility criteria: Inclusion Criteria:

* all construction worker

Exclusion Criteria:

* has chronic lung impairment

Primary outcomes:
measure: Number of participants with Occupational exposure to dust
timeFrame: 2019-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Kota Kinabalu
country: Malaysia
facility: Universiti Malaysia Sabah
state: Sabah
Study officials:
References:
Clinical trial NCT04724031: Real World Data Analysis of PARP Inhibitors Use in Patients With Ovarian Cancer
Official title: Real World Data Analysis of PARP Inhibitors Use in Patients With Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: women with advanced high grade ovarian cancer who receive Parp inhibitors at any line of treatmen

Brief summary: Real-world clinical outcomes and toxicity data will be evaluated in patients with advanced high grade ovarian cancer who will receive PARP inhibitors.

Detailed description: A prospective-retrospective analysis of patients with histologically confirmed high grade ovarian cancer who will receive or received olaparib or niraparib will be conducted at any line of treatment.

Eligibility criteria: Inclusion Criteria:

- women \>18 years old with advanced high grade ovarian cancer

Exclusion Criteria:

-

Primary outcomes:
measure: Evaluation of Progression Free Survival
timeFrame: 12/2022
Secondary outcomes:
measure: Assessment of the safety profile of olaparib in women with advanced high grade ovarian cancer
timeFrame: 12/2021
measure: Assessment of the safety profile of niraparib in women with advanced high grade ovarian cancer
timeFrame: 12/2021
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Adamantia Nikolaidi
state: Attiki
Study officials:
References:
Clinical trial NCT01869231: Evaluating the Efficacy of Current Treatments for Reducing Postoperative Ileus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Ileus
Lead sponsor: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim was to investigate efficacy of current treatments - water, chewing gum, and olive oil, in resolving postoperative ileus.


Eligibility criteria: Inclusion Criteria:

* Patients underwent abdominal surgery for non neoplastic diseases

Exclusion Criteria:

* Metastatic disease
* History of inflammatory bowel disease
* Postoperative fever
* Gastrointestinal fistula
* Mint or olive allergy; and/or
* Earlier abdominal radiation

Primary outcomes:
measure: time to flatus
timeFrame: two days
Secondary outcomes:
measure: time to stool
timeFrame: five days
Other outcomes:
measure: length of hospital stay
timeFrame: seven days
Locations:
city: Palermo
country: Italy
facility: Università di palermo
Study officials:
References:
citation: Matros E, Rocha F, Zinner M, Wang J, Ashley S, Breen E, Soybel D, Shoji B, Burgess A, Bleday R, Kuntz R, Whang E. Does gum chewing ameliorate postoperative ileus? Results of a prospective, randomized, placebo-controlled trial. J Am Coll Surg. 2006 May;202(5):773-8. doi: 10.1016/j.jamcollsurg.2006.02.009.
citation: Bonventre S, Inviati A, Di Paola V, Morreale P, Di Giovanni S, Di Carlo P, Schifano D, Frazzetta G, Gulotta G, Scerrino G. Evaluating the efficacy of current treatments for reducing postoperative ileus: a randomized clinical trial in a single center. Minerva Chir. 2014 Feb;69(1):47-55.
Clinical trial NCT01553331: Day Case Laparoscopic Cholecystectomy: Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook
Official title: Day Case Laparoscopic Cholecystectomy: Comparison of Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystolithiasis
Keywords: laparoscopic cholecystectomy
Lead sponsor: Central Finland Hospital District
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting at triangle of Calot´s. Ultrasonic dissection starting from the gallbladder fundus is another option. The aim is to test the hypothesis that with ultrasonic dissection technique a better same day discharge and a shorter operative time can be achieved.

Detailed description: After initiation of general anesthesia patients are randomized either to conventional or ultrasonic dissection group. The patients and recovery room personnel are blinded to the operative technique used.

Eligibility criteria: Inclusion Criteria:

* ASA I-II
* BMI under 35
* normal liver enzymes
* no bile duct dilatation in ultrasound
* cholecystolithiasis

Exclusion Criteria:

* NSAID allergy
* previous upper gi-surgery
* common bile duct stones in preoperative imaging
* history of severe acute pancreatitis

Primary outcomes:
measure: same day discharge
timeFrame: 30 days
measure: operative time
timeFrame: 30 days
measure: intraoperative complications
timeFrame: 30 days
Secondary outcomes:
measure: analgetic use
timeFrame: 30 days
measure: postoperative nausea and vomiting
timeFrame: 30 days
measure: readmission
timeFrame: 30 days
measure: morbidity
timeFrame: 30 days
Other outcomes:
Locations:
city: Jyvaskyla
country: Finland
facility: Jyvaskyla Central Hospital
Study officials:
affiliation: Jyvaskyla Central Hospital
name: Ilmo Kellokumpu, Docent
role: STUDY_DIRECTOR
affiliation: Jyvaskyla Central Hospital
name: Anne K Mattila, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cengiz Y, Janes A, Grehn A, Israelsson LA. Randomized trial of traditional dissection with electrocautery versus ultrasonic fundus-first dissection in patients undergoing laparoscopic cholecystectomy. Br J Surg. 2005 Jul;92(7):810-3. doi: 10.1002/bjs.4982.
citation: Cengiz Y, Dalenback J, Edlund G, Israelsson LA, Janes A, Moller M, Thorell A. Improved outcome after laparoscopic cholecystectomy with ultrasonic dissection: a randomized multicenter trial. Surg Endosc. 2010 Mar;24(3):624-30. doi: 10.1007/s00464-009-0649-2. Epub 2009 Aug 18.
Clinical trial NCT00530231: Capsule Endoscopic Miss Rates Determined by Back-to-Back Capsule Endoscopy
Official title: Capsule Endoscopic Miss Rates Determined by Back-to-Back Capsule Endoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Capsule Endoscopy
Keywords: Capsule endoscopy
Missing rate
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2007-09-17
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to determine the missing rate of capsule endoscopy using back-to-back capsule endoscopy.


Eligibility criteria: Inclusion Criteria:

* Patients with obscure gastrointestinal bleeding

Exclusion Criteria:

* Intestinal stenosis or obstruction
* Swallowing difficulty
* History of abdominal surgery
* History of radiation therapy for abdominal or pelvic lesion
* Age \< 15 years
* Pregnancy
* Unstable vital sign or massive hematochezia
* Bleeding lesion, mass \> 2 cm, or intestinal stenosis found by CT angiography

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Dong Kyung Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05080231: COVID-19 Immunity Assessment
Official title: Blood Specimen Collection for COVID-19 Immunity Assessment Mailer Kit Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: DxTerity Diagnostics
Sponsor class: INDUSTRY
First posted: 2021-10-15
Enrollment: 662
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females ≥13 years old. Not vaccinated and were previously positive for COVID-19 OR are vaccinated for COVID-19.

Provides test report to demonstrate prior COVID-19 positive result (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects).

Provides informed consent and completed questionnaire. Able to register the collection kit on the DxTerity portal. Able to collect and ship blood samples back to DxTerity.

Brief summary: The purpose of this study is to collect blood specimens from individuals post infection or post vaccination over time to assess COVID19 Immunity.

Detailed description: The DxTerity COVID-19 Immunity Assessment Collection Mailer Kit contains the DxCollect MicroCollection Device (MCD) Serology fingerstick blood collection device packaged as a home collection kit, designed for collection and shipment of fingerstick blood back to DxTerity CLIA (Clinical Laboratory Improvements Amendment) certified laboratory for testing.

The clinical performance of the collection device for use with anti-SARS-CoV-2 antibody tests will be evaluated for use with cPASS™ anti-SARS-CoV-2 neutralizing antibody detection kit (EUA 201427).

The samples may also be used for assessing immunity or protection post COVID-19 vaccination.

Eligibility criteria: Inclusion Criteria:

* Males and females ≥13 years old.
* Not vaccinated and were previously positive for COVID-19 OR are vaccinated for COVID-19.
* Provides test report to demonstrate prior COVID-19 positive result (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects).
* Provides informed consent and completed questionnaire.
* Able to register the collection kit on the DxTerity portal.
* Able to collect and ship blood samples back to DxTerity.

Exclusion Criteria:

* Unable to provide COVID-19 positive test report (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects).
* Unable to complete informed consent and/or questionnaire.
* Unable to complete the study activities in a timely manner.

Primary outcomes:
measure: Neutralizing Antibody Levels
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Compton
country: United States
facility: DxTerity Diagnostics Inc.
state: California
Study officials:
References:
Clinical trial NCT01760031: Longterm Follow-up After Remote Ischemic Preconditioning for Prevention of Contrast-induced Nephropathy
Official title: Remote Preconditioning for Contrast-Induced Acute Kidney Injury: Long-Term Follow up (RenPro Longterm)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Impaired Renal Function
Keywords: preconditioning
contrast-induced acute kidney injury
renal faliure
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients refered for elective cardiac catherization to the university hospital of Cologne. All patients who participated to the RenPro trial (www.germanctr.de; DRKS-ID DRKS00000666)

Brief summary: Remote ischemic preconditioning reduces the incidence of contrast-induced acute kidney injury in patients undergoing elective coronary angiography. This study was designed to acquire long-term data of initially randomized patients in the RenPro Trial.

Detailed description: Data of the RenPro Trial has been already published. In the present study data of longterm follow up are collected.

Eligibility criteria: All patients who participated to the RenPro trial

Primary outcomes:
measure: MACCE
timeFrame: 1 Year
Secondary outcomes:
measure: Renal function
timeFrame: 1 year
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne
state: NRW
Study officials:
affiliation: University Hospital of Cologne
name: Fikret Er, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Er F, Nia AM, Dopp H, Hellmich M, Dahlem KM, Caglayan E, Kubacki T, Benzing T, Erdmann E, Burst V, Gassanov N. Ischemic preconditioning for prevention of contrast medium-induced nephropathy: randomized pilot RenPro Trial (Renal Protection Trial). Circulation. 2012 Jul 17;126(3):296-303. doi: 10.1161/CIRCULATIONAHA.112.096370. Epub 2012 Jun 26.