louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05760976: Median Effective Dose of Cisatracurium for the Prevention of Fasciculation Caused by the Injection of Succinylcholine
Official title: Median Effective Dose of Cisatracurium for the Prevention of Fasciculation Caused by the Injection of Succinylcholine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fasciculation
Succinylcholine
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Succinylcholine is currently the only depolarizing neuromuscular blocker widely used in anesthesia induction and is the drug of choice for rapid sequential anesthesia induction. However, with succinylcholine, varying degrees of muscle fibrillation and muscle pain occur. Intravenous injection of succinylcholine caused by myomuscular fibrillation can cause increased intragastric pressure, intraocular pressure and intracranial pressure, increased serum potassium and postoperative myalgia, increased the incidence of adverse events such as needle prolapse, extravasation of injected drugs, and reduced perioperative comfort of patients. Pretreatment with cisatracurium provides limited prevention of muscular fibrillation due to succinylcholine, but the choice of dose often depends on user experience, and there have been no previous studies of age-related doses of cisatracurium for the prevention of muscular fibrillation caused by succinylcholine, and its half-effective amount (ED50) has not been established. In this study, patients treated with elective general anesthesia surgery were the subjects, and in the process of general anesthesia induction, cis-atracurium was pretreated to evaluate the degree of inhibition of muscular fibrillation caused by succinylcholine, and half of the effective dose of cis-atracurium inhibition of muscular fibrillation caused by succinylcholine was calculated by sequential method.


Eligibility criteria: Inclusion Criteria:

1. Ages ranged from 18 to 80.
2. ASA # or # level.

Exclusion Criteria:

* Allergy or contraindication to cisatracurium or succinylcholine;
* Associated with cardiovascular disease, diabetes, hyperkalemia, increased intraocular pressure, increased intracranial pressure, gastroesophageal reflux, difficult airway, malignant hyperthermia, neuromuscular disease Sick;
* Take drugs that may affect neuromuscular function before surgery
* Liver or kidney failure
* Pregnancy

Primary outcomes:
measure: The appearance of fasciculation Yes or No
timeFrame: an average of 2 minutes
measure: The levels of fasciculation
timeFrame: an average of 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University
state: Jiangsu
Study officials:
References:
Clinical trial NCT00173576: Clinical Study of SARS in Children
Official title: Clinical Study of SARS in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epidemiology
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2005-09-15
Enrollment: 800
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: Severe acute Respiratory Syndrome (SARS) is an emerging infectious disease. It is caused by a novel SARS-associated coronavirus. According to the epidemiological data, it is highly infectious by intimate contact, respiratory secretion, or direct contact with infectious body fluid. By June 1, 2003, Center for Disease Control Taiwan, R.O.C reported 677 probable SARS cases. Among them, 93.2% (631/677) were more than 20 years old. Only 6.8% (46/677) were under 20 years old. Usually the major hosts of respiratory viruses are children, but evidence up to now shows that SARS is mainly a disease of adults. The data of clinical presentation and epidemiological prevalence in teenage group and children are lacking. Therefore, this project is aimed at the children and teenager among 1 month to eighteen years old. Seroepidemiology of SARS-CoV infection in children would be investigated. Patients who admitted to pediatric wards or visited ER and received blood sampling due to the need of clinical diagnosis/management would be enrolled. After the necessary laboratory examinations were done, the remaining serum would be collected and tested for anti-SARS-CoV IgG by ELISA.


Eligibility criteria: Inclusion Criteria:

* Patients aged from 1 month to 18 years old
* Received blood sampling during admission or at emergency department due to the need of clinical diagnosis/management

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Pediatrics, College of Medicine, National Taiwan University and Graduate Institute of Preventive Medicine, College of Public Health, National Taiwan University
name: Li-Min Huang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02887976: Extension of SoluMatrix TM Abiraterone Acetate in Patients Who Completed Study Number CHL-AA-201
Official title: An Open-label Extension (OLE), Expanded Access Study, to Assess Long-term Safety of SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) With Methylprednisolone (4mg Bid) in Patients Who Completed Study Number CHL-AA-201
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Castrate Resistant Prostate Cancer (CRPC)
metastatic
castrate resistant
Lead sponsor: GU Research Network, LLC
Sponsor class: OTHER
Collaborators: name: Churchill Pharmaceutical LLC
First posted: 2016-09-02
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Open-label extension (OLE), expanded access study, to assess long-term safety of SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid) in patients who completed study number CHL-AA-201.

Detailed description: An Open-label extension (OLE), expanded access study, to assess long-term safety of SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid) in patients who completed study number CHL-AA-201. An exploratory endpoint of Improved safety from switching from Zytiga (aberaterone Acetate 1000mg(4 x 250 mg qd) to SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) will also be ascertained..

Eligibility criteria: Inclusion Criteria:

1. Written informed consent obtained prior to any study-related procedure being performed
2. Previous, uninterrupted enrollment and treatment in trial number CHL-AA-201.

Exclusion Criteria:

1. Progressive disease as ascertained by the investigator using standard-of-care evaluations.
2. CHL-AA-201 D84 blood counts of the following:

   1. Absolute neutrophil count \> 1500/µL
   2. Platelets \> 100,000/µL
   3. Hemoglobin \> 9 g/dL
3. CHL-AA-201 D84 chemistry values of the following:

   1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x Upper Limit of Normal (ULN)
   2. Total bilirubin \< 1.5 x ULN
   3. Creatinine\< 1.5 x ULN
   4. Albumin \> 3.0 g/dL
   5. Potassium \> 3.5 mmol/L

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: Month 9
Secondary outcomes:
measure: Change in incidence of Treatment-Emergent Adverse Events in relation to Core Study
timeFrame: Month 9
Other outcomes:
Locations:
city: Wichita
country: United States
facility: GU Research Network/Wichita Urology Group
state: Kansas
city: Lincoln
country: United States
facility: GU Research Network/Urology PC
state: Nebraska
city: Omaha
country: United States
facility: GU Research Network/Urology Cancer Center
state: Nebraska
Study officials:
References:
Clinical trial NCT00396227: Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone
Official title: A Multi-center, Randomized, Open-label, Active Controlled, Parallel Arm Study to Compare the Efficacy of 12 Weeks of Treatment With Vildagliptin 100 mg, qd to Thiazolidinedione (TZD) as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy in a Community-based Practice Setting.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
hemoglobin A1c
metformin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-11-06
Enrollment: 2665
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.


Eligibility criteria: Inclusion Criteria:

* Patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to Visit 1 (week-2)
* Agreement to maintain the same dose of metformin from screening to the end of the study
* Age in the range of 18-80 years
* Body mass index (BMI) in the range of 22-40 kg/m2
* HbA1c in the range of 7.0 to 10%
* FPG \<270 mg/dL (15 mmol/L)

Exclusion Criteria:

* A history of type 1 diabetes
* Liver disease
* Treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to Visit 1

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HemoglobinA1c (HbA1c)
timeFrame: after 12 weeks of treatment
Secondary outcomes:
measure: Change from baseline in body weight
timeFrame: after 12 weeks of treatment
measure: Change from baseline in fasting plasma glucose (FPG)
timeFrame: after 12 weeks of treatment
measure: Incidence of prespecified adverse events while on treatment with study drug
timeFrame: 12 week treatment duration
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Blonde L, Dagogo-Jack S, Banerji MA, Pratley RE, Marcellari A, Braceras R, Purkayastha D, Baron M. Comparison of vildagliptin and thiazolidinedione as add-on therapy in patients inadequately controlled with metformin: results of the GALIANT trial--a primary care, type 2 diabetes study. Diabetes Obes Metab. 2009 Oct;11(10):978-86. doi: 10.1111/j.1463-1326.2009.01080.x. Epub 2009 Jul 13.
Clinical trial NCT06196827: Safety and Tolerability of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations
Official title: A Multi-center Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of rAAV2-RPE65 Gene Therapy (LX101) in Subjects With Biallelic RPE65 Mutation-associated Inherited Retinal Dystrophy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Inherited Retinal Dystrophy Associated With RPE65 Mutations
Lead sponsor: Innostellar Biotherapeutics Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-09
Enrollment: 9
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety, tolerability and efficacy of LX101 in subjects with biallelic RPE65 mutation-associated inherited retinal dystrophy.


Eligibility criteria: Inclusion Criteria:

Subject and/or their guardian signing a written informed consent.

Diagnosed with biallelic RPE65 mutation-associated inherited retinal dystrophy.

Subjects are 6 years of age or older.

Visual acuity of ≤ 20/63 or visual field less than 20 degrees in the eye to be injected.

Exclusion Criteria:

Prior gene therapy for IRD and other hereditary eye diseases.

Pre-existing eye conditions that would interfere with interpretation of study endpoints.

Active intraocular or periocular infections in the study eye.

Lacking of sufficient surviving retinal cells.

Prior ocular surgery within six months.

Complicating systemic diseases or clinically significant abnormal baseline laboratory values.

Pre-existing systemic diseases that should not discontinue the use of any retinal toxic compounds.

Primary outcomes:
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: 12 months
measure: Incidence of dose-limiting toxicity (DLT)
timeFrame: 1 month
Secondary outcomes:
measure: Efficacy of LX101 in study eye
timeFrame: 12 months
measure: Efficacy of LX101 in study eye
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
city: Shanghai
country: China
facility: Shanghai General Hospital
Study officials:
References:
Clinical trial NCT02770027: Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity for Colon Surgery
Official title: Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During Colon Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Surgery
Keywords: Colon Surgery
blood viscosity
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 30
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: After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing colon surgery are enrolled in this prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES (n=15).

All recruited patients will be given patient identification number (PIN) for the present study of 01-30 according to their order of interview and recruitment. Investigators will prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30 (Envelop number).

According to the color of the card, attending anesthesiologists will give crystalloid for yellow card or HES for green cards, respectively, to maintain stroke volume variation \< 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.

Patient data and statistical analyses:

Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be determined from the patients' medical record after patient's discharge.

All statistical analyses will be performed after the 30th patient's discharge and data acquisition


Eligibility criteria: Inclusion Criteria:

* Patients undergoing colon surgery
* Patients provided a written informed consent.
* Patients with preoperative serum hemoglobin concentration \>13 g/dL (male) and \>12 g/dL (female)
* Patients with PaO2/FiO2 ratio \>150

Exclusion Criteria:

* Patients with history of anemia, dyspnea, active infection.
* Patients with endocrine disease
* Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-platelet drug, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.

Primary outcomes:
measure: whole blood viscosity
timeFrame: with 1 hour after the completion of procedure
Secondary outcomes:
measure: PaO2/FiO2 ratio
timeFrame: 1 hour after the completion of procedure
measure: hematocrit
timeFrame: 1 hour after the completion of procedure
measure: glucose
timeFrame: 1 hour after the completion of procedure
measure: osmolarity
timeFrame: 1 hour after the completion of procedure
measure: urine output
timeFrame: 1 hour after the completion of procedure
measure: Maximum clot formation
timeFrame: 1 hour after the completion of procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05831527: An Exploratory Investigation of a Supplement to Promote Gut Health
Official title: An Exploratory Investigation of a Supplement to Promote Gut Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Symptoms
Exercise Performance
Lead sponsor: Armra
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multiarm study, both arms receiving the same intervention drug.
Primary purpose: OTHER

Brief summary: Bovine colostrum is a dairy food and the first milk produced by the mother cow. Abundant research exists revealing the valuable health benefits it confers due to its unique nutritional properties., including benefits to gastrointestinal health, fitness, and overall well-being.This study aims to test a specific food-grade supplement, ARMRA Colostrum Immune Revival, over a 12-week trial to better understand the well-being, fitness, and gut benefits. This trial will use two groups, one that suffers from gastrointestinal complaints frequently and another that exercises at least three days a week.


Eligibility criteria: Inclusion Criteria:

* Male or Female between 18-65 years of age.
* Self-reported digestive issues (abdominal pain, gas production, bloating after meals, or heartburn after meals) (GUT HEALTH GROUP ONLY)
* Must be physically active three or more days a week and willing to maintain their current activity level (PERFORMANCE GROUP ONLY)
* Must be willing to refrain from lifestyle changes affecting their gastrointestinal tract.
* Must be in good health with no significant chronic conditions.
* Following a stable, consistent diet regimen.
* Have a reliable way to measure their weight.

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Suffers from pre-existing conditions that would prevent them from adhering to the protocol.
* Has a lactose allergy or intolerance.
* Serious food allergies

Primary outcomes:
measure: Change in overall well-being [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Change in hs-CRP [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in self-reported gastrointestinal outcomes, such as bloating, heartburn, irregular bowel movements, and gas [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
measure: Change in recovery and fitness levels [Time Frame: Baseline to Week 12]
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT02125227: Phase 1 Clinical Trial to Investigate the Effect on the Pharmacokinetics of YH14755 Compared to Co-administration of Rosuvastatin and Metformin SR in Healthy Volunteers
Official title: A Randomized, Open-label, Single-dose, 2-Way Cross-over Study to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the Effect of Food on the Pharmacokinetics of YH14755
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2014-04-29
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this study is to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the Effect of Food on the Pharmacokinetics of YH14755 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

1. Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
2. Who has not suffered from clinically significant disease
3. Provision of signed written informed consent

Exclusion Criteria:

1. History of and clinically significant disease
2. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
3. Administration of other investigational products within 3 months prior to the first dosing.
4. Administration of herbal medicine within 4 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
5. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.

Primary outcomes:
measure: AUClast of rosuvastatin and metformin
timeFrame: 0~48hr, totally 17 points
measure: Cmax of rosuvastatin and metformin
timeFrame: 0~48hr, totally 17 points
Secondary outcomes:
measure: Tmax of rosuvastatin and metformin
timeFrame: 0~48hr, totally 17 points
measure: t1/2 of rosuvastatin and metformin
timeFrame: 0~48hr, totally 17 points
measure: %AUC of rosuvastatin and metformin
timeFrame: 0~48hr, totally 17 points
measure: AUCinf of rosuvastatin and metformin
timeFrame: 0~48hr, totally 17 points
Other outcomes:
Locations:
city: Jeonju-si
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: Mingul Kim, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: