louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06263465: Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis
Official title: Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bacterial Vaginosis
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: ZhuHai Hospital
First posted: 2024-02-16
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study was to explore the efficacy and safety of a new vaginal microbiome transplantation technique, using Lactobacillus cispatus from healthy donors as a treatment of bacterial vaginosis.

Detailed description: The volunteers will be recruited from the women who come to the hospital to do the bacterial vaginosis test. After being informed about the potential risks, each volunteer giving written informed consent will be asked to complete a questionnaire.

Then, posterior fornix of vagina secretions will be taken from each volunteer to perform 16S rRNA gene sequencing microecology assessment , Clue cell detection and amine test.

After 2weeks ,1 month ,3 months,6 months,12 monthssince the entry, each volunteer will be asked to go back to research center to do the same sampling and examination as previously did in entry.

Eligibility criteria: Inclusion Criteria:

1. History of sexual behaviour 2.18-55 years old 3. Women were diagnosed as bacterial vaginosis

Exclusion Criteria:

1. During pregnancy, or within 8 weeks after delivery;
2. presence of systemic diseases (such as SLE, malignant tumors, etc.)

Primary outcomes:
measure: BV recurrence rate
timeFrame: month 12
Secondary outcomes:
measure: vaginal secretions 16s rRNA gene sequencing
timeFrame: 2 weeks，month 1，month 3、month 6、month 12
measure: BV recurrence rate
timeFrame: 2 weeks，month 1，month 3、month 6
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: Zhuhai People'S Hospital
state: Guangdong
Study officials:
affiliation: Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University
name: Hongwei Zhou, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03166865: Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis
Official title: Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis (OA)
mesenchymal stem cells(MSC)
Lead sponsor: Liaocheng People's Hospital
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoarthritis (OA) is one of the most common joint diseases that is considered a chronic degenerative disorder. There is no effective therapy available today. This prospective clinical trial is designed in an attempt to study the efficacy of mesenchymal stem cells with platelet rich plasma in knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* 30-70 years old.
* No serious infection, chronic diseases, diabetes and tuberculosis.
* Osteoarthritis of the knee with grade1-3 defined by the modified Kellgren-Lawrence classification.
* Written informed consents were obtained from all subjects.

Exclusion Criteria:

* Pregnant women or cognitively impaired adults.
* Inflammatory or post infectious arthritis.
* Intra-articular drug injection within the previous 2 months.
* Serious medical illness with a life expectancy of less than 1 year.
* Prior admission for substance abuse.
* Arthroscopy during the previous 6 months.
* Systemic autoimmune rheumatic disease.
* Poorly controlled diabetes mellitus.
* Immunosuppressive or anticoagulant treatments.
* Treatment with corticosteroids in the 3 months prior to inclusion in the study.
* NSAID therapy within 15 days prior to inclusion in the study.

Primary outcomes:
measure: Change From Baseline in visual analogue scale (VAS)
timeFrame: Baseline, 1, 3, 6 and 12 weeks
measure: Change From Baseline in western Ontario and McMaster Universities Osteoarthritis Index score
timeFrame: Baseline, 1, 3, 6 and 12 weeks
measure: Change From Baseline in knee society score (KSS)
timeFrame: Baseline, 1, 3, 6 and 12 weeks
measure: Change From Baseline in MOS item short from health survey(SF-36)
timeFrame: Baseline, 1, 3, 6 and 12 weeks
Secondary outcomes:
measure: The number of cartilage defects, thickness of cartilage evaluated by X-ray and MRI
timeFrame: Baseline, 1, 3, 6 and 12 weeks
measure: The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid
timeFrame: Baseline, 1, 3, 6 and 12 weeks
Other outcomes:
Locations:
city: Liaocheng
country: China
facility: Liaocheng city people's hospital
state: Shandong
Study officials:
affiliation: Liaocheng People's Hospital
name: Dawang Wang, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03805165: Associations of Nighttime Light Exposure During Pregnancy With Neonatal Jaundice：a Multi-centre Prospective Study in China
Official title: Associations of Nighttime Light Exposure During Pregnancy With Neonatal Jaundice：a Multi-centre Prospective Study in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Jaundice, Neonatal
Keywords: nighttime light exposure ，neonatal jaundice，China
Lead sponsor: Guangdong Women and Children Hospital
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 2977
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Term and near term newborns, whos gestational age was more than 35 weeks(≥35)

Brief summary: Make a neonatal jaundiced nomogram on Chinese jaundice data by joinning the major neonate centers all around China.

Detailed description: This was a multi-centre prospective study. All infants included were born in 8 hospitals in the southern, eastern, northern, western and central regions of mainland China in 2019. A total of 20839 transcutaneous bilirubin(TCB) measurements were performed with 2977 neonates at designated time points. The mean NTL exposure during pregnancy was respectively calculated based on each participant's residential address over the study course. The primary outcome was whether the neonate was diagnosed with hyperbilirubinemia within the first seven days of life. The effect of maternal nocturnal light exposure on neonate jaundice analyzed with lasso regression and random forest machine learning methods.

Eligibility criteria: Inclusion Criteria:

gestational age more than 35 weeks(≥35) -

Exclusion Criteria:

all kinds of congenital diseases, infants with pathologic jaundice

-

Primary outcomes:
measure: Hour-specific Transcutaneous Bilirubin Level
timeFrame: 1 year
measure: whether the neonate was diagnosed with hyperbilirubinemia within the first seven days of life
timeFrame: 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jie Yang
state: Guangdong
Study officials:
References:
Clinical trial NCT05792865: A Registry Study of Patients Hospitalized With Confirmed COVID-19
Official title: A Registry Study of Patients Hospitalized With Confirmed COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: Hospitalized
paxlovid
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will focus on COVID-19 infected patients who are admitted to the Beijing Chaoyang Hospital, affiliated with Capital Medical University, from November 15th, 2022 to March 30th, 2023.

Brief summary: The design of this registered study aims to evaluate the efficacy and safety of Paxlovid in the treatment of hospitalized COVID-19 patients, and to explore factors related to the efficacy and safety of Paxlovid.


Eligibility criteria: Inclusion Criteria:

1. Confirmed diagnosis of COVID-19 infection.
2. Presence of at least one high-risk factor, including age ≥60 years, diabetes, hypertension, cardiovascular disease, stroke, chronic liver or kidney disease, cancer, history of smoking or obesity.

Exclusion Criteria:

* No specific exclusion criteria in this study.

Primary outcomes:
measure: Disease progression rates
timeFrame: up to 28 days
Secondary outcomes:
measure: all-cause deaths rates
timeFrame: up to 28 days
measure: rehospitalization event rates
timeFrame: up to 28 days
measure: COVID-19 repositive event rates
timeFrame: up to 28 days
measure: adverse drug reaction event
timeFrame: up to 28 days
measure: thromboembolic event rates
timeFrame: up to 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Yi Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Chao Yang Hospital
name: Zhuoling An, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Chao Yang Hospital
name: Chaohui Tong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05818865: "Principle Test" for Isolation and Characterization of Circulating Cancer Cells (CTC)-CXCR4+.
Official title: "Principle Test" for Isolation and Characterization of Cancer Cells (CTC)-CXCR4+ Circulating in Belotero Loaded With CXCL12 in Patients With Solid Neoplasms (Endometrium, Kidney, Glioblastoma, Colorectal, Ovary and Lung).
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neoplasm Malignant
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The development of an innovative device (CLG) consisting of an aqueous gel based on hyaluronic acid and commercially available (Belotero) able to be loaded and to release chemokine CXCL12 recreating a kind of "fake niche" able to attract immune cells- and CTCs-CXCR4+. The added value is the ability to attract and trap cells capable of leaking out and potentially with a higher metastatic capacity.
Primary purpose: TREATMENT

Brief summary: This is multicentric, interventional, non farmacological and prospective study.

Detailed description: The new CLG platform, a prototype owned by IRCCS Pascale Institute, is able to reconstruct a PMN for the capture of CTCs able to extravasare and colonize tissues at distance, a fundamental requirement to begin the process of metastasis formation. The purpose of the study is to evaluate in vitro the effectiveness of CLG in the isolation, recovery and subsequent molecular characterization of CTCs from peripheral blood of patients suffering from solid neoplasms (endometrium, kidney, colorectal, glioblastoma and lung).

Eligibility criteria: Inclusion Criteria:

* Age ≥18
* Signature of Informed Consent
* Advanced solid neoplasm with metastases

Exclusion Criteria:

* Age \<18
* Refusal to sign informed consent

Primary outcomes:
measure: In vitro isolation of CTCs.
timeFrame: 2 years
measure: Real-Time PCR to evaluate the expression of Epithelium-Mesenchymal Markers
timeFrame: 2 years
Secondary outcomes:
measure: The correlation of the number and of biological/molecular characteristics of CTCs with the clinical/pathological characteristics of the patients in analysis and their prognosis.
timeFrame: 2 years
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Istitute Nazionale Tumori - Fondazione G. Pascale
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS
Study officials:
affiliation: IRCCS I.N.T. "G. Pascale"
name: Luigi Portella
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02572765: Evaluation of Splenic Metabolic Activity With 18FDG-PET in Hypertension
Official title: Evaluation of Splenic Metabolic Activity With 18FDG-PET in Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2015-10-09
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be selected from patients who will undergo FDG-PET/CT imaging of chest and abdomen in the Department of Nuclear Medicine of IRCCS Neuromed, accordingly to the following inclusion/exclusion criteria. All the enrolled patients must have an indication for FDG-PET/CT. Approximately 120 hypertensive and normotensive subjects of both genders (at least 45 per group, in order to have the appropriate statistical power) will be included in the study.

Brief summary: The purpose of this study is to evaluate the splenic activation in hypertensive patients, as compared to normotensives, using FDG-PET/CT imaging. Moreover, the investigators will investigate whether the splenic metabolic activity relates to the expression of circulating inflammatory proteins (high-sensitivity C-reactive protein \[hsCRP\]), interleukin-1b (IL-1b), tumor necrosis factor-a (TNF-a) or to immune profiles of activated T cells.


Eligibility criteria: Inclusion Criteria:

* absence of prior cancer diagnosis or remission from cancer at the time of FDG-PET/CT imaging (from at least 6 months)
* age ≥ 30 and ≤ 85 years
* absence of acute cardio/cerebrovascular disease (myocardial infarction, stroke, transient ischemic attack, revascularization)
* absence of acute or chronic inflammatory or autoimmune disease
* diagnosis of presence/absence of hypertension, on the basis of documented medical history

Exclusion Criteria:

* diabetes
* atrial fibrillation
* use of anti-inflammatory drugs in the week preceding the FDG-PET/CT imaging
* chronic use of anti-inflammatory drugs

Primary outcomes:
measure: Splenic metabolic activity
timeFrame: At enrollment
Secondary outcomes:
measure: Circulating pro-inflammatory markers
timeFrame: At enrollment
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCCS Neuromed
state: (is)
Study officials:
References:
Clinical trial NCT01677065: A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers
Official title: An Open-label, Single-dose, Randomized, Two-way Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Bioavailability
Oxycodone
Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-08-31
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers

Brief summary: To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.

Detailed description: Serial sampling of venous blood

Eligibility criteria: Inclusion Criteria:

* healthy volunteers, greater than 50 kg, able and willing to sign informed consent

Exclusion Criteria:

* Evidence of significant illness, condition affecting drug absorption, history of sleep apnea, and allergy to opioid drugs

Primary outcomes:
measure: pharmacokinetic endpoints - area under the concentration curve (AUC)
timeFrame: 0-48 hr
Secondary outcomes:
measure: Peak concentration (Cmax) and time to peak concentration (Tmax)
timeFrame: 0-48 hr
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02770365: Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrophy
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
Collaborators: name: Impax Laboratories, LLC
First posted: 2016-05-12
Enrollment: 695
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of vulvar and vaginal atrophy.


Eligibility criteria: Inclusion Criteria:

* postmenopausal female and otherwise healthy, 30 - 75 years of age.
* ≤ 5% superficial cells on vaginal smear cytology at Visit 1/Screening.
* vaginal pH \> 5.0 at Visit 1/Screening
* Have at least one self-assessed moderate to severe symptom of Vulvar and Vaginal Atrophy identified by the subject as being the most bothersome
* For women with an intact uterus, vaginal ultrasonography confirmation at Visit 1/Screening of an inactive endometrial lining with an endometrial thickness less than 4 mm.
* Systolic blood pressure no greater than 150 mm Hg and diastolic blood pressure no greater than 90 mm Hg at Visit 1/Screening and at Visit 2/Randomization

Exclusion Criteria:

* Undiagnosed vaginal bleeding or a history of significant risk factors for endometrial cancer.
* Known, suspected, or history of cancer of the breast or mammogram indicating any abnormalities or subject has a history of cervical cancer.
* Vaginal ultrasonography for all women with an intact uterus confirming endometrial thickness of 4mm or more
* History of hypersensitivity or allergy to estradiol or any of the other study medication ingredients.
* Known or suspected estrogen-dependent neoplasia.
* Has deep vein thrombosis, pulmonary embolism or history of these conditions.

  • Subject has active arterial thromboembolic disease (e. g. stroke, myocardial infarction) or history of these conditions.
* Known acute or chronic hepatic disease or dysfunction

Primary outcomes:
measure: Percentage of Subjects Identified as Responders
timeFrame: Day 8
Secondary outcomes:
measure: Most Bothersome Symptom
timeFrame: Day 8
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
Study officials:
References:
Clinical trial NCT01457365: Vitamin D Deficiency Epidemiological Research in Sichuan, China
Official title: Vitamin D Status and Its Correlation to Bone Density, Bone Turnover Markers and Muscle Function in Community-dwelling People in Sichuan Province , P.R. China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2011-10-21
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: In total, 1500 female subjects aged more than 30 years old (750 urban and 750 rural females) will be included

Brief summary: Vitamin D insufficiency and deficiency is pandemic in the world.Sichuan Basin has a subtropical monsoon climate with China's lowest sunshine totals. Inferably, the prevalence of vitamin D insufficiency/deficiency in Sichuan basin is high, and possibly the highest in China. This study will research the serum 25OHD level to get the prevalence of vitamin D deficiency and insufficiency of urban and rural residents in Sichuan Province, China.


Eligibility criteria: Inclusion Criteria:

* Females aged 30 years old living in Sichuan province.

Primary outcomes:
measure: Serum 25OHD
timeFrame: 0 day.
measure: serum calcium and phosphate, creatinine, PTH, BALP and CTX
timeFrame: 0 day
measure: Bone mineral density of lumbar spine and hip
timeFrame: 0 day.
measure: Short physical performance battery
timeFrame: 0 day.
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China hospital, Sicuhuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT06035965: Comparison of Quality of Life and Changes Experienced by Patients After Epilepsy Surgery
Official title: Comparison of Quality of Life and Changes Experienced by Patients After Epilepsy Surgery, With Long-term Epileptological Objective Results
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 160
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient operated in the context of epilepsy surgery dating back more than 2 years in the epileptology center of the Toulouse University Hospital.

Brief summary: Epilepsy is one of the most common chronic neurological diseases. According to data from the World Health Organization (WHO), it affects 0.5 to 1% of the population, or around 70 million people world-wide and around 600,000 in France. There are several more or less severe forms of epilepsy depending on the type of epileptic seizures and the frequency of these seizures. About 30% of epileptic patients respond poorly to well-conducted medical treatment, which makes the number of so-called "drug-resistant" patients estimated at between 100,000 and 150,000 patients.

Epilepsy surgery is possible in some cases of drug-resistant epilepsy and can lead to complete seizure control. Beyond the impact on the control of seizures, surgery can have an impact on the lives of patients at the psychological, emotional and cognitive level, with consequences on their socio-professional but also personal life. Thus the impact on the daily life of patients after epilepsy surgery can vary greatly from one patient to another and the personal feelings of operated patients do not always seem to correspond to the objective elements collected by doctors. 2.3 The investigators want to retrospectively assess the satisfaction and quality of life of patients operated on for more than 2 years based on their epileptological results (frequency of seizures).


Eligibility criteria: Inclusion Criteria:

* Patient operated in the context of epilepsy surgery dating back more than 2 years in the epileptology center of the Toulouse University Hospital.
* Patient covered by a social security scheme.
* Patient having given his non-objection to participate in the research.

Exclusion Criteria:

* Minor under the age of 15 at the time of the questionnaires.
* Serious psychiatric pathology unrelated to epilepsy surgery.
* Severe intellectual disability limiting responses to self-questionnaires.
* Language barrier.
* Patients under guardianship and protection of justice.

Primary outcomes:
measure: Evaluation of the changes felt by patients
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: HELENE MIRABEL
role: PRINCIPAL_INVESTIGATOR
References: