louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04772326: Impact of Containment and the Current Epidemic on the Sexual Risk-taking of People Using PrEP to Prevent HIV Infection.
Official title: Impact of Containment and the Current Epidemic on the Sexual Risk-taking of People Using PrEP to Prevent HIV Infection.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PREP
Lead sponsor: Tourcoing Hospital
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted in all persons using PrEP as prevention against HIV infection undergoing follow-up at Tourcoing Hospital and receiving counseling during months of inclusion.

Brief summary: People using PrEP to prevent HIV infection have sexual risk-taking behaviors that motivated the prescription of PrEP. Both containment and the current epidemic may affect the sexual behavior of people using PrEP and the risk of acquiring STIs.

Hypotheses regarding the impact of the current epidemic-motivated confinement and its gradual lifting are as follows:

* A decrease in sexual risk-taking during the confinement period, followed by an increase when the confinement is lifted.
* An increase in sexual violence and the use of psychoactive substances.
* An impact on PrEP monitoring and compliance.
* An increase in the incidence of STIs when the confinement is lifted.


Eligibility criteria: Inclusion Criteria:

* People using PrEP for HIV prevention being followed up at Tourcoing hospital
* Having given their consent to participate in this study
* Beneficiary of a social insurance plan or entitled person

Exclusion Criteria:

* Minor patient
* Refusal to participate
* Trusteeship
* Curatorship

Primary outcomes:
measure: Impact of the current epidemic on sexual risk taking of Prep users in the number of partners per month
timeFrame: At day 1
measure: Impact of the current epidemic on sexual risk taking of Prep users in the number of sexual encounters per month
timeFrame: At day 1
measure: Impact of the current epidemic on sexual risk taking of Prep users in the frequency of condom use during anal intercourse
timeFrame: At day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Tourcoing
country: France
facility: CH Tourcoing
Study officials:
affiliation: CH TOURCOING
name: Agnes Meybeck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02878226: Outcomes of Uterine Rupture
Official title: Uterine Rupture: Prevalence and Feto-maternal Outcomes in Assiut Women Health Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maternal Mortality
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 65
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients presented with clinical symptoms and signs of rupture uterus, whatever the duration of pregnancy, and the diagnosis proved on surgical exploration to be a case of rupture uterus

Brief summary: Uterine rupture (UR) is a serious, life-threatening obstetric complication. UR is associated with an increased risk of maternal and perinatal morbidity and mortality, particularly in developing countries compared to developed countries. UR occurs mainly as a consequence of poorly managed labour


Eligibility criteria: Inclusion Criteria:

* women with ruptured uterus
* accept to share in the study

Exclusion Criteria:

* women refuse to participate

Primary outcomes:
measure: number of women undergoes repair
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT06994026: Feasibility Study of a Relapse Investigation Questionnaire Administered by an MS Care Coordinator Nurse in Patients With Multiple Sclerosis
Official title: Feasibility Study of a Relapse Investigation Questionnaire Administered by an MS Care Coordinator Nurse in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Sclerosis
Disease Management
Feasibility Studies
Lead sponsor: Centre Hospitalier de Gonesse
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants will be selected from adult patients with Multiple Sclerosis (MS) who are under the care of Dr. Manchon at a single neurology center. Specifically, the population includes individuals diagnosed with either Relapsing-Remitting MS or active Secondary Progressive MS. All participants must have provided informed consent to be included in a local task-sharing protocol that allows a specialized nurse (IDEC) to conduct initial evaluations during suspected relapses. This population reflects patients who are actively monitored for MS and may experience acute neurological symptoms requiring timely assessment and intervention.

Brief summary: This study aims to evaluate a questionnaire used by a specialized nurse to help manage relapses in people with multiple sclerosis (MS). The questionnaire is completed during a phone call when the patient reports new or worsening symptoms. It helps the nurse decide whether further tests or treatments are needed, based on a protocol developed with a neurologist. The goal is to improve how quickly and effectively patients receive care during a relapse. The study will include 10 adult patients with active forms of MS over a two-month period.


Eligibility criteria: Inclusion Criteria:

* Patients followed by Dr. Manchon for Relapsing-Remitting Multiple Sclerosis or active Secondary Progressive Multiple Sclerosis
* Adult patients (aged 18 or older)
* Patients who have provided informed consent for participation in the local task-sharing protocol

Exclusion Criteria:

* Pregnant women
* Minors (under 18 years old)
* Patients with known renal failure
* Patients who have not provided or are unable to provide consent for the local task-sharing protocol

Primary outcomes:
measure: Effectiveness of the relapse investigation questionnaire completed by the MS care coordinator nurse (IDEC) in guiding the patient's care pathway during a suspected relapse, according to the local task-sharing protocol.
timeFrame: June 2025 - August 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Gonesse
country: France
facility: France
Study officials:
References:
Clinical trial NCT00945126: Allogeneic Stem Cell Transplantation in Pediatric Patients With Malignant and Non-malignant High-risk Diseases
Official title: Allogeneic Stem Cell Transplantation With CD3/CD19 Depleted Stem Cells of Related or Unrelated Haploidentical Donors in Pediatric Patients With Malignant and Non-malignant Diseases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Malignant and Non-malignant High Risk Diseases
Keywords: Allogeneic stem cell transplantation in pediatric patients
CD3/CD19 depleted stem cells
malignant and non-malignant high risk diseases
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2009-07-23
Enrollment: 68
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the feasibility and toxicity of allogeneic haploidentical or unrelated transplantation with CD3/CD19 depleted stem cells associated with a reduced or a standard conditioning regimen in pediatric patients with malignant and non-malignant high-risk diseases, for whom allogeneic stem cell transplantation represents the only possible therapy option and no human leukocyte antigen (HLA) compatible related donors are available.


Eligibility criteria: Inclusion Criteria:

* Patients aged 0 to 30 years
* Written informed consent from patient and/or parents or guardian
* Patients with Karnofsky Index \> 60%
* Malignant disease:

  * acute lymphoblastic leukemia
  * acute myeloid leukemia
  * myelodysplastic syndrome
  * chronic myeloid leukemia according to the standard indications
  * solid tumors (e.g. neuroblastoma recurrence, soft-tissue sarcoma, Ewing's sarcoma, osteosarcoma, hepatoblastoma)

    . Non malignant disease:
  * acquired anemias (e.g. severe aplastic anemia, particularly severe Evans syndrome)
  * congenital anemias (e.g. thalassemia and sickle cell anemia)
* Women reliable contraception method when appropriate

Exclusion Criteria:

* Participation in other clinical trials
* Patients, parents, or guardians unable to understand the nature, the importance and the implications of the procedure
* Pregnant or nursing women
* Patients who underwent a stem cell transplantation in the last 250 days
* Patients with kidney, heart or liver insufficiency

Primary outcomes:
measure: To evaluate engraftment after CD3/CD19 depletion of the graft
timeFrame: within 1 year
Secondary outcomes:
measure: To evaluate immunoreconstitution after transplantation by assessing lymphocyte subsets
timeFrame: within 1 year
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: University Hospital Frankfurt, Dept. for Children and Adolescents, Division for Stem Cell Transplantation, Goethe University
state: Hessen
Study officials:
affiliation: University Hospital Frankfurt, Dept. for Children and Adolescents, Division for Stem Cell Transplantation, Goethe University.
name: Peter Bader, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00700726: Cohort Study of the Patterns of Microvesicles in the Serum of Participants With Atopic and Non-atopic Asthma
Official title: Study of the Patterns of Microvesicles in the Serum of Participants With Atopic and Non-atopic Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Allergies
Keywords: blood test
asthma
skin test
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2008-06-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The purpose of this study is to determine if a simple blood test can help in disease management, particularly asthma. This will be researched by looking at certain features of the blood and to compare asthmatics without allergies to those that have allergy-induced asthma.

Detailed description: A total of 20 participants (men or women) between the ages of 18-50 years with asthma will be enrolled. Participants will remain on their usual asthma treatments as prescribed by their usual asthma care provider. Current asthma treatments and any changes will be recorded at baseline and each subsequent visit. The primary outcome measures are correlation of microvesicle patterns with atopic state and variation from baseline with episodes of poor asthma control. Secondary outcomes include correlations between microvesicle patterns and spirometry, eNO levels, and glucorcorticoid sensitivity.

Eligibility criteria: Inclusion Criteria:

* be between the ages of 18 and 50.
* have diagnosed asthma.
* must have less "one pack per day for 10 years" smoking history

Exclusion Criteria:

* You have had a fever of 100.4º within 24 hours of Visit 2.
* You are enrolled in another interventional research trial.
* Have other major chronic illnesses that would interfere with participation in the study.
* You are pregnant.
* You chronically use oral corticosteroids.
* You have taken anti-coagulants, insulin, and any investigative drugs within 2 months.
* You have the inability or unwillingness to provide consent.
* Inability to perform aerobic exercise.
* Inability to perform baseline measurements.
* Less than 80% completion of screening period diaries.
* Inability to be contacted by telephone.
* Intention to move out of the area within 6 months.

Primary outcomes:
measure: correlation of microvesicle patterns with atopic state and variation from baseline with episodes of poor asthma control
timeFrame: 6 months
Secondary outcomes:
measure: correlations between microvesicle patterns and spirometry, eNO levels, and glucorcorticoid sensitivity
timeFrame: 6 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State Univeristy Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Clay M. Marsh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05891626: Group Intervention on Vaccine Confidence
Official title: Group Intervention to Improve Vaccine Confidence and Vaccination in a Community Healthcare System: A Mixed Methods Study Design
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vaccination Refusal
Keywords: Vaccine confidence
Adult patient
Caregiver of pediatric patients
Missed opportunities for vaccination (MoV)
Vaccination rates
Vaccine hesitancy
Lead sponsor: MultiCare Health System Research Institute
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2023-06-07
Enrollment: 429
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster randomized controlled trial, mixed methods
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study has one primary objective and two secondary objectives, with an overall goal of understanding barriers to vaccination and vaccination confidence, so that effective interventional strategies can be further developed and tested to improve vaccination outcomes in a community healthcare setting.

Detailed description: The study will use a mixed methods approach, combining focus group discussion, virtual interviews with healthcare professionals, cross-sectional survey on vaccination attitude, and clinic-based intervention with a cluster randomized controlled trial design for the quantitative stage. They study will also follow up patients with interviews after the quantitative stage completes.

Eligibility criteria: Qualitative study standards:

Inclusion Criteria:

* having used MultiCare's services in the past 12 months or whose minor child(ren) has/have used MultiCare's services in the past 12 months, and who have been involved in the child(ren)'s immunization decision-making as a caregiver
* current residential location in Washington State
* willing to participate

Exclusion Criteria:

* terminal disease (to be decided)
* cognitive impairment
* main immune deficiency conditions

Quantitative study standards:

We will randomly (and) equally select clinics from 1) Puget Sound and 2) Eastern Washington areas. Since the intervention is on facility level (group intervention), instead of at patient level, blinding will also be impractical. We plan to use stratified random allocation within the pediatric (n1 = 2) or adult stratum (n2 = 4), to decide which sites will get the intervention.

Primary outcomes:
measure: Vaccine confidence scale(s)
timeFrame: 6 months over vaccination attitude for each subpopulation
Secondary outcomes:
measure: Missed opportunities for vaccination (MOVs)
timeFrame: 6 months over vaccination attitude for each subpopulation
measure: Vaccination rates
timeFrame: 6 months over vaccination attitude for each subpopulation
Other outcomes:
Locations:
city: Puyallup
country: United States
facility: Jin
state: Washington
Study officials:
References:
Clinical trial NCT03177226: Safety & Feasibility of Functional Electrical Stimulation for The Treatment of Premature Ejaculation
Official title: Safety & Feasibility of Functional Electrical Stimulation for The Treatment of Premature Ejaculation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Ejaculation
Lead sponsor: Virility Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-06
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Prospective, non-randomized, controlled, single-center study, to evaluate the efficacy of applied nominal electrical stimulation parameters given to premature ejaculation (PE) patients in order to prolong the ejaculatory latency time which will eventually increase the quality of their sexual life.


Eligibility criteria: Inclusion Criteria:

* Good general health
* Clinical history of premature ejaculation
* Familiar with self- stimulation
* Ability to follow study instructions and complete study assessment tools
* Washout period of two weeks

Exclusion Criteria:

* History of cardio-vascular disorders
* Any type of implanted pacemaker/defibrillator
* Hypertension
* Diabetes Mellitus
* Local dermatological disease
* Local skin irritation/ lesions
* Any neurological disorder
* Any psychiatric disease and/or any psychiatric medications
* Any neoplastic disease in the past two years

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Procedure day
measure: Change in ejaculation latency time
timeFrame: Procedure day
Secondary outcomes:
measure: Incidence of post-treatment Adverse Events
timeFrame: 72 hours
Other outcomes:
measure: Effects of applied electrical stimulation on Erection using Self Reported - User Questionnaire
timeFrame: Procedure day
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Ilan Gruenwald, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05616026: Texts for Diabetes Control Among Homeless Persons
Official title: Short-messaging Services (SMS) Text for Uncontrolled Diabetes Among Persons Experiencing Homelessness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes
Homelessness
SMS text
mobile Health
Clinical trial
Health disparities
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: NYU Langone Health
First posted: 2022-11-14
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention versus Control group; Randomized at the Individual level
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This mixed method study includes a Randomized Controlled Trial (RCT) and qualitative methods to assess the impact of a SMS text strategy in diabetes control among persons who experience homelessness.

Detailed description: Diabetes mellitus (DM) is common among persons experiencing homelessness (PEH), often inadequately managed, and carries significant costs. SMS strategies for DM have not been tested among PEH despite the accessibility of mobile phones. This study uses a SMS strategy to offer better communication, education, and information management; improve outreach; facilitate care coordination; explore barriers to care; and support behavior changes. This mixed-methods (RCT and qualitative) study will be implemented in shelter-clinics in New York City in collaboration with community organizations, allowing for sustainability and scalability. Aim 1 will evaluate the efficacy of a 6-month SMS program for DM management versus an attention control on changes in HbA1c and adherence to DM self-care activities, medications, and appointments at 9 months in adult PEH with uncontrolled DM (n=100). Outcomes will be measured at 0, 3, 6, \&9 months. Aim 2 will assess patients' and providers' attitudes, acceptability, and experience of the program through semi-structured interviews with PEH and providers.

Eligibility criteria: Inclusion Criteria:

* Homeless person age ≥ 21
* Diagnosed with type 2 DM
* Most recent visit HbA1c ≥ 8%
* English/Spanish speaking
* Connected to study sites' shelter-clinics for care

Exclusion Criteria:

* Pregnant or within 3 months postpartum
* Has an uncontrolled severe illness
* Has had a heart attack or stroke in the previous 6 months
* Inability to read/respond to texts
* Inability to provide informed consent
* Receiving inpatient care for severe substance abuse

Primary outcomes:
measure: Change in HbA1c
timeFrame: 9 months
Secondary outcomes:
measure: Summary of Diabetes Self-Care Activities (SDSCA)
timeFrame: 9 months
measure: Proportion of Days Covered (PDC)
timeFrame: 9 months
measure: Appointment Adherence
timeFrame: 9 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: New York City
country: United States
facility: NYU Langone Health
state: New York
Study officials:
References:
Clinical trial NCT02880826: Measurement of Care Safety Culture in French ICU, Correlation With the Characteristics of Morbi-mortality Reviews
Official title: Study on the Measurement of Care Safety Culture in French ICU, Correlation With the Characteristics of Morbi-mortality Reviews
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 4800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 intensive care units in France. Each unit is estimated that an average of 80 professionals will be subject to the evaluation of the CS (doctors, IDE, assistant nurses, physiotherapists...) and thus nearly 4800 people will be included for the CS measurement.

Includes: all professionals providing care to patients and working full-time or part-time work in the respondent unit.

Brief summary: The tools to measure safety culture (CS) have recently become available. No study has focused on the measure in France, apart from pilot studies. intensive services are particularly at risk of serious adverse events occurred (SAEs). Patients who are hospitalized are in fact fragile and precarious clinical condition requires rapid decision taken often. Diagnostic or therapeutic strategies have report "risk-benefit" narrow. They may well be complicated by EIG.Safety of care is a priority in the field of health in general, and especially in intensive care. CS measure in this context seems particularly relevant.

The main objective is to describe the CS intensive care units in France. The study will explore the development of the CS level for the units investigated.

This study will also describe the main features of RMM practiced in intensive care units in France.


Eligibility criteria: Inclusion Criteria:

* practicing resuscitation activity (this practice is medical or surgical, pediatric or adult, in public or private sector)
* volunteer to participate in the study (agreement of the head of the unit)
* for which at least 2 matching / references for the study were identified:

  * a medical officer,
  * caregiver responsible (Health Framework).

Exclusion Criteria:

* measurement safety culture done in a period of significant change during a period where the staff and activities of the respondent unit of work is relatively stable.
* the responses of professionals to the questionnaire can be influenced by internal factors in their work unit (recent accident occurred, change of close supervision, personnel changes ...) and by factors external to their unit work (establishment certification period, arrival of a new director, recent media coverage of medical accidents ...).

Primary outcomes:
measure: The measure of the CS of intensive care units in France using a validated questionnaire
timeFrame: The planned project duration is 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: