louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06426823: The Role of GIP in Postprandial Splanchnic Blood Flow Distribution and Metabolism in Patients With Type 2 Diabetes
Official title: The Role of GIP in Postprandial Splanchnic Blood Flow Distribution and Metabolism in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Flow
Keywords: Gut hormones
GIP
Physiology
Type 2 diabetes
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2024-05-23
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single blind, placebo controlled, randomized, crossover study
Primary purpose: BASIC_SCIENCE

Brief summary: This project will describe the mechanisms of action and the relative contributions of GIP to changes in gastrointestinal blood flow induced by oral glucose and endogenous GIP with the use of a receptor antagonists GIP(3-30)NH2 in patients with type 2 diabetes.

Detailed description: Each participant will attend four independent randomised experimental days in the MRI-scanner with intravenous infusion (hormone/placebo) and oral ingestion (glucose/water): An intravenous infusion of saline or GIP(3-30)NH2 starts at time point -20 minutes.The infusions are combined with an oral glucose tolerance test (75 gram of glucose dissolved in 250 ml water ingested orally) at time point 0 minutes on two of the experimental days (with and without GIP(3-30)NH2).

MRI measurements are repeatedly performed and blood samples are drawn to be analysed for endocrine responses from the intestines, pancreas, and bones.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* BMI 20-35 kg/m\^2
* Age 20-80

Exclusion Criteria:

* Not MRI-compatible implants
* Claustrophobia
* Abnormal kidney or liver function
* Anemia
* Planned weight loss or change in diet
* Hypertension
* Other conditions that could be expected to affect the primary or secondary outcomes

Primary outcomes:
measure: Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (functional MRI)
timeFrame: 80 minutes
Secondary outcomes:
measure: GIP levels
timeFrame: 80 minutes
measure: GIP(3-30)NH2 levels
timeFrame: 80 minutes
measure: Glucose
timeFrame: 80 minutes
measure: C-peptide
timeFrame: 80 minutes
measure: Insulin
timeFrame: 80 minutes
measure: Glucagon
timeFrame: 80 minutes
measure: Blood flow in portal vein
timeFrame: 80 minutes
measure: Blood flow in coeliac trunc
timeFrame: 80 minutes
measure: Blood flow in hepatic artery
timeFrame: 80 minutes
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT04476823: European Pathology Laboratories and COVID-19
Official title: Practice in Clinical and Molecular Thoracic European Pathology Laboratories During the COVID-19 Pandemic.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinical Practice During the COVID-19 Crisis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 71
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pathology laboratories belonging to the Lung working group of the European Society of Pathology and to additional European pathology laboratories expert in thoracic diseases

Brief summary: The infectivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), notably when handling human samples, remains poorly understood, as well as the impact of the COVID-19 pandemic in routine clinical and molecular pathology practice, and for personal working in pathology laboratories. This study evaluates the consequences of the COVID-19 crisis in clinical and molecular pathology laboratories in Europe mostly those orientated for diagnosis of thoracic diseases.


Eligibility criteria: Inclusion Criteria:

* laboratories following the COVID-19 crisis

Primary outcomes:
measure: Activity
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References:
Clinical trial NCT01577823: Utility of Indwelling Catheter in Orthopaedic Patients Receiving Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Joint Arthroplasty
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2012-04-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: A study measuring utility of indwelling bladder catheter placement in orthopaedic surgical patients receiving spinal anesthesia. Study will track clinical outcomes, patient satisfaction and cost efficacy. Absence of indwelling bladder catheter may decrease urinary tract infection (UTI) incidence, increase patient satisfaction, and decrease cost burden without increasing postoperative urinary retention (POUR) incidence.


Eligibility criteria: Inclusion Criteria:

Elective orthopaedic surgical patients of all ages undergoing lower extremity adult reconstructive surgery with spinal anesthesia will be interviewed.

Exclusion Criteria:

Patients are excluded from the study preoperatively with a history of prostate or urological surgery, renal failure, previous documented POUR, current indwelling catheter, or acute UTI.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04245150: Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity
Official title: Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: DCIS
Invasive Breast Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with biopsy proven DCIS or invasive breast cancer, 18 years of age or older, undergoing breast conserving surgery and adjuvant radiation therapy at Cleveland Clinic.

Brief summary: Microorganisms in the human body (such as virus, bacteria, fungus) may have an important role in breast cancer side effects. In this study, microorganisms will be analyzed to determine which, if any,are present. It will then be determined if side effects from breast radiation are associated with these microorganisms. Understanding the association of microorganisms with side effects will allow the study team to look at strategies to reduce side effects for patients undergoing radiation to the breast.

Detailed description: This study will prospectively enroll 50 participants with with biopsy proven Ductal carcinoma in situ (DCIS) or invasive breast cancer 18 years of age or older, undergoing breast conserving surgery and adjuvant radiation therapy at Cleveland Clinic.

Each participant will have a post-surgery pre-radiotherapy stool and breast skin sample obtained, complete a medical record review for clinical data, and have complete an interview/questionnaire in order to learn about potential risk factors which will be included in the data collection form. Included information will include Stage (T, N, M, composite), receipt of chemotherapy, radiation fields and dose, BMI, hypertension (HTN), Diabetes Mellitus (DM), smoking status, history of breast infection yes/no (Data Collection Form).

Eligibility criteria: Inclusion Criteria:

* Breast cancer patients with DCIS or invasive breast cancer
* Undergoing breast conserving surgery and adjuvant radiation
* Subjects must be willing and able to provide breast skin samples

Exclusion Criteria:

* Active clinical breast infection (on antiobiotic for skin/breast infection or clinical diagnosis)
* Refuse or are unable to sign informed consent form
* Past history of breast cancer

Primary outcomes:
measure: Microbiome profile as assessed by stool sample
timeFrame: At baseline
measure: Microbiome profile as assessed by breast skin sample
timeFrame: At baseline
measure: Correlation of the microbiome to incidence of at least grade 3 skin toxicity using the CTCAE version 4.0 scoring
timeFrame: 3 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Chirag Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00460850: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.
Official title: An Open Label Study to Evaluate the Effect of PEGASYS on ALT and HBV DNA Levels in Patients With Lamivudine-Resistant HbeAg-Negative Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-04-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-65 years of age;
* HBeAg negative chronic hepatitis B;
* treated with lamivudine for \>=6 months;
* demonstrated lamivudine resistance;
* compensated liver disease.

Exclusion Criteria:

* severe hepatic dysfunction;
* previous treatment with antivirals other than lamivudine;
* immunosuppressant treatment in past 6 months;
* co-infection with hepatitis A, C, or D virus or human immunodeficiency virus;
* medical condition associated with chronic liver disease.

Primary outcomes:
measure: Normalization of ALT, and HBV-DNA <10,000 copies/mL
timeFrame: Week 96
Secondary outcomes:
measure: Normalization of ALT, and HBV-DNA <10,000 copies/mL
timeFrame: Weeks 48 and 72
measure: HBsAg loss and anti-HBs seroconversion
timeFrame: Weeks 48, 72 and 96
measure: AEs and lab parameters
timeFrame: Throughout study
Other outcomes:
Locations:
city: Ankara
country: Turkey
city: Antalya
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01249950: Study on the Appropriateness of Bariatric Surgery in Adolescents
Official title: Study on the Appropriateness of Bariatric Surgery in Adolescents
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Morbid Obesity
Keywords: Morbid obesity
teenagers
co-morbidities
bariatric surgery
epidemiology
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adolescents

Brief summary: single-center study carried out in order to evaluate in prospective among patients seen or treated in the pediatric endocrinology unit and multidisciplinary management of obesity, the potential number of patients eligible for surgery.

Detailed description: This is a feasibility study in order to file a subsequent national project as part of a PHRC on bariatric surgery in adolescents.

Eligibility criteria: Inclusion Criteria:

* failure of weight loss in an organized care\> 6 months
* BMI \> à 35 kg/m2 with presence of severe co-morbidities (diabetes, moderate or severe OSAS, intracranial hypertension, severe hepatic steatosis), which can be improved by a significant weight loss and sustainable OR BMI \> or = 40 kg/m2 with less severe co-morbidities (hypertension, GERD) and may worsen the health status including reduced quality of life.
* Patients must have completed their growth (bone age \> 13 for girls and \>15 for boys).
* The teenager and his legal representative must have given their informed consent.
* The subject must be affiliated to a social security scheme

Exclusion Criteria:

* syndromic obesities
* tumor-induced obesity
* Patient with severe psychiatric disorders
* Patient with eating disorders
* Patients under judicial protection
* Patient under guardianship or curatorship
* Patient participating in another study

Primary outcomes:
measure: potential number of patients eligible for surgery
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UHToulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Béatrice JOURET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02141750: THIRD NATIONAL REGISTRY OF ACUTE CORONARY SYNDROMES
Official title: THIRD NATIONAL REGISTRY OF ACUTE CORONARY SYNDROMES
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndromes
Lead sponsor: Third National Registry of Acute Coronary Syndromes
Sponsor class: OTHER
First posted: 2014-05-19
Enrollment: 8296
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: It will include patients older than 18 years with ACS final diagnosis and objective evidence of atherosclerotic coronary disease. Patients will be identified in the emergency department, coronary care units, intensive care units, hospital and hemodynamic laboratories

Brief summary: The Registry pretends to identify stratification, diagnosis and treatment approaches in patients with Acute Coronary Syndrome (ACS) in community hospitals with tertiary hospitals to optimize resources and identify strategies to improve health care quality through the creation of clinical guidelines that serve for unify management and treatment methods with adherence to international guidelines which include suggestions for treatment and medication.


Eligibility criteria: Inclusion Criteria:

all patients with suspected ACS and will analyze risk factors, chest pain and electrocardiographic characteristics.

Exclusion Criteria:

Patients with secondary ischemia (anaemia, pulmonary thromboembolism, myocarditis) and type II infarction.

Primary outcomes:
measure: Number of patients with complications after presenting ACS
timeFrame: up to one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04236323: The Effect of Remifentanil on Rebound Pain
Official title: The Effect of Remifentanil on Rebound Pain in Patients Receiving General Anesthesia for Shoulder Arthroplasty After Brachial Plexus Block for Postoperative Pain Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: hyperalgesia
brachial plexus block
remifentanil
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators will evaluate the influence of intraoperative remifentanil infusion on the postoperative hyperalgesia in patients receiving rotator cuff repair after brachial plexus block for postoperative analgesia.

Detailed description: The study will include 68 patients undergoing rotator cuff repair. All patients will receive brachial plexus block for postoperative analgesia, followed by general anesthesia. In the experimental group, remifentanil infusion will not be used intraoperatively, and in the control group, remifentanil will be infused. After surgery, both groups will be given the same postoperative pain management using patient controlled analgesia(PCA), and pain patterns will be assessed using the Numerical rating scale (NRS) at 4 hour intervals for 24 hours. The primary end point of this study is the total dose of PCA medication over 24 hours.

Eligibility criteria: Inclusion Criteria:

* ASA class I,II,III
* Patients undergoing arthroscopic rotator cuff repair surgery under general anesthesia after interscalen brachial plexus block for post operative analgesia
* Age ranges from 20 to 70

Exclusion Criteria:

* Patients who didn't agree to study
* Patients can't control PCA(Patient-Controlled-Analgesia) independently
* Patients who have conciousness disorder or can't express their pain level by NRS(Numeric Rating Scale) system
* Patients who have severe respiratory disease or hepatic failure
* Patinets who have known neuropathy or coagulopathy
* Pregnancy
* Patients with allegies to the drugs used in this study

Primary outcomes:
measure: Total infused dose of patient controlled analgesia(PCA) drug during 24 hours
timeFrame: From end of operation to the 24hours after operation
Secondary outcomes:
measure: Numerical Ratings Scale
timeFrame: Pain levels are checked using Numerical Ratings Scale at 4 hour intervals for 24 hours after surgery
measure: Total patient's trial to PCA bolus infusion
timeFrame: 24 hours after surgery
measure: Incidence of postoperative nausea and vomiting
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02847923: Software for Alternative Communication
Official title: Software for Alternative Communication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Speech Impairment
Keywords: Mobile Devices
Augmentative and Alternative Communication
Cerebral Palsy
Lead sponsor: University of Mogi das Cruzes
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Instituto Federal de Educação, Ciência e Tecnologia de São Paulo - IFSP
First posted: 2016-07-28
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is evaluate a software developed for alternative communication designed for people with speech difficulties. The software was executed by 30 volunteers using mobile devices that helped to play the scenarios simulated of communication situations.

Detailed description: Communication is a fundamental element that contributes to the development of the human being, promoting their coexistence in society. However, several factors, among them the Cerebral palsy (CP), can cause changes in muscle tone, causing injury in phono-articulatory which prevent or impair the speech production. This research aims to the development of a mobile application to promote the augmentative and alternative communication for people with CP, which adapt to the characteristics of motor limitations of these users. A mobile application was developed with pictographic resources and a voice synthesis engine, which can be customized according to the level of motor impairment and need for communication of the user. Were recruited 30 volunteers with CP who have speech difficulties and motor impairment. By means of a test script, these volunteers have used the mobile application and evaluated their usability using the questionnaire System Usability Scale (SUS), which contains 10 questions related to the ease of learning, efficiency, ease of memorization, occurrence of runtime errors of execution and level of user satisfaction.

Eligibility criteria: Inclusion Criteria:

* Cerebral Palsy and speech disorder

Exclusion Criteria:

* visual impairment and / or severe cognitive impairment

Primary outcomes:
measure: Questionnaire
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mogi das Cruzes
country: Brazil
facility: Cid Torquato
state: São Paulo
city: Suzano
country: Brazil
facility: Sesi Suzano
state: São Paulo
Study officials:
affiliation: Núcleo de Pesquisas Tecnologicas - NPT/UMC
name: Flávio C Amate, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05362123: Survey on the Effectiveness of the PLAB Examination in Continuing Clinical Education in British Doctors.
Official title: Survey the Effectiveness of PLAB Examination in Further Clinical Training in the United Kingdom
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: International Medical Graduate Student
Lead sponsor: Jabir Ibn Hayyan Medical University
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cross-sectional

Brief summary: Online survey for all international medical graduate doctors who decided to get a job in the UK; they must do GMC registration.


Eligibility criteria: Inclusion Criteria:

* Post-PLAB exam and GMC registration international medical graduate
* Candidates who practise in NHS as FY1 and FY2

Exclusion Criteria:

* Pass PLAB one exam
* Pass PLAB two exam
* Candidates pass PLAB one and two but still not working in NHS

Primary outcomes:
measure: cross section online google form questioner
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Westbury On Severn
country: United Kingdom
facility: West Suffolk Hospital
state: West Suffolk
Study officials:
References: