louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00605085: Safety and Tolerability of the Japanese Encephalitis Vaccine IC51
Official title: Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Japanese Encephalitis
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
First posted: 2008-01-30
Enrollment: 2675
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged \> or = 18 years


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Written informed consent obtained prior to study entry

Exclusion Criteria:

* Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
* History of any previous JE vaccination (e.g. JE-VAX®)
* Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
* A family history of congenital or hereditary immunodeficiency
* History of autoimmune disease
* Any acute infections within 2 weeks prior to enrollment
* Known or suspected HIV Infection
* Pregnancy, lactation or unreliable contraception in female subjects

Primary outcomes:
measure: Safety and Tolerability up to Day 56
timeFrame: Day 56
Secondary outcomes:
measure: Rates of Serious Adverse Events and Medically Attended Adverse Events
timeFrame: until Day 56
measure: Changes in Laboratory Parameters
timeFrame: until Day 56
measure: SCR and GMT of Subjects With Concomitant Vaccinations
timeFrame: until Day 56
Other outcomes:
Locations:
Study officials:
affiliation: Valneva Austria GmbH
name: Astrid Kaltenboeck, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02330185: Comparison of Two Anatomic Landmarks With Ultrasonography in Spinal Anesthesia
Official title: Phase IV Study of Landmarks for Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthropathy of Knee
Keywords: spinal anesthesia
ultrasonography
anatomical landmark
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2015-01-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The most used anatomical landmark for application of spinal anesthesia is Tuffier's line. Other alternative landmark is tenth rib. However there is no trial that compare these landmarks based on using ultrasonography.

Detailed description: The investigators aim to compare two landmarks (Tuffier's line and tenth rib line) for accuracy by using ultrasonography. 40 patients will be included in each groups. all of them will be assessed by ultrasonography during application of spinal anesthesia. And the investigators will examine the percentage of successful estimation of correct vertebral space.

Eligibility criteria: Inclusion Criteria:

* knee arthroscopic surgery

Exclusion Criteria:

* BMI\>30
* anatomical anomaly of vertebrae

Primary outcomes:
measure: success of estimation the correct vertebral space
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: anesthesiology and reanimation
name: dilek yazıcıoğlu
role: STUDY_CHAIR
References:
citation: Jung CW, Bahk JH, Lee JH, Lim YJ. The tenth rib line as a new landmark of the lumbar vertebral level during spinal block. Anaesthesia. 2004 Apr;59(4):359-63. doi: 10.1111/j.1365-2044.2004.03657.x.
Clinical trial NCT06059885: Tislelizumab Plus TKI as Adjuvant Therapy Versus Active Surveillance in Patients With HCC
Official title: Tislelizumab Plus Tyrosine Kinase Inhibitor (TKI) as Adjuvant Therapy Versus Active Surveillance in Patients With HCC at High Risk of Recurrence After Curative Ablation: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Liver Neoplasms
Keywords: HCC
Liver Cancer
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Ablation is important radical treatment in hepatocellular carcinoma (HCC). However, the 5-year recurrence rate of HCC after ablation is up to 80%. Early and late recurrences are more likely related to tumor size, tumor multiplicity, vascular invasion, higher serum AFP level and disease etiology, etc. Some studies suggested that adjuvant immunotherapy might be associated with decreased recurrence and prolonged RFS. Adjuvant atezolizumab + bevacizumab (IMbrave 050) showed RFS improvement following curative resection or ablation. Currently, there is limited study on immunotherapy combined with TKI as postoperative adjuvant therapy for HCC. This is an open-label, prospective cohort study to compare the efficacy and safety of tislelizumab plus tyrosine kinase inhibitor (TKI) as adjuvant therapy versus active surveillance in HCC patients with high risk of recurrence after curative ablation.


Eligibility criteria: Inclusion Criteria:

* Eligible patients are ≥18 years, diagnosed with HCC confirmed by histopathology or cytology, with no prior targeted or immune checkpoint therapy for HCC, and have undergone curative ablation with no residual lesions according to imaging or pathological assessment. Patients are at high risk of recurrence meeting one of the following criteria:

solitary tumor \>2cm but ≤5cm, or multiple tumors ≤4tumors and all≤5cm； poor tumor differentiation； macrovascular invasion of the portal vein(Vp1/Vp2) ； the absence or infiltration of a tumor capsule ； AFP≥32ng/ml； HBV DNA ≥105IU/ml； history of recurrence after curative treatment； family history of tumors.

Exclusion Criteria:

Concurrent with other primary malignant tumors; severe coagulation dysfunction or severe thrombocytopenic purpura; There is serious infection or organ failure; have previously received targeted drugs or other PD-1 antibody therapy;

Primary outcomes:
measure: Tumor recurrence rate (DRR)
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 Hospital
state: Beijing
Study officials:
affiliation: 302 Hospital Beijing, China
name: Fanping Meng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04436185: Effectiveness of Different Non-pharmacological Methods in Pain Management During Vaccination.
Official title: Conducted to Determine and Compare the Effectiveness of Different Non-pharmacological Methods in Pain Management During Vaccination.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pain
infants
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 175
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed as a randomized experimental study with placebo and control groups in order to compare the effects of ShotBlocker® and sucrose on pain reduction during vaccine injections.
Primary purpose: PREVENTION

Brief summary: Aim: This study was conducted to determine and compare the effectiveness of different non-pharmacological methods in pain management during vaccination.

Methods: This randomized experimental study with placebo and control groups was conducted with 175 infants assigned to the ShotBlocker® (n = 35), ShotBlocker®-placebo (n = 35), sucrose (n = 35), sucrose-placebo (n = 35) and control (n = 35) groups. The pain levels of the infants were determined by blind assessors (nurses, parents, and observer) using the Neonatal Infant Pain Scale (NIPS) before and during vaccination.


Eligibility criteria: Inclusion Criteria:

* Born at full term
* No infection, redness, deteriorated skin integrity, or nerve damage in the area of application
* Had not undergone any clinical injection.

Exclusion Criteria:

* Infants who have applied analgesics before the vaccination

Primary outcomes:
measure: Neonatal Infant Pain Scale (NIPS)
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: İnonu Üniversity
Study officials:
References:
Clinical trial NCT03232385: Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/MR)
Official title: Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/MR)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Renal Biopsy or Ablation
Lead sponsor: Clear Guide Medical
Sponsor class: INDUSTRY
Collaborators: name: University of Maryland
First posted: 2017-07-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this research is to evaluate functional validation of the MR-US fusion for the Clear Guide SCENERGY system, as well as to evaluate benefits derived from system performance.

Detailed description: Human subjects are proposed to validate the MR-US fusion aspects of the Clear Guide SCENERGY product. For these modalities, Clear Guide Medical will work with the subcontract PI to determine the appropriate clinical procedure to evaluate (1) functional validation of the fusion system and (2) benefits derived from system performance. The selected procedure must be a single-patient interaction (i.e., no follow-up visits). Clinical studies will require approval through the subcontract's IRB. The Clear Guide SCENERGY will be compared to standard clinical practice (either no fusion or an electromagnetic-based fusion system). Clear Guide Medical plans to determine sample size based upon statistical powering for a predetermined clinically-meaningful difference (delta). This delta has not been selected, because this depends on the procedure selected. The anticipated sample size is expected to be around 100 subjects (i.e., 50 per arm), per modality. Blinding will be used, where possible. Clinician-related endpoints cannot be blinded due to obvious equipment differences. Subjects will be placed into treatment group by random. Retention strategies are unnecessary, as there will not be any planned follow-up visits or activities.

Eligibility criteria: Inclusion Criteria:

* Undergoing radiological, oncological, or urological intervention procedures
* Able to give written informed consent

Exclusion Criteria:

* Unable to give informed consent
* Vulnerable populations and children

Primary outcomes:
measure: Success of Needle Placement
timeFrame: Immediately following intervention (within 2 hours)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05337085: Comparison of Dexmedetomidine and Midazolam for Intra-op Sedation in TIVA in Children Undergoing Inguinal Hernia Repair
Official title: To Compare Dexmedetomidine and Midazolam for Intra-op Sedation in TIVA in Children Undergoing Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Inguinal Hernia
Lead sponsor: Sheikh Zayed Medical College
Sponsor class: OTHER_GOV
First posted: 2022-04-20
Enrollment: 185
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To compare dexmedetomidine and midazolam for intra-op sedation in TIVA in children undergoing inguinal hernia repair. The results of the study if found significant will guide the anesthetist in appropriate choice and dose of sedative drug with highest efficacy and minimum side effects to avoid post operative adverse effects associated with anesthesia


Eligibility criteria: Inclusion Criteria:

* Male and female paediatric patients In age range neonates to 15 years
* Planned for elective inguinal hernia repair
* Patients with uncomplicated hernia With ASA class I or II

Exclusion Criteria:

* Patients undergoing emergency inguinal repair
* Patients with ASA class III,IV,V or VI
* Patients present with complicated hernia
* Patients with BMI above 40kg/m2
* Patients with any allergy to anesthesia
* Patients with coagulopathy
* Patients with narcotic/opioid addiction

Primary outcomes:
measure: Level of sedation assessed through Ramsay Sedation Scale RSS
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05986656: X-ray Evaluation of the Effectiveness of the Atlas Correction in Patients With Chronic Subluxation of the Atlas
Official title: X-ray Assessment of the Effectiveness of Hardware Medical Acupressure of the Suboccipital Muscles According to the "Atlas-Standard" Method in Patients With Chronic Subluxation of the First Cervical Vertebra
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subluxation and Dislocation of C0/C1 Cervical Vertebrae
Lead sponsor: Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of the procedure of medical acupressure of the suboccipital muscles according to the Atlas-Standard method on the normalization of the position of the first cervical vertebra and the angles of the spinal column in patients with diagnosed chronic subluxation with objectification of the results by radiography and inclinometry.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic subluxation of the first cervical vertebra with complaints of pain in the occiput/cervical/thoracic/lumbar spine/limitation of head rotation in one or both directions.
* Scoliotic deformity of the spine 1-2 degrees.

Exclusion Criteria:

* Pregnancy
* Fractures of the first / second cervical vertebra in history
* Fractures of the spine in any of the departments in the anmenesis
* Assimilation of the atlas with the occipital bone or the second cervical vertebra
* Operations on the spine using metal structures
* Scoliosis 3-4 degree
* Botulinum toxin injections in the suboccipital region within the last year
* Taking muscle relaxants
* Corrective surgery on muscles and bones
* Braces
* Active period of dental implants installation
* Postoperative period (any operation, including on the eyes) less than 6 months
* Acute infectious diseases - less than 2 weeks from the start of recovery
* Skin diseases with inflammatory manifestations in the neck
* Oncological diseases
* Recovery period after injury (cervical and brain injury) or stroke less than a year
* Established mental illness
* Extreme malnutrition (cachexia)

Primary outcomes:
measure: Distance between righr and left inner surface of the lateral mass of the atlas and the outer surface of the odontoid process of the axis on x-ray
timeFrame: 1 month.
Secondary outcomes:
measure: Pain level
timeFrame: 6 month
measure: Painkillers
timeFrame: 6 month
measure: The functional disability
timeFrame: 6 month
measure: Changes in the angles of deviation of the spinous processes
timeFrame: 6 month
measure: Changes in the range of motion of the spine
timeFrame: 6 month
Other outcomes:
Locations:
city: Astrakhan
country: Russian Federation
facility: Astrakhan Regional Clinical Hospital
Study officials:
affiliation: South Ural Medical University
name: Denis Borsuk
role: STUDY_CHAIR
References:
Clinical trial NCT02545556: Liver Cancer HepaSphere Combined With Cryosurgery
Official title: HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）Combined With Cryosurgery for Liver Cancer: Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Liver Cancer
Keywords: Liver Cancer
HepaSphere
cryosurgery
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）combined with cryosurgery for liver cancer.

Detailed description: By enrolling patients with liver cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA） combined with cryosurgery for liver cancer.

Eligibility criteria: Inclusion Criteria:

1. Age:18-80
2. Karnofsky performance status \>60
3. Diagnosis of pancreatic cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive interventional therapy
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except liver cancer
2. History of coagulation disorders or anemia

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of lesions interventional therapy that show no sign of recurrence 12 months after
timeFrame: 1 year
measure: Progress free disease (PFS)
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 3 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Central laboratory in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PhD
role: STUDY_CHAIR
References:
citation: Niu L, Chen J, Yao F, Zhou L, Zhang C, Wen W, Bi X, Hu Y, Piao X, Jiang F, Zeng J, Liu W, Li J, He L, Mu F, Zuo J, Xu K. Percutaneous cryoablation for stage IV lung cancer: a retrospective analysis. Cryobiology. 2013 Oct;67(2):151-5. doi: 10.1016/j.cryobiol.2013.06.005. Epub 2013 Jun 24.
Clinical trial NCT01856556: Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers
Official title: A Randomized, Double-Blind, Placebo-Controlled Single Intravenous and Oral Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: safety
tolerability
pharmacokinetics
Lead sponsor: Naurex, Inc, an affiliate of Allergan plc
Sponsor class: INDUSTRY
First posted: 2013-05-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety and tolerability of a single intravenous (IV) and oral (PO) ascending dose of NRX-1074 as evidenced by the incidence and severity of adverse events (AEs), changes in serum chemistry, hematology, and urinalysis, changes in physical examination findings and subject-reported symptoms.

The secondary objectives of this study are to assess the plasma and cerebrospinal fluid (CSF) pharmacokinetics (PK), the oral bioavailability of experimental formulations and the renal elimination through urine concentration of NRX-1074 through 24 hours following dosing.

Detailed description: Randomized, double-blind, placebo-controlled, single ascending dose level study. On Day 1, eligibility of each subject will be confirmed, physical examination will be performed, and blood and urine for laboratories will be obtained. Each subject will be randomized, then will receive either a single IV, SC or IN dose of GLYX-13 or placebo.

Eligibility criteria: Inclusion Criteria:

1. Male and female subjects
2. Aged 18 to 55 years
3. For female subjects, surgically sterile or at least 2 years menopausal, or using an acceptable method of birth control from date of screening to at least 30 days after the last dose of study drugIf of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours prior to dosing.
4. Clinical laboratory values less than or equal to 2 times the upper limit of normal (ULN) or deemed not clinically significant by the Investigator.
5. Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.

Exclusion Criteria:

Primary outcomes:
measure: Observed and laboratory-confirmed safety
timeFrame: 28 days
Secondary outcomes:
measure: Plasma concentration of parent drug will be assessed over time to estimate duration of pharmacodynamics in future efficacy trials. Plasma concentration and pharmacokinetics will be related in time to observed side effects.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Lotus Clinical Research
state: California
Study officials:
affiliation: Lotus Clinical Research
name: Grace Ting, MD
role: PRINCIPAL_INVESTIGATOR
References: