louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02871180: Late Night Snack and Insulin Glargine
Official title: A Late Night Snack May be Necessary to Prevent Nocturnal Hyperglycemia in Type 1-diabetic Patients Using Insulin Glargine (LANTUS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Hypoglycemia
Keywords: Hypoglycemia
Type 1 diabetes
Lead sponsor: Diabeteszentrum Bad Lauterberg im Harz
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Twenty patient with Type 1 diabetes, using insulin glargine as basal insulin, participated in a prospective, controlled crossover trial comparing blood glucose profiles over two 24 h periods with and without a late night snack (a slice of rye bread, 20 g carbohydrates, at 10 p.m.), in randomized order. The main endpoint was the number of hypoglycemic episodes with a confirmed laboratory blood glucose ≤ 50 mg/dl between 10 p.m. and 8 p.m. the following day. Secondary endpoint was the blood glucose profile during this period.

Detailed description: The order of studies (with and without a late night snack) was determined by randomization. Study-related procedures started at 6 p.m. (standard blood glucose profiles with determinations at 6, 8, and 10 p.m, at midnight, at 2, 4, 6:45, 8:45 a.m., and at noon and 2, 6, and 8 p.m. of the following day). At 10 p.m. a late night snack (one slice of whole meal rye bread containing approximately 20 g of carbohydrate) was eaten or no nutrients were consumed, as determined by the randomization protocol. After one day without study-related activities, the study was repeated with the complementary protocol (crossover design). Patients were instructed to use fast-acting insulin to correct hyperglycemia three times per day (before major meals) or to take in additional carbohydrate when symptomatic or chemical hypoglycemia was noted. They were asked not to perform strenuous exercise beyond their normal daily activities.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Basal insulin substitution with insulin glargine at least 3 month

Exclusion Criteria:

* Severe disorders
* Severe and clinical significant gastroparesis
* History of pancreatitis or pancreatic cancer
* Severe Liver disorder (liver enzymes \> three times upper normal limit)
* Pregnancy
* Drug- or alcohol abuse

Primary outcomes:
measure: Hypoglycemia
timeFrame: 26 hours
Secondary outcomes:
measure: Blood glucose profile
timeFrame: 26 hours
Other outcomes:
Locations:
city: Bad Lauterberg
country: Germany
facility: Diabeteszentrum Bad Lauterberg
state: Niedersachsen
Study officials:
affiliation: St. Josef-Hospital
name: Michael A. Nauck, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04401280: Bioactive Glass in the Treatment of Enamel White Spot Lesions
Official title: Effectiveness of Novel Bioactive Glass in the Treatment of Enamel White Spot Lesions : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: White Spot Lesion of Tooth
Keywords: Bioactive glass
CPP-ACP
Remineralization
White spot lesions
Lead sponsor: Alexandria University
Sponsor class: OTHER
Collaborators: name: Queen Mary University of London
First posted: 2020-05-26
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of this study is to evaluate the effectiveness of BiominF® and Novamin® in comparison to Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in the treatment of enamel white spot lesions


Eligibility criteria: Inclusion Criteria:

* Not less than 1 white spot lesion on the labial surface of teeth in the anterior region with code 2 International Caries Detection and Assessment System II (ICDAS-II) or less
* Absence of any active periodontal disease.
* Written informed consent

Exclusion Criteria:

* Known hypersensitivity/allergy to study products and/or materials used
* teeth having deep carious lesions or extensive restorations
* Unwillingness to be randomly assigned to 1 of the 3 treatment groups
* Advanced periodontal disease.

Primary outcomes:
measure: Change in White spot lesions dimension
timeFrame: 6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)
Secondary outcomes:
measure: change in lesion fluorescence
timeFrame: 6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT01833780: Effectiveness of Intrapartum Group B Streptococcus (GBS) Polimerase Chain Reaction Reaction (PCR) Screening
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: GBS
Keywords: carriage status
Culture
PCR
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
Collaborators: name: Clalit Health Services
First posted: 2013-04-17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Unknown GBS pregnant women

Brief summary: Study hypothesis: Intrapartum polimeraze chain reaction (PCR)of group B streptoccocus (GBS) test is more accurate than Culture of GBS at 35-37 weeks gestation for GBS carriage.

The investigators will compare GBS culture and PCR results taken at 35-37 weeks gestation to intrapartum PCR GBS and GBS cultures status.

The larger perspective of this trial is to check the possibility of replacing the GBS culture screening program at 35-37 weeks gestation with a more accurate examination (PCR), avoiding the changing GBS carriage status from the time of culture at 35-37 weeks to delivery.


Eligibility criteria: Inclusion Criteria:

* Unknown GBS pregnant women at 35-37 weeks

Exclusion Criteria:

* Known GBS pregnant women at 35-37 weeks

Primary outcomes:
measure: Intrapartum GBS carriage staus measured by PCR and culture compared to GBS culture and PCR at 35-37 weeks gestation
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04019080: Real-Life Use of Anti-fibrotic Drugs in Patients With Idiopathic Pulmonary Fibrosis in Sweden
Official title: Real-Life Use of Anti-fibrotic Drugs in Patients With Idiopathic Pulmonary Fibrosis in Sweden
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with idiopathic pulmonary fibrosis included in the Swedish IPF-registry

Brief summary: The objective of the current research project is, by using high quality Swedish registry data, to evaluate use, tolerance and effect of anti-fibrotic drugs in IPF-patients. Secondary study objectives are to determine the clinical profile, determinants of treatment adherence, long-term safety and to describe the patient journey from the first sign of disease to end of treatment.


Eligibility criteria: Inclusion Criteria:

* All subjects included in the Swedish IPF-registry

Exclusion Criteria:

* None

Primary outcomes:
measure: Anti-fibrotic drugs among the patients recorded in the Swedish IPF-registry
timeFrame: 2014-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
Clinical trial NCT01081080: Cardiac Magnetic Resonance in Children With Muscular Dystrophy
Official title: PITT0110 - Cardiac Magnetic Resonance: A Parallel Protocol to Cardiac Outcome Measures in Children With Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne Muscular Dystrophy
Becker Muscular Dystrophy
Limb Girdle Muscular Dystrophy
Keywords: cardiac
muscle
pediatric
dystrophy
Lead sponsor: Cooperative International Neuromuscular Research Group
Sponsor class: NETWORK
Collaborators: name: National Institutes of Health (NIH)
First posted: 2010-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from the parallel protocol: PITT1109 Cardiac Outcome Measures in Children with Muscular Dystrophy

Brief summary: This protocol will exploit novel state of the art cardiovascular magnetic resonance techniques to examine important changes in the heart in children with muscular dystrophy. The purpose of this study is to compare cardiac magnetic resonance (CMR) with the collected cardiac outcome data obtained in protocol: PITT1109 - Cardiac Outcome Measures in Children with Muscular Dystrophy.


Eligibility criteria: Inclusion Criteria:

* Participant enrolled in the CINRG study: PITT1109 - Cardiac Outcome Measures in Children with Muscular Dystrophy

Exclusion Criteria:

* Pregnant woman (when uncertain, participants will undergo urine testing) or lactating women
* Decompensated congestive heart failure (unable to lie flat during CMR)
* Impaired renal excretory function (calculated Glomerular Filtration Rate less than 30mL/min)
* Contra-indications to Magnetic Resonance Imaging:

  * Cardiac pacemaker or implantable defibrillator
  * Cerebral aneurysm clip
  * Neural stimulator
  * Metallic ocular foreign body
  * Harrington-rod
  * Any implanted device (i.e. insulin pump, drug infusion device)
  * Claustrophobia
  * Metal shrapnel or bullet

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Paula R Clemens, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03235180: Ultrasound Evaluation of Crohn's Disease
Official title: Ultrasound Evaluation of Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Crohn Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the effectiveness of a new ultrasound technology for evaluating Crohn's disease.

Detailed description: The investigators will study the efficacy of ultrasound shear wave elastography and vascularity imaging for Crohn's Disease (CD) evaluation. Literature evidences demonstrate that bowel stiffness is correlated with fibrosis, while bowel vascularity and perfusion is correlated with inflammation. Therefore, the investigators expect the combination of shear wave elastography and vascularity imaging can increase the sensitivity and specificity of CD evaluation.

Ultrasound is safe, cost-effective, and widely accessible, thus provides an attractive alternative to the clinical standard Computed Tomography (CT), risks of radiation)) and Magnetic Resonance Imaging (MRI), more expensive and limited accessibility)).

Because ultrasound may not be able to image bowel loops deep in the body, its main role is for follow-up after initial screening by CT or MRI, especially for terminal ileum, which is easily accessible by ultrasound and the most frequently affected bowel segment for CD.

Eligibility criteria: Inclusion Criteria:

- Crohn's disease patients with involvement of terminal ileum (thickness \> 3mm).

Exclusion Criteria:

* Patients with change of medicine or going to surgery over the 6-months follow-up period.
* Patients with unreliable ultrasound images due to conditions such as large body habitus or poor ultrasound imaging window.
* Adults lacking capacity to consent.
* Vulnerable subjects such as prisoners.
* Pregnant women and nursing mothers.
* Patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts.
* Patients with history of hypersensitivity allergic reactions to ultrasound contrast agents.

Primary outcomes:
measure: Change in Shear Wave Speed
timeFrame: baseline, 6 months
measure: Change in Vessel Density
timeFrame: baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Shigao Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01997580: Electrophysiologic Parameters and Biomarkers Predicting Treatment Response in Patients With Major Depressive Disorder
Official title: Phase 4 Study of Escitalopram Treatment and Biomarkers in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: depression
treatment
electrophysiology
biomarker
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
First posted: 2013-11-28
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: To explore electrophysiologic parameters and biomarkers predicting treatment response of patients with major depressive disorder To explore electrophysiologic parameters and biomarkers predicting suicide risk of patients with major depressive disorder

Detailed description: Case-control study Repeated measures design

Eligibility criteria: Inclusion Criteria:

* DSM-IV-TR major depressive disorder
* aged between 20 and 80
* durg-naive or drug-free

Exclusion Criteria:

* DSM-IV-TR substance-related disorders (except nicotine)
* significant medical or neurological conditions
* mental retardation or organic brain damage

Primary outcomes:
measure: Change in baseline frequency of maximum of cross-spectrum during 6 weeks (Hz)
timeFrame: 0, 3, 7, 14, and 42 days
Secondary outcomes:
measure: Change in cardiorespiratory coupling during 6 weeks
timeFrame: 0, 3, 7, 14, and 42 days
measure: Change in HF during 6 weeks
timeFrame: 0, 3, 7, 14, and 42 days
measure: Change in persistent homology during 6 weeks
timeFrame: 0, 3, 7, 14, and 42 days
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jae Seung Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang JS, Yoo CS, Yi SH, Her JY, Choi HM, Ha TH, Park T, Ha K. An integrative assessment of the psychophysiologic alterations in young women with recurrent major depressive disorder. Psychosom Med. 2012 Jun;74(5):495-500. doi: 10.1097/PSY.0b013e31824d0da0. Epub 2012 Mar 9.
Clinical trial NCT01526980: Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 Diabetes
Official title: A Single-Centre, Randomised, Open-Labelled, Two-Period, Crossover Trial In Subjects With Type 2 Diabetes Comparing the Glycaemic Control of Two Treatment Regimens: A Thrice Daily Regimen With Biphasic Insulin Aspart 70 and - 30 and a Twice Daily Regimen With Biphasic Human Insulin 30
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
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 glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Subjects with Type 2 diabetes
* Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months
* HbA1c maximum 10.0%
* BMI (Body Mass Index) maximum 35.0 kg/m2
* Able and willing to perform self-blood glucose monitoring (SBGM)

Exclusion Criteria:

* The receipt of any investigational drug within the last 30 days prior to this trial
* Total daily insulin dose minimum 2.0 U/(kg·day)
* A history of drug abuse or alcohol dependence within the last 5 years
* Impaired hepatic function
* Impaired renal function
* Cardiac disease
* Severe, uncontrolled hypertension

Primary outcomes:
measure: Glucose average in 24-hour blood glucose profiles
Secondary outcomes:
measure: Pre-meal glucose level
measure: Post-meal excursion of glucose (0-4 hours)
measure: Cmax, maximum concentration of total insulin
measure: tmax, time of maximum concentration of total insulin
measure: The area under the 24-hour total insulin concentration time curve
measure: Adverse events
Other outcomes:
Locations:
city: Newcastle
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR,1452)
role: STUDY_DIRECTOR
References:
citation: Dashora U, Ashwell SG, Home PD. An exploratory study of the effect of using high-mix biphasic insulin aspart in people with type 2 diabetes. Diabetes Obes Metab. 2009 Jul;11(7):680-7. doi: 10.1111/j.1463-1326.2008.01024.x.
Clinical trial NCT04320680: Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation
Official title: Cohort Follow-up of Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation at the CHRU of Brest
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: cutaneous lupus
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: diagnosis and follow up of a lupus cohort
Primary purpose: DIAGNOSTIC

Brief summary: Diagnosis and follow up of a lupus cohort in a multidisciplinary consultation in Brest ( France)

Detailed description: all patients coming to the LUPUS multidisciplinary consultation in brest ( France) will have a clinical examination, a biological and immunogical blood samples, cutaneous biopsies or renal biospies if necessary, an ultrasonographic articular and salivary glandular examination if needed. In case of articular involvement, some Xrays ( hands and feet) will be done at the inclusion and during the follow up each year during 5 years .

Eligibility criteria: Inclusion Criteria:

* women or men, more than 18 years old, coming to the multidisciplinary consultation in brest ( France).
* With written consentment

Exclusion Criteria:

* patients less than 18 years old
* refusing to participate
* Under legal protection

Primary outcomes:
measure: Cohort lupus: epidemiologic lupus study about diagnosis and follow up
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT02072980: DAILIES TOTAL1® Lubricity Post Wear
Official title: Evaluation of the Lubricity of DAILIES TOTAL1® Contact Lenses After Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: DT1
DAILIES TOTAL1®
Lubricity
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-02-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1® (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.

Detailed description: In this study, participants wore study lenses for 2 specified time periods (16 hours and 15 minutes, treatment sequence randomized) following which lenses were collected for ex vivo lubricity analysis. The ex vivo lubricity analysis was evaluated under a separate non-clinical protocol.

Eligibility criteria: Inclusion Criteria:

* Willing and able to sign Informed Consent document.
* Adapted, current soft contact lens wearer.
* Requires contact lens powers within the specified range of -0.50 diopters (D) to -10.00D.
* Cylinder between 0.00D and -1.00D (inclusive) in both eyes at Visit 1 manifest refraction.
* Vision correctable to 20/25 or better in each eye at distance with study lenses.
* Willing to wear study lenses at least 16 waking hours in one day and attend all study visits.
* Able to be successfully fitted with study lenses.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any ocular infection, inflammation, abnormality or active disease that would contraindicate contact lens wear, as determined by the Investigator.
* Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
* Use of artificial tears and rewetting drops during the study.
* Monocular (only one eye with functional vision) or fit with only one lens.
* Any abnormal ocular condition observed during the Visit 1 slit lamp examination.
* History of herpetic keratitis, ocular surgery, or irregular cornea.
* Pregnant.
* Participation in any clinical study within 30 days of Visit 1.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn
timeFrame: Day 1 (for each period), 16 hours
Secondary outcomes:
measure: Average Coefficient of Friction at 15 Minutes
timeFrame: Day 1 (for each period), 15 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Lisa L. Zoota, MPH, CCRA
role: STUDY_DIRECTOR
References: