louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06508645: Study to Evaluate the Safety/Tolerability, PK and PD After Intravenous DWJ1521 Administration in Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple-dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics After Intravenous DWP14012 Injection in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2024-07-18
Enrollment: 33
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind, placebo-controlled, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy volunteers


Eligibility criteria: Inclusion Criteria:

1. Healthy adults aged ≥ 19 and ≤ 50 years at screening
2. Subjects with a body weight of ≥ 55.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 and ≤ 28.0 at screening

   ☞ BMI(kg/m2) = weight (kg) / {Height (m)}2
3. Subjects who have given written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study
4. Subjects eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, investigator questioning, etc.

Exclusion Criteria:

1. Present or prior history of clinically significant hepatic, renal, nervous system, immune, respiratory, and endocrine diseases, hematologic and oncologic diseases, cardiovascular diseases, or mental diseases
2. Gastrointestinal diseases (gastric ulcer, gastritis, gastric cramps, gastroesophageal reflux, Crohn's disease, etc.) that may affect the safety and pharmacokinetic evaluation results of investigational drugs and those with a history of gastrointestinal surgery (except for appendix surgery and hernia surgery alone).
3. Helicobacter pylori positive.

Primary outcomes:
measure: AUC0-24h of Fexuprazan
timeFrame: Part1 for 8 days, Part2 for 5 days
measure: 24h pH monitoring, the ratio of the time remaining above pH 4, 6 (time%)
timeFrame: Part1 for 8 days, Part2 for 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul-National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Injin Jang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05341245: Graphene Oxide in the Surgical Management of Intrabony Periodontal Defects
Official title: Graphene Oxide in the Surgical Management of Intrabony Periodontal Defects: A Randomized Experimental Study With Histomorphometric Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 6
Sex: MALE
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using Graphene oxide in the surgical management of periodontal intrabony defects.

Detailed description: Evaluation of the effect of Graphene oxide in the surgical management of periodontal intrabony defects in animals in periodontal clinical parameters with histomorphometric evaluation .

Eligibility criteria: Inclusion Criteria:

* male dogs
* 12-24 months old with approximate weight of 20-30 kg and general good health will be used

Exclusion Criteria:

-

Primary outcomes:
measure: periodontal probing depth
timeFrame: 2 months
measure: Clinical attachment level
timeFrame: 2 month
Secondary outcomes:
measure: Histomorphometric evaluation
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00115947: Renal and Cardiovascular Effects of Terlipressin in Patients With Cirrhosis and Ascites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cirrhosis
Ascites
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2005-06-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to investigate the effect of terlipressin on myocardial perfusion and renal function.

Hypothesis: Significant improvement of renal function reflected by: glomerular filtration rate (GFR), renal blood flow (RBF), excretion of salt and metabolites in the urine and related hormones and peptides in the blood. No effect on the systolic function of the heart.


Eligibility criteria: Inclusion Criteria:

* Cirrhosis and ascites

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre Hospital
state: Hvidovre
Study officials:
affiliation: Hvidovre University Hospital
name: Aleksander Krag Krag, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01012947: Cognitive Health Promotion Project in the Community
Official title: Cognitive Health Promotion Project in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alteration of Cognitive Function
Dietary Modification
Keywords: MMSE
activity
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 1115
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was based on baseline data derived from a large prospective study called the Suwon Project (SP), a cohort comprising random clustering samples of elderly people, all of whom are ethnic Koreans aged over 60 years.

Detailed description: There is growing evidence supporting the protective effect of health behaviors against cognitive decline and dementia in older persons. With this increasing evidence and a better understanding of the underlying mechanisms, lifestyle modification is likely to be increasingly promoted as a convincing strategy for maintaining cognitive health in later life.

The study protocol included cognitive screening through the Korean version of the Mini-Mental State Examination (K-MMSE), which has been validated for the Korean-speaking population ({YW, 1997 #88}Kang YW et al., 1997), recording of the subject's medical history. A Korean study in the community defined the cut-off point of K-MMSE score during the screening of dementia as 17/18 points; the sensitivity and specificity of the findings were 91% and 86%, respectively ({YW, 1997 #88}Kim et al., 2003). Based on these results, we defined cognitive impairment (CI) as the group that had a K-MMSE score lower than 17, and not cognitive impairment (NCI) was defined as the group that had a K-MMSE score higher than 18.

Eligibility criteria: Inclusion Criteria:

* more than 60 years old

Exclusion Criteria:

* those with a history of significant hearing or visual impairment that rendered participation in the interview difficult
* those with a history of neurological disorders (e.g., stroke, Parkinson's disease, or active epilepsy)
* those with psychiatric illness (e.g., schizophrenia, mental retardation, severe depression, or mania)
* those taking psychotropic medications, or those with significant alcohol and other substance abuse.

Primary outcomes:
measure: Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group
timeFrame: baseline and 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ajou University
name: Chang Hyung Hong, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06716047: Effects of DL-endopeptidase Producing Probiotics on Human Intestinal NOD2 Ligands and Related Functions
Official title: Effects of DL-endopeptidase Produced by Probiotics on Human Intestinal NOD2 Ligands and Related Functions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intestinal Barrier Function
Keywords: probiotics
intestinal barrier
safty
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Probiotics are beneficial to human gut health. We found that a DL-endopeptidase producing probiotic could repair the intestinal barrier and regulate enteritis. Thus, a population-based trial was conducted.

Detailed description: This trial requires the subjects to take probiotics for a certain period of time, and we will collect blood, stool and questionnaires for subsequent testing, efficacy evaluation and safety evaluation.

Eligibility criteria: Inclusion Criteria:

* tend to participate the trial

Exclusion Criteria:

* severe digestive symptoms, such as severe vomiting, hematochezia, bloody or tarry stool within one month before intervention; antibiotics or laxatives or probiotics or intestinal antiulcer agent within one month before intervention; previous or current treatment for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, celiac, ulcerative colitis, etc.); other chronic diseases (diabetes, kidney disease, etc.) or immunecompromising diseases or conditions (HIV/AIDS, autoimmune, hepatitis, cancer, transplant patient etc.); pregnant or lactating.

Primary outcomes:
measure: NOD2 activation level
timeFrame: up to 2 or 6 months，compare to the baseline after intervention
measure: safty
timeFrame: up to 2 or 6 months，compare to the baseline after intervention
Secondary outcomes:
measure: Intestinal barrier
timeFrame: up to 2 or 6 months，compare to the baseline after intervention
Other outcomes:
Locations:
city: Canton
country: China
facility: Industrial Avenue 253, canton
state: Guangzhou
Study officials:
References:
Clinical trial NCT03874247: Clinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Traumatic Injury
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-14
Enrollment: 94
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind, placebo-controlled, parallel, multi-center phase III clinical trial


Eligibility criteria: Inclusion Criteria:

* Adult patient, ages over 19 years
* Patients with post traumatic acute pain within 48 hr(sprain/strain)
* Patient whose pain scale is over 50 mm(VAS score)

Exclusion Criteria:

* Patients with chronic pain
* Presence of a fracture or more than one injury
* Previous adverse reaction or known allergy to NSAIDs

Primary outcomes:
measure: SPID-D3
timeFrame: Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Seodaemun-gu
Study officials:
References:
Clinical trial NCT01885247: 4-10 Week Observational Study Comparing 3 Management Strategies for Obstructive Chronic BronchoPneumopathy (OCBP) in Common Clinical Practice
Official title: 4-10 Week Observational Study Comparing 3 Management Strategies for Obstructive Chronic BronchoPneumopathy (OCBP) in Common Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Chronic BronchoPneumopathy (OCBP)
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2013-06-24
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Obstructive Chronic BronchoPneumopathy (OCBP) stage ≥ 2

Brief summary: The management of patients with Obstructive Chronic BronchoPneumopathy (OCBP) is based on a progression of therapeutic options and on a sensitization to physical activity.

For these patients selected on OCBP stage 2, the treatment options include Long Acting Beta-Agonist Bronchodilator (LABA) or Long Acting Muscarinic Antagonist Anticholinergic (LAMA) or both (LAMA+LABA).

The purpose of this study is to observe in common clinical practice the benefit of physical activity on quality of life, dyspnoea and walking distance for these patients under treatment (LABA and/or LAMA) and to determine whether these 3 medical strategies (LABA/LAMA/LABA+LAMA) benefit from physical activity.


Eligibility criteria: Inclusion Criteria:

* Patients with Obstructive Chronic BronchoPneumopathy stage ≥ 2.
* Patients under treatment with LABA or LAMA or LABA+LAMA since at least 1 month.
* VEMS/CVF\<70%
* VEMS\<80%
* Patients without regular physical activity and without physical activity program since 1 year.

Exclusion Criteria:

* Patients under treatment with LABA + inhaled Corticoids.
* Contraindication to physical activity.
* Patients with previous history of respiratory exacerbations.

Primary outcomes:
measure: Change in quality of life after 4 to 10 weeks of physical activity program
timeFrame: Visit 1 before physical activity program and Visit 2 after 4 to 10 weeks of physical activity program
Secondary outcomes:
measure: Medical Research Council dyspnea scale (grade degree 0 to 4)activity
timeFrame: Grade degree of dyspnea will be evaluated one time before and after the physical activity program an expected average of 10 weeks.
measure: 6 Minute Walking Test (6MWT) (unit : meter)
timeFrame: 6MWT will be realized one time before and after the physical activity program an expected average of 10 weeks.
measure: Actimetry by accelerometer (unit : number of body movement)
timeFrame: Accelerometer will be installed one time before and after the physical activity program an expected average of 10 weeks.
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Gilles Devouassoux, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05210647: Robotic Assisted Colon and Rectal Surgery Prognostic and Outcome Analysis
Official title: Analysis of Surgical Outcome of Robotic Surgery Versus Conventional Laparoscopy Surgery. Retrospective Case Control Study in Single Institute.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Disorders
Keywords: robot, laparopscopy, MIS, surgical outcome, da Vinci Xi,
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 291
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From 2019.1.1 to 2022.1.8. Robot surgery team in department of colorectal surgery in TCVGH leaded by Surgeon A and B conducted 142 robot surgery using da Vinci Xi. Meanwhile, they also done 150 conventional laparoscopy surgery. The study compare the surgical outcome and relative prognostic factors between laparoscopy and robotic surgery.

Brief summary: To analysis surgical outcome between robotic and laparoscopy colon and rectal surgery. Retrospective case-control study of single institute.

Detailed description: Microinvasive surgery bring minor pain, faster recovery and comparable oncological outcome. Robotic surgery seems to be superior in precise dissection then before. This study compare robot assisted to laparoscopy surgery in colon and rectal disease. To analysis the surgical outcome and prognostic factors.

Eligibility criteria: Inclusion Criteria:

* for colon and rectal disease, using conventional laparoscopy and da Vinci Xi robot system.

Exclusion Criteria:

* emergent operation, combined other open surgery, for non-colorectal disease, carcinomatosis found to be unsuitable for surgery once peritoneum entered, taTME in laparoscopy group and other robot system in robotic surgery group.

Primary outcomes:
measure: surgical outcomes
timeFrame: 2019.1.1-2022.1.8
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References:
Clinical trial NCT02299947: Bloodtranfusions After Aortic Surgery
Official title: Comparison of a Single Dose Fibrinogen With Placebo and the Number of Blood Transfusions After Ascending Aorta Surgery (FIBTEG Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hemorrhage
Thoracic Aneurysm
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 27
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 answer the following question: Leads a primary coagulation corrected with a single dose of fibrinogen concentrate after ascending aorta-arc reconstruction to a decrease in the number of allogenic blood transfusions, compared to placebo?

Detailed description: Cardiothoracic surgery (CTC) is associated with blood loss and an increased risk for impaired coagulation by the use of a CBP. Coagulation is a process of primary hemostasis by adhesion of trombocytes and aggregation, followed by secondary coagulation and fibrin formation. During CTC fibrinogen is the first coagulation factor which reaches critical concentration necessary for clotting. Point of Care clotting assay with thromboelastography (TEG) provides qualitative information on coagulation factors and clot strength. Specific coagulation factor correction of impaired clotting improves clot strength and may reduces the number of perioperative allogeneic blood transfusions, resulting in possible reduction of postoperative blood loss and reduction of the risk of re-operation in the short and long term. The hypothesis of this study is that a single dose fibrinogen concentrate immediately after CTC leads to a decrease in the number of allogenic blood transfusions in patients with clinically impaired clotting, verified by TEG.

Eligibility criteria: Inclusion Criteria:

* Elective surgery for thoracic aneurysm

Exclusion Criteria:

* Prior trombosis or myocardial infarction, congenital coagulation disorder, use of anti-coagulants prior to surgery, prior thoracic surgery, pregnancy, pre-operative fibrinogen concentration \<1g/L

Primary outcomes:
measure: Number of transfused blood products
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Blood loss
timeFrame: 24 hours after surgery
measure: Re-operation
timeFrame: 30 day after surgery
measure: Mortality
timeFrame: 30 day mortality
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius hospital
state: Utrecht
Study officials:
affiliation: St. Antonius Hospital
name: Peter Noordzij, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01555047: Correlation Among Sperm DNA Fragmentation, Genitourinary Infection by Mycoplasma in Male and the Pregnancy Outcomes After IUI in Their Partner
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mycoplasma
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 200
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Genital ureaplasmas (Ureaplasma urealyticum and Ureaplasma parvum) and genital mycoplasmas (Mycoplasma hominis and Mycoplasma genitalium) are natural inhabitants of the male urethra contaminating the semen during ejaculation. However, these microorganisms, especially Ureaplasma urealyticum (Uu) and Mycoplasma hominis (Mh), are potentially pathogenic species playing an etiologic role in both genital infections and male infertility. Despite there are many consentaneous opinions about its relationship with infertility, its correlation with sperm regular parameters is still controversially. Sperm DNA damage can negatively influence fertilization rate, embryo cleavage rate, implantation rate, pregnancy and live birth rate, and is a novel indicator for intrauterine insemination (IUI) pregnancy rate and IVF or ICSI pregnancy loss rate. Until now, there were fewer clinical researches about the relationship among Uu and/or Mh infection, sperm DNA damage, and the IUI pregnancy rate. Thus, the investigators conduct this prospective study to investigate the relationship among them.


Eligibility criteria: Inclusion Criteria:

* Male with primary sterility with or without mycoplasma infection

Exclusion Criteria:

1. Combination with chlamydial infection
2. History of using hormone or cytotoxic drugs.
3. Having some other surgical diseases, such as genital tract infection or varicocele
4. Having some congenital diseases, such as Klinefelter and Y chromosome deficiency
5. Having some endocrine diseases, such as Kallmann, abnormality in pituitary gland, hyperthyroidism, hypercorticoidism, and so on
6. Patients' spouse had some diseases that could not carry out spontaneous pregnancy, such as tubal obstruction or ovulatory failure.

Primary outcomes:
measure: pregnancy rate
timeFrame: up to 3 monthes after IUI
Secondary outcomes:
measure: sperm DNA fragmentation index (DFI)
timeFrame: one month before IUI
Other outcomes:
Locations:
Study officials:
References: