louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04198961: Electronic Intervention to Chronic Opioid Therapy
Official title: An Electronic Chart Intervention to Improve Safety for Patients on Chronic Opioid Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Opioid Therapy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This pilot study will attempt to apply an electronic chart intervention to improve safety for patients on chronic opioid medications.


Eligibility criteria: Inclusion Criteria:

* Patients prescribed long-term opioid therapy of doses greater than 90 morphine equivalent daily dose (MEDD)

Exclusion Criteria:

* Patients prescribed short-term opioid medications for acute pain (less than a 90-day supply over the past 120 days), sublingual buprenorphine, methadone maintenance for opioid use disorder or with oncology or palliative care diagnoses will be excluded.

Primary outcomes:
measure: Change in the number of patients who receives naloxone prescription
timeFrame: baseline, 1, 3- and 6-months and 12 months
measure: change of number of documentation about safety discussions
timeFrame: baseline, 1, 3- and 6-months and 12 months
measure: change of number of order for urine toxicology screening
timeFrame: baseline, 1, 3- and 6-months and 12 months
measure: change of number of documentation of prescription drug monitoring program (CURES) results
timeFrame: baseline, 1, 3- and 6-months and 12 months
measure: change of number of signed opioid informed consent forms
timeFrame: baseline, 1, 3- and 6-months and 12 months
Secondary outcomes:
measure: Change in number of patients on long-term high risk doses of opioid pain medications
timeFrame: baseline, 1, 3- and 6-months and 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford Univeristy
name: Huiqiong Deng, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03659461: Glucagon-like Peptide-1 Levels, Insulin Resistance and Insulin Sensitivity Index in Type 2 Diabetes Mellitus
Official title: Comparative Study of Incretin System in Three Ethnic Groups With Abnormal Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
PreDiabetes
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is conducted to examine GLP-1, insulin resistance and insulin sensitivity portfolio in Malay, Chinese and Indian populations in Malaysia and to study the effect of DPPIV inhibitor in T2DM patients with different GLP-levels.


Eligibility criteria: Inclusion Criteria:

* Subjects are newly diagnosed of T2DM according to World Health Organisation criteria) and do not receive any glucose-lowering drugs
* Subjects with normal glucose tolerance test according to World Health Organisation criteria which is carried out immediately before inclusion in the study
* Subjects who are willing to participate and sign the informed consent form

Exclusion Criteria:

* Patients with pre-existing T2DM
* Patients with family history of diabetes
* Patients receiving glucose-lowering medications
* Patients with anemia, abnormal serum creatinine level, macroalbuminuria, proliferative retinopathy, impaired liver function

Primary outcomes:
measure: change in blood glucose load response to sitagliptin
timeFrame: pre-treatment of sitagliptin and post 12-week treatment of sitagliptin
measure: change in blood insulin response to sitagliptin
timeFrame: pre-treatment of sitagliptin and post 12-week treatment of sitagliptin
Secondary outcomes:
Other outcomes:
Locations:
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail
state: Johor
Study officials:
affiliation: National University of Malaysia
name: Kamaruddin Nor Azmi
role: STUDY_DIRECTOR
affiliation: National University of Malaysia
name: Shiau Chin Chong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05742061: Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis Patients
Official title: Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Osteoarthritis Knee
Corticosteroid
Platelet Rich Plasma
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee osteoarthritis is the most common type of osteoarthritis in the lower extremity and constitutes 23% of all arthritis cases, about 13% of females and 10% of males aged above 60 years have symptomatic knee OA. Intra-articular corticosteroids (IACs) are a frequently-used treatment regimen for pain relief from symptomatic knee OA as it inhibits inflammation and reduces prostaglandin synthesis. Platelet-rich plasma (PRP) is an autologous blood product containing a high percentage of various growth factors (GFs), such as fibroblast growth factor, epidermal growth factor, vascular endothelial growth factor, transforming growth factor-β and platelet-derived growth factor. The aim of this study is to compare effect of intra-articular injection of platelet rich plasma versus corticosteroid in treatment of primary knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Patients 40-70 years of age suffering from knee OA with Kellgren Lawrence grade II or III on standing antero-posterior and lateral knee radiographs.
* Patients diagnosed according to ACR classification criteria.

Exclusion Criteria:

* Systemic diseases as Patients having diabetes mellitus,Cardiovascular diseases or coagulopathies.
* Those receiving treatment with anticoagulant , anti_platelet medications or systemic corticosteroid 10 days before injection or recent use of NSAIDs.
* Pregnant and breast feeding females.
* Patients have hemoglobin values \<10 g/dl or platelet values\<150,000/ml.

Primary outcomes:
measure: Assessment of knee pain, stiffness and physical function prior knee injection
timeFrame: Assessment will be done just before injection
measure: Assessment of knee pain, stiffness and physical function 2 weeks after injection
timeFrame: 2 weeks after injection
measure: Assessment of knee pain, stiffness and physical function 6 weeks after injection
timeFrame: 6 weeks after injection
measure: Assessment of knee pain, stiffness and physical function 12 weeks after injection
timeFrame: 12 weeks after injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03966261: The Role of Incretins in Bone Remodeling in Humans
Official title: INcrétines et REModelage OSseux
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Incretins
Osteoporosis
Bone Remodeling
Healthy
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-05-29
Enrollment: 104
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women and men aged from 30 to 70 years without bone patholog nor pathological condition influencing bone remodeling nor treatment influencing bone remodeling

Brief summary: The role of incretins (GIP and GLP-1) on cells and bone tissue has been shown in cellular and animal studies. In humans, the role of these hormones is mainly studied in the pathophysiology of diabetes, their effect on bone is unknown. The serum incretin concentration is low and increases rapidly after a meal. This increase is brief, incretins being rapidly degraded by dipeptidylpeptidase 4 (DPP-4). The dosage of these hormones is complex and the basal "normal" serum concentrations and after feeding in healthy subjects are unknown. Before any study on the effect of incretins on bone remodeling in humans, it is necessary to establish physiological concentrations of incretins in healthy subjects.

The aim of this study is to estimate physiological concentrations of incretins in healthy subject.


Eligibility criteria: Inclusion Criteria:

* healthy women and men

Exclusion Criteria:

* known osteoporosis
* osteoporotic fracture
* tobacco
* alcohol : \> 2 glasses/day
* type 1 and type 2 diabetes
* BMI \< 19kg/m² or \> 30kg/m²
* heart failure, kidney failure
* cancer
* bariatric surgery
* graft
* cirrhosis
* use in the past year : bisphosphonate, denosumab, raloxifene, teriparatide, oral or IV glucocorticoid during 3 months or more

Primary outcomes:
measure: incretins concentrations before and after a meal in healthy subjects
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
References:
citation: Mabilleau G. Interplay between bone and incretin hormones: A review. Morphologie. 2017 Mar;101(332):9-18. doi: 10.1016/j.morpho.2016.06.004. Epub 2016 Aug 8.
citation: Mabilleau G, Gobron B, Mieczkowska A, Perrot R, Chappard D. Efficacy of targeting bone-specific GIP receptor in ovariectomy-induced bone loss. J Endocrinol. 2018 Nov;239(2):215-227. doi: 10.1530/JOE-18-0214.
citation: Mabilleau G, Gobron B, Bouvard B, Chappard D. Incretin-based therapy for the treatment of bone fragility in diabetes mellitus. Peptides. 2018 Feb;100:108-113. doi: 10.1016/j.peptides.2017.12.008.
Clinical trial NCT04383561: Relationship Between LRG and Periodontal Disease
Official title: Leucin-rich alpha2 Glycoprotein (LRG): A Novel Acute Phase Protein Related With Stage 3 Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Acute-Phase Response
Inflammation
Keywords: periodontitis
gingival crevicular fluid
serum
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
Collaborators: name: Giresun University
name: Bulent Ecevit University
First posted: 2020-05-12
Enrollment: 50
Sex: ALL
Minimum age (years): 26
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aimed to investigate gingival crevicular fluid (GCF) and serum levels of LRG, interleukin (IL)-6 and tumor necrosis factor (TNF)-α in patients with periodontitis before and after non-surgical periodontal treatment.

Detailed description: Twenty-five stage 3 periodontitis and twenty-five periodontally healthy individuals were enrolled in the study. Clinical periodontal measurements were recorded; periodontitis patients received non-surgical periodontal treatment, and GCF and serum samples were obtained at baseline and at 6 weeks after treatment. LRG, IL-6 and TNF-α were determined by ELISA.

Eligibility criteria: Inclusion Criteria:

1. 25-50 years of age
2. having at least 20 natural teeth, excluding third molars
3. having no systemic disease
4. non-smokers
5. criteria for healthy control group: BOP \< 10% and PD ≤ 3 mm without clinical attachment loss or radiographic sign of alveolar bone destruction
6. criteria for stage 3 periodontitis group: interdental CAL ≥ 5 mm at least 2 non-adjacent teeth, PD ≥ 6 mm and radiographic bone loss extending to the mid-third of the root or beyond.

Exclusion Criteria:

1. having any systemic diseases,
2. smoking
3. current pregnancy or lactation
4. a history of periodontal treatment in the past 6 months
5. using antibiotic, anti-inflammatory drugs or any other drugs within the past 6 months.

Primary outcomes:
measure: Changes in the levels of biochemical parameters
timeFrame: Baseline and 6 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Giresun University
Study officials:
References:
Clinical trial NCT02289261: A Comparison of Morphine and Morphine Plus Dexmedetomidine in Chronic Cancer Pain
Official title: A Comparison of Morphine and Morphine Plus Dexmedetomidine in Chronic Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pain
Keywords: Chronic pain
Morphine
Dexmedetomidine
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2014-11-13
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
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 determine whether dexmedetomidine added to morphine is effective in the treatment of chronic cancer pain.

Detailed description: We conduct the study in Cukurova University Faculty of Medicine Research Hospital after obtaining ethics committee approval and patient's informed consent. Patients with cancer pain are allocated into two group to receive Patient Controlled Analgesia with morphine or morphine plus dexmedetomidine.

Eligibility criteria: Inclusion Criteria:

* patients with chronic cancer pain
* between 20-80 years old age

Exclusion Criteria:

* the presence of severe systemic disease(cardiac, pulmonary, hepatic or renal)
* psychiatric or neurologic disease
* unable to communicate verbally
* nausea and vomiting
* patient's refusal

Primary outcomes:
measure: Morphine consumption (mg)
timeFrame: 24 hours
Secondary outcomes:
measure: Pain score
timeFrame: 24 hours
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University Faculty of Medicine Research Hospital
Study officials:
affiliation: Cukurova University
name: Selcuk Gök, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blaudszun G, Lysakowski C, Elia N, Tramer MR. Effect of perioperative systemic alpha2 agonists on postoperative morphine consumption and pain intensity: systematic review and meta-analysis of randomized controlled trials. Anesthesiology. 2012 Jun;116(6):1312-22. doi: 10.1097/ALN.0b013e31825681cb.
citation: Lin TF, Yeh YC, Lin FS, Wang YP, Lin CJ, Sun WZ, Fan SZ. Effect of combining dexmedetomidine and morphine for intravenous patient-controlled analgesia. Br J Anaesth. 2009 Jan;102(1):117-22. doi: 10.1093/bja/aen320. Epub 2008 Nov 5.
Clinical trial NCT01130961: Management of Advanced Non-Small Cell Lung Cancer (NSCLC) and Clinical Outcomes in Patients Who Received Gefitinib in Thailand
Official title: Management of Advanced Non-Small Cell Lung Cancer and Clinical Outcomes in Patients Who Received Gefitinib (IRESSA) in Tertiary Care Setting in Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Advanced NSCLC
Gefitinib
Thai patient
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lung cancer patients admitted in Chulalongkorn and Siriraj hospitals between January 2004 and December 2008 and treated with gefitinib for at least 3 months

Brief summary: The purpose of this study is to determine progression-free survival of lung cancer patients who received gefitinib in clinical practice in Thailand.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as having lung cancer based on histological/cytological findings
* Admitted to the hospital between January 2004 and December 2008
* Treated with gefitinib for at least 3 months

Exclusion Criteria:

* Involvement in the planning and/or conduct of the study
* Participation in another clinical study during the last 3 months

Primary outcomes:
measure: Progression-free survival
timeFrame: median time from the first date of treatment until date of disease progression during Jan 2004- Dec 2008 or 5 years approx.
Secondary outcomes:
measure: Time to maximum response
timeFrame: Median time from the first date of treatment until the date that the disease can be maximum controlled during Jan 2004- Dec 2008 or 5 years approx.
measure: Overall survival
timeFrame: time from the first date of treatment until date of patients dead during Jan 2004- Dec 2008 or 5 years approx.
measure: Prevalence of EGFR & KRAS mutation from laboratory result
timeFrame: During Jan 2004- Dec 2008 or 5 years approx.
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Research Site
Study officials:
affiliation: Chulalongkorn Hospital, Bangkok, Thailand
name: Virote Sriuranpong, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Siriraj Hospital, Bangkok, Thailand
name: Vichien Srimuninnimit, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02802761: Nutritional Assessment Tool in Childhood Chronic Liver Disease
Official title: Nutritional Assessment Tool in Childhood Chronic Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Liver Disease
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Children (Age: 3 months to 18 years, corrected age upto 2 years for preterm children) with CLD attending Pediatric Hepatology OPD/IPD.

Brief summary: Study Cohort:

All Children (Age: 3 months- 18 years, corrected age upto 2 years for preterm children) with Chronic Liver Disease attending Pediatric Hepatology Out Patient Department/In Patient Department


Eligibility criteria: Inclusion Criteria:

1. Children from age of 3 months- 18 years (corrected age upto 2 years for preterm children)
2. Chronic liver disease.

Exclusion Criteria:

1. Any metabolic or endocrinal diseases independently affecting nutritional status
2. Refusal to give written informed consent to participate in the study

Primary outcomes:
measure: Reliability of SGNA versus nutritional status as assessed by standard anthropometric measures in children with chronic liver disease.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Seema Alam, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03820661: High Resolution Ultrasound in Pancreatic Ductal Adenocarcinoma
Official title: Advancing The Local Staging Of Pancreatic Ductal Adenocarcinoma Through High-Resolution Ultrasound: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Ductal Adenocarcinoma
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Pancreatic cancer patients at UHN who have had a CT at UHN and have surgery planned will undergo a high resolution ultrasound pre-operatively and intra-operatively. This study is being done to see if using high resolution ultrasound before and during surgery will help the doctors accurately diagnose pancreatic ductal adenocarcinoma and identify if the disease has spread to other areas of the body.


Eligibility criteria: Inclusion Criteria:

1. Males and females \> 18 y
2. PDAC diagnosed by typical imaging findings or pathology
3. Scheduled for surgical resection
4. Contrast enhanced CT scan performed locally at UHN

Exclusion Criteria:

1) Inability or unwillingness to provide informed consent

Primary outcomes:
measure: High-resolution U/S will be used to measure vascular invasion and regional lymph node metastases in PDAC
timeFrame: within 2 weeks of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: UHN
name: Korosh Khalili, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02013661: Clinical Evaluation of Sutures in Periodontal Surgery
Official title: Clinical Evaluation of Four Types of Suture in Periodontal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Debridement
Keywords: periodontal debridement
sutures
tissue reaction
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients treated at the CUO (dental clinic at the Universitat Internacional de Catalunya) that are prescribed for periodontal resective surgery

Brief summary: The aims of this study were to evaluate and compare tissue erythema, edema and knot loosening among four types of suture one week after periodontal surgery.

Detailed description: Forty patients participated in this prospective, randomized, double-blind clinical trial. Vertical mattress sutures were used following resective periodontal surgery performed by one operator. Four suture materials were selected for evaluation: 5-0 silk; 5-0 polypropylene; 5-0 polyglycolic acid (PGA), and 4-0 polytetrafluoroethylene (PTFE). Seven days after the surgical procedure, the surgeon assessed suture loosening and removed the sutures. A blind researcher clinically evaluated erythema and edema.

Eligibility criteria: Inclusion Criteria:

* Qualification for the study was based on the need for resective periodontal surgery (apically positioned flap and osseous recontouring) at four or more consecutive interproximal sites per quadrant

Exclusion Criteria:

* systemic diseases, such as diabetes, chronic obstructive pulmonary disease, or an immunologic disease that would affect wound healing; allergies to prescribed medication; and/or current pregnancy or breast feeding were excluded from the study

Primary outcomes:
measure: presence or absence of Suture loosening
timeFrame: seven days after surgery
Secondary outcomes:
measure: presence and level of erythema and edema.
timeFrame: seven days after surgery
Other outcomes:
Locations:
city: San Cugat del Valles
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Jose Nart, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: