louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05348551: Overview of Telemedicine in Children With Type 1 Diabetes
Official title: State of Play of Telemedicine in the Follow-up of Children With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Telemedicine
Diabetes Mellitus, Type 1
Children, Only
Keywords: Diabetes mellitus type 1
Children
Telemedicine
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 4800
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 0 to 17 years with type 1 diabetes

Brief summary: Assessment of the proportion of pediatric patients with type 1 diabetes with access to remote monitoring

Detailed description: In the follow-up of type 1 diabetes in children, contact with families besides the appointements with medical et paramedic staff (paediatrician, diabetologist, nurses) is very common but not well coded, start from telehealth hubs (like myDiabby), to less unofficial contact by phone or email. This is even more so widespread since generalization of continuous glucometer (freestyle, dexcom,...), which allowed a quick data transfer to the medical staff.

Some studies had shown that telemedicine in diabetes allowed a better glycemic control and a higher implication in the desease. Indeed, in 1999 already, HbA1c significant improvement was shown when patients was regularly called by a nurse (Thompson et al.). Same finding was demonstrated in Schiaffini and al. clinical trial in 2016. This trial also shown a better adhesion to the follow up into the telemedicine group. Despite all of this studies, in France, remote monitoring isn't standardised and financed, except the national experimentation ETAPES which promotes and financially supports the deployment of remote monitoring projects around the territory.

Eligibility criteria: Inclusion Criteria:

* Children with type 1 diabetes

Exclusion Criteria:

* No consent

Primary outcomes:
measure: Assessment of the proportion of pediatric patients with access to remote monitoring
timeFrame: 1 day
Secondary outcomes:
measure: Description of the different means and modalities of remote monitoring for patients
timeFrame: 1 day
measure: Description of the different means and modalities of remote monitoring for patients
timeFrame: 1 day
measure: Evaluation of patients' (and parents') perception of telemonitoring using a scale
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Grenoble
name: Clémentine DUPUIS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05399251: Relationship Between Serum 1,25-dihydroxy Vitamin D and Markers of Bone Metabolism in Renal Dysfunction Patients
Official title: Relationship Between Serum 1,25-dihydroxy Vitamin D and Markers of Bone Metabolism in Renal Dysfunction Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease-Mineral and Bone Disorder
Keywords: renal dysfunction
bone metabolism marker
1,25(OH)2 vitamin D
Lead sponsor: Aga Khan University Hospital, Pakistan
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 1553
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Laboratory data of patients tested for 1,25(OH)2D from January 2015 to December 2021 was retrieved from laboratory integrated systems (ILMS), and only the initial results for 1,25(OH)2D were included.

Brief summary: This cross-sectional study was conducted, including those subjects tested for 1,25(OH)2D during Jan 2015-Dec 2021. Estimated glomerular filtration rate (eGFR) was calculated and subjects were classified into chronic kidney disease (CKD) stages. Associations between biochemical marker, calcium, phosphorus, magnesium, alkaline phosphatase, 1,25(OH)2D and CKD stages was determined.


Eligibility criteria: Inclusion Criteria:

• Data of serum 1,25(OH)2D available

Exclusion Criteria:

• Serum1,25(OH)2D is not available

Primary outcomes:
measure: concentration of serum 1,25 dihydroxy vitamin D in U/L in five stages of chronic kidney disease
timeFrame: 7 year
measure: concentration of serum calcium in mg/dl in five stages of chronic kidney disease
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01646151: A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 2580
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with POAG and OHT

Brief summary: An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of POAG or OHT
* Previous use of IOP-lowering medication

Exclusion Criteria:

* None

Primary outcomes:
measure: Intraocular Pressure (IOP) at Baseline
timeFrame: Baseline
measure: IOP at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Physician Evaluation of IOP Lowering in the Study Eye(s)
timeFrame: Week 12
measure: Patient Assessment of Tolerability on a 4-Point Scale
timeFrame: Week 12
measure: Physician Assessment of Tolerability on a 4-Point Scale
timeFrame: Week 12
measure: Physician Assessment of Patient Compliance Compared to Previous Therapy
timeFrame: Week 12
measure: Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment
timeFrame: 12 Weeks
measure: Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops
timeFrame: Week 12
Other outcomes:
Locations:
city: Dresden
country: Germany
city: Amsterdam
country: Netherlands
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00816751: Paracervical Versus Intracervical Lidocaine
Official title: Paracervical Versus Intracervical Lidocaine for Suction Curettage: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, Induced
Pain
Keywords: Local anesthesia
Paracervical
Intracervical
Abortion
Pain
Local anesthesia for elective first trimester abortion
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2009-01-05
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to estimate the efficacy of intracervical versus paracervical block on pain experienced during first trimester suction curettage without the use of preoperative cervical ripening. Because of the theoretical improved reliability of stromal block, the investigators hypothesize that intracervical block would produce lower pain scores than paracervical block at the time of cervical dilation.


Eligibility criteria: Inclusion Criteria:

* Women presenting for elective first trimester abortion

Exclusion Criteria:

* Gestation over 12 weeks by ultrasound
* Weight less than 98 pounds
* Known allergy to lidocaine
* Known nonviable pregnancy

Primary outcomes:
measure: Pain Score, as Assessed Using a 10 cm Linear Visual Analog Scale (VAS)
timeFrame: at completion of procedure
Secondary outcomes:
measure: Gestational Age at Time of Procedure
timeFrame: At the time of the procedure
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Planned Parenthood
state: California
Study officials:
References:
Clinical trial NCT01535651: Using Social Media to Enhance the Impact of the Teen Outreach Program
Official title: Using Social Media to Enhance the Impact of the Teen Outreach Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Prevention
Lead sponsor: Colorado School of Public Health
Sponsor class: OTHER
Collaborators: name: Denver Health and Hospital Authority
First posted: 2012-02-20
Enrollment: 852
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators are exploring the use of short message service (text) messaging by cell phones to enhance the effects of the Teen Outreach Program, an effective teen pregnancy prevention program.


Eligibility criteria: Inclusion Criteria:

* boys and girls club member in metro Denver, age 14-18

Exclusion Criteria:

* non-english speaking

Primary outcomes:
measure: pregnancy
timeFrame: 21 months
Secondary outcomes:
measure: school drop out
timeFrame: 21 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Boys and Girls Clubs of Metro Denver
state: Colorado
Study officials:
References:
citation: Devine S, Bull S, Dreisbach S, Shlay J. Enhancing a Teen Pregnancy Prevention Program with text messaging: engaging minority youth to develop TOP (R) Plus Text. J Adolesc Health. 2014 Mar;54(3 Suppl):S78-83. doi: 10.1016/j.jadohealth.2013.12.005.
Clinical trial NCT00715351: Observational Study of Patients Using Levemir® or Insulatard® as Start Insulin for Treatment of Diabetes
Official title: Efficacy and Safety of Glycaemic Control of Levemir® or Insulatard® in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-07-15
Enrollment: 342
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Insulin naïve patients with type 2 diabetes treated with oral antidiabetics

Brief summary: This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control, weight change and hypoglycaemic effects in patients with type 2 diabetes with Levemir® compared to Insulatard® under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes failing on oral blood glucose lowering therapy, and requiring insulin therapy.

Exclusion Criteria:

* Type 1 diabetes
* Previous use of insulin

Primary outcomes:
measure: Body weight change
timeFrame: at 3 months and 6 months after baseline
Secondary outcomes:
measure: Hypoglycemic events
timeFrame: at 3 months and 6 months after baseline
measure: Changes in glycaemic parameters
timeFrame: at 3 months and 6 months after baseline
measure: Safety parameters by collecting (serious) adverse events and the pregnancies.
timeFrame: at 3 months and 6 months after baseline
measure: Evaluation of general well-being by using the WHO-5 well-being questionnaire (Appendix I).
timeFrame: at 3 months and 6 months after baseline
measure: Treatment satisfaction of subjects treated with insulin Levemir or NPH insulin by using insulin satisfaction ('Tevredenheid met insuline behandeling': Appendix II)
timeFrame: at 3 months and 6 months after baseline
measure: Satisfaction of physicians who treat the subjects with insulin Levemir or NPH in-sulin by using a scale of 0-10 (Appendix III).
timeFrame: at 3 months and 6 months after baseline
measure: Changes in doses
timeFrame: at 3 months and 6 months after baseline
measure: HbA1c
timeFrame: at 3 months and 6 months after baseline
measure: Changes in daily blood glucose values
timeFrame: at 3 months and 6 months after baseline
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03722251: Active Video-game Playing and Food Intake in Children
Official title: Active Video-game Playing and a Glucose Preload on Food Intake Regulation in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Behavior
Keywords: appetite, food intake, active gaming
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 27
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Repeated measures cross-over design.
Primary purpose: PREVENTION

Brief summary: The purpose of this experiment is to investigate the effect of active video game playing for 30 minutes on food intake and subjective appetite. The investigators hypothesize that video game playing will affect food intake in children. Food intake will be measured at 30 minutes following a glucose (50g glucose in 250ml of water) or sweetened non-caloric (150mg Sucralose® in 250ml of water) beverage with or without active video game playing. Subjective appetite will be measured at 0, 15, 30 and 60 minutes.


Eligibility criteria: Inclusion Criteria:

healthy boys with no emotional, behavioral or learning problems

Exclusion Criteria:

* Exclusion criteria are children with significant behavioral or emotional difficulties, those with dietary restrictions, or those taking medications.

Primary outcomes:
measure: Food Intake (kcal)
timeFrame: 30 minutes after treatment
measure: Subjective appetite (mm)
timeFrame: baseline and then 15, 30, and 60 minutes after preload consumption
Secondary outcomes:
measure: Subjective Mood (mm)
timeFrame: baseline and then 15, 30, and 60 minutes after preload consumption
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: School of Nutrition, Ryerson University
state: Ontario
Study officials:
References:
Clinical trial NCT01750151: Video Game Playing on Lunch-time Food Intake in Children
Official title: The Effect of Sedentary Video Game Playing Before a Mixed Meal on Subjective Appetite and Satiety Signals From a Glucose Preload in Normal Weight and Overweight/Obese Boys
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exogenous Obesity
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
Collaborators: name: Danone Institute International
name: Mount Saint Vincent University
First posted: 2012-12-17
Enrollment: 41
Sex: MALE
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this experiment is to investigate the effect of video game playing for 30 minutes on food intake and subjective appetite. The investigators hypothesize that video game playing will affect food intake in children. Food intake will be measured at 30 minutes following a glucose (50g glucose in 250ml of water) or sweetened non-caloric (150mg Sucralose® in 250ml of water) beverage with or without video game playing. Subjective appetite will be measured at 0, 20, 35 and 65 minutes.


Eligibility criteria: Inclusion Criteria:

* healthy boys with no emotional, behavioral or learning problems

Exclusion Criteria:

* girls

Primary outcomes:
measure: Food Intake (kcal)
timeFrame: at 30 min after the treatment
Secondary outcomes:
measure: Subjective appetite (mm)
timeFrame: 0-65 min
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Department of Applied Human Nutrition
state: Nova Scotia
city: Toronto
country: Canada
facility: School of Nutrition, Ryerson University
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Nick Bellissimo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Branton A, Akhavan T, Gladanac B, Pollard D, Welch J, Rossiter M, Bellissimo N. Pre-meal video game playing and a glucose preload suppress food intake in normal weight boys. Appetite. 2014 Dec;83:256-262. doi: 10.1016/j.appet.2014.08.024. Epub 2014 Aug 20.
Clinical trial NCT01438151: Understanding the Relationship Between Infliximab Levels to Clinical Response of Remicade in Crohn's Disease
Official title: Association of Serum Infliximab and Antibodies Toward Infliximab (ATI) to Clinical Outcomes in Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Crohn's Disease
Keywords: Crohn's disease
Remicade
infliximab
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Prometheus Laboratories
First posted: 2011-09-21
Enrollment: 11
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to improve the investigators understanding of the relationship between Crohn's disease and blood levels of the drug infliximab (Remicade). The investigators want to determine whether measuring drug levels can be helpful in understanding how patients respond to this treatment.

Detailed description: The efficacy of infliximab to maintain remission in Crohn's disease has been confirmed by randomized, controlled trials, however the utility of serum infliximab and ATI titers is less clearly described in the clinical practice setting to manage dose and interval levels.

The primary objective of this study is to evaluate the clinical responsiveness of active (HBI \>10) Crohn's disease to infliximab as it relates to serum infliximab levels. Though the assay for an infliximab level is commercially available, current dosing practices rely on the assessment of clinical data (laboratory data, symptoms, colonoscopy, etc). In order to understand this relationship, serum infliximab and ATI titers will be collected over the course of 8 (approximately 1 year) infusions. The results of these levels will be retrospectively correlated to the patient's clinical response to treatment.

The secondary objective is to identify predictors of poor response to infliximab by evaluating the efficacy of a dose escalation strategy in patients classified as primary or secondary non-responders.

Understanding the association of serum infliximab levels to disease response may be a useful objective tool to optimize and individualize dosing amount and frequency especially in patients with incomplete or loss of response to therapy.

Eligibility criteria: Inclusion Criteria:

* Patients with active (HBI \>10) refractory inflammatory and/or perianal fistulizing Crohn's disease who are prescribed infliximab as standard of care by their gastroenterologist.

Exclusion Criteria:

* Pregnant women.

Primary outcomes:
measure: Remicade Dose Escalation
timeFrame: 2/16/12-3/22/13
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Shradha Agarwal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Lloyd Mayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05670951: Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
Official title: A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Intestinal Malabsorption
Lead sponsor: Elgan Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-04
Enrollment: 360
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the effect of ELGN-2112 on intestinal malabsorption in preterm infants.


Eligibility criteria: Inclusion Criteria:

* Male or female pre-term infant 26 and up to 32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound
* Birth weight ≥ 500g
* Singleton or twin birth

Exclusion Criteria:

-

Primary outcomes:
measure: Numbers of days to achieve full enteral feeding
timeFrame: 28 days or discharge from hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Laniado Hospital
Study officials:
References:
Clinical trial NCT02255851: Sentinel(TM) Post-Market Registry
Official title: Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transcatheter Aortic Valve Replacement
Severe Symptomatic Calcified Native Aortic Valve Stenosis
Keywords: selected for TAVR by heart team consensus
treated with CE-Marked TAVR devices
Lead sponsor: Claret Medical
Sponsor class: INDUSTRY
First posted: 2014-10-03
Enrollment: 300
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: The registry population comprises subjects with severe symptomatic calcified native aortic valve stenosis who are selected for TAVR by heart team consensus and treated with CE-Marked TAVR devices.

Brief summary: The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR.

Subjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic information and detailed procedural data will be captured and documented in a registry case report form.

All Sentinel filters will be sent for histopathology at an independent core-lab.


Eligibility criteria: Inclusion Criteria:

1. Approved indications for commercially available CE-Marked TAVR devices.
2. Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (\> 70%).
3. The subject or the subject's legal representative has been informed of the nature of the registry, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee of the respective site.

Exclusion Criteria:

1. Vasculature in the right extremity precluding 6Fr sheath radial/brachial access
2. Inadequate circulation to the right extremity as evidenced by signs of artery occlusion or absence of radial or brachial pulse
3. Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
4. Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion
5. Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel device access and insertion
6. Patient whose brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium
7. Currently participating in an investigational drug or investigational (non CE-mark) device study

Primary outcomes:
measure: Primary Observational Endpoint
timeFrame: Post-Procedure (day 1)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Elisabeth-Krankenhaus Essen GmbH, Essen, Germany
name: Christoph Naber, MD
role: PRINCIPAL_INVESTIGATOR
References: