louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06269406: A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults
Official title: A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults, Randomized, Double- Blind, Parallel-Group, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Pain
Keywords: Postoperative Dental Pain
Curcumin and Licorice Root
Ibuprofen
Anti-inflammatory Properties
molars
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: NMSI DENTMASTER
First posted: 2024-02-21
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dental pain, a common issue in stomatology, requires a multifaceted treatment approach. This study explores the efficacy of combining Ibuprofen with curcumin and liquorice root supplements for managing postoperative dental pain. Curcumin, known for its antioxidant and anti-inflammatory properties, along with liquorice root, may enhance pain relief beyond conventional NSAIDs like Ibuprofen. This randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of this combination therapy in adults undergoing the removal of impacted third molars. Participants, aged 18-85, were divided into groups receiving different doses of Ibuprofen and curcumin with liquorice root, compared to a control group receiving Ibuprofen and placebo. The primary outcome is the sum of pain intensity differences over 8 hours, with secondary outcomes including total pain relief and the occurrence of any adverse events. The anticipated sample size, considering a 20% dropout rate, is 264 participants, ensuring the study is powered to detect significant differences in pain management efficacy.


Eligibility criteria: Inclusion Criteria:

* Removal of 2 to 4 impacted third molars

Exclusion Criteria:

* Pregnancy or breastfeeding
* Ibuprofen contraindications.
* Allergy to any of the intervention components.

Primary outcomes:
measure: Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points)
timeFrame: 8 hours
Secondary outcomes:
measure: Total pain relief (TOTPAR) %
timeFrame: 8 hours
measure: Time to pain half pain gone (in minutes)
timeFrame: 8 hours
measure: Duration of pain half gone (in minutes)
timeFrame: 8 hours
measure: Any adverse events (facial swelling, nausea, vomiting, headache) (%)
timeFrame: 8 hours
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Nmsi Dentmaster
state: Novosibirsk Region
Study officials:
References:
Clinical trial NCT02646306: A New Shoulder Proprioceptive Rehabilitative Tool (SRPT) for the Evaluation of the Role of the Shoulder During Reaching
Official title: A New Neurocognitive Interpretation of the Shoulder Position Sense During Reaching
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Impingement Syndrome
Keywords: shoulder
proprioception
movement
reaching
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 44
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects affected by shoulder impingement syndrome and healthy subjects.

Brief summary: The aim of the study focused on the creation of a rehabilitative measuring device (SRPT-shoulder proprioceptive rehabilitation tool) and the development of the examination methodology for assessing the proprioception of the glenohumeral joint respect to scapula abduction, within the movement of antepulsion on the sagittal plane both in healthy subjects and in patients with shoulder impingement syndrome.


Eligibility criteria: Inclusion Criteria:

* Right-handed
* Diagnosis of subacromial right impingement syndrome performed by the orthopedic specialist (nuclear magnetic resonance and/or ultrasound examination)
* Neer stages 1, 2 and 3
* Presence of pain 3 \<VAS\<8 at baseline
* Age between 55 and 65 years.

Exclusion Criteria:

* Diabetes mellitus
* Inflammatory systemic diseases
* CNS and/or PNS diseases
* Systemic infectious diseases
* Neoplastic diseases
* Assumption of antidepressants and/or anxiolytics and/or other medications that can affect attention and sensory
* Visual problems not properly compensated
* Previous surgery to the shoulder

Primary outcomes:
measure: Evaluation of the Visual Analogue Scale (VAS) at baseline
timeFrame: baseline
Secondary outcomes:
measure: Evaluation of the short form of the Disabilities of the Arm, Shoulder and Hand questionnaire (Quick-DASH) at baseline
timeFrame: baseline
measure: Evaluation of the Constant-Murley shoulder outcome score at baseline
timeFrame: baseline
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Umberto I Hospital
Study officials:
affiliation: Umberto I Hospital, University "Sapienza" of Rome
name: Vincenzo Maria Saraceni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03020706: Effect of Magnesium Sulphate on Neostigmine
Official title: Effect of Magnesium Sulphate on Neostigmine-induced Reversal of Neuromuscular Block by Rocuronium
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuromuscular Blockade
Keywords: magnesium sulphate
neostigmine
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
First posted: 2017-01-13
Enrollment: 166
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the effect of magnesium sulphate on neostigmine-induced reversal of neuromuscular block by rocuronium

Detailed description: Comparison of reversa time by neostigmine in magnesium group and control group

Eligibility criteria: Inclusion Criteria:

* ASA status 1 or 2
* patients undergoing surgery for more than 60 min under general anesthesia

Exclusion Criteria:

* electrolyte abnormalities
* medication on aminoglycoside, antiepileptic drug, magnesium
* underweight or obesity (BMI \<18.5 or \>30)
* renal insufficiency (Cr\>1.4 mg/dl)
* AV block
* neuromuscular disease (ex: Myathenia gravis)

Primary outcomes:
measure: reversal time
timeFrame: through study completion, an average of 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyungi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sang-Hwan Do, MD, Ph D
role: STUDY_CHAIR
References:
Clinical trial NCT01322906: Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by Hepatitis B Virus (HBV)
Official title: Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by HBV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Failure
Keywords: ABMLF
Allogenic Bone marrow Mesenchymal Stem Cells
Liver Failure
Transplantation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2011-03-25
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients with Liver Failure Caused by hepatitis B virus (HBV)


Eligibility criteria: Inclusion Criteria:

* Liver failure caused by HBV
* Model for End-Stage Liver Disease (MELD) \< 30

Exclusion Criteria:

* Liver Failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on.
* History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment.
* Severe problems in other vital organs (e.g.the heart,renal or lungs).
* Tumor on ultrasonography, CT or MRI examination.
* Pregnant or lactating women.
* HIV infection.

Primary outcomes:
measure: Liver Function
timeFrame: 12months
measure: Immune state
timeFrame: 12months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04965506: A Study of IBI362 in Chinese Patients With Type 2 Diabetes
Official title: A Randomized Phase II Study to Evaluate the Efficacy and Safety of IBI362 Versus Placebo and Dulaglutide in Chinese Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-16
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 efficacy and safety of IBI362 in Chinese patients with Type 2 Diabetes.


Eligibility criteria: Inclusion Criteria:

1. Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (WHO 1999)
2. T2D patients with poorly controlled blood glucose treated with lifestyle intervention or stable dose of metformin (≥ 1000mg/day or maximum tolerated dose) within 3 months prior to screening.
3. Have HbA1c of 7.0% to 10.5%, inclusive(detected by local laboratory at screening).
4. Have a body mass index (BMI) between 20(Inclusive) and 40 kilograms per square meter

Exclusion Criteria:

1. Type 1 diabetes, special types of diabetes, or gestational diabetes.
2. Have uncontrolled diabetes defined as more than 2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening.
3. History of severe hypoglycemic episodes within 6 months prior to screening.
4. Have had any of the following within the last 6 months prior to screening: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted),transient ischemic attack (TIA), cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure.

Primary outcomes:
measure: The change in HbA1c from baseline to 20 weeks
timeFrame: Baseline,20 weeks
Secondary outcomes:
measure: Percentage of Participants Achieving HbA1c Target of <7.0%
timeFrame: Baseline,20 weeks
measure: Number of participants with treatment-related adverse events
timeFrame: Baseline,25 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Japan Friendship Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05115006: A Study of Adjuvant Melanoma Stakeholder Treatment Preferences
Official title: Adjuvant Melanoma Stakeholder Treatment Preference Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: Melanoma
Discrete choice experiment
Resected melanoma
Adjuvant treatment
Patient preference
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-11-10
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is to include 350 adult participants from the US, Australia, UK, Germany, France, Spain, and Italy who self-report to have stage IIb, IIc, or III melanoma and who have had surgery for melanoma within 12 months.

Brief summary: The purpose of this study is to understand the trade-offs that participants with surgically treated melanoma would be willing to make among key features and outcomes of adjuvant anti-cancer treatments or no adjuvant treatment / observation.


Eligibility criteria: Inclusion Criteria:

* Self-reported medical diagnosis of stage II or stage III melanoma
* Have been resected (had surgery) for their melanoma within 12 months prior to study participation

Exclusion Criteria:

* Self-reported stage IIa
* Self-reported recurrence of melanoma after surgery

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Preference weights or utilities (a measure of relative preference; on a continuous variable scale) for each treatment attribute level based on responses to the Discrete Choice Experiment (DCE) choice tasks
timeFrame: At Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03887806: Cost Effectiveness Analysis of an Ancillary Study of the REMOTEV Study
Official title: Efficacy Cost Analysis: Retrospective Study on the REMOTEV Study's Ancillary Data
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Venous Thromboembolic Disease
Keywords: Venous
Thromboembolic
Direct Oral Anticoagulants
AOD
Cost analysis
REMOTEV
AVK
Pulmonary embolism
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with a diagnosis of MTEV: pulmonary embolism or deep vein thrombosis diagnosed by the diagnostic reference methods according to the recommendations

Brief summary: The implications of the medico-economic impact are essential in the choice of first-line therapists. The economic impact is an important criterion to recommend the privileged use of Direct Oral Anticoagulants (AOD) in first intention.


Eligibility criteria: Inclusion criteria

* Major patient whose age is ≥18 years
* Patient with a diagnosis of MTEV: pulmonary embolism or deep vein thrombosis diagnosed by the diagnostic reference methods according to the recommendations
* Major patient included in the REMOTEV registry
* Patient having accepted that his data recorded in the REMOTEV register be re-used for research and publication purposes

Criteria of non-inclusion

* Refusal to participate in the REMOTEV register
* Patient who refused to have his data reused for research and publication purposes
* Pregnant woman
* Subjects under safeguard of justice Subject under guardianship or curatorship

Primary outcomes:
measure: Cost-effectiveness analysis between 2 therapeutic strategies, Direct Oral Anticoagulants (Rivaroxaban) versus standard anticoagulant (AVK)
timeFrame: The period from November 1st, 2013 to July 01, 2015 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Des Maladies Vasculaires - Hta - Nhc
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Dominique STEPHAN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03200106: Retrospective Study in the Use of the Alfapump and the Treatment of Malignant Ascites
Official title: Retrospective Study in the Use of the Alfapump and the Treatment of Malignant Ascites
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Ascites
Lead sponsor: Sequana Medical N.V.
Sponsor class: INDUSTRY
First posted: 2017-06-27
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of up to 20 patients' charts who have previously been treated with alfapump will be reviewed.

Brief summary: Treatment of malignant ascites with the alfapump offers a new treatment option for this patient group. So far, there is no systematic analysis of patients with this indication available in the literature.

This retrospective analysis offers the possibility to assemble already existing data within a reasonably short time frame. Based on this analysis, a prospective analysis can be designed.


Eligibility criteria: Inclusion Criteria:

* Patients with malignant ascites
* Patients with alfapump implanted for malignant ascites
* Patients 18 years or older at the time of death

Exclusion Criteria:

* Patient is alive at the time of inclusion assessment

Primary outcomes:
measure: Change in frequency of LVP after implantation of the alfapump
timeFrame: 3-6 months post implant
Secondary outcomes:
measure: The safety and tolerability of alfapump in patients with malignant ascites
timeFrame: 3-6 months post implant
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Bern
country: Switzerland
facility: Inselspital
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: Sequana Medical
name: Jeroen Capel, MSc
role: STUDY_DIRECTOR
affiliation: Hammersmith Hospitals NHS Trust
name: Christina Fotopoulou, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fotopoulou C, Berg T, Hausen A, Hennig R, Jalan R, Malago M, Capel J, De Gottardi A, Stirnimann G. Continuous low flow ascites drainage through the urinary bladder via the Alfapump system in palliative patients with malignant ascites. BMC Palliat Care. 2019 Dec 5;18(1):109. doi: 10.1186/s12904-019-0497-3.
Clinical trial NCT02011906: The Effects of Omega 3 and Vitamin E Supplementation on the Serum Antioxidant Enzymes and Gene Expressions of PGC-1a, h TERT, FOXOs and SIRTs in CAD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: antioxidant enzymes
omega 3
vitamin E
CAD
Sirtuins
FOXOs
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 20
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effects of omega 3 supplementation and its concurrent supplementation with vitamin E on the serum levels of antioxidant enzymes and the expressions of the PGC-1a, h TERT, FOXO1, FOXO3a , SIRT1,SIRT3, SIRT6 genes in PBMC cells in the patients with coronary artery disease


Eligibility criteria: Inclusion Criteria:

-

literate, willingness to participation, CAD patients 45- 65 years old, body mass index\< 30, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention, willing to maintain body weight during the study

Exclusion Criteria:

* people who have used vitamin E or omega 3 supplements in last 3 months, having chronic renal disease ,cancer, Hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, diabetes, treatment with PPAR-gamma agonists or Thiazolidinediones, Smokers

Primary outcomes:
measure: serum total cholesterol
timeFrame: change from baseline at 2 months
measure: serum HDL cholesterol
timeFrame: change from baseline at 2 months
measure: serum triglycerides level
timeFrame: change from baseline at 2 months
measure: serum LDL cholesterol
timeFrame: change from baseline at 2 months
measure: serum insulin
timeFrame: change from baseline at 2 months
measure: serum Hs-CRP
timeFrame: change from baseline at 2 months
measure: serum gluthatione peroxidase
timeFrame: change from baseline at 2 months
measure: serum catalase
timeFrame: change from baseline at 2 months
measure: serum superoxide dismutase
timeFrame: change from baseline at 2 months
measure: serum total antioxidant capacity
timeFrame: change from baseline at 2 months
Secondary outcomes:
measure: gene expression of SIRT1
timeFrame: change from baseline at 2 months
measure: gene expression of SIRT3
timeFrame: change from baseline at 2 months
measure: gene expression of SIRT6
timeFrame: change from baseline at 2 months
measure: gene expression of PGC-1a
timeFrame: change from baseline at 2 months
measure: gene expression of FOXO3a
timeFrame: change from baseline at 2 months
measure: gene expression of FOXO1
timeFrame: change from baseline at 2 months
measure: gene expression of h TERT
timeFrame: change from baseline at 2 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
References:
Clinical trial NCT05745506: Effect of Sleep Disorder on the Development of Lung Tumors
Official title: Effect of Sleep Disorder on the Development of Lung Tumors, a Perspective, Single-centered Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sleep Disorder, Lung Tumor
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are 18-75 years old man or women diagnosed with primary lung tumor.

Brief summary: The goal of this observational study is to observe the lung tumor development in lung tumor patients with long-term sleep disorder. The main questions it aims to answer are:

* will long-term sleep disorder promote the malignancy of lung tumor
* if so, how exactly will the microenvironment of lung tumor change Participants will receive PSQI scale and MRI functional brain imaging before surgery, blood and tumor tissue will be collected during the surgery.

Researchers will set non-sleep disorder group as control group to see if lung tumor microenvironment change when long-term sleep disorder exists in lung tumor patiens.


Eligibility criteria: Inclusion Criteria:

* 18-75 years old
* elective sublobectomy for primary lung tumor
* ASA grade I-II
* Informed consent of the patient or family

Exclusion Criteria:

* Combination of serious heart, liver, kidney, central nervous system, blood system, immune system diseases or serious mental illness
* Combination of other cancers
* untreated active lung infection
* patients with preoperative neoadjuvant radiotherapy

Primary outcomes:
measure: tumor microenvironment in sleep-disordered lung cancer patients
timeFrame: 3 months after surgery
Secondary outcomes:
measure: peripheral blood levels of neurotransmitters in sleep-disordered lung cancer patients
timeFrame: 3 months after surgery
measure: Functional brain imaging in sleep-disordered lung cancer patients
timeFrame: 3 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology, Renji Hospital, Shanghai Jiaotong University School of Medicine
name: Weifeng Yu
role: STUDY_DIRECTOR
References: