louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05480787: Pharmacokinetic Study of Continuous Infusion of Remazolam in Mechanically Ventilated Patients in ICU
Official title: Pharmacokinetic Study of Continuous Infusion of Remazolam in Mechanically Ventilated Patients in ICU : Establishment of Population Pharmacokinetic Model and Exploration of Clinical Influencing Factors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intensive Care Unit
Mechanical Ventilation
Anesthesia
Liver Failure
Pharmacokinetics
Keywords: Remimazolam
Intensive Care Unit
Mechanical Ventilation
Anesthesia
Sedation
Liver Failure
Pharmacokinetics
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 30
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: To study the pharmacokinetics of continuous infusion of remazolam in ICU mechanically ventilated critically ill patients, and the characteristics of PK in patients with liver failure; to explore whether liver failure affects the metabolism of remazolam by established population pharmacokinetics.


Eligibility criteria: Inclusion Criteria:

Patients admitted to ICU for tracheal intubation and mechanical; Patients aged \>18 years; Patients with expected mechanical ventialation time \>24 hours.

Exclusion Criteria:

Patients on long-term anti-anxiety medication or sleeping pills; Patients with known or suspected hypersensitivity to remimazolam; Patients with severe central nervous system diseases; Patients who do not wish to sign the informed consent form.

Primary outcomes:
measure: Plasma concentration of Remimazolam
timeFrame: 24 hours
Secondary outcomes:
measure: Adverse reactions
timeFrame: 28 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT01210287: Incidence of Hepatitis B Virus (HBV) Reactivation in HBsAg Negative/HBcAb Positive Lymphoma Patients Treated With RCHOP
Official title: Incidence of HBV Reactivation in HBsAg Negative/HBcAb Positive Diffuse Large B Cell Lymphoma or High Grade Follicular Lymphoma Patients: A Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Lymphoma
Keywords: hepatitis B virus reactivation
HBsAg negative
HBcAb positive
lymphoma
rituximab
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2010-09-28
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of this study is to identify the incidence of hepatitis B virus reactivation rate in Diffuse Large B Cell or high grade Follicular lymphoma patients with prior resolved hepatitis B undergoing RCHOP immuno-chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Naive DLBCL or high grade FL patients
* Age range 18-75 years old
* ECOG performance status 0-3
* Life expectancy of more than 3 months
* Adequate organ function
* HBsAg negative/HBcAb positive at baseline

Exclusion Criteria:

* Infection of HAV,HCV,HIV
* Pregnant or lactating women
* Serious uncontrolled diseases

Primary outcomes:
measure: incidence of HBV reactivation
timeFrame: from the first cycle of RCHOP (day 1) to six months after the last cycle of RCHOP
Secondary outcomes:
measure: the outcome of antiviral therapy in HBV-DNA abnormal patients
timeFrame: from the initiation of antiviral thearpy to six months after the last cycle of RCHOP
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: member of Fudan University
name: Junning Cao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01855087: Safety and Efficacy of Sitagliptin Added to Insulin Therapy for Type 2 Diabetes
Official title: A Study of Safety and Efficacy of Sitagliptin Added to Insulin Therapy in the Treatment of Type 2 Diabetes in Kanagawa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: Kanagawa Physicians Association
Sponsor class: OTHER
Collaborators: name: The Japan Kidney Foundation
First posted: 2013-05-16
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One-thousand Japanese patients with type 2 diabetes

Brief summary: There is paucity of information about the combination therapy with dipeptidyl peptidase-4 inhibitor sitagliptin and insulin. This study aimed to retrospectively investigate the safety and efficacy of this therapeutic modality in Japanese patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* outpatients with type 2 diabetes
* addition of sitagliptin to insulin therapy
* aged 20 years or older
* HbA1c of 6.9% or higher (NGSP) at the time of adding sitagliptin

Exclusion Criteria:

* history of hypersensitivity to sitagliptin
* severe ketosis, diabetic coma, and/or precoma within 6 months before sitagliptin administration
* sever infection and/or severe trauma, and/or patients who are scheduled to undergo / have recently underwent surgery
* severe renal dysfunction (serum creatinine \[mg/dL\]: 2.5 or higher for men; 2.0 or higher for women)
* ongoing treatment with glinide(s)
* judgment as ineligible for the study by the attending physician

Primary outcomes:
measure: Blood glucose level
timeFrame: Six months after starting sitagliptin-insulin combination therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Kamakura
country: Japan
facility: Takai Naika Clinic
state: Kanagawa
Study officials:
References:
Clinical trial NCT00453687: A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK233705 In Healthy Volunteers.
Official title: A Single-centre, Randomized, Double-blind Placebo-controlled, Dose-ascending, Cross-over Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK233705, Formulated With the Excipient Magnesium Stearate, in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
GSK233705,
Magnesium Stearate,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-03-29
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety and tolerability of inhaled doses of GSK233705 with a new formulation.

Detailed description: A single-centre, randomized, double-blind placebo-controlled, dose-ascending, cross-over study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of GSK233705 (50, 100 and 200Âµg), formulated with the excipient magnesium stearate, in healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects 18-55 years old
* Non-Smokers

Exclusion Criteria:

* Any subject with breathing problems.
* High blood pressure and heart abnormalities.
* Any subjects currently taking prescription and non-prescription medications.

Primary outcomes:
measure: General safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead electrocardiogram (ECG), Holter and Lead II ECG monitoring, lung function (FEV1, FVC) and clinical laboratory safety tests over 24 hours.
timeFrame: over 24 hours.
Secondary outcomes:
measure: Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters from 0 to 24 hours. Serial Specific airway conductance (sGaw) and Forced Expiratory Volume in 1 second (FEV1) measurements over 24 hours post-dose.
timeFrame: over 24 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: This study has not been published in the scientific literature.
Clinical trial NCT03944187: Sonographic Assessment for Prediction of Labor Induction Success
Official title: Sonographic Assessment of Fetal Head Circumference, Cervical Length and Fetal Head to Cervix Angle for Prediction of Labor Induction Success
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with singleton pregnancy over 37 weeks' gestation

Brief summary: The study is conducted to assess several sonographic parameters for prediction of labor induction success. These parameters include cervical length, fetal head circumference, and fetal head to cervix angle.

Detailed description: Pregnant women at term over 37 weeks' gestation visiting the obstetric emergency room for various obstetric indications will be assessed. Women with obstetric or medical indication for induction will receive an explanation regarding the study protocol and will sign an informed consent.

After recruitment and during the evaluation in the obstetric emergency room, patients will undergo transvaginal sonography during which, cervical length, fetal head circumference and fetal head to cervix angle will be measured.

Relevant demographic and obstetric information will be collected from a computerized database.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy.
* Term pregnancy.

Exclusion Criteria:

* Multiple gestation.
* Fetal anomalies and malformations.
* Preterm pregnancy.

Primary outcomes:
measure: Success in induction of labor
timeFrame: From admission to the obstetric emergency room up to 24 hours postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam healthcare campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05747287: Evaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions
Official title: A Post-Market Study to Evaluate the Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Peripheral Arterial Disease
Lead sponsor: BrosMed Medical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, multi-center, single-group post-market study. It is planned to be carried out in about 3 clinical institutions, and a total of 60 subjects are expected to be enrolled.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old;
2. Patients with symptomatic ischemic heart disease who are suitable for non-acute percutaneous coronary intervention (PCI);
3. Patients with target lesion diameter stenosis ≥ 70% (visually) or de novo coronary chronic total occlusion (CTO), or tortuous lesions, who plan to use Pronavi Microcatheter;
4. Patients or their guardians who understand the purpose of the trial, voluntarily participate and sign the written informed consent, and are able to be followed up.

Exclusion Criteria:

1. Patients with clinical symptoms consistent with ST-elevation myocardial infarction and/or ECG changes within 12 hours before the procedure;
2. Patients who are known to be intolerant to antiplatelet drugs or allergic to contrast media;
3. Patients with in-stent occlusion;
4. Patients with unprotected left main coronary artery disease;
5. Women who are pregnant or lactating;
6. Patients who are participating in clinical trials of other drugs or medical devices;
7. Patients with contraindications to the investigational device;
8. Other patients considered by the investigators to be unsuitable for this trial.

Primary outcomes:
measure: Technical success
timeFrame: 0 day
Secondary outcomes:
measure: Device success
timeFrame: 0 day
measure: Procedural success
timeFrame: 0 - 7 days
measure: Device super-selective angiography (if applicable)
timeFrame: 0 day
measure: Guide wire exchange supported (if applicable)
timeFrame: 0 day
measure: Device Performance Evaluation
timeFrame: 0 day
Other outcomes:
measure: Major adverse cardiac events (MACE) during the study
timeFrame: 0 - 7 days
measure: Adverse events and serious adverse events related to the study device during the study
timeFrame: 0 - 7 days
measure: Occurrence of other adverse events and serious adverse events during the study
timeFrame: 0 - 7 days
Locations:
city: Shijiazhuang
country: China
facility: The Shijiazhuang People's Hospital
state: Hebei
city: Zhengzhou
country: China
facility: The Seventh People's Hospital of Zhengzhou
state: Henan
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
References:
Clinical trial NCT01875887: Treatment of Bilateral Maxillofacial Post-traumatic Deformities
Official title: Application of Surgery Planning Software, Rapid Prototyping Model and Preshaped Titanium Plates in Treatment of Bilateral Maxillofacial Post-traumatic Deformities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Therapeutics of Bilateral Maxillofacial Injuries
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with Bilateral maxillofacial Post-traumatic Deformities

Brief summary: Combined application of surgery planning software and rapid prototyping technology and preshaped titanium plates can effectively promote the accuracy of the diagnosis and treatment of bilateral maxillofacial post traumatic deformities, reduce operation time and improve surgical effect.

Detailed description: All patients underwent preoperative CT scan. Firstly, SurgiCase were used to analyze CT data and design preliminary surgery plans. Secondly, three-dimensions resin skull models were produced by rapid prototyping technology. Model surgeries were performed to determine the location, reduction direction and shift distance of osteotomy. Based on the surgical simulation, the preliminary surgery plans were validated and optimized. Then, the titanium plates and mesh were preshaped on the models. Finally, according to the final surgery plans the operations were performed. The operation time, therapeutic effects and complications were observed. The follow-up periods were 1-12 months.

Eligibility criteria: Inclusion Criteria:

* Bilateral maxillofacial Post-traumatic Deformities

Exclusion Criteria:

* unilateral maxillofacialPost-traumatic Deformities

Primary outcomes:
measure: improvement in mouth openning
timeFrame: from 1 month to 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Stomatology
state: Sichuan
Study officials:
affiliation: Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University
name: Lei Liu, DMD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05812287: Exploring the Difference Between Gastric Cardia Cancer and Non-cardia Gastric Cancer Based on Multiomics
Official title: Exploring the Difference Between Gastric Cardia Cancer and Non-cardia Gastric Cancer Based on Multiomics
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stomach Neoplasm
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Case:

The population in the case group signed an informed consent form, aged between 18 and 75 years. All subjects underwent endoscopic examination and were confirmed by pathological diagnosis as gastric cancer, including high-grade intraepithelial neoplasia, early gastric cancer, and advanced gastric cancer.

Control:

The age and gender of the study subjects in the control group were matched to the study population in the case group. The pathological results of the stomach of all subjects showed no malignant changes, including normal gastric mucosa, superficial gastritis, non atrophic gastritis, and gastric polyps, etc.

Brief summary: This is an observational study with a case control design. This study included patients with gastric cancer confirmed by pathological diagnosis of gastric tissue, and matched the control population according to age, gender, etc. In this study, researchers collected clinical information and multiple biological samples such as saliva, serum, and feces from the study subjects. We combined 16S rRNA sequencing and metabolomics to explore the differences in microbial and metabolic characteristics between gastric cardia cancer and non-cardia gastric cancer for early screening of gastric cancer.


Eligibility criteria: Inclusion Criteria:

* Study population signing informed consent form
* Age: 18-75 years old
* The study population must underwent endoscopic examination and was confirmed by pathological diagnosis as gastric cancer: including high-level intraepithelial neoplasia, early gastric cancer, and advanced gastric cancer.

Exclusion Criteria:

* Those who have undergone gastrointestinal surgery within the past 1 year; Patients who have undergone neoadjuvant chemotherapy and have developed tumors in the residual stomach after previous partial gastrectomy.
* Those who have used proton pump inhibitors, antibiotics, probiotics, and prebiotics daily within the past month, and those who have recently received hormone therapy.
* People with infectious diseases and other digestive system diseases that interfere with the experimental results, such as inflammatory bowel disease, irritable bowel syndrome, etc.

Primary outcomes:
measure: Early gastric cancer detection rate
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03983187: Effect of Rotating Magnetic Therapy on Blood Glucose Spectrum of Type 2 Diabetic Patients With Glargine Therapy
Official title: Effect of Rotating Magnetic Therapy on Blood Glucose Spectrum of Type 2 Diabetic Patients With Glargine Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the eﬀect of Rotating Magnetic Therapy on blood glucose spectrum of type 2 diabetic patients with glargine therapy using flash glucose monitors


Eligibility criteria: Inclusion Criteria:

* Volunteer to participate and sign informed consent prior to the study
* Patients with type 2 diabetes, who met WHO1999 diagnostic criteria, aged 18-70 years old, and were treated with insulin glargine alone and/or insulin glargine combined with oral hypoglycemic drugs, the treatment regimen was stable for more than 2 months
* Fasting blood glucose ranged from 6.1 to 13.9mmolL, and postprandial (or random) blood glucose was \<22.2mmol/L.
* Subjects can and are willing to conduct flash glucose monitoring and regular diet and exercise

Exclusion Criteria:

* Patients with insulin allergy
* Patients treated with GLP-1a or DPP-4 inhibitors or multipoint subcutaneous insulin injection in the last three months
* Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value and serum creatinine 1.3 times higher than the upper limit of normal value
* Patients with metal foreign bodies or pacemakers
* Patients with a history of surgery in magnetic therapy site within one year
* Patients with obvious discomfort to magnetic therapy
* Patients with bleeding or bleeding tendency
* Patients with poor compliance and irregular diet and exercise
* Patients with acute complications of diabetes, such as infection, diabetic ketoacidosis, hypertonic coma and so on, and patients with stress status within four weeks
* Patients who are pregnant, breast-feeding, or intending to become pregnant
* Any other apparent conditions or associated diseases determined by the investigator: severe cardiopulmonary, endocrine, neurological, tumor, other pancreatic diseases, history of mental illness

Primary outcomes:
measure: the standard deviation of blood glucose
timeFrame: 2 weeks
Secondary outcomes:
measure: mean blood glucose
timeFrame: 2 weeks
measure: time in range
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References: