louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00782418: A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)
Official title: A Randomized Clinical Trial to Study Glucose Dependent Insulin Secretion Methodologies in Healthy Lean Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: The Methodology Assessment of Glucose Dependent Insulin Secretion
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will compare graded glucose infusion (GGI) to the hyperglycemic clamp (HGC) for assessment of glucose-dependent insulin secretion (GDIS) using exenatide as a probe.


Eligibility criteria: Inclusion Criteria:

* Subject has a Body Mass Index (BMI) of less than or equal to 26 kg/m2 at screening
* Subject is judged to be in good health
* Subject has been a nonsmoker for at least 3 months
* Subject is willing to avoid strenuous physical activity for the duration of the study

Exclusion Criteria:

* Subject has a history of high blood pressure requiring treatment
* Subject has a history of diabetes or a family history of diabetes mellitus
* Subject is unable to discontinue all prescription and non-prescription drugs for duration of study
* Subject consumes more than 3 alcoholic beverages per day
* Subject consumes more than 6 servings of caffeinated beverages per day (1 serving = 120mg caffeine)
* Subject has had major surgery or has donated or loss 1 unit of blood within 4 weeks of screening
* Subject has multiple and/or severe allergies to foods or drugs
* Subject is a regular user of illegal drugs
* Subject is unwilling or unable to consume the standardized meals during the study and/or is on a carbohydrate restricted diet

Primary outcomes:
measure: Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose
timeFrame: Steady-state of HGC: 90 - 120 minutes post dose; highest glucose infusion rate of GGI: 120 - 160 minutes post dose
measure: Change From Baseline in C-peptide Concentration
timeFrame: Pre and Post glucose infusion
measure: Change From Baseline in Insulin Concentration
timeFrame: Pre and Post glucose infusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Shankar SS, Shankar RR, Mixson LA, Miller DL, Chung C, Cilissen C, Beals CR, Stoch SA, Steinberg HO, Kelley DE. Linearity of beta-cell response across the metabolic spectrum and to pharmacology: insights from a graded glucose infusion-based investigation series. Am J Physiol Endocrinol Metab. 2016 Jun 1;310(11):E865-73. doi: 10.1152/ajpendo.00527.2015. Epub 2016 Apr 12.
Clinical trial NCT02049918: Residual Sample Collection for Respiratory Viral Panel
Official title: De-identified Residual Sample Collection for the Respiratory Viral Panel on the GenMark Sample to Answer Platform (ARM 1)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Viral Illnesses: Influenza A/B, RSV, Adenovirus
Keywords: Respiratory viruses
Lead sponsor: GenMark Diagnostics
Sponsor class: INDUSTRY
First posted: 2014-01-30
Enrollment: 1487
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children and adults of any age suspected of having respiratory infection.

Brief summary: Collect de-identified, residual samples to support a clinical trial. Samples may be prospectively or retrospectively collected. Overall Study Objective Obtain clinical performance data to characterize clinical performance of the Respiratory Viral Panel on the GenMark Sample-to-Answer Platform.

Detailed description: The purpose of this investigational study is to collect clinical samples to establish the clinical performance characteristics of the in vitro diagnostic (IVD) Respiratory Viral Panel on the GenMark Sample-to-Answer Platform. Data obtained from the samples will be used to support premarket submissions/registrations for this GenMark product. Samples will be aliquotted, characterized by comparator methods and banked until the instrument and assay are available for testing.

Sample collection may be prospective or retrospective. Prospective collection will preserve prevalence. Retrospective collection will be used to obtain sufficient numbers of certain sample types such as where the organism of interest is of low prevalence. The Sponsor will ensure that information identifying samples as prospectively or retrospectively collected is documented.

Eligibility criteria: Inclusion Criteria:

* Sample from patients exhibiting signs/symptoms of respiratory viral infection
* All medical standard-of-care testing requested by the submitting clinician is complete and has been reported to the clinician/requestor.

Exclusion Criteria:

* Samples that are incorrectly de-identified

Primary outcomes:
measure: Sample collection study only
timeFrame: prospective and retrospective sample collection
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Wallace Green, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ingalls Memorial Hospital
name: Michelle Fennell, MHA, MT(ASCP)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01215318: FDG Uptake in Vaginal Tampons is Due to Urine
Official title: Source and Prevention of Urinary Contamination of Vaginal Tampons During 18F-2-fluoro-2-deoxy-D-glucose (FDG) Positron Emission Tomography (PET) Examinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: FDG PET/CT, vaginal tampon, urinary contamination, pitfall
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-10-06
Enrollment: 44
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The etiology of FDG uptake in vaginal tampons during PET/CT examinations remains unclear and can potentially impair image interpretation.

The aim of this study is to determine the etiology of this artefact and identify potential means how to prevent it.

Detailed description: In this prospective, Institutional Review board approved study we included 44 women referred to FDG PET/CT for staging or follow-up in an oncology setting. All women were provided a normal commercial or modified vaginal tampon with a silicon coated base to be used during examination. Images were analyzed to determine the localization and the FDG uptake in the tampons. Between the uptake phase and imaging, all patients were asked to void. After image acquisition, tampons were individually analyzed for creatinine concentration, blood traces, position relative to the pubococcygeal line, and FDG activity. Statistical significance was determined by means of the Mann-Whitney U test.

Eligibility criteria: Inclusion criteria: premenopausal women with known or suspected malignancies who regularly used vaginal tampons during menstruation and thus were familiar with their use

Exclusion criteria: No cervical or genital carcinoma. No vaginal infection.

Primary outcomes:
measure: Number of FDG Positive Tampoons
timeFrame: 1 month
Secondary outcomes:
measure: Tampon Position Relative to the Pubococcygeal Line
timeFrame: 1 month
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT03594318: Versailles Hospital Cardiac Arrest Registry
Official title: Versailles Hospital Cardiac Arrest Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrest
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 1000
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: Cardiac arrest requiring Intensive Care Unit Management

Brief summary: Out-of-hospital and in-hospital cardiac arrest (CA) requiring intensive care unit management.

Data collection using a standardized form : demographic data and data related to the CA according to the Utstein guidelines.. Circumstances of onset, dates and times of onset and control of abnormal movements (myoclonus and.or seizures).

On-scene clinical findings, pre-hospital and hospital care providers, timing of various treatments and supportive care, results of etiological investigations, cause of CA. Dates and times of EEG monitoring, EEG results. Outcomes including vital status and Cerebral Performance Category scale score at ICU and hospital discharge, day-90 and 1-year after CA and determined based on data in the ICU and/or hospital/neurologist charts and/or general practitionner phone interview.


Eligibility criteria: Inclusion Criteria:

* Cardiac arrest requiring Intensive Care Unit management
* Age \>= 18 years

Exclusion Criteria:

- Refusal to participate

Primary outcomes:
measure: Long term favorable outcome
timeFrame: 1 year
Secondary outcomes:
measure: Short term favorable outcome
timeFrame: 3 months
measure: Postanoxic Status Epilepticus
timeFrame: 28 days
measure: Complications of anticoagulant/ antiplatelet therapies
timeFrame: 28 days
measure: Short term quality of life as assessed by the Short Form (36) Health Survey (SF36)
timeFrame: 3 months
measure: Long term quality of life as assessed by the Short Form (36) Health Survey (SF36)
timeFrame: 1 year
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: CH Versailles
Study officials:
affiliation: Intensive care unit
name: Legriel Stephane, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00320918: Chart Review: Unresectable/Metastatic Cholangiocarcinoma Treated With Irinotecan, Capecitabine and Celecoxib
Official title: Chart Review on Patients With Unresectable/Metastatic Cholangiocarcinoma Treated in the UNM Cancer Center With a Combination of Irinotecan, Capecitabine and Celecoxib
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cholangiocarcinoma
Keywords: Unresectable/metastatic cholangiocarcinoma
Cancer
Chart Review
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2006-05-03
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with unresectable/metastatic cholangiocarcinoma treated in the UNM Cancer Center with a combination of irinotecan, capecitabine and celecoxib.

Brief summary: Chart Review on Patients with unresectable/metastatic cholangiocarcinoma treated in the UNM Cancer Center with a combination of irinotecan, capecitabine and celecoxib.

Detailed description: As above.

Eligibility criteria: Inclusion Criteria:

* Patients with unresectable/metastatic cholangiocarcinoma treated in the UNM Cancer Center with a combination of irinotecan, capecitabine and celecoxib.

Exclusion Criteria:

* Not specified.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Fa-Chyi Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00128518: IDEAL Study: Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs
Official title: IDEAL Study : Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension - Drugs - Blood pressure response - Responders - pharmacogenetics
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2005-08-10
Enrollment: 139
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The principal scientific objective of the trial is to identify the factors that are associated with differential blood pressure responses between drugs. This may allow investigators to produce new hypotheses on the pathophysiology of hypertension and on the mechanisms of drug action.

These factors can be of different types:

* Environmental factors (sodium or alcohol intake);
* Morphological (height, weight, body mass index, body surface area);
* Initial blood pressure;
* Electrocardiogram (ECG) parameters of left ventricular hypertrophy;
* Biological parameters as the activity level of the renin angiotensin aldosterone system;
* Genetic polymorphisms.


Eligibility criteria: Inclusion Criteria:

* Participants have to be 25 to 60 years of age
* Both genders
* Systolic blood pressure of 140 mmHg or above; diastolic blood pressure of 90 mmHg or above.
* Cardiovascular risk must not be high, to allow for two periods of 4 weeks of placebo without ethical concern.

Primary outcomes:
measure: Blood pressure at the end of each 4 week treatment period
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: BRon
country: France
facility: Hôpital Louis Pradel
Study officials:
affiliation: Hospices Civils de Lyon
name: Francois GUEYFFIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gueyffier F, Subtil F, Bejan-Angoulvant T, Zerbib Y, Baguet JP, Boivin JM, Mercier A, Leftheriotis G, Gagnol JP, Fauvel JP, Giraud C, Bricca G, Maucort-Boulch D, Erpeldinger S; IDEAL Trial Group. Can we identify response markers to antihypertensive drugs? First results from the IDEAL Trial. J Hum Hypertens. 2015 Jan;29(1):22-7. doi: 10.1038/jhh.2014.29. Epub 2014 Apr 17.
Clinical trial NCT02967718: Innovation Research of Differentiation and Treatment Methods Based on CHD Phlegm and Blood Stasis Syndrome
Official title: Clinical Observation of CHD Phlegm and Blood-stasis Syndrome Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 13000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy, metabolic or coronary heart disease people, whose age is between 35-85 years old, either female or male, without any inflammation, fever, trauma, burn or operation within 1 week.

Brief summary: Coronary heart disease is still the major cause of death in China. Chinese medicine plays more and more important role in CHD prevention and treatment. Phlegm and blood stasis are its major pathological basis. Based on that, the investigator aims to evaluate the evolutionary process of CHD phlegm-blood stasis syndrome by large samples, multi-centre, cross-section observation combining with longitudinal tracking on-site survey method so as to guide the clinical treatment of CHD.

Detailed description: Coronary heart disease (CHD) is a major cause of myocardial infarct (MI) and death induced by atherosclerosis or coronary artery spasm. Despite improvements in interventional and pharmacological therapy for acute MI, the mortality early after AMI remains high. Nowadays, as our life quality develops and dietary structure changes, the morbidity of hyperlipidemia dramatically increased. Based on the Chinese medicine, hyperlipidemia belongs to phlegm and it's the basis of atherosclerosis, blood-stasis is the pathological basis of ischemia. Therefore, the investigator proposes that phlegm and blood-stasis syndrome is the main differentiation on CHD. Based on that, the investigator prospectively and retrospectively explores the evolutionary process of CHD phlegm-blood stasis syndrome by large samples, multi-centre, cross-section observation combining with longitudinal tracking on-site survey method.It will provide evidence and guidance to the future clinical treatment using Chinese medicine.

Eligibility criteria: Inclusion Criteria:

* Healthy or metabolism syndrome people
* Clinical diagnosis of CHD stable stage or acute coronary disease or CHD heart failure

Exclusion Criteria:

* Any inflammation, fever, trauma, burn or operation within 1 week
* Obstructive pulmonary disease
* Cerebral vascular disease
* Severe renal or hepatic dysfunction
* Malignant neoplasms
* Hematopoietic system disease
* Sever mental disease

Primary outcomes:
measure: all cause mortality
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijin
country: China
facility: The First Integrative Hospital of Beijing
state: Beijing
Study officials:
References:
Clinical trial NCT05619718: Loneliness Group Intervention
Official title: Loneliness Group Intervention for Geriatric Psychiatry Inpatients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Loneliness
Keywords: loneliness
geriatric
functional analytic psychotherapy
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Western University, Canada
First posted: 2022-11-17
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this pilot study is to determine the feasibility and acceptability of a group loneliness intervention in geriatric psychiatry inpatients. This type of group loneliness intervention is based on functional analytic psychotherapy and is called Awareness, Courage, and Love Groups.

Detailed description: The objective of our clinical trial is to adapt, implement, and evaluate a type of loneliness group intervention called Awareness, Courage, and Love Groups for older adults in a psychiatric unit. The following research questions will be answered: (a) Are ACL groups with geriatric psychiatry inpatients feasible and acceptable? (b) Do such ACL groups demonstrate preliminary efficacy?

Eligibility criteria: Inclusion Criteria:

* Admission to geriatric psychiatry inpatient unit

Exclusion Criteria:

* Individuals who are disoriented to person, delirious, unable to tolerate or participate meaningfully in the group, or otherwise unable to provide consent to research and psychotherapy

Primary outcomes:
measure: Inclusion of Other in the Self Scale (IOS)
timeFrame: Up to 2 months
measure: UCLA Loneliness Scale (ULS-6)
timeFrame: Up to 2 months
measure: Relational Health Indices (RHI)
timeFrame: Up to 2 months
measure: Quantitative Program Satisfaction
timeFrame: Up to 2 months
Secondary outcomes:
measure: Cantril Self-Anchoring Striving Scale
timeFrame: Up to 2 months
measure: Sacred Moment Qualities (SMQ)
timeFrame: Up to 2 months
Other outcomes:
measure: Satisfaction Questionnaire
timeFrame: Up to 2 months
Locations:
city: London
country: Canada
facility: Parkwood Institute Mental Health
state: Ontario
Study officials:
affiliation: St. Joseph's Health Care London
name: Elisabeth VanBussel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04922918: Ligilactobacillus Salivarius MP101 for Elderly in a Nursing Home
Official title: Administration of Ligilactobacillus Salivarius MP101 in an Elderly Nursing Home During the COVID Pandemics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Keywords: covid-19
elderly
nursing home
probiotics
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 25
Sex: ALL
Minimum age (years): 74
Maximum age (years): 98
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this work was to investigate the effect of Ligilactobacillus salivarius MP101 on the functional (Barthel index), cognitive (GDS/FAST) and nutritional (MNA) status, and on the nasal and fecal inflammatory profiles of elderly living in a nursing home highly affected by COVID-19.


Eligibility criteria: Inclusion Criteria:

* Living in the nursing home
* Informed consent obtained

Exclusion Criteria:

* Absence of informed consent
* Parenteral nutrition (exclusively)
* Allergy to cow's milk protein

Primary outcomes:
measure: Barthel index
timeFrame: 4 months
measure: MNA score
timeFrame: 4 months
measure: nasal and fecal immune profile
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Moralzarzal
country: Spain
facility: Centro Para Mayores Santa Isabel, S.L.
state: Madrid
Study officials:
References:
Clinical trial NCT05348018: Serious Games for Training in Oral Rehabilitation
Official title: Implementation of Game-based Training in Oral Rehabilitation of Edentulous Patients in Undergraduate Dental Course
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Keywords: health education
Lead sponsor: Hôpital Rothschild
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 89
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were allocated either to a "test" group which accessed Serious games during a four-week test period in addition to conventional lectures or to a "control" group which benefited solely from conventional lectures
Primary purpose: BASIC_SCIENCE

Brief summary: Coronavirus disease-19 (COVID-19) dramatically changed the learning conditions of dental students, with restricted access to training sessions and clinical practice. The "Playdent" project proposed the integration of serious games (SGs) in the third-year curriculum, based on tailor-made scenarios questioning the first dental visit of edentulous patients, and examined whether training with the games would advance students' learning outcomes.

Detailed description: Three Serious games proposed in addition to conventional lectures and practical exercises in oral rehabilitation of edentulous patients were supposed to improve knowledge and skills of undergraduates. However, in order to assess the influence of SGs on students' learning outcomes and subsequent satisfaction, a single-blind controlled protocol was designed. The null hypothesis was that SGs had no impact on the learning outcomes of undergraduate students.

Eligibility criteria: Inclusion Criteria:

* adult students (aged at least 18)
* enrolled in the third-year at the faculty of dental surgery of the University of Paris,
* agreeing to participate in the study

Exclusion Criteria:

* Third-year students who had repeated their courses

Primary outcomes:
measure: performance
timeFrame: One month
Secondary outcomes:
measure: students' satisfaction
timeFrame: one month
Other outcomes:
Locations:
city: Paris
country: France
facility: Université de Paris
state: Parisl
Study officials:
affiliation: Unievrsité de Paris
name: Adeline Braud, PhD
role: PRINCIPAL_INVESTIGATOR
References: