louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05815667: Effects of the Swedish Internet-based Individualised Active Communication Education (I-ACE) in FTU
Official title: Effects of the Swedish Internet-based Individualised Active Communication Education (I-ACE) in First Time Hearing Aid Users: a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Impairment
Lead sponsor: Horselvarden Region Ostergotland
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hearing impairment affects the ability to communicate, which can adversely affect both mental and physical health. The most common used rehabilitation method in hearing impairment is hearing aid fitting. Even with optimally fitted hearing aids, many struggle to hear in situations with difficult listening conditions. Active Communication Education (ACE) is an interactive group rehabilitation programme aiming to help those with hearing loss communicate more effectively using communication strategies to cope better in everyday life. An Individualised Active Communication Education (I-ACE) distributed digitally could enable those unable to get to the hearing care facility, or don't want to join the group sessions to benefit from the programme.

This project aims to investigate the effects of the swedish digital version of the I-ACE in first time hearing aid users.


Eligibility criteria: Inclusion Criteria:

* Adults \>20 years old who have been fitted with hearing aids for the first time (first time users) 6 - 12 months prior.
* Computer experience and access to computer, tablet and/or smartphone with internet access.
* Access to BankID or equivalent.

Exclusion Criteria:

* Those who have participated in Active Communication Education prior.

Primary outcomes:
measure: Communication and Acceptance Scale (CAS)
timeFrame: Baseline, directly post intervention and 6 months post intervention.
Secondary outcomes:
measure: Communication Strategies Scale (CSS)
timeFrame: Baseline, directly post intervention and 6 months post intervention.
measure: The Hearing Handicap Inventory for the Elderly (HHIE)
timeFrame: Baseline, directly post intervention and 6 months post intervention.
measure: The International Outcome Inventory for Hearing Aids (IOI-HA)
timeFrame: Baseline, directly post intervention and 6 months post intervention.
measure: The International Outcome Inventory for Alternative Interventions (IOI-AI)
timeFrame: Directly post intervention and 6 months post intervention.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Hörselvården Region Östergötland
Study officials:
References:
Clinical trial NCT03887767: sST2 and Cardiac Surgery
Official title: Prognostic Value of sST2 in Cardiac Surgery on Long Term Morbimortality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients included before cardiac surgery

Brief summary: Evaluation of the prognosis value of sST2 dosed before cardiac surgery on prognosis of long terme prognosis after cardiac surgery.

The patients where initialy recruted for another cohort named micro-SIRS and inflammation but the gaved their consent to analyse the blood samples for other studies


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80
* cardiac surgery includind coronary arterial bypass of valvular surgery

Exclusion Criteria:

* other surgery

Primary outcomes:
measure: Mortality rate
timeFrame: 1 year
Secondary outcomes:
measure: Number of rehospitalisation
timeFrame: 1 day
measure: Number of cardiac events
timeFrame: 1 day
measure: Number of cardiac stroke
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: Hopital de Montpellier
name: Kada KLOUCHE, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03306667: Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)
Official title: Clinical Pharmacology Study of FYU-981 for Subjects With Hepatic Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Insufficiency
Healthy
Lead sponsor: Mochida Pharmaceutical Company, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Fuji Yakuhin Co., Ltd.
First posted: 2017-10-11
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic function.


Eligibility criteria: Inclusion Criteria:

* Adult healthy subjects or adult cirrhosis patients
* Body mass index: \>=18.5 and \<30.0

Exclusion Criteria:

* Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study (except for cirrhosis patients with hepatic diseases)

Primary outcomes:
measure: Pharmacokinetics (Cmax: Maximum plasma concentration)
timeFrame: 48 hours
measure: Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
timeFrame: 48 hours
measure: Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
timeFrame: 48 hours
measure: Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
timeFrame: 48 hours
measure: Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
timeFrame: 48 hours
measure: Pharmacokinetics (kel: Elimination rate constant)
timeFrame: 48 hours
measure: Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
timeFrame: 48 hours
measure: Pharmacokinetics (MRT: Mean residence time)
timeFrame: 48 hours
measure: Pharmacodynamics (Serum concentration of uric acid)
timeFrame: 48 hours
measure: Pharmacodynamics (Amount of uric acid excreted in urine)
timeFrame: 48 hours
measure: Safety (Incidence of treatment-emergent adverse events)
timeFrame: 192 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Mochida Investigational sites
Study officials:
affiliation: Clinical Research Department
name: Shigeki Matsumoto
role: STUDY_DIRECTOR
References:
Clinical trial NCT06899867: Comparing Montiroing Cardiac Index by Transpulmonary Thermodilution and Transesophageal Echocardiography During Liver Transplantation
Official title: Is Cardiac Index, Assessed by Transpulmonary Thermodilution, Reliable During Liver Transplantation Compared to Transesophageal Echocardiography : a Monocentric Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Transplantation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: age \> 18 years old, undergoing liver transplantation at Croix-Rousse hospital, HCL, Lyon

Brief summary: Liver transplantation poses challenges due to hemodynamic changes throughout different surgical phases. Monitoring devices are essential for therapeutic adjustments. Transpulmonary thermodilution and transesophageal echocardiography are commonly used, but thermodilution may have limitations depending on the surgery.

This study aims to compare cardiac index variations between thermodilution and transesophageal echocardiography during liver transplantation. Patients undergo monitoring with both techniques. Measurements are recorded and reported at multiple time points.


Eligibility criteria: Inclusion Criteria:

* liver transplantation
* adults

Exclusion Criteria:

* - Oesophageal varice ligation \< 14 days
* Mediastinal radiotherapy
* Femoral bypass
* Severe lower extremity artery disease

Primary outcomes:
measure: Cardiac index variation measured by thermodilution compared with transesophageal echography
timeFrame: At 4 times of surgery: after starting anesthesia, anhepatic phase, reperfusion and surgical anastomosis of biliary ducts. Data reported : - Cardiac Index before and after end-expiratory test. - Transoesophageal echography measurement of cardiac function
Secondary outcomes:
Other outcomes:
Locations:
city: France
country: France
facility: Croix Rousse Hsopital
state: Lyon
Study officials:
References:
Clinical trial NCT04077567: An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis
Official title: An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: RA
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-04
Enrollment: 401
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the long-term safety and efficacy of TS-152 in subjects with Rheumatoid Arthritis who have completed the previous study (TS152-3000-JA study or TS152-3001-JA study).


Eligibility criteria: Inclusion Criteria:

1. At visit1(-4 weeks), Subject must be fully informed about the study and must obtain written informed consent from the subject himself.
2. At Visit2(0 week), Subjects must have completed the previous study (TS152-3000-JA or TS152-3001-JA) ,and must have completed all evaluations required at the follow-up visit.

etc.

Exclusion Criteria:

1. Subjects who had serious adverse drug reactions in the previous study.
2. At Visit1(-4 weeks) or Visit2 (0 week), Subjects who have not recovered from clinically important adverse events.

etc.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: through study completion, an average of 3 year
measure: ACR20
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
References:
citation: Tanaka Y, Miyazaki Y, Kawanishi M, Yamasaki H, Takeuchi T. Long-term safety and efficacy of anti-TNF multivalent VHH antibodies ozoralizumab in patients with rheumatoid arthritis. RMD Open. 2024 Aug 22;10(3):e004480. doi: 10.1136/rmdopen-2024-004480.
Clinical trial NCT02382367: Prevalence of Alpha-1 Antitrypsin Dysfunction in Pulmonary Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Emphysema
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main objective of this trial is to evaluate the prevalence of alpha-1 antitrypsin quantitative and functional deficiency in an adult French population presenting with pulmonary emphysema. Phenotypic and genotypic studies will be carried whenever quantitative and/or functional deficiency will be displayed.


Eligibility criteria: Inclusion Criteria:

* Pulmonary emphysema highlighted by computed tomography
* Ratio Forced Expiratory Volume in 1 second (FEV1) / Vital Capacity (VC) \< 70% measured by lung function test

Exclusion Criteria:

* Hepatic transplant
* Patient under legal protection
* Patient not benefiting from the French Health Insurance

Primary outcomes:
measure: Number of patient with alpha-1 antitrypsin dysfunction
timeFrame: Samples for evaluation of alpha-1 antitrypsin dysfunction will be performed the day of the patient enrollment
Secondary outcomes:
measure: Determination of alpha-1 antitrypsin protein phenotype
timeFrame: Samples for phenotype analysis will be performed the day of the patient enrollment
measure: Molecular genotyping of gene coding alpha-1 antitrypsin
timeFrame: Samples for molecular genotyping will be performed the day of the patient enrollment
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel - service de pneumologie
Study officials:
References:
Clinical trial NCT04242667: Penn Biobank Return of Research Results Program
Official title: A Randomized Protocol Evaluating Return of Actionable Genetic Research Results to Biobank Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Cardiovascular Diseases
Hereditary Cancer
Hereditary Cardiac Amyloidosis
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: Fox Chase Cancer Center
First posted: 2020-01-27
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall goal of the proposed research is to assess the feasibility of a randomized study evaluating the non-inferiority of an electronic Health (e-Health) delivery alternative (e.g. private web portal) as compared to return of actionable genetic research results with a genetic counselor.


Eligibility criteria: Inclusion Criteria:

1. Consented participant in University of Pennsylvania Biobank who previously submitted a DNA sample for research testing
2. English speaking
3. Aged 18 years or older
4. Agreed to be re-contacted in the future or did not indicate a preference on future contact regarding research results
5. Have an actionable mutation or have been selected as a control participant
6. Have not previously received actionable results of clinical genetic testing

Exclusion Criteria:

1. Deceased assessed by electronic medical record, death index or identified after contact
2. Evidence in the electronic medical record that the subject has already received the same actionable result through clinical genetic testing

Primary outcomes:
measure: Completion of surveys
timeFrame: Baseline survey prior to disclosure of results, and then two post-disclosure surveys at 2-7 days and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Angela Bradbury, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03609567: Aromatherapy as Treatment for n/v of Pregnancy
Official title: Aromatherapy as Treatment for Nausea and Vomiting of Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Emesis
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A double-blinded randomized controlled trial comparing essential oil aromatherapy versus placebo for treatment of first trimester nausea and vomiting of pregnancy.

Detailed description: This is a double-blinded randomized controlled trial investigating the utility of essential oils for aromatherapy, compared to placebo, for treatment of nausea and vomiting in the first trimester of pregnancy.

Eligibility criteria: Inclusion Criteria:

* Pregnancy at \<14 weeks gestation
* English-speaking
* Baseline PUQE score \>=6

Exclusion Criteria:

* Non-compliant with prenatal care or study procedures
* Hyperemesis gravidarum
* Allergies to perfumes, essential oils or cosmetics
* Abnormal sense of smell
* Known acute or chronic GI disease
* Asthma
* Use of prescription anti-emetics

Primary outcomes:
measure: Mean difference in Pregnancy-Unique Quantification of Emesis (PUQE) score
timeFrame: First trimester of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
affiliation: Albany Medical College
name: Zelig
role: STUDY_CHAIR
References:
Clinical trial NCT03285867: Liver Stiffness Measurement (LSM) in Predicting Progress of Liver Fibrosis After TACE for Hepatocellular Carcinoma
Official title: Value of Liver Stiffness Measurement (LSM) in Predicting the Progress of Liver Fibrosis After Transcatheter Arterial Chemoembolization (TACE) for Hepatocellular Carcinoma, an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Liver Failure
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted to our department

Brief summary: Objective: To evaluate the efficacy of preoperative liver stiffness measurement(LSM) by FibroScan in predicting the progress of liver fibrosis and prognosis after transcatheter arterial chemoembolization (TACE) in hepatocellular carcinoma (HCC).

Background: Progress of liver fibrosis and liver failure and related poor prognosis after TACE which are not completely predictable by current method including Child-Pugh Classification. LSM is used to calculate the degree of liver fibrosis and is affected by several liver injury, e.g. elevated Alanine aminotransferase（ALT）, Aspartate transaminase(AST) and Bilirubin et al. The investigators assume that LSM could be use to predict progress of liver fibrosis and adverse effects after TACE in HCC.

Methods: At least 200 patients will be recruited in this prospective observational study with preoperative LSM, demographic, laboratory, radiological and other treatment-related factors. Participants will be followed up till death or to the end of study no matter the liver failure occurs or not. Data will be analyzed to build a mathematical predicting model.

Research hypothesis：TACE is related to progress of liver fibrosis and a mathematical model with LSM is able to predict the risk of liver failure and prognosis in HCC.


Eligibility criteria: Inclusion Criteria:

* age：18-80
* HCC diagnosed by pathologist or physician according to Guidelines
* Chronic Hepatitis B (CHB) background
* receive at least 1 TACE
* volunteer to join the research

Exclusion Criteria:

* massive lesion with insufficient liver left for LSM examination
* associated with other liver diseases: Chronic Hepatitis C(CHC),Autoimmune Hepatitis(AIH),Wilson's disease.
* severe obesity(BMI\>28)
* pregnancy
* other inappropriate situation defined by investigators.

Primary outcomes:
measure: The change of LSM(kpa) measured by FibroScan(a kind of external harmless ultrasonoscope)
timeFrame: within 1 week pre-TACE and 1 week post-TACE
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04362267: Longitudinal Study of Covid-19 Infection Among HCW in a French University Hospital
Official title: Incidence of SARS-Cov2 Infection Among HCW in Lille University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sars-CoV2
Keywords: Incidence
Health Care Workers
occupational exposure
environmental exposure
serological testing
RT-PCR
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Fondation Santé Roquette
First posted: 2020-04-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health Care workers exposed to covid occupational exposure

Brief summary: The aim of the study is to determine the incidence o of SARS-cov2 infection among health care workers highly exposed to covid 19 during 10 weeks et to analyze the determinants of their occupational and environmental exposure. Every 14 days, we performed SARS-Cov2 RT- PCR, serological testing and clinical questionnaire among a cohort of 100 HCW with a high degree of exposure to covid19 infection. Information about occupational exposure as the workplace, the activity of care, the characteristics of patient infected are captured, as well as environmental or personal exposure.

The results will support the design of a new care organization and will define new ways of protection for patients (covid or not covid 19) and prevention for HCW.


Eligibility criteria: Inclusion Criteria:

- Health Care workers with covid high exposure during the care activities

Exclusion Criteria:

* Heath Care Worker with SARS-Cov2 infection ( RT-PCR +) or SARS-Cov2 immunity in serological testing
* HCW off work
* Subjects on leave

Primary outcomes:
measure: the incidence of SARS- Cov2 infection Heath Care Worker diagnosed by the positivity of SARS-Cov2 RT-PCT and serological testing
timeFrame: at 14 weeks
Secondary outcomes:
measure: the incidence of SARS- Cov2 infection Heath Care Worker diagnosed by the positivity of SARS-Cov2 RT-PCT and serological testing
timeFrame: once every 14 days for an average of 14 weeks
measure: Occupational exposures associated with the SARS-Cov2 infection
timeFrame: once every 14 days for an average of 14 weeks
measure: Environmental exposures associated with the SARS-Cov2 infection
timeFrame: once every 14 days for an average of 14 weeks
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHU
Study officials:
affiliation: University Hospital, Lille
name: Annie SOBASZEK, MD
role: PRINCIPAL_INVESTIGATOR
References: