louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05666479: CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Official title: Clinical Effectiveness of Continuous Blood Glucose Monitoring In Patients With Type 2 Diabetes Undergoing Orthopaedic Hip or Knee Replacement Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetes Mellitus, Type 2
Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Keywords: Type 2 Diabetes
Orthopaedic Hip Replacement
Orthopaedic Knee Replacement
Continuous Blood Glucose Monitoring
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2022-12-27
Enrollment: 32
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 type 2 diabetes undergoing orthopaedic hip or knee replacement surgery.

Brief summary: The purpose of this study is to analyze the efficacy and accuracy of real-time continuous glucose monitoring devices (rtCGM) in patients with Type 2 diabetes undergoing inpatient elective hip or knee surgery in the pre-, peri-, and post-operative setting at Stony Brook University Hospital (SBUH).


Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 18 years of age
* Scheduled for elective inpatient hip or knee replacement surgery at Stony Brook University Hospital (SBUH)
* Clinically diagnosed Type 2 Diabetes at least 6 months prior to surgery
* Literate and able to provide written informed consent
* Negative pregnancy test by serum or urine HCG at screening \[as documented in subject's medical record) for women of childbearing potential (WCBP)\]

Exclusion Criteria:

* Less than 18 years of age
* Not scheduled for elective inpatient hip or knee replacement surgery at SBUH
* No clinical diagnosis of Type 2 diabetes at least 6 months prior to surgery
* Not literate or unable to provide written informed consent
* Documented diagnosis of organ failure
* Documented diagnosis of chronic infection
* Documented diagnosis of any active malignancy
* Documented diagnosis of hepatic (liver) dysfunction or cirrhosis
* Pregnant by serum or urine HCG at screening \[as documented in subject's medical record) for women of childbearing potential (WCBP)\]

Primary outcomes:
measure: Accuracy of Real-Time Continuous Glucose Monitoring
timeFrame: 10 days
Secondary outcomes:
measure: Interference of Intraoperative Electrocautery on Real-Time Continuous Glucose Monitoring
timeFrame: 60-90 minutes
measure: Assess Irreversible Damage/Interference of Real-Time Continuous Glucose Monitoring Devices Caused by Electrocautery
timeFrame: 6-7 days
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
References:
Clinical trial NCT00502879: Study Evaluating Etanercept 25mg or 50mg Administered Subcutaneously to Healthy Chinese Male Subjects
Official title: A Randomized, Open-Label, Single-Dose Administration, Parallel-Group Study of the Pharmacokinetics of Etanercept, 25mg or 50 mg, Administered Subcutaneously to Healthy Chinese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-07-18
Sex: MALE
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: The primary purpose of this study is to assess the pharmacokinetics of etanercept in healthy Chinese male subjects. Safety and tolerability data will also be obtained.


Eligibility criteria: 1. Men, aged 18 to 45 years, of Chinese descent and living in China.
2. Body mass index in the range of 18.0 to 30.0 kg/meter squared and body weight equal to or greater than 50 kg.
3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, chest x-ray, and 12-lead electrocardiogram (ECG).
4. Have a high probability for compliance with and completion of the study.

Primary outcomes:
measure: To assess the pharmacokinetics of etanercept in healthy Chinese male subjects.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For China: medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03707379: The Effect of Share Care Model in the Improvement of Diabetes Management
Official title: The Effect of Share Care Model in the Improvement of Diabetes Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes mellitus
Diabetic management
Share care
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients in Ruijing Diabetes Hospital

Brief summary: The situation of diabetes management in China is serious. To set up hierarchical medical system is necessary, though there was no mature or effective diabetes management model in the mainland. To explore a new path for hierarchical medical system, we would localize the share care model of diabetes management in Taiwan. Diabetic experts, diabetic educators and community doctors would use interactive information platform and self-glucose monitor with application on mobile phone to manage diabetic patients together. The model will be applied in six diabetic centers, and patients we will be managed in the new model and followed, and at the same time patients that managed in the conventional model in the real world, the differences of proportion who achieve a composite goal will be compared yearly for 5 years.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients

Exclusion Criteria:

* Patients had not signed the consent form
* Patients with sever hart failure, hepatic failure, renal failure

Primary outcomes:
measure: HbA1c
timeFrame: 1 year
Secondary outcomes:
measure: blood pressure
timeFrame: 1 year
measure: LDL-C
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ruijing Diabetes Hospital
state: Beijing
Study officials:
affiliation: Beijing Tsinghua Changgeng Hospital
name: Jianzhong Xiao
role: STUDY_DIRECTOR
References:
citation: An L, Wang Y, Cao C, Chen T, Zhang Y, Chen L, Ren S, Tang M, Ma F, Li X, Yuan S, Zhao W, Lee Y, Xiao J. Screening cardiovascular risk factors of diabetes patients in the primary diabetes clinics. Medicine (Baltimore). 2021 Jul 30;100(30):e26722. doi: 10.1097/MD.0000000000026722.
Clinical trial NCT03222479: Smartphone-based Stress Management Intervention for Employees
Official title: Development of Stress Guide for Employees: Smartphone-based Stress Management Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: KT Corporation
First posted: 2017-07-19
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Healthy individuals recruited through advertisement
Primary purpose: SUPPORTIVE_CARE

Brief summary: Participants were able to use the application the investigators developed for four weeks. With the application, the participants were able to monitor their stress level and life style patterns. The participants were also provided personalized stress management techniques including psychoeducation and cognitive behavioral technique. In 2014, additional relaxation techniques-abdominal breathing, progressive muscular relaxation, and meditation-were incorporated. Participants' mental health status and life style patterns were evaluated at baseline and at 4 weeks. Pre- and post-intervention statuses were compared after adjusting for degrees of life stress factors. Brief encounter psychosocial instrument (BEPSI-K) score and Center for Epidemiologic Studies Depression Scale (CES-D) score were used as primary outcome measures.


Eligibility criteria: Inclusion Criteria:

* Any employee from three corporations (the Korea Gas Corporation (KOGAS), the Korea District Heating Corporation (KDHC), and the Korea Expressway Corporation (KEC)); any individual who visited the health promotion center for a health checkup at Seoul National University Bundang Hospital

Exclusion Criteria:

* None

Primary outcomes:
measure: Change from baseline Center for Epidemiologic Studies Depression Scale (CES-D) score at 4 weeks
timeFrame: Baseline and after the intervention for 4 weeks
measure: Change from baseline Brief encounter psychosocial instrument (BEPSI-K) score at 4 weeks
timeFrame: Baseline and after the intervention for 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National Univerysity Bundang Hospital
name: Jeong Hyun Kim, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02092779: Growth Hormone Deficiency and Empty Sella Cardio-Metabolic Risk Factors in Obesity: a Cross-Sectional Study
Official title: Growth Hormone Deficiency, Empty Sella and Cardio-Metabolic Risk Factors in Obesity: a Cross-Sectional Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 447
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese

Brief summary: Obesity is a disease not always attributable to nutritional imbalance, frequently associated with changes in key hypothalamic-pituitary (HP) axes. The regain of weight loss after hypochaloric diets has been ascribed to these HP disregulations. The aim of the study is to explore pituitary morphology and its association with pituitary function and metabolic phenotype in outpatient obese individuals evaluated in the period 2010-2013 at the Department of Experimental Medicine of the University of Rome La Sapienza, with features of HP disease in a cross-sectional .


Eligibility criteria: Inclusion Criteria:

* Adult obese

Exclusion Criteria:

* psychiatric disturbances, pregnancy, lactation, or drugs known to affect pituitary function

Primary outcomes:
measure: Cranio-caudal pituitary diameter in millimeters
timeFrame: Participants will be followed for the duration of day hospital stay, an expected average of 1 week
Secondary outcomes:
measure: Growth hormone releasing hormone plus arginine test for GH secretion μg/L
timeFrame: Participants will be followed for the duration of day hospital stay, an expected average of 1 week
Other outcomes:
Locations:
Study officials:
affiliation: University of Roma La Sapienza
name: Lucio Gnessi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06203379: Efficacy of Neuromuscular Training in Youth Soccer Players
Official title: Effects of Preseason Neuromuscular Training Improves , Youth, Male Soccer Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injuries
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 41
Sex: MALE
Minimum age (years): 15
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Soccer stands as one of the most widespread sports that ensures active participation . It has continued to grow and develop since its inception in all societies

Detailed description: Footballers suffer injuries in various ways during training sessions and matches throughout the season due to excessive strain. Hence, numerous studies have investigated the injury sites and frequencies of footballers. According to these findings, it has been determined that young footballers experience more lower extremity injuries compared to professional footballers.

Eligibility criteria: Inclusion criteria:

* Being between the ages of 15-16
* Playing amateur football for at least 2 years
* Being a male athlete
* Voluntarily participate in the study
* Obtaining informed consent from them

Exclusion criteria:

* Bone fractures, fractures, ligament and muscle tears in the body.
* Has a systemic disease
* Having a serious injury in the last 3 months.
* Having any neurological problem

Primary outcomes:
measure: vertical jump height
timeFrame: 8 weeks
measure: jump duration (flight time)
timeFrame: 8 weeks
measure: Y Balance Test
timeFrame: 8 weeks
measure: Fatigue Severity Scale
timeFrame: 8 weeks
measure: The Shuttle Run Test
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahçehir University
Study officials:
References:
Clinical trial NCT00326079: A Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2
Official title: A Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2 Stents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Open-Angle Glaucoma
Keywords: Open angle
Glaucoma
Surgery
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2006-05-16
Enrollment: 61
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 evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma.

Detailed description: The study compares 1 stent versus 2 stents.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with open-angle glaucoma (OAG)
* Subject on at least one glaucoma medication
* Signed informed consent

Exclusion Criteria:

* Angle closure glaucoma
* Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma
* Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
* Fellow eye already enrolled

Primary outcomes:
measure: Efficacy
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Medical University
city: Augsburg
country: Germany
facility: Klinik Vincentinum
city: Mainz
country: Germany
facility: Mainz University
city: Weinheim
country: Germany
facility: Private Practice
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Zaragoza
country: Spain
facility: Instituto Oftalmológico de Aragón
city: Istanbul
country: Turkey
facility: Beyoglu Eye Research and Education Hospital
Study officials:
affiliation: Glaukos Corporation
name: Head of Clinical Affairs
role: STUDY_DIRECTOR
References:
Clinical trial NCT03308279: Prediction Model for Minimizing the Risk of Median Nerve Puncture
Official title: Ultrasound and Anthropometric Prediction Model for Minimizing the Risk of Median Nerve Puncture With Dry Needling Approach Into the Pronator Teres Muscle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pronator Teres Nerve Syndrome
Keywords: dry needling
median nerve
Pronator Teres
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asinthomatic subjets who respond to the researchers calls

Brief summary: The main aim of this study was to correlate anthropometric measures of the forearm in healthy subjects with the ultrasound pronator teres depth to determine the needle length in order to avoid injury of the median nerve during pronator teres dry needle approach. A cross-sectional study, was carried out in order to perform a predictive model for the median nerve depth into the pronator teres muscle using a decision tree analysis algorithm.


Eligibility criteria: Inclusion Criteria:

* Asinthomatic subjets

Exclusion Criteria:

* Pain in the 3 moths before in the forearm

Primary outcomes:
measure: Muscle thicknesses
timeFrame: 10 minutes
measure: Median Nerve depth
timeFrame: 5 minutes
measure: Forearm Perimeter
timeFrame: 2 minutes
measure: Forearm Longitude
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gurses IA, Altinel L, Gayretli O, Akgul T, Uzun I, Dikici F. Morphology and morphometry of the ulnar head of the pronator teres muscle in relation to median nerve compression at the proximal forearm. Orthop Traumatol Surg Res. 2016 Dec;102(8):1005-1008. doi: 10.1016/j.otsr.2016.08.016. Epub 2016 Nov 11.
citation: Dang AC, Rodner CM. Unusual compression neuropathies of the forearm, part II: median nerve. J Hand Surg Am. 2009 Dec;34(10):1915-20. doi: 10.1016/j.jhsa.2009.10.017.
citation: Kowalska B, Sudol-Szopinska I. Ultrasound assessment on selected peripheral nerve pathologies. Part I: Entrapment neuropathies of the upper limb - excluding carpal tunnel syndrome. J Ultrason. 2012 Sep;12(50):307-18. doi: 10.15557/JoU.2012.0016. Epub 2012 Sep 30.
Clinical trial NCT01258179: Peri-operative Expression Analysis of Pancreatic Stone Protein in a Surgical Study Population
Official title: Peri-operative Expression Analysis of Pancreatic Stone Protein and Pancreatitis-associated Protein in a Surgical Study Population
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Patients Undergoing Major Abdominal Surgery
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-12-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing major abdominal surgery

Brief summary: The purpose of this study is to analyze the peri-operative expression of pancreatic stone protein and pancreatitis-associated protein in surgical patients following major abdominal surgery by blood samples.


Eligibility criteria: Inclusion criteria: - \>= 18 years

* abdominal major surgery
* need for post-operative ICU care

Exclusion criteria: - \<18 years

- patients who do not agree the written informed consent

Primary outcomes:
measure: Diagnosed Infections according to the Systemic Inflammatory Response System (SIRS) Criteria of the german interdisciplinary Association of Intensive and Emergency Medicine
timeFrame: 2 years
Secondary outcomes:
measure: Intensive Care Unit (ICU) stay in days
timeFrame: 2 years
measure: hospital stay in days
timeFrame: 2 years
measure: postoperative complications according to the "Clavien-Dindo Classification" System
timeFrame: 2 years
measure: hospital costs
timeFrame: 2 years
measure: comparisons to other known infectious parameters: c-reactive protein (CRP), procalcitonin (PCT), Interleukin 6 (IL-6), Tumor Necrosis Factor Alpha (TNF-alpha), Leucocytes
timeFrame: 2 years
measure: Bacteriaemia in the blood
timeFrame: 2 years
measure: Platelets in the blood
timeFrame: 2 years
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Visceral and Transplantation Surgery
state: CH/Zürich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: Christian E Oberkofler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fisher OM, Raptis DA, Vetter D, Novak A, Dindo D, Hahnloser D, Clavien PA, Nocito A. An outcome and cost analysis of anal fistula plug insertion vs endorectal advancement flap for complex anal fistulae. Colorectal Dis. 2015 Jul;17(7):619-26. doi: 10.1111/codi.12888.
citation: Fisher OM, Oberkofler CE, Raptis DA, Soll C, Bechir M, Schiesser M, Graf R. Pancreatic stone protein (PSP) and pancreatitis-associated protein (PAP): a protocol of a cohort study on the diagnostic efficacy and prognostic value of PSP and PAP as postoperative markers of septic complications in patients undergoing abdominal surgery (PSP study). BMJ Open. 2014 Mar 6;4(3):e004914. doi: 10.1136/bmjopen-2014-004914.
Clinical trial NCT04297579: Congenital Naevi of Lower Limb in the Child
Official title: Congenital Nevi in the Lower Limb in Children : Which Size Can be Afforded by a Simple Surgical Procedure ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Melanocytar Nevi in the Lower Limb
Keywords: congenital nevi
naevus
Congenital skin neoplasm
Reconstructive surgical procedures
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 176
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children that had congenital nevi surgery removal, in the lower limb.

Brief summary: Depending on its dimensions, it is difficult to predict if a congenital nevi of the lower limb can be surgically removed by a unique simple procedure or by a complex procedure (expander, skin graft etc..), with a good result.

This study retrospectively reviewed the practice of our team of surgeons depending on the size of the naevus to reveal a dimension threshold that can be used in the future to help to choose between a simple or a complex procedure.

Detailed description: Retrospective study using medical file data only. No intervention nor phone call etc.. to the patients or their parents.

Eligibility criteria: Inclusion criteria:

- Child + congenital nevi in the lower limb + had removal surgery

Exclusion criteria:

- More than one congenital nevi in the lower limb.

Primary outcomes:
measure: Nevi Estimated Size
timeFrame: within three weeks after surgery
Secondary outcomes:
measure: post-operative complications depending on the initial size of the naevus
timeFrame: assessed within 6 months after surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Guillaume CAPTIER, MD.PhD
role: STUDY_DIRECTOR
References: