louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05769023: A Spatial Analysis of Hotspots and Targeted Injection Settings Pilot Intervention for HIV Prevention Among People Who Inject Drugs
Official title: A Spatial Analysis of Hotspots and Targeted Injection Settings Pilot Intervention for HIV Prevention Among People Who Inject Drugs in Baltimore, Maryland, Supplement
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: COVID-19
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pilot of an intervention
Primary purpose: PREVENTION

Brief summary: Conduct a study of people who use drugs (PWUD) perceptions of and access to COVID-19 vaccines as well as reasons for vaccine hesitancy/barriers

Detailed description: Conduct a qualitative rapid longitudinal assessment of 20 PWUD's perceptions of and access to COVID-19 vaccines as well as reasons for vaccine hesitancy/barriers. The investigators will also assess frequency and content of COVID-19 communication with peers. The investigators will also assess changes in the social network dynamics of drug use and access to illicit drugs, drug treatment, and HIV care. The brief qualitative interviews will be conducted biweekly over a period of one year. These interviews will be quickly transcribed, summarized, and provided to local and state health departments. The investigators will also use the findings from this aim to inform the proposed app and peer education pilot outlined in aims 2 \& 3.

2. Development of an app provide real-time information on COVID-19 vaccine availability and nearby risk reduction resources (naloxone distribution sites, syringe exchanges, drug treatment). The app will be built for mobile download and as an online webpage. 20 PWUD will be included in this study component, split between the mobile and web-based app.

3. Develop training materials and pilot the training of 40 PWUD to promote vaccine uptake among the participants network and other community members. PWUD will be trained to become peer educators to promote COVID-19 vaccine uptake over 4 sessions. These 40 participants will be administered pre- and post-surveys as well as daily check-in questions through the app to assess effectiveness as peer educators.

Eligibility criteria: Inclusion Criteria:

* opioid use in prior 2 weeks

Exclusion Criteria:

* none

Primary outcomes:
measure: Vaccine acceptance as assessed by the Oxford COVID-19 Vaccine Hesitancy Scale
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Carl Latkin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02994823: The "Pooling" Expressed Breast Milk: A Method for Improving the Nutritional Intake of Premature Infants
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breastfeeding Mothers of Infants Hospitalized
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 10
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breastfeeding mothers of infants hospitalized

Brief summary: The investigators compared a pooled mother's expressed breastmilk for 24 hours with individual pump session collection of milk to provide a more consistent caloric product without increasing bacterial contamination.


Eligibility criteria: Inclusion Criteria:

* Mother of newborn hospitalized in intensive care unit
* Mother using a breast pump in the unit and / or at home
* Mother respected the rules of handling and transport breastmilk
* No opposition mother

Exclusion Criteria:

* refusal

Primary outcomes:
measure: caloric value of breastmilk
timeFrame: at the end of each 24 hours collection from inclusion to the end of collection during 4 days
Secondary outcomes:
measure: bacterial contamination of breastmilk
timeFrame: at the end of each 24 hours collection from inclusion to the end of collection during 4 days
Other outcomes:
Locations:
city: Brest
country: France
facility: CHUR de Brest
Study officials:
affiliation: CHRU de Brest
name: Murielle Dobrzynski
role: STUDY_DIRECTOR
References:
Clinical trial NCT03139123: Prevalence of Hypotension Associated With Preload Dependence During Continuous Renal Replacement Therapy
Official title: Prevalence of Hypotension Associated With Preload Dependence During Continuous Renal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Injury
Renal Failure, Acute
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 42
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: This study concerns patients hospitalized in intensive care unit at the Croix-Rousse hospital in Lyon with acute renal insufficiency (stage 3 of the Kidney Disease: Improving Global Outcomes classification) for which treatment with continuous hemofiltration was initiated less than 24 hours ago and for whom a hemodynamic monitoring device (PiCCO® device) has been implanted due to acute circulatory failure and is functional.

Brief summary: Per-dialytic hypotension is common in Intensive Care Unit patients under continuous renal replacement therapy, and occurs in nearly 50% of the patients. To date, there is a lack of study having characterized the underlying mechanism of hypotension in this setting. New diagnostic methods are now available with high reliability to identify hypovolemia as the underlying cause of hypotension, among which change in cardiac index during passive leg raising may be the less affected by restrictive validity criteria. A change in cardiac index greater than 10% during this test is highly predictive of preload dependence, i.e the probability than cardiac index will increase if cardiac preload increases.

The aim of this study is then to identify, among hypotensive episodes occurring during renal replacement therapy in Intensive Care Unit patients, the percentage of episodes related to preload dependence as identified by passive leg raising.


Eligibility criteria: Inclusion Criteria:

* Intensive Care Unit patients with acute kidney injury
* under continuous renal replacement therapy initiated since less than 24 hours
* under hemodynamic monitoring by the PiCCO® device.

Exclusion Criteria:

* lower limb amputation
* inferior vena cava compression
* intracranial hypertension
* age below 18 year
* pregnancy
* advance directives to withhold or withdraw life sustaining treatment,
* lack of written informed consent by patient or next of kin
* lack of affiliation to social security as required by French regulation
* patient under a legal protective measure
* previous inclusion in current study
* inclusion in another research study

Primary outcomes:
measure: Presence of hypotensive episode by hemodynamic monitoring
timeFrame: 7 days
measure: Preload dependence identified by cardiac index greater than 10% during passive leg raising
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de réanimation médicale- Hôpital de la Croix-Rousse
Study officials:
References:
Clinical trial NCT06289023: HA-WBRT-SIB for Brain Metastasis of Lung Cancer
Official title: Hippocampal Avoidance Whole Brain Irradiation With Simultaneous Integrated Boost for the Treatment of Lung Cancer Brain Metastases：A Prospective Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Neoplasm
Brain Metastases
Simultaneous Integrated Boost
Hippocampal Avoidance
Cognitive Function
Keywords: Lung Neoplasm
Brain Metastases
Simultaneous integrated boost
Hippocampal avoidance
Cognitive function
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with lung cancer and brain metastases undergo HA-WBRT-SIB using image-guided radiotherapy, receiving a total dose of 30-36 Gy delivered in 18-20 fractions to the whole brain (CTV), while the dose to the GTV is boosted to 44 Gy-52 Gy in 18-20 fractions, ﬁve times a week. The optimal mean dose (Dmean) to the bilateral hippocampus should optimally be ≤ 8 Gy, with a mandatory maximum dose (Dmax) to the hippocampus not exceeding 10 Gy; the preferred Dmean to the hippocampus PRV should optimally be ≤ 9 Gy, while the mandatory Dmax to the hippocampus PRV should be ≤ 12 Gy. The HVLT-R immediate recall scores are obtained at baseline and 1, 3, and 6 months after treatment.


Eligibility criteria: Inclusion Criteria:

1. pathologically diagnosed primary lung cancer with brain metastasis confirmed via magnetic resonance imaging (MRI);
2. 18-75 years old;
3. BM outside a 10 mm margin around either hippocampus;
4. at least one BM existed if prior resection of BM was done;
5. BM measuring less than 5.0 cm in maximal extent;
6. Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-2

Exclusion Criteria:

1. previous brain radiotherapy or brain metastasis resection;
2. history of malignancies other than lung cancer;
3. radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, leptomeningeal metastases
4. presence of other serious illnesses such as acute myocardial infarction, severe arrhythmia, or psychiatric disorders within the past 6 months.

Primary outcomes:
measure: OS
timeFrame: 24 months
Secondary outcomes:
measure: PFS
timeFrame: 24 months
measure: iPFS
timeFrame: 24 months
measure: HVLT-R learning score
timeFrame: at baseline and 1, 3, and 6 months after radiotherapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College
state: Beijing
Study officials:
References:
Clinical trial NCT04080323: Single-dose Vaginal Dinoprostone and Hysterectomy
Official title: Effect of a Single Preoperative Dose of Vaginal Dinoprostone on Intraoperative Blood Loss During Abdominal Hysterectomy:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hysterectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, we will assess the efficacy of dinoprostone in minimizing blood loss during hysterectomy when used as a single preoperative dose via the vaginal route. The reduction of blood flow may be due to the combined effect of myometrial contraction and vasoconstrictive effect


Eligibility criteria: Inclusion Criteria:

* • Patients presenting for hysterectomy for any benign indication including uterine fibroids.

  * Age ≥ 18 years
  * Pre-operative hemoglobin \>8 g/dl
  * Willing to have dinoprostone or a placebo prior to hysterectomy
  * Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* • Patients with known or suspected endometrial/ovarian/cervical cancer.

  * Patients undergoing hysterectomy for endometrial hyperplasia or cervical dysplasia.
  * Patients currently undergoing treatment for any type of cancer.
  * Patients with known bleeding/clotting disorders or a history of thromboembolism (including deep venous thrombosis or pulmonary embolism)
  * History of allergic reactions to dinoprostone.

Primary outcomes:
measure: decrease blood loss during hysterectomy
timeFrame: intraoperative
Secondary outcomes:
measure: postoperative hemoglobin level
timeFrame: 24 hours
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahmed Samy
Study officials:
affiliation: Cairo University
name: AHMED SAMY
role: STUDY_DIRECTOR
affiliation: Cairo University
name: ayman taher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: faculty of medicine al-azhar university
name: ahmed S Ali
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01098123: Metabolic Effects of Rowing Multi-races Events
Official title: Nutritional and Metabolic Context in Rowers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet
Nutritional Status
Fatigue
Maximal Exercise
Lead sponsor: University of Paris 5 - Rene Descartes
Sponsor class: OTHER
Collaborators: name: University of Bordeaux
First posted: 2010-04-02
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Competitive athletes

Brief summary: The aim of this study was to assess the relevance of NRI or athletes' NRI (ANRI) utilization to detect nutrition-related risks of failure in competition in the particular population of rowers.

In the morning, 60 to 90 minutes before the first race of a national level multi-races competition (three races for each subjects), body weight were measured and blood samples were collected with subjects at rest and in post-absorptive condition (last meal at least 2.5 hours before blood collection). Body weight was also recorded in the same conditions six weeks before the competition to calculate weight state (actual weight /usual weight ´ 100) and subjects were asked to identify the date of diet beginning. Body weight was measured using a floor scale (Mettler-Toledo floor scale, France), body mass index (BMI) was calculated from the ratio of weight (in kg) by height squared (in meters) and training volume (total duration of training in a week) was determined after discussion with athletes and coaches.


Eligibility criteria: Inclusion Criteria:

Competitors, volunteers

Exclusion Criteria:

non competitors

Primary outcomes:
measure: Infrared spectroscopy for serum albumin concentrations determinations
timeFrame: 30/05/2006
Secondary outcomes:
measure: Assessment of fatigue clinical signs
timeFrame: 25/04/06
Other outcomes:
Locations:
city: Paris
country: France
facility: INSEP
Study officials:
affiliation: University Paris Descartes
name: François Desgorces, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bouillanne O, Morineau G, Dupont C, Coulombel I, Vincent JP, Nicolis I, Benazeth S, Cynober L, Aussel C. Geriatric Nutritional Risk Index: a new index for evaluating at-risk elderly medical patients. Am J Clin Nutr. 2005 Oct;82(4):777-83. doi: 10.1093/ajcn/82.4.777.
Clinical trial NCT01352923: Study of Polymorphisms in pear1 Gene Link to Platelet Activation and Signaling Pathway Variations
Official title: Study of Polymorphisms in pear1 Gene Link to Platelet Activation and Signaling Pathway Variations
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Platelet Function
Keywords: PEAR1 gene
PEAR 1 gene
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: healthy voluntary donors

Brief summary: In this study PEAR1 polymorphisms effects will be analyze in blood platelets to determine how PEAR1 regulates platelet activation.

Detailed description: Several large-scale studies have confirmed the long held notion that platelet responses to different agonists are highly variable, within well defined populations of healthy donors. Single nucleotide polymorphisms in genes encoding platelet proteins can explain the wide range of responses to standard platelet agonists. Yet, numerous SNPs point towards proteins with previously unknown function in platelets, wich modulate the complex network of signaling events that regulate platelet function and further augment variability. PEAR1 is mainly expressed in platelets and endothelial cells. A few studies have linked SNPs in PEAR1 with decreased or increased platelet responses to various agonists. However, hitherto, no direct functional studies have been carried out to determine whether and how PEAR1 modulate intracellular signaling pathways relevant for platelet function.

Eligibility criteria: Inclusion Criteria:

* healthy voluntary donors

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KUleuven/UZ Gasthuisberg
state: Vlaams Brabant
Study officials:
affiliation: KU Leuven
name: Marc Hoylaerts
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06831123: Pathways 2 Success
Official title: Pathways 2 Success: A Study of School-Based Prevention Programs Supporting Positive Adolescent Development
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Conduct Disorder
Oppositional Defiant Disorder
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of three different intervention conditions.
Primary purpose: PREVENTION

Brief summary: This study involves a 3-arm randomized controlled trial designed to investigate the feasibility and acceptability of three preventive interventions designed to reduce risk for escalations in adolescent conduct problems. High school students identified to be at risk for conduct problems will be randomly assigned to one of three intervention options, including a mindfulness-based program, a mindfulness-based program augmented by a new mobile app, and a life skills program. Assessments related to intervention outcomes will be completed by adolescents, parents/guardians, and teachers at baseline, 2 weeks post-intervention, and at a 3-month follow-up.


Eligibility criteria: Inclusion Criteria:

1. A 9th or 10th grade student in a partner school district
2. Referral due to elevated social/emotional risk indicated on a standardized screening tool or a referral from school support staff due to concerns about school-based conduct problems
3. Adolescents and their parents must be fluent in English

Exclusion Criteria:

1. Currently receiving special education services (i.e., an IEP) due to a behavioral or emotional disturbance
2. Existing diagnoses of autism spectrum disorder, pervasive developmental disorders, developmental/intellectual disability, or serious psychiatric disorders requiring specialized mental health treatment (e.g., psychosis, bipolar, substance use disorder, etc.)

Primary outcomes:
measure: Add Health Self-Report of Delinquency
timeFrame: Baseline; up to 15 weeks; through study completion, approximately 6 months
measure: Behavioral Rating Inventory of Executive Functioning - Second Edition Screening Form
timeFrame: Baseline; up to 15 weeks; through study completion, approximately 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Timothy Piehler
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01789723: Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn
Official title: An Open Label, Multicenter, Dose Finding, Phase 1 Study of Fusilev® (Levoleucovorin) to Prevent or Reduce Mucositis in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Receiving Folotyn® (Pralatrexate)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Non Hodgkin's Lymphoma
Lead sponsor: Acrotech Biopharma Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is determine the optimal dose and schedule of Fusilev to prevent or reduce Mucositis in patients with Non-Hodgkin's Lymphoma receiving Folotyn treatment.

Detailed description: This is an open label, uncontrolled, nonrandomized, multicenter, dose finding, Phase 1 study primarily to determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral Mucositis.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Patients with relapsed or refractory NHL who are eligible for Folotyn treatment. Patient has histologically/cytologically confirmed, measurable (lesion or node ≥ 2 cm by computed tomography \[CT\]
* Progressive disease or persistent disease after at least 1 prior treatment
* ECOG performance status ≤ 2
* Adequate hematological, hepatic, and renal function

Exclusion Criteria:

* Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix)
* Congestive heart failure
* Uncontrolled hypertension
* Known human immunodeficiency virus (HIV)-positive diagnosis
* Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
* Major surgery within 14 days of enrollment
* Pregnant or breast-feeding women
* Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible
* Previous exposure to pralatrexate

Primary outcomes:
measure: Optimal dose and schedule of Fusilev to prevent or reduce mucositis
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Impact of Fusilev on Folotyn related Oral Mucositis
timeFrame: 7 weeks
measure: Relationship between Fusilev use and oral mucositis
timeFrame: 7 weeks
Other outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 24 months
Locations:
Study officials:
affiliation: Columbia University
name: Ahmed Sawas, MD
role: PRINCIPAL_INVESTIGATOR
References: