louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05749783: Responsiveness of the Object Permanence Scale
Official title: Responsiveness of the Object Permanence Scale
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Developmental Delay
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 27
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants aged 7-16 months with motor developmental delay

Brief summary: The aim of the study is the examining responsiveness of the Object Permanence Scale. The sample of the study will be 7-16 months old babies with motor developmental delay. Inclusion criteria: 7-16 months of age, sitting for at least 3 seconds but not being able to switch independently between sitting and other positions, and showing at least one developmental delay in the motor development subscale of the Bayley III Developmental Assessment. Evaluations will be done at baseline and 3 months. Exclusion criteria: Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder.


Eligibility criteria: Inclusion Criteria:

* 7-16 months,
* Sitting for at least 3 seconds but unable to independently switch between sitting and other positions
* To show at least one retardation in motor subscale of Bayley III.

Exclusion Criteria:

* Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder

Primary outcomes:
measure: Object Permanence Scale
timeFrame: Baseline
measure: Object Permanence Scale
timeFrame: 3rd month
measure: The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) motor and cognitive subscales
timeFrame: Baseline
measure: The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) motor and cognitive subscales
timeFrame: 3rd month
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Faculty of Health Sciences, Tokat Gaziosmanpaşa University
Study officials:
References:
Clinical trial NCT06805383: Randomized Trial of Follow-up to Mailed FIT Kits
Official title: Follow-up to Mailed FIT Kits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Keywords: fecal immunochemical tests (FIT)
cancer screening
Nurse follow-up
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 2135
Sex: ALL
Minimum age (years): 45
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to assess whether follow-up calls can increase the return rate of mailed FIT Kits. To assess this, a randomly selected half of eligible patients were randomized to receive a follow-up call reminding the patient to return the FIT Kit.

Detailed description: This study aims to assess whether follow-up calls can increase the return rate of mailed FIT Kits. Patients ages 45 to 59 due for colorectal cancer screening, who had not received a FIT Kit in the previous 3 months but had completed one sometime in the past and had an assigned primary care provider, were sent a FIT Kit in October of 2024. Half of patients were randomized to receive a follow-up call reminding the patient to return the FIT Kit. This work analyzes the return rate of the mailed FIT Kit, with or without phone call follow-up.

Eligibility criteria: Inclusion Criteria:

* Age 45-59
* Due for colorectal cancer screening
* Not sent a FIT Kit in the past 3-months
* Previously returned a FIT Kit.

Exclusion Criteria:

* Under age 45 or over age 59;
* incarcerated;
* not due for colorectal cancer screening
* sent a FIT Kit in the past 3-months

Primary outcomes:
measure: Return Rate
timeFrame: 60 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Martinez
country: United States
facility: Contra Costa Health Services
state: California
city: Martinez
country: United States
facility: Contra Costa Health
state: California
Study officials:
References:
Clinical trial NCT04471883: LATAM Bif Registry
Official title: Latin American Registry of Percutaneous Interventions in Coronary Bifurcations
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Bifurcation Lesion
Lead sponsor: LATAM Bifurcation Club
Sponsor class: NETWORK
First posted: 2020-07-15
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients ≥18 years of age, who have at least one significant lesion in a coronary bifurcation on diagnostic cinecoronary angiography and who are candidates to treatment with PCI, regardless of the dedicated-technique used. Those patients who present lesions involving vessels \<2 mm by visual estimation and those who refuse to be included in the registry will be excluded.

Brief summary: The LATAM Bif Registy is an international and prospective registry of percutaneous coronary interventions (PCI) in coronary bifurcation lesions. The main goal of the study is to investigate the current state and long-term outcomes of PCI in this complex subset of coronary lesions in Latin America.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Any type of bifurcation lesion
* Side-branch reference diameter \>= 2 mm

Exclusion Criteria:

* Protected left main disease in patients with previous CABG
* Patients who refuse to be included in the registry

Primary outcomes:
measure: Cardiac Death
timeFrame: 5 years
measure: Myocardial Infarction
timeFrame: 5 years
measure: Target Lesion Revascularization
timeFrame: 5 years
measure: Stent thrombosis
timeFrame: 5 years
measure: Major bleeding
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01431183: Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions
Official title: Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Influenza Vaccination
Keywords: influenza
vaccine
reminder / recall
immunization registry
immunization information systems
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2011-09-09
Enrollment: 3618
Sex: ALL
Minimum age (years): 24
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study was to assess the feasibility and effectiveness of using a statewide immunization information system (IIS) to send seasonal influenza vaccine reminders from Local Health Departments (LHDs), targeting children with high-risk conditions.


Eligibility criteria: Inclusion Criteria:

* children, 24-60 months
* current or previous enrollment in Medicaid (Michigan)
* presence of at least 1 chronic condition, as indicated by the Michigan Care Improvement Registry (MCIR)
* resident of Kalamazoo, Ottawa, or Kent counties (Michigan)

Exclusion Criteria:

* receipt of influenza prior to notification date
* ineligible for reminder/recall notification in the Michigan Care Improvement Registry (MCIR)

Primary outcomes:
measure: seasonal influenza vaccination
timeFrame: up to 4 months following reminder notification
Secondary outcomes:
measure: invalid mailing address
timeFrame: up to 4 months following reminder notification
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan, Child Health Evaluation and Research Unit
state: Michigan
Study officials:
affiliation: University of Michigan
name: Kevin J Dombkowski, DrPH, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dombkowski KJ, Harrington LB, Dong S, Clark SJ. Seasonal influenza vaccination reminders for children with high-risk conditions: a registry-based randomized trial. Am J Prev Med. 2012 Jan;42(1):71-5. doi: 10.1016/j.amepre.2011.09.028.
Clinical trial NCT00885183: Adjuvant Acupuncture Care for Breast Cancer Patients Experiencing Side Effects From Chemotherapy
Official title: Adjuvant Acupuncture Care for Breast Cancer Patients Experiencing Side Effects From Chemotherapy. A Randomised Controlled Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
chemotherapy
adjuvant therapy
acupuncture
fatigue
Early stage breast cancer patients
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Norwegian Cancer Society
First posted: 2009-04-21
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Breast cancer patients report many symptoms while undergoing conventional care, including nausea/vomiting, fatigue, pain, depression and anxiety. Existing interventions to address these common side effects of treatment are limited. Patients diagnosed with cancer frequently seek complementary medicine (CAM), and there is a need to investigate potential effects of CAM therapies. This phased pilot and feasibility study has two aims:

1. Develop an acupuncture treatment protocol for adjuvant acupuncture care for breast cancer patients undergoing chemotherapy using structured interviews with established acupuncture teams in Norway.
2. Implement the treatment protocol in a pilot study to evaluate outcome measures, effect sizes and acceptability of acupuncture care delivered alongside conventional care.

Study results will support the design of future research; including a Phase III randomised controlled trial.


Eligibility criteria: Inclusion Criteria:

* Females, 18 years or older with early stage breast cancer, no previous chemotherapy and no metastatic disease

Exclusion Criteria:

* Needle phobia, use of anticoagulant drugs, inability to comply with study regimen

Primary outcomes:
measure: Fatigue scale
timeFrame: Weeks 16 and 29
Secondary outcomes:
measure: Health related quality of life: EORTC QLQ-C30, EORTC QLQ-BR23, MYCaw
timeFrame: Weeks 16, 19 and 29
measure: Hospital anxiety and depression scale (HADS)
timeFrame: Weeks 16, 19 and 29
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: Clinical Research Centre, University Hospital of North Norway
name: Sameline Grimsgaard, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01029483: The Energy Balance Study
Official title: Energy and Appetite Regulation by Low CHO Diets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Obesity
Weight loss
low carbohydrate diets
high complex carbohydrate diets
Healthy adults
Body composition
Energy Expenditure
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
First posted: 2009-12-10
Enrollment: 39
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Very low carbohydrate diets and high-complex carbohydrate, low-fat diets are popular weight-loss methods in the United States. The purpose of the Energy Balance Study is to explore how extreme differences in diet affect eating behaviors, activity and calorie-use, and body composition.

We will conduct a controlled feeding study (all food will be provided for the duration of the study) in which obese adults will be randomly assigned to one of three dietary groups: a low-carbohydrate-eat as much as you like diet, a high-carbohydrate-eat as much as you like diet, or a high-carbohydrate-calorie-restricted diet. The low-carbohydrate diet will be modeled after the Induction Phase of the Atkins Diet. The high carbohydrate diet will be based on the "Dietary Approaches to Stop Hypertension (DASH)" diet. During the first 3 weeks, participants will eat a typical diet adjusted so that they neither gain or lose weight. Then, for 6 weeks, they will eat their assigned research diet. Resting calorie use and body composition measurements will be taken at the end of week 2 and week 9. Frequent blood sampling for 24 hours will be done through a catheter (tube) placed in an arm vein at the end of weeks 2 and week 9 and for 12 hours at the end of week 3.

Change in body composition, activity and energy expenditure, and blood components known to influence eating behavior will be measured under typical diet conditions and after one-day and 6 weeks of the research diet.


Eligibility criteria: Inclusion Criteria:

* BMI; 30-50 kg/m2
* Age at least 21 years
* Relative good health

Exclusion Criteria:

* Major debilitating mental or physical illness that would interfere with participation
* Renal or hepatic disease, diabetes
* History of gallbladder disease/removal
* Hyper-or hypothyroidism
* Poorly controlled hypertension
* Use of lipid lowering medications
* Pregnancy or lactation
* Current excessive use of alcohol
* Current/recent chronic use of tobacco

Primary outcomes:
measure: weightloss
timeFrame: 6 weeks
Secondary outcomes:
measure: weight regulation hormones (insulin, leptin, ghrelin, GLP-1, PYY)
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health and Science University
name: Diane D Stadler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02688283: The Effect on Glycemic Responses and Subjective Ratings of Satiety of a Snack With or Without Ingredients to Slow Carbohydrate Digestion
Official title: Randomized, Controlled, Cross-over Study Comparing The Effect on Glycemic Responses and Subjective Ratings of Satiety of a Snack With or Without Ingredients to Slow Carbohydrate Digestion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Response; Satiety
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2016-02-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this trial is to compare a snack with ingredients (whole grains and dietary fiber) to slow carbohydrate digestion to a similar control snack without such ingredients and evaluate the effect of the snack on glycemic response and subjective satiety. The test product will be compared with a control product as well as white bread in a randomized, controlled, crossover trial including 20 healthy males or females between the ages of 18 and 70 and having a body mass index (BMI) between 25 and 30 kg/m2. Following an overnight fast, participants will be given each of the study products in a random order at least a week apart. Glucose and insulin will be measured before product consumption and over a period of four hours. Visual analog scales to measure subjective satiety will also be administered over a period of four hours.


Eligibility criteria: Inclusion Criteria:

1. Healthy males or females between the ages of 18 and 70 inclusive
2. No chronic medications other than oral contraceptives
3. Body Mass Index (BMI) between 25 and 30 kg/m2 inclusive.
4. Body weight stable in a 5 kg range in the 3 months prior to study entry

Exclusion Criteria:

1. Pregnant or nursing a baby
2. Women with child-bearing potential who are unwilling to use an effective means of contraception during the study which could include abstinence.
3. Adults unable to consent and prisoners

Primary outcomes:
measure: area under the curve (AUC) for glucose and insulin
timeFrame: 0-4 hours post consumption
Secondary outcomes:
measure: AUC for the visual analog scale (VAS) ratings of satiety
timeFrame: 0-4 hours post consumption
Other outcomes:
Locations:
Study officials:
affiliation: Pennington Biomedical Research Center
name: Frank Greenway, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00328783: Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer
Official title: A Pilot Study Investigating Active Breathing Coordinator (ABC) to Reduce Radiation Dose to Normal Structures in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Active Breathing Control
Active Breathing Coordinator
ABC
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2006-05-22
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the use of a device that helps coordinate the breathing cycle in the radiation treatment of the breast in order to minimize the radiation dose to the normal structures around the breast.

Detailed description: The Active Breathing Coordinator (ABC) allows for temporary and reproducible immobilization of internal thoracic structures by monitoring the patient's breathing cycle and implementing a breath hold at a predefined lung volume level. While ABC is FDA approved and commercially available, only preliminary dosimetric data is available on a small number of patients with breast cancer. There is some data using ABC for intrathoracic malignancies, which shows that it is feasible and safe to use. ABC can be used to optimize the distance between chest wall, heart and liver. This allows adequate treatment of the breast and underlying chest wall while minimizing irradiated cardiac and liver volume.

Eligibility criteria: Inclusion Criteria:

* Requiring adjuvant or post mastectomy radiation therapy with tangential fields or 3-fields
* Adequate pulmonary function
* Presence of 5 cc of the heart or liver with the simulation fields
* Karnofsky Performance Status (KPS) equal to or greater than 70

Exclusion Criteria:

* Pregnant women
* Patients who have had previous ipsilateral breast or thoracic radiation therapy

Primary outcomes:
measure: Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues
timeFrame: At time of radiation
measure: Proportion of Patients With Reduction in Radiation
timeFrame: 30 days
Secondary outcomes:
measure: Toxicity Evaluation
timeFrame: 30 days post-treatment
measure: Change in Organs at Risk (OAR) Dosimetric Paramaters
timeFrame: 30 days post-treatment
measure: Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device.
timeFrame: 30 days post-treatment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Pramila Rani Anne, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00036361: Broad Effectiveness: Study With Aripiprazole
Official title: Broad Effectiveness: Study With Aripiprazole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2002-05-10
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn if aripiprazole is effective in the treatment of a large number of persons diagnosed with schizophrenia or schizoaffective disorders


Eligibility criteria: * Patients with Schizophrenia or Schizoaffective Disorder

Primary outcomes:
measure: Safety Assessments
Secondary outcomes:
measure: Safety Assessments
Other outcomes:
Locations:
city: Wallingford
country: United States
facility: Local Institution
state: Connecticut
Study officials:
References:
Clinical trial NCT03415061: Effect of Intranasal Insulin on POCD and POD
Official title: Does Intranasal Insulin Administration Reduce the Incidence of Cognitive Dysfunction After Cardiac Surgery?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delirium
Heart Diseases
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 494
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Decline in cognitive function after surgery occurs most commonly in older patients and patients undergoing major surgeries, such as heart surgery. Postoperative Cognitive Dysfunction (POCD) may last a prolonged period of time while Postoperative Delirium (POD) is a more acute disturbance in attention, awareness and cognition. The cause of POCD and POD are not fully understood, however some of the pathophysiology of POCD is similar to that of Alzheimer's disease (AD).

Insulin given intravenously during heart surgery has been shown to preserve short and long-term memory function after the operation. Clinical trials further demonstrated that insulin given via the nose (intranasal) improves memory performance of patients with AD or cognitive impairment suggests that intranasal insulin also could be a therapeutic option for POCD and POD.

This study is designed to examine the effect intranasal insulin on POCD and POD. The goal is to investigate whether administration of intranasal insulin during and after heart surgery improves cognitive function postoperatively.


Eligibility criteria: Inclusion Criteria:

•elective open heart surgery requiring cardiopulmonary bypass

Exclusion Criteria:

* inability to provide informed consent
* allergy to insulin
* pregnancy
* mother tongue other than English or French
* visual or hearing impairment interfering with the ability to complete cognitive tests.

Primary outcomes:
measure: Confusion Assessment method for the ICU
timeFrame: Up to 7 days after surgery
measure: Rey Auditory Verbal Leaning
timeFrame: up to 12 month
measure: Rey-Osterrieth Complex Figure Test
timeFrame: up to 12 month
Secondary outcomes:
measure: Stroop Test
timeFrame: up to 12 month
measure: Trail Making Test
timeFrame: up to 12 month
measure: Tower of London test
timeFrame: up to 12 month
measure: Symbol Digit Modalities Test
timeFrame: up to 12 month
measure: Boston Naming Test
timeFrame: up to 12 month
measure: Clock Drawing Test
timeFrame: up to 12 month
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital McGill University Health Centre
state: Quebec
Study officials:
References: