louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01497574: Within-subject Variability of Insulin Detemir in Children and Adolescents With Type 1 Diabetes
Official title: A Single-centre, Randomised, Double-blind, Cross-over Trial Comparing the Within-subject Variability of the Pharmacokinetic Profiles of Insulin Detemir and Insulin Glargine in Children and Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-22
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in children and adolescents with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Body mass index (BMI) for children (6 to 12 years): 15-20 kg/m\^2 (both inclusive)
* Body mass index (BMI) for adolescents (13 to 17 years): 18-25 kg/m\^2 (both inclusive)
* HbA1c (glycosylated haemoglobin) below 11.0% according to central laboratory results
* Current treatment with insulin at least twice daily

Exclusion Criteria:

* Any significant disease such as endocrine, hepatic, renal, cardiac, neurological, malignant, or pancreatic disease other than diabetes
* Receipt of any investigational product within the last four weeks
* Known or suspected allergy to trial products or related products

Primary outcomes:
measure: Area under the insulin concentration curve (AUC)
Secondary outcomes:
measure: Maximum insulin concentration (Cmax)
measure: Time to maximum insulin concentration (tmax)
measure: Adverse events
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Danne T, Datz N, Endahl L, Haahr H, Nestoris C, Westergaard L, Fjording MS, Kordonouri O. Insulin detemir is characterized by a more reproducible pharmacokinetic profile than insulin glargine in children and adolescents with type 1 diabetes: results from a randomized, double-blind, controlled trial. Pediatr Diabetes. 2008 Dec;9(6):554-60. doi: 10.1111/j.1399-5448.2008.00443.x. Epub 2008 Aug 27.
Clinical trial NCT01903174: Study of AeroForm Tissue Expander for Breast Reconstruction
Official title: AeroForm Patient Controlled Tissue Expansion for Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast Reconstruction
Keywords: Breast Cancer
Breast Reconstruction
Breast Tissue Expansion
Breast Tissue Expander
Two Stage Breast Reconstruction
Lead sponsor: AirXpanders, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-19
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction

Detailed description: The objective of this study is to provide performance and safety data to support the clinical use of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction in a patient population with a broad selection criteria

Eligibility criteria: Inclusion Criteria:

1. Subject is female between the ages of 18 - 70.
2. Subject has elected two stage breast reconstruction with tissue expanders.
3. Subject's tissue is amenable to tissue expansion.
4. Subject is able to provide written informed consent.
5. Subject is able and willing to comply with all of the study requirements.
6. Subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen.

Exclusion Criteria:

1. Subject has residual gross malignancy following mastectomy.
2. Subject has a current infection at the intended expansion site.
3. Subject has clinically significant radiation fibrosis at the expansion site.
4. Subject has planned radiation at the intended expansion site during the time the expander is implanted.
5. Subject has any co-morbid condition determined by the Investigator to place the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes).
6. Subject is currently participating in a concurrent investigational drug or device study.
7. Subject is a current tobacco smoker.
8. Subject is overweight with a BMI \> 33.
9. Subject has currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.
10. Subject is pregnant or planning to become pregnant during the study period.
11. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.

    -

Primary outcomes:
measure: Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event
timeFrame: 6 months
Secondary outcomes:
measure: Adverse Events related to the Breast Reconstruction Procedure
timeFrame: 6 months
Other outcomes:
Locations:
city: Subiaco
country: Australia
facility: Mount Hospital
state: Western Australia
Study officials:
affiliation: Mount Hospital
name: Tony Connell, F.R.A.C.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01072474: Capnography During ERCP
Official title: Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for ERCP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoxemia
Complications
Keywords: Safety
Sedation
Gastrointestinal endoscopy
Colonoscopy
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2010-02-22
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the study the value of capnography for avoiding complications during sedation for ERCP is evaluated.

Detailed description: In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.

Eligibility criteria: Inclusion Criteria:

* Age\>=18
* Scheduled for colonoscopy with midazolam and propofol sedation

Exclusion Criteria:

* No informed consent
* ASA V
* Pregnancy
* Prexisting hypotension, bradycardia or hypoxemia

Primary outcomes:
measure: Hypoxemia
timeFrame: From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h
Secondary outcomes:
measure: Further complications
timeFrame: From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technische Universität München
state: Bavaria
city: Bochum
country: Germany
facility: Knappschaftskrankenhaus der Ruhr-Universität Bochum
city: Wiesbaden
country: Germany
facility: Deutsche Klinik für Diagnostik
Study officials:
affiliation: Technical University of Munich
name: Stefan von Delius, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, Parsi MA, Sanaka MR, Zuccaro G. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology. 2009 May;136(5):1568-76; quiz 1819-20. doi: 10.1053/j.gastro.2009.02.004.
citation: Klare P, Reiter J, Meining A, Wagenpfeil S, Kronshage T, Geist C, Heringlake S, Schlag C, Bajbouj M, Schneider G, Schmid RM, Wehrmann T, von Delius S, Riphaus A. Capnographic monitoring of midazolam and propofol sedation during ERCP: a randomized controlled study (EndoBreath Study). Endoscopy. 2016 Jan;48(1):42-50. doi: 10.1055/s-0034-1393117. Epub 2015 Sep 28.
Clinical trial NCT06089174: Assessment of the Increased Risk of Infection Following an Ultratrail
Official title: Assessment of the Increased Risk of Infection Following an Ultratrail
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Running
Immune Deficiency
Infections
Keywords: Immune deficiency
Ultra-running
Infection
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
Collaborators: name: Jean Monnet University
name: Hôpital Privé de la Loire- Saint Etienne
First posted: 2023-10-18
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a descriptive cohort study comparing the occurrence of infection between exposed (runners of an ultra-trail) and unexposed subjects (their companions).
Primary purpose: DIAGNOSTIC

Brief summary: The increase in the practice of running has encouraged a proliferation of studies evaluating the impact of this sport on health. A number of these studies have looked at the influence of endurance events on the immune system. After prolonged exercise, a systemic inflammatory syndrome sets in, with repercussions for the functioning of the immune system. The number of lymphocytes in the blood is reduced, the function of natural killer (NK) cells is impaired and secretory immunity is impaired. During this period of immunosuppression, often referred to as the 'open window', the host may be more susceptible to micro-organisms that bypass the first line of defence.

The invetigators' hypothesis is therefore that ultratrailers are overexposed to the risk of infection due to immunodepression resulting from practising this sport. In order to support this hypothesis, the investigators would like to look at infectious complications in general and ear-nose and throat episodes (rhinitis, pharyngitis, laryngitis, etc.) in particular, which are the most common infections encountered in primary care, along with urinary tract infections.


Eligibility criteria: Inclusion Criteria:

* \> 18 years
* Participating in a Grand Raid de la Réunion 2023 race (Mascareignes, Trail de Bourbon, Diagonale des Fous)
* Have a companion living under the same roof during the week preceding the race and the 21 days following the race and who agrees to answer the questionnaires
* Do not object to the research

Exclusion Criteria:

* Do not understand French
* A protected adult (guardianship or curatorship) or under court protection

Primary outcomes:
measure: Increased risk of infection
timeFrame: Day 21
Secondary outcomes:
measure: Kinetic of infections' appearance
timeFrame: Day 21
measure: Risk factors: running distance
timeFrame: Day 21
measure: Risk factors: training volume
timeFrame: Day 21
measure: Risk factors: sex of the runner
timeFrame: Day 21
measure: Risk factors: age category
timeFrame: Day 21
Other outcomes:
Locations:
city: Saint-Denis
country: Réunion
facility: CHU Réunion
Study officials:
affiliation: CHU de la Réunion
name: Nicolas BOUSCAREN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00501774: A Search for Helicobacter Pylori in Localized Vulvodynia
Official title: A Laboratory and Clinical Search for the Presence of H. Pylori and Treatment Against it in Localized Vulvodynia (Vestibulitis, Vestibulodynia).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vulvodynia
Vulvar Vestibulitis
Keywords: Localized vulvodynia
Helicobacter pylori
peptic disease
omeprazole
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2007-07-16
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Hypothesis: to examine a possible association between localized vulvodynia and H. pylori infection.

Detailed description: Subsequent sections from the paraffin blocks were prepared and stained by modified Giemsa. Immunostaining for H. pylori was done as described. In short, tissue sections were deparaffinized in xylene, rehydrated through decreasing concentrations of alcohol ending in phosphate-buffered saline (PBS), and subjected to pretreatment with Proteinase K (8 minutes). The sections were quenched with 3% hydrogen peroxidase, incubated with protein block for 15 minutes at room temperature, and washed in PBS. Tissues then were incubated with polyclonal rabbit anti-H pylori antibody (dilution, 1:10; clone ch-20 429, DAKO, Carpinteria, CA). Finally, sections were washed in 0.05% polysorbate 20 in PBS, pH 7.4, and the bound antibody was detected using streptavidin and biotinylated secondary antibody with diaminobenzidine as the chromogen. Sections were counterstained with hematoxylin, dehydrated, and mounted. Negative controls were sections treated as above, but instead of incubation with the primary antibody, they were incubated with 1% bovine serum albumin in PBS.

Vulvar biopsies of seven other women without localized vulvodynia served as healthy controls.

The positive and negative control gastric tissues for the immunohistochemical stain of the H. pylori microorganisms were obtained from the archives of the Department of Pathology.

Eligibility criteria: Inclusion Criteria:

* Paraffin blocks of vestibular tissues from patients with Vestibulodynia

Exclusion Criteria:

* Patients without vestibulodynia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Pathology Laboratory
Study officials:
affiliation: westen Galilee Hospital
name: Jacob Bornstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harlow BL, Stewart EG. A population-based assessment of chronic unexplained vulvar pain: have we underestimated the prevalence of vulvodynia? J Am Med Womens Assoc (1972). 2003 Spring;58(2):82-8.
citation: Gray SF, Wyatt JI, Rathbone BJ. Simplified techniques for identifying Campylobacter pyloridis. J Clin Pathol. 1986 Nov;39(11):1279. doi: 10.1136/jcp.39.11.1279-a. No abstract available.
Clinical trial NCT06141174: Predictors of Outcome in Patients With Pleural Infection at Sohag University Hospital
Official title: Predictors of Outcome in Patients With Pleural Infection at Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pleural Infection
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients more than 18 years old with pleural infection

Brief summary: pleural infection remains a common medical problem with significant mortality and morbidity despite a better undrstanding of the aetiology , pathophysiology and recent advances in management approaches .

the cornerstones of the managment op pleural infection include early identification of cases and accurate diagnosis . suitable antibiotic therapy , nutrition managment , efficient drainage of infected collection via chest tube with or without adjunctive therapies including intrapleural agents and ultimately surgical managment .


Eligibility criteria: Inclusion Criteria:

* patients more than 18 years old with pleural infection

Exclusion Criteria:

* hemothorax
* chest trauma within 3 month
* underwent thoracic surgery within 60 days

Primary outcomes:
measure: lenght of hospital stay
timeFrame: 1 month
Secondary outcomes:
measure: mortality rate
timeFrame: up to 30 days , 3 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: Gould J. Pleural infection: a case where clinical improvement was misleading. BMJ Case Rep. 2013 Apr 18;2013:bcr2013008700. doi: 10.1136/bcr-2013-008700.
citation: Rahman NM, Maskell NA, West A, Teoh R, Arnold A, Mackinlay C, Peckham D, Davies CW, Ali N, Kinnear W, Bentley A, Kahan BC, Wrightson JM, Davies HE, Hooper CE, Lee YC, Hedley EL, Crosthwaite N, Choo L, Helm EJ, Gleeson FV, Nunn AJ, Davies RJ. Intrapleural use of tissue plasminogen activator and DNase in pleural infection. N Engl J Med. 2011 Aug 11;365(6):518-26. doi: 10.1056/NEJMoa1012740.
citation: Davies CW, Gleeson FV, Davies RJ; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of pleural infection. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii18-28. doi: 10.1136/thorax.58.suppl_2.ii18. No abstract available.
citation: Davies HE, Davies RJ, Davies CW; BTS Pleural Disease Guideline Group. Management of pleural infection in adults: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii41-53. doi: 10.1136/thx.2010.137000. No abstract available.
Clinical trial NCT05094674: Clinical Validation of Breath Analyser Tests for Diagnosis of COVID-19.
Official title: Clinical Validation of Biosafety Technologies Breath Analyser Tests for the Diagnosis of COVID-19; the Project Aims to Validate the Diagnostic Device and to Assess the Comparative Performance With RT-PCR Currently Being Deployed in the NHS.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Tera Group
Sponsor class: INDUSTRY
First posted: 2021-10-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The participant's breath sample is taken by blowing preferably three times into a disposable TeraTube. Thereafter, the tube is sealed, sterilized, and scanned by the BioSafety Station for analysis of its bio-chemical spectral signature. This will take place once during the study.
Primary purpose: DIAGNOSTIC

Brief summary: The Sponsor has developed a rapid screening tool intended to determine if the subject tested is COVID-19-free (Negative to COVID-19).

Detailed description: Within this proposed project, the NHS will collect two diagnostic or screening tests per participant. One sample will be used by NHS and be run through regular diagnostics. The second, will be breath sample which will be tested using the BioSafety Technologies Ltd, rapid screening tool. This will use a pre-defined protocol. These tests would then be compared to assess the diagnostic efficacy including sensitivity and specificities. We will be aiming to achieve a significant comparison to ensure certainty and to exploit the information for proposing a novel diagnostic system to enhance capabilities to scale up the testing of patients. The proposed activity involves clinical validation of BioSafety Testing, to enhance the performance of detection along with clinicians.

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Requiring a diagnostic or screening RT-PCR test for COVID-19

Exclusion Criteria:

* Subjects under general anaesthesia
* The inability to personally sign the consent form.
* The inability to exhale breath

Primary outcomes:
measure: Rate of positive and negative cases in collected breath samples using breath analyser test.
timeFrame: The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample
Secondary outcomes:
Other outcomes:
Locations:
city: Ashton Under Lyne
country: United Kingdom
facility: Tameside and Glossop Integrated Care NHS
state: Lancashire
Study officials:
affiliation: Tameside and Glossop Integrated Care NHS England
name: Ilan Lieberman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00376974: The Effect of Education on Patient Compliance
Official title: The Effect of Patient Education on Glaucoma Medication Compliance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Glaucoma
Keywords: glaucoma
compliance
intraocular pressure
video
Lead sponsor: Michael E. DeBakey VA Medical Center
Sponsor class: FED
Collaborators: name: Baylor College of Medicine
First posted: 2006-09-15
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: With patient education, the compliance with glaucoma medications will increase.

Detailed description: We divided glaucoma patients into two groups; one watched a video the others did not. We checked their intraocular pressures before and after the intervention to see if there was a difference

Eligibility criteria: Inclusion Criteria:

* Glaucoma patients coming in for routine examination

Exclusion Criteria:

* If glaucoma was unstable and treatment regimen required a change

Primary outcomes:
measure: Intraocular pressure
Secondary outcomes:
measure: Score on glaucoma educational test
Other outcomes:
Locations:
city: Houston
country: United States
facility: MDVAMC
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Silvia Orengo-Nania, m.d.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06398574: Effects of Dry Needling on the Behavior of the Shoulder Muscles
Official title: Effect of Dry Needling Technique on Shoulder Muscle Functionality in Subjects With and Without Shoulder Pain.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Pain
Keywords: Dry needling
Shoulder muscle strength
Surface electromyography
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study will be to evaluate the effects of the application of the dry needling technique on the activity of the rotator cuff muscles in the shoulder.

The evaluation of the effects of the application of the dry needling technique will be carried out in subjects with and without shoulder pain.To do this, muscle strength, possible thickness changes in the muscle and electromyographic activity will be measured before and immediately after the application of a dry needling technique.

Likewise, other variables will be measured such as the pressure pain threshold (PPT), pain with a Numeric Verbal Scale, kinesiophobia and catastrophism, the shoulder pain and disability index (SPADI) and the influence of expectations about dry needling.


Eligibility criteria: Inclusion Criteria:

* Subjects of legal age
* Subjects without shoulder pain or with unilateral shoulder pain of \> 3 months duration.
* Have shoulder mobility of 90º of abduction and at least 30º of glenohumeral external rotation.

Exclusion Criteria:

* Have neck pain.
* Whiplash
* Having had trauma to the shoulder.
* Having fibromyalgia.
* Be pregnant.
* Being afraid of needles.

Primary outcomes:
measure: Muscle strength
timeFrame: Change from Baseline at 15 minutes.
Secondary outcomes:
measure: Muscle function
timeFrame: Change from Baseline at 15 minutes.
measure: Shoulder Pain
timeFrame: Change from Baseline at 15 minutes.
measure: Disability
timeFrame: Change from Baseline at 15 minutes.
measure: Pressure Pain Threshold (PPT)
timeFrame: Change from Baseline at 15 minutes.
Other outcomes:
Locations:
city: Alcala de Henares
country: Spain
facility: Clinical University Physiotherapy and pain
state: Madrid
Study officials:
affiliation: Alcala University
name: Daniel Pecos-Martin, PhD
role: STUDY_CHAIR
References: