louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06673251: School Readiness in Children with Type 1 Diabetes
Official title: Investigation of the Effects of Motor Performance, Sensory Processing, Quality of Life and Participation on School Readiness in Children with Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type1diabetes
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 78
Sex: ALL
Minimum age (years): 60
Maximum age (years): 78
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: TYPE 1 DİABETES CHİLDREN

Brief summary: It is known that motor and sensory functions are affected in children with type 1 diabetes (T1DM).This may cause children to have restrictions in their daily lives and decrease their participation in activities.Motor and sensory factors and participation are important factors affecting children's school readiness.This study was planned to investigate the effects of motor performance, sensory processing, quality of life and participation on school readiness in preschool children with T1DM.


Eligibility criteria: Inclusion Criteria:

Having been diagnosed with Type 1 DM in the last 6 months (for type 1 diabetes group) Being 60-78 months old

Exclusion Criteria:

* - Having any neurodevelopmental disorder in addition to diabetes (EX: cerebral palsy, down syndrome, muscular dystrophies..)
* Starting 1st grade

Primary outcomes:
measure: school readiness
timeFrame: through study completion, an average of 1 year
measure: motor performance
timeFrame: through study completion, an average of 1 year
measure: Quality of Life
timeFrame: through study completion, an average of 1 year
measure: Sensory Processing
timeFrame: through study completion, an average of 1 year
measure: participation
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: physical fitness
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01882777: Evaluation of a Project to Distribute Water Filters and Cookstoves in Western Rwanda
Official title: ASSESSING THE IMPACT OF WATER FILTERS AND IMPROVED COOK STOVES ON DRINKING WATER QUALITY AND INDOOR AIR POLUTION: A RANDOMISED CONTROLED TRIAL IN RWANDA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Faecal Contamination of Household Drinking Water (Environmental Outcome)
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: DelAgua
name: Portland State University
name: University of Colorado, Boulder
name: University of Zurich
name: Ministry of Health, Rwanda
First posted: 2013-06-20
Enrollment: 566
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: DelAgua Health and Development, Manna Energy and the Rwanda Ministry of Health are collaborating on a project financed by carbon credits that will distribute household-based water filters and high-efficiency cook stoves to approximately 700,000 households in Rwanda. Prior to the full roll out of the campaign, the implementers are conducting a pilot project among 2000 households in western Rwanda. The objectives of this pilot evaluation are to document the delivery of the intervention to the intervention population, assess coverage and uptake of the intervention target households and conduct a 5-month randomised controlled trial among 500 households to assess the impact of the intervention on drinking water quality and indoor air quality.


Eligibility criteria: Inclusion Criteria:

* All households in three selected villages

Exclusion Criteria:

* None

Primary outcomes:
measure: Thermotolerant coliforms in household drinking water
timeFrame: 5 months
Secondary outcomes:
measure: Particulate matters 2.5 mg/m3 (PM2.5) concentrations
timeFrame: once
measure: Adherence - use of water filters and cookstoves
timeFrame: 5 months
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: Manna Energy Ltd.
Study officials:
References:
citation: Rosa G, Majorin F, Boisson S, Barstow C, Johnson M, Kirby M, Ngabo F, Thomas E, Clasen T. Assessing the impact of water filters and improved cook stoves on drinking water quality and household air pollution: a randomised controlled trial in Rwanda. PLoS One. 2014 Mar 10;9(3):e91011. doi: 10.1371/journal.pone.0091011. eCollection 2014.
Clinical trial NCT06574477: Impacted Canine and Mixed-reality Technology - RCT
Official title: Alignment of an Impacted Canine Using Mixed-reality HoloLens 2 Goggles - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tooth, Impacted
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 72
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine whether the use of HoloLens 2 mixed reality goggles for planning alignment of palatally impacted canine reduces: 1) treatment time and 2) the risk of complications compared to planning alignment of palatally impacted canine without HoloLens 2 goggles.

Participants will have an impacted canine on palatal side.

Researchers will use or will not use HoloLens 2 goggles in planning therapy

Participants will wear fixed orthodontic appliances for the treatment of impacted canine. During treatment, attachment will fixed to an impacted canine and the direction of traction will be established.


Eligibility criteria: Inclusion Criteria:

* Healthy boys/men and girls/women aged between 10 and 20 years.
* Palatally impacted canine on one side
* Axis of the canine \> 10 degrees to the midline as measured on a pantomographic radiograph
* During orthodontic treatment, in preparation for alignment of the impacted canine with adequate space for the retained canine

Exclusion Criteria:

* Dental abnormalities (hyperodontia, hypodontia, etc.)
* Impacted canines bilaterally
* Previous trauma to the teeth or face
* Congenital craniofacial malformations
* Systemic diseases that would hinder orthodontic treatment/operation
* Recent radiotherapy

Primary outcomes:
measure: Alignment duration
timeFrame: 6 months, 12 months
Secondary outcomes:
measure: Resorption
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Jagiellonian University Medical College
Study officials:
References:
Clinical trial NCT02417077: Perception of Facial Expression in Subjects With and Without Crow's Feet Lines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-04-15
Enrollment: 393
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: This study will examine the perception of facial expressions among individuals with and without crow's feet lines.


Eligibility criteria: Inclusion Criteria:

* English fluency

Exclusion Criteria:

* None

Primary outcomes:
measure: Independant Observers' Perception of Expressed Emotions on a 7-Point Scale
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Saratoga Springs
country: United States
state: New York
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02461277: Postoperatory Recovery in Thoracic Surgical Procedure, Fast-track Protocol vs. Conventional Care
Official title: Postoperatory Recovery in Thoracic Surgical Procedure, Fast-track Protocol vs. Conventional Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Surgery
Keywords: postoperative care
exercise test
early ambulation
Fast-track
Lead sponsor: Instituto do Coracao
Sponsor class: OTHER_GOV
First posted: 2015-06-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study was to compare the functional capacity of exercise by six-minute walk test before and after thoracic surgical procedure in subjects who have undergone the Fast-track protocol with those who were under conventional care. Researchers want to find out if Fast-track is a strategy to enhance functional capacity after thoracic surgery.

Detailed description: Fast track programs represents a new approach to the management of patients undergoing surgery. It is perioperative care pathway designed to achieve early recovery and helps to minimize postoperative morbidity and mortality.

These multimodal approaches focuses on enhancing recovery and reducing of surgical stress by minimal invasive surgery, optimized pain relief, early nutrition and ambulation.

In postoperative, the bed rest leads to the increase in muscle loss and weakness, impairs pulmonary function, predisposes to venous stasis and thromboembolism, increases infection complications and reduces functional capacity.

However, information on the results of Fast-track protocols in functional capacity of exercise during hospital stay is sparse.

The six-minute walk test is use to measure of functional capacity of exercise in different populations and to detect changes after interventions. The distances traveled in two six-minute walk test (preoperative and postoperative) will be compared between the two groups (Fast-track and Conventional).

In this trial the investigators will consider Fast-track protocol to be feasible to enhance functional capacity of exercise after thoracic surgery.

Eligibility criteria: Inclusion Criteria:

* patients who are scheduled to undergo a thoracic surgical procedure
* sign the informed consent form
* independent ambulation
* ability to understand and follow instructions

Exclusion Criteria:

* contraindications for epidural catheter placement
* refusal to do physical exercises on postoperative

Primary outcomes:
measure: Functional capacity of exercise ( six-minute walk test)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 days
Secondary outcomes:
measure: Time to first postoperative ambulation
timeFrame: up 2 hour after surgery
measure: The length of hospital stay
timeFrame: expected average of 6 days
measure: Surgical complications
timeFrame: up 6 days after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03350477: Bioinformation Therapy for Gastric Cancer
Official title: Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresctable Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Advanced Gastric Cancer
Keywords: Cancer ablation
Life information rehabilitation therapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shengxin Biotechnology Institute, Beijing
First posted: 2017-11-22
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable gastric cancer.

Detailed description: By enrolling patients with unresectable gastric cancer adapted to enrolled criteria,this study will document for the first time the synergistic effect of cancer according to local relief degree,progress free survival(PFS)and overall survival(OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies
* Body tumor 1-6, with at least one tumor length \> 2 cm
* KPS ≥ 70, lifespan：3-6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT03043677: Ex-vivo Modulatory Effect of Biological Drugs for Inflammatory Bowel Disease on the Mucosa and on Peripheral Blood Mononuclear Cells
Official title: Ex-vivo Modulatory Effect of Biological Drugs for Inflammatory Bowel Disease on the Mucosa and on Peripheral Blood Mononuclear Cells
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Lead sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sponsor class: OTHER
First posted: 2017-02-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy controls and patients with active inflammatory bowel disease (ulcerative colitis and Crohn´s disease).

Brief summary: To characterize circulating DC subsets from healthy controls and IBD patients and to assess, following an ex vivo challenge, the effect of anti-TNF (infliximab, adalimumab and golimumab), anti-p40 -IL-12/IL-23- (ustekinumab) and anti-α4β7 (vedolizumab) immunomodulators on both the GI production of soluble immune mediators and the mucosal capacity to alter the recruitment capacity of circulating DC subsets. It is expected that such approach will provide further information on the action mechanisms of such therapies on IBD patients, allowing a better understanding of the pathophysiology of this disease and the identification of tissue-specific therapeutic targets, thus avoiding collateral problems associated with systemic immunomodulation.


Eligibility criteria: Inclusion Criteria:

Patients with active IBD, and endoscopic and histological diagnosis of CD or UC that attend a colonoscopy with sedation performed by medical criteria.

Patients without an IBD diagnosis, or other types of inflammatory, allergic, malignant or autoimmune diseases, prior to their inclusion in this project. All patients will attend a colonoscopy with sedation at medical judgment with biopsy indication for histopathological study as in cases of diarrhea but also due to changes in the bowel transit, rectal bleeding or screening for gastrointestinal diseases. Patients will be paired in age and gender with the IBD groups. All patients will have no signs of macroscopic or microscopic inflammation hence excluding the presence of microscopic colitis.

Exclusion Criteria:

1. Age less than 18 years
2. Chronic disease or any other advanced clinically significant pathology, uncontrolled by investigator judgment.
3. Should be with medication, this will be unchanged in the 3 months prior to colonoscopy.
4. Alcohol or drugs.
5. Pregnancy or lactation
6. Do not sign the informed consent form (see "Ethical Issues") In any case NO colonoscopies exclusively targeted for sampling for this project will be made

Primary outcomes:
measure: Effect of biological drugs on the secretion of gut-chemoattractants by the intestinal mucosa
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01513577: Percutaneous Minimal Invasive Pedicular Screw and Rod Insertion in Circumferential Lumbar Fusion
Official title: Percutaneous Minimal Invasive Pedicular Screw and Rod Insertion Reduces Hospital Stay and Morbidity Compared to Open Midline Approach in Circumferential Lumbar Fusion. A Randomized Study With 2 Years Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Disc Disease
Keywords: Lumbar fusion
Pedicular screws
Minimal invasive technique
Randomized controlled trial
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Convalescence after lumbar surgery is dependent on the extensiveness of the surgical procedure. Minimal invasive techniques in lumbar spine surgery are reported to achieve excellent clinical results with less pain, morbidity and disability.

Detailed description: To achieve lumbar fusion when there is no need for decompression of the neural structures a posterior midline approach and a left anterior retroperitoneal approach is used. The retroperitoneal anterior approach to the lumbar spine offers some benefits compared with the posterior approach. Dural injury and epidural scarring can be avoided, and an interbody fusion graft can be placed with minimal risk to the nerve roots. However, the extensive posterior midline approach with extensive muscle dissection is necessary to place the pedicular screws.

A report of a follow-up period of 2 years of a randomized trial of minimal invasive insertion of pedicular screws and rods in lumbar fusion.

Eligibility criteria: Inclusion criteria:

* Degenerative disc disease in one of the three lower lumbar levels.

Exclusion criteria:

* Previous fusion, metabolic bone disease, co-morbidity or psychological instability.

Primary outcomes:
measure: Percutaneous technique versus conventional open technique.
timeFrame: Two years
Secondary outcomes:
measure: Improvements of recovery and convalescence.
timeFrame: Two years
Other outcomes:
Locations:
Study officials:
affiliation: Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
name: Sten Rasmussen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopaedic Surgery, Vejle and Give Hospital
name: Henrik Kehlet, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06635577: Modifying Cognitive Strategies for Comparing Proportions
Official title: Changing Quantitative Reasoning Across Development
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Proportional Reasoning
Keywords: proportions
mathematical concepts
strategy use
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Rutgers, The State University of New Jersey
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-10-10
Enrollment: 300
Sex: ALL
Minimum age (years): 7
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to understand the cognitive processes underlying quantitative and relational reasoning, including the understanding of mathematical information (e.g., numbers, proportions, percentages, geometry) and related relational concepts (e.g., analogies, the concepts same/different), as well as how people's reasoning can be changed by external factors. The main question it aims to answer is:

How does the introduction of a secondary task affect the behavior of children and adults when reasoning about proportions in different formats? Participants will be asked to make judgements about images with and without the presence of a distractor task.


Eligibility criteria: Inclusion Criteria:

* Typically developing people within the target age range (either 8-years-old OR 18- to 64-years-old) for the study version

Exclusion Criteria:

* Individuals with known developmental or cognitive disorders
* Participants or parents of participants must speak/read sufficient English to read and complete the informed consent document

Primary outcomes:
measure: Overall Performance
timeFrame: After enrollment in a single study session
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers Center for Cognitive Science
state: New Jersey
Study officials:
References:
citation: Boyer TW, Levine SC, Huttenlocher J. Development of proportional reasoning: where young children go wrong. Dev Psychol. 2008 Sep;44(5):1478-90. doi: 10.1037/a0013110.
citation: Hurst MA, Piantadosi ST. Continuous and discrete proportion elicit different cognitive strategies. Cognition. 2024 Nov;252:105918. doi: 10.1016/j.cognition.2024.105918. Epub 2024 Aug 16.
Clinical trial NCT00997477: Correct Use of Sequential Formoterol and Budesonide Inhaler Capsule Treatment Via Aerolizer and Patient Satisfaction in Asthmatics
Official title: A Single Arm, 12 Week, Multicentre, Open Label, Phase IV Study to Evaluate Correct Use of and Patient Satisfaction From Sequential Use of Formoterol and Budesonide Inhaler Capsules Via Aerolizer™ Device in Patients With Asthma.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Asthma
Keywords: aerolizer
formoterol
budesonide
asthma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the correct use of sequential formoterol and budesonide inhaler capsule treatment via Aerolizer and patient satisfaction in adult asthmatics.


Eligibility criteria: Inclusion Criteria:

* Moderate persistent asthmatic patients.
* No previous Aerolizer experience.

Exclusion Criteria:

* Life-threatening asthma: A subject must not have life-threatening asthma as a history of significant asthma episode(s)requiring intubation associated with hypercapnia, respiratory arrest or hypoxic seizures, or asthma-related syncopal episode(s).
* Worsening of asthma: A subject must not have experienced a worsening of asthma which involved a hospitalization within 6 months of screening, or an emergency room visit three or more times in the past 6 months, or use of oral corticosteroids for worsening asthma within 3 months of screening.
* Unstable asthma: During screening period, a patient requires the use of \>8 puffs/day of salbutamol 100 mcg per actuation pMDI on two consecutive days.
* A subject must not have had an upper respiratory tract infection within 4 weeks of screening.
* FEV1\< 60% at screening.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Proper use of Foradil Combi
timeFrame: Day 0, Day 30, Day 90
Secondary outcomes:
measure: Asthma control test
timeFrame: Day 0, Day 30, Day 90
measure: Ease of use: FSI-10 Questionnaire
timeFrame: Day 30, Day 90
measure: Patient Satisfaction: PSAM and FSI-10
timeFrame: Evaluations will be made at visit 2 (Day 30± 1) and 3 (Day 90± 3)
measure: Safety: Adverse events and severe adverse events
timeFrame: 3 Months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Novartis Investigator Site
city: Istanbul
country: Turkey
facility: Novarits Investigator Site
city: Istanbul
country: Turkey
facility: Novartis Investigator Site
city: Izmir
country: Turkey
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: