louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06372665: Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization
Official title: Safety Observation of the Vero Cell-derived Inactivated Japanese Encephalitis Vaccine (JEV-I) Given With Primary Immunization in a Large Amount of Healthy Children Aged 8 Months and Older
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Japanese Encephalitis
Lead sponsor: Liaoning Chengda Biotechnology CO., LTD
Sponsor class: INDUSTRY
First posted: 2024-04-18
Enrollment: 28547
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children aged 8 months and older who voluntarily receive the research vaccines within Jiangsu Province

Brief summary: This is a single-arm, non-randomized, open-label post-marketing safety observation study. The purpose of this study is to investigate the safety of JEV-I given with primary immunization in a large amount of healthy children aged 8 months and older.

Detailed description: Healthy children aged 8 months and older who choose to receive the study vaccine for primary immunization at their own expense in Jiangsu Province will be invited to participate in this study. No study vaccine will be supplied or administered as part of this study, participants will be monitored following vaccine administration in clinical settings.

The primary immunization program with JEV-I requires 2 intramuscular doses administered 7-10 days apart. All participants will be observed for the incidence of any adverse events (AEs) within 30 minutes and from 30 minutes to 7 days after each vaccination, including local and systemic reactions. Additionally, all participants will be observed for unsolicited AEs within 30 days after after each vaccination.

Eligibility criteria: Inclusion Criteria:

* Healthy children who have received the inactivated Japanese encephalitis vaccine.
* Legal guardian of the participants voluntarily participates in the clinical trial and signs an informed consent form.
* Legal guardian of the subject has the ability to understand the procedures of the study and accept all scheduled visits.

Exclusion Criteria:

-

Primary outcomes:
measure: Number of Participants Reporting Solicited Local and Systemic Adverse Events, and Unsolicited Adverse Events
timeFrame: 30 days following each vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Liaoning Chengda Biotechnology CO., LTD
name: Huanyu Wang
role: STUDY_DIRECTOR
References:
Clinical trial NCT02026765: Clinical Outcomes About Heparin Surface Modified Aspheric Lens
Official title: Clinical Outcomes About Heparin Surface Modified Aspheric Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Reaction
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to obverse the effect of this type lens in the same as traditional aspheric intraocular lens at the same time, whether can further improve the effects of operation.

Detailed description: 1. Heparin surface treatment lens can reduce inflammatory reaction.
2. Modified aspheric lens are more in line with human optical properties than the traditional aspheric lens.
3. To obverse the effect of this type lens in the same as traditional aspheric intraocular lens at the same time, whether can further improve the effects of operation.
4. After one day, one week, one month, three month follow-up，Key observation on the flare, the optical quality, contrast sensitivity and other parameters.Study the postoperative inflammatory reaction with test group lens，and the impact on the visual quality.

Eligibility criteria: Inclusion Criteria:

* Cataract patients

Exclusion Criteria:

* Eyed patients

Primary outcomes:
measure: flare value in the anterior chamber after surgery
timeFrame: six months
Secondary outcomes:
measure: the ocular and the anterior corneal aberration after surgery
timeFrame: six months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Affiliated Eye hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: AYong Yu, MD. PhD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04413565: Infection Rate of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study
Official title: Infection Rate of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infection Joint
Joint Infection
Arthroplasty Complications
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 413
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 use of bilateral total knee replacements (TKR) is increasing with the number of patients with bilateral end-stage knee osteoarthritis. Bilateral TKR can be performed in three different ways: single-stage, two-team simultaneous bilateral TKR (two surgeons bilateral TKR); single-stage, a sequential bilateral TKR (single surgeon bilateral TKR); and two-stage bilateral TKR. Periprosthetic joint (PJI) infections are serious complications after TKR that negatively affect the aimed outcome, decrease patient satisfaction, and increase morbidity and mortality. The incidence of PJI is 1-2% and the number of cases is projected to grow as the indications for TKR continue to increase. Investigators will prospectively compare the incidence of periprosthetic joint infection between groups.

Detailed description: 924 knees (462 participants) will prospectively be randomized into 2 groups: two surgeons bilateral TKA and single surgeon bilateral TKA. While 2 surgeons will perform simultaneous total knee arthroplasty in the two surgeons' bilateral TKA group, one surgeon will perform sequentially in the single surgeon bilateral TKA group. The primary outcome is to compare the incidence of PJI between the groups. Secondary, logistic regression use to estimate the effect of two surgeons bilateral TKA and single surgeon bilateral TKA on the likelihood of a patient being infected.

Eligibility criteria: Inclusion Criteria:

Primary bilateral knee osteoarthritis with refractory to conservative treatment Patients who accept participation in the research and the randomization

Exclusion Criteria:

no history of malignancy without severe extra-articular deformities

Primary outcomes:
measure: Infection incedence
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih
Study officials:
References:
Clinical trial NCT05018065: Sexual Functions and Covid-19
Official title: Evaluation of Women's Sexual Functions After Having Covid-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Sexual Behavior
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2021-08-24
Enrollment: 101
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Sexual health is one the important components of life quality. The aim of this study is to compare sexual dysfunction of women who survived Covid-19 and who didn't undergo Covid-19.

Detailed description: With identifying a new type of coronavirus, the infection disease known as Coronavirus disease-2019 (Covid-19) is still effective worldwide. Within the frame of the description that the health is "a complete physical, mental and social welfare," many physical and mental modality may be expected due to the pandemic and the measures against pandemic. Among them, sexual health is one of the basic indicative factors of human welfare. There are few data on sexual dysfunctions from the previous clinic pandemic experiences. From the very early stages of Covid-19 pandemic, health systems and researches focused on mortalities and short-term morbidities. Although there are similar studies about effects of pandemic on sexual behaviors of general community, there is no comparative study about the effects on sexual functions of women survived from Covid-19 and women having no Covid-19 history, yet. This study aims to compare women survived from Covid-19 and women having no Covid-19 history and having similar characteristics in terms of sexual dysfunctions.

Eligibility criteria: Inclusion Criteria:

* previously diagnosed for mild - medium Covid-19 infection and had ambulatory care
* being sexually active

Exclusion Criteria:

* having psychiatric disease
* having any malignity
* having endometriosis
* having a gynecologic surgery history
* having a previous sexual dysfunction

Primary outcomes:
measure: Sexual function assesment of women previously diagnosed with mild - medium Covid-19 and comparision of results with helath women
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Saglık Bilimleri University Istanbul Gaziosmanpa Trainig and Research Hospital
Study officials:
References:
Clinical trial NCT06502665: Second Ovulation Induction
Official title: Outcomes From Secondary Ovulation Induction Following Failed Oocyte Pick-up IVF Cycles
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: IVF
Infertility
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2024-07-16
Enrollment: 87
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Electronic medical record from 2018 to 2023 of patients having undergone an IVF cycle

Brief summary: Studies reported various risk factors for inadequate ovulation induction such as body mass index, low ovarian reserve, low baseline FSH and LH, and previous use of contraception or agonist.

The flexibility to use human chorionic gonadotropin (hCG) or gonadotropin-releasing hormone agonist (GnRHa) in ovulation induction for antagonist protocol or progestin primed ovarian stimulation (PPOS) is an advantage helping fertility doctors to decrease the risk of ovarian hyperstimulation syndrome. However, luteinizing hormone (LH) levels \<15UI/L and progesterone ≤11.13nmol/L eight to twelve hours post GnRHa trigger were highly correlated to failed oocyte pickup (FOP).

Rescue hCG have been found to increase favorable outcomes in patients with FOP. The presence of false FOP could be due pharmaceutical reasons and human error. Genuine FOP could be due to intrinsic ovarian pathology.

The FOP is defined as the absence of oocytes after ovarian stimulation and follicular aspiration. It is an uncomfortable situation for the patient and medical team to deal with due to the apparent expectations of favorable results.

Ovulation induction could be via GnRHa, HCG, or both in antagonist protocol and PPOS protocol. Long or short agonist protocol could be triggered only via HCG.


Eligibility criteria: Inclusion Criteria:

* Participants with no oocytes retrieved in the first ovum pick-up

Exclusion Criteria:

* Error in trigger medication or timing by the patient/ medical team
* Major absence of information (primary objective, trigger medication, time interval of trigger and ovum pick-up

Primary outcomes:
measure: Oocyte pick-up at retrieval
timeFrame: 36 hours after ovulation triggering
Secondary outcomes:
measure: Timing of ovulation triggering
timeFrame: 24 to 36 hours after ovulation triggering
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Simon Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02988765: Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma
Official title: Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vulvar Cancer
Keywords: vulvar cancer
inguinal lymph node
lymph node status
cytology
core biopsy
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Vulvar cancer is a rare and very aggressive cancer, mainly spreading through lymphatics, in which the preoperative evaluation is critical to address surgery between sentinel node biopsy or radical groin lymphadenectomy.

Detailed description: In the absence of clearly an specific guidelines on preoperative vulvar cancer assessment, the investigators decided to better investigate the role of ultrasound in groin nodes evaluation through the study 10 sonographic features of suspicion for nodal involvement:

* globular shape (loss of the normal elliptical form)
* long/short axis ratio
* cortical/medulla ratio
* cortical focal bulging or thickening
* hilum anomalies
* inhomogeneous echostructure
* intranodal deposits
* extracapsular spread
* grouping
* vascularization

The standard of comparison is histopathology.

The prospectively evaluation of these parameters will be obtained on the enrolled patients.

The investigators also provided the retrospective review - by specialized staff - of ultrasound images collected in archives associated with information relating to the cyto/histological procedures (performed in case of suspicious lymph nodes) in patients who underwent surgical treatment in the last five years at the study center.

Eligibility criteria: Inclusion Criteria:

* Invasive vulvar cancer (all infiltrating histotypes)
* Age \>18 years

Exclusion Criteria:

* patient unable to follow the study procedures
* patient with major depressive disorder

Primary outcomes:
measure: Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of ultrasound morphometry (USM) in the prediction of groin lymph node status
timeFrame: within the first 30 days after surgery
measure: Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of fine needle aspiration in the prediction of groin lymph node status
timeFrame: within the first 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Division of Gynecologic Oncology/Fondazione Policlinico Gemelli
Study officials:
References:
Clinical trial NCT00796965: Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects
Official title: A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Phase 1
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Single Ascending Dose Study


Eligibility criteria: Inclusion Criteria:

* Provision of Informed Consent
* Healthy male subjects and female subjects (of non-child bearing potential) with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria:

* Inability to understand or cooperate with given information
* Positive human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test
* Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology, and urinanalysis

Primary outcomes:
measure: To assess the safety and tolerability of single ascending dose administration of AZD7268 when given orally to healthy male subjects and female subjects of non-childbearing potential.
timeFrame: Safety assessments are made at each visit, at least daily, during the study.
Secondary outcomes:
measure: To characterize the pharmacokinetics of AZD7268 in plasma and urine.
timeFrame: Blood and urine samples will be taken during the study.
measure: To assess the effect of food on the safety and pharmacokinetic profile of AZD7268.
timeFrame: Safety assessments and blood and urine samples will be taken throughout the study.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: AstraZeneca Clinical Pharmacology Unit, US
name: Sylvan Hurewitz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06323265: A Real-world Study of Adebrelimab Combined With Chemotherapy±Chest Radiotherapy in Patients With Extensive Stage Small Cell Lung Cancer
Official title: A Real-world Study of Adebrelimab Combined With Chemotherapy±Chest Radiotherapy in Patients With Extensive Stage Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Extensive Stage Small Cell Lung Cancer
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: extensive stage small cell lung cancer

Brief summary: The purpose of this study is to assess efficacy and safety of patients who receive Adebrelimab combined with chemotherapy±chest radiotherapy as first-line treatment of extensive stage small cell lung cancer in the real world.


Eligibility criteria: Inclusion Criteria:

1. Age:≥18 years old;
2. Patients with extensive stage small cell lung cancer confirmed by histopathology;
3. Normal function of major organs;
4. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

1. Patients with drug allergy sufferers;
2. Serious and uncontrolled organic lesions or infections, such as decompensated heart, lung, kidney failure, etc;
3. History of psychiatric drugs abuse and can't quit or patients with mental disorders;
4. The researchers think inappropriate.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: evaluated in 24 months since the treatment began
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: tumor assessment every 6 weeks since the treatment began，up to 24 months
measure: Disease control rate (DCR)
timeFrame: tumor assessment every 6 weeks since the treatment began，up to 24 months
measure: Duration of Overall Response（DoR）
timeFrame: tumor assessment every 6 weeks since the treatment began，up to 24 months
measure: Overall survival (OS)
timeFrame: the first day of treatment to death or last survival confirm date,up to 24 months
measure: Adverse events
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Jun Wang
state: Hebei
Study officials:
References:
Clinical trial NCT02424565: Effect of Topical Application of Iodex® Balm on Local Surface Temperature
Official title: An Exploratory Study to Assess the Effect of Topical Application of Iodex® Balm on Local Surface Temperature Using Infra Red Thermal Imaging Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-04-23
Enrollment: 15
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The rationale of this study is to map out changes in temperature distribution brought about by topical application of our test product, and use this physiological phenomenon to visualize the onset of action involved in overall mechanism of action of the product.


Eligibility criteria: Inclusion Criteria:

* Participants suffering from chronic osteoarthritis of knee joint (as per American College of Rheumatology criteria) for \> 3 months
* Participants in good general and mental health with no clinically significant and relevant abnormalities of medical history or physical examination

Exclusion Criteria:

* Women of child bearing potential, pregnant and lactating women
* Intolerance/hypersensitivity to study material/ingredient
* Recent history of alcohol or drug abuse
* Participants receiving topical non-steroidal antiinflammatory drugs (NSAIDs), other topical analgesics/counterirritants/mineral oils, or other medication, which might interfere with study results
* Participants having psoriasis/active atopic dermatitis/eczema/skin infected lesions/burn/wound at the site of application

Primary outcomes:
measure: Time to Significant Increase in Local Surface Temperature
timeFrame: Every minute from baseline to 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Indiranagar, Banglador
country: India
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: