louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02010541: The Influence of Technology, Education and Psychological Support on Metabolic Control in Children With T1D
Official title: The Influence of Diabetes Related Technology, Education and Psychological Support on Metabolic Control in Young Children With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes among young children, sensor, insulin pump, education, psychological support
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Slovenian Research Agency (ARRS)
First posted: 2013-12-12
Enrollment: 40
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children that have diabetes in Slovenia are controlled at the Dept. of Pediatric Endocrinology, Diabetes \& Metabolism, University Children's Hospital, UMCL and the population will be taken from here

Brief summary: The first purpose of this study is to is to compare metabolic control of type 1 diabetes among children under the age of 7 years who use an insulin pump and a real-time (RT) glucose sensor, and children who use only insulin pump; the investigators will also determine dietary habits, their knowledge of type 1 diabetes management and emotional aspects of experiencing illness in the family, in both groups of children.


Eligibility criteria: Inclusion Criteria:

* age up to 7 years
* insulin pump for at least 6 months
* more than 6 months of duration of type 1 diabetes
* complete remission
* normal blood pressure for age, only therapy insulin.

Exclusion Criteria:

* age over 8 years
* type 1 diabetes less than 6 months
* insulin pump less than 6 months
* still in remission
* associated diseases on drug therapy, high blood pressure

Primary outcomes:
measure: Glycaemic control
timeFrame: 3 months
Secondary outcomes:
measure: knowledge on diet and diabetes management
timeFrame: 3 months
Other outcomes:
measure: Number of adverse events
timeFrame: 3 months
measure: Quality of Life measures
timeFrame: 3 months
Locations:
city: Ljubljana
country: Slovenia
facility: Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL
Study officials:
affiliation: Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL
name: Tadej Battelino
role: STUDY_CHAIR
References:
Clinical trial NCT04775641: Italian Survey on Paediatric and Neonatal MRI
Official title: Children and Neonates Anaesthesia in Magnetic Resonance Environment in Italy. An Active Call Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Disorders Congenital
Premature Birth
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 876
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All center perforing a paediatric discharge in Italy in the 2014

Brief summary: Paediatric anaesthesia care in the Magnetic Resonance Imaging is a challenge for clinicians. The recent debate about the role of anaesthetic agent on neural development, encouraged an evaluation of their actual activity in this environment. In this active call survey, the authors sought to delineate the Italian situation regarding national centers, staff involved, monitoring and tools available. The primary aim was to evaluate clinical practice in childhood management in Magnetic Resonance suite.

This study was designed as prospective phone survey on the setting of a complete sample of all national centers performing almost a paediatric discharge in the 2014, obtained from Italian Health Ministery registers.

The three section survey was fill out with the Physician in charge in Magnetic Resonance suite. The Main outcome was a descriptive and exploratory analyses about the organization setting of the Centers (procedures, performers, monitoring and tools).


Eligibility criteria: Inclusion Criteria:

* Uncooperative children \< 14 years old
* premature babies

Exclusion Criteria:

. collaborating children

Primary outcomes:
measure: Descriptive practice for children and neonates management in MRI
timeFrame: 3 monthes
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli
Study officials:
References:
citation: Sbaraglia F, Spinazzola G, Adduci A, Continolo N, De Riso M, Ferrone G, Festa R, Garra R, Tosi F, Rossi M. Children and neonates anesthesia in magnetic resonance environment in Italy: an active call survey. BMC Anesthesiol. 2022 Sep 2;22(1):279. doi: 10.1186/s12871-022-01821-3.
Clinical trial NCT04215341: Physiotherapy for Children With Dysfunctional Breathing
Official title: Feasibility Study for a Multi-centre Trial Investigating Whether Physiotherapy Improves Outcomes for Children With Dysfunctional Breathing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysfunctional Breathing
Lead sponsor: Sheffield Children's NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Sheffield
First posted: 2020-01-02
Enrollment: 31
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Dysfunctional breathing in children primarily affects the ability to participate in sport or exercise but can also stop children doing other activities such as playing musical instruments. Clinical experience has shown that physiotherapy (through the use of breathing retraining and other associated techniques) can stop the symptoms of dysfunctional breathing, allowing children to return to normal activities and reduce or stop inhaled medications.

Whilst there is some evidence in adults with this condition to support the use of physiotherapy, there have been no studies carried out in children investigating whether physiotherapy is beneficial for children with dysfunctional breathing.

This study therefore aims to investigate the feasibility of a future large scale multicentre clinical trial designed to investigate whether physiotherapy improves outcomes for children with dysfunctional breathing. The improved management of this common but under recognised condition would lead to significant improvements in the quality of life of children coupled with the reduction in potentially harmful medications.


Eligibility criteria: Inclusion Criteria:

Aged 8-16 years Clinical diagnosis of dysfunctional breathing

Exclusion Criteria:

Uncontrolled comorbidities Participant and parents/guardians not fluent in written and spoken English Inability to follow instructions

Primary outcomes:
measure: Child and parent proxy report versions of the quality of life questionnaire(PedsQL)
timeFrame: 24 months
Secondary outcomes:
measure: Symptom questionnaire (Nijmegen questionnaire)
timeFrame: 24 months
measure: Structured light plethysmography (SLP) scan (Thora-3DI)
timeFrame: 24 months
measure: Reliever inhaler usage recorded using a data logger device
timeFrame: 24 months
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Children's NHS Foundation Trust
state: Sheffield (South Yorkshire District)
Study officials:
affiliation: Investigator
name: Nicola Barker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03599141: Testing TRUST Depression Management Intervention
Official title: Pilot RCT to Evaluate the Effects of a Trust-Building Depression Management Intervention on Moderate Depressive Symptoms in Low-Income Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Quality of Life
Keywords: adolescent
parent
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-07-26
Enrollment: 16
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effectiveness of a novel depression self-management intervention in adolescents with depression.

Detailed description: Half of participants will receive a traditional depression self-management intervention, while the other half will receive the novel depression self-management intervention. In an exploratory, pilot 2-group randomized controlled trial (RCT), 16 adolescents were followed over 6 months. Data were collected at baseline, 3 months, and 6 months.

Eligibility criteria: Inclusion Criteria:

* Lives in the Cleveland metro area
* Ages 14-17 years old
* Reports moderate depressive symptoms
* Able to read, speak, and understand the English language

Exclusion Criteria:

* Current suicide risk
* Diagnosis with bipolar disorder, schizophrenia, or a personality disorder
* Severe behavioral problems that preclude group participation (as reported by parent)
* Family plans to move from the region within 6 months

Primary outcomes:
measure: Patient Health Questionnaire-8 Adolescent
timeFrame: 3 months and 6 months post baseline
Secondary outcomes:
measure: Youth Quality of Life Scale
timeFrame: 3 and 6 months post baseline
measure: Adolescent Sleep Hygiene Scale
timeFrame: 3 and 6 months post baseline
measure: Stress Management
timeFrame: 3 and 6 months post baseline
measure: Medication Adherence
timeFrame: 3 and 6 months post baseline
measure: Appointment Keeping
timeFrame: 3 and 6 months post baseline
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
References:
Clinical trial NCT00562341: Effect of Lap-Band Induced Weight Loss on Serum PSA Levels
Official title: Effect of Lap-Band Induced Weight Loss on Serum PSA Levels, Testosterone, Estrogen and Other Serum Markers
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obesity
Prostate Cancer
Keywords: obesity
psa
prostate cancer
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2007-11-22
Enrollment: 0
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients asked to enroll will be obese men who are undergoing bariatric surgery, lap-band surgery, at Maimonides Medical Center.

Brief summary: The proposed prospective study aims to determine whether interpretation of PSA levels in morbidly obese men require correction due to the obesity itself. If PSA levels are found to rise after weight loss, interpretation of PSA levels in morbidly obese men may be improved by upward correction of the PSA level. A 'correction factor' may be proposed for the interpretation of PSA levels in obese men, toward the clinical decision regarding indication for prostate biopsy.

Detailed description: The main objective of this study is to determine whether interpretation of PSA levels in morbidly obese men require correction due to the obesity itself. Secondary outcome measures that will be followed include the affect of obesity and weight loss on testosterone, estradiol and leptin. In as much as these might also affect PSA, we will be measuring these values as well. Also, we do not know the effects of lap-band induced weight loss on clinical outcome measures of sexual, bowel and urinary function. Thus we will aim to investigate these parameters as well.

Eligibility criteria: Inclusion Criteria:

* obese men undergoing lap-band surgery

Exclusion Criteria:

* prior diagnosis of prostate cancer
* prior prostate surgery
* use of 5-alpha reductase inhibitors
* history of prostatitis
* recurrent Urinary Tract Infection (UTI).

Primary outcomes:
measure: Prostate-Specific Antigen (PSA) value
timeFrame: 18 months
Secondary outcomes:
measure: Effect of Lapband-induced weight loss on quality of life
timeFrame: 18 months
measure: Effect of Lapband-induced weight loss on sexual function
timeFrame: 18 months
measure: Effect of Lapband-induced weight loss on prostate size and associated urinary symptoms
timeFrame: 18 months
measure: Receiver Operating Curve (ROC) analysis to evaluate PSA cancer detection performance
timeFrame: 18 months
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
affiliation: MMC
name: Jason Wynberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00440141: Brimonidine 0.1% Versus Brinzolamide 1% as Adjunctive Therapy to Latanoprost 0.005%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-02-26
Enrollment: 40
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: Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering will be randomized to receive either brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to latanoprost 0.005%


Eligibility criteria: Inclusion Criteria:

* Glaucoma or ocular hypertension in both eyes
* Currently being treated with latanoprost 0.005% QD
* IOP greater than or equal to 18mm Hg on latanoprost 0.005%
* Best-corrected VA of 20/200 or better in each eye
* Visual field within 6 months of study entry

Exclusion Criteria:

* Secondary glaucoma
* Active intraocular inflammation or macular edema
* Intraocular surgery or laser surgery within the past 3 months

Primary outcomes:
measure: IOP
timeFrame: Month 3
Secondary outcomes:
measure: Tolerability
timeFrame: Month 3
Other outcomes:
Locations:
city: Atlanta
country: United States
state: Georgia
Study officials:
affiliation: Allergan
name: Medical Affairs
role: STUDY_DIRECTOR
References:
citation: Day DG, Hollander DA. Brimonidine purite 0.1% versus brinzolamide 1% as adjunctive therapy to latanoprost in patients with glaucoma or ocular hypertension. Curr Med Res Opin. 2008 May;24(5):1435-42. doi: 10.1185/030079908x301848. Epub 2008 Apr 9.
Clinical trial NCT00902941: Olfaction in Patients With Parkinson's Disease Following Treatment With Rasagiline
Official title: Reversibility of Olfactory Loss in Patients With Idiopathic Parkinson's Disease Following Treatment With Rasagiline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson´s Disease
Keywords: Parkinson´s disease
olfaction
rasagiline
smell testing
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2009-05-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is convincing evidence from numerous studies using both psychophysical and electrophysiological approaches that olfaction is markedly reduced in Parkinson´s disease (PD). Data on the prevalence of olfactory dysfunction in PD however, range from 45% and 49% in the pioneering studies of Ansari \& Johnson, and Ward, respectively, up to 74% in the work of Hawkes et al., or as high as 90% in a study published by Doty et al. Quality of life, safety, and interpersonal relations, as well as food behavior/nutritional intake are severely altered in a large proportion of patients with olfactory loss. Thus, the same can be assumed in patients with Parkinson's disease. If it was possible to improve olfactory function this would appear as a significant effect in patients with Parkinson's disease. Provided the study would reveal an improvement of olfactory function following therapy with rasagiline, this would have tremendous worldwide impact on the use of this drug. Considering the frequency of PD a very large number of patients would benefit from these findings, especially in terms of quality of life.


Eligibility criteria: Inclusion Criteria:

* Parkinson´s disease, Hoehn \& Yahr stage ≤ III
* aged 18-64 yrs
* hyposmia/functional anosmia defined as TDI\<30
* written consent

Exclusion Criteria:

* congenital olfactory loss
* significant infections of the nose and nasal sinuses
* diseases/states apart from PD which may significantly affect olfactory function, e.g., asthma, head trauma etc.
* dementia, psychiatric illness, addictive behaviour
* smoker
* severe liver disease
* pregnant or breastfeeding women
* any contraindication for the treatment with Rasagiline
* women without reliable contraception

Primary outcomes:
measure: olfactory function
timeFrame: 4 months
Secondary outcomes:
measure: quality of life
timeFrame: 4 months
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University of Dresden Medical School, Smell & Taste Centre, Dept. of Neurology
Study officials:
affiliation: University of Dresden Medical School
name: Heinz Reichmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06088641: Preoperative BNP and MINS in AAA Open Repair
Official title: Prognostic Impact of Preoperative B-type Natriuretic Peptide for Predicting Myocardial Injury After Non-cardiac Surgery in Patients Who Underwent Open Repair for Abdominal Aortic Aneurysm: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myocardial Injury After Non-cardiac Surgery
Keywords: AAA
MINS
BNP
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 198
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who underwent AAA open repair

Brief summary: The aim of this study was to investigate whether preoperative B-type natriuretic peptides serves as an independent predictor of myocardial injury after non-cardiac surgery (MINS) in abdominal aortic aneurysm open repair.

Detailed description: The incidence of MINS was compared between the lower BNP and higher BNP groups, and a stepwise logistic regression analysis was performed to evaluate the predictors for MINS.

Eligibility criteria: Inclusion Criteria:

patients who underwent open repair with AAA from September 2010 to October 2021

Exclusion Criteria:

1. Ruptured AAA
2. Traumatic aortic injury
3. Absence of troponin-T value within 30 days of surgery
4. Diagnosis of elevation of troponin-T due to non-ischemic cause (ex: sepsis, pulmonary embolism, atrial fibrillation, cardioversion, etc.)
5. Insufficient medical records

Primary outcomes:
measure: MINS
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam severance Hospital
Study officials:
References:
Clinical trial NCT02816541: Effects of Pilates-based Therapeutic Exercises on the Postural Control
Official title: Effects of Pilates-based Therapeutic Exercises on the Postural Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Disorders
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 20
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The Pilates Method (PM) has been widely used in the daily practice of many professionals. It is well known that anticipatory postural adjustments (APAs) have a strong relation with the improvement in performance through motor control improvement. However, no studies have investigate the PM exercises performed with pelvis in different positions on the improvement of performance, APAs and these influences on motor control. This study aims to compare the effects of practicing a single session of Pilates-based therapeutic exercises with posterior pelvic tilt and neutral position of the pelvis on the APAs of elderly subjects.


Eligibility criteria: Inclusion Criteria:

* no history of previous abdominal or spine surgery in the last two years
* no history of low back pain in the past 2 years (as incapacitate pain lasting at least seven days)
* no neurological disorder diagnosis

Exclusion Criteria:

* significant postural asymmetry (misalignment that exceed 2 cm of the anterior superior iliac spine)

Primary outcomes:
measure: Balance via Center of Pressure (COP) displacement assessed by force platform
timeFrame: change pre to post-treatment (at least 40 min)
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Health Sciences of Porto Alegre
state: Rio Grande Do Sul
Study officials:
References:
Clinical trial NCT06472141: Effectiveness of Cervical Stabilization Exercises in Individuals With Temporomandibular Joint Disorder
Official title: Effectiveness of Cervical Stabilization Exercises in Individuals With Temporomandibular Joint Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: Temporomandibular Joint Disorders
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was planned as a randomized controlled trial. The individuals included in the study will be divided into 2 groups as Stabilization and Control group by block randomization method.
Primary purpose: TREATMENT

Brief summary: It is planned to examine the effect of cervical stabilization exercises on Temporomandibular Joint (TMJ) symptoms in individuals with TMJ disorder.

Detailed description: Individuals included in the study will be divided into 2 groups, Stabilization and Control groups, by block randomization method. A standard treatment program (Education + home exercises) will be applied to both groups. In addition to the stabilization group, cervical stabilization exercises will be applied. Individuals will be evaluated with the Sociodemographic Data Form before the application.

Before and after the application, individuals were assessed for TMJ pain with the Numeric Pain Rating Scale (NPRS), TMJ symptom severity with the Fonseca Anamnestic Index (FAI) and cervical posture, mobility and muscle performance will be evaluated with craniovertebral angle, goniometer and craniocervical flexion test.

Eligibility criteria: Inclusion Criteria:

* Having a TMJ disorder according to the TMJ Disorders Research Diagnostic Criteria (RDC/TMD),
* Being between the ages of 18-65,

Exclusion Criteria:

* Neurological diseases (such as Multiple Sclerosis, Parkinson's disease),
* Metabolic and systemic diseases (such as Hypothyroidism, Hypercalcemia, Diabetes mellitus, Celiac disease),
* Rheumatologic diseases (such as Rheumatoid arthritis, Scleroderma),
* History of head and spine trauma/surgery in the last 6 months,
* History of malignancy and pregnant women will be excluded.

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Change from baseline at 8 weeks
measure: Fonseca Anamnestic Index (FAI)
timeFrame: Change from baseline at 8 weeks
measure: Cervical Posture
timeFrame: Change from baseline at 8 weeks
measure: Cervical Mobility
timeFrame: Change from baseline at 8 weeks
measure: Cervical Muscle Performance
timeFrame: Change from baseline at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Bitlis Eren Üniversitesi
state: Bitlis
Study officials:
References: