louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05572112: The Performance / Safety of the Celsite® Venous Access Ports
Official title: Post Market Clinical Follow-up Study on the Performance /Safety of Celsite® Venous Access Ports in Patients Who Need Repeated Venous Access
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: The Performance / Safety of the Celsite® Venous Access Ports
Lead sponsor: B.Braun Médical - CoE Chasseneuil
Sponsor class: INDUSTRY
First posted: 2022-10-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient is at least 18 years old

Brief summary: The Celsite® Venous Access Ports System are intended to be used for repeated intravenous administration of, for example, chemotherapy, antibiotic and antiviral drugs, total parenteral nutrition, blood sampling or transfusion.

The objective is to assess the device's safety to deliver medication over the time in regard to the rate of adverse events related to the Celsite® access ports written in the IFU.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years old
* Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Ethics Committee (EC) prior to all evaluations.
* Patient for whom the access port placement has already been determined as the best treatment option within the regular planning of the patient's treatment in accordance with the IFU.
* Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol

Exclusion Criteria:

* Patient for whom the technical and/ or clinical characteristics of the access port placement or use is outside the scope of the IFU.
* Patient not followed-up in the center where the access port is implanted.
* Pregnancy
* Patient \< 18 years of age

Primary outcomes:
measure: To assess the device's safety
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06982612: Glycemic Control Following Occupational Work in a Hot Environment
Official title: Glycemic Control Following Occupational Work in a Hot Environment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Plasma Glucose Following Prolonged Heat Exposure
Keywords: heat
plasma glucose
worker
glycemia
OGTT
Lead sponsor: Loughborough University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised, crossover design
Primary purpose: BASIC_SCIENCE

Brief summary: Occupational workers regularly perform physically demanding tasks in hot environments, exposing them to heat stress and potential dehydration. While the physiological impacts of heat exposure are well-documented, its effects on glycemic control remain less understood. Given the rising global temperatures due to climate change and the increasing prevalence of metabolic disorders such as obesity and type 2 diabetes, it is essential to investigate how heat exposure during work influences glycemic regulation. Understanding these interactions will help inform future occupational health guidelines and metabolic health recommendations in physically demanding industries.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Generally fit and healthy
* Participate in endurance or intermittent exercise at least 3 times a week or minimum of 150 minutes moderate intensity activity per week

Exclusion Criteria:

* Under 18 or 45 and over,
* any morbidity or medication that might influence carbohydrate/fat metabolism (i.e., liver/renal/cardiovascular disease) or cycling ability (musculoskeletal injury etc),
* coagulation or bleeding disorders,
* blood-borne illness,
* heart conditions,
* congenital heart disease,
* uncontrolled exercise-induced asthma,
* smoking (including vaping),
* allergies to the products used in the study,
* dieting or restrained eating behaviours.
* Females with amenorrhea would be an exclusion criteria.

Primary outcomes:
measure: Plasma glucose
timeFrame: 8hours
Secondary outcomes:
measure: Plasma insulin
timeFrame: 8hours
measure: Plasma osmolality
timeFrame: 8hours
measure: Plasma volume change
timeFrame: 8hours
measure: Urine volume
timeFrame: 8hours
measure: Body mass
timeFrame: 8hours
measure: Urine specific gravity/osmolality
timeFrame: 8hours
measure: Rectal temperature
timeFrame: 8hours
measure: Blood pressure
timeFrame: 8hours
measure: Respiratory gas exchanges
timeFrame: 8hours
measure: Rate of perceived exertion
timeFrame: 8hours
measure: Rate of thermal sensation
timeFrame: 8hours
measure: Feelings of thirst, urge to urinate, GI comfort, and stomach bloatedness
timeFrame: 8hours
Other outcomes:
measure: N-back task for working memory (cognitive function)
timeFrame: 8hours
measure: Go/no-go task for response inhibition (cognitive function)
timeFrame: 8hours
measure: Stroop test
timeFrame: 8hours
Locations:
Study officials:
References:
Clinical trial NCT06739512: Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation
Official title: Efficacy and Safety of Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Keywords: ablation
atrial fibrillation
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Albert Einstein College of Medicine and Montefiore Medical Center
name: Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
name: Shandong University of Traditional Chinese Medicine
name: Yuhuan Second People's Hospital
name: Changshu Hospital of Traditional Chinese Medicine
name: Jinan People's Hospital
name: Xuzhou Central Hospital
name: The PLA Navy Anqing Hospital
First posted: 2024-12-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of pulsed field ablation (PFA) in patients with persistent atrial fibrillation (PeAF). We will compare three distinct substrate ablation strategies: anatomical guided ablation (ANAT group), electrogram guided ablation (EGM group), and extensive electro-anatomical guided ablation (EXT group). The study seeks to identify which ablation strategy yields the highest efficacy and safety profiles to potentially guide future clinical practice in the management of PeAF.


Eligibility criteria: Inclusion Criteria:

1. Adults aged 18-80 years diagnosed with persistent atrial fibrillation.
2. Ineffectiveness or intolerance to at least one Class I or III anti-arrhythmic drug.

Exclusion Criteria:

1. Major valvular diseases needing surgical intervention.
2. Presence of a left atrial thrombus on recent imaging.
3. Recent myocardial infarction or severe heart failure (LVEF ≤ 30%).
4. Current Severe Infection.

Primary outcomes:
measure: Freedom from Atrial Arrhythmia Recurrence at 12 Months
timeFrame: 12 months after ablation procedure
Secondary outcomes:
measure: Procedural Safety
timeFrame: From enrollment to completion of follow-up（at least 12 months）
measure: Symptom Relief and Quality of Life Enhancement.
timeFrame: From enrollment to completion of follow-up（at least 12 months）
measure: Atrial Fibrillation Burden Reduction
timeFrame: From enrollment to completion of follow-up（at least 12 months）
Other outcomes:
Locations:
city: Shanghai
country: China
facility: No. 241, West Huaihai Road
state: Shanghai
Study officials:
References:
Clinical trial NCT04731012: Immunological and Cardiovascular Phenotyping of Oocyte-donation Pregnancies
Official title: Immunological and Cardiovascular Phenotyping of Oocyte-donation Pregnancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preeclampsia
Oocyte-donation Pregnancies
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * oocyte donation pregnancies
* IVF or ICSI pregnanies
* spontaneous conception pregnancies

Brief summary: The investigators conduct a study to evaluate the underlying causes of preeclampsia in oocyte-donation pregnancies.

Detailed description: A detailed medical history, questionnaires as well as blood, urine and placental samples will be used to analyse several factors leading to the high risk of preeclampsia in oocyte-donation pregnancies.

Eligibility criteria: Inclusion Criteria:

* pregnancy

Exclusion Criteria:

* severe auto immune disorders

Primary outcomes:
measure: Preeclampsia in oocyte-donation pregnancies is caused by an altered composition of immune cells in placenta and blood.
timeFrame: 01.01.2020 - 01.12.2025
Secondary outcomes:
measure: Preeclampsia in oocyte-donation pregnancies is caused by an activation of pro-inflammatory factors and endothelial dysfunction.
timeFrame: 01.01.2020 - 01.12.2025
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Experimental and Clinical Research Center (ECRC)
Study officials:
References:
Clinical trial NCT03659812: Magnetic Activated Cell Sorting in Artificial Insemination With Donor Sperm
Official title: Application of Magnetic Activated Cell Sorting (MACS) of Spermatozoa in Artificial Insemination Cycles With Donor Sperm (AID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Magnetic activated cell sorting (MACS)
Artificial insemination with donor sperm (AID)
Spermatozoa
Sperm
Lead sponsor: Vida Recoletas Sevilla
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to analyse the efficacy of MACS technique for the selection of spermatozoa and its effects on implantation, pregnancy and miscarriage rate. This study will be performed by two IVI clinics (IVI Sevilla and IVI Madrid) with the purpose of finding new techniques that allow us to better select spermatozoa and improve the results of assisted reproduction techniques.


Eligibility criteria: Inclusion Criteria:

* Women who undergo artificial insemination with donor sperm
* Signing an informed consent form to participate in the study

Primary outcomes:
measure: Pregnancy rate
timeFrame: Ultrasound examination is performed 5 weeks after artificial insemination. Pregnancy rate is calculated during the phase of data analysis.
measure: Implantation rate
timeFrame: The beta hCG analysis is performed 15 days after artificial insemination. Implantation rate is calculated during the phase of data analysis.
measure: Live birth rate
timeFrame: Live births are assessed at delivery (end of pregnancy period). Live birth rate is calculated during the phase of data analysis
Secondary outcomes:
measure: Sperm cell concentration
timeFrame: This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).
measure: Sperm cell motility
timeFrame: This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).
measure: Sperm cell morphology
timeFrame: This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).
measure: Sperm cells vitality
timeFrame: This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).
measure: Sperm sample volume
timeFrame: This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: IVI Sevilla
Study officials:
References:
Clinical trial NCT01652612: Positive End-expiratory Pressure and Alveolar Recruitment for One Lung Ventilation
Official title: Effects of Positive End-expiratory Pressure and Alveolar Recruitment on the Oxygenation and Respiratory Mechanics During One-lung Ventilation in the Supine Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: One Lung Ventilation
Keywords: positive end expiratory pressure
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-07-30
Enrollment: 99
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Hypoxia frequently develops during one lung ventilation in the supine position.The objective of this article is to study the impact of preemptive alveolar recruitment and subsequent positive end expiratory pressure on arterial oxygenation and lung mechanics during one lung ventilation in the supine position in patients undergoing thoracic surgery .

Detailed description: outcome measures: respiratory parameters (Paw, Ppla, Compliance, Vd/Vt)and oxygenation parameters (PaO2, shunt fraction, Pa-AO2)

Eligibility criteria: Inclusion Criteria:

* ASA I-II
* age: 20-75 years

Exclusion Criteria:

* moderate to severe impaired respiratory function,
* heart failure,
* patients' refusal

Primary outcomes:
measure: PaO2, number of patients with hypoxia (PaO2< 90mmHg)
timeFrame: participants will be followed for the duration of anesthesia, an expected average of 3 hours
Secondary outcomes:
measure: intrapulmonary shunt
timeFrame: participants will be followed for the duration of anesthesia, an expected average of 3 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yong Seon Choi
Study officials:
affiliation: Assistant professor
name: Yongseon Choi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04851912: Speech-based Digital Biomarker for Psychiatric Disease
Official title: Preclinical Development of a Speech-based Digital Biomarker for Psychiatric Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Speech
Psychiatric Disorder
Language
Lead sponsor: Winterlight Labs
Sponsor class: INDUSTRY
First posted: 2021-04-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Anyone who does not have hearing or vision impairment.

Brief summary: The general objectives of this study are to build a proof-of-concept, speech-based, digital biomarker for identifying the presence and tracking the severity of psychiatric disease.

Detailed description: The purpose of this study is to gather longitudinal data to examine how speech features and symptoms change over different intervals of time and the reliability of repeated, high frequency test administration. Participants will complete a variety of speech and language tasks using the Winterlight Assessment (iOS app) everyday for 30 days. The following is the list of assessments that participants will complete; 1) Daily assessment of mood, 2) Winterlight assessment which contains a series of verbal response tasks where participants are recorded through a tablet app, and 3) Clinical assessments.

Eligibility criteria: Inclusion Criteria:

* Male and Female adults aged 18 to 95.
* English as a first language, or English as a second language with conversational proficiency.
* Own an iOS device (iPhone or iPad) and willing to install the study app.
* A reliable (cellular or WiFi) home internet connection and accessible email address

Exclusion Criteria:

* Residence outside of Canada or the United States.
* Clinically significant vision impairment (corrected vision is acceptable).
* Clinically significant hearing impairment (use of hearing aids is acceptable)

Primary outcomes:
measure: Speech recordings
timeFrame: Everyday for 30 business days until study completion, about 2 years
Secondary outcomes:
measure: Depression scores
timeFrame: Everyday for 30 business days until study completion, about 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Winterlight Labs
state: Ontario
Study officials:
affiliation: Clinical Research Director, Winterlight Labs
name: Jessica Robin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00450112: Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee
Official title: A Multi-Center Extension and Open-Label Study of a Single or Repeat Intra-Articular Injection of Gel-200 in Osteoarthritis of the Knee.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee
Lead sponsor: Seikagaku Corporation
Sponsor class: INDUSTRY
First posted: 2007-03-21
Enrollment: 202
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a single or repeat intra-articular injection of Gel-200 is safe and effective in subjects with symptomatic osteoarthritis of the knee and to determine if original SI-6606/01 Gel-200 therapy is durable beyond the original study.


Eligibility criteria: Inclusion Criteria:

* Previous participation in study SI-6606/01.

Exclusion Criteria:

* Female subjects who are pregnant or lactating.

Primary outcomes:
measure: Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200
timeFrame: 13 weeks
Secondary outcomes:
measure: Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)
timeFrame: Baseline and Week 13
measure: Improvement From Baseline in WOMAC VAS (Stiffness Subscore)
timeFrame: Baseline and Week 13
measure: Improvement From Baseline in WOMAC VAS (Physical Function Subscore)
timeFrame: Baseline and Week 13
measure: Improvement From Baseline in WOMAC VAS (Total Score)
timeFrame: Baseline and Week 13
measure: Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response
timeFrame: Weeks 13
measure: Improvement From Baseline in Subject Global Evaluations
timeFrame: Baseline and Week 13
measure: Improvement From Baseline in Physician Global Evaluations
timeFrame: Baseline and Week 13
measure: Acetaminophen Consumption
timeFrame: Week 9 to Week 13
Other outcomes:
Locations:
city: Plantation
country: United States
facility: SKK
state: Florida
Study officials:
References:
citation: Takamura J, Seo T, Strand V. A Pooled Analysis of Two Multicenter, Randomized Controlled Trials of a Single Intra-articular Injection of Gel-200 for Treatment of Osteoarthritis of the Knee. Clin Med Insights Arthritis Musculoskelet Disord. 2018 May 9;11:1179544118773068. doi: 10.1177/1179544118773068. eCollection 2018.
citation: Strand V, Lim S, Takamura J. Evidence for safety of retreatment with a single intra-articular injection of Gel-200 for treatment of osteoarthritis of the knee from the double-blind pivotal and open-label retreatment clinical trials. BMC Musculoskelet Disord. 2016 Jun 1;17:240. doi: 10.1186/s12891-016-1101-0.
Clinical trial NCT04468412: Influence of COVID-19 on Vascular Endothelial Function
Official title: Influence of COVID-19 on Vascular Endothelial Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Vascular; Damage
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Bernhoven Hospital
First posted: 2020-07-13
Enrollment: 203
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with past COVID-19 infection will be recruited at Bernhoven hospital, the Netherlands.

Brief summary: Rationale: Infection with severe acute respiratory syndrome coronavirus (SARS-CoV) 2 could result in endothelial dysfunction with increased risk of arterial thrombotic events by downregulating the expression of angiotensin converting enzyme 2 (ACE2). Endothelial function can be easily and non-invasively determined by carotid artery reactivity (CAR) testing.

Objective: To investigate the predictive value of endothelial dysfunction, measured by carotid artery reactivity testing, for 1-year cardiovascular events in patients with past COVID-19 infection.

Study design: A prospective observational longitudinal cohort study.

Study population: Patients recovered from confirmed infection with SARS-CoV2.

Main study parameters/endpoints: macrovascular endothelial function measured by carotid artery reactivity testing.


Eligibility criteria: Inclusion Criteria:

* Confirmed SARS-CoV2 infection by polymerase chain reaction on nasopharyngeal swab, sputum or bronchoalveolar lavage.
* At least 6 and no more than 20 weeks after resolution of COVID-19 related symptoms
* ≥ 16 years old

Exclusion Criteria:

* Recent (\<3 months) angina pectoris, myocardial infarction, stroke, or heart failure
* Raynaud syndrome, scleroderma, complex regional pain syndrome of the upper extremity or presence of arteriovenous fistula or open wounds on both the upper extremities.

Primary outcomes:
measure: Endothelial dysfunction
timeFrame: CAR will be measures between 6 and 20 weeks and 1 year after recovery from COVID-19.
Secondary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: 1 year
Other outcomes:
Locations:
city: Uden
country: Netherlands
facility: Bernhoven
Study officials:
affiliation: Radboud University Medical Center
name: Michiel C Warle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Benhoven
name: Andre S van Petersen, PhD
role: PRINCIPAL_INVESTIGATOR
References: