louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04557631: Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol
Official title: Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alcohol Abuse
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study will be proposed to all major ethanol-consuming patients with an alcohol use disorder, seen in consultation, in anticipation of hospital withdrawal in addiction service.

Brief summary: For an analytical validation of the method for the determination of blood hosphatidylethathanol, it is necessary to:

* to compare the results of chronic and excessive ethanol patients with the cut-off proposed in the literature.
* Also assess the stability of phosphatidylethanol in total blood collected, and in blotted dried blood stains (DBS), depending on temperature (ambient temperature and +4°C)


Eligibility criteria: Inclusion Criteria:

* Person with alcohol consumption ≥ 40g/day (women) and ≥ 60g/day (men) according to WHO criteria
* Person hospitalized for a hospital withdrawal in the addiction service of Lille's hospital, without other distinctions.

Exclusion Criteria:

* Patient opposing the use of their personal data in the study
* Patient subject to protective measures (guardianship or curatorship)
* Person deprived of liberty

Primary outcomes:
measure: Frequency of patients with a Peth concentration greater than 200 µg/L
timeFrame: at the end of study (at 6 months)
Secondary outcomes:
measure: the concentration of Peth in blood in ambiant temperature
timeFrame: between T0 and 96h and the end of study (at 6 months)
measure: the concentration of Peth in blood at 4°C
timeFrame: between T0 and 96h and the end of study (at 6 months)
measure: the concentration of Peth in blood in DBS
timeFrame: between T0 and 4 weeks and the end of study (at 6 months)
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Olivier COTTENCIN, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06449131: Persistent Pleural Effusion Treatment Following Cardiothoracic Surgery by Platelet-Fibrin Glue
Official title: Persistent Pleural Effusion Treatment Following Cardiothoracic Surgery by Platelet-Fibrin Glue: A Clinical Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pleural Effusion
Keywords: Pleural Effusion
Persistent
Cardiac surgery
PRP
Fibrin Glue
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Persistent pleural effusion is a life-threatening complication after cardiac surgery. The traditional treatment is chest tube drainage, which may not respond to treatment. This study introduces a new noninvasive approach for treating persistent pleural effusion using platelet-rich plasma fibrin glue (PRP-FG). This method has been successfully applied for the treatment of postoperative persistent chylothorax and pneumothorax in previous studies, which significantly decreased morbidity, mortality, and hospital stay.

Detailed description: This pilot clinical trial recruited 19 patients at Imam Reza Hospital in Mashhad, Iran (2023) who had developed unilateral or bilateral refractory postoperative effusion resistant to conventional thoracostomy treatment. Treatment success was defined as effusion \<50 ml/day after 48 hours, along with symptomatic improvement and no adverse events.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of pleural effusion after cardiac surgery in open-heart surgery
* patients who sign an informed consent form

Exclusion Criteria:

* Hemodynamically unstable patients
* Patients who did not sign an informed consent form

Primary outcomes:
measure: The rate of air leak that is assessed by Cerfolio classification of the air leak by a single observer
timeFrame: within 48 hours after application of platelet-rich plasma
measure: Rate of radiolucency
timeFrame: within 48 hours after application of platelet-rich plasma
measure: Patient hospitalization time
timeFrame: From the time the patient is admitted to the hospital to the time of discharge
measure: Percentage of patients completely recovered
timeFrame: Through study completion, an average of 40 weeks
measure: Percentage of untreated patients who died
timeFrame: Through study completion, an average of 40 weeks
measure: The number of injections until the bubble stops
timeFrame: Through study completion, an average of 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad University of Medical Sciences
state: Razavi Khorasan
Study officials:
affiliation: Mashhad university of medical sience
name: Daryoush Hamidi-Alamdari, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT02619331: Evaluation of High Speed Laser Doppler Imaging Technology
Official title: Evaluation of High Speed Laser Doppler Imaging Technology to Quantify Skin Prick Tests in Allergic Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hay Fever
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Skin prick tests (SPT) are commonly used in daily allergological practice to assess skin reactivity to allergens. Multiple factors can contribute to non-optimal results of conventional wheal and flare measurement (CWFM) of SPT such as inaccurate measurements, observer-dependency and absence of traceability.

This study aims to evaluate the quantification of SPT by a novel High Speed Laser Doppler Imaging (HSL-DI) and to compare it with CWFM. First, SPT with birch and/or grass pollen extracts as well as positive and negative controls will be performed in 20 volunteers (11 atopics, 9 non-atopics) to establish the characteristics (cut-off, optimal reading time and allergen concentration) of HSL-DI analysis based on two parameters ("area" and "flow" measurement). In a second step, fifty patients will be tested with birch and grass pollen extracts at optimal allergen concentration and time window. Analysis of SPT by HSL-DI and CWFM will be compared.


Eligibility criteria: Inclusion Criteria:

* age 18 to 65 years
* history of allergic rhinitis to birch pollen and/or grass pollen.

Exclusion Criteria:

* any medical condition (including pregnancy) that could influence the study (viral or bacterial airway infection, active allergic rhinitis)
* uncontrolled asthma (peak expiratory "flow" \<80% of volunteer's best personal value)
* treatment with antihistamine medication less than two weeks before enrolment or during the trial.

Primary outcomes:
measure: Skin microcirculation flow changes over time (composite autcome)
timeFrame: tests reading at 2.5 min., 5 min., 7.5 min., 10 min., 12.5 min., 15 min., 17.5 min. and 20 min.
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV , Division of Immunology and Allergy
Study officials:
affiliation: CHUV
name: François Spertini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03110731: Effect of Strength Training on the Quality and Duration of Sleep and Daytime Sleepiness of Institutionalized Adolescents
Official title: Effect of Strength Training on the Quality and Duration of Sleep and Daytime Sleepiness of Institutionalized Adolescents: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Sleep Disorder
Lead sponsor: University of Pernambuco
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 20
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to analyze the effects of strength training on sleep quality and daytime sleepiness in institutionalized adolescents (14 to 19 years of age). Thirty-one adolescents were randomly assigned in two sample groups: intervention group (IG, n = 19) and control group (CG, n = 12). Anthropometric measures were performed (height and body mass) and BMI was determined. Sleep quality and daytime sleepiness were assessed using the questionnaires, Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESE), and total sleep time by accelerometer. Physical training (2x / week) was performed for 12 weeks. The OMNI Perceived Exertion Scale for Resistance Exercise (OMNI-RES) scale was used to control the effort intensity and the exercises followed an alternate pre-follow-up.


Eligibility criteria: Inclusion Criteria:

* Institutionalized adolescents (14 to 19 years of age)

Exclusion Criteria:

* refuse to participate,
* incomplete evaluation

Primary outcomes:
measure: sleep quality
timeFrame: 12 weeks
measure: Daytime sleepiness
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Santiago LCS, Lyra MJ, Germano-Soares AH, Lins-Filho OL, Queiroz DR, Prazeres TMP, Mello MT, Pedrosa RP, Falcao APST, Santos MAM. Effects of Strength Training on Sleep Parameters of Adolescents: A Randomized Controlled Trial. J Strength Cond Res. 2022 May 1;36(5):1222-1227. doi: 10.1519/JSC.0000000000003629. Epub 2020 Apr 29.
Clinical trial NCT02883231: Plasma Level of Mitochondrial DNA in Patients With ARDS and Its Clinical Significance
Official title: Plasma Level of Mitochondrial DNA in Patients With ARDS and Its Clinical Significance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Evaluate the Correlation Between the Level of Mitochondrial DNA in Plasma and the Prognosis of the Patients With ARDS.
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population admitted to ICU of Zhongda hospital ，diagnosed of ARDS。

Brief summary: To observe the changes of plasma mitochondrial DNA (mtDNA) levels in patients with ARDS, and to explore its clinical significance.

Detailed description: 60 patients who diagnosed as ARDS were included in this study.Then keep blood samples from these patients in the first day、the third day and the sveventh day,detect the mitochotndrial DNA level in plasma by real-time quantitative PCR. Recored Severity of illness and survival status of every patient within 28 days.Objective to evaluate the correlation between the level of mitochondrial DNA in plasma and the prognosis of the patients.

Eligibility criteria: Inclusion Criteria:

1. Patients admitted to ICU diagnosed of ARDS (Berlin criteria),
2. Patients age between 18 years old and 80 years.

Exclusion Criteria:

1. Pregnant women,
2. Patients with malignant tumor,
3. Immunosuppression or immunocompromised patients.

Primary outcomes:
measure: mortality
timeFrame: 28-day
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
References:
citation: Peng F, Liang C, Chang W, Sun Q, Xie J, Qiu H, Yang Y. Prognostic Significance of Plasma Hepatocyte Growth Factor in Sepsis. J Intensive Care Med. 2022 Mar;37(3):352-358. doi: 10.1177/0885066621993423. Epub 2021 Feb 22.
Clinical trial NCT00920231: Computer Vision System for the Blind Veteran
Official title: Computer Vision System for the Blind Veteran
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Blindness
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-06-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a feasibility study involving a small number of blind subject to evaluate the effectiveness of using a software and associated hardware components to assist the blind in identifying and locating objects of interests and to assist in way finding tasks. After the system has been successfully tested by the blindfolded engineers, it will be evaluated in a small number of blind subjects.

Detailed description: This is primarily an engineering project to develop computer vision algorithms for an integrated system comprising of a laptop computer, webcam, gps, digital compass, microphone, and stereo earphones. The system will be voice controlled. The algorithm will be trained to identify and located objects and navigationally landmarks in real-time, previously selected by sighted developers. After the system has passed objective engineering milestones, blind subjects will be tested to determine whether the novel system will improve the ability of the blind to travel over a test course in a hospital setting.

Eligibility criteria: Inclusion Criteria:

* age 18 and over
* legally blind

Exclusion Criteria:

* decreased hearing
* unable to understand or follow instructions
* inability to walk and stand for 10 minutes

Primary outcomes:
measure: Frequency of Device Failures Per Attempt to Complete a Navigation Course
timeFrame: The subject is given as much time as needed to complete the task
Secondary outcomes:
measure: Ability to Meet the Subjective Travel Needs of the Blind Subject
timeFrame: no time limit
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur
state: Georgia
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Cha-Min Tang, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00562731: Open-Label Study of ARD-0403 in Testosterone Deficient Men
Official title: A Phase III, Open-Label Follow-on Study for Long-Term Safety and Efficacy of Testosterone Cream, in Testosterone Deficinet Men Completing Study ARD-0403-004
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypogonadism
Lead sponsor: Ardana Bioscience Ltd
Sponsor class: INDUSTRY
First posted: 2007-11-22
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient well-being. The purpose of this study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy in testosterone deficient men.


Eligibility criteria: Inclusion Criteria:

* Testosterone deficiency
* Completed study ARD-0403-004

Exclusion Criteria:

* Previous treatment with testosterone replacement therapy within 4 weeks
* Moderate-severe benign prostatic hypertrophy or prostatic cancer
* Haematocrit \>50%

Primary outcomes:
measure: Efficacy
timeFrame: Study Duration
Secondary outcomes:
measure: Safety and Tolerability
timeFrame: Study Duration
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc
state: Alabama
city: Stanford
country: United States
facility: Stanford University
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: dgd Research
state: Texas
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: University of California, Los Angeles
name: R Swerdloff
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01706731: Effectiveness of Buddhist Monks in Providing Cognitive Behavior Therapy
Official title: A Randomized Controlled Trial of Cognitive Behavior Therapy Provided by Buddhist Monks vs. Treatment as Usual in the Treatment of Late Life-depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Buddhist monks
CBT
elderly
depression
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2012-10-15
Enrollment: 62
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research is to study the effectiveness of cognitive behavioral therapy-CBT and Psychotherapy by trained buddhist monks. There are generally accepted that both cognitive and Buddhist concepts are related. This randomized controlled trial is to study the elderly participants who suffer major depressive disorder according to DSM-IV. The subjects will be divided into two groups. The experimental group will receive 12 sessions of CBT 2 times per week for 6 weeks in addition to usual treatment. The control group will receive treatment as usual and general conversation (non-CBT) with monks. Pretreatment factors (such as attachment style, interpersonal factors) of both therapist monks and patient participants will be studied.


Eligibility criteria: Inclusion Criteria:

* Meet criteria for Major depressive disorder
* receiving antidepressant

Exclusion Criteria:

* presence of intense suicidal intent behaviors that require inpatient admission
* history of alcohol or drug dependence
* presence of hallucinations or delusions
* currently receiving electroconvulsive therapy or repetitive-transcranial magnetic stimulation,
* patients' involvement in other clinical trials.

Primary outcomes:
measure: Evidence of clinically depression confirmed by clinician
timeFrame: 2 months after the end of the intervention
measure: Depression- self report
timeFrame: 2 month after the end of the inetrvention
Secondary outcomes:
measure: Dimensional psychological distress (anxiety, depression,and somatization)
timeFrame: week 6, 12, 20
measure: Dimensional psychological distress ( perception of stress)
timeFrame: Week 6, 12, 20
Other outcomes:
measure: working alliance
timeFrame: after session 3, 6, and 12
measure: Pretreatment measure (attachment)
timeFrame: at baseline
measure: Pretreatment measure (interpersonal problems)
timeFrame: at baseline
measure: Pretreatment measure(neuroticism)
timeFrame: at baseline
Locations:
city: Chiang Mai
country: Thailand
facility: Geriatric clinic, Maharaj Nakorn Chiang Mai Hospital
Study officials:
affiliation: Chiang Mai University
name: Nahathai - Wongpakaran, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03106831: Small Doses of Pituitrin Versus Norepinephrine for the Management of Vasoplegic Syndrome in Patients After Cardiac Surgery
Official title: Small Doses of Pituitrin Versus Norepinephrine for the Management of Vasoplegic Syndrome in Patients After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Vasoplegic Syndrome
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vasoplegic syndrome is a common complication after cardiac surgery. Low dose vasopressin can up-regulate blood pressure and improve clinical outcomes compared with norepinephrine (mainly acute kidney injury Anesthesiology 2017; 126:85-93). Pituitrin is used as a substitute for vasopressin in our center, which contains both vasopressin and oxytocin. Oxytocin may alleviate inflammatory process-associated kidney injury (Peptides 2006;27:2249-57). Therefore, the investigators hypothesize Pituitrin may be preferable to norepinephrine in the renal protection of patients with vasoplegic syndrome after cardiac surgery. Moreover, the serum levels of vasopressin, catecholamine, corticosteroid and corticotropin-releasing hormone will be measured.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed as vasoplegic syndrome(defined as mean arterial pressure less than 65 mmHg resistant to fluid challenge and cardiac index greater than 2.2 L/min · m2) within 24 hours after cardiac surgery.

Exclusion Criteria:

1. Age \< 18 and \> 75 years.
2. Received renal replacement therapy before cardiac surgery.
3. Diagnosed as endocrine disease before cardiac surgery.
4. Diagnosed as sever peripheral vascular disease before cardiac surgery.
5. Extracorporeal membrane oxygenation support before admission.
6. To receive heart transplantation.
7. Infection on admission.
8. Pregnant or maternal patients.
9. Refusal of consent

Primary outcomes:
measure: Rate of in-hospital acute renal injury
timeFrame: 30 days
Secondary outcomes:
measure: In-hospital mortality
timeFrame: 30 days
measure: Rate of new arrhythmias
timeFrame: 30 days
measure: Hormone levels
timeFrame: 30 days
measure: Rate of ECMO or LVAD support
timeFrame: 30 days
measure: Duration on ventilator support
timeFrame: 30 days
measure: ICU length of stay
timeFrame: 30 days
measure: Hospital length of stay after cardiac surgery
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
state: Beijing
Study officials:
References: