louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05866523: Teamwork Makes the Dream Work
Official title: Teamwork Makes the Dream Work: Team-based Inpatient Anti-Retroviral Treatment and Access to Services (ARTAS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Inpatient Facility Diagnoses
Keywords: HIV, linkage to care, hospital readmission
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2023-05-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is a prospective, observational cohort study design with patients enrolled at Loma Linda University Medical Center (LLUMC), evaluating a multidisciplinary inpatient linkage to care program compared to historical control.
Primary purpose: OTHER

Brief summary: Exploring the effect of team-based ARTAS intervention in an inpatient setting on HIV linkage to care and hospital readmission rates.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or greater
* newly diagnosed HIV
* Known diagnosis of HIV not on ART within 30 days of admission
* Known HIV and not virally suppressed based on interview
* Known HIV and has not been under the care of an HIV specialist within the past 6 months

Exclusion Criteria:

* All three criteria must be present for exclusion:
* virally suppressed
* actively taking ART
* are under active care of an HIV specialist within the last 6 months
* Less than 18 years of age (stand alone exclusion)

Primary outcomes:
measure: Rate of linkage to HIV care post discharge
timeFrame: Up to 90 days post-study enrollment hospitalization discharge
Secondary outcomes:
measure: Readmission Rate after initial post-study hospitalization
timeFrame: Up to 90 days post-study enrollment hospitalization discharge
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
References:
citation: Craw JA, Gardner LI, Marks G, Rapp RC, Bosshart J, Duffus WA, Rossman A, Coughlin SL, Gruber D, Safford LA, Overton J, Schmitt K. Brief strengths-based case management promotes entry into HIV medical care: results of the antiretroviral treatment access study-II. J Acquir Immune Defic Syndr. 2008 Apr 15;47(5):597-606. doi: 10.1097/QAI.0b013e3181684c51.
citation: Gardner LI, Metsch LR, Anderson-Mahoney P, Loughlin AM, del Rio C, Strathdee S, Sansom SL, Siegal HA, Greenberg AE, Holmberg SD; Antiretroviral Treatment and Access Study Study Group. Efficacy of a brief case management intervention to link recently diagnosed HIV-infected persons to care. AIDS. 2005 Mar 4;19(4):423-31. doi: 10.1097/01.aids.0000161772.51900.eb.
citation: Gardner LI, Marks G, Craw J, Metsch L, Strathdee S, Anderson-Mahoney P, del Rio C; Antiretroviral Treatment Access Study Group. Demographic, psychological, and behavioral modifiers of the Antiretroviral Treatment Access Study (ARTAS) intervention. AIDS Patient Care STDS. 2009 Sep;23(9):735-42. doi: 10.1089/apc.2008.0262.
Clinical trial NCT05359523: Ultrasonographic Muscles and Fascia Measurement With Myofascial Pain Syndrome
Official title: Investigation of the Diagnostic Effect of Ultrasonographic Measurement Values of Upper Back Muscles and Fascia in Patients With Myofascial Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Pathologies in the trapezius muscle and rhomboid muscle are important in the course and treatment of the disease in patients with myofascial pain syndrome.

Detailed description: In this study, the role of the thickness of these muscles and the shift during movement in the activity and diagnosis of the disease in myofascial pain syndrome will be investigated.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* myofascial pain syndrome

Exclusion Criteria:

* Cervical radiculopathy
* Fibromyalgia
* Shoulder joint disease,
* Peripheral and central nervous system disease
* Polyneuropathy,
* Inflammatory rheumatic disease,
* Malignancy

Primary outcomes:
measure: Trapezius muscle and rhomboid muscle thickness
timeFrame: 20 minute
measure: fascial sliding
timeFrame: 20 minute
Secondary outcomes:
measure: VAS
timeFrame: 6 th month
measure: NPDS
timeFrame: 6th month
measure: SF-12
timeFrame: 6th month
Other outcomes:
Locations:
city: Nilüfer
country: Turkey
facility: Burcu Metin Ökmen
state: Bursa
city: Bursa
country: Turkey
facility: Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Study officials:
affiliation: Bursa Yuksek Ihtisas Training and Research Hospital
name: Korgün Ökmen, Assoc. PhD.
role: STUDY_CHAIR
References:
Clinical trial NCT06819423: The Impact of AI-Based Fundus Imaging on Blood Glucose Control and Fundus Examination Completion Rates in Outpatient Diabetic Patients
Official title: The Impact of AI-Based Fundus Imaging on Blood Glucose Control and Fundus Examination Completion Rates in Outpatient Diabetic Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study aims to evaluate the impact of AI-based fundus imaging on blood glucose control and fundus examination completion rates in diabetic patients by comparing outcomes between those who undergo AI fundus imaging and those who do not. The study is designed as a parallel randomized controlled trial (RCT).

Using a random number table, 200 diabetic patients visiting the Department of Endocrinology at Sichuan Provincial People's Hospital between December 2024 and December 2025 will be equally divided into two groups: an intervention group and a control group. Each group will consist of 100 patients, assigned unique random numbers. The intervention group will undergo AI-based fundus imaging once, with the imaging process taking approximately 5 minutes. The control group will receive standard eye health education without AI fundus imaging.

The primary outcomes, including blood glucose control, systemic indicators, and fundus examination completion rates, will be assessed and compared between the two groups at 3-month and 6-month follow-ups. This study seeks to determine the value of AI-based fundus imaging in improving diabetes management and complication prevention in diabetic patients.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Diagnosis of Type 2 Diabetes Mellitus.
* Patients with a glycated hemoglobin (HbA1c) level \> 7%.
* Ability to comply with all required examinations and provide signed informed consent.

Exclusion Criteria:

* No previous diabetic fundus examination.
* No known diabetic retinopathy.
* Absence of other ocular diseases that could lead to retinopathy.
* Subjects from whom clear fundus photographs could not be obtained.
* Patients with comorbid malignant tumors or severe cardiovascular diseases.
* Patients anticipated to have difficulties with follow-up or those residing in other provinces.

Primary outcomes:
measure: fasting blood glucose level
timeFrame: From enrollment to reexamination at 3 months and 6 months
measure: Blood Glucose Control Status in Two Groups of Patients after 3 Months and 6 Months
timeFrame: From enrollment to reexamination at 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT04082923: Effect of Meal Texture on Glucose-metabolism and Gut Hormone Response After Bariatric Surgery
Official title: Does Meal Texture Have Different Impact on Glucose Metabolism and Intestinal Hormone Response After Gastric Bypass and Sleeve Gastrectomy Operated Patients?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism Disorders
Obesity
Sleeve Gastrectomy
Gastric Bypass
Gut Hormones
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators want to evaluate the difference in glucose metabolism and intestinal hormonal response after a liquid meal versus a solid meal in patients after bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* RYGB or SG operation \> 12 months prior to inclusion
* Weight stable (± 3 kg during the last month)
* HbA1c \< 48 mmol/mol before surgery, and no history of diabetes
* HbA1c \< 48 mmol/mol and fasting plasma glucose \< 6.1 mmol/l at inclusion

Exclusion Criteria:

* Thyrotoxicosis or inadequately treated hypothyreosis
* Hemoglobin \< 6.5 mmol/l at inclusion
* Pregnancy or breast feeding
* Medication affecting the planned examinations

Primary outcomes:
measure: GLP-1 response
timeFrame: 240 minutes
Secondary outcomes:
measure: Difference in gut hormone response after bariatric surgery
timeFrame: 240 minutes
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Endocrinology, Hvidovre University Hospital
state: Hvidovre
Study officials:
affiliation: Department of Endocrinology Hvidovre Hospital Denmark
name: NOra Hedbäck, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hedback N, Hindso M, Bojsen-Moller KN, Linddal AK, Jorgensen NB, Dirksen C, Moller A, Kristiansen VB, Hartmann B, Holst JJ, Svane MS, Madsbad S. Effect of Meal Texture on Postprandial Glucose Excursions and Gut Hormones After Roux-en-Y Gastric Bypass and Sleeve Gastrectomy. Front Nutr. 2022 Apr 29;9:889710. doi: 10.3389/fnut.2022.889710. eCollection 2022.
Clinical trial NCT05661123: Effect of Modified Complete Decongestive Therapy on Lower Limbs Fibrosis Post Cellulitis
Official title: Effect of Modified Complete Decongestive Therapy on Lower Limbs Fibrosis Post Cellulitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Limb Lymphedema
Fibrosis
Cellulitis of Leg
Keywords: Lymphedema
complete decongestive therapy
kinesio tape
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study will be designed to investigate the therapeutic benefits of kinesio tape in combination to complete decongestive therapy on limb volume , skin fibrosis, functional capacity ,ankle range of motion, lymphedema associated symptoms (pain, tightness, heaviness and hardness) and quality of life in patients with lower limbs fibrosis post cellulitis ,as well as finding out a physical therapy approach that has positive effect in treatment and care such cases which would enhance the physical therapy field.

Detailed description: Lymphedema patient need a rehabilitative intervention in two phases : decongestion phase to reduce edema volume , improve the skin extensibility and provide him a better quality of life, followed by the maintenance phase to keep the outcomes. When we use the kinesio tape in addition to the complete decongestive therapy, the patient will experience a better improvement in the edema volume and the skin extensibility within a shorter period of time , a lesser number of sessions and a lower cost. So, the patient will have a better quality of life and could be a productive person in the society.

Eligibility criteria: Inclusion Criteria:

The patient will be according the following criteria:-

1. Males and females with Lower limb lymphedema Stage 2.
2. Age will range from45 to 55years old.
3. BMI \<40 (kg/m2).
4. All patients will be clinically and medically stable when attending the study.
5. Patients free from any acute conditions.
6. Post cellulitis for at least 2 weeks.

Exclusion Criteria:

1. Unstable cardiovascular problems.
2. Altered mental status or poor cognition.
3. Lower limb ischemia (ABI ≤0.8).
4. Lower limb lymphedema stage 3\&4.
5. Acute deep venous thrombosis.
6. Any acute infection.
7. Patients with orthopedic or neurological limitations to exercise.
8. Any lower limb acute ulcer or arterial wounds.

Primary outcomes:
measure: To assess limb volume
timeFrame: 6 weeks
measure: To assess skin extensibility
timeFrame: 6 weeks
measure: To evaluate ankle range of motion
timeFrame: 6 weeks
measure: To evaluate patient quality of life
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Sahel teaching hospital
Study officials:
References:
Clinical trial NCT05304650: A Usability Study of External Neuromodulation With iTEAR100 Generation 2
Official title: A Usability Study of External Neuromodulation With iTEAR100 Generation 2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dry Eye Syndromes
Lead sponsor: Olympic Ophthalmics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Open Label Study
Primary purpose: OTHER

Brief summary: A Usability Study of External Neuromodulation With iTEAR100 Generation 2. A study which evaluates user ability to train and access the iTEAR100 device in a telehealth environment.

Detailed description: A Usability Study of External Neuromodulation With iTEAR100 Generation 2. A study which evaluates user ability to train and access the iTEAR100 device in a telehealth environment. Subjects sign a consent form and are sent a device. After downloading a mobile app, they can access the device and download a prescription. At 7 days, an official telehealth visit evaluates their success in the set up and training. At 30 days, the trial ends, A usability survey and symptom evaluation survey are used to determine success.

Eligibility criteria: Inclusion Criteria: Able to sign English language consent form and over age 18 and reside in the U.S.

-

Exclusion Criteria:

-

Primary outcomes:
measure: Usability
timeFrame: 30 days
Secondary outcomes:
measure: Symptom Scores
timeFrame: 30 days
measure: Adverse Events
timeFrame: 30 days
measure: Symptom Score
timeFrame: 30 Days
Other outcomes:
Locations:
city: Issaquah
country: United States
facility: Olympic Ophthalmics
state: Washington
Study officials:
References:
Clinical trial NCT04185350: Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma
Official title: Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Insulinoma
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Glucagon-like peptide-1 receptor (GLP-1R) is a kind of G protein coupled receptor which regulate the insulin secretion and serves as potential target in the diagnosis of functional pancreas neuroendocrine tumor. The aim of this study was the clinical evaluation of a potential GLP-1R targeted tracer 68Ga-NOTA-MAL-Cys39-exendin-4 for the detection of insulinoma.

Detailed description: Since GLP-1R is expressed in human β-cells and highly overexpressed in insulinomas，multiple GLP-1R-targeted radiopharmaceuticals were devoted to insulinoma localization imaging.68Ga-NOTA-MAL-Cys39-exendin-4 is an optimal probe targeting GLP-1R. A single dose of 111-185 Mega-Becquerel (MBq) 68Ga-NOTA-MAL-Cys39-exendin-4 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.The investigators will determine the use of 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT in the detection of insulinomas, and to compare its diagnostic value with conventional imaging.

Eligibility criteria: Inclusion Criteria:

1. The patient volunteers and signs an informed consent form.
2. age ≥18 and ≤75 years old;
3. Patients with hypoglycaemia in the presence of neuroglycopenic symptoms and documented Whipple's triad;
4. Biochemically proven endogenous hyperinsulinemic hypoglycaemia (plasma glucose concentration \<3.0 mM, insulin \>3 µU/ml, and C-peptide \>0.6 ng/ml);
5. Conventional imaging within 3 month.

Exclusion Criteria:

1. Having a history of allergy to similar drugs, allergic constitution or suffering from allergic diseases;
2. Breast feeding;
3. Pregnancy or the wish to become pregnant within 6 months;
4. Renal function: serum creatinine \> 3.0 mg/dl;
5. Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.

Primary outcomes:
measure: Standardized uptake value
timeFrame: 1 year
Secondary outcomes:
measure: GLP-1 receptor expression by histology compared to tracer uptake
timeFrame: 1 year
measure: Incidence of Adverse Events
timeFrame: Adverse events within 1 week after the injection and scanning of patients will be followed and assessed
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Feng Wang, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT02872350: Prognostic Contribution of Abdominal Ultrasound in Necrotizing Enterocolitis in Preterm Infants Less Than 33SA.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: the Necrotizing Enterocolitis
Preterm Infants
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 95
Sex: ALL
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Enterocolitis necrotizing (ECUN) is a common and serious gastrointestinal disease in premature infants.

The diagnosis of ECUN based on clinical and radiological criteria. The abdomen plain film to date is the reference examination to confirm or refute the diagnosis. Indeed, the presence of pathognomonic signs (pneumatosis, aéroportie) on the abdomen of cliché can confirm the diagnosis. The prognostic value of these radiographic findings is currently controversial.

Abdominal ultrasound is a test whose possibilities in diagnostic and prognostic term began to be considered for some years. It also has other advantages, including that of not being a radiating examination. Studies on the prognostic value of abdominal ultrasound are rather few. Moreover, they involve a series of heterogeneous patients in terms of gestational age. Or the pathophysiology of ECUN in children born at term and in children born prematurely is not the same.

The objective is to study prospectively the prognostic contribution of abdominal ultrasound in the ECUN in premature under 33SA.


Eligibility criteria: Inclusion Criteria:

* Birth Term strictly less than 33SA
* Gestational age some (assessed on early ultrasound dating)
* Congenital malformation of Absence
* Suggestive clinical symptomatology of ECUN defined by the presence of abdominal bloating, increased residues (\> 20% of the volume of enteral feeding) and the presence of blood in stool (macro- or microscopic)
* Radiologic investigation with a radiograph of abdomen and abdominal ultrasound done for the episode of ECUN
* Maximum interval between imaging tests 2 hours
* No parental opposition to the participation of children in the study

Exclusion Criteria:

* Term higher or equal to 33 weeks
* Congenital malformation
* Parental Opposition (or legal representatives) to participate in the study

Primary outcomes:
measure: Comment prognostic evaluation by abdominal ultrasound
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
References:
Clinical trial NCT04814550: Diagnostic Accuracy of CFD-Based Fractional Flow Reserve Derived From Coronary Angiography
Official title: Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with stable angina, unstable angina or myocardial infarction after the acute phase

Brief summary: This is a prospective, multicenter, self-control clinical trial designed to assess the efficacy of AccuFFRangio, a novel method for evaluating the functional significance of coronary stenosis from coronary angiography, with FFR as the reference standard.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years;
* Stable or unstable angina, or myocardial infarction after the acute phase, indication for FFR in at least one vessel;
* Able to provide informed consent.

Exclusion Criteria:

* Subjects judged unsuitable for diagnostic intervention or FFR;
* Myocardial infarction within 6 days;
* LVEF ≤50%;
* eGFR \<60ml/min（1.73m²）
* Severe coagulation dysfunction or bleeding disorders;
* Allergic to iodine contrast agent or adenosine, or ineligible for adenosine;
* Participated in other clinical trials within 1 months;
* Other situations that were not suitable for inclusion, as judged by investigators.

Primary outcomes:
measure: Diagnostic accuracy of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard
timeFrame: 7 days
Secondary outcomes:
measure: Sensitivity and specificity of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard
timeFrame: 7 days
measure: AUC of AccuFFRangio for discrimination of hemodynamically significant coronary artery stenosis
timeFrame: 7 days
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: