louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06542939: Scaling Telehealth Models to Improve Co-morbid Diabetes and Hypertension in Immigrant Populations (Phase II)
Official title: Scaling Telehealth Models to Improve Co-morbid Diabetes and Hypertension in Immigrant Populations (Phase II)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes Mellitus Type II
Hypertension
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-08-07
Enrollment: 450
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effectiveness and implementation process of a culturally and contextually tailored telehealth-based community health workers (CHW) led coaching intervention for hypertension control among South Asian patients with co-morbid Diabetes Mellitus type II (DMII) and hypertension. The primary aims are to test the effectiveness of a CHW-led telehealth intervention compared to usual care, and using Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR), examine the reach, adoption, fidelity, and maintenance of the intervention within clinical and community settings.


Eligibility criteria: Inclusion Criteria:

* identified as of South Asian ethnicity
* at least 21 years of age
* a diagnosis of diabetes
* a diagnosis of hypertension
* an uncontrolled BP reading (\>130/80mmHg) in the last 6 months

Exclusion Criteria:

* under the age of 21
* Women who are pregnant
* Type 1 diabetes or diabetes secondary to other conditions (e.g. steroid-induced, pancreatic insufficiency, or chemotherapy-induced)
* inability to perform unsupervised physical activity

Primary outcomes:
measure: Percent of participants achieving BP control, defined as <130/80 mmHg
timeFrame: Month 6
Secondary outcomes:
measure: Percent of participants achieving BP control, defined as <130/80 mmHg
timeFrame: Month 12
measure: Change from Baseline in hemoglobin A1c (HbA1c) levels at Month 6
timeFrame: Baseline, Month 6
measure: Change from Baseline in HbA1c levels at Month 12
timeFrame: Baseline, Month 12
measure: Change from Baseline in Body mass index (BMI) at Month 6
timeFrame: Baseline, Month 6
measure: Change from Baseline in BMI at Month 12
timeFrame: Baseline, Month 12
measure: Change from Baseline in Systolic blood pressure (SBP) at Month 6
timeFrame: Baseline, Month 6
measure: Change from Baseline in SBP at Month 12
timeFrame: Baseline, Month 12
measure: Change from Baseline in Diastolic blood pressure (DBP) at Month 6
timeFrame: Baseline, Month 6
measure: Change from Baseline in DBP at Month 12
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Nadia Islam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04946539: Value of Ultrasonographic Enthesitis Assessment in Spondyloarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondyloarthritis
Enthesitis
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Spondyloarthritis

Brief summary: The aim of the study is to determine how valuable ultrasonographic enthesitis to asssess disease activity, functionality and quality of life.


Eligibility criteria: Inclusion Criteria:

* Spondyloarthritis patients that fulfill 2009 ASAS criteria

Exclusion Criteria:

* history of elbow, ankle or knee surgery, local injection at the examination sites within the six weeks, peripheral neuropathy, infection and wound at examination site

Primary outcomes:
measure: Disease activity,
timeFrame: between November 2016 and January 2017
measure: Disease activity,
timeFrame: between November 2016 and January 2017
measure: functionality
timeFrame: between November 2016 and January 2017
measure: to measure quality of life
timeFrame: between November 2016 and January 2017
measure: to measure quality of life
timeFrame: between November 2016 and January 2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01545739: Evia/Entovis HF-T Master Study
Official title: Master Study of the Evia/Entovis HF-T Pacemaker
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Indication for Cardiac Resynchronization Therapy (CRT)
Keywords: Pacemaker therapy
Cardiac resynchronisation therapy (CRT)
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with indication for CRT therapy

Brief summary: The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and efficacy of these pacemakers. In particular, the left ventricular (LV) capture control feature is evaluated, which automatically measures the LV pacing threshold and subsequently adjusts the pacing output.


Eligibility criteria: Inclusion Criteria:

* Standard indication for CRT therapy
* Legal capacity and ability to consent
* Signed patient informed consent

Exclusion Criteria:

* Contraindication for CRT therapy
* ICD indication
* Age \< 18 years
* Pregnant or breast-feeding woman
* Cardiac surgery planned within the next 6 months
* Life expectancy of less than 6 months
* Participating in another clinical study of an investigational cardiac drug or device

Primary outcomes:
measure: Safety: Serious Adverse Device Effect (SADE) free rate
timeFrame: Until 3 month follow-up
measure: Efficacy of the left ventricular capture control feature (focus on threshold measurements)
timeFrame: At pre-hospital discharge, 1 and 3 month follow-up
Secondary outcomes:
measure: Efficacy of the left ventricular capture control feature (focus on pulse amplitude adjustment)
timeFrame: 1 and 3 month follow-up
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University
Study officials:
References:
Clinical trial NCT00751439: Verification of Pulse Oximetry in Neonatal Population
Official title: Verification of Pulse Oximetry in Neonatal Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome
Keywords: Oximeter
Arterial blood gas
comparison
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
First posted: 2008-09-12
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates 25 weeks gestation to full term

Brief summary: The purpose of this his post-market, observational study titled Verification of Pulse Oximetry in the Neonatal Population is to gather data to further support the accuracy of Nonin's pulse oximeters when used in the neonate population. Neonates who are currently undergoing arterial blood gas (ABG) sampling, as part of their medical care will be recruited to participate in this study for collecting opportunity samples. Nonin's PureLight® noninvasive sensor will be applied to a foot of the neonate; an adhesive wrap secures the sensor to the neonate. The sensor immediately begins obtaining SpO2 and pulse rate measurements which are sent to the oximeter module for display on the Electronic Data Collection System (EDCS). At the time the prescribed ABG is drawn, the EDCS must have a marker captured to identify the end of the ABG for SpO2 comparison. The SpO2 accuracy of pulse oximeter will be measured by comparing SpO2 readings of the pulse oximeter to values of SaO2 (opportunity samples) determined by a CO-oximeter.


Eligibility criteria: Inclusion Criteria:

* Gestational age: 25 weeks to full term
* Weight range: No minimum or maximum range
* Age: up to 1 month (30 DAYS)
* Gender: Both
* ABGs as part of their medical care, to be analyzed by co-oximeter
* Consent signed by at least one legal guardian

Exclusion Criteria:

* Presence of any skin irritation or breakdown on the foot
* Foot impediments which would preclude proper placement of the sensor
* Clinical condition precluding the use of adhesive materials
* Cessation of ABGs during study enrollment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
Study officials:
affiliation: Children's Hospitals & Clinics of Minnesota
name: Mark C Mammel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05846139: Slow-release Locally Administered 0.02% Hypochlorite Formulation
Official title: The Effectiveness of an Incremental Approach to Nonsurgical Periodontal Therapy With the Use of Adjunctive Slow-release Locally Administered 0.02% Hypochlorite Formulation: A Single-blind Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: Tuscan Dental Institute
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: The presence of bacterial plaque is associated with the development of periodontal inflammation. The aim of this single-blind randomized clinical study was to prospectively evaluate the efficacy of two different agents in a staged approach for nonsurgical periodontal treatment in terms of clinical and patients related outcomes in a cohort of patients with periodontitis: NitrAdine® based disinfectant formula (PerioTabs®) vs Chlorhexidine 0.12 toothpaste and mouthwash 0.20.

Material and methods: Patients with a diagnosis of periodontal disease (stage I-III) scheduled for non surgical periodontal treatment were randomly allocated to the preparatory home use of a chlorhexidine mouthwash or a NitrAdine® based brushing solution called PerioTabs® for 10-15 days. Active decontamination with ultrasonic scalers was performed after the completion of the preparation period. Clinical and patient-related outcomes were recorded at baseline, at the moment of professional intervention, and after 30 and 90 days from baseline.


Eligibility criteria: Inclusion Criteria:

* older than 18 y.o,
* systemically healthy,
* with a clinical diagnosis of periodontitis

Exclusion Criteria:

* alcohol or drug abuse,
* regular drug use of bisphosphonates,
* non-steroidal or steroidal anti-inflammatory,
* daily antacid therapy,
* selective serotonin reuptake inhibitors and other therapy that might affect periodontal health,
* antibiotics during the previous 6 months,
* smoking more than ten cigarettes per day;
* pregnancy;
* lactation;
* previous periodontitis treatment within the last 6 months,
* radiotherapy to the head or neck, current chemotherapy.

Primary outcomes:
measure: change in full mouth bleeding score (ΔFMBS)
timeFrame: Between baseline and the active debridement which occurred 15 days later
Secondary outcomes:
Other outcomes:
Locations:
city: Forte Dei Marmi
country: Italy
facility: Fortis Centro Odontoiatrico
state: Lucca
Study officials:
References:
Clinical trial NCT03422939: Dietary Guidelines, Portion Sizes, and Time Frame
Official title: How Dieticians Deliver Dietary Guidelines Using Portion Sizes and Time Frame
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet Habit
Food Habits
Keywords: FBDG
dietitians
portion sizes
time frame
visual references
Lead sponsor: Grenoble Ecole de Management
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Most participants were female (96%), were under age 45, were working in a health institution and/or had a private practice, and had, on average, 12.5 years of professional experience. Seventy-five percent received mainly adults in their practice and 62.5% received mainly patients with a health condition.

Brief summary: During the last update of the French FBDG, a survey with a representative sample of dieticians investigated 1) how to communicate portion sizes and 2) the most relevant time frame when delivering dietary guidelines. The objective was to determine how to express portion sizes and time frame for Food Based Dietary Guidelines (FBDG) using the feedback of dietitians. Data were obtained from an internet-based survey of 441 French dieticians (collected from November 24, 2013 through January 2, 2014).

Detailed description: Background: Food Based Dietary Guidelines (FBDG) need to accessible and understandable to consumers. During the last update of the French FBDG, a survey with a representative sample of dieticians investigated 1) how to communicate portion sizes and 2) the most relevant time frame when delivering dietary guidelines.

Objective: To determine how to express portion sizes and time frame for Food Based Dietary Guidelines (FBDG) using the feedback of dietitians.

Design: Data were obtained from an internet-based survey of 441 French dieticians (collected from November 24, 2013 through January 2, 2014).

Eligibility criteria: Inclusion Criteria:

All members of the AFDN (French Association of Dietitians and Nutritionists) were invited to participate (n=2500 except the ones that had already participated in the pre-test n=10).

Members of the AFDN who have completed the online questionnaire were retained for analysis (n= 441).

Exclusion Criteria:

Incomplete questionnaires Participants of the pre-test (n=10)

Primary outcomes:
measure: Questionnaire to measure number of dietitians using different types of portion size and time frame
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03027739: CART-19 Cells For MRD Positive CD19+ ALL
Official title: CART-19 Cells For Patients With Minimal Residual Disease (MRD) Positive CD19+ Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: CART-19 cells has emerged as a powerful targeted immunotherapy, showing striking responses in highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the safety and toxicity of CART-19 cells to patients who are refractory or at highest risk of relapse as defined by MRD+ status.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Aged between 1-60 years
* Patients with MRD positive CD19+ ALL
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of CART-19 cells.

Primary outcomes:
measure: Leukemia free survival
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events that are related to treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Jianda Hu, 86-13959169016
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02333539: Adherence Intervention to Promote Optimal Use of Insulin Pumps in Adolescents With Type 1 Diabetes
Official title: Adherence Intervention to Promote Optimal Use of Insulin Pumps in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to address the critical need of improving insulin pump adherence in adolescents with Type 1 Diabetes (T1D) by providing personalized intervention using evidence-based techniques during routine diabetes clinic visits at point of care.

Detailed description: To achieve optimal use of the insulin pump, patients must engage in frequent Blood Glucose Monitoring (BGM) and insulin bolusing, and have an understanding of their relationship. BGM must occur and then it must be followed by a decision about what to do (or not do) regarding insulin bolusing. If insulin bolusing occurs in the absence of BGM, hypoglycemia and less than ideal glycemic control can occur. Of the few insulin pump adherence studies, only very basic adherence behaviors such as BGM and insulin bolusing frequency or number of hypoglycemic events have been reported.

The overall objective of this study is to address the critical need of improving insulin pump adherence in adolescents with T1D by providing personalized intervention using evidence-based techniques during routine diabetes clinic visits at point of care.

Eligibility criteria: Inclusion Criteria:

* ages 10-17 years
* type 1 diabetes diagnosis at least 1 year
* use insulin pump

Exclusion Criteria:

* developmental delay

Primary outcomes:
measure: Frequency of Insulin Pump Adherence Behaviors
timeFrame: every 3 months up to 12 months
Secondary outcomes:
measure: Change in Glycemic Control (A1C)
timeFrame: every 3 months up to 12 months
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: University of Colorado, Denver
name: Kimberly A Driscoll, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04187339: Study of NGM395 in Adult Participants
Official title: A Phase 1, Randomized, Placebo-controlled, Double-blind, Two-part Study to Evaluate the Safety and Tolerability of NGM395 in Adult Obese Patients (Part 1) and in Adult Patients With Nonalcoholic Fatty Liver Disease (NAFLD) (Part 2).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
NAFLD
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2019-12-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Study of NGM395 in adult participants.


Eligibility criteria: Inclusion Criteria:

Part 1:

1. Body mass index (BMI) in the range of 27 - 45 kg/m², inclusive, at screening, with maximum body weight of 140 kg.

   Part 2:
2. Liver fat ≥8% as assessed by MRI-PDFF.
3. BMI in the range of 27 - 45 kg/m2, inclusive, with maximum body weight of 140 kg at screening.
4. Waist circumference \> 40 inches for males or \> 35 inches for females.

Exclusion Criteria:

Part 1:

1. Diagnosed with type 2 diabetes (T2D) and/or the use of metformin, dipeptidyl peptidase-4 (DPP4) inhibitors, sodium/glucose cotransporter 2 (SGLT2) inhibitors, sulfonylurea agents, acarbose, or insulin for T2D within 3 months prior to Screening.
2. Subjects with T2D managed with diet alone with HbA1c level \> 6.5% or fasting glucose ≥ 126 mg/dL at Screening.
3. History of bariatric surgery.
4. Fasting triglycerides \> 400 mg/dL at Screening.

   Part 2:
5. Diagnosed with type 2 diabetes with a HbA1c \>9.5%, on thiazolidinediones, sodium/glucose cotransporter 2 (SGLT2) inhibitors, acarbose, or insulin for T2D within 3 months prior to Screening.

Primary outcomes:
measure: Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
timeFrame: 140 Days
Secondary outcomes:
measure: Serum Concentration of NGM395
timeFrame: 140 Days
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: NGM Clinical Study Site
Study officials:
affiliation: NGM Biopharmaceuticals, Inc
name: NGM Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04708639: Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients
Official title: Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lung Cancer
ALK Gene Mutation
Resistance, Disease
Mutation
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2021-01-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All newly diagnosed ALK translocated lung cancer adenocarcinomas.

Brief summary: Circulating tumor DNA can be used to monitor the treatment effect and identify developing resistance mutations during ALK directed TKI treatment.

Detailed description: The purpose and objectives of the non-interventional study with primary data collection is

* To determine if monitoring the amount of translocated DNA in the blood reflects alectinib treatment effect.
* To assess the presence and type of resistance mutations using ctDNA at the time patients experience clinical progression on alectinib.
* To investigate if the resistance mutations identified at clinical progression could have been identified in blood samples taken before clinically evident progression.

Eligibility criteria: Inclusion Criteria:

1. Patients with ALK translocated metastatic NSCLC, treated with alectinib as 1st line therapy in routine clinical practice
2. Written (personally dated and signed) informed consent

Exclusion Criteria:

Primary outcomes:
measure: PFS on alectinib
timeFrame: 46 month
measure: mechanism of resistance
timeFrame: 15.2 month
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Peter Meldgaard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: