louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02771327: Use of a Pressurized Face Mask for Preventing Respiratory Complications After Chest Surgery
Official title: Phase 4, Randomized, Controlled Trial on the Efficacy as Prophylaxis of Postoperative Respiratory Complications and Safety of Continuous Positive Airways Pressure (CPAP) Applied Throughout Boussignac Mask During the Immediate Postoperative Period of Patients Undergoing Lung Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lung Resection
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2016-05-13
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluation of efficacy and safety from 6hours of 7 cmH2O CPAP after weaning in patients undergoing lung resection, on the prevention of atelectasis / pneumonia and gas exchange improve.

Detailed description: Multicenter randomized clinical trial. 460 patients randomly assigned to treatment and control groups will be studied. The main variables are the frequency of atelectasis or pneumonia, defined by clinical and radiological criteria, the FiO2/PaO2 ratio, 7 and 24 h after weaning, and hospital stay.

Eligibility criteria: Inclusion Criteria:

* Undergoing thoracic surgery including resection of lung parenchyma.
* To have given signed consent to enter in the study.

Exclusion Criteria:

Weaning in the first 4h after the intervention end.

* Suspected bronchopleural fistula at the admission to the surgical ICU.
* Patients with facial problems or a history of intolerance to CPAP masks.
* Having significant bullous emphysema defined as the presence of more than 5 contiguous bullae \<2cm or the existence of a pulmonary bulla\> 2 cm or dystrophy bullosa, not in the area to dry and having had a previous pneumothorax.
* Known Obstructive Apnea Hypopnea syndrome known or some form of noninvasive ventilation prescribed.
* Immunocompromised patients, or having used an immunosuppressor drug at least one month prior to surgery with potential (except corticosteroids administered by inhalation)

Primary outcomes:
measure: Frequency of atelectasis- Pneumonia, and other postoperative complications,
timeFrame: 1 week after the surgical intervention
Secondary outcomes:
measure: Gas exchange ( Pa/FiO2)
timeFrame: 1 week after the surgical intervention
measure: Hospital stay comparison between arms
timeFrame: from the surgical intervention date to hospital discharge date up to 1month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hopsital universitario La Princesa
city: Madrid
country: Spain
facility: HGU Gregorio Marañón
city: Madrid
country: Spain
facility: H. Ramón y Cajal
city: Madrid
country: Spain
facility: HU 12 de octubre
Study officials:
References:
Clinical trial NCT01350427: Branched-chain Amino Acids, and Resistance Exercise on Skeletal Muscle Signaling Pathways
Official title: Effects of Leucine, Branched-chain Amino Acids, and Resistance Exercise on Skeletal Muscle Remodelling Signaling Pathways: a Randomized, Double-blind, and Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: leucine supplementation
BCCA supplementation
resistance exercise-induced muscle remodeling
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-05-09
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to evaluate the effects of leucine and branched-chain amino acids supplementation on skeletal muscle remodeling signaling pathways induced by resistance exercise.


Eligibility criteria: Inclusion Criteria:

* Sedentaries
* Must be able to exercise
* Must be able to swallow tablets

Exclusion Criteria:

* Use of nutritional supplements
* Use of anti-inflammatory drugs

Primary outcomes:
measure: Protein synthesis
timeFrame: 1 hour
measure: Protein degradation
timeFrame: 1 hour
measure: Inflammation
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo - School of Physical Education and Sports
Study officials:
affiliation: University of Sao Paulo
name: Claudia R da Luz, Master Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02149927: Neural Mechanisms of Sevoflurane Induced Anesthesia: an EEG fMRI Study in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Anesthesia
Drug Effects
Keywords: EEG
fMRI
connectivity
sevoflurane
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In imaging functional connectivity (FC) analyses of the resting brain, alterations of FC during unconsciousness have been reported. These results are in accordance to recent electroencephalographic studies observing impaired top-down processing during anesthesia. In this study, simultaneous records of functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) were performed to investigate the causality of neural mechanisms during sevoflurane anesthesia by correlating FC in fMRI and directional connectivity (DC) in electroencephalogram.


Eligibility criteria: Inclusion Criteria:

* ASA I
* male
* age \> 18y

Exclusion Criteria:

* drug abuse
* history of psychiatric or neurologic diseases
* amblyacousia, deafness
* contradictions to the study drug (sevoflurane)
* implants
* piercings, tatoos

Primary outcomes:
measure: Changes of information processing (entropy) in EEG and functional connectivity (BOLD ICA and small group network architecture) in fMRI during sevoflurane anesthesia at states awake, 2vol%, 3vol% and EEG endpoint burst suppression
timeFrame: 10 minutes for each condition
Secondary outcomes:
measure: Assessment of the brain network structure during recovery in EEG and fMRI
timeFrame: 10 minutes for each condition
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar
state: Bayern
Study officials:
affiliation: Klinikum rechts der Isar, Technische Universität München, Munich, Germany
name: Eberhard F Kochs, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01363427: Retrospective Data Analysis in Crohn's Disease
Official title: Retrospective Data Analysis of Newly Diagnosed Crohn's Disease Patients in Gastroenterological Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-06-01
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Private practices

Brief summary: The purpose of this study is to identify prognostic parameters about efficacy of Mesalazine in recently diagnosed patients with Morbus Crohn by retrospective data collection.


Eligibility criteria: Inclusion Criteria:

* therapeutic need according to SPC
* written informed consent

Primary outcomes:
measure: Response to Mesalazine: measured by time to step up therapy
timeFrame: 12 to 48 months
Secondary outcomes:
measure: Identification and characterisation of the responding sub-population
timeFrame: 12 to 48 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Investigational Site, Ehrenfelsstraße 47
city: Berlin
country: Germany
facility: Investigational Site, Möllendorfstraße 111
city: Dachau
country: Germany
facility: Investigational Site, Münchner Straße 64
city: Dinkelsbühl
country: Germany
facility: Investigational Site, Karlsbader Straße 7
city: Hof
country: Germany
facility: Investigational Site, Heiligengrabstraße 16
city: Karlstadt
country: Germany
facility: Investigational Site, Am Tiefen Weg 2
city: Kiel-Altenholz
country: Germany
facility: Investigational Site, Erdbeerfeld 8
city: Koblenz
country: Germany
facility: Investigational Site, Hohenfelder Straße 20
city: Köln
country: Germany
facility: Investigational Site, Graseggerstraße 105
city: Leipzig
country: Germany
facility: Investigational Site, Funkenburgstraße 19
city: Leverkusen
country: Germany
facility: Investigational Site, Franz-Kail-Straße 2
city: Mainz
country: Germany
facility: Investigational Site, Bahnhofplatz 2
city: Minden
country: Germany
facility: Investigational Site, Uferstraße 3
city: Münster
country: Germany
facility: Investigational Site, Hammer Straße 95
city: Nürnberg
country: Germany
facility: Investigational Site, Weiltinger Str. 11
city: Rottenburg
country: Germany
facility: Investigational Site, Marktplatz 23
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT05013827: Opinions of Company Representatives About Neuromodulation
Official title: Opinions of Company Representatives About Neuromodulation for Pain: an Online Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromodulation
Pain
Survey
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female adults who are involved in the management of chronic pain and more specifically in neuromodulation for pain as company representatives will be eligible to complete the survey. The survey will be spread at the 2nd Joint Congress of the INS European Chapters (e-INS 2021) in Paris from 2/9/2021 to 4/9/2021.

Brief summary: The goal of this online survey is to gain further insight in the goals, expectations and definition of success for neuromodulation for pain, according to neuromodulation company representatives.


Eligibility criteria: Inclusion Criteria:

- Male and female adults who are involved in the management of chronic pain and more specifically in neuromodulation for pain as company representatives will be eligible to complete the survey.

Exclusion Criteria:

- Not a company representative.

Primary outcomes:
measure: Goals of company representatives, evaluated with a self-constructed question.
timeFrame: Cross-sectional evaluation during 2nd Joint Congress of the INS European Chapters (e-INS 2021) in Paris in September.
measure: Company representatives expectations, evaluated with a self-constructed question.
timeFrame: Cross-sectional evaluation during 2nd Joint Congress of the INS European Chapters (e-INS 2021) in Paris in September.
measure: Company representatives definition of success of neuromodulation for pain, evaluated with a self-constructed question.
timeFrame: Cross-sectional evaluation during 2nd Joint Congress of the INS European Chapters (e-INS 2021) in Paris in September.
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Vrije Universiteit Brussel
Study officials:
References:
Clinical trial NCT05025527: Biparametric MRI in Prostate Cancer Screening: a Noninferior Randomized Controlled Study
Official title: Biparametric MRI in Prostate Cancer Screening: a Noninferior Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
screen
bpMRI
PSA
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 500
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This is a single centre non-inferiority randomized controlled trial in comparison of the bpMRI between the traditional pathway in prostate cancer screening


Eligibility criteria: Inclusion Criteria:

1. age between 18 and 80 years old
2. life-expectancy at least 10 years
3. fully understand the clinical trial protocol and sign the informed consent;

Exclusion Criteria:

1. Already diagnosis with prostate cancer;
2. cannot tolerate prostate biopsy or has contraindication to biopsy;
3. cannot tolerate prostate biopsy or has contraindication to MRI examination;
4. undergo biopsy within 1 year
5. patients judged by the investigator to be unsuitable to participate in the clinical trial;

Primary outcomes:
measure: The proportion of men with clinically significant cancer
timeFrame: Within 1 month after the biopsy
Secondary outcomes:
measure: The proportion of men with clinically insignificant cancer
timeFrame: Within 1 month after the biopsy
measure: The proportion of men who do not undergo biopsy
timeFrame: Within 1 month after the biopsy
measure: The proportion of men with adverse events after the intervention
timeFrame: Within 1 week after the biopsy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital, Tongji University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital,Tongji University School of Medicine
name: Haifeng Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01194427: A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer
Official title: A Multi-Institutional Phase II Study Evaluating Surrogate Biomarkers of Response to Short Term Oral Vorinostat and Tamoxifen in Women With Newly Diagnosed Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Invasive Breast Cancer
Keywords: Preoperative
Neoadjuvant
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-09-03
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This research study is designed to look at the effects of the combination of vorinostat (Suberoylanilide Hydroxamic Acid or Zolinza) and tamoxifen on breast cancer tissue. The investigators will do this by comparing tissues from the original breast biopsy to tissues obtained after taking vorinostat and tamoxifen for 2 weeks.

Detailed description: Key eligibility criteria include:

* Newly diagnosed invasive breast cancer awaiting surgery or neoadjuvant (preoperative) treatment
* No use of hormone contraceptives or replacement therapy within 30 days prior to the diagnostic breast cancer biopsy (unless willing to have an additional biopsy prior to starting the study)
* No prior or current use of any therapy to treat the current breast cancer.

Eligibility criteria: Inclusion Criteria:

* Stage I-III invasive breast cancer
* Awaiting surgery or neoadjuvant treatment
* ECOG performance status 0, 1 or 2
* Adequate organ function
* Prior use of hormone contraception or replacement therapy must have been discontinued at least 30 days prior to diagnostic biopsy (unless participant is willing to undergo an additional biopsy for the study)

Exclusion Criteria:

* Prior or current treatment of any kind for the current breast cancer
* Current use of any other investigational drugs
* Uncontrolled or active infection, congestive heart failure, cardiac arrythmia, or psychiatric illness

Primary outcomes:
measure: Changes in Markers of Proliferation Prior to and After Study Drug Administration
timeFrame: Baseline and 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Vered Stearns, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02446327: The Metabolic Road to Diastolic Heart Failure: Diastolic Heart Failure Study
Official title: The Metabolic Road to Diastolic Heart Failure : Diastolic Heart Failure Study (MEDIA-DHF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diastolic Heart Failure
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2015-05-18
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main objective is to replicate the validation of omics biomarkers of left ventricular diastolic dysfunction in patients with metabolic syndrome.

The aim was to recruit overall 750 patients in Europe (100 for France). Currently, 625 patients were enrolled in Europe and 47 in France.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* Signs or symptoms of HF
* Able and willing to provide freely given written informed consent including analysis of genomics

Exclusion Criteria:

* Patients with acute myocardial infarction
* Recent trauma or surgery (\< 3 months)
* Hemodynamically significant valvular disease
* Serious cerebrovascular disease or stroke in the last 3 months
* Chronic dialysis
* Chronic liver disease
* Chronic infectious (bacterial or viral) disease
* Any malignant concomitant diseases or a malignant disease in the last 5 years
* Systemic inflammatory diseases, such as autoimmune diseases, connective tissue diseases or collagenoses
* Pregnant women

Primary outcomes:
measure: Cardiovascular Hospitalizations or Cardiovascular Death
timeFrame: 12 months
Secondary outcomes:
measure: Cardiovascular Hospitalizations
timeFrame: 3 months, 6 months, 12 months
measure: Heart Failure Hospitalizations
timeFrame: 3 months, 6 months, 12 months
measure: Other cardiovascular hospitalizations
timeFrame: 3 months, 6 months, 12 months
measure: Non cardiovascular hospitalizations
timeFrame: 3 months, 6 months, 12 months
measure: Cardiovascular Death
timeFrame: 3 months, 6 months, 12 months
measure: Non cardiovascular Death
timeFrame: 3 months, 6 months, 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Stienen S, Ferreira JP, Kobayashi M, Preud'homme G, Dobre D, Machu JL, Duarte K, Bresso E, Devignes MD, Andres NL, Girerd N, Aakhus S, Ambrosio G, Rocca HB, Fontes-Carvalho R, Fraser AG, van Heerebeek L, de Keulenaer G, Marino P, McDonald K, Mebazaa A, Papp Z, Raddino R, Tschope C, Paulus WJ, Zannad F, Rossignol P. Sex differences in circulating proteins in heart failure with preserved ejection fraction. Biol Sex Differ. 2020 Aug 24;11(1):47. doi: 10.1186/s13293-020-00322-7.
Clinical trial NCT06714227: Genetics of Prostate Cancer in Young Patients
Official title: Genetics of Prostate Cancer in Young Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Carcinoma
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients aged 18 years or older with a diagnosis of prostate cancer and age ≤55 years at first diagnosis.

Brief summary: The aim of the study is to identify genetic variants in genes responsible or potentially responsible for the etiology of prostate cancer in a population of patients with early onset of the malignancy.

Detailed description: The data collected from the study will provide a preliminary picture of the prevalence and type of germline pathological variants in the context of early-onset prostate cancer in the Italian population. In addition, alterations in DNA repair genes other than BRCA1-2 and ATM, including any genes yet undescribed as causative or predisposing, have yet to be explored in detail: in many cases the significance of variants is not well defined in terms of pathogenicity, prognostic value, and predictive indicator of response to different treatments. Therefore, an extensive mutational analysis-even if performed on a limited number of patients-can generate a large number of variants for evaluation, bringing knowledge about the relationship between these variants and the onset of malignancy The information obtained, although merely exploratory, may indicate the desirability of conducting systematic genetic investigations in this particular patient population in the future, especially in view of the new therapeutic strategies available such as immunotherapy or PARP inhibitors

Eligibility criteria: Inclusion Criteria:

* Patients with histologic or cytologic diagnosis of prostate cancer
* Age ≥18 years and ≤55 years at first diagnosis of prostate carcinoma
* Availability of clinical and instrumental data related to prostate cancer
* Patients who knowingly express willingness to participate in the study after signing written informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Presence/absence and type of pathogenic/probably pathogenic germline variants in genes previously implicated in prostate cancer etiology
timeFrame: 4 years
Secondary outcomes:
measure: Presence/absence and type of variants in genes potentially implicated in the etiology of prostate cancer (candidate genes).
timeFrame: 4 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Cesare Rossi, Biologist
role: PRINCIPAL_INVESTIGATOR
References: