louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01192373: Modulation of Free Fatty Acids in Heart Failure Patients With Diabetes: "Effect on Left Ventricular Function"
Official title: Short Term Modulation of Circulating Free Fatty Acids in Heart Failure Patients With Type 2 Diabetes: "Effect on Myocardial Lipid Content, Left Ventricular Function and Exercise Capacity"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Diabetes
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Heart Foundation
First posted: 2010-09-01
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators wish to investigate the the short term effect of low circulating free fatty acids in congestive heart failure patients with type 2 diabetes.

Hypothesis: Low levels of circulating free fatty acids decrease myocardial and peripheral muscle lipid content, improves cardiac performance and exercise capacity.


Eligibility criteria: Inclusion Criteria:

* ejection fraction at or lower than 45%
* type 2 diabetes

Exclusion Criteria:

* known s-creatinine \>220mM
* known S-alanine aminotransferase \>3 times normal upper limit
* other disabilitating conditions
* pregnancy
* insulin treatment

Primary outcomes:
measure: Left ventricular function
timeFrame: 1-6 weeks
measure: intracellular lipid content
timeFrame: 1-6 weeks
measure: Exercise capacity and oxygen consumption
timeFrame: 1-6 weeks
Secondary outcomes:
measure: Regional left ventricular function
timeFrame: 1-6 weeks
measure: 6 minutes hall walk test
timeFrame: 1-6 weeks
measure: metabolic and hormonal profile
timeFrame: 1-6 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dept. of cardiology, Aarhus University hospital Skejby,
state: Region Midjylland
Study officials:
affiliation: Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark
name: Roni R Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nielsen R, Norrelund H, Kampmann U, Kim WY, Ringgaard S, Schar M, Moller N, Botker HE, Wiggers H. Failing heart of patients with type 2 diabetes mellitus can adapt to extreme short-term increases in circulating lipids and does not display features of acute myocardial lipotoxicity. Circ Heart Fail. 2013 Jul;6(4):845-52. doi: 10.1161/CIRCHEARTFAILURE.113.000187. Epub 2013 Jun 3.
Clinical trial NCT05094973: Predictability of Distalization and Derotation of the Carriere Motion Appliance.
Official title: Predictability of Distalization and Derotation of the Carriere Motion Appliance. A Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Malocclusion
Keywords: Class II malocclusion
Carriere Motion Appliance
Distalization
Derotation
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 15
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study included 15 patients with Class II molar relationship and Class II canine relationship treated using Carriere Motion Appliance®.
Primary purpose: TREATMENT

Brief summary: To analyze the distalization or distal tooth displacement and derotation angle produced by Carriere Motion Appliance® (CMA) by using a repeatable and reproducible measurement digital technique.

Detailed description: 15 patients with Class II molar and canine relationship were submitted to orthodontic treatment with CMA. All patients were exposed preoperatively (STL1) and postoperatively (STL2) to a digital impression and afterwards were uploaded into a specific cephalometric software to allow the automatic mesh networks alignment of the STL digital files. Subsequently, the distal tooth displacement of upper canines and first upper molars and also the derotation angle of first upper molars were measured. The repeatability and reproducibility were analyzed by Gage R\&R statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Growing patients
* Late mixed dentition or permanent dentition
* Fully erupted definitive molars
* No history of previous orthodontic treatment
* Complete pre- and post-treatment records (digital study models)
* Dental Class II relationship.

Exclusion Criteria:

* Permanent dentition
* Adults
* Dental Class I, III

Primary outcomes:
measure: Mean Canine Distalization
timeFrame: 4 months
measure: Mean Molar Distalization
timeFrame: 4 months
measure: Mean Molar Derotation
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: University of Salamanca
state: Castilla Leon
Study officials:
affiliation: University of Salamanca
name: Aldara Nercellas Rodríguez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01371773: Repositioning Method for Left-sided Double Lumen Tubes
Official title: Repositioning Method for Left-sided Double Lumen Tubes Introduced Into Right Mainstem Bronchus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Morbidity
Intubation Complication
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-06-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 devise repositioning method of a left-sided double lumen tube into left mainstem bronchus in case of misplacement into right mainstem bronchus.


Eligibility criteria: Inclusion Criteria:

* patients undergoing thoracic surgery that requires the placement of left-sided double lumen tubes

Exclusion Criteria:

* intraluminal lesion of left bronchus
* very distorted anatomy of tracheobronchial tree

Primary outcomes:
measure: repositioning success rate
timeFrame: up to 10 minutes
Secondary outcomes:
measure: anatomic parameters
timeFrame: up to 1 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Seo JH, Bae JY, Kim HJ, Hong DM, Jeon Y, Bahk JH. Misplacement of left-sided double-lumen tubes into the right mainstem bronchus: incidence, risk factors and blind repositioning techniques. BMC Anesthesiol. 2015 Oct 28;15:157. doi: 10.1186/s12871-015-0138-1.
Clinical trial NCT03020173: The Difference Seen in Granulosa Cells and Immature Oocytes in IVF Treated Patients Sorted by Body Mass Index (BMI)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Female
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-01-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infertile women undergoing IVF treatment

Brief summary: This study aims to discover the connection between BMI and oocyte and granulosa consistencies.


Eligibility criteria: Inclusion Criteria:

* Infertile women undergoing IVF
* Consent to participate in study

Exclusion Criteria:

* Fertility preservation due to cancer
* Endocrine disorders

Primary outcomes:
measure: Measurement of composition of granulosa cells and oocytes
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01496573: Biomarkers in Tumor Tissue Samples From Younger Patients With Rhabdomyosarcoma
Official title: Observational - CRKL Expression at the Protein Level in Rhabdomyosarcoma Tumors by Tissue Microarray (TMA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alveolar Childhood Rhabdomyosarcoma
Childhood Rhabdomyosarcoma
Embryonal Childhood Rhabdomyosarcoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-12-21
Enrollment: 77
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Alveolar rhabdomyosarcoma and embryonal rhabdomyosarcoma

Brief summary: This research trial studies biomarkers in tumor tissue samples from younger patients with rhabdomyosarcoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

Detailed description: PRIMARY OBJECTIVES:

I. To demonstrate CRKL expression at the protein level in rhabdomyosarcoma tumors by tissue microarray (TMA).

OUTLINE:

Archived tumor tissue samples are analyzed for CRKL expression.

Eligibility criteria: Inclusion Criteria:

* Alveolar rhabdomyosarcoma and embryonal rhabdomyosarcoma specimens from the Children Oncology Group (COG) tumor microarrays (TMAs)

Primary outcomes:
measure: CRKL expression at the protein level
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Lee Helman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03963973: A 28 Day Parallel Group Study to Assess the Effects of RDN-929
Official title: A Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetic (PK) Profile of Multiple Oral Doses of RDN-929 in Healthy Older Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-28
Enrollment: 7
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Eligibility will be assessed during a screening period of up to 4 weeks. Subjects will take study medication once daily up to and including Day 28. Safety, tolerability and PK will be measured at each visit.


Eligibility criteria: Inclusion Criteria:

* Adult males or postmenopausal or surgically sterile females age 55 - 85 years old.
* Healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, neurological examination, laboratory tests and ECG recording

Exclusion Criteria:

* Any history of major psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal (ULN)
* A clinically significant abnormality on physical examination, neurological examination, ECG, or laboratory evaluations
* A clinically significant vital signs abnormality, as judged by the principal investigator

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: up to 9 weeks
measure: Number of subjects with Physical exam findings
timeFrame: up to 9 weeks
measure: Number of subjects with Clinical safety lab changes
timeFrame: up to 9 weeks
measure: Number of subjects with Systolic blood pressure changes
timeFrame: up to 9 weeks
measure: Number of subjects with Heart rate changes
timeFrame: up to 9 weeks
measure: Number of subjects with 12 Lead ECG changes
timeFrame: up to 9 weeks
Secondary outcomes:
measure: Maximum observed plasma concentration, Cmax
timeFrame: Day 1 to Day 28
measure: Area Under the plasma and CSF concentration time curve, AUC
timeFrame: Day 1 to Day 28
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Brain Research Center
city: Leeuwarden
country: Netherlands
facility: QPS Netherlands B.V.
Study officials:
affiliation: QPS Holdings LLC
name: PI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03577873: RCT on Necessity of Cholecystectomy for Patients After Clearance of Bile Duct Stones
Official title: Randomized Controlled Trial on Necessity of Cholecystectomy for Patients With Bile Duct Stones Combined With Gallbladder Stones After Clearance of Stones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallbladder Stones
Complication
Cholecystectomy
Keywords: gallbladder stones
common bile duct stones
Endoscopic retrograde cholangiopancreatography
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To discuss necessity of cholecystectomy for patients with stones in their bile ducts and gallbladders in the absence of absolute operation indications of cholecystectomy after clearance of bile duct stones with ERCP.

Detailed description: Cholecystectomy was recommended for patients with stones in their bile ducts and gallbladders in European and American countries after clearance of bile duct stones with ERCP, which reduced the incidence of biliary events. However, some researches showed that the incidence of biliary events was not reduced but increased.The purpose of this study is to discuss the necessity of cholecystectomy for patients with stones in their bile ducts and gallbladders in the absence of absolute operation indications of cholecystectomy after clearance of bile duct stones with ERCP.

Eligibility criteria: Inclusion Criteria:

Obtention of a written informed consent; Clinical diagnosis of gallbladder stones and common bile duct stones; No absolute operation indications of cholecystectomy

Exclusion Criteria:

Intrahepatic stones; Malignant tumor disease ;

Primary outcomes:
measure: biliary events
timeFrame: 12 months
Secondary outcomes:
measure: adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
Study officials:
affiliation: First People's Hospital of Hangzhou
name: Xiangfeng Zhang, M.S
role: STUDY_DIRECTOR
References:
citation: Heo J, Jung MK, Cho CM. Should prophylactic cholecystectomy be performed in patients with concomitant gallstones after endoscopic sphincterotomy for bile duct stones? Surg Endosc. 2015 Jun;29(6):1574-9. doi: 10.1007/s00464-014-3844-8. Epub 2014 Oct 8.
Clinical trial NCT01139073: A New Portable Monitor for Measuring Odorous Compounds in Oral, Exhaled and Nasal Air
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Halitosis
Keywords: Halitosis
Lead sponsor: Okayama University
Sponsor class: OTHER
First posted: 2010-06-08
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects were recruited at the Clinic of Preventive Dentistry, Okayama University Hospital.

Brief summary: The B/B Checker, a new portable device for detecting odorous compounds in oral, exhaled, and nasal air, is now available. As a single unit, this device is capable of assessing several kinds of gases mixed with volatile sulfur compounds (VSCs) in addition to other odorous gasses. The purpose of the present study was to evaluate the effectiveness of the B/B Checker for detecting the malodor level of oral, exhaled, and nasal air.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of oral malodor

Exclusion Criteria:

* Smoker
* Medical disorders
* Undergoing any antibiotic or other antimicrobial therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Tamaki N, Kasuyama K, Esaki M, Toshikawa T, Honda S, Ekuni D, Tomofuji T, Morita M. A new portable monitor for measuring odorous compounds in oral, exhaled and nasal air. BMC Oral Health. 2011 Apr 20;11:15. doi: 10.1186/1472-6831-11-15.
Clinical trial NCT06830473: KTRSensor Scotland Study: An Observational Study Into Predictors and Diagnosis of Kidney Transplant Rejection
Official title: KTRSensor Scotland Study: Investigating the Role of Biomarkers in Kidney Transplant Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplant
Kidney Disease, Chronic
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population sampled from those who have recently undergone renal transplant in a Scottish transplant centre

Brief summary: An observational study capturing real world transplant patients in the post-operative setting aiming to further determine the utility of biomarkers to improve outcomes.

Detailed description: A prospective longitudinal observational study capturing patients receiving kidney transplants in Scotland. The primary objective is to assess whether there are clinical biomarkers present in the urine that determine the outcome of kidney transplants and predict early graft rejection.

Eligibility criteria: Any patient within a Scottish Transplant centre who has undergone renal transplant (+/- pancreas/islet) and is due to attend routine follow-up appointments at the index centre.

Exclusion criteria:

* no previous kidney transplant
* patient attending follow-up at a peripheral site
* unable to provide urine samples across the study duration

Primary outcomes:
measure: Number of participants that experience acute transplant rejection
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
Study officials:
affiliation: University of Edinburgh
name: Marc Vendrell, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02727673: Relationship Between Circulating Tumor Stem Cells and the Clinical Pathology
Official title: A Prospective Randomized Trial on the Relationship Between Circulating Tumor Stem Cells and the Clinical Pathology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Stem Cells
Postoperative Recurrence and Metastasis
Hepatocellular Carcinoma
Keywords: cancer stem cells
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 250 healthy volunteers, 250 patients with hepatitis cirrhosis, 500 patients with HCC;

Brief summary: The aim of this study is to establish a platform of detecting and sorting circulating tumor stem cells from peripheral blood in HCC patients; to investigate the relationship between circulating tumor stem cells and their effects on postoperative recurrence and metastasis, in order to provide a new therapeutic target for hepatocellular carcinoma treatment.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients \> 18 years and \<=70 years of age;
2. No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
3. Patients who can understand this trial and have signed information consent

Exclusion Criteria:

1. Reject to attend；
2. Impossible to come to our hospital for physical examination regularly;
3. Patients with other diseases which may affect the treatment mentioned

Primary outcomes:
measure: the overall survival rate of each group
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern hepatobilliary surgery hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01201031: Reduction of Nosocomial Vancomycin -Resistant Enterococci (VRE) Colonization and Infection by Active Surveillance and Intervention of Infection Control
Official title: Reduction of Nosocomial VRE Colonization and Infection by Active Surveillance and Intervention of Infection Control (no)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: for the active surveillance of VRE colinization and infection
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-09-14
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: PROBABILITY_SAMPLE
Study population: patients admitted to RCC unit , and these patients received active surveillance of VRE colinization

Brief summary: Vancomycin -resistant enterococci(VRE) has emerged as one of the most common nosocomial pathogen of health-care associated infection since 1988. Although the new antimicrobial agents such as Tigecycline , Daptomycin, Linezolid have clinically effectiveness for the treatment of VRE, but there was not appropriate drugs for eradicating the colonization of VRE. So the active surveillance and strict contact precaution are the best methods for VRE colonization and transmission.

This is a one year study program, we select a unit as the study site. First month (January) is the prepare period. Therefore , we collect 3 months (from February to April) baseline data, then interrupted one month(May) for the health care worker's infection control education.

Then the intervention period are three months (from June to August), and the last four months(from September to December) are the analysis and evaluation period. In the baseline period, we only do the patient's active surveillance and environmental culture. In the intervention period, beside the patient's active surveillance and environmental culture, we add contact precaution as the infection control method. If patient has VRE infection, we prescribe appropriate antibiotic therapy until the culture result proved no growth of VRE.

The aim of this study is to compare and analyze these two period (baseline period and intervention period) for understanding the transmission, risk factors and carriage rate of VRE, as the important guidelines for the VRE infection control in the future.


Eligibility criteria: Inclusion Criteria:

* all patients admitted to RCC unit

Exclusion Criteria:

* if the patients or family refused the exam of anal swab .

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University-WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Wen-Sen Lee
role: PRINCIPAL_INVESTIGATOR
References: