louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01030471: Supporting Treatment Adherence Needs in Diabetes
Official title: Supporting Treatment Adherence Needs in Diabetes: The STAND Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 1 Diabetes
Keywords: adolescents
depression
adherence
family functioning
intervention
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-12-11
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: There is an unmet treatment need for depressed adolescents with type 1 diabetes. To address this unmet need, we have designed a new, family-based, cognitive-behavioral intervention to reduce depressive symptoms, improve family functioning, and improve medication compliance. The intervention is delivered in two phases (1 - reduction of depressive symptoms and family conflict, 2 - adherence promotion) as efforts to improve adherence will have a greater likelihood of success if individual and family functioning variables are addressed first. To test the effectiveness of this intervention in reducing depressive symptoms and improving adherence, we will conduct a randomized controlled trial comparing this new intervention to usual care in a sample of fifty-two adolescents with type 1 diabetes and their primary caregivers. Given the absence of this type of intervention and the significance of the problem, this study is timely and important, as it has the potential to positively impact diabetes-specific health outcomes.


Eligibility criteria: Inclusion Criteria:

* Age 13-17
* Diagnosis of type 1 diabetes according to criteria from the ADA for at least 1 year
* Daily insulin dosing of at least 0.5 units per kilogram per day
* Clinical elevation on the CDI (i.e., score at or above 13)
* Assent to participation in study

Exclusion Criteria:

* Other chronic, physical disease or condition except for celiac or thyroid disease
* Diagnosis of major mental disorder (e.g., bipolar disorder, thought disorder, anorexia nervosa)
* Diagnosis of developmental disorder (e.g., mental retardation, autism, Asperger's)
* Current enrollment in psychotherapy specifically targeting depression

Primary outcomes:
measure: Children's Depression Inventory (CDI)-Measure of adolescent depressive symptoms
timeFrame: Assessed at 0, 1.5, 3, and 6 months after enrollment
measure: Diabetes-Related Family Conflict Scale (DFCS)-Measure of family conflict around diabetes-specific tasks
timeFrame: Assessed at 0, 1.5, 3, and 6 months from enrollment
Secondary outcomes:
measure: Hemoglobin A1c value
timeFrame: Obtained at 0, 3, and 6 months after enrollment
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Korey K Hood, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01042171: Evaluation of Image Quality Over Time After Injection of the ﬂuorescein Sodium for Confocal Laser Endomicroscopy
Official title: Evaluation of Image Quality Over Time After Injection of the ﬂuorescein Sodium for Confocal Laser Endomicroscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Change of Image Quality of CLE
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2010-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients without any disease of heart,liver or kidney;patients without serious gastritis and other serious stomach lesions.

Brief summary: Confocal laser endomicroscopy (CLE) is a newly developed endoscopic technique. The most commonly used fluorescent substance is Fluorescein sodium.The plasma half-life of ﬂuorescein is 11 minutes. A recent test estimated that ﬂuorescein-based CLSM(confocal laser scanning microscopy) of the upper-GI tract of pigs delivers the best contrast and image quality within the ﬁrst 8 minutes after injection of ﬂuorescein .However, despite its increasing use in clinical examination,there are no data on contrast dynamics and image quality over time after injection of the ﬂuorescein sodium in the inspection of gastrointestinal tract of human being.


Eligibility criteria: Inclusion Criteria:

* These subjects will include male or female aged between 18 and 60 years with indications for upper-endoscopy ,but without serious gastritis and other serious stomach lesions

Exclusion Criteria:

* Complications such as gastric and/or duodenal peptic ulcer, stenosis
* Esophageal, gastric or duodenal cancer or other malignancy
* History of stomach surgery
* A history of bronchial asthma, or known allergy to fluorescein.
* Pregnant or breast-feeding (for females)
* Below 18 or above 60 years of age
* Severe comorbidities ( e.g. such as renal failure, congestive cardiac failure, liver cirrhosis).

Primary outcomes:
measure: The ideal time period for the best CLE imaging when using ﬂuorescein sodium is about 10 minutes
timeFrame: Within the 30 minutes after injection of fluorescein
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology, Qilu Hospital
name: Yanqing Li, PhD. MD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03867071: Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients
Official title: Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of our study is to demonstrate the interest of early administration of recombinant erythropoietin in trauma patients

Detailed description: Could an early use of rHuEPO (recombinant Human ErythroPOietin ) be lead to an individual benefice on transfusion savings after traumatic surgery?

Eligibility criteria: Inclusion Criteria:

* Patients between 18 to 65 years old
* Patient with an ASA 1 or 2 (ASA 1 corresponding to a patient in perfect health and ASA 2 to a patient with moderate involvement and well controlled organ function)
* patient presenting at least one of the following fractures: Basin and / or femur with surgical indication, associated or not with other fractures.
* patient with hemoglobin between 9 and 13 g / dl at the time of admission on trauma department

Exclusion Criteria:

* patient with contraindication to synthetic erythropoietin
* Patient with intravenous iron contraindication
* pregnant patient or with a risk of pregnancy
* patient who has not given his consent or does not understand the protocol
* Patient with hemodynamic instability
* patient participating in another research protocol for less than 3 months.

Primary outcomes:
measure: number of administered red blood cells
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Nimes university hospital
Study officials:
References:
Clinical trial NCT03882671: Development of a Minimally Invasive Seizure Gauge
Official title: Development of a Minimally Invasive Seizure Gauge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: Seer Medical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2019-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The researchers are trying to assess changes in physiological signals before and during seizures.

Detailed description: Subjects that are undergoing video EEG monitoring in their home for their epilepsy at Seer Medical will be consented to participate in this study for a minimum of two days and/or the duration of their monitoring period for their clinical care. Subjects will be asked to wear up to 4 different commercially available seizure detection devices and complete surveys.

When the subjects clinical EEG monitoring is completed data scientists will analyze the data to identify patterns.

Eligibility criteria: Inclusion Criteria:

* Patients with epilepsy undergoing scalp EEG for clinical care, or an implanted device capable of monitoring brain activity and identifying seizures
* Patients of age 18 or above

Exclusion Criteria:

* Cognitive or psychiatric condition rendering patient unable to cooperate with data collection, or manage and recharge smart watch and tablet computer devices.

Primary outcomes:
measure: Multimodal Assessment of Physiological Signals During Seizure Events Measurable with Wearable Sensors
timeFrame: 2-7 days approximately
measure: Wearable Sensors Comfort Assessment
timeFrame: 2-7 days approximately
measure: Seizure Detection and Prediction using Multimodal Physiological Data
timeFrame: 2-7 days approximately
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Seer Medical
state: Victoria
Study officials:
affiliation: CEO
name: Dean R Freestone, PhD BEng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06659471: Brief Title: a Clinical Study to Assess Gingivitis
Official title: A Three-Month Bleeding Model Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Diseases
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2024-10-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this learning clinical study is to evaluate the effects of formulation chemistry on gingivitis.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Have at least 20 gradable teeth;
* Have established gingivitis with 10-70 % bleeding sites;
* Agree to return for scheduled visits and follow the study procedures;
* Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.

Exclusion Criteria:

* Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
* Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
* Having known hypersensitivity to the test products;
* Having removable oral appliances;
* Having fixed facial or lingual orthodontic appliances;
* Self-reported pregnancy or lactation;
* Having any diseases or condition that might interfere with the safe participation in the study;
* Having an inability to undergo study procedures.

Primary outcomes:
measure: Number Bleeding Sites
timeFrame: 3 months, 1 month
Secondary outcomes:
measure: Löe-Silness Gingivitis Evaluation
timeFrame: 3 months, 1 month
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Silverstone Research
state: Nevada
Study officials:
References:
Clinical trial NCT03449771: PrEP and Consumptions
Official title: Screening of Psychoactive Substances Use and Anxio-depressive Disorders in Consultation for HIV Pre-exposure Prophylaxis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Psychoactive Substance Use
Mood Disorders
Keywords: HIV
Pre-exposure prophylaxis
Recreational drugs
Chemsex
Mental disorders
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: HIV pre-exposure prophylaxis (PrEP) with Truvada®, a combination of two antiretrovirals (tenofovir \& emtricitabine) is a prevention strategy for HIV-negative people at high risk of acquiring HIV. PrEP has thus been integrated as a new tool to significantly reduce the risk of HIV infection, especially among men who have sex with men (MSM). Since its introduction, an increase in sexually transmitted infections (STIs) has been observed, particularly in relation to the use of psychoactive substances in a sexual context (Chemsex).

In this context, the description and evaluation of these practices seem necessary, as well as the impact on the risk of addiction and mental health.

Detailed description: Interventional, multi-center pilot study, including all subjects aged 18 years or older presenting in consultation for a PrEP renewal.

The newsletter and a self-questionnaire will be systematically given in the waiting room to any PrEP consultant to evaluate the consumption of psychoactive substances (ASSIST questionnaire) and to identify anxio-depressive disorders (HAD questionnaire - Hospital Anxiety and Depression). scale). After consent, the answers will be discussed with the doctor during the consultation for appropriate care, including a referral to a psychiatrist and / or addictologist if necessary.

The duration of the inclusions will be 6 months and the number of patients to include is 250.

Eligibility criteria: Inclusion Criteria:

* Subject aged over 18,
* Subject seen in consultation in one of the centers of the study for a renewal of the Prep
* Subject having agreed to participate in the study

Exclusion Criteria:

* Subject not speaking French / illiterate

Primary outcomes:
measure: Estimate the acceptability and the impact on the management of a systematic identification of the use of psychoactive substances and / or anxio-depressive disorders by self-questionnaire in PrEP consultants
timeFrame: 1 year after the study start date
Secondary outcomes:
Other outcomes:
Locations:
city: Alès
country: France
facility: Hospital of Alès
city: Montpellier
country: France
facility: Uh Montpellier
city: Nîmes
country: France
facility: CEGIDD
city: Nîmes
country: France
facility: UH NIMES
city: Perpignan
country: France
facility: Hospital of Perpignan
Study officials:
References:
Clinical trial NCT01627171: Colonoscopy Preparation Optimization for INpatients- COIN Study
Official title: A Randomized Control Trial Comparing 4L PEGlyte to Regular Dose Pico-Salax and Split Dose Pico-Salax for Colonoscopy Bowel Preparation in Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Endoscopy
Bowel Preparation Solutions
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2012-06-25
Enrollment: 126
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: Colonoscopic examinations are performed routinely in hospitalized patients for a variety of indications. However, numerous limitations exist in hospitalized patients preventing an endoscopist from performing high quality examinations; possibly necessitating repeated procedures leading to increased cost and re-exposure to their inherent risks. One such prominent challenge lays in the adequacy of bowel cleansing. Inpatient status has been shown to be a predictor of poor bowel preparation as these patients are older, less mobile and have more co morbidities than the outpatient population. Currently, no standardized (or optimized) bowel preparation type or regimen for administration exists for the hospital inpatient population undergoing colonoscopy. Studies in the outpatient population have demonstrated that timing and choice of cathartic medication effects the cleanliness of the bowel preparation but there is no such clinical evidence for in-patients who receive whatever cathartic agent is on hospital formulary. The purpose of the study is compare efficacy, patient satisfaction, and adverse effects associated with low volume cathartic (Pico-Salax) to the current standard volume 4 liter (PEG-Lyte) and the effect of alternate timing of dosages.


Eligibility criteria: Inclusion Criteria:

* Inpatient colonoscopy
* Age greater than 18 years old
* Able to give consent

Exclusion Criteria:

* No consent obtained
* Pregnancy or lactating
* Renal impairment
* Severe CHF (NYHA class 3/4)
* Recent myocardial infarction (preceding 6 months)
* Ileus
* Ascites
* Severe Colitis
* Toxic Megacolon
* Gastrointestinal Obstruction
* PEG tube
* Previous large bowel resection
* Allergy to study drug

Primary outcomes:
measure: Ottawa Bowel Prep Score
timeFrame: 30 minutes after procedure
Secondary outcomes:
measure: Procedures Cancelled or repeated due to inadequate bowel preparation
timeFrame: During admission (average of 2 weeks)
measure: Individual Components of Ottawa Bowel Prep Score
timeFrame: 30 minutes after procedure
measure: Adverse Effects
timeFrame: Up to 48 hours after procedure
measure: Tolerability of the preparation
timeFrame: Within 1 day of intervention
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St Joseph Hospital
state: Ontario
Study officials:
affiliation: St Josephs
name: Khurram J Khan, MD, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02434471: Single Breath Hold Abdominal MRI
Official title: Single Breath Hold Abdominal MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal MRI
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate a single breath hold abdominal MRI protocol and compare the image quality of respiratory triggered 3D T1-weighted images against conventional breath hold images.


Eligibility criteria: Inclusion Criteria:

* undergoing abdominal MRI

Exclusion Criteria:

* none

Primary outcomes:
measure: Motion Artifact Scores
timeFrame: During MRI, up to 60 minutes
measure: Noise Scores
timeFrame: During MRI, up to 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: DukeUMC
state: North Carolina
Study officials:
affiliation: Duke University
name: Mustafa R Bashir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05235971: Behavioral Economic Treatment to Enhance Rural (BETTER) Living
Official title: Behavioral Economic Treatment to Enhance Rural Living
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use, Unspecified
Keywords: Heavy alcohol consumption
Alcohol misuse
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-02-11
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to get feedback to help develop programs delivered by phone and text messages to improve wellness and health behaviors. This study will enroll adult participants that have been seen in primary care settings and live in rurally designated areas.

Detailed description: This study will evaluate acceptability and feasibility of two remotely-delivered behavioral economic intervention components, alone and in combination, using remote text message delivery. The two intervention components are an episodic future thinking component and a volitional choice component. The goal of this work is to develop and determine acceptability and feasibility of a well-specified, accessible, and theory-driven mobile health intervention to reduce harmful alcohol use in people living in rural regions.

Eligibility criteria: Screening Inclusion Criteria:

* adults presenting in Michigan Medicine primary care
* home address in a rurally designated area (e.g., zip code, county),
* documented alcohol use in the Electronic Health Record (EHR) (e.g., alcohol use disorder diagnosis, alcohol misuse or heavy alcohol consumption).

Baseline inclusion criteria:

* an Alcohol Use Disorders Identification Test (AUDIT-C) score of ≥3 in females or ≥4 in males
* regular access to an internet-enabled device (e.g., smart phone, computer, tablet).

Exclusion Criteria:

* Does not understand English
* currently pregnant
* unable to provide informed consent due to medical/psychiatric reasons
* currently in treatment for a substance use disorder.

Primary outcomes:
measure: Feasibility of the Intervention - Screening
timeFrame: Day 1 of Intervention
measure: Feasibility of the Intervention - Enrollment
timeFrame: Day 1 of Intervention
measure: Intervention Acceptability: Number of Participants Who Rated the Intervention as Acceptable
timeFrame: 2 Weeks Post-Intervention
Secondary outcomes:
measure: Alcohol Consumption
timeFrame: The 2 weeks (14-days) of the intervention period
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Lara Coughlin, PhD
role: PRINCIPAL_INVESTIGATOR
References: