louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01810835: Prevention of Hepatitis B Virus Mother-to-child Transmission by Serovaccination.
Official title: Prevention of Hepatitis B Virus (HBV) Mother-to-child Transmission (MTCT): Impact of Serovaccination in Lariboisiere Hospital, Paris, France.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Keywords: HBV mother-to-child transmission
women with HBV DNA > 105 I.U./mL
France
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This monocentre, observational study will include pregnant women whom HBV-DNA is \> 105 IU/mL and who are not currently treated for HBV hepatitis.

Brief summary: The prevalence of HBsAg carriage in pregnant women varies in France, according to the native country, with highest rates in those originating from sub-Saharan Africa and Asia (5 to 8 % in Parisian area). The level of HBV-DNA varies according to HBe status and geographical origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). It has been shown that the rate of vertical transmission (Chinese study by Yuan J et al) was 0 % in newborns to mothers whom HBV-DNA was \< 105 copies/mL and up to more than 40 % in newborns to mothers with high viral loads \> 108 copies/mL, despite HBIg and vaccine at birth. Thus, data are needed concerning the current practices about the prevention of HBV MTCT in France, and their results.

Detailed description: This monocentre, observational study will include pregnant women whom HBV-DNA is \> 105 IU/mL. HBV MTCT rates will be evaluated, according to the level of HBV-DNA in the women during the last three months of pregnancy and at childbirth (between 105 and 108 IU/mL, or \> 108 IU/mL), and according to the clinical practices of serovaccination in the participating center. The evaluation will be based on the rate of HBsAg positivity in infants at 9 months, despite a correct immunization at birth. The rate of detectable HBV-DNA will be also evaluated in infants at the same date.

Eligibility criteria: Inclusion Criteria:

* Pregnant woman
* whom HBs Ag +
* whom HBV-DNA \>105 IU/mL

Exclusion Criteria:

* Women who have to be treated for HBV hepatitis, (AST/ALT \>2 ULN without any explanation, liver biopsy performed before pregnancy showing hepatitis requiring initiation of treatment)

Primary outcomes:
measure: Rate of HBsAg positivity in infants at 9 months, despite a correct immunization at birth
timeFrame: 9 months of life
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
Study officials:
affiliation: Hopital Lariboisiere, Paris, France
name: Pierre O Sellier, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00249535: Vouchers vs. Prizes for Cocaine-Dependent Methadone Patients - 2
Official title: Vouchers vs. Prizes for Cocaine-Dependent Methadone Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Dependence
Keywords: Substance Abuse
Contingency Management
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-11-07
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare voucher-based contingency management (CM) procedures to a lower-cost CM system that provides opportunities to win prizes. Cocaine-dependent outpatients are randomly assigned to (a) standard treatment, (b) standard treatment plus usual magnitude prize CM, (c) standard treatment plus higher magnitude prize CM, or (d) standard treatment plus voucher CM. Urine and breath samples are collected 2-3x/week for 14 weeks. Follow-up interviews are conducted at 1,3,6 and 9 months following intake during which substance use and psychosocial functioning are assessed.


Eligibility criteria: Inclusion criteria:

* age \> 18 years
* current DSM-IV diagnosis of cocaine dependence
* received methadone treatment at the clinic for at least 3 months
* on a stable dose of methadone (no changes in dosing) for at least one month and not presently requesting a dose alteration
* submitted one or more clinic-collected cocaine positive urine samples in the previous 3 months
* English speaking
* pass a brief quiz related to understanding of the informed consent form

Exclusion criteria:

* have a serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk)
* have dementia (\<23 on the Mini Mental State Exam; Folstein et al. 1975)
* are in recovery from pathological gambling

Primary outcomes:
measure: Cocaine use
timeFrame: baseline and each follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Nancy Petry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00406835: Prospective Randomized Trial Between WBRT Plus SRS Versus SRS Alone for 1-4 Brain Metastases
Official title: Phase 3 Study of Whole Brain Radiation Therapy Plus Stereotactic Radiosurgery Versus Stereotactic Radiosurgery Alone for 1-4 Brain Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Metastasis
Keywords: Whole Brain Radiation Therapy
Stereotactic Radiosurgery
Brain metastases
Lead sponsor: Hokkaido University Hospital
Sponsor class: OTHER
First posted: 2006-12-04
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to determine if WBRT combined with SRS resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death.

Detailed description: Whole-Brain Radiation Therapy (WBRT) had been a mainstay in the treatment of brain metastases. However, treatment strategy which rely on Stereotactic Radiosurgery (SRS) has becoming popular in Japan. It is not well understood if the Whole-Brain Radiation Therapy (WBRT) combined with Stereotactic Radiosurgery (SRS) resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death. In orer to determine the role of WBRT, we conducted prospective randomized trial between WBRT+SRS and SRS-alone for 1-4 brain metastatic patients.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older with 1-4 brain metastases, each with a maximum diameter of no more than 3 cm on contrast-enhanced MRI scans, and were derived from a histologically confirmed systemic cancer, Karnofsky Performance Status (KPS) score of 70 or more

Exclusion Criteria:

* Patients with metastases from small cell carcinoma, lymphoma, germinoma, and multiple myeloma were excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Hokkaido University School of Medicine
state: Hokkaido
Study officials:
affiliation: Hokkaido University School of Medicine
name: Hidefumi Aoyama, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hokkaido University School of Medicine
name: Hiroki Shirato, MD, PhD
role: STUDY_CHAIR
affiliation: Tokyo University
name: Keiichi Nakagawa, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04852835: Follow-up of COVID-19 Vaccine Response in Strasbourg University Hospitals
Official title: Follow-up of COVID-19 Vaccine Response in Strasbourg University Hospitals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19 Vaccines
Keywords: COVID-19
SARS-CoV-2
Vaccine
Humoral response
Anti-spike antibodies
Neutralizing antibodies
Gender
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any person, male or female, over 18 years of age who underwent vaccination and anti-SARS-CoV-2 serological test after vaccination

Brief summary: Vaccination remains the main promising measure to fight against the COVID-19 pandemic. The presumed efficacy of the vaccines is quite remarkable since it varies between 62 and 95%. There is increasing evidence that sex-specific effects may lead to different outcomes of vaccine safety and efficacy. However, sex-disaggregated data after COVID-19 vaccine are lacking. The first purpose of the study is to determine antibody titers against SARS-CoV-2 spike after COVID-19 vaccination. The secondary purpose is to identify predictor factors of immune response including age, gender and biological factors.


Eligibility criteria: Inclusion Criteria:

- Any person, male or female, over 18 years of age who underwent vaccination and

* anti-SARS-CoV-2 serological test after vaccination
* having already given their consent for their biological resources to be:

  * stored in a biocollection of the Microbiology Technical Platform (PTM) having received an approval from the CPP Est-IV and declared to the Ministry of Education and Research under reference No. DC2009-1002;
  * subsequently reused, as well as the anonymized associated data, for research purposes

Exclusion Criteria:

* Inability to give clear information (person in an emergency, difficulty understanding the subject, etc.)
* Person under safeguard of justice
* Person under guardianship or curatorship-

Primary outcomes:
measure: Study of the relationship between the serological response to the COVID-19 vaccine and the demographic characteristics of the patient
timeFrame: up to 1 month post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Virologie - Hôpital Civil
Study officials:
affiliation: Service de Virologie - Hôpital Civil
name: Samira FAFI-KREMER, PharmD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03785535: Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia
Official title: Functional MRI Study of the Effects of Vibrotactile Sensory Stimulation on Brain Activity in Fibromyalgia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Neurovoxel SLP
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
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 investigate the effects of low-intensity and prolonged vibrotactile sensory stimulation on brain activity and functional connectivity in fibromyalgia patients.


Eligibility criteria: Inclusion Criteria:

1. A diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) (Arthritis Care Res 2010;62:600-10).
2. Clinical symptoms are not a consequence of other medical disorder (although the presence of other disorders is not an exclusion criterion)
3. Diagnoses established by an expert on fibromyalgia.
4. Stable treatment of chronic use.
5. Subject demonstrates an understanding of the study and a willingness to participate as evidenced by voluntary written informed consent.

Exclusion Criteria:

1. Generalized inflammatory articular or rheumatic disease.
2. Severe, non-stable medical, endocrinological or neurological disorder.
3. Psychotic disorder or drug abuse.

Primary outcomes:
measure: Functional MRI measures of brain functional connectivity. A correlation scale ranging from 0 to 1 will be used.
timeFrame: 3 weeks
measure: Functional MRI measures of brain activity. A functional MRI signal change scale ranging from 0 to 1 will be used.
timeFrame: 3 weeks
Secondary outcomes:
measure: Functional MRI measures of sensory system activity. A functional MRI signal change scale ranging from 0 to 1 will be used.
timeFrame: 3 weeks
measure: Measured fibromyalgia symptoms using a 101-point numerical rating scale.
timeFrame: 3 weeks
measure: Tolerability rated using a numerical rating scale ranging from 0 to 100 points.
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
References:
Clinical trial NCT05398835: Promoting HIV Self-testing Among MSM During COVID-19 Pandemic
Official title: An Online Intervention Promoting Home-based HIV Self-testing Among Men Who Have Sex With Men in Hong Kong During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Behavior
Keywords: HIV testing
HIV self-testing
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A community-based organization (CBO) recruited Chinese-speaking men who have sex with men who are HIV-negative or unknown sero-status through multiple channels in Hong Kong, China.

Participants first complete a baseline telephone survey, and then receive the following health promotion components: 1) viewing an online video promoting HIVST, 2) visiting the project webpage containing demonstration video of how to use HIVST kits, information about local HIV epidemic and benefits of HIV testing and HIVST, and a discussion forum containing positive feedback of HIVST users, and 3) having access to a chargeable HIVST services implemented by the CBO.

All participants are invited to complete a follow-up telephone survey six months after completion of the baseline survey.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or above
* Having access to internet
* Anal intercourse with at least one man in the past six months
* Willing to complete telephone follow-up survey at Month 6

Exclusion Criteria:

* Self-reported to be HIV positive

Primary outcomes:
measure: HIV testing
timeFrame: 6 months
measure: HIV self-testing
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Centre for Health Behaviours Research, the Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT04941235: The Effectiveness of Different Techniques of Interscalene Brachial Plexus Block With General Anesthesia for Shoulder Arthroscopy
Official title: The Effectiveness of Different Techniques of Interscalene Brachial Plexus Block With General Anesthesia for Shoulder Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder and Upper Arm Injury
Keywords: shoulder arthroscopy
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There are different techniques of interscalene brachial plexus block, we aimed to evaluate the effectiveness of 3 of them as analgesia during shoulder arthroscopy surgery under general anesthesia.

Detailed description: Prospective randomized controlled study

There were 4 groups included in our study:

Group N: nerve stimulator guided interscalene brachial plexus block was done Group U: ultrasound guided interscalene brachial plexus block was done Group NU: dual guidance (using both nerve stimulator and ultrasound) Group C: control group We assessed in each group: heart rate, noninvasive blood pressure, time needed for block, onset of sensory and motor power loss and their offset, and finally patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* Age: 18-65 years old.
* Sex: Both sexes.
* ASA I \& II.

Exclusion Criteria:

* - Patient refusal.
* Bleeding disorders.
* Damage or disease of the brachial plexus.
* ASA more than II.
* Pre-existing peripheral neuropathy.
* Patients with neuromuscular diseases.
* Patients with known hypersensitivity to drugs of the study.
* Patients with local skin infection at the site of injection.
* Psychiatric diseases interfering with evaluation of the block.

Primary outcomes:
measure: Analgesic effect of each technique
timeFrame: 12 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medcine
Study officials:
affiliation: Professor
name: Ahmed K Mohamed, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01052935: A Study to Assess the Persistence of a GBS Antibody in Women Previously Immunized With a GBS Vaccine
Official title: A Phase I Extension Study to Assess the Long-Term Persistence of GBS Serotype Ia Antibodies in Women Previously Immunized With a GBS Ia Crm-Glycoconjugate Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Group B Streptococcus (GBS) Disease
Keywords: Group B streptococcus
GBS
Vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2010-01-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study looks at the body's immune responses to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P1 study. Blood will be drawn and evaluated for GBS antibody levels.


Eligibility criteria: Inclusion Criteria:

* Individuals who have given written consent.
* Individuals who participated in V98P1 and received the complete schedule of vaccinations.

Exclusion Criteria:

* Individuals who have not given written consent.
* Subjects who did not receive the complete schedule of vaccination in V98P1.

Primary outcomes:
measure: Antibody (Ab) response data at 24-months after the last injection given in study V98P1 GMCs, GMRs and associated 95% confidence intervals will also be determined
timeFrame: 24- months post last injection from V98P1
Secondary outcomes:
Other outcomes:
Locations:
city: Via Mastri, 36
country: Switzerland
facility: Institute for Pharmacokinetic and Analytical Studies
state: CH - 6853 Ligornetto
Study officials:
References:
Clinical trial NCT01146535: Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment
Official title: Pilot Study of Interferon Alpha Lozenges Plus Oseltamivir in the Treatment of Influenza A Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza A Virus Infection
Keywords: interferon-alpha
oseltamivir
drug therapy, combination
influenza
therapies, investigational
Lead sponsor: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Sponsor class: INDUSTRY
Collaborators: name: CytoPharm, Inc.
First posted: 2010-06-17
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the safety and effect of interferon-alpha lozenges when used in combination with oseltamivir (Tamiflu) to treat influenza.


Eligibility criteria: Inclusion Criteria:

* fever \>=38C
* one or more respiratory symptoms (e.g. cough, rhinorrhea or sore throat) plus one or more constitutional symptoms (e.g. chills, headache, malaise and myalgias)of \< 48 hours' duration
* body weight \> 40 kg
* positive for influenza A (nasal swab rapid test)

Exclusion Criteria:

* pregnancy/lactation
* history of depression or psychiatric disorders
* history of conditions that could complicate flu infection, such as chronic pulmonary, cardiac, renal, or metabolic disorders
* use of immunosuppressive therapy
* HIV infection

Primary outcomes:
measure: Resolution of fever and flu symptoms
timeFrame: Days 1-5
Secondary outcomes:
measure: Clinical response
timeFrame: Day 3 and Day 6
measure: Proportion of poor responders
timeFrame: Day 3 and Day 6
measure: Time to resolution of fever
timeFrame: Days 1-5
measure: Time to resolution of influenza illness
timeFrame: Days 1-5
measure: Symptom improvement
timeFrame: Days 1-5
measure: OTC medication usage
timeFrame: Days 1-5
measure: Physician visits
timeFrame: Days 6-10
measure: Treatment failure
timeFrame: Days 1-28
Other outcomes:
Locations:
city: Guishan
country: Taiwan
facility: Chang Gung Medical Foundation, LinKou Branch
state: Taoyuan County
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Veterans General Hospital
state: Zuoying District
city: Changhua
country: Taiwan
facility: Show-Chwan Memorial Hospital
city: Tainan
country: Taiwan
facility: Taiwan Municipal Hospital
Study officials:
References:
Clinical trial NCT06241235: Study of ZG005 in Combination With Paclitaxel＋Platinum-based ± Bevacizumab in Patients With Advanced Cervical Carcinoma
Official title: A Phase I/II Study to Evaluate Safety and Pharmacokinetics and Initial Efficacy of ZG005 in Combination With Paclitaxel Plus Cisplatin/Carboplatin ± Bevacizumab in Patients With Advanced Cervical Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cervical Carcinoma
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-05
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label phase I/II study for the first-line treatment of advanced cervical cancer.


Eligibility criteria: Inclusion Criteria:

* Fully understand the study and voluntarily sign the informed consent form.
* Female 18-70 years of age;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
* Life expectancy ≥ 3 months.

Exclusion Criteria:

* Patients were deemed unsuitable for participating in the study by the investigator for any reasons.

Primary outcomes:
measure: Dose Limiting Toxicity (DLT)
timeFrame: Up to 2 years
measure: Objective Response Rate (ORR)
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
state: Hangzhou
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_CHAIR
References: