louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00638573: The Incretin Effect in Patients With Chronic Pancreatitis
Official title: The Incretin Effect in Patients With Chronic Pancreatitis With and Without Secondary Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pancreatitis
Type 2 Diabetes Mellitus
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2008-03-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic pancreatitis with and without secondary diabetes mellitus

Brief summary: The phenomenon that oral glucose elicits a higher insulin response than does intravenous (iv) glucose, even at identical plasma glucose (PG) profiles (isoglycemia), is called the incretin effect. In type 2 diabetes mellitus (T2DM) the incretin effect has been shown to be markedly reduced or even abolished. It is not known whether the reduced incretin effect in T2DM is a primary event leading to T2DM or if it is merely a consequence of the diabetic state. To answer this question the investigators plan to estimate the incretin effect in 8 patients with secondary diabetes mellitus (DM) to chronic pancreatitis (CP) and compare it to the incretin effect of 8 patients with CP and normal glucose tolerance (NGT). Eight patients with T2DM and 8 healthy control subjects are studied for comparison. The incretin effect is measured by a 50-g oral glucose tolerance test and an isoglycemic intravenous glucose infusion.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic pancreatitis with secondary diabetes mellitus
* Diagnosis of chronic pancreatitis with normal glucose tolerance
* Diagnosis of type 2 diabetes
* Normal level of hemoglobin
* Normal level of se-creatinine

Exclusion Criteria:

* GAD-65 autoantibodies
* ICA autoantibodies
* Albuminuria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte University Hospital
state: Copenhagen County
Study officials:
affiliation: University of Copenhagen
name: Filip K Knop, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Jens J Holst, MD DMSc
role: STUDY_DIRECTOR
affiliation: Gentofte University Hospital
name: Thure Krarup, MD DMSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT06597773: Online Patient Navigation Program for Patients with Breast Cancer
Official title: Online Patient Navigation Program for Timely Access to Supportive Care Services Among Patients with Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Supportive Care in Cancer
Patient Navigation
Keywords: breast cancer
supportive care
patient navigation
online patient navigation
Lead sponsor: Medicos e Investigadores en la Lucha contra el Cancer de Mama
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this prospective 1:1 randomized controlled trial is to evaluate if an online patient navigation program, designed to identify targeted supportive care needs and to facilitate referrals and web-based interventions to address these needs, can increase patients' access to supportive care services, compared to traditional in-person patient navigation providing referrals to in-person supportive care services

The main questions it aims to answer are:

* Does online patient navigation increase access to supportive care services by ≥30% among patients with breast cancer?
* Which are the barriers that hinder patients\&#39; access to the supportive care services they require?
* What is patients\&#39; level of satisfaction with online patient navigation?

Researchers will compare the online patient navigation program to traditional in-person patient navigation providing referrals to in-person supportive care services to assess if online patient navigation increases patients' access to supportive care services.

Participants will:

* Participate in an online or in-person patient navigation program for 4 weeks
* Answer the study surveys at baseline and 4 weeks of follow-up


Eligibility criteria: Inclusion Criteria:

* Female sex
* Age ≥18 years
* Diagnosis of non-metastatic breast cancer
* Internet access at home or in their mobile phone
* Availability to answer the study surveys
* Provision of signed informed consent

Exclusion Criteria:

* Disease recurrence
* Inability to read or write

Primary outcomes:
measure: Access to supportive care services
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Pedro Garza Garcia
country: Mexico
facility: Hospital Zambrano Hellion
state: Nuevo Leon
Study officials:
References:
Clinical trial NCT01413373: 3D Craniofacial Cephalometric Analysis
Official title: Clinical Validation of the Three-dimensional Computer Tomography Based Craniofacial Cephalometric Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malocclusion
Keywords: cephalometry
three-dimensional
CT scan
lateral radiography
facial symmetry
maxillomandibular dysmorphoses
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2011-08-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient more than 18 yeras old, no pregnant women, no child

Brief summary: Development of three-dimensional craniofacial cephalometric analysis for virtual planning in orthognathic surgery.

Detailed description: Cone beam computed tomography is taken for diagnosis independently from this study. Investigators are using this medical imaging for performing the 3D cephalometric analysis. Investigators apply a set of well described landmarks of three-dimensional reconstruction of the skull from patients suffering from diverse craniofacial malformations. Then a set of specific measurements is taken from the patient and provide insights how to modify the anatomy of the patient to improve the skull's architecture and symmetry

Eligibility criteria: Inclusion Criteria:

* maxillomandibular dysmorphoses,
* facial asymmetry,
* craniofacial syndromes

Exclusion Criteria:

* patients with orthodontic treatment only
* growing patients

Primary outcomes:
measure: topological description of maxillomandibular dysmorphosis (angles, distances)
timeFrame: 2014
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Department of oral and maxillofacial surgery, Cliniques universitaires saint Luc
Study officials:
affiliation: Department of Oral and maxillofacial surgery, Cliniques Universitaires saint Luc
name: Raphael Olszewski, DDS,MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06996873: Aggressive Spinal Hemangioma
Official title: Management Of Aggressive Spinal Hemangioma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aggressive Spinal Hemangiomas
Keywords: hemangiomas
management
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic, radiologically confirmed aggressive spinal hemangiomas treated at Assiut University Hospital. Excludes incidentally discovered cases.

Brief summary: This research is a case series analysis to evaluate aggressive vertebral hemangiomas. It focuses on clinical presentation, diagnostic imaging accuracy (X-ray, MRI, MSCT, angiography), and treatment efficacy. The primary goal is to establish optimal management protocols.

Detailed description: Hybrid methodology integrating retrospective case reviews (from Assiut University Hospital's Orthopedic Surgery Department) with synthesis of existing literature.

Objectives:

Characterize clinical presentations and imaging findings. Compare diagnostic accuracy across modalities. Analyze treatment outcomes, including procedural success rates and complications.

Tools:

Imaging: X-ray for initial screening, MRI/MSCT for soft tissue and spinal cord involvement, angiography for vascular mapping.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with aggressive spinal hemangiomas based on clinical symptoms and imaging findings.
* Cases confirmed through diagnostic modalities such as X-ray, MRI, MSCT, or angiography.
* Patients presenting with symptoms such as pain, neurological deficits, or spinal instability attributable to the hemangioma.

Exclusion Criteria:

* Patients with incidentally discovered spinal hemangiomas (asymptomatic cases found during evaluations for unrelated conditions).
* Cases lacking sufficient diagnostic evidence to confirm aggressive spinal hemangioma.

Primary outcomes:
measure: Neurological Symptom Resolution
timeFrame: 3 months
Secondary outcomes:
measure: Functional Status Improvement
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02107573: Comparing the Outcomes Between Rotator Cuff Repair With and Without Suprascapular Nerve Decompression
Official title: Will Routine Suprascapular Nerve Release During Arthroscopic Rotator Cuff Repair Improve Patient Outcomes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: Randomized Controlled Trial
Rotator Cuff Tear
Suprascapular Nerve
Decompression
Shoulder Surgery
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Endeavor Health
First posted: 2014-04-08
Enrollment: 36
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 purpose of the study is to compare the differences in outcome between the traditional rotator cuff repair surgery and rotator cuff repair with suprascapular nerve decompression surgery.

Detailed description: The suprascapular nerve is intimately related to the function and likely recovery of the rotator cuff musculature. Retracted rotator cuff tears have recently been shown to effect both the physical path in which the suprascapular nerve travels, as well as its physiologic function.

This study will be a randomized control trial with long term follow up that will add to and elaborate on the positive outcomes reported in other trials. Patients that have a rotator cuff tears with greater than or equal to 1 cm of retraction that have failed conservative treatment and require operative repair will qualify for the study. They will be randomized into two arms: In one arm, patients will undergo suprascapular nerve release immediately after their rotator cuff repair; they will be compared to patients that have rotator cuff repair with no release of the nerve. Post operatively, at different time intervals, patients will be expected to fill out multiple standardized, well established surveys that assess the patients pain level and shoulder function.

Eligibility criteria: Inclusion Criteria:

* Reparable full thickness supraspinatus and or infraspinatus rotator cuff tears regardless of retraction

Exclusion Criteria:

* Patients less than 18 years of age
* Irreparable rotator cuff tears

Primary outcomes:
measure: American Shoulder and Elbow Surgeons (ASES) Shoulder Score
timeFrame: one year
Secondary outcomes:
measure: Constant Shoulder Score
timeFrame: one year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Evanston
country: United States
facility: Northshore University
state: Illinois
Study officials:
affiliation: University of Chicago
name: Lewis L Shi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northshore University
name: Jason Koh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03924973: 3 Year Follow up Study of the IDEA Population
Official title: Long-term Efficacy of Early Intervention With Early Start Denver Model (ESDM) on the Severity of Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 93
Sex: ALL
Minimum age (years): 39
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single blind
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the efficiency of early treatment for ASD children 5 years after initial treatment.

The early treatment implemented was 12 hours per week of ESDM versus treatment as usual during 2 years. This was done as an RCT, called IDEA. Children will now be included in IDEA-2 SCOLA, a three year follow up study.

Detailed description: 180 children with ASD, younger than 3 years old, were included in the IDEA RCT. Children were allocated to the ESDM treatment group or the treatment as usual group. The aim of IDEA-2 is to follow-up this population for 3 years after the initial 2 years of intervention, that is, 5 years after initial inclusion to IDEA.

Investigators hypothesize that children who received ESDM 12 hours per week will have a significant decrease of autism symptoms and will have a better scholastic level 5 years after initial inclusion to IDEA.

Eligibility criteria: Inclusion Criteria:

* Inclusion in the initial IDEA trail
* Requiring less than 40 minutes travel to the assessment center

Exclusion Criteria:

* Impossibility of coming in for assessment
* Exclusion from IDEA

Primary outcomes:
measure: ADOS (Autism Diagnostic Observation Schedule )
timeFrame: 3 YEARS
Secondary outcomes:
measure: Wechsler (Wechsler Intelligence Scale for Children)
timeFrame: 3 YEARS
measure: VABS (Vineland Adaptive Behavior Scales)
timeFrame: 3 YEARS
measure: PPVT ( Peabody Picture Vocabulary Test )
timeFrame: 3 YEARS
measure: Parental self-assentiment
timeFrame: 3 YEARS
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Vinatier
Study officials:
affiliation: CH LE VINATIER
name: GEOFFRAY MARIE-MAUDE, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06483373: A Clinical Study of SPH7854 Granules in Healthy Subjects.
Official title: A Single and Multiple Dose-escalation, and Food Effects of Phase I Clinical Study to Evaluate the Tolerability/Safety/Pharmacokinetics of SPH7854 Granules in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Inflammatory Bowel Disease
Lead sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-07-03
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety of SPH7854 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent；
2. Healthy volunteers;
3. Before receiving the investigational drug, the examination results were normal or clinically insignificant;
4. Subjects who have no fertility plan/sperm donation/egg donation plan and voluntarily take effective contraceptive measures, from signing the informed consent to the prescribed time after the last dosing.

Exclusion Criteria:

1. Female subjects who are breastfeeding or have positive pregnancy results;
2. Subjects with chronic, unstable, or recurrent disease or surgery history who are judged by the investigator to be ineligible before signing informed consent;
3. Subjects suffering from allergic diseases or having a history of severe allergies;
4. Subjects who took the drug or food prohibited by the protocol prior to the first dose;
5. Subjects with evidence of infection who could not be enrolled according to the investigator's judgement;
6. Other circumstances that meet the protocol exclusion criteria.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Approximately 2 years
Secondary outcomes:
measure: PK(Pharmacokinetics):Tmax
timeFrame: Approximately 2 years
measure: PK(Pharmacokinetics):Cmax
timeFrame: Approximately 2 years
measure: PK(Pharmacokinetics):AUC
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Second University Hospital, Sichuan University
Study officials:
References:
Clinical trial NCT00654173: Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR)
Official title: A 12-Week, Randomized, Open-Label, 3 Arm Parallel Group, Multicenter, Phase IIIb Study Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin Achieving NCEP ATP III LDL-C Goals in High Risk Subjects With Hypercholesterolaemia in the Managed Care Setting.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: Cholesterol
low density lipoproteins
dyslipidaemia
Rosuvastatin
Crestor
Atorvastatin
Lipitor
Zocor
simvastatin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-07
Enrollment: 4444
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 purpose of this study is to compare the efficacy and safety of rosuvastatin with simvastatin and atorvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia


Eligibility criteria: Inclusion Criteria:

* Member of managed care plan for hypercholesterolemia
* Fasting blood lipid levels as defined by the protocol
* Diagnosis of coronary heart disease, diabetes, or atherosclerotic disease, or presence of multiple risk factors giving high risk of coronary heart disease

Exclusion Criteria:

* The use of lipid lowering drugs or dietary supplements after Visit 1.
* Active arterial disease eg Unstable angina, or recent arterial surgery
* Blood lipid levels above the limits defined in the protocol.
* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

Primary outcomes:
measure: Percentage of subjects who achieve low density lipoprotein cholesterol goals while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin.
timeFrame: 6 weeks
Secondary outcomes:
measure: Percentage changes in other blood lipid levels while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin
timeFrame: 6 & 12 weeks
measure: Safety: adverse events & abnormal laboratory markers
timeFrame: 6 & 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Alex Gold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Russell Esterline
role: STUDY_DIRECTOR
References:
Clinical trial NCT06259773: The Roles of MRI, DYNEELAX and Stress X-ray in First-Line Diagnosis of Cruciate Ligament Injury
Official title: The Roles of MRI, DYNEELAX and Stress X-ray in First-Line Diagnosis of Cruciate Ligament Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Injuries
Anterior Cruciate Ligament Injuries
Knee Ligament Injury
Knee Arthritis
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Over 20 years old, suspected ligament damage caused by knee contusion

Brief summary: Background: Cruciate ligament tears are clinically diagnosed by detection of anterior or posterior tibial translation on physical examination; however, this manual method of assessment is imprecise, subjective, and not reproducible. Recently a new instrument, a stress radiographic device and knee stability test (DYNEELAX), were produced to objectively measure these displacements.

Objective: To assess new diagnostic methods, in the measurement of anterior/posterior tibial translation in cruciate ligament-deficient knee compared to the healthy knee.

Material and method: The MRI, stress radiographic device and knee stability test was applied to cruciate ligament-tear knees that were diagnosed by physical examination as having partial or complete cruciate ligament tears. Each knee was tested under a force 120 Newtons in a posterior to anterior direction to create anterior tibial translation at 20 degrees knee flexion. Side-to-side difference of anterior/posterior tibial translation (mm) was measured from radiographs. Measurement of rotation and translation by DYNEELAX was also recorded.


Eligibility criteria: Inclusion Criteria: Patients are diagnoed as ACL/PCL injury or suspect ligament sprain at Kaohsiung veteran general hospital.

Exclusion Criteria: Unable receing MRI exam, any op history of knee or fracture history on the impaired knee.

Primary outcomes:
measure: anterior/posterior tibial translation (mm)
timeFrame: post-op 3 months, 6 months
measure: patient reported outcome measure
timeFrame: post-op 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
state: 高雄市
Study officials:
affiliation: Kaohsiung veteran general hospital
name: Yi Ping Wei, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01564173: Dependence of LV Hemodynamics on Pacing Site
Official title: Characterization of LV Hemodynamics During Epicardial and Endocardial Pacing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-03-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients indicated for epicardial mapping and ablation of arrhythmia(s) utilizing a transcutaneous subxiphoid approach

Brief summary: The purpose of this study is to evaluate the effects of epicardial and endocardial pacing at each side of the left ventricular (LV) segments on cardiac hemodynamics in patients with impaired LV function undergoing epicardial ablation and mapping procedure. Hemodynamic function will be assessed during a pacing protocol with a pressure catheter inserted in the LV.


Eligibility criteria: Inclusion Criteria:

* Patient is already indicated for epicardial mapping and ablation of arrhythmia(s) utilizing a transcutaneous subxiphoid approach
* Be in sinus rhythm
* Have LVEF \< 40%
* Have the ability to provide informed consent for study participation and be willing and able to comply with the CIP (Clinical Investigational Plan) described evaluations

Exclusion Criteria:

* Have permanent AF
* Have pericardial disease
* Have a recent myocardial infarction within 40 days prior to enrollment
* Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
* Have had a recent CVA or TIA within 3 months prior to enrollment
* Be less than 18 years of age
* Be pregnant

Primary outcomes:
measure: Invasive Dp/dt Max
timeFrame: Acute E.P. Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU
Study officials:
affiliation: University Hospital, Bordeaux
name: Pierre Jais, MD
role: PRINCIPAL_INVESTIGATOR
References: