louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06547320: Sensor-based Just-in Time Adaptive Interventions (JITAIs) Targeting Eating Behavior
Official title: Sensor-based Just-in Time Adaptive Interventions (JITAIs) Targeting Eating Behavior
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Overweight and Obesity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a sensor device called an Automatic Ingestion Monitor (AIM) that is worn on eyeglasses can be used with a smartphone to change eating behavior. Participants will wear the device for one week of no-intervention observation. They will then test behavioral interventions focused on eating for two weeks. The researchers hypothesize that messages sent to a smartphone that are based on information from the AIM can reduce the amount of food that is eaten and slow eating.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 27 and 45 kg/m-squared
* Weight stable within 5% in the past 6 months
* Self-reports basic familiarity with use of a smartphone

Exclusion Criteria:

* Diagnosed diabetes (type 1 and 2)
* Any poorly controlled medical condition that could affect weight and/or eating behavior (e.g., hypothyroidism)
* Medical conditions or use of medications or diets/supplements known to affect energy regulation or appetite
* Difficulty chewing or swallowing
* Diagnosed eating disorder
* Night or shift work
* Current participation in a weight loss program
* History of bariatric surgery
* Current pregnancy or lactation within the past 1 year, or planning a pregnancy during the study participation period
* Consuming a medically-prescribed or unusual diet (e.g., macrobiotic)
* Food allergies or sensitivities, or other conditions which result in avoidance of a wide range of foods (e.g. celiac disease, tree nut allergy)
* Reported recreational drug use
* Report of conditions that would significantly interfere with an ability to follow the protocol including terminal illness, substance abuse, or other significant uncontrolled psychiatric problem

Primary outcomes:
measure: Total energy intake
timeFrame: Daily average computed for the 7-day observation period and each 7-day intervention period
Secondary outcomes:
measure: Energy intake per eating occasion
timeFrame: Average intake per eating occasion computed for the 7-day observation period and each 7-day intervention period
measure: Rate of eating per eating occasion
timeFrame: Average intake per eating occasion computed for the 7-day observation period and each 7-day intervention period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Providence
country: United States
facility: The Miriam Hospital Weight Control and Diabetes Resarch Center
state: Rhode Island
Study officials:
References:
Clinical trial NCT02869620: Institut Paoli Calmettes Thyroid Cancer Database
Official title: Institut Paoli Calmettes Thyroid Cancer Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Neoplasms
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of Thyroid Cancer

Brief summary: Database of Institut Paoli-Calmettes patients diagnosed with thyroid cancer


Eligibility criteria: Inclusion Criteria:

* Diagnosis of thyroid cancer

Exclusion Criteria:

* Non applicable

Primary outcomes:
measure: Survival of patients
timeFrame: 10 years
Secondary outcomes:
measure: Collection of patients characteristics
timeFrame: 10 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Bouches-du Rhône
Study officials:
References:
Clinical trial NCT03476720: Improving Defibrillation Pad Position
Official title: Accuracy of Instructional Diagrams for Automated External Defibrillator (AED) Pad Positioning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults who have had no training in basic life support or public access/AED defibrillation.

Brief summary: Manufacturer's diagrams showing defibrillation pad positioning (as used on public access defibrillators) are anatomically incorrect and are likely to lead to poor position of defibrillation pads, with reduced defibrillation efficacy.

We will ask untrained members of the public to observe the diagrams and place pads as indicated on the diagram. We will asses the accuracy of pad placement and repeat the study using an anatomically correct diagram to see if we can improve the accuracy of pad placement.

Detailed description: As above

Eligibility criteria: Inclusion Criteria:

- 16 yrs age and willing to participate.

Exclusion Criteria:

* Previous BLS training
* Previous AED training
* Clinical staff (doctor, nurse, HCA, paramedic etc)

Primary outcomes:
measure: Pad position
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
state: Hampshire
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Charles Deakin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06473220: Evaluation of the Effectiveness of Narrative Nursing
Official title: Evaluation of the Effectiveness of Narrative Nursing in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Narrative
Depression, Anxiety
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To explore the effects of narrative nursing on mental state, life ability and emotion of patients with Alzheimer's disease (AD).

Detailed description: There is no effective clinical treatment, mainly through taking Western drugs to control the Alzheimer's disease, but the treatment cycle is long, the cost of drugs is high, and the patient's family nee care, resulds long-termting in a huge economic and psychological burden on the patient and family recipients. Narrative nursing is an intervention mode of psychological nursing.In practice, narrative nursing can guide patients to actively organize experiences into various events with certain practical significance, attach importance to personal feelings and experiences, promote the psychological growth of patients and promote the generation of upward motivation.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of Alzheimer's Disease.
2. Forgetting is the main cognitive impairment;.
3. The patient has basic language communication ability.
4. Patients were treated with the same regimen.

Exclusion Criteria:

1. Patients with other common neurological and mental disorders (depression, psychosis, vascular cognitive impairment).
2. Patients with heart, liver and other vital organ dysfunction.
3. Patients with severe cardiovascular disease.
4. Patients with severe physical disorders.

Primary outcomes:
measure: MMSE sore
timeFrame: After 1, 2 and 4 weeks after hospitalization
measure: ESCA score
timeFrame: After 1, 2 and 4 weeks after hospitalization
measure: HAMD score
timeFrame: After 1, 2 and 4 weeks after hospitalization
measure: HAMA score
timeFrame: After 1, 2 and 4 weeks after hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Gulou District
state: Jiangsu
Study officials:
affiliation: The Affiliated Brain Hospital of Nanjing Medical University
name: Huang C ying, Bachelor
role: STUDY_CHAIR
References:
Clinical trial NCT00218920: Effective Training in Overweight and Obese People
Official title: Effective Training in Overweight and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: aerobic capacity
endothelial function
exercise
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim is to come to a consensus about how to prescribe exercise training that actually helps overweight and obese people. Thus, the present study determines the effects of several types of exercise training to define the one with the largest effect with the least effort.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) over 30

Exclusion Criteria:

* Not able to walk on a treadmill
* Participating in an other study
* Serious cardiovascular diseases

Primary outcomes:
measure: Body weight
timeFrame: 12 weeks
measure: Aerobic capacity
timeFrame: 12 weeks
measure: Endothelial function
timeFrame: 12 weeks
Secondary outcomes:
measure: Molecular markers in fat and skeletal muscle biopsies for the effects of exercise training
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Ulrik Wisløff, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schjerve IE, Tyldum GA, Tjonna AE, Stolen T, Loennechen JP, Hansen HE, Haram PM, Heinrich G, Bye A, Najjar SM, Smith GL, Slordahl SA, Kemi OJ, Wisloff U. Both aerobic endurance and strength training programmes improve cardiovascular health in obese adults. Clin Sci (Lond). 2008 Nov;115(9):283-93. doi: 10.1042/CS20070332.
Clinical trial NCT05476120: The Effect of the Use of BATHE Interview Technique on Treatment Compliance in Hypertension Patients in Primary Care
Official title: The Effect of the Use of BATHE Interview Technique on Treatment Compliance in Hypertension Patients in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Hypertension
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blind, parallel-group, randomized-controlled intervention study
Primary purpose: OTHER

Brief summary: The research is planned to evaluate the treatment compliance after the BATHE interview technique in hypertension patients.

Detailed description: In order to be evaluated for suitability for the study, patients aged 18-80 who have been diagnosed with hypertension for at least 6 months (n= 220) were interviewed and 86 hypertension patients who met the inclusion criteria and volunteered for the study were included in the study. Participants whose eligibility was determined as a result of the evaluation in terms of inclusion and exclusion criteria were asked about their volunteerism in the intervention study, their written consent was obtained from those who volunteered, and those who volunteered were randomized.

Eligibility criteria: Inclusion Criteria:

* Being a patient of hypertension
* Be over 18 years old
* Be less than 80 years old
* To have been diagnosed for at least 6 months
* Volunteering
* To be able to use any of the online video calling channels

Exclusion Criteria:

* Communication problem
* Presence of psychiatric illness and/or use of psychiatric medication
* Pregnancy

Primary outcomes:
measure: The Scale for Evaluating the Success of Treatment Adherence and Lifestyle Change in Hypertensive Individuals
timeFrame: Baseline and sixth month
measure: Turkish Modified Morisky Scale
timeFrame: Baseline and sixth month
Secondary outcomes:
measure: Waist circumference
timeFrame: Baseline and sixth month
measure: BMI
timeFrame: Baseline and sixth month
measure: Blood pressure
timeFrame: Baseline and sixth month
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Vildan MEVSİM
state: Balçova
Study officials:
References:
Clinical trial NCT03166020: Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident
Official title: Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Motor Activity
Keywords: Serious Game
Stroke
Rehabilitation
Connected objects
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
Collaborators: name: Fondation Garches
First posted: 2017-05-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this randomized controlled study with stroke patients is to demonstrate that a re-education with interactive table with instrumented objects delivering sensory feedback and serious game improve certain motor functions of the paretic upper limb than rehabilitation based on a standardized self-rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* Stroke patients
* Subject with gripping ability: capable of peeling off the connected object from the table, presented in its grip area.

Exclusion Criteria:

* Severe cognitive disorders preventing the completion of the task
* Bilateral brain lesions

Primary outcomes:
measure: Speed of the gesture to reach each target
timeFrame: 10 minutes
Secondary outcomes:
measure: Wolf Motor Functional Test
timeFrame: 15 minutes
measure: Box and block
timeFrame: 5 minutes
measure: Fugl Meyer
timeFrame: 10 minutes
measure: MOCA
timeFrame: 5 minutes
measure: Pain
timeFrame: 1 minute
measure: Spasticity
timeFrame: 5 minutes
measure: SF12 Quality of life
timeFrame: 10 minutes
measure: Canadian Occupational Performance Measure
timeFrame: 20 minutes
measure: Frenchay activities Index
timeFrame: 15 minutes
measure: Cinematic Evaluation
timeFrame: 10 minutes
measure: Clamping force
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
city: Garches
country: France
facility: Nicolas ROCHE, Md PhD
Study officials:
affiliation: Raymond Poincare HOSPITAL
name: Nicolas ROCHE, MD phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04376320: Comparison of Two Pre-prosthetic Surgical Techniques for Augmentation of Mandibular Vertical Ridge Defects
Official title: Comparison of Two Pre-prosthetic Surgical Techniques for Augmentation of Mandibular Vertical Ridge Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Ridge Enlargement
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare two pre-prosthetic surgical techniques for augmentation of vertical mandibular ridge defects in preparation for implant placement, the first using customized ceramic membranes and the second using tenting titanium screws in conjunction with particulate bone graft and collagen membrane (modified sausage technique).

Detailed description: Background: Expansion of the periosteum and soft tissue matrix by tenting has been described as a method of Guided Bone Regeneration (GBR) for reconstruction of atrophic alveolar ridges.

Materials and Methods: The current study is a prospective controlled clinical trial, conducted on 14 patients, having about 7 mm of vertical bone height in the posterior mandible above the inferior alveolar canal. They are divided into 2 equal groups, each consisting of 7 patients. The first group receives customized ceramic membranes with a vertical height 5 mm above the crest of the ridge to tent out the soft tissue matrix, while in the second group, tenting of the soft tissue is done by fixation of two tenting screws, particulate bone graft is packed then covered by collagen membrane that is fixed by bone tacks (modified sausage technique).

Eligibility criteria: Inclusion Criteria:

* patients of both genders
* with age range from 40 to 60 years,
* having about 7 mm of vertical bone height in the posterior mandible above the inferior alveolar canal and
* requiring prosthetic rehabilitation with dental implants.

Exclusion Criteria:

* heavy smokers,
* patients undergoing radiotherapy or chemotherapy,
* those having infection or local lesions in the area of surgery, and
* patients with bone diseases which may compromise the results

Primary outcomes:
measure: mean percentage of change of alveolar bone height
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT03988920: A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP
Official title: A Long-Term, Open Label Study to Evaluate the Ability of Tenapanor Alone or in Combination With Sevelamer to Treat to Goal Serum Phosphorus in Patients With End-Stage Kidney Disease on Dialysis (NORMALIZE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperphosphatemia
End Stage Renal Disease
Lead sponsor: Ardelyx
Sponsor class: INDUSTRY
First posted: 2019-06-18
Enrollment: 172
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate the ability of tenapanor alone or in combination with sevelamer to achieve serum phosphorus concentration (sP) within the population reference range (sP \>2.5 and ≤4.5 mg/dL) in patients with end-stage renal disease (ESRD) on dialysis with hyperphosphatemia (\>4.5 mg/dL).

Detailed description: Patients who complete the TEN-02-301 study (PHREEDOM) may be eligible to enroll into TEN-02-401 (NORMALIZE).

Patients from the TEN-02-301 tenapanor arm will either receive only tenapanor or be given sevelamer in addition to tenapanor based on their sP. Patients from the TEN-02-301 sevelamer arm will be given tenapanor in addition to their sevelamer dose and the sevelamer dose will then be adjusted based on their sP following a protocol-specified dose titration schedule. Patients will be monitored for safety and efficacy with in-office and telephone visits for up to an additional 18 months.

Laboratory assessments will be measured at every visit (Weeks 1, 2, 3, 4, 6 and 8 and Months 3, 6, 9, 12, 15 and 18) using a central laboratory.

Safety assessments will be performed during the study and will include physical examinations, vital signs (blood pressure and pulse), body weights, clinical laboratory evaluations, 12-lead electrocardiograms (ECGs), and adverse event (AE) monitoring.

Eligibility criteria: Inclusion Criteria:

* Must complete TEN-02-301 (PHREEDOM)

Exclusion Criteria:

1. Schedlued for kidney transplant
2. Life expectancy \<12 months

Primary outcomes:
measure: Achieving Normal Serum Phosphorus Level
timeFrame: 18 months
Secondary outcomes:
measure: Change in Serum Phosphorus (s-P) From TEN-02-301 (Parent Study) Baseline
timeFrame: up to 2.5 years
measure: Change From Baseline in Serum Phosphorus (of Extension Study; TEN-02-401) to Endpoint Visit
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Ardelyx Site #509
state: California
Study officials:
affiliation: Ardelyx
name: David P Rosenbaum, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04044482: Evaluation of Health Related Quality of Life and Patient Adherence in Case of Hungarian Patients Affected by Osteoarthritis
Official title: Evaluation of Health Related Quality of Life and Patient Adherence in Case of Hungarian Patients Affected by Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both sex, above 18 years old

Brief summary: Translation and Cross-cultural adaptation process of the Osteoarthritis Knee and Hip Quality of Life questionnaire. According to granted guidelines, shared by the developer of the questionnaire, the study was conducted among Hungarian patients affected by osteoarthrosis.

Detailed description: This prospective study was performed among patients diagnosed - by the doctors acting as the expert panel of this study - with OA of the lower limb. The recruitment period was: June 2017 and November 2017, in six hospitals situated in six different geographical regions of Hungary. The participating hospitals were selected in a way to represent different geographic and cultural areas of the country; the patients were selected randomly by the doctors of the given sites. The process was conducted with the contribution of: (1) Translation committee (4 members), (2) Our research team, as moderator (4 members), (3) Expert panel (6 doctors professors of the study sites: orthopaedists, rheumatologists, musculoskeletal rehabilitation doctors). The used instruments were for the validation process: Short version of World Health Organization Quality of life questionnaire (WHOQoL-BREF), EuroQuality of Life - 5-dimension questionnaire as generic quality of life measurement tools (EQ-5D - VAS). In addiction 99 patients filled the questionnaires in an appropriate way. The results were evaluated by 23.0 version of SPSS program.

Eligibility criteria: Inclusion Criteria:

* age over 18 years
* clinically/doctor diagnosed knee and/or hip osteoarthritis
* native Hungarian language
* ability of self-filling and completely filled patient data sheet.

Exclusion Criteria:

* age under 18 years
* other type of OA osteoarthritis
* psychiatric disorders
* surgeries within 1 month
* incapable of filling out the forms/tools

Primary outcomes:
measure: Validity and Reliability of the translated and adapated questionnaire
timeFrame: 17 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: