louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03425344: Discriminative Validity of Strain Elastography of the Supraspinatus Tendon
Official title: Discriminative Validity of Real-time Sonoelastography of the Supraspinatus Tendon: Comparison of Findings Between Patients With Supraspinatus Tendinopathy and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elasticity Imaging Techniques
Tendinopathy
Rotator Cuff Tendinitis
Musculoskeletal Disease
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Sygehus Lillebaelt
name: Gigtforeningen
name: Region of Southern Denmark
name: Radiograf Rådet
First posted: 2018-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A case-control study without intervention
Primary purpose: DIAGNOSTIC

Brief summary: This study aims at testing the discriminative validity of strain elastography in the normal and abnormal/pathological Supraspinatus tendon due to tendinopathy

Detailed description: The case-control trial will include 96 participants. 48 of them diagnosed with supraspinatus tendinopathy by MRI and 48 healthy subjects.

In this study the investigators will compare the outcome of tissue elasticity measured by sonoelastography, with MRI and conventional ultrasound.

Patients will be recruited through different radiology department and healthy volunteers will be recruited primarily through advertising in local newspapers and social media.

Eligibility criteria: Inclusion Criteria:

* Body mass index \< 30
* Symptomatic: Positive on 3/5 clinical tests (full can, empty can, resisted external rotation, neers, hawkins.
* Asymptomatic: No shoulder pain in the last year, negative on 5/5 clinical tests (full can, empty can, resisted external rotation, neers, hawkins).

Exclusion Criteria:

* Shoulder-fracture, operation and luxation, known-neuromuscular disease, rheumatoid arthritis, cancer, fibromyalgia, spondyloarthropathy and psychiatric disorders, pregnancy and inability to read and understand Danish. Biceps rupture, labrum lesions, supraspinatus tears (\> 1/3 of the vertical tendon height) and calcifications (\> 2 mm in length) (MRI).

Primary outcomes:
measure: Tendon quality (SEL)
timeFrame: Baseline
Secondary outcomes:
measure: Pain on a VAS scale
timeFrame: Baseline
measure: Quality of life on the E!-5D-3L questionnaire
timeFrame: Baseline
measure: Disability
timeFrame: Baseline
measure: Tendon quality (MRI)
timeFrame: Baseline
measure: Tendon quality (US)
timeFrame: Baseline
Other outcomes:
measure: Demographic
timeFrame: Baseline
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
Study officials:
affiliation: Department of Sport Science and Biomechanics
name: Birgit Juul-Kristensen, Assoc. Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT02332044: Drug Interaction Study Between Erdosteine and Bepotastine Besilate in Healthy Adult Volunteers
Official title: A Randomized, Open-label, Single Dose, Three-treatment, Three-period, Six-sequence Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Erdosteine and Bepotastine Besilate After Oral Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2015-01-06
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the drug-drug interaction between Erdosteine and Bepotastine besilate in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects aged 20 - 45 years
* A body mass index in the range 18.5 - 25 kg/m2
* Willingness to participate during the entire study period
* Written informed consent after being fully informed about the study procedures

Exclusion Criteria:

* Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
* History of clinically significant drug hypersensitivity
* Use of medication within 7 days before the first dose
* Heavy drinker/smoker
* Whole blood donation during 60 days before the study
* Judged not eligible for study participation by investigator

Primary outcomes:
measure: Cmax
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
measure: AUClast
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05402644: Hepatectomy for Early-stage HCC Patients With CSPH
Official title: Clinically Significant Portal Hypertension (CSPH) on Early-stage HCC Following Hepatectomy: What's the Impact?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCC
Portal Hypertension
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 320
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 311 HCC patients treated from December 2009 to January 2017.

Brief summary: Clinically significant portal hypertension (CSPH) can affect the surgical prognosis of early-stage (BCLC stage A) HCC. An additional stage, such as the BCLC stage A-B, can be considered.


Eligibility criteria: Inclusion Criteria:

HCC was diagnosed by two experienced pathologists in Child-Pugh grade A/B negative resection margin Initial diagnosis of HCC in the patients

Exclusion Criteria:

Distant transfer Not HCC

Primary outcomes:
measure: death
timeFrame: 2009--2025
measure: recurrence
timeFrame: 2009--2025
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04040244: Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis
Official title: A Pilot Study of Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis After Chemoradiotherapy For Stage III Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pneumonitis
Nonsmall Cell Lung Cancer Stage III
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-07-31
Enrollment: 16
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: This is a prospective pilot study investigating exhaled breath condensate analyses to quantify the variability over time of various biomarkers associated with symptomatic pneumonitis.

Detailed description: Primary Objective:

• To quantify the intra-person variability of concentrations of TGF-β1, IL-6, IL-1α, and IL-10 measured in exhaled breath condensate.

Secondary Objectives:

* To examine the associations between differences in pre-treatment and post-treatment exhaled breath condensate concentrations of TGF-β1, IL-6, IL-1α, and IL-10 and the development of CTCAE grade 2+ symptomatic pneumonitis.
* To examine the associations between serum measures of TGF-β1, IL-6, IL-1α, and IL-10 and:
* Exhaled breath condensate measures of the same biomarkers, and
* The development of CTCAE grade 2+ symptomatic pneumonitis.
* To examine the association between microbiome signatures found in pre-treatment exhaled breath condensate and the development of CTCAE grade 2+ symptomatic pneumonitis.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years old.
* Clinically diagnosed or suspected Stage III non-small cell lung cancer to be treated with chemoradiotherapy as part of cancer treatment, as determined by the treating clinician.
* Plan for treatment with definitive radiotherapy (≥60 Gy) with concurrent chemotherapy at the discretion of the treating radiation and medical oncologists.
* Willing and able to tolerate exhaled breath collection.
* Able to provide informed consent.

Exclusion Criteria:

* Systemic (oral, intravenous or intramuscular) corticosteroid use for any reason within 5 days of registration.
* Prior radiotherapy directed at the chest (thoracic inlet superiorly to diaphragm inferiorly).
* Any systemic antibiotic use within 2 weeks of registration.

Primary outcomes:
measure: Variability of Biomarkers
timeFrame: At baseline and one month after completion of chemotherapy
Secondary outcomes:
measure: Differences in Concentrations of Biomarkers in Exhaled Breath Condensate From Baseline to 1 Month Post CRT
timeFrame: One month after completion of chemotherapy
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael Farris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04768244: Impact of Maternal COVID-19 Disease on Breast Milk and Infant Health
Official title: Impact of Maternal SARS-CoV-2 Infection and Vaccination on Breast Milk Antibodies, Milk Bioactive Compounds and Maternal-child Health (MilkCORONA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Breast milk
Microbiota
Sars-CoV-2
metabolites
immune compounds
infant growth and development
Lead sponsor: Institute of Agrochemistry and Food Technology, National Research Council
Sponsor class: OTHER_GOV
Collaborators: name: Hospital Universitario La Fe
name: INCLIVA
name: Hospital Clínico Universitario de Valencia
name: Hospital Universitario Doctor Peset
name: Universidad de Granada
name: Universitat Jaume I
name: Hospital Sant Joan de Deu
name: Fetal Medicine Research Center, Spain
name: Instituto de Investigación Sanitaria Aragón
First posted: 2021-02-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with SARS-CoV-2 infection at the end of pregnancy, before delivery following hospitals COVID19 screening protocols.

Brief summary: prospective multicenter study The main aim is to study the impact of maternal COVID-19 on breast milk immune, microbiological, and metabolic profile and infant growth and development


Eligibility criteria: Inclusion Criteria:

* pregnant or nursing women with positive PCR for SARS-CoV-2 in nasopharynge and/or presence of SARS-CoV-2 antibodies in serum determined in hospitals

Exclusion Criteria:

* aggravation of symptomatology requiring specific treatment and/or hospitalization

Primary outcomes:
measure: SARS-CoV-2 RNA
timeFrame: 1 month
Secondary outcomes:
measure: breast milk immune
timeFrame: 1st year
measure: breast milk microbiota
timeFrame: 1st year
measure: breast milk metabolite
timeFrame: 1st year
measure: infant microbiota
timeFrame: 1st year
measure: infant growth and development
timeFrame: 1st year
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Fundacion Investigacion Sanitaria INCLIVA
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico la Fe
Study officials:
References:
citation: Bauerl C, Randazzo W, Sanchez G, Selma-Royo M, Garcia Verdevio E, Martinez L, Parra-Llorca A, Lerin C, Fumado V, Crovetto F, Crispi F, Perez-Cano FJ, Rodriguez G, Ruiz-Redondo G, Campoy C, Martinez-Costa C, Collado MC; MilkCORONA study team. SARS-CoV-2 RNA and antibody detection in breast milk from a prospective multicentre study in Spain. Arch Dis Child Fetal Neonatal Ed. 2022 Mar;107(2):216-221. doi: 10.1136/archdischild-2021-322463. Epub 2021 Aug 20.
Clinical trial NCT04460144: Rapid Diagnostic Test for Septic Arthritis
Official title: Diagnostic Validation Study of a Test Based on the Analysis of the Proteome by Mass Spectrometry for the Diagnosis of Septic Arthritis in Children Under 16 Years of Age.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Juvenile Idiopathic Arthritis
Arthritis, Septic
Arthritis, Unspecified
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 274
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute arthritis

Brief summary: Diagnostic Validation Study of a Test Based on the Analysis of the Proteome by Mass Spectrometry for the Diagnosis of Septic Arthritis in Children Under 16 Years of Age

Detailed description: Arthritis is an inflammation of the joints that can have many causes. In children, septic arthritis (SA) is the most common cause of acute arthritis (around 45% of cases). Juvenile Idiopathic Arthritis (JIA) is a disease characterized the presence of arthritis in one or more of unknown origin in children under 16 years of age, lasting more than 6 weeks. It is the most common pediatric rheumatological disease with a prevalence of 16 to 150 cases per 100,000 children. Finally, in approximately 40% of children the origin of acute arthritis remains undetermined (ND arthritis). In this group, all the examinations performed are not in favor of a bacterial origin and the evolution of arthritis do not allow the diagnosis of JIA to be retained and no other disease is found.

During the first few days of arthritis, differentiation between AS and non-septic arthritis is difficult. The available clinical and biological parameters do not allow for easy and rapid differentiation between AS and non-septic arthritis.

This project aims to develop a new diagnostic technique based on molecular analysis of the proteome in the joint puncture fluid.

Eligibility criteria: Inclusion Criteria:

* Patients \>3 months of age \<16 years of age
* Hospitalized for arthritis that started less than 6 weeks ago or patients with diagnosed inflammatory arthritis whose clinical course suggests bacterial superinfection
* Indication of a joint puncture for diagnostic purposes, confirmed by a senior physician after study of all available clinical and biological elements.
* Holders of parental authority who have accepted the participation of their children
* Patients benefiting from a social security scheme (excluding AME)

Exclusion Criteria:

* Contraindications to joint puncture

Primary outcomes:
measure: Mass spectrometry profile
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debre Hospital
Study officials:
affiliation: APHP
name: Ulrich MEINZER, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP
name: Stephane BONACORSI, MD-PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04701944: Clinical Study of Pregnant Women With COVID-19
Official title: Clinical Study of Pregnant Women With COVID-19: A Retrospective Review of Medical Records at Strasbourg University Hospitals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Keywords: COVID-19
COVID-19 Pandemic
Sars-cov-2
Pregnant women
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant woman suffering from a confirmed or suspected COVID-19 infection

Brief summary: A new pandemic, COVID-19, has spread rapidly around the world. She does not spare pregnant women. Little is known about the clinical course of pregnant women infected with COVID-19. As of April 1, 2020, six case series and one case report for a total of 61 pregnancies affected by COVID-19, all from the pandemic epicenter in China, except for one state case report -Unis, have been published. These preliminary reports suggest that pregnant women are not more seriously affected than the general population and show a certain gap with what we have observed in the care of pregnant women at HUS. For these reasons, additional information, especially from parts of the world other than China, as the severity of the disease can vary from country to country, is urgently needed to determine whether pregnant women with the disease of COVID-19 will not present with severe pneumonia to COVID-19.


Eligibility criteria: Inclusion criteria:

* Adult woman (≥18 years old)
* Pregnant woman
* Suffering from a confirmed or suspected COVID-19 infection
* Patient who has been medically treated at Strasbourg University Hospitals as well as for his newborn baby, between 03/01/2020 and April 30, 2020
* Woman having given, after information, her agreement for the reuse of her data for the purposes of this research

Exclusion criteria:

* Patient who expressed her opposition to participating in the study
* Patient under guardianship or under guardianship
* Patient under legal protection

Primary outcomes:
measure: A retrospective review of the medical records of pregnant women with COVID-19 at the University Hospitals of Strasbourg
timeFrame: Files analysed retrospectively from March 01, 2020 to April 30, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Department of Gynecology-Obstetrics and Fertility - Strasbourg University Hospitals
Study officials:
affiliation: Department of Gynecology-Obstetrics and Fertility - Strasbourg University Hospitals
name: Philippe DERUELLE, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03846544: Double Pick up in Poor Prognosis Women
Official title: Double Trigger and Ovum Retrieval vs. Conventional Antagonist Ovarian Stimulation Protocol in Poor Prognosis Women Undergoing IVF/ICSI: A Pilot Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fertility Disorders
Lead sponsor: CRG UZ Brussel
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 48
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized pilot study is to compare the efficacy of double oocyte retrieval vs. conventional antagonist ovarian stimulation protocol in poor prognosis patients undergoing in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI).


Eligibility criteria: Inclusion Criteria:

* Age 25-40 years
* Body mass index (BMI) ≤ 35 and ≥ 19
* Antimüllerian hormone (AMH) level of ≤1.5 ng/mL or antral follicular count (AFC) of ≤6 follicles or ≤5 oocytes retrieved in a previous cycle following standard conventional ovarian stimulation.

Exclusion Criteria:

* Testicular sperm extraction
* History of \> 3 three consecutive previous unsuccessful IVF cycles
* BMI \>35 or \<19
* Use of oral contraceptives \<3 months before start of the treatment
* polycystic ovary syndrome (PCOS) according to the Rotterdam criteria
* Ovarian stimulation for pre-implantation genetic testing (PGT-A/M)
* Medical/social freezing
* In vitro maturation (IVM)
* History of untreated autoimmune, endocrine or metabolic disorders,
* Ovarian cystectomy or oophorectomy

Primary outcomes:
measure: Number of MII Oocytes Retrieved Between the Two Arms
timeFrame: 1 month
Secondary outcomes:
measure: Number of Preovulatory Follicles
timeFrame: 1 month
measure: Number of Cumulus Oocyte Complexes (COCs) Retrieved
timeFrame: 1 month
measure: Number of Oocytes Fertilized
timeFrame: 1 month
measure: Total Number of Available Embryos
timeFrame: 1 month
measure: Duration of Ovarian Stimulation
timeFrame: 1 month
measure: Clinical Pregnancy Rates
timeFrame: 4 months
measure: Live Birth Rates
timeFrame: 12 months
measure: Cumulative Live Birth Rates
timeFrame: 24 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel
state: Jette
Study officials:
References:
Clinical trial NCT06549244: Preoperative Maximum Inspiratory Pressure and Outcomes After Interscalene Block in Obese Patients
Official title: A Pilot Study on Inspiratory Dynamics and the Effect of Body Mass Index on Respiratory Outcomes After Temporary Hemi Diaphragmatic Paresis Related to Brachial Plexus Blocks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspnea After Interscalene Nerve Block
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 45
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: Adult patients presenting for shoulder surgery with preoperative interscalene block (Groups 1 and 2). Group 3 includes adult patients presenting for non thoracic, non abdominal surgery under general anesthesia.

Brief summary: The study aims to explore if Maximum Inspiratory Pressure can predict postoperative breathlessness in obese patients receiving interscalene blocks for shoulder surgery.

The main question is: does baseline Maximum Inspiratory Pressure have any association with postoperative breathlessness after interscalene blocks in class 2 or higher obese patients (BMI\>35).

Preoperative and postoperative lung volumes, pressures, breathlessness score and respiratory outcomes will be measured on participants already receiving shoulder surgery with interscalene blocks.


Eligibility criteria: Inclusion Criteria Groups 1 and 2

* Adults \>18 years of age receiving shoulder surgery with preoperative interscalene block and general anesthesia;
* Speak English;

Group 3

· Adults \>18 years of age receiving cystoscopy or lower extremity procedures receiving general endotracheal anesthesia

Exclusion Criteria All Groups

* Less than 18 years of age;
* currently pregnant;
* currently incarcerated;
* those with significant neuromuscular disease, tracheo-bronchial structural abnormalities, severe respiratory or severe cardiovascular comorbidity;
* those undergoing intra-abdominal or intrathoracic surgeries due to the potential to independently effect breathing

Primary outcomes:
measure: Incidence of Moderate to Severe Breathlessness
timeFrame: Baseline (Arrival to pre-operative phase), Recovery (Immediately post-surgical, up to 3 hours)
Secondary outcomes:
measure: Oxygen Saturation in post-anesthesia care unit
timeFrame: Recovery (Immediately post-surgical, up to 3 hours)
measure: Post-anesthesia care unit length-of-stay
timeFrame: Recovery (Immediately post-surgical, up to 3 hours)
measure: Duration of Oxygen supplementation in post-anesthesia care unit
timeFrame: Recovery (Immediately post-surgical, up to 3 hours)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Monika Nanda
role: PRINCIPAL_INVESTIGATOR
References: