louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02914730: Insulin Dosing Practices in Persons With Diabetes on Multiple Daily Injections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Medication Adherence
Technology
Insulin
Keywords: diabetes
insulin
medication adherence
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this cross-sectional study the investigators will examine two populations: young adults with (ages 18-35) and older adults (ages 65 and over) with diabetes who are on \> 2 insulin injections per day. The sample size for this observational study will be up to 125 patients.

Brief summary: In this cross-sectional study the investigators will examine two populations: young adults with (ages 18-35) and older adults (ages 65 and over) with diabetes who are on \> 2 insulin injections per day. The sample size for this observational study will be up to 125 patients. The investigators will issue a Common Sensing GoCap bluetooth-enabled pen cap that fits on the end of Solostar Lantus and Apidra insulin pens; this pen cap registers the position of the insulin pen plunger and automatically sends confirmation of dose delivery to a smartphone app.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes or insulin-requiring Type 2 diabetes
* \> 2 insulin injections
* Age 18-35 or older than 65 years
* Use of glargine insulin as basal insulin
* Stable insulin doses for past 3 months

Exclusion Criteria:

* Previous tape/adhesive allergies with CGM sensors
* Visual or cognitive impairment with inability to self-administer insulin

Primary outcomes:
measure: Number of Missed Insulin Doses
timeFrame: 4 week use of blue tooth pen cap
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin DIabetes Center
state: Massachusetts
Study officials:
References:
citation: Munshi MN, Slyne C, Greenberg JM, Greaves T, Lee A, Carl S, Atakov-Castillo A, Toschi E. Nonadherence to Insulin Therapy Detected by Bluetooth-Enabled Pen Cap Is Associated With Poor Glycemic Control. Diabetes Care. 2019 Jun;42(6):1129-1131. doi: 10.2337/dc18-1631. Epub 2019 Mar 12.
Clinical trial NCT04057430: Effectiveness of the GumChucks® Flossing System Compared to String Floss for Interdental Plaque Removal in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Plaque
Keywords: Interdental plaque
Flossing aid
Children
Gingival inflammation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the interdental plaque removal efficacy, flossing speed, and reduction in gingival inflammation of a new flossing system (GumChucks®) compared to string floss, and to assess preference between the two flossing products in children, parents, and dentists.


Eligibility criteria: Inclusion Criteria:

* healthy children aged 4-15 years, who were not on any type of medication
* presence of at least 4 posterior interdental contacts
* ability to follow verbal and/or written instruction
* availability for a 4-week study period
* one parent or legal guardian of each included child participant.

Exclusion Criteria:

* had antibiotics within the last 6 months
* are pregnant.

Primary outcomes:
measure: Interdental plaque score - after first use
timeFrame: Baseline and Day 1
measure: Interdental plaque score - after 4 weeks of usage
timeFrame: Baseline and 4 weeks
measure: Gingival index - after 4 weeks of usage
timeFrame: Baseline and 4 weeks
measure: Flossing speed
timeFrame: Day 1
Secondary outcomes:
measure: Floss preferences by children, parents and dentists
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01560130: State-wide Health Approach to Increase Reach and Effectiveness: Study 2
Official title: Using a State-wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-03-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Behavioral weight loss programs can successfully reduce body weight, but these programs are available to limited numbers of overweight and obese individuals. This project evaluates a unique weight loss approach that combines a self-sustaining weight loss campaign (for outreach) with training in behavioral weight loss strategies and tests the efficacy of adding components designed to enhance accountability and increase motivation for weight loss.

Detailed description: This is a randomized trial. Participants will be randomly assigned to 1 of 3 treatment arms: (1) Shape Up Rhode Island (a community-based weight loss campaign) plus and Internet-based behavioral weight loss program (SURI+IBWL), (2) SURI + IBWL + optional group sessions (SURI+IBWL+Group), or (3) SURI+IBWL + monetary incentives for submitting self-monitoring information and achieving clinically significant weight loss. The primary outcome is weight loss at 12 weeks.

Eligibility criteria: Inclusion Criteria:

1. Body mass index \>=25 kg/m2
2. English speaking

Exclusion Criteria:

1. Health problems that make weight loss or unsupervised exercise unsafe
2. Current pregnancy or plan to become pregnant in the next 12 months
3. Planned relocation
4. Previous participation in Shape Up Rhode Island research studies

Primary outcomes:
measure: Weight change from the initial assessment to the 3-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram
timeFrame: 0 to 3 months
Secondary outcomes:
measure: Weight change from the initial assessment to the 6-month assessment measured on a digital scale to the nearest 0.1-kilogram
timeFrame: 0 to 6 months
measure: Weight change from the initial assessment to the 12-month assessment measured on a digital scale to the nearest 0.1-kilogram
timeFrame: 0 to 12-months
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital's Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Rena R Wing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06424730: Team Based Equity Conscious Telemedicine Approach to Hypertension
Official title: Team Based Equity Conscious Telemedicine Approach to Improve Hypertension Among Black Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertension
Keywords: high blood pressure
telemedicine
African-American
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study has two main objectives. First, to evaluate multi-level barriers and facilitators for recruitment and participation of Black patients in a TET-HTN clinical trial (Aim 1). Second objective is to evaluate the feasibility of TET-HTN intervention in a randomized comparison with usual clinic-based hypertension care approach (Aim 2).
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of study is to understand the different factors (patient, societal, provider, clinic, health system) relevant in recruitment and participation of patients in Team Based Equity Conscious Telemedicine Approach to Improve Hypertension clinical trial.

Detailed description: Black patients suffer disproportionate hypertension (HTN) burden with worse control, resulting in HTN-related mortality rates twice those observed in non-Hispanic White patients. Contextually informed care approach is urgently needed in Black patients for HTN management. This study will evaluate multi-level barriers and facilitators for recruitment and participation of Black patients in a Team Based Equity Conscious Telemedicine Approach to Improve Hypertension (TET-HTN) clinical trial. This study will also evaluate the feasibility of TET-HTN intervention in a randomized comparison with usual clinic-based hypertension care approach.

Eligibility criteria: Inclusion Criteria:

* African American or Black
* Patients with last clinic systolic Blood Pressure \>140 mmHg or diastolic Blood Pressure \>90 mmHg or both

Exclusion Criteria:

* Unable to read or speak English
* diminished ability to measure home BP (dementia, or psychosis)
* acute health changes in past 3 months increasing chance of BP instability (hospitalization);
* terminal illness.

Primary outcomes:
measure: Barriers / Facilitators for Recruitment
timeFrame: Day 1
measure: Feasibility of Telemedicine Approach - Proportion of Subjects
timeFrame: Month 6
Secondary outcomes:
measure: Change in Blood Pressure
timeFrame: Month 6
measure: Percentage of Medication adherence
timeFrame: Month 6
Other outcomes:
measure: Number of Emergency Department and Urgent Care Visits
timeFrame: Month 6
measure: Number of Subjects using Blood Pressure Monitors
timeFrame: Month 6
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Yashashwi Pokharel, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03835130: Pleuropulmonary Echography Versus Standard Chest X-ray in the Post-operative Follow-up of Pleuropulmonary Surgery
Official title: Interest of Pleuropulmonary Echography Versus Standard Chest X-ray in the Post-operative Follow-up of Pleuropulmonary Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleuro-pulmonary Surgery
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing pleuro-pulmonary surgery

Brief summary: In postoperative pleuro-pulmonary surgery, the monitoring of the appearance of complications is guided, depending on the centres, by the systematic daily performance or, in the event of a call point, by chest x-ray at the patient's bed until the drains are ablative.

This repeated performance of radiographs results in irradiation of patients but also of medical staff and a significant cost.

In the thoracic study, ultrasound imaging is a fast, cost-effective, non-irradiating solution that can be performed at the patient's bedside. It could guide the performance of chest x-ray, limit their number, with increased clinical relevance.


Eligibility criteria: Inclusion Criteria:

* Patient with a higher age to 18 and undergoing pleuro-pulmonary surgery
* Hospitalized patient at Martinique University Hospital
* Patient receiving social security
* Patient giving his free and informed consent orally

Exclusion Criteria:

* Patient minor
* Woman who is pregnant and breast feeding
* Patient no giving his free and informed consent orally

Primary outcomes:
measure: Number of pleural disorders identified by each imaging technique
timeFrame: between 2 and 10 days
Secondary outcomes:
measure: Number of ultrasounds performed/number of chest x-ray performed
timeFrame: one year
measure: Proportion of "negative" ultrasounds
timeFrame: one year
Other outcomes:
Locations:
city: Fort de France
country: Martinique
facility: CHU Martinique
Study officials:
affiliation: CHU de Martinique
name: Nicolas VENISSAC, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02445430: Genetics of Arteriovenous Malformations
Official title: Genetics of Arteriovenous Malformations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arteriovenous Malformation
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
Collaborators: name: Translational Genomics Research Institute
name: The Joe Niekro Foundation
First posted: 2015-05-15
Enrollment: 59
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female persons with AVM and their immediate family members

Brief summary: The goal of this study is to identify genetic alterations resulting in the development of arteriovenous malformation (AVM) in the central nervous system.

Detailed description: The study will include AVM patients and members of their nuclear family. All patients will donate a sample of saliva (5 mL) or blood (10 mL). Basic demographic and clinical parameters will be collected, including ethnicity, age at first presentation, symptoms at presentation, history of subsequent symptoms, treatment history, Spetzler-Martin AVM grade, medication history, and other pertinent medical information. In patients undergoing AVM resection, a small sample of the AVM will be collected for concurrent genomic analysis. Family members will donate saliva (5mL) and document their relationship to the patient (i.e., parent, sibling, child, etcl). Nucleic acids will be isolated from the saliva/blood samples, and genetic sequencing will be carried out. When a surgical sample of the AVM is available, nucleic acids will be obtained and transcriptome profiling will be performed. Identification of genetic alterations common to patients with AVM and not present in samples from parents and siblings will greatly aid in identification of pathways associated with AVM formation. Candidate sequences will be chosen by differential expression (p\<0.05) and fold-changes. Once identified, mechanisms for the rapid detection of marker sequences will be developed and their predictive value tested in future collections.

Eligibility criteria: Inclusion Criteria:

* Age between 6 and 60 years inclusive
* Diagnosis of AVM or nuclear family member of a patient with AVM
* Grants access to saliva, blood, and/or tissue

Exclusion Criteria:

* Age less than 6 years or greater than 61 years
* Nuclear family members who do not share the same parents as the AVM patient

Primary outcomes:
measure: Identification of genetic alterations common to patients with AVM
timeFrame: sample analysis will take an expected average of six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
Study officials:
affiliation: Barrow Neurosurgical Associates
name: Joseph Zabramski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04700930: CBD Cigarettes Instead of Normal Cigarettes as Innovative Treatment for Schizophrenia
Official title: CBD Cigarettes Instead of Normal Cigarettes Against Enforcement Measures, for Improved Acute Treatment and for Harm Reduction of Smoking - Innovative Treatment for Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia and Other Psychotic Disorders
Harm Reduction
Lead sponsor: Psychiatric Hospital of the University of Basel
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 31
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: TREATMENT

Brief summary: Interventional study using Cannabidiol containing cigarettes as replacement of usual cigarettes

Reduction of enforcement measures, improved acute treatment, harm reduction, and improvement of psychotic symptoms


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Schizophrenia or Related Disorders
* PANNS \> 21,
* Tobacco-smokers
* inpatient status
* within age 18 - 65 years
* German-speaking

Exclusion Criteria:

* personality disorder
* non-smokers
* organic psychotic diseases
* breast feeding
* pregnancy

Primary outcomes:
measure: Change in psychotic symptoms
timeFrame: 1 Months (acute therapy), 6 Months (Follow up)
measure: Change in violent behaviour.
timeFrame: 1 Month (acute therapy), 6 Months (Follow up)
measure: Change in depressive Symptoms
timeFrame: 1 Month (acute therapy), 6 Months (Follow up)
measure: Change in subjective well being under neuroleptic medication
timeFrame: 1 Month (acute therapy), 6 Months (Follow up)
measure: Change of necessary neuroleptic medication
timeFrame: 1 Month (acute therapy), 6 Months (Follow up)
Secondary outcomes:
measure: Total number of Isolation-Events (enforcement measures)
timeFrame: 1 Month (acute therapy), 6 Months (Follow up)
measure: Total number of enforced medication-events (enforcement measures)
timeFrame: 1 Month (acute therapy), 6 Months (Follow up)
measure: Tobacco use
timeFrame: 1 Month (acute therapy), 6 Months (Follow up)
measure: Cannabis use
timeFrame: 1 Month (acute therapy), 6 Months (Follow up)
measure: Correlation of CBD and THC levels with psychotic symptoms via PANSS
timeFrame: 1 Month (acute therapy), 6 Months (Follow up)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitäre Psychiatrische Kliniken
Study officials:
affiliation: Director
name: Undine Lang, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kock P, Lang E, Trulley VN, Dechent F, Mercer-Chalmers-Bender K, Frei P, Huber C, Borgwardt S. Cannabidiol Cigarettes as Adjunctive Treatment for Psychotic Disorders - A Randomized, Open-Label Pilot-Study. Front Psychiatry. 2021 Nov 4;12:736822. doi: 10.3389/fpsyt.2021.736822. eCollection 2021.
Clinical trial NCT04342130: Brain Effects of Opiate Agonist and Antagonist
Official title: Brain Effects of Opiate Agonist and Antagonist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Low-back Pain
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will look at the short-term effect of morphine on brain response to food.

Detailed description: Chronic low back pain patients and healthy controls will be recruited for this study. Participants' brain will be scanned at baseline and then again on a different day after the administration of an oral dose of 30 mg morphine in an open label design. Participants will receive morphine 60 minutes prior to the start of the second scanning session. The brain scans will include structural scans, functional scans at rest and functional scans during the ingestion of a highly caloric drink.

Eligibility criteria: Inclusion Criteria:

* Healthy participants
* Patients in pain: suffering from persistent pain more days than not, 3/10 in intensity on a numerical rating scale, for at least 6 weeks or more.

Exclusion Criteria:

* Any DSM diagnosis
* diabetes
* food allergies
* lactose intolerance
* participants seeking to quit smoking or to lose weight
* participants on any psychotropic medication including opiate based analgesics (e.g. oxycodone, methadone, suboxone)
* pregnant or nursing women
* pacemaker or other implanted electrical devices
* Participants with a past history of head trauma or seizures
* Any past history of illegal drug or alcohol misuse
* Participants who cannot undergo an MRI scan.

Primary outcomes:
measure: Mean Change in Subcortical Brain Structure Volume
timeFrame: baseline to 1 hour
measure: Change in Brain Response to Highly Caloric Drink
timeFrame: baseline to 1 hour
measure: Mean Change in Resting Brain Activity in the Nucleus Accumbens
timeFrame: baseline to 1 hour
Secondary outcomes:
measure: Mean Change in Back Pain Intensity
timeFrame: baseline to 1 hour
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Department of Psychiatry in University of Rochester
name: Paul Geha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00700830: Observational Study to Evaluate the Safety and Efficacy of Levemir® in Type 2 Diabetes
Official title: Assessment of Safety and Efficacy of Levemir® (Insulin Detemir) Treatment for Insulin Naive Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 1976
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes insulin naive patients

Brief summary: This study is conducted in Africa. The aim of this study is to assess the safety and efficacy of Levemir® treatment for insulin naive patients with type 2 diabetes under normal clinical practice conditions in Algeria.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial-related activities
* Type 2 diabetes
* HbA1c between 7-9%
* Insulin naive
* Inadequate control with oral antidiabetics therapy as judged by investigator

Exclusion Criteria:

* Patients with type 1 diabetes
* Hypersensitivity to Levemir® or to any of the excipients
* Pregnancy, or desire of pregnancy within next 6 months
* HbA1c greater than or equal to 9%
* Known or suspected allergy to the trial product or to any of the excipients
* Subjects who are unlikely to comply with protocol

Primary outcomes:
measure: Assessment the incidence of the Serious Adverse Events including the major Hypoglycaemia.
timeFrame: During study
Secondary outcomes:
measure: HbA1c
timeFrame: after 12 weeks (3 months) AND after 24 weeks (6 months)
measure: FBG (Fasting Blood Glucose)
timeFrame: Monthly average for each month, and average of the past quarter
measure: Weight
timeFrame: after 12 weeks (3 months) AND after 24 weeks (6 months)
Other outcomes:
Locations:
city: Algiers
country: Algeria
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: