louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03830450: Biomarkers of Acute Kidney Injury in Cardiac Surgery
Official title: Biomarkers in Estimation for Risk of Acute Kidney Injury in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury (Nontraumatic)
Keywords: Acute kidney injury
Cardiac surgery
NGAL
GDF-15
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for cardiac surgery with usage of cardiopulmonary bypass

Brief summary: Acute kidney injury (AKI) is the most common complication in patients after cardiac surgery. An usual estimation of risk for AKI is estimation of serum creatinine, which is unreliable indicator of AKI risk. Because of that, today different biomarkers are investigated to predict incidence for development AKI after cardiac surgery. This investigation will try to find potentially risk patients for developing AKI after cardiac surgery by using conventional markers (creatinine, glomerular filtration rate) in perioperative period comparing with two different biomarkers neutrophil gelatinase-associated lipocalin (NGAL) and growth differentiation factor 15 (GDF-15) which are proven markers in patients with increased risk for AKI development.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for cardiac surgery (CABG, valve replacement/repair, combined)
* older than 18 years

Exclusion Criteria:

* previous known renal disease
* patients on chronic dialysis

Primary outcomes:
measure: Consecutive values of neutrophil gelatinase-associated lipocalin (NGAL)
timeFrame: One year
measure: Consecutive values of growth differentiation factor 15 (GDF-15)
timeFrame: One year
measure: Consecutive values of glomerular filtration rate (GFR)
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04312750: Adhesion of Lidocaine Topical System 1.8%
Official title: An Open Label, Single-treatment, Single-period, Single-application, Adhesion Performance Study of Lidocaine Patch 36 mg/Patch (1.8%) in Healthy, Adult, Human Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Scilex Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this study is to evaluate the adhesion performance of ZTlido (lidocaine topical system) 1.8% in normal, healthy volunteers.

Detailed description: In this open-label, single-treatment, single-period, single-application adhesion performance study, 54 healthy, adult male and female subjects are treated with one lidocaine topical system to their back for 12 hours. Adhesion will be monitored throughout the wear time and skin irritation will be assessed after the topical system is removed.

Eligibility criteria: Key Inclusion Criteria:

* Must be healthy based on by medical history, laboratory work, and physical exam
* Be at least 18 years of age
* If childbearing potential, use of acceptable form of birth control
* In the case of females of childbearing potential, have a negative serum pregnancy test

Key Exclusion Criteria:

* Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics, or any component of the product formulation
* Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness
* Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin)
* History of addiction, abuse, and misuse of any drug

Primary outcomes:
measure: Mean Cumulative Adhesion Score
timeFrame: 0, 3, 6, 9, 12 hours post-dose
Secondary outcomes:
measure: Dermal Response Score
timeFrame: 12.5 and 14 hours post-dose
Other outcomes:
Locations:
Study officials:
affiliation: AXIS Clinicals
name: Anthony Godfrey, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gudin J, Webster LR, Greuber E, Vought K, Patel K, Kuritzky L. Open-Label Adhesion Performance Studies of a New Lidocaine Topical System 1.8% versus Lidocaine Patches 5% and Lidocaine Medicated Plaster 5% in Healthy Subjects. J Pain Res. 2021 Feb 23;14:513-526. doi: 10.2147/JPR.S287153. eCollection 2021.
Clinical trial NCT00414050: A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)
Official title: A Study to Assess the Safety, Tolerability, and Immunogenicity of 2 Antigen Doses of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process Administered to Healthy Infants at 2, 4, and 6 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-12-21
Enrollment: 1718
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine. This study was conducted to address the following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the modified process hepatitis B vaccine compared with a 10 microgram dose of the modified process hepatitis B vaccine, to evaluate another dosing schedule of 2, 4, and 6 months, and to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B®).


Eligibility criteria: Inclusion Criteria:

* Participant is a healthy infant approximately 2 months of age

Exclusion Criteria:

* Birth mother is a known carrier of hepatitis B virus or another known carrier has lived in close contact with the participant
* Participant's birth mother did not receive any prenatal care
* Participant has previous history of hepatitis B infection
* Participant has been vaccinated against hepatitis B or birth mother was vaccinated within 6 months before birth of participant
* Participant has had a fever within 72 hours of study start
* Participant has received any blood-derived product or birth mother received blood-derived product within 6 months of birth of participant

Primary outcomes:
measure: The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B®
timeFrame: 7 months of age (1 month after 3 doses)
Secondary outcomes:
measure: Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (Anti-HBs GMT) Responses for Modified Process Vaccine (5 μg and 10 μg), RECOMBIVAX™ Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B®
timeFrame: 7 months of age (1 month after 3 doses)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Vesikari T, Martin JC, Liss CL, Liska V, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy infants. Pediatr Infect Dis J. 2011 Jul;30(7):e109-13. doi: 10.1097/INF.0b013e31821ed1a4.
Clinical trial NCT02531555: Clinical Efficacy Of 810 Nanometer Diode Laser As An Adjunct To Mechanical Periodontal Treatment Of Residual Periodontal Pockets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Keywords: chronic periodontitis
dental scaling
gingival crevicular fluid
lasers
periodontal pocket
root planing
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2015-08-24
Enrollment: 11
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Aim of this randomized controlled parallel-designed study was to evaluate the effects of diode laser as an adjunct to mechanical periodontal treatment on clinical parameters and gingival crevicular fluid (GCF) volume of the residual pockets diagnosed following initial periodontal treatment in chronic periodontitis (CP) patients.

Methods: A total of 84 residual pockets on single-rooted teeth in 11 CP patients were included and randomly assigned into 3 groups. Residual pockets were treated either only by mechanical treatment (Group M) (n=28), only by diode laser disinfection (Group L) (n=28) or by combination of these techniques (Group M+L) (n=28). Plaque index, gingival index (GI), bleeding on probing (BoP), probing depth (PD), clinical attachment level and gingival recession were assessed at baseline and 8 weeks after treatment of residual pockets. GCF samples were collected at baseline, 1 and 8 weeks after treatment.


Eligibility criteria: Inclusion Criteria:

* Systemically healthy,
* Non-smoker,
* Chronic periodontitis diagnosed according to Armitage 1,
* Aged between 35 and 65,
* Not received any periodontal treatment within the last 3 months,
* Have horizontal bone loss radiographically,
* Presence at least 20 natural teeth except third molars
* Consent to participate in the study.

Exclusion Criteria:

* Any systemic disease that might interfere with the prognosis of periodontal disease (i.e. diabetes mellitus, HIV infection),
* Smoking,
* Antibiotics, anti-inflammatory drugs or any other medication taken within the previous 6 months that may affect the outcome of the study,
* Any physical limitations or restrictions that might preclude normal oral hygiene procedures.

Primary outcomes:
measure: Probing depth
timeFrame: 8 week
Secondary outcomes:
measure: Plaque index
timeFrame: 8 week
measure: Gingival index
timeFrame: 8 week
measure: Clinical attachment level
timeFrame: 8 week
measure: Bleeding on probing via periodontal probe
timeFrame: 8 week
measure: Change of gingival crevicular fluid volume
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University, Faculty of Dentistry
Study officials:
References:
Clinical trial NCT06301555: Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms
Official title: Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: Adai Technology (Beijing) Co., Ltd.
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To collect preliminary data and assess the preliminary effectiveness of a game-based digital therapeutics (DTx) intervention for individuals with symptoms of anxiety and depression, and to investigate whether reinforcement learning (RL) can personalize the intervention and enhance effectiveness. Design: Randomized controlled trial with three arms. Setting: Internet-based recruitment and delivery of the intervention. Participants: 223 individuals with symptoms of anxiety and depression, aged between 18 and 50 years. Interventions: Participants were randomly assigned to one of three groups: game-based DTx with RL algorithm (RL algorithm group), game-based DTx without RL algorithm (no algorithm group), and a blank control group. Main Outcomes and Measures: The primary outcomes were reductions in symptoms of anxiety and depression, measured using the Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7-item scales. Response rates and rates of recovery, as well as the impact of demographic variables, were also examined.


Eligibility criteria: Inclusion Criteria:

1. age between 18 and 60 years;
2. having a PHQ-9 score or a GAD-7 score upon enrollment;
3. being able to operate a smartphone fluently;
4. having normal vision after correction

Exclusion Criteria:

1. clinical diagnoses of severe psychiatric conditions such as schizophrenia or bipolar disorder;
2. at high risk of suicide or self-harm;
3. having significant cognitive impairments;
4. active substance abuse or dependence;
5. currently undergoing other psychological or pharmacological treatments for depression or anxiety;
6. pregnant individuals or those with postpartum depression, and those with serious physical health conditions that could impact mental health.

Primary outcomes:
measure: PHQ9 Response
timeFrame: Immeidately after intervention
measure: GAD7 Response
timeFrame: Immeidately after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
References:
Clinical trial NCT01579955: Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors Under Normal Clinical Practice
Official title: Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors Under Normal Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-04-18
Enrollment: 321
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with haemophilia A and B with inhibitors who received NovoSeven® (eptacog alpha)

Brief summary: This study is conducted in Japan. The aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Patients with haemophilia A and B with inhibitors who received eptacog alpha (NovoSeven®) as treatment

Exclusion Criteria:

* Patients who was not deemed to be appropriate to the treatment of eptacog alpha (NovoSeven®)

Primary outcomes:
measure: Percentage of bleed treatments resulting in effective bleed resolution: Markedly effective, effective, moderate or ineffective
timeFrame: Year 1
measure: Percentage of bleed treatments resulting in effective bleed resolution: Markedly effective, effective, moderate or ineffective
timeFrame: Year 10
Secondary outcomes:
measure: Number of adverse events (AEs), including serious adverse events (SAEs)
timeFrame: Baseline, every 1 year, Year 10
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04399850: Impact of Hypnosis During Invasive Procedure in Intensive Care Unit
Official title: Impact of Hypnosis During Invasive Procedure in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: invasive procedure
pain distress
hypnosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Pain during ICU stay remains one of the major complaints for patients. Beside pain intensity, well described by patients' self reports, pain distress, which is an emotional experience, cannot be treated with usual analgesia. The aim of the study is to analyze the impact of hypnosis on pain intensity and distress on short and long term outcomes in non-sedated ICU patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18 years and older
* ICU hospitalisation
* Non-sedated patients who need an invasive procedure (Invasive procedures are defined as chest tube (insert or remove), fibroscopy, catheter insert, lumbar punction and bone marrow aspiration)
* Physician experienced in hypnosis available
* written informed consent
* health insurance

Exclusion Criteria:

* sedation and intubation, delirium, end-of-life decision,
* deaf patient,
* patient who does not understand French language,
* pregnancy
* patient under guardianship or curatorship
* lack of health insurance

Primary outcomes:
measure: Pain distress
timeFrame: within the before and the first hour after the procedure
Secondary outcomes:
measure: Pain intensity
timeFrame: within first hour and first 24 hours after procedure
measure: Number of adverse events
timeFrame: during procedure
measure: Length of each painful procedure
timeFrame: up to 3 months
measure: Analgesia dose
timeFrame: within first and 24 hours after procedure
measure: Type of analgesia
timeFrame: within first and 24 hours after procedure
measure: Anxiety
timeFrame: within first and 24 hours after procedure
measure: Hospital Anxiety and Depression (HAD) scale
timeFrame: at 3 months
measure: Post traumatic stress disorder assessed using Impact of Event Scale Revisited (IES R)
timeFrame: at 3 months
measure: Proportion of patients who had hypnosis transe
timeFrame: during procedure
measure: Description of the experience of hypnosis
timeFrame: at 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint-Louis
Study officials:
References:
Clinical trial NCT02902250: The Comparative Study About the Effect of Vertebral Body Decompression Procedure
Official title: The Comparative Study About the Effect of Vertebral Body Decompression Procedure and Conservative Treatment for Benign Vertebral Compression Fracture - Prospective Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporotic Vertebral Compression Fracture
Keywords: Vertebroplasty
Core decompression
Osteoporosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the treatment efficacy between vertebral body decompression procedure and conservative treatment with non-inferiority design


Eligibility criteria: Inclusion Criteria:

* osteoporotic vertebral compression fracture

Exclusion Criteria:

* malignancy or inflammatory disease
* severe pain in other joints
* coagulopathy
* an inappropriate person considered by investigator

Primary outcomes:
measure: Visual Analog Pain Scale
timeFrame: until 3 months after procedure
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: until 3 months after procedure
measure: EQ5D-5L
timeFrame: until 3 months after procedure
measure: Leed Dyspepsia Questionnaire
timeFrame: until 3 months after procedure
measure: Radiographic outcome
timeFrame: until 3 months after procedure
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyounggido
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sang-Min Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02261350: Post-hospitalisation Nutritional Support and Gait Speed in COPD
Official title: The Effect of Nutritional Support on Gait Speed Following Hospitalisation for Acute Exacerbation of COPD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Bronchitis, Chronic
Pulmonary Emphysema
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Medical Research Council
name: The Hillingdon Hospitals NHS Foundation Trust
First posted: 2014-10-10
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine the feasibility of delivering different community nutritional interventions to chronic obstructive pulmonary disease (COPD) patients at moderate or severe risk of malnutrition following a hospitalisation for an acute exacerbation of COPD.


Eligibility criteria: Inclusion Criteria:

* Ability to consent
* Patients at moderate or severe risk of malnutrition
* Adults over the age of 40
* Hospitalised with an AECOPD

Exclusion Criteria:

* Receiving long term parental or enteral nutrition
* Inability to swallow or difficulty liquids
* Lactose intolerance, galactosaemia, cow's milk protein allergy or intolerance
* Co-existing active cancer, progressive neurological condition or active GI disorder.
* Receiving palliative care with expectation of death within 3 months
* Cognitive dysfunction or unable to consent

Primary outcomes:
measure: Change in four-metre gait speed (m/s) following nutritional support
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Change in weight (kg) following nutritional support
timeFrame: Change from baseline to 12 weeks
measure: Change in fat free mass (kg) as measured by bioelectrical impedence following nutritional support
timeFrame: Change from baseline to 12 weeks
measure: Change in fat free mass index (kg/m2) as measured by bioelectrical impedence following nutritional support
timeFrame: Change from baseline to 12 weeks
Other outcomes:
Locations:
city: Uxbridge
country: United Kingdom
facility: The Hillingdon Hospital NHS Foundation Trust
state: Middlesex
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: William Man, PhD FRCP
role: PRINCIPAL_INVESTIGATOR
References: