louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03090542: GPur- Luminating Oral Cholesterol Kinetics Pilot Study
Official title: 39 Day Randomized, Open Label, Two Arm Cross Over Study of Clinoptilolite (Gpur) in Healthy Adult Subjects Not Requiring or Receiving Lipid Lowering Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholesterol Absorption
Lead sponsor: Canadian Collaborative Research Network
Sponsor class: OTHER
Collaborators: name: GLOCK HEALTH, Science and Research, G.m.b.h.
First posted: 2017-03-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In healthy subjects not receiving or requiring lipid lowering therapy and who do not have diabetes, the use of clinoptilolite (GPUR) will result in a reduction of absorbed dietary cholesterol observed over 6 days of therapy.


Eligibility criteria: Inclusion Criteria:

* Adults over 18 years of age
* Not receiving or requiring lipid lowering therapy
* Willingness to give informed consent
* Able to keep a dietary log
* Willing to maintain a consistent day to day routine during the study (no major changes in lifestyle, exercise, food pattern, smoking habits, etc)

Exclusion Criteria:

* Current use of oral lipid binding agents (colesevelam, cholestyramine, ezetimibe) fibrates, niacin or statins
* Current use of dietary supplements enriched with fat soluble vitamins, mono/polyunsaturated fat (fish-oil etc.) or probiotics
* Any oral antibiotic use, currently or within the past 14 days
* Diabetes, Type I and Type II
* Currently following a restrictive diet
* GI motility disorders (irritable bowel syndrome, diabetic gastroparesis, etc)
* Prior gastric or bowel resection
* Inflammatory bowel disease (Crohns, ulcerative colitis, diverticulitis, celiac sprue, etc)
* Co-morbidities with anticipated life expectancy \< 12 months
* ESRD on dialysis
* Known intolerance to silicium or aluminum compounds
* Excess alcohol consumption (\>1 drink per day)
* Pregnancy, nursing or not taking/using contraception
* Hepatobiliary disorders or renal disease
* Plasma total cholesterol \> 240mg/dl or Triglycerides \> 265.5 mg/dl
* No plant-sterol enriched food products allowed in diet \& supplements
* BMI \> 35

Primary outcomes:
measure: Percent change in fractional cholesterol absorption in human subjects taking clinoptilolite over 6 days
timeFrame: 39 days
Secondary outcomes:
measure: Percent change from baseline by gender to determine gender difference in fractional cholesterol absorption rates
timeFrame: 39 days
measure: Percent change from baseline to end of treatment to evaluate for safety changes in metabolic profile measurements
timeFrame: 39 days
Other outcomes:
Locations:
city: Cumming
country: United States
facility: Atlanta Heart Specialists
state: Georgia
Study officials:
affiliation: Canadian Collaborative Research Network
name: Narendra Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00374842: Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate
Official title: A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of Adjuvanted Influenza Vaccine Candidates Compared to Fluarix™ Administered Intramuscularly in Subjects Aged 18-59 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza vaccine
Prophylaxis Influenza vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years


Eligibility criteria: Inclusion Criteria:

* A male or female aged 18-59 years at the time of the first vaccination.
* Free of obvious health problems

Exclusion Criteria:

* Use of non-registered products
* Administration of immune-modifying drugs.
* Administration of vaccine 30 days before enrolment in study.
* Immunosuppressive or immunodeficient condition.
* Hypersensitivity to a previous dose of influenza vaccine
* Previous vaccination against influenza in 2006
* Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
* History of confirmed influenza infection within the last 12 Months.
* Acute disease at the time of enrolment/vaccination.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine

Primary outcomes:
measure: Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed.
timeFrame: At Day 0 and at Day 21.
measure: Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.
timeFrame: At Day 0 and at Day 21.
measure: Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed
timeFrame: At Day 21.
measure: Seroconversion Factor Against Each of the 3 Influenza Strains Assessed.
timeFrame: At Day 21.
Secondary outcomes:
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: Within the 7-day follow-up period (Days 0-6) after vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: Within the 7-day follow-up period (Days 0-6) after vaccination
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: Within the 30-day follow-up period (Days 0-29) after vaccination
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs)
timeFrame: From study start to study end, from Day 0 to Day 30
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03237442: Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn
Official title: Placebo-Controlled,Randomized,Double-blind Trial of Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Ocular Corneal Burn
Lead sponsor: Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2017-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ocular chemical burn is one of the causes of vision loss in China, and there are no satisfactory treatment. Human umbilical cord mesenchymal stem cells(UC-MSCs) have the biological characteristics of self-renewal, immune regulation, multidirectional differentiation and tissue repair. Our preliminary research showed that in corneal alkali injury rabbits, the UC-MSCs can accelerated the cornea repair, inhibited angiogenesis. The aim of this study is to access the efficacy and safety of UC-MSCs in the treatment of corneal burn in human.


Eligibility criteria: Inclusion Criteria:

* must be ocular burns including chemically burned or the thermally burned;
* the subjects are willing to accept this research, and promise to coordinate with the researchers during the follow up period;
* the subjects should abide by the laws and rules of the study.

Exclusion Criteria:

* the visual acuity is blind in any of the eye;
* have corneal perforation or have the corneal perforation tendency;
* have been accepted surgery on eyeball after trauma;
* IOP\>=25 mmHg even after antiglaucoma;
* have the history of other corneal disease or surgery;
* have the history of radiotherapy or surgery in the eyeball;
* associated with corneal ulcer or endoophthalmitis;
* uncontrolled hypertension(\>=150/95 mmHg);
* abnormal liver and renal function;
* the pregnant women.

Primary outcomes:
measure: the percent of cornea perforation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
Study officials:
References:
Clinical trial NCT05775042: Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy
Official title: A Phase II Clinical Study Evaluating the Efficacy and Safety of CM338 Injection in Subjects With Immunoglobulin A Nephropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: IgA Nephropathy
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2023-03-20
Enrollment: 70
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: This study is a multicenter, randomized phase II clinical study to evaluate Efficacy and safety, while observing pharmacokinetic profiles, pharmacodynamic effects, and immunogenicity of CM338 in subjects with Immunoglobulin A(IgA) nephropathy.

Detailed description: In 1968, immunoglobulin A nephropathy (IgAN) was developed by French pathologist Dr. Jean Berger and his colleague Dr. Nicole Hinglais that what is described as glomerular "immunoglobulin A (IgA)-immune globule" - immune globule Protein G (IgG) intercapillary deposition" of kidney disease, the main pathological feature of which is on the glomerulus IgA deposition, usually accompanied by local cell proliferation and stromal dilation. Since there is not enough specificity and spirit Biomarkers of sensitivity, the only way to confirm the diagnosis is renal biopsy.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18-75.
* Understand the nature of the study and sign the Informed Consent Form voluntarily.
* Take effective contraception measures throughout the study period.

Exclusion Criteria:

* Used other investigational drugs within 30 days before the first study administration.
* With previous history of Human immunodeficiency virus(HIV) infection.
* Treponema pallidum antibody positive in screening period.
* May have active Mycobacterium tuberculosis infection.
* Major surgery is planned during the study.
* Other reasons the investigator believes that the subject is not suitable to participate in this study.

Primary outcomes:
measure: The incidence of adverse events of CM338 in subjects with immunoglobulin A nephropathy
timeFrame: up to week 112
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Jicheng Lv
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06638242: Indicators of Quality Care and Services for Adults With Acute Ischemic Stroke in Different Types of Hospitals in Quebec : Research Protocol
Official title: Indicators of Quality Care and Services for Adults With Acute Ischemic Stroke in Different Types of Hospitals in Quebec (IndiQ-AVC) : Research Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: clinical and organizational quality incdicators
practices assessment
stroke acute phase
interdisciplinarity
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with ischemic stroke All persons hospitalized for ischemic stroke within the 6 months preceding approval of the Research Ethics Board (REB). The study will be conducted based on their health records.

Brief summary: The goal of this study is to describe the performance of care and services offered to people hospitalized with ischemic stroke. More specifically, this study aims to answer the following questions:

* Is stroke care and service delivered to the population optimally?
* Are these services equitable, regardless of the hospital where the patient is hospitalized?
* Are all patients treated in the same way, regardless of individual characteristics such as age, sex or risk factors?

An evaluation of the quality of practices will be carried out on the health records of patients hospitalized in different hospital centers in Quebec such as a subspecialized center, a regional center and a center in a remote region. An in-depth analysis will also be conducted to determine whether certain individual patient characteristics may influence how they are managed during a stroke.


Eligibility criteria: Inclusion Criteria:

- Adults 18 years old or over with ischemic stroke requiring hospitalization in an acute care unit or special stroke unit

Exclusion Criteria:

* Adults with hemorrhagic stroke

Primary outcomes:
measure: Descriptives analyses
timeFrame: All persons hospitalized for ischemic stroke within the 6 months preceding approval of the Research Ethics Board (REB).
Secondary outcomes:
Other outcomes:
Locations:
city: Trois-Rivières
country: Canada
facility: Centre intégré universitaire de santé et services sociaux de la Mauricie et du Centre-du-Québec
state: Quebec
Study officials:
References:
Clinical trial NCT00922142: Cesarean Postoperative Pain Satisfaction
Official title: Cesarean Postoperative Pain Satisfaction With Intravenous Patient-Controlled Analgesia Intravenous, Oral, or Epidural Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean
Lead sponsor: Saint Elizabeth Regional Medical Center
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 120
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: post-operative cesarean patients

Brief summary: Hypothesis:

There is no significant difference in Cesarean patients' perceptions of overall pain management satisfaction between methods used for postoperative pain management.

Detailed description: There is a significant difference between Cesarean patients' perceptions of advantages and disadvantages of three postoperative pain management methods identified by obstetrical patients.

Participants will be introduced to study by anesthesia personnel in labor and delivery. The subject will be informed of the desire for their input on their perceived satisfaction with their chosen method for post-operative pain management and will be asked to participate in an anonymous survey by their second day after surgery. They will be informed that this is voluntary. Method of post-operative medication administration will be determined by attending physician to be either: epidural, IVPCA, or oral medication. Methods will be initiated in recovery room or the operative suite.

Subjects will be identified on a postpartum admission log and a screening log will be created for study purposes.

Informed Consents will be obtained. The screening log entries will be numbered corresponding to a numbered survey. The screening log will contain demographic and other patient identifiers including age, ethnicity, parity, presence of labor prior to cesarean, admission status of baby, cost associated with method and presence of rescue drugs and costs of rescue drugs and method services. Refusal information, exclusion criteria, and time/date of survey completion will also be recorded. This log will be maintained under lock and key.

Eligibility criteria: Inclusion Criteria:

* English speaking post-operative cesarean patients

Exclusion Criteria:

* Cesarean patients with know fetal demise
* General/Local Anesthetic Method for Cesarean

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Saint Elizabeth Regional Medical Center
state: Nebraska
Study officials:
affiliation: Saint Elizabeth Regional Medical Center
name: Deb Chambers, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05089942: Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021
Official title: Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021 in Healthy and Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: type1diabetes
Type2 Diabetes
Keywords: insulin patch
type 1 diabetes mellitus
type 2 diabetes mellitus
safety
efficacy
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the efficacy，safety， and tolerability of the recombinant human insulin patch ZJSRM2021 in healthy subjects, type 1diabetes mellitus and type 2diabetes mellitus patients


Eligibility criteria: Inclusion Criteria:

* Type 1or type 2 diabetes Body mass index：19\~35kg/m2（include） HbA1c≤11.0% Diabetic duration of T1DM was ≥1 year, and the subjects received insulin injections during the past year .Metformin and glycosidase inhibitors were also allowed.

Newly diagnosed T2DM or metformin-only, and the drug dose remained stable for ≥30 days. Or T2DM patients withdrawed drug ≥30 days of drug after diagnosis.

Exclusion Criteria:

* other type diabetes Use of other oral antidiabetics drugs within the 1 months prior to screening. With a history of malignant tumor. With acute or chronic infection. With evidence of major active psychiatric disorders. Drug abuse or alcohol abuse. Drunk too much tea or coffee(more than 2000ml per day). History of any drug allergies. Anti-insulin antibody positive. Participated in clinical trials within 3 months prior to signing the informed consent.

Primary outcomes:
measure: Efficacy of Recombinant Human Insulin Patch ZJSRM2021
timeFrame: maximum 1 years
Secondary outcomes:
measure: Incidence of adverse event of Recombinant Human Insulin Patch ZJSRM2021
timeFrame: maximum 1 years
measure: Skin irritation assessment and pain assessment of Recombinant Human Insulin Patch ZJSRM2021
timeFrame: maximum 1 years
measure: Pain assessment of Recombinant Human Insulin Patch ZJSRM2021
timeFrame: maximum 1 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang provincial people's hospital
state: Zhejiang
Study officials:
affiliation: Department of Endocriology, Zhejiang Provincial People's Hospital
name: Xiaohong X Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04714242: OCTA and Polypoidal Choroidal Vasculopathy
Official title: Choroid and Choriocapillary Changes in Polypoidal Choroidal Vasculopathy After Intravitreal Anti-VEGF Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polypoidal Choroidal Vasculopathy
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participans were older than 60 years with diagnosis of polypoidal choroidal vasculopathy They did not present other ophthalmological diseases.

Brief summary: To investigate the structural and vascular features of choroid in patients affected by PCV after Ranibizumab intravitreal injection.

Detailed description: Polypoidal choroidal vasculopathy represents a distinct form of choroidal neovascularization.

The study investigated the changes in choroidal vascular network after anti-VEGF therapy using optical coherence tomography angiography, a novel and non invasive diagnostic technique that allows to better understand the pathophysiologic mechanism of this neovascularization.

Eligibility criteria: Inclusion Criteria:

* age older than 60 years
* diagnosis of polypoidal choroidal vasculopathy
* absence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* absence of significant lens opacities, low-quality OCT-A images.

Exclusion Criteria:

* age older than 80 years
* absence of diagnosis of polypoidal choroidal vasculopathy
* presence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* presence of significant lens opacities, low-quality OCT-A images.

Primary outcomes:
measure: Study of vascular features of choroid in polypoidal choroidal vasculopathy after intravitreal injections of Ranibizumab
timeFrame: 12 Months
Secondary outcomes:
measure: Study of structural features of choroid in polypoidal choroidal vasculopathy after intravitreal
timeFrame: 12 Months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
affiliation: Federico II University
name: Gilda Cennamo
role: PRINCIPAL_INVESTIGATOR
References: