louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03869346: Impact of CYP3A4*1G Polymorphism on Non-analgesic Effects of Fentanyl in Chinese Han Patients
Official title: Impact of CYP3A4*1G Polymorphism on Non-analgesic Effects of Fentanyl in Chinese Han Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fentanyl
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Yichang Humanwell Pharmaceutical Co., Ltd., China
First posted: 2019-03-11
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 Chinese Han patients receiving elective surgery under general anesthesia

Brief summary: Purpose: This study aimed to investigate the impact of CYP3A4\*1G genetic polymorphism on non-analgesic effects of fentanyl in Chinese Han patients. Methods: 200 patients receiving elective surgery under general anesthesia were recruited into this study. Venous blood was withdrawn for genotyping of CYP3A4\*1G before operation. Fentanyl 2 µg/kg was administered preoperatively. Bispectral Index (BIS), Respiratory rate(RR), etc at Tb (entering room), T0 (drug administration), T1 (2min), T2 (4min), T3(6min), T4(8min), T5(10min), T6(20min) were recorded.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists GradeⅠ-II,Patients undergo elective surgery for benign Reproductive diseases (including laparoscopic ovarian cyst removal, laparoscopic tubal ligation, laparoscopic tubal drainage, laparoscopic salpingoplasty, etc.) or breast disease.
* Aged 18-45 years
* Body Mass Index 18-25kg/m2,body weight 40-65 kilograms
* Agreed to participate the research

Exclusion Criteria:

* Difficult airway
* upper respiratory tract infection within 2 weeks
* history of allergy or long-term use of propofol and opioids
* self-rating anxiety scale before operation indicates anxiety
* pregnancy or lactation.

Primary outcomes:
measure: bispectral index
timeFrame: 20 min after administration
measure: respiratory rate
timeFrame: 20 min after administration
measure: CYP3A4*1G Polymorphism
timeFrame: 1 week after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Yi Feng, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01044446: Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients During Acute Peritonitis
Official title: Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peritonitis
Keywords: peritoneal dialysis
peritonitis
CAPD
end-stage renal disease
peritonitis outcome and ultrafiltration
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2010-01-07
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the present study is to evaluate the a prior hypothesis that treatment with icodextrin during acute peritonitis would improve the treatment outcomes of peritonitis complicating peritoneal dialysis. The safety and effectiveness of icodextrin for decreasing glucose exposure, extent and severity of peritonitis will be evaluated in the setting of acute peritonitis complicating peritoneal dialysis among patients who are not receiving icodextrin.


Eligibility criteria: Inclusion Criteria:

* aged 18 or older on peritoneal dialysis, who develop clinical evidence of peritonitis
* stable peritoneal dialysis with Baxter connection system
* willingness to give written consent and comply with the study protocol

Exclusion Criteria:

* already on icodextrin dialysate prior to acute presentation with peritonitis
* known allergy or hypersensitivity to icodextrin, starch or have a glycogen storage disease
* participation in another interventional study within last 30 days of randomization
* history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures

Primary outcomes:
measure: peritoneal dialysate total white cell count on day 3 of acute peritonitis
timeFrame: day 3
Secondary outcomes:
measure: need of additional hypertonic exchanges, ultrafiltration volumes according to patient diary, fluid control as denoted by changes in body weight, and the timing of peritonitis resolution
timeFrame: within the period of peritonitis treatment
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital, Chinese University of Hong Kong
state: New Territories
Study officials:
References:
citation: Chow KM, Szeto CC, Kwan BC, Pang WF, Ma T, Leung CB, Law MC, Li PK. Randomized controlled study of icodextrin on the treatment of peritoneal dialysis patients during acute peritonitis. Nephrol Dial Transplant. 2014 Jul;29(7):1438-43. doi: 10.1093/ndt/gfu033. Epub 2014 Feb 26.
Clinical trial NCT01514669: Analyzing the Composition of Tears and Blood for Discovery of Novel Signatures of Aggressive Prostate Cancer
Official title: Analyzing the Composition of Tears and Blood for Discovery of Novel Signatures of Aggressive Prostate Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2012-01-23
Enrollment: 75
Sex: MALE
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be selected from those outpatients followed in the Winthrop P. Rockefeller Cancer Institute (located at the University of Arkansas for Medical Sciences).

Brief summary: The purpose of this research study is to compare profiles in the blood and tears of patients with and without prostate cancer with the goal of developing a method of separating men with aggressive and non-aggressive disease.


Eligibility criteria: Inclusion Criteria:

1. Male, 35-85 years old
2. Patients who present for the evaluation of an abnormal exam or test (elevated PSA, abnormal DRE, etc.)
3. Patients who present for the evaluation of a palpable nodule or induration on prostate exam
4. Patients who meet the requirements of Group 1, 2, or 3 of the protocol

Exclusion Criteria:

1. Patient \< 35 or \> 85 years of age
2. Concurrent eye infection or trauma, including active conjunctivitis
3. Abnormal production of tears (too much or too little)
4. Any other conditions the PI or staff feels will not fulfill the criteria for study entry or will place the subject in a harmful environment
5. Atypia on prostate biopsy report

Primary outcomes:
measure: Tear Sample
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Alan Diekman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05220969: Total Genotype Score, Growth, Maturation and Loading Exposure as Risk Factors for Injury in Elite Male Youth Football
Official title: Total Genotype Score, Growth, Maturation and Loading Exposure as Risk Factors for Injury in Elite Male Youth Football
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractures in Children
Apophysitis
Muscle Strain
Ligament Injury
Tendon Injuries
Genetic Predisposition
Lead sponsor: St Mary's University College
Sponsor class: OTHER
Collaborators: name: Fulham Football Club
First posted: 2022-02-02
Enrollment: 95
Sex: MALE
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elite male football players aged 12-40

Brief summary: A total genotype risk score was generated based on the findings of previous research for non-contact injury, non-contact muscle injury, tendon injury, ligament injury, fracture injury and apophysitis injury. This score was then compared with the incidence of injury between those with high, medium and low risk scores for each injury. The influence of different rates of growth, stages of physical maturation and loading exposure were then also included in the risk model to see if any interaction effects could be observed between genetic risk score and susceptibility to injury in different categories of growth, maturation and loading exposure.


Eligibility criteria: Inclusion Criteria:

* Elite male football players

Exclusion Criteria:

* Female
* non-elite

Primary outcomes:
measure: Fracture Injury Risk
timeFrame: 8 Years
measure: Non-Contact Injury Risk
timeFrame: 8 Years
measure: Non-Contact Muscle Injury Risk
timeFrame: 8 Years
measure: Tendon Injury Risk
timeFrame: 8 Years
measure: Ligament Injury Risk
timeFrame: 8 Years
measure: Apophysitis Injury Risk
timeFrame: 8 Years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Fulham Football Club
state: New Malden
city: London
country: United Kingdom
facility: St Mary's University, Twickenham
state: Twickenham
Study officials:
References:
Clinical trial NCT04086069: Sit-to-stand Trainer in Patients After Lower Limb Amputation
Official title: Effect of Sit-to-stand Trainer in Patients With Unilateral Lower Limb Amputation on the Ability of Independent Standing up
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lower Limb Amputation
Keywords: unilateral lower-lim amputation
sit-to-stand trainer device
30-Second Chair Stand Test
kinesiological analysis
Lead sponsor: University Rehabilitation Institute, Republic of Slovenia
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 0
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 study will include rehabilitation inpatients after unilateral lower limb amputation who are candidates for walking with a prosthesis. Those in the experimental group will receive training using a sit-to-stand trainer device in addition to standard training of standing-up with the help of a physiotherapist. Those in the control group will only receive the standard training. The effects of the rehabilitation programme will be assessed using the 30-Second Chair Stand Test before the start of the training and after 10 days of training. For the first five patients from each group who will be able to stand up with the use of hands, detailed kinesiological analysis of standing-up pattern will be performed.


Eligibility criteria: Inclusion Criteria:

* unilateral lower-limb amputation
* candidate for walking with a prosthesis
* Montreal Cognitive Assessment (MoCA) test score 26 or more

Exclusion Criteria:

* associated neurological or orthopaedic disease
* amputation caused by cancer or injury
* BMI below 18.5 or above 30

Primary outcomes:
measure: Change in 30-Second Chair Stand Test
timeFrame: Change from day 0 to day 10
Secondary outcomes:
measure: Standing-up pattern
timeFrame: On day 10 after the last training session
Other outcomes:
measure: Berg Balance Scale
timeFrame: On day 10 after the last training session
measure: 6-Minute Walk Test
timeFrame: On day 10 after the last training session
Locations:
city: Ljubljana
country: Slovenia
facility: University Rehabilitation Institute, Republic of Slovenia
Study officials:
affiliation: University Rehabilitation Institute, Republic of Slovenia
name: Helena Burger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04134169: Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202)
Official title: A Multi-center, Open, Long-term Follow-up Study to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis : 5-year Results From the K0202 Extension Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Lead sponsor: Kang Stem Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-22
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderate to Severe Rheumatoid arthritis

Brief summary: Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202)

Detailed description: A Multi-center, Open, Long-term Follow-up Study to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid arthritis: 5-year Results From the K0202 Extension Study

Eligibility criteria: Inclusion Criteria:

1. Subject who enrolled K0202 Clinical Trial(parent study) and has been given more than one medication.
2. Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

1. Any other condition which the investigator judges would make patient unsuitable for study participation

Primary outcomes:
measure: Safety Assessment
timeFrame: 5 years
Secondary outcomes:
measure: 1. Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate
timeFrame: 5 years
measure: 2. Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate
timeFrame: 5 years
measure: change in DAS(Disease activity scores)28-ESR from baseline
timeFrame: 5 years
measure: change in KHAQ(Korean Health assessment questionnaire) from baseline
timeFrame: 5 years
measure: change in CDAI (clinical disease activity index) from baseline
timeFrame: 5 years
measure: change in 100mm Pain VAS(Visual analogue scale) from baseline
timeFrame: 5 years
measure: change in Modified Sharp/Van der Heijde Socre from baseline
timeFrame: 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national University Boramae medical center
Study officials:
References:
Clinical trial NCT03693469: Virtual Reality vs. Standard-of-Care for Comfort During Immunizations in Children
Official title: A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Immunizations in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaccination
Keywords: Virtual Reality
Pain
Anxiety
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Children need routine immunizations which can be a painful procedure associated with pain and anxiety. This is particularly true of children visiting the children's hospital to visit relatives during flu season. No topical anesthetic or oral analgesia is commonly used.

Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.

This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care while receiving immunizations. Investigators will measure pain, anxiety and satisfaction.


Eligibility criteria: Inclusion Criteria:

1. Children age 6 to 16 years
2. Patients arriving to the immunization clinic for immunization.
3. Parents will sign a consent form and children will sign an assent form

Exclusion Criteria:

1. Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay)
2. Facial features or injury prohibiting wearing the VR goggles
3. VR system may interfere with immunization

Primary outcomes:
measure: Pain using the Faces Pain Scale - Revised
timeFrame: Pain is reported by children immediately following completion of the immunization (within two minutes post-immunization). This scale should take less than one minute to complete.
Secondary outcomes:
measure: Anxiety using the Venham Situational Anxiety Score
timeFrame: Anxiety is reported by children immediately following completion of the immunization (within two minutes post-immunization). This scale should take less than one minute to complete.
measure: Patient Satisfaction determined by Global Rating Scale
timeFrame: Satisfaction question is reported by children immediately following completion of the immunization (within 5 minutes post immunization)
measure: Medication Dose
timeFrame: These will be recorded during the procedure and immediately following the procedure using the patient chart
measure: Length of time of procedure
timeFrame: This will be documented during the procedure
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Ran Goldman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02064569: Safety Evaluation of Gene Therapy in Leber Hereditary Optic Neuropathy (LHON) Patients
Official title: An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Tolerability of GS010 (rAAV2/2-ND4) in Patients With Leber Hereditary Optic Neuropathy Due to Mutations in the Mitochondrial NADH Dehydrogenase 4 Gene
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leber Hereditary Optic Neuropathy
Lead sponsor: GenSight Biologics
Sponsor class: INDUSTRY
First posted: 2014-02-17
Enrollment: 19
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: The purpose of this study is to evaluate the safety and tolerability profile of ascending doses of GS010 in Leber Hereditary Optic Neuropathy (LHON) patients.


Eligibility criteria: Inclusion Criteria:

Documented diagnosis of LHON based on a genetic test confirming the presence of the G11778A mutation in the mitochondrial ND4

Age 18 years old or older at the time of study entry (informed consent signature)

Visual acuity ≤ 1/10 of the less functional eye

Exclusion Criteria:

Any known allergy or hypersensibility to one of the product used during the trial

Contraindication to IVT surgery (anaemia Hb \<8g/dl, severe cardiovascular disease, severe coagulopathy...)

Disorder of the ocular humors and of the internal retina involving visual disability

Glaucoma

Presence of other pathology whose symptoms or associated treatments might affect the retina or the optic nerve Vascular retinal occlusion

Narrow angle contra-indicating pupillary dilation

Other cause of optic neuropathy (inflammatory conditions or exposure to toxins...)

Patients presenting known mutation of other genes implicated in pathological retinal conditions

Primary outcomes:
measure: Incidence of local and general adverse events and Serious Adverse Events
timeFrame: Up to 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: CIC du CHNO DES QUINZE-VINGTS
Study officials:
affiliation: CIC CHNO DES QUINZE VINGTS
name: CATHERINE VIGNAL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00387569: Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers
Official title: A Randomized, Observer-Blinded, Parallel-Group, Active-Control, Phase 1/2 Trial of the Safety, Immunogenicity, and Tolerability of 20 µg, 60 µg, and 200 µg of Meningococcal Group B rLP2086 Vaccine in Healthy Adolescents Aged 10 to 12 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Toddlers
Vaccine
Safety
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-13
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A study to assess the safety of an investigational meningitis vaccine in toddlers and their immune response to it.


Eligibility criteria: Inclusion Criteria

* Aged 18- to 36-months
* Healthy male or female subjects

Exclusion Criteria

* Prior vaccination with a serogroup B meningococcal vaccine
* Prior history of any invasive meningococcal disease

Primary outcomes:
measure: Local and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months
timeFrame: Vaccinations at 0,1,6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Perth
country: Australia
state: Western Australia
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Australia, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01574469: Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (France)
Official title: Effect of Low-fat, Fermented Milk Enriched With Plant Sterols on Serum Lipid Profile in Moderate Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mildly Hypercholesterolemic Subjects
Keywords: Plant sterol - Cholesterol absorption - diet - dairy - LDL
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to investigate the effect on cholesterolemia profile of a low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in mildly hypercholesterolemic people treated or not by statins.


Eligibility criteria: Inclusion Criteria:

* male and female aged 18-75 years; BMI between 19 and 30 kg/m2 , LDL-cholesterol plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without statin monotherapy and without any other hypocholesterolemic treatment, accepting to follow the AFSSAPS dietary recommendations for hypercholesterolemic patients, affiliated to a health coverage system, agreeing to a written informed consent

Exclusion Criteria:

* Subject with plasma triglycerides (TG) levels\>250 mg/dL, with any cardiovascular event in the last 6 months, taking any hypocholesterolemic treatment) other than statin in monotherapy, Diabetic (type I and type II), receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, with any acute or chronic disease which could impact on results of the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
Study officials:
References: