louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05397509: Effect of the Olive Leaf Tea Ingestion in Post-prandial Glycemic Response (OLIFTEA)
Official title: Effect of the Olive Leaf Tea Ingestion in Post-prandial Glycemic Response (OLIFTEA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Glucose
Lead sponsor: Instituto Politécnico de Bragança
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will test one beverage on the first visit and the other one on the second visit. A wash-out period of two weeks will be done.

Allocation of the first beverage to each participant is made by randomization.
Primary purpose: PREVENTION

Brief summary: This study tests the effect of Olive Tea Ingestion in ameliorating glycemic response after a high-glycemic meal

Detailed description: This study is a double-blinded, randomized, placebo-controlled clinical trial with cross-over design.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* currently taking drugs interfering with glucose regulation

Primary outcomes:
measure: Blood glucose
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bragança
country: Portugal
facility: escola Superior de Saúde
Study officials:
affiliation: Instituto Politécnico de Bragança
name: Manuela Meireles, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00682409: Magnetic Resonance (MR) Imaging in the Post Operative Follow-up of Cholesteatoma in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholesteatoma
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 37
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Classical imaging techniques are inaccurate to detect residual cholesteatoma. The aim of our study is to evaluate the value of diffusion-weighted MR imaging and delayed contrast enhanced T1 weighted spin-echo sequences in the detection of residual cholesteatoma in children, in a large serie of surgically verified cases.

Detailed description: Classical imaging techniques are inaccurate to detect residual cholesteatoma. Thin-section CT detects that the postoperative cavity is filled with a soft tissue mass. Classical MR imaging (T2 and T1 weighted spin-echo sequences) can not provide additionnal information about the nature of this filling : cholesteatoma, granulation or fibrous tissue.

Eligibility criteria: Inclusion Criteria:

* Female or male child enters 5 and 18 years
* Child having benefited from a surgical operation for cholesteatoma of the average ear acquired or congenital, one-sided or bilateral
* Child for whom an additional operating time is indicated
* Child without contraindication in the MRI
* Child having signed a enlightened assent
* Child among whom the parents or the legal representatives signed a enlightened assent

Exclusion Criteria:

* Child of less than 5 years old and more than 18 years
* Child presenting a chronic renal insufficiency
* Child for whom an additional operating time is not indicated
* Child having a contraindication in the MRI
* Child not having signed the assent or the parents of which did not sign the assent

Primary outcomes:
measure: Technical characteristics of the examination MRIs represented by the sensibility and the specificity of the test, with regard to the results stemming from the surgical operation
timeFrame: 24 months
Secondary outcomes:
measure: Only a surgical operation will confirm the diagnosis of cholesteatoma doing it again or residual.
timeFrame: 24 months
measure: It is necessary to test the following diagnostic method: the analysis of the morphological sequences in T1 and in T2 will allow to appreciate the existence or not of a filling of the cavity tympanique or the mastoïde and to clarify its localization.
timeFrame: 24 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital de la Timone- Service de radiologie pédiatrique et d'ORL pédiatrique
Study officials:
affiliation: Assistance Publique des Hôpitaux de Marseille
name: Brigitte BOURLIERE NAJEAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02573909: The Safety and Efficacy of Epidural Oxycodone
Official title: The Safety and Efficacy of Epidural Oxycodone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Admescope Ltd
First posted: 2015-10-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are conflicting results in earlier studies concerning the safety and efficacy of epidural oxycodone. In a study by Bäcklund and colleagues, epidural oxycodone was as effective as intravenous oxycodone, so they did not recommend epidural use of oxycodone. In another study, Yanagidate and Dohi reported that oxycodone was as effective in pain treatment with double dose compared to epidural morphine. In our previous study, epidural oxycodone provided safe and effective pain relief when compared to intravenous oxycodone.

In the present study, the aim was to compare the efficacy and safety of epidural or intravenous oxycodone in patients undergoing elective gynecological surgery with planned epidural pain treatment.


Eligibility criteria: Inclusion Criteria:

* Planned gynecological lower abdomen surgery with epidural pain treatment
* Informed consent obtained

Exclusion Criteria:

* Planned surgery under regional anesthesia
* contraindication to the study drug
* contraindication to the lumbar puncture
* Contraindication to oxycodone
* Pregnancy or lactation
* no informed consent

Primary outcomes:
measure: amount of rescue medicine
timeFrame: from zero hours up to four hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Northern Savo
Study officials:
affiliation: Kuopio University Hospital, Kuopio, Finland
name: Merja Kokki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05267509: An Integrated Radio-immunological Approach
Official title: Identification of the Immuno Suppressive Characteristics of Glioma Patients by an Integrated Radio-immunological Approach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioma, Malignant
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero-Universitaria Careggi
name: Azienda Ospedaliera di Padova
First posted: 2022-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologic confirmation of malignant glioma

Brief summary: The most aggressive primary brain tumors in adults, glioblastomas, are characterized by a profound local and systemic immune suppression. During tumor progression, the infiltration of inflammatory leukocytes, especially of myeloid origin, endowed with immunosuppressive function is observed. Aim of this study is to evaluate myeloid cell infiltrate and iron metabolism in tumor-associated macrophages by combining a multimodal MRI imaging technique with immunophenotyping of the tumor microenvironment.


Eligibility criteria: Inclusion Criteria:

* All patients with histologic confirmation of malignant glioma
* Patients must be age \>= 18 years
* Patients must be able to obtain an MRI scan with gadolinium contrast
* Patients must sign informed consent indicating that they are aware of the investigational nature of this study:

Primary outcomes:
measure: Evaluate leukocyte/myeloid cell-infiltrate in gliomas by using a multimodal PET/MRI imaging technique
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: Italy
facility: University Hospital
city: Padova
country: Italy
facility: University Hospital
Study officials:
affiliation: Istituto Oncologico Veneto IOV-IRCCS
name: Susanna Mandruzzato, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03193970: Measuring Surgical Recovery After Radical Cystectomy
Official title: Measuring Surgical Recovery After Radical Cystectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Keywords: Bladder Cancer
Registry
Post-surgical outcomes
Radical cystectomy
MD Anderson Symptom inventory
MDASI
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 2000
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: Bladder cancer patients undergoing radical cystectomy at the MD Anderson Cancer Center and the collaborating centers.

Brief summary: The intent of this study is to establish a registry of post-surgical outcomes in patients undergoing radical cystectomy at MD Anderson Cancer Center and the collaborating institutions. The goals of this initiative are to obtain a detailed baseline of multiple patient-reported outcomes (PRO) and clinician-reported outcomes (CRO) as well as various presenting conditions associated with them, so that future quality improvement interventions can be evaluated accurately as to their relative contribution to improved outcomes.


Eligibility criteria: Inclusion Criteria:

1. Bladder cancer patients undergoing radical cystectomy at the MD Anderson Cancer Center and the collaborating centers.

Exclusion Criteria:

N/A

Primary outcomes:
measure: Post-Surgical Outcomes in Patients Undergoing Radical Cystectomy
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Lawrence
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: John Hopkins Medical Institutions
state: Maryland
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group
state: Michigan
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Dallas
country: United States
facility: University of Texas - Southwestern
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Neema Navai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03876509: Non-invasive Diagnosis of Pulmonary Hypertension by Impedance Cardiography
Official title: Non-invasive Diagnosis of Pulmonary Hypertension by Thoracic Impedance Cardiography - a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Keywords: impedance cardiography
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 86
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: Patients of the clinical department of Pulmonology of the Medical University of Graz undergoing right heart catheterization for clinical reasons will be included

Brief summary: The goal of the study is to prospectively evaluate Impedance Cardiography as a tool to detect pulmonary hypertension. According to our hypothesis Impedance Cardiography is a valuable method to differentiate patients without pulmonary hypertension from patients with pulmonary hypertension. The main objective is to determine the sensitivity and specificity in comparison to the gold standard right heart catheterization.


Eligibility criteria: Inclusion Criteria:

* Written Informed Consent
* Patients with clinical indication for right heart catheterization

Exclusion Criteria:

* known Pregnancy

Primary outcomes:
measure: Diagnosis of pulmonary hypertension
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz, Division of Pulmonology
state: Steiermark
Study officials:
affiliation: Medical University of Graz
name: Horst Olschewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00717509: Association of Multiple Genetic Polymorphisms With Clozapine-Associated Metabolic Change in Schizophrenia
Official title: Cross-Sectional Study of the Association Between Multiple Genetic Polymorphisms and the Metabolic Side Effects in Patients With Schizophrenia Taking Clozapine More Than 1 Year
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Metabolic Syndrome
Genetic Polymorphism
Keywords: schizophrenia
metabolic side effect
clozapine
genetic polymorphism
Lead sponsor: Seoul National Hospital
Sponsor class: OTHER_GOV
First posted: 2008-07-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients with schizophrenia taking clozapine more than 1 year

Brief summary: We are going to investigate the association of multiple genetic polymorphisms with the metabolic side effects in patients with schizophrenia taking clozapine.

Detailed description: The use of antipsychotics, especially clozapine and olanzapine is associated with metabolic side effects, which put patients with schizophrenia at risk for cardiovascular morbidity or diabetes.

The prevalence of the metabolic syndrome was 53.8% of patients who taking clozapine. The high interindividual variability in antipsychotic-induced metabolic abnormalities suggests that genetic makeup is a possible determinant.

The genotypes of the multiple gene such as HTR2C, LEP, adrenergic receptor,PPAR,GNB3 are suggested to have associations with the metabolic side effects (weight,glucose,lipid,BP,metabolic syndrome) in patients using antipsychotics.

We are going to investigate whether those multiple genetic polymorphisms are associated with the metabolic side effects in patients taking clozapine.

Eligibility criteria: Inclusion Criteria:

* age 18-65
* who can understand and sign the informed consent

Exclusion Criteria:

* who refuse to participate this study

Primary outcomes:
measure: The associations between multiplegenetic polymorphisms (HTR2C,leptin,adrenergic receptor,PPAR,GNB3) and the metabolic side effects (weight,glucose,lipid,BP,metabolic syndrome)
timeFrame: more than 1 year after starting clozapine
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National Hospital
Study officials:
affiliation: Seoul National Hospital
name: Shi Hyun Kang, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03039309: Endoscopic Submucosal Dissection for Early GI Neoplasia in the United Kingdom
Official title: Endoscopic Submucosal Dissection in the Treatment of Early Gastrointestinal Neoplasia: A UK Cohort Study to Assess Effectiveness and Safety
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endoscopic Submucosal Dissection
Keywords: Endoscopic Submucosal Dissection
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2017-02-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing endoscopic submucosal dissection for early gastrointestinal neoplasia (e.g colorectal/gastric/oesophageal) in tertiary referral centres in the UK

Brief summary: Multicentre cohort study on the use of endoscopic submucosal dissection for the treatment of early gastrointestinal neoplasia.

Detailed description: Data will be collected from participating centres on en bloc resection, curative resection, R0 resection and complications/adverse events over a 2 year follow up period.

Demographic details on the patients included in the study will be captured alongside details on the size and location of their early gastrointestinal dysplastic/neoplastic lesions.

Eligibility criteria: Inclusion Criteria:

* Male or Female, aged 18 years or above undergoing endoscopic submucosal dissection
* Participant is able to give informed consent for participation in the study

Exclusion Criteria:

* Patients under the age of 18
* Patients unable to give informed consent

Primary outcomes:
measure: Curative resection rate
timeFrame: 2 years
Secondary outcomes:
measure: En bloc resection rate
timeFrame: At the time of procedure
measure: Complication rates
timeFrame: 28 days post procedure
measure: Mortality rates
timeFrame: 2 years
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmputh Hospitals NHS Trust
Study officials:
affiliation: Portsmouth Hospitals NHS Trust
name: Prof Pradeep Bhandari, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01192009: Leucine Supplementation and Skeletal Muscle Disuse
Official title: Leucine and Skeletal Muscle Disuse: Clinical Anti-Atrophic Effectiveness and Related Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disuse Atrophy
Keywords: Leucine
Skeletal Muscle Disuse
Atrophy
Proteolysis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-08-31
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Leucine supplementation is widely known for promoting strong influence on skeletal muscle remodeling. This study aims to evaluate the effect of leucine supplementation on disuse-induced skeletal muscle atrophy.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of anterior cruciate ligament injury
* Physically active
* Must be able to swallow tablets
* Non-smokers
* Do not use nutritional supplements

Exclusion Criteria:

* Post-surgical complications

Primary outcomes:
measure: Skeletal muscle structure (cross-sectional area)
timeFrame: 2 weeks
Secondary outcomes:
measure: Molecular signalling pathways (hypertrophy, atrophy, and inflammation)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo - School of Physical Education and Sports
Study officials:
affiliation: University of Sao Paulo
name: Humberto Nicastro, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zanchi NE, Nicastro H, Lancha AH Jr. Potential antiproteolytic effects of L-leucine: observations of in vitro and in vivo studies. Nutr Metab (Lond). 2008 Jul 17;5:20. doi: 10.1186/1743-7075-5-20.
citation: Nicastro H, Artioli GG, Costa Ados S, Solis MY, da Luz CR, Blachier F, Lancha AH Jr. An overview of the therapeutic effects of leucine supplementation on skeletal muscle under atrophic conditions. Amino Acids. 2011 Feb;40(2):287-300. doi: 10.1007/s00726-010-0636-x. Epub 2010 Jun 1.
Clinical trial NCT02616809: Effects of Standing and Light-intensity Activity on Ambulatory Blood Pressure and Blood Glucose
Official title: Effects of Standing and Light-intensity Activity on Ambulatory Blood Pressure and Blood Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Hypertension
Sleep
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study aims to test the short-term effects of intermittent standing, slow cycling and slow walking, compared to sitting, on continuous blood glucose and ambulatory blood pressure among pre-hypertensive and pre-diabetic adults.

Detailed description: This study will enroll 10 adults who will each complete four experimental conditions in random order. Each of the four experimental conditions are as follows: 1) sit continuously for 8 hours in a simulated office environment, 2) break-up sitting time with standing based on set hourly intervals, 3) break-up sitting time with slow-walking on a treadmill desk based on set hourly intervals, 4) increase energy expenditure by slow cycling based on set hourly intervals. Participants will completed each condition one week apart and dietary intake will be standardized by giving participants the same meals during each intervention condition. Study measures will include: anthropometrics (height and weight), blood pressure, fasting glucose, 24-continuous glucose monitoring, full-day ambulatory blood pressure monitoring, cognitive testing (cognitive performance), energy expenditure, physical activity via accelerometer, sleep via accelerometer, and heart rate.

Eligibility criteria: Inclusion Criteria:

* pre-hypertensive (systolic blood pressure 120-139 mmHg, or diastolic blood pressure 80-89 mmHg)
* impaired fasting glucose (5.6-6.9 mmil/L)
* not meeting the physical activity guidelines for adults (\>=150 min/wk of moderate-to-vigorous physical activity)

Exclusion Criteria:

* smoking, pregnancy, known coronary heart disease, orthopedic limitations for performing physical activity, taking medications to control high blood pressure or high blood glucose, special dietary requirements, and being advised by a doctor to avoid prolonged periods of sitting.

Primary outcomes:
measure: Evidence of change in blood pressure following changes in posture and increasing energy expenditure
timeFrame: single-day intervention
measure: Evidence of change in blood glucose following changes in posture and increasing energy expenditure
timeFrame: single-day intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: