louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06317454: Determinants of Metabolic Control in Children With Type 1 Diabetes Mellitus
Official title: Genetic and Environmental Determinants of Metabolic Control in Children and Young Adults With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 1
Keywords: Type 1 diabetes
Metabolic control
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 800
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between 6 and 21 years with or without type 1 diabetes

Brief summary: A good metabolic control of type 1 diabetes mellitus (T1DM) is crucial to avoid long-term complications associated with the disease. Although recent evidences suggest that a good metabolic control of T1DM is partly independent of management intensity and could be anticipated since onset, factors that influence glycated haemoglobin (HbA1c) patterns remain poorly understood and are likely to be genetic.

While significant progress has been made in understanding of the genetic contribution to T1DM onset, very few studies have evaluated the role of genetic factors on T1DM metabolic control.

This study aims to create a comprehensive database of genetic and phenotypic data in a cohort of children and young adults with T1DM and to evaluate genetic and environmental factors that might predict trajectories in glycemic control


Eligibility criteria: Inclusion Criteria

Cases:

* age between 6 and 21 years;
* patients suffering from type 1 diabetes

Controls:

* age between 6 and 21 years;
* patients for whom a venous sampling is planned

Exclusion criteria

Cases:

* patients for whom it is not possible to collect information on the clinical history, starting from the onset of diabetes
* patients with other types of diabetes mellitus (type 2, monogenic diabetes, diabetes related to cystic fibrosis...)
* patients incapable of expressing valid informed consent or whose parents are incapable of expressing valid informed consent.

Controls:

* subjects with type 1 and 2 diabetes
* obese subjects and those with a family history of diabetes and obesity or other metabolic disorders
* subjects with HbA1c \>6%
* patients incapable of expressing valid informed consent or whose parents are incapable of expressing valid informed consent.

Primary outcomes:
measure: Identification of environmental factors affecting T1DM metabolic control
timeFrame: Through study completion, an average of 18 months
measure: Identification of genetic factors affecting T1DM metabolic control
timeFrame: Through study completion, an average of 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Study officials:
References:
Clinical trial NCT00247754: VP3: Vancouver Primary Prevention Program (Anxiety Disorders Prevention in School Children)
Official title: VP3: Vancouver Primary Prevention Program (Anxiety Disorders Prevention in School Children)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Therapy
Behaviour
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-11-02
Enrollment: 281
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective:

1. To evaluate the efficacy of a school-based cognitive behavior therapy (CBT) program in reducing anxiety disorder symptoms in at-risk public school children.
2. To determine whether parent education and involvement improves outcome in anxious children treated with CBT.
3. To determine the ability of school personnel in a) recognizing classroom behaviors as anxiety disordered after targeting training of observable child behaviors e.g., avoidance, over-worry, etc.), and b) delivering a cognitive behavior intervention and
4. To evaluate a new measure of teacher-rated anxiety disorder symptoms in children.

Hypothesis:

1. A CBT oriented intervention as delivered by school personnel will be superior to an attention control procedure in reducing anxiety symptoms in at-risk children.
2. Children who have parental involvement will post stronger and more enduring treatment gains.


Eligibility criteria: Inclusion Criteria:

Children enrolled in school between the ages of 7 and 13 who display anxiety symptoms.

1. Anxiety disorder symptoms (identified by a score of 56 or higher on the MASC; and teacher report, and /or parent recommendation) as the primary presenting problem. An enrolled child must have at least 2 of these criterions.
2. Fluency in English.
3. Parent willingness to sign consent form and to complete required assessments.
4. Student willingness to participate (child assent) in 10-week affective education program and completion of required assessments.

Exclusion Criteria:

Primary outcomes:
measure: Anxiety symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia, Faculty of Education
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Lynn Miller, PhD, R.Psych.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02456454: Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder
Official title: Placebo Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2015-05-28
Enrollment: 46
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Controlled trial of the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.

Detailed description: The objective of this study was to study the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.

Eligibility criteria: Inclusion Criteria

* Subjects were male or female outpatient subjects,
* 3.0 - 7 years 11 months of age
* Bipolar I or II Disorder, mixed, manic or hypomanic episode, psychotic or non-psychotic, according to DSM IV criteria (American Psychiatric Association 1994)
* with a score \> 20 on the Young Mania Rating Scale (YMRS.

Exclusion Criteria

* clinically significant or unstable hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions;
* neurologic disorders including epilepsy, stroke, or severe head trauma those clinically significant laboratory abnormalities, on any of the following tests:

  * CBC with differential,
  * electrolytes,
  * BUN,
  * creatinine,
  * hepatic transaminases,
  * urinalysis,
  * thyroid indices (T3, Total T4, Free T4, TSH) and
  * EKG
* mania due to a general medical condition or substance-induced mania
* mental retardation (IQ \<70),
* evidence of Fetal Alcohol Syndrome or an Alcohol-Related Neurodevelopmental Disorder,
* Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.

Primary outcomes:
measure: Young Mania Rating Scale
timeFrame: 6 weeks
Secondary outcomes:
measure: Clinical Global Improvement Scale
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Nationwide Children's Hospital
name: Robert A Kowatch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kowatch RA, Scheffer RE, Monroe E, Delgado S, Altaye M, Lagory D. Placebo-controlled trial of valproic Acid versus risperidone in children 3-7 years of age with bipolar I disorder. J Child Adolesc Psychopharmacol. 2015 May;25(4):306-13. doi: 10.1089/cap.2014.0166.
Clinical trial NCT01312454: Safety and Intraocular Pressure (IOP) Lowering Effect of AL-59412C
Official title: A Proof of Concept Study to Assess the Safety and IOP-Lowering Effect of AL-59412C Injected Intravitreally
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Open-angle Glaucoma
Ocular Hypertension
Keywords: intravitreal injection
intraocular pressure
open-angle glaucoma
ocular hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-03-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess the safety and efficacy of AL-59412C injected intravitreally relative to Vehicle.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma or ocular hypertension.
* Retinal pathology (eg, retinal degeneration), anterior ischemic optic neuropathy, or vascular occlusion resulting in poor vision in the study eye.
* Able to discontinue all intraocular-lowering (IOP) medications according to the minimum washout period, based upon the class of medication.
* Mean washed out IOP ≥ 24 millimeters mercury (mmHg) to ≤ 36 mmHg at 8 AM in the study eye on two separate Eligibility Visits.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Lens/corneal/vitreal opacity preventing adequate posterior segment visualization of the study eye.
* Current or recent (within 30 days) use of any drug that may prolong the QT interval.
* Poor vision resulting from advanced glaucoma in the study eye.
* Intraocular surgery within the past 6 months in the study eye.
* Ocular laser surgery within the past 3 months in the study eye.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Maximum intraocular (IOP) reduction from baseline up to 24 hours post-injection
timeFrame: Time to event, up to 24 hours post-injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Theresa Landry, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00242554: Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases
Official title: Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Bone Metastases
Zoledronic acid
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-20
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Histological confirmed diagnosis of carcinoma of the prostate
* Current or previous evidence of metastatic disease to the bone
* Receiving currently or not, hormonal therapy
* ECOG performance status of 0, 1, or 2

Exclusion Criteria:

* Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal, or by a calculated creatinine clearance of 60 ml/minute or less.
* Corrected serum calcium concentration, adjusted for serum albumin \< 8.0 mg/dl (2.00 mmol/L).
* WBC\<3.0x10\^9, ANC \< 1500/mm3, Hb \< 8.0 g/dL, platelets \< 75 x 10\^9/L.
* Liver function tests \>2.5 ULN, serum creatinine \>1.5 ULN.
* Patients with another non malignant disease, which could confound the evaluation of primary endpoints, or prevent the patient complying with the protocol.
* Known hypersensitivity to zoledronic acid or other bisphosphonates or each of the compounds which perform the formula.

Other protocol-related inclusion / exclusion criteria may apply

Primary outcomes:
measure: To evaluate the tolerability and safey of zoledronic acid 4mg, IV, for the following eficacy metrics: QoL, Safety (Aes) and evaluation of pain
Secondary outcomes:
measure: No secondary outcomes/objectives planned
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02498054: Diabetic Mellitus Patients Glucose Range Awareness After Experiencing a New Blood Glucose Meter Feature
Official title: Diabetic Mellitus Patients Glucose Range Awareness After Experiencing a New Blood Glucose Meter Feature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: LifeScan
Sponsor class: INDUSTRY
First posted: 2015-07-15
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A single visit \& single arm study in 80 subjects with diabetes to determine if a short educational experience with a new blood glucose meter feature improves the ability of each subject to better classify glucose results into acceptable glucose ranges.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Type 1 diabetes Mellitus (T1DM) or Type 2 diabetes Mellitus (T2DM) for ≥ 3 months
* Currently performing self monitoring of blood glucose (SMBG) at home
* Aged ≥16 years

Exclusion Criteria:

* Previous use of any blood glucose meter with the colour range indicator feature to be evaluated in this study.

Primary outcomes:
measure: Success rate to categorize blood glucose values into accepted ranges.
timeFrame: On average within 30 mins post intervention.
Secondary outcomes:
measure: Actual time taken to categorize blood glucose values into accepted ranges on the questionnaire provided.
timeFrame: On average within 30 mins post intervention.
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
Study officials:
affiliation: LifeScan
name: Mike Grady, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT02327754: Effect of Topiroxostat on Urinary Albumin Excretion Early Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout
Official title: Effect of Topiroxostat on Urinary Albumin Excretion in Patients With eARly Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout: a Randomized, Placebo-controlled, Double-blind Phase 2a Trial (UPWARD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Nephropathy
Lead sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Fuji Yakuhin Co., Ltd.
First posted: 2014-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of topiroxostat on urinary albumin excretion and the safety in patients with early stage diabetic nephropathy and hyperuricemia with or without gout. Participants are randomized to placebo (n=20) or topiroxostat (n=40) for 28 weeks. The investigational drugs for this study are supplied by FUJI YAKUHIN CO., LTD.


Eligibility criteria: Inclusion Criteria:

* Diabetes patients
* Clinically or pathologically diagnosed diabetic nephropathy
* Hyperuricemic or gout patients
* Estimated glomerular filtration rate (eGFR) \>= 30 mL/min/1.73m\^2 and urine albumin creatinine ratio (UACR) greater than or equal to 45 and less than 300 mg/g

Exclusion Criteria:

* Patient has known non-diabetic nephropathy (other than nephrosclerosis)

Primary outcomes:
measure: Change from baseline in urine albumin creatinine ratio
timeFrame: 28 weeks
Secondary outcomes:
measure: sUA, eGFR, L-FABP, HbA1c, SBP, DBP, TC
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Sanwa Kagaku Kenkyusho Co., Ltd.
state: Aichi
Study officials:
References:
Clinical trial NCT03431454: Comparison of Three Vision Therapy Approaches for Convergence Insufficiency
Official title: Comparison of Three Vision Therapy Approaches for Convergence Insufficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Comparison of Three Vision Therapy Approaches for Convergence Insufficiency
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 48
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We compared the effectiveness of three active vision therapy approaches for convergence insufficiency (CI). Patients with eligible criteria and symptomatic CI were included in a prospective study and randomly allocated into three groups. In the home-based vision orthoptic therapy (HBVOT) group, patients were trained to do the pencil push-ups procedure 15 minutes per day, five days a week. In the office-based vision orthoptic therapy (OBVOT) group, 60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional home orthoptic therapy was prescribed. For the augmented office-based vision orthoptic therapy (AOBVOT) group, orthoptic exercises using three diopter over-minus lenses and a base out prism, in addition to major amblyoscope and additional home reinforcement was prescribed in the same period of time.


Eligibility criteria: Inclusion Criteria:

* patients between 15 and 35 years of age who have symptomatic CI using the Convergence Insufficiency Symptom Survey (CISS) scoring system.
* best-corrected visual acuity ≥ 20/25
* exophoria at near at least 4 prism diopters (△) greater than at distance
* near point of convergence more than 6.0 cm break
* insufficient positive fusional vergence (PFV) (failing Sheard's criterion or PFV ≤ 15 △ base-out) at near distance.

Exclusion Criteria:

* amblyopia (VA worse than 20/30 in each eye), presence of manifest strabismus, history of ocular surgery, any systemic disorder, anisometropia of more than 1.5 diopter of myopia or hyperopia or significant refractive error, and nystagmus and usage of medications that may impair accommodation or convergence. ,ocular surface abnormalities or history of ocular allergy or those who had previously been treated for CI

Primary outcomes:
measure: symptomatic convergence insufficiency
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
citation: Scheiman M, Kulp MT, Cotter SA, Lawrenson JG, Wang L, Li T. Interventions for convergence insufficiency: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 2;12(12):CD006768. doi: 10.1002/14651858.CD006768.pub3.
Clinical trial NCT00419354: The Impact of Right Ventricular Pacing on Tricuspid Regurgitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tricuspid Regurgitation
Keywords: Pacemaker
Tricuspid regurgitation
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2007-01-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients, clinically stable, with a permanent pacemaker and who are not pacemaker dependent.

Brief summary: "1" To examine whether right ventricular pacing has an impact on tricuspid regurgitation grade that is related to pacing rather than to valve closure interference by the electrode.

Detailed description: "1" Traditionally, tricuspid regurgitation in the presence of pacemaker is attributed to the physical interference of the valve closure by the electrode.

"2" Right ventricular pacing may be associated with dyssynchrony in contraction of the right ventricular wall (i.e. septum and free wall.

"3" The tricuspid sub-valvar apparatus is anchored to the septum and free wall, thus may be sensitive to dyssynchrony in those wals contraction.

"4" The study hypothesis is that the dyssynchrony in right ventricular contraction, induced by pacing, may increase tricuspid regurgitation grade and that this is a mechanism is independent of the mechanical effect of the electrode on the valve closure.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Permanent pacemaker

Exclusion Criteria:

* Epicardial pacing
* Left ventricular dysfunction
* Organic tricuspid regurgitation
* Bi-ventricular pacemaker
* Atrial fibrillation
* Complete pacemaker dependence

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Department of Cardiology, Rabin Medical Center
name: Mordehay Vaturi, MD
role: PRINCIPAL_INVESTIGATOR
References: