louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06564870: Efficacy and Safety Study of DURVALUMAB Maintenance in Patients With Stage III Non-Small Cell Lung Cancer
Official title: Retrospective Observational Study of the Efficacy and Safety of DURVALUMAB Maintenance Therapy in Patients With Stage III Non-Small Cell Lung Cancer (DURVABREIZH)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bronchial Cancer
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unresectable locally advanced non-small cell lung cancer (stages IIIA, IIIB and IIIC) who have responded to or are stable after concurrent or sequential platinum-based radiochemotherapy and have received maintenance durvalumab therapy

Brief summary: The aim of this study is to evaluate the real-life efficacy of durvalumab treatment in consolidation after radio-chemotherapy.

Detailed description: Immune checkpoint inhibitors (ICIs) such as anti-PD-1/PD-L1 have revolutionized the field of immuno-oncology, inducing significant and durable responses in patients with all types of tumor, and in particular advanced stage (II-IV) non-small cell lung cancer (NSCLC). The use of durvalumab in consolidation, after radiochemotherapy, in locally advanced NSCLC has significantly improved progression-free survival and overall survival (see PACIFIC trial). Durvalumab now has marketing authorization for this indication, in cases of PD-L1≥1% overexpression on tumor cells.

However, 50% of patients experience tumor progression at 1 year, and there is currently no biomarker (clinical, biological or radiological) predictive of tumor response to durvalumab in consolidation.

Elucidating the determinants of response and resistance to treatment, as well as predicting severe immune-mediated adverse events, are essential to improving patient outcomes and developing new therapeutic strategies

Translated with DeepL.com (free version)

Eligibility criteria: Inclusion Criteria:

* Patients with unresectable locally advanced non-small-cell lung cancer (stages II, IIIA, IIIB and IIIC) responding to or stable after concomitant or sequential platinum-based radiochemotherapy and having received durvalumab consolidation therapy
* Minimum radiotherapy dose of 54 Gy to 66 Gy
* Age greater than or equal to 18 years
* WHO 0-1
* Non-opposition of living patients formulated

Exclusion Criteria:

* Age \< 18 years.
* Refusal to participate
* Patients under legal protection (curatorship, guardianship, etc.)

Primary outcomes:
measure: Real-life efficacy of durvalumab treatment in maintenance after chemoradiotherapy.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
References:
Clinical trial NCT05558670: Brain Network Characteristics in Patients With Disorders of Consciousness
Official title: Assessing Brain Network Characteristics in Patients With Disorders of Consciousness by Simultaneous Trimodal Positron Emission Tomography-Functional Magnetic Resonance Imaging-Electroencephalograph（PET-fMRI-EEG）Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disorders of Consciousness
Keywords: PET-fMRI-EEG
brain network
coma
Vegetative state(VS)
Unresponsive wakefulness syndrome (UWS)
Minimally conscious state(MCS)
Emerged from minimally conscious state(EMCS)
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants are selected in patients hospitalised in neurology department of Xijing hospital

Brief summary: Simultaneous measurement of the three modalities, functional magnetic resonance imaging (fMRI), positron emission tomography (PET) and electroencephalography (EEG) was proven to be feasible and advantageous in evaluating brain structural and functional (via fMRI), metabolic (via PET) and electrophysiological (via EEG) signatures simultaneously under the same conditions. Investigators use trimodal PET-fMRI-EEG imaging to explore the characteristics of brain network damage in patients with disorders of consciousness(DOC), assess the trajectory of consciousness recovery in a prospective observational cohort study.


Eligibility criteria: Inclusion Criteria:

1. Coma, VS/UWS, MCS and EMCS according to diagnostic criteria
2. Age ≥18 years
3. Written informed consent obtained

Exclusion Criteria:

1. Patients with contraindications to PET, MRI, EEG examinations or inability to complete PET-fMRI-EEG examinations (presence of ferromagnetic metal implants or hyperthermia)
2. Hyperglycemia that is difficult to correct
3. Patients with long-term use of corticosteroids
4. Patients with coexisting severe systemic disease and limited life expectancy

Primary outcomes:
measure: CRS-R total score
timeFrame: Patients in coma after 3 weeks enrolled
measure: GOSE score
timeFrame: Patients are followed up for 6 months after enrolled
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Wen Jiang
role: STUDY_DIRECTOR
References:
Clinical trial NCT02894970: A New Device for Measuring of Lung Photoplethysmography and Pulmonic Arterial Saturation
Official title: A New Device for Measuring of Lung Photoplethysmography and Pulmonic Arterial Saturation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patent Ductus Arteriosus
Pulmonary Hypertension
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
Collaborators: name: Israel Science Foundation
First posted: 2016-09-09
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteer adults and children, normal newborns, normal premature newborns and newborns suffering from patent ductus arteriosus and pulmonary hypertension

Brief summary: To evaluate feasibility of photoplethysmography (PPG) of pulmonary arteries in adults children and neonates and to compare normal controls to premature newborns suffering from patent ductus arteriosus and neonates suffering from pulmonary hypertension.

Detailed description: This study aims to check a new device for measuring lung photoplethysmography (PPG) of pulmonary arteries by delivering light through the chest wall. The aim is to evaluate pulmonary arteries' elasticity and oxygen saturation.

We will study adults children and neonates. We will study 20 healthy adults, 20 healthy children aged 2-8 years, twenty healthy neonates, 20 preterm neonates with patent ductus arteriosus (PDA) and 20 preterm neonates with no PDA. We will study also 20 neonates with pulmonary hypertension.

Each participant will be examined for 5 minutes and PPG signal will be recorded in a computer and evaluated offline later on. Pulmonic saturation will be calculated from absorption difference between two wave lengths of infrared light that will be used.

Our hypothesis is that the mentioned clinical conditions will affect PPG signal and pulmonary arterial oxygen saturation.

Eligibility criteria: Inclusion Criteria:

* Hemodynamic stability

Exclusion Criteria:

* hemodynamic instability

Primary outcomes:
measure: difference in PPG or pulmonary saturation between conditions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Nitzan M, Nitzan I. Pulse oximetry in the pulmonary tissue for the non-invasive measurement of mixed venous oxygen saturation. Med Hypotheses. 2013 Aug;81(2):293-6. doi: 10.1016/j.mehy.2013.04.026. Epub 2013 May 13.
Clinical trial NCT03297970: Bogota School Children Cohort
Official title: Bogota School Children Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition
Child Health
Child Growth
Neurocognitive Development
Sexual Maturation
Infectious Morbidity
Behavior Problem
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Universidad de la Sabana
name: Foundation for Research in Nutrition and Health (FINUSAD)
First posted: 2017-09-29
Enrollment: 3202
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children were selected from primary public schools in Bogota, Colombia.

Brief summary: This observational study investigates the associations of nutritional indicators, biomarkers, sociodemographic conditions, and infections with child health, as well as physical, behavioral, and cognitive development. Investigators recruited a random sample of 3202 children from primary public schools in Bogota, Colombia in February 2006 and followed them for a median of 6.5 years. Investigators hypothesized that poor nutritional status at the time of recruitment in middle childhood would be related to adverse health outcomes through adolescence.


Eligibility criteria: Inclusion Criteria:

* Primary public school enrollment in February 2006

Exclusion Criteria:

* None

Primary outcomes:
measure: Externalizing behavior problems
timeFrame: Assessed at one point in time when the children were 11-18 years old.
measure: Internalizing behavior problems
timeFrame: Assessed at one point in time when the children were 11-18 years old.
Secondary outcomes:
measure: Behavior problem subscale scores (aggressive behavior, rule breaking behavior, anxious/depressed, withdrawn/depressed, somatic complaints, attention problems, social problems, and thought problems)
timeFrame: Assessed at one point in time when the children were 11-18 years old.
Other outcomes:
measure: Body mass index change
timeFrame: Median 6.5 years from recruitment
measure: Linear growth
timeFrame: Median 6.5 years from recruitment
measure: Age at menarche
timeFrame: Median 6.5 years from recruitment
measure: Grade repetition
timeFrame: 5 years
measure: Blood pressure
timeFrame: Median 6.5 years from recruitment
Locations:
city: Bogota
country: Colombia
facility: FINUSAD - Foundation for Research in Nutrition and Health
city: Chia
country: Colombia
facility: University of La Sabana
Study officials:
affiliation: University of Michigan
name: Eduardo Villamor, MD MPH DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robinson SL, Marin C, Oliveros H, Mora-Plazas M, Richards BJ, Lozoff B, Villamor E. Iron Deficiency, Anemia, and Low Vitamin B-12 Serostatus in Middle Childhood Are Associated with Behavior Problems in Adolescent Boys: Results from the Bogota School Children Cohort. J Nutr. 2018 May 1;148(5):760-770. doi: 10.1093/jn/nxy029.
Clinical trial NCT05175170: Fertility Decision-Making in Youth and Young Adults
Official title: Fertility Decision-Making in Youth and Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transgender Adolescents & Young Adults
Keywords: fertility
decision-making
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to test if using a web-based medical decision-making tool on the topics of fertility and fertility-preservation increases knowledge among transgender youth and young adults.

Detailed description: The pilot trial of Aid for Fertility-Related Medical Decisions (AFFRMED) is a single-arm, pre-/post- feasibility, acceptability, and preliminary efficacy trial. 10 transgender adolescents and young adults (AYA) and 10 parents of transgender AYA participated in a 90-120 min, virtual research visit via Zoom. During this visit they completed pre-test measures of fertility knowledge and decisional self-efficacy, followed by up to 1 hour to freely navigate AFFRMED decision aid. After using AFFRMED, participants completed post-test measures of fertility knowledge and decisional self-efficacy, as well as implementation outcomes measures (Acceptability of Intervention, Intervention Appropriateness Measure, and Feasibility of Intervention Measure).

Eligibility criteria: Inclusion Criteria:

* (1) youth is between the ages of 8-14 years
* (2) youth self-asserts a transgender identity
* (3) youth has expressed interest in GnRHa or is currently on GnRHa treatment; or
* (1) AYA is between the ages of 13-24 years,
* (2) AYA self-asserts a transgender identity, and
* (3) AYA has expressed interest in gender-affirming hormone (GAH) or is currently on GAH treatment.
* Parents of eligible youth will be eligible to participate.

Exclusion Criteria:

* (1) youth/parents are unable to read, speak or understand English
* (2) youth/parents are unable or unwilling to provide consent/assent/parental permission for study participation.

Primary outcomes:
measure: Change in Fertility-related Knowledge
timeFrame: Pre-treatment and immediately post-treatment (same day)
Secondary outcomes:
measure: Change in Decisional Self-Efficacy
timeFrame: Pre-treatment and immediately post-treatment (same day)
Other outcomes:
measure: Participant-Reported Feasibility of AFFRMED
timeFrame: Immediately post-treatment (same day)
measure: Participant-Reported Acceptability of AFFRMED
timeFrame: Immediately post-treatment (same day)
measure: Participant-Reported Appropriateness of AFFRMED
timeFrame: Immediately post-treatment (same day)
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Diane Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06869070: OPTImisation and Standardization of CIRCulating Cell-free DNA Ex-traction Protocols in a Diagnostic Setting
Official title: Optimisation and Standardization of Circulating Cell-free DNA Ex-traction Protocols in a Diagnostic Setting
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Healthy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population has to be older than 18 years, can be of any gender and have a disease-free status

Brief summary: comparison of blood collection tubes and cell-free DNA extraction to evaluate the best possible combination to obtain high quantity and quality cell-free DNA sample for NGS analyses


Eligibility criteria: Inclusion Criteria:

* at least 18 years
* no serious condition

Exclusion Criteria:

* younger than 18 years
* serious health condition that leads to higher cfDNA content in blood

Primary outcomes:
measure: cfDNA quantity
timeFrame: Baseline, at enrollment
measure: cfDNA quality
timeFrame: Baseline, at enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06495970: Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)
Official title: Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Hypertension
Lead sponsor: Gradient Denervation Technologies
Sponsor class: INDUSTRY
First posted: 2024-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm study
Primary purpose: TREATMENT

Brief summary: Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

Detailed description: The Gradient Denervation System delivers ultrasound ablation to planned locations in the pulmonary artery to down-regulate the sympathetic nervous drive. The system includes a sterile, single-use catheter that is designed to centrally position the transducer within the arterial target zone for consistency of ablation.

Eligibility criteria: Inclusion Criteria:

* Mean Pulmonary Artery Pressure (mPAP) \>20 mmHg at rest
* Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest
* Pulmonary Capillary Wedge Pressure \> 15 mmHg (at rest) or \> 18 with passive leg raise
* NYHA Class II or III
* Glomerular Filtration Rate (GFR) ≥ 25 ml/min

Exclusion Criteria:

* Unwilling to provide informed consent or complete follow-up assessments
* Life expectancy of \< 2 years
* Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
* Unable to tolerate right heart catheterization
* Severe aortic, mitral or pulmonary valve regurgitation
* Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)
* Systemic infection or localized infection/rash at planned access site at time of procedure
* CRT, ICD, Pacemaker or other Interventional cardiac procedure (except RHC) within the last 3 months

Primary outcomes:
measure: Device related serious adverse events
timeFrame: 30-days post-treatment
Secondary outcomes:
measure: Mean change from baseline in Pulmonary Vascular Resistance (woods units)
timeFrame: 6 month post-treatment
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
affiliation: Gradient
name: Julie Etheridge
role: STUDY_DIRECTOR
References:
Clinical trial NCT03011970: Temporal Dynamics and Pharmacokinetics of Intranasally Administered Oxytocin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 116
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala response vary as a function of treatment dose and dose-test latency.

Detailed description: The objective of the present study is to determine whether intranasal oxytocin (IN-OXT) effects on blood oxygenation level-dependent functional magnetic resonance imaging (BOLD fMRI) in the amygdala vary as a function of dose and latency. In particular, the investigators plan to compare effects of three different IN-OXT doses (12, 24, and 48 international units, IU) and three different dose-test latencies of IN-OXT administration (task starting at 15, 45 and 75min after administration) on established neural and behavioural correlates of emotion processing. As effects of OXT are particularly promising in autism, the investigators further want to investigate how autistic-like traits influence the OXT effects in exploratory post-hoc analyses

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers
* Right-handed

Exclusion Criteria:

* Current or past psychiatric disease
* Current or past physical illness
* Psychoactive medication
* Tobacco smokers
* MRI contraindication (e.g. metal in body, claustrophobia)

Primary outcomes:
measure: Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala
timeFrame: 45min after nasal spray administration
Secondary outcomes:
measure: Ratings of emotional faces
timeFrame: 45min after nasal spray administration
measure: Questionnaire measurement of mood (PANAS)
timeFrame: 10 min before and 105 min after nasal spray administration
measure: Questionnaire measurement of anxiety (STAI).
timeFrame: 10 min before and 105 min after nasal spray administration
measure: Saliva oxytocin concentrations
timeFrame: immediately before the nasal spray administration and (on average) 15,40,80 and 105 min after administration
measure: Plasma oxytocin concentrations
timeFrame: immediately before the nasal spray administration and immediately after the fMRI experiment
measure: Modulatory effects of autistic like traits on neural and behavioral outcome measures
timeFrame: screening session, ~7days prior to imaging session
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Department of Psychiatry, University of Bonn
state: North Rhine-Westphalia
Study officials:
References:
Clinical trial NCT02335970: Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery
Official title: Effects of a Training Intervention After Thoracoabdominal Oesophagus Surgery -a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oesophagus Cancer
Keywords: Pain
Range of motion
Quality of life
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2015-01-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of a training intervention after thoracoabdominal resection of the oesophagus. Half of the patients scheduled for thoracoabdominal oesophagus surgery were randomized to an intervention group while the other half a control group.

Detailed description: It is well known that thoracoabdominal oesophageal resection for cancer is a procedure with high risks for complications. Earlier trials have shown that respiratory restrictions persist after the operation as well as lower physical function, range of motion in the rib-cage and limitations in activities in daily living. There are, however, only two clinical studies that evaluate postoperative breathing exercises and none evaluating any other rehabilitation interventions.

In other types of extensive surgery that may affect mobility with trauma to muscles and bone structures in the thorax and thoracic spinal column, there is strong evidence that speaks for an active rehabilitation approach in favour of a less active one.

The intervention evaluated was a rehabilitation program including exercises to restore lung function, range of motion in the thoracic spine and shoulders and strength exercises for the back extensors, shoulders and legs.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for thoracoabdominal oesophageal resection
* Ability to perform 90 W during a sub-maximal bicycle test
* Ability to speak Swedish

Exclusion Criteria:

* Serious untreated cardiac disease that may be critical
* Musculoskeletal or neurological disease or trauma affecting respiration or range of motion in the rib cage

Primary outcomes:
measure: Degree of physical disability estimated by the Disability Rating Index (DRI)
timeFrame: 3 months
Secondary outcomes:
measure: Pain in the neck, rib cage and shoulders (visual analogue scale)
timeFrame: 3 months
measure: FVC (Forced Vital Capacity)
timeFrame: 3 months
measure: Range of motion
timeFrame: 3 months
measure: Physical function (Time stand test and heel rise test)
timeFrame: 3 months
measure: Physical Activity (six-level scale)
timeFrame: 3 months
measure: Quality of Life by EORTC QLQ-C30
timeFrame: 3 months
measure: FEV1 s
timeFrame: 3 months
measure: PEF (Peak Expiratory Flow)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Professor at Sahlgrenska Academy at Gothenburg University, Sweden
name: Monika Fagevik Olsén, PhD
role: PRINCIPAL_INVESTIGATOR
References: