louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02827435: Acute Pharmacokinetic-pharmacodynamic Change of Rocuronium After Reperfusion of Renal Graft
Official title: Acute Pharmacokinetic-pharmacodynamic Change of Rocuronium After Reperfusion of Renal Graft During Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease
Transplantation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Reperfusion of renal graft in kidney transplantation can change the pharmacokinetic-pharmacodynamic (PKPD) parameters of rocuronium. The immediate increase of urine output during surgery may change the PKPD parameters of the drugs, including elimination rate. The goal of this study is to characterize the PKPD model of rocuronium during kidney transplantation and establish a basis for adequate dosage of rocuronium in kidney transplantation.

Through PKPD modeling, the changes during reperfusion of the renal graft will be evaluated. Furthermore, the factors related to the changes will be assessed. Adjusting the infusion rate according to the step of kidney transplantation will lead to stable muscle relaxation and fast recovery.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for elective living donor kidney transplantation
* end stage renal disease with oliguria or anuria
* normal BMI (BMI 18.5 \~ 25)
* obtained informed consent

Exclusion Criteria:

* patient with underlying neuromuscular disease

Primary outcomes:
measure: rocuronium plasma concentration (mcg/ml)
timeFrame: 0, 1, 3, 5, 10, 30, 60, 90, 120 minutes after rocuronium second bolus injection
measure: acceleromyography data (TOF ratio %)
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chul-Woo Jung, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03571035: The Vision System for Mandibular Trajectory Assessment in Women With Mild Temporomandibular Joint Disorder
Official title: Presentation of Light and Affordable Vision System for Mandibular Trajectory Assessment in Women With Mild Temporomandibular Joint Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mandibular Deviation
Keywords: Mandibular deviation
mandibular movement recording
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Recording mandibular movements plays an important role in stomatognathic system diagnosis and has been the subject of numerous research projects. This study presents theoretical assumptions and a practical solution in the form of a novel method of mandibular motion assessment.

Detailed description: In the presented method, mandibular movements are recorded by a mono vision system where a digital camera is fixed on a special extension arm attached to patient's head. During movement the camera records changing positions of two markers placed on two selected two points on a patient's face. With such data, it possible to assess the absolute range of mandibular abduction as well as displacements from optimal trajectory occurring during movement, which indicative of stomatognathic dysfunctions.

Eligibility criteria: Inclusion Criteria:

* temporomandibular joint disorder
* qualitative and quantitative impairments of mandibular movements

Exclusion Criteria:

* no impairments of mandibular movements

Primary outcomes:
measure: Range of mandibular abduction [mm]
timeFrame: about 2 minutes
measure: Maximum displacement in frontal plane [mm]
timeFrame: about 2 minutes
measure: Normalized displacement in frontal plane [mm^2/s]
timeFrame: about 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Poznań University of Medical Sciences
name: Przemysław Lisiński, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06961435: An Analysis of the Relationship Between the Genetic Polymorphisms of Plasminogen Activator Inhibitor-1 and Ulcerative Colitis in Chinese Patients
Official title: An Analysis of the Relationship Between the Genetic Polymorphisms of Plasminogen Activator Inhibitor-1 and Ulcerative Colitis in Chinese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colitis, Ulcerative
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: There was no statistically significant difference in the gender ratio, average age, and proportion of smokers between UC group and normal control group. All study subjects are from the Zhejiang Han population who are not related by blood

Brief summary: From January 2019 to February 2025, diagnosed ulcerative colitis(UC) patients and gender- and age-matched normal controls were enrolled from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Our study aimed to explore the associations of plasminogen activator inhibitor-1 (PAI-1) gene polymorphisms with the risk and clinicopathological characteristics of UC, and to analyze the effects of PAI-1 gene variations on the clinical response of vedolizumab (VDZ) treatment in UC patients.

Detailed description: From January 2019 to February 2025, diagnosed ulcerative colitis(UC) patients and gender- and age-matched normal controls were enrolled from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Genotypes of PAI-1 were determined by multiplex polymerase chain reaction-ligase detection reaction technique. Chi-square test and unconditional logistic regression model were used to analyze the difference in distribution of PAI-1 gene polymorphisms between UC group and normal control group, as well as the effects of PAI-1 gene variations on the clinicopathological characteristics and 14-week clinical response to VDZ treatment of UC patients.

Eligibility criteria: Inclusion Criteria:

* diagnosed UC based on comprehensive clinical, colonoscopy, histopathological, laboratory, and radiographic examination results

Exclusion Criteria:

* rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc.

Primary outcomes:
measure: Genotypes of PAI-1
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: the Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
Clinical trial NCT04713163: COVID-19 Vaccine Induced Immunity
Official title: Prospective Evaluation of COVID-19 Vaccine Induced Immunity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Canada (PHAC)
name: Cadham Provincial Lab
First posted: 2021-01-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers eligible to receive Covid-19 vaccines

Brief summary: This study aims to address the following three objectives:

1. Longitudinal evaluation of the development of CMI responses in response to SARS-CoV-2 Vaccine: T cells isolated from the blood of COVID-19 vaccine recipients will be evaluated for their functionality in response to vaccine antigens. The temporal and functional properties of CMI responses will be correlated with the humoral or antibody responsiveness. CMI responses will be measured in vaccine recipients prior to vaccination to determine whether the presence or functionality of pre-existing responses to common cold coronaviruses (CCCs) or previous SARS-CoV-2 infections affect the development of CMI responses to the COVID-19 vaccine.
2. Identification of cellular and soluble factors that influence vaccine responsiveness:

   While it is known that poor clinical outcomes in COVID-19 patients are strongly associated with markers of systemic inflammation, the influence these systemic markers will have on COVID-19 vaccine responsiveness is not clear. Using systems biology approaches, the investigators will perform comprehensive profiling of cellular immune subsets, inflammatory signatures to identify determinants influencing the development of CMI responses to vaccine.
3. Examine variability of immune and viral genes and their relationship to vaccine induced immune responses: Human leukocyte antigen (HLA), T cell receptor (TCR) and B cell receptor (BCR) proteins are highly genetically diverse and critical to development of protective immunity. The investigators will perform HLA sequencing on whole blood-derived DNA samples and TCR and BCR sequencing on sorted, SARS-CoV2 vaccine antigen-specific T cells and B cells, respectively, to assess how different sequence combinations impact the CMI responses to vaccine.


Eligibility criteria: Inclusion Criteria:

* all individuals eligible to receive one of the approved SARS-CoV-2/COVID-19 vaccines.

Exclusion Criteria:

* individuals under 18 years of age

Primary outcomes:
measure: Nasal T cell responses
timeFrame: Change from Baseline to 12 days post second vaccine dose
measure: Systemic T cell responses
timeFrame: Change from Baseline to 12 days post second vaccine dose
measure: Systemic and nasal antibody responses
timeFrame: Change from Baseline to 12 days post second vaccine dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06786663: MALE Mamm Organoids
Official title: Feasibility Study for the Generation of Organoids From Male Breast Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasms, Male
Keywords: Organoids
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: San Giovanni Addolorata Hospital
name: Weizmann Institute of Science, Israel
name: S. Andrea Hospital
First posted: 2025-01-22
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male breast cancer (MBC)

Brief summary: It is believed that the use of organoids derived from male breast tumors can be of fundamental support for the definition of the molecular mechanisms underlying the onset of the tumor. Furthermore, the development of such preclinical models could be of significant support for the identification of specific personalized and ad hoc therapeutic treatments for male pathology.

Detailed description: The main objective of the project is to set up at least 5 organoid cultures of male breast cancer derived from patients who have undergone surgery. This study will allow to define the success rate in the generation of organoids.

A secondary objective is to verify the correspondence between the organoids generated and the tumor tissue of origin.

In this regard, broad-spectrum molecular investigations will be carried out, such as mutational analysis of DNA through Whole Exome Sequencing (WES), gene expression profiles through RNA sequencing (RNAseq) and small RNA sequencing, proteomic and metabolomic analysis of both the tumors of origin and the cultures of derived organoids (PDO).

Furthermore, to verify the functional correspondence of the organoids with the tumor of origin, in vitro viability tests will be carried out by treating the PDOs with the same drugs administered to the patients.

Eligibility criteria: Inclusion Criteria:

* Men aged \>18 years
* Patients with histologically confirmed breast cancer with or without synchronous metastases, who will undergo the relevant surgical intervention
* Adequate biological material to be able to carry out the analyses described above
* Signing of the relevant informed consent form

Exclusion Criteria:

not present

Primary outcomes:
measure: Tumor tissue samples collected
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS National Cancer Institute "Regina Elena"
Study officials:
References:
Clinical trial NCT01884363: Walnut Consumption, Endothelial Function, and Biomarkers
Official title: Walnut Consumption, Endothelial Function, and Plasma Adipokines in Subjects With Diabetes or Coronary Disease: a Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Type 2 Diabetes
Keywords: Endothelial function
walnuts
clinical trial
Nutrition
cardiovascular disease
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 26
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will examine whether a twelve-week intervention with one ounce (28 g) per day of walnuts improves endothelial function measured non-invasively using finger probe (EndoPat-2000) in people with coronary heart disease or type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Age 30+ years
* Prevalent coronary artery disease
* Prevalent type 2 diabetes

Exclusion Criteria:

* Current eating disorder
* Pregnant or lactating women
* Allergy to walnuts or other nuts
* Inability to provide informed consent or blood samples
* History or prevalent diagnosis of cancer, asthma, kidney insufficiency, stroke, seizures, allergic disorders, or congestive heart failure
* Diagnosis of coronary heart disease or diabetes \< 1 year prior to enrollment
* Intention to move out of greater Boston area within one year
* Current use of walnuts for more than 2 ounces per day
* Bleeding disorder
* Treatment with blood thinning drugs (i.e. warfarin, clopidogrel)
* Major surgical operation 3 months before or after screening
* Organ transplantation
* Current participation in another trial or plan to do so during the study
* Use of vasodilators such as nitroglycerin
* Inability to give informed consent
* Inability to travel to the study center at Brigham and Women's Hospital

Primary outcomes:
measure: Change in reactive hyperemia index occurring between baseline and 12 weeks (end of intervention)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in blood levels of hormones produced by fat cells between baseline and 12 weeks (end of intervention)
timeFrame: 12 weeks
Other outcomes:
measure: Change in heart rate variability between baseline and 12 weeks post-intervention
timeFrame: 12 weeks
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Luc Djousse, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Djousse L, Lu B, Gaziano JM. Effects of Walnut Consumption on Endothelial Function in People with Type 2 Diabetes: a Randomized Pilot Trial. Curr Nutr Rep 2016;5:1-8
Clinical trial NCT04373863: Assessment of Lifestyle, Blood Pressure, Cholesterol and Glycated Hemoglobin in a Specific Population
Official title: Let's Get to Know Your Health Better? Assessment of Lifestyle, Blood Pressure and Cholesterol in the Population of Employees Libbs Farmacêutica LTDA.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholesterol; Lipidosis
Arterial Hypertension
Blood Glucose, High
Keywords: glycated hemoglobin
Cholesterol
Arterial Hypertension
smoking
Lead sponsor: Libbs Farmacêutica LTDA
Sponsor class: INDUSTRY
First posted: 2020-05-05
Enrollment: 2472
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This research project will be conducted during various internal and external institutional events, and in specific actions carried out at Libbs units located in Barra Funda (administrative unit) and in the city of Embu das Artes (production unit).

Brief summary: The project Shall we get to know your health better? Lifestyle assessment, blood pressure and cholesterol in the population of Libbs Farmacêutica employeesLTDA.; consists of a study that will bring knowledge and enable quantificationof risk factors related to cardiovascular diseases in this population above mentioned.

Detailed description: The social relevance of this study is related to the knowledge and quantification of eating habits and lifestyles related to cardiovascular diseases in the population of employees, also referred to in this document as "employees", from Libbs Farmacêutica Ltda. Based on an observation and statistical analysis of the data obtained in this study, internal policies will be promoted that aim to improve eating habits, physical activity and decrease smoking.

Eligibility criteria: Inclusion Criteria:

* Being an employee Libbs Farmacêutica Ltda;

Exclusion Criteria:

* not applicable

Primary outcomes:
measure: Descriptive questionnaire
timeFrame: until December 2020
Secondary outcomes:
measure: Prevalence of hypercholesterolemia and arterial hypertension
timeFrame: until December 2020
measure: Glycated hemoglobin (HbA1c) values
timeFrame: until December 2020
measure: Data correlation
timeFrame: until December 2020
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Augusto Theodoro de Figueiredo
Study officials:
References:
Clinical trial NCT01223963: Macrolane Retrospective Study
Official title: A Multi-center Retrospective Chart Review of Medical Records on the Use of Macrolane Volume Restoration Factor for Breast Enhancement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Women Who Have Had Breast Enhancement With Macrolane VRF
Keywords: Macrolane
Retrospective
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2010-10-19
Enrollment: 93
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women that have had breast enhancement in clinics in Sweden (and UK).

Brief summary: This is a retrospective, multicenter chart review of medical records on the use of Macrolane for female breast enhancement.

The primary objective is to evaluate the safety profile of Macrolane Volume Restoration Factor 20 and Macrolane Volume Restoration Factor 30 when used for female breast enhancement in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Females treated with Macrolane Volume Restoration Factor 20 and/or Volume Restoration Factor 30 for breast enhancement.
* Signed Informed Consent

Exclusion Criteria:

* Subjects that have actively asked not to be contacted by the clinic
* Subjects that have participated or participates in clinical studies with Macrolane for breast enhancement

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 01may2008 - 31dec2009
Secondary outcomes:
Other outcomes:
measure: Number of Participants Who Reported Being at Least Somewhat Satisfied at Any Tine Post-procedure
timeFrame: up to 12 months post-procedure
Locations:
city: Göteborg
country: Sweden
facility: Stureplanskliniken
city: Malmö
country: Sweden
facility: Akademikliniken
city: Stockholm
country: Sweden
facility: Stureplanskliniken
city: Stockholm
country: Sweden
facility: Akademikliniken
Study officials:
affiliation: Akademikliniken
name: Per Hedén, Md PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02538263: Volume-targeted Versus Pressure-limited Noninvasive Ventilation in Patients With Acute Hypercapnic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Hypercapnic Respiratory Failure
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 58
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: Volume-targeted noninvasive ventilation (VT-NIV), a hybrid mode that targets a preseted tidal volume (VT) by automated adjustment of pressure support, could guarantee the delivered VT over pressure-limited noninvasive ventilation (PL-NIV) with fixed level pressure support. Whether VT-NIV is more effective in improving gas exchange in patients with acute hypercapnic respiratory failure (AHRF) as compared with PL-NIV remains unclear. Our aim was to verify whether in comparison with PL-NIV, use of VT-NIV was more effective in correcting hypercapnia, hence reducing the need for intubation and improving survival in patients with AHRF.


Eligibility criteria: Inclusion Criteria:

* acute hypercapnic respiratory failure (AHRF)
* arterial pH \<7.35 and ≥7.25
* PaCO2 \>45 mmHg

Exclusion Criteria:

* age \<18 years
* excessive amount of respiratory secretions or weak cough
* upper airway obstruction
* recent oral, facial or cranial trauma or surgery
* recent gastric or esophageal surgery
* severe metabolic acidosis; severe abdominal distension
* cardiac or respiratory arrest
* PaO2/FiO2 \<150 mmHg
* pneumothorax
* severe ventricular arrhythmia or myocardial ischemia
* severe hemodynamic instability despite fluid repletion and use of vasoactive agents
* active upper gastrointestinal bleeding
* lack of cooperation
* refusal to receive NIV

Primary outcomes:
measure: The decrease of arterial partial pressure of carbon dioxide (PaCO2) values from baseline to 6 hours after randomization
timeFrame: 6 hours after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical University
Study officials:
References:
citation: Cao Z, Luo Z, Hou A, Nie Q, Xie B, An X, Wan Z, Ye X, Xu Y, Chen X, Zhang H, Xu Z, Wang J, An F, Li P, Yu C, Liang Y, Zhang Y, Ma Y. Volume-Targeted Versus Pressure-Limited Noninvasive Ventilation in Subjects With Acute Hypercapnic Respiratory Failure: A Multicenter Randomized Controlled Trial. Respir Care. 2016 Nov;61(11):1440-1450. doi: 10.4187/respcare.04619. Epub 2016 Oct 18.