louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04574128: Retransfusion or Not of Cardiotomy Blood
Official title: Blood Loss With Cardiopulmonary Bypass, Re-transfusion or Not.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Loss, Surgical
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomised controlled non-inferiority trial
Primary purpose: TREATMENT

Brief summary: This randomised controlled trial has a non-inferiority design. The aim is to test if the blood loss (volume in mL and hemoglobin) is effected by heart and lung cardiotomy retransfusion, or not? Forty CABG (Coronary Artery By pass Grafting) patients will be allocated to either receive retransfusion (n=20) of cardiotomy blood via the heart and lung mashine, or no retransfusion (n=20).


Eligibility criteria: Inclusion Criteria:

* Elective CABG.

Exclusion Criteria:

* Anaemia, infection, massive bleeding, CABG off pump.

Primary outcomes:
measure: blood loss
timeFrame: During 5 days hemoglobin will be measured as the clinical rutine or as needed.
measure: Blood loss
timeFrame: During 2 days or while surgical drains remains, blood volume in mL is measured.
Secondary outcomes:
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: University Hospital in Örebro
Study officials:
affiliation: Örebro University, Sweden
name: Camilla Wistrand, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00488228: Behavioral Self-Regulation
Official title: Behavioral Self-Regulation for Weight Loss in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2007-06-20
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to determine whether incorporating self-regulation training using daily weighing is efficacious within a behavioral weight loss program specifically targeting young adults.


Eligibility criteria: Inclusion Criteria:

* body mass index between 27 and 40
* age between 21 and 35

Exclusion Criteria:

* report a history of eating disorder or a current eating disorder
* report a heart condition or other medical condition that would limit ability to participate in an exercise program without direct supervision from physician
* report major psychiatric diseases or organic brain syndromes
* currently participating in another weight loss program, are taking a weight loss medication, or have lost more than 5% of body weight curing last 6 months
* pregnant, lactating, or less than 6 months post-partum
* intend to move out of city within the time frame of the investigation or will miss multiple meetings during the study time frame

Primary outcomes:
measure: weight change
timeFrame: 10 weeks and 20 weeks
Secondary outcomes:
measure: eating disorder symptoms, physical activity, body image, mood symptoms, and self-efficacy about eating behavior
timeFrame: 10 weeks and 20 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Jessica G LaRose, Ph.D.
role: STUDY_DIRECTOR
affiliation: The Miriam Hospital
name: Rena R Wing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gokee-Larose J, Gorin AA, Wing RR. Behavioral self-regulation for weight loss in young adults: a randomized controlled trial. Int J Behav Nutr Phys Act. 2009 Feb 16;6:10. doi: 10.1186/1479-5868-6-10.
Clinical trial NCT04289428: Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays
Official title: Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hepatitis B
Keywords: Hepatitis B
Diagnostics
HBV DNA
ALT
Point of care
Dried blood spot
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
First posted: 2020-02-28
Enrollment: 0
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: Participants will be enrolled into the study in two parts until the following sample sizes are met for the prospective samples Part A: At least 30 paired specimens of venous EDTA whole blood and DBS in treatment naive adults (HBV DNA detectable) Part B: At least 30 paired specimens of venous EDTA whole blood and DBS in HBV DNA undetectable adults on antiviral therapy

Brief summary: Evaluation of novel point of care Hepatitis B diagnostic assays.

Detailed description: This study aims to evaluate the sensitivity of the following novel assays for evaluation of HBV infection and assessment of treatment eligibility;

* GeneXpert HBV DNA via Fingerstick testing,
* Dried Blood Spot based HBV DNA
* Point of care ALT.

Eligibility criteria: Inclusion Criteria:

1. Have voluntarily signed the informed consent form.
2. 18 years of age or older.
3. HBsAg positive
4. Part A: Not currently on antiviral therapy for HBV and HBV DNA detectable OR Part B: Stable on HBV antiviral therapy for at least 3 months with HBV DNA \< 20 IU/ml

Exclusion Criteria:

1) Inability or unwillingness to provide informed consent or abide by the requirements of the study.

Primary outcomes:
measure: Sensitivity and specificity of the Xpert® HBV DNA fingerstick point of care assay
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Sensitivity and specificity of the point of care ALT
timeFrame: Through study completion, an average of 1 year
measure: Sensitivity and specificity of the Xpert® HBV DNA point of care assay on dried blood spots
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital Sydney
state: New South Wales
Study officials:
affiliation: Kirby Institute
name: Gail Matthews, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06528028: Relationship Between Different Administration Regimens of Ceftazidime/Avibactam and Clinical Outcomes
Official title: Relationship Between Different Administration Regimens of Ceftazidime/Avibactam and Clinical Outcomes in Patients With Severe Infection: a Multicenter, Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Anti-Infective Agent
Keywords: Anti-Infective Agent
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment group and control group
Primary purpose: TREATMENT

Brief summary: Ceftazidime/avibactam (CAZ/AVI) is a new β-lactam drug, which has good antibacterial effect against carbapenem resistant enterobacter. However, previous studies found that CAZ/AVI had a low PK/PD compliance rate after the recommended dose of the drug instructions.Therefore, this study was intended to explore the clinical efficacy of different administration schedules of CAZ/AVI for patients with severe infection, and further analyze the correlation between CAZ/AVI PK/PD parameters and clinical efficacy and adverse reactions.

Detailed description: 1. Main purpose The main objective of this study was to verify that the clinical efficacy of treatment group (load dose of 2.5g, then continuous infusion of 2.5gQ8h, the dose can be adjusted according to renal function) with severe infection was superior to that of the control group (standard dose and administration regimen of ceftazidime/avibactam, i.e. 2.5gQ8h, 2h infusion).Dose can be adjusted according to renal function).
2. Secondary purpose (1) To investigate the relationship between different administration regimens and bacterial clearance and 28-d mortality (2) To explore the correlation between different dosing regimens and PK/PD compliance rate (3) To explore the correlation between different administration regimens and adverse drug reactions

Eligibility criteria: Inclusion Criteria:

Multiple-resistant negative bacteria Sensitive to ceftazidime/avibactam Received intravenous infusion of ceftazidime/avibactam

Exclusion Criteria:

Allergic to ceftazidime/avibactam Blood sample not be collected Pregnant or lactating

Primary outcomes:
measure: Clinical effective rate
timeFrame: 14 days
Secondary outcomes:
measure: Bacterial removal
timeFrame: 14 days
measure: 28-d mortality
timeFrame: 28 days
measure: PK/PD compliance rate
timeFrame: 14 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Intensive Care Unit, Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Ying Xu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00810628: Cognitive Behavioral Therapy for Depression in Parkinson's Disease
Official title: Depression in Parkinson's Disease: A Pilot Project Using Cognitive Behavioral Therapy (CBT) to Improve Depression and Coping
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson's Disease
Depression
Keywords: Parkinson's disease
depression
Parkinson's disease with mild to moderate depression.
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Parkinson Foundation
First posted: 2008-12-18
Enrollment: 12
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this pilot program is to develop and evaluate a new treatment program for depression in Parkinson's disease (PD). The treatment uses Cognitive Behavior Therapy(CBT)to teach patients how to become more aware of their thoughts and feelings and to change thinking patterns and behaviors that may be related to depressive symptoms. This is the first time that this treatment has been used in a group setting for depression in PD.

Target population is patients in the Movement Disorders Clinic at Oregon Health \& Science University who have Parkinson's disease and mild to moderate depression.


Eligibility criteria: Inclusion Criteria:

* Parkinson's disease, mild to moderate depression, seen at Oregon Health \& Science University

Exclusion Criteria:

* Suicidal
* Cognitive impairment with MOCA \<26

Primary outcomes:
measure: The change in CESD score
timeFrame: Baseline and 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Julie H. Carter, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Kristine Hanna, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dobkin RD, Allen LA, Menza M. Cognitive-behavioral therapy for depression in Parkinson's disease: a pilot study. Mov Disord. 2007 May 15;22(7):946-52. doi: 10.1002/mds.21455.
Clinical trial NCT06557928: Protocol for Evaluating Physiological and Psychological Adaptation Mechanisms in Tibetan Plateau Environments
Official title: Protocol for Evaluating Physiological and Psychological Adaptation Mechanisms in Tibetan Plateau Environments: A Clinical Study of Doctors From Peking Union Medical College Hospital
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: High Altitude
Keywords: high altitude
adaptation
acclimatization
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Doctors in Tibet from Peking Union Medical College Hospital

Brief summary: This study is a single-center prospective observational study. It plans to use a series of physiological and medical instruments and international common physiological and psychological questionnaires. To dynamically detect the changes of physiological and psychological adaptability of doctors in Peking Union Medical College Hospital before leaving Beijing, 1-7 days after arriving at the plateau in Tibet during the acute phase of plateau hypoxic stress, 2 weeks, 3 months, 6 months, 12 months after staying in Tibet during the chronic phase of plateau hypoxic stress, and after returning to Beijing.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals aged 20-65 years
* They can sign a written informed consent and is willing to cooperate
* They have the qualification to aid Tibet and meet the basic requirements of physical examination for aid to Tibet

Exclusion Criteria:

* Age less than 20 years or more than 65 years
* Unable to sign a written informed consent or unwilling to cooperate
* They do not have the qualification for supporting Tibet or do not meet the basic requirements of medical examination for supporting Tibet

Primary outcomes:
measure: help understand the physiological mechanisms and psychological changes of hypoxic adaptation
timeFrame: 2024-5-27~2026-12-1
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT04111328: the Effect of Different Drugs and Infusion Ways on Degree of Postoperative Comfort
Official title: the Effect of Different Drugs and Infusion Ways on Degree of Comfort for Patients Undergoing Spinal Neoplasm Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia, Patient-Controlled
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To explore the effect of different drugs and infusion ways on degree of postoperative comfort.Patients undergoing spinal neoplasm surgery receive different patient controlled analgesia(PCA) drugs postoperatively,one group is sufentanil,the other is hydromorphone. Then each drug group will be divided into two subgroups according to the infusion way,intravenously,subcutaneously. During the patient controlled analgesia period, patients' degree of comfort,pain score,sleep quality, the degree of side reaction will be recorded.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I or II .

Exclusion Criteria:

* history of severe heart, hepatic or renal disease,
* history of chronic pain condition or opioid use,
* body mass index (BMI) ≤18 or ≥30 kg/m2,
* alcohol or drug abuse,
* relevant drug allergy,
* inability to properly describe postoperative pain,
* inability to use PCA pump.

Primary outcomes:
measure: Visual Analogue Scale of Comfort level
timeFrame: 48 hours after the use of PCA.
Secondary outcomes:
measure: Ramsay sedation score
timeFrame: 6hours,12hours,24hours and 48 hours after the use of PCA.
measure: The degree of nausea
timeFrame: 6hours,12hours,24hours and 48 hours after the use of PCA.
measure: The degree of dizziness
timeFrame: 6hours,12hours,24hours and 48 hours after the use of PCA.
measure: Pupil diameter
timeFrame: 6hours,12hours,24hours and 48 hours after the use of PCA.
Other outcomes:
measure: Pittsburgh sleep quality index
timeFrame: 1 day before the surgery,1 month after the surgery.
Locations:
city: Shenyang
country: China
facility: The First Affiliated Hosipital of China Medical University
state: Liaoning
Study officials:
References:
citation: Wang J, Cui L, Fan L, Wang J. Clinical Effect of Different Drugs and Infusion Techniques for Patient-controlled Analgesia After Spinal Tumor Surgery: A Prospective, Randomized, Controlled Clinical Trial. Clin Ther. 2021 Jun;43(6):1020-1028. doi: 10.1016/j.clinthera.2021.03.019. Epub 2021 May 2.
Clinical trial NCT03153228: Acute Response to Cigarette and E-cigarette Smoking Assesed in Exhaled Breath Condensate in Healthy Smokers of Traditional and E-cigarettes
Official title: The Comparison of Biomarkers of Acute Response to Cigarette Smoking and E-cigarettes Smoking Assesed in Exhaled Breath Condensate in Healthy Smokers of Traditional and Electronical Cigarettes.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: E-cigarettes
Keywords: E-cigarettes
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy smokers of traditional cigarettes, healthy smokers of e-cigarettes, healthy nonsmoking volunteers

Brief summary: Electronical cigarettes, also known as "e-cigarettes" are a new phenomenon, which steadily wins more aprobation among smokers. However, there exists no much data concerning the effects of acute exposure to electronic cigarettes vapour on the respiratory system.

The aim of the present study is to evaluate and compare the acute response to electronic and traditional cigarettes in healthy smokers.

Detailed description: The aim of the study is:

* to evaluate the acute response to traditional cigarettes on the respiratory system
* to evaluate the acute response to electronic cigarettes on the respiratory system
* to assess the relationship between the type of smoked cigarettes (traditional vs. electronic) and concentration of markers of airway inflammation released in healthy smokers

Material and methods:

* 29 healthy smokers of traditional cigarettes
* 29 healthy smokers of electronic cigarettes
* 29 healthy, nonsmoking volunteers

After 8 hours of smoking abstinence:

* the spirometry test
* the first collection of the exhaled breath condensate (EBC I)
* smoking a traditional / electronic cigarette
* the second collection of the exhaled breath condensate (EBC II) - one hour after smoking
* the third collection of the exhaled breath condensate (EBC III) - six hours after smoking
* the measurement of biomarkers of oxidative stress in the EBC (isoprostane-8, malondialdehyde MDA, IL-8) and pH of the EBC

Eligibility criteria: Inclusion Criteria:

* healthy smokers of traditional cigarettes - min. 1 packyear
* healthy smokers of e-cigarettes - min. 1 year of smoking history
* control group - healthy nonsmoking volunteers without any history of lung disease

Exclusion Criteria:

* age below 18 years
* inhaled corticosteroid therapy at least 6 weeks prior to study enrollment
* any co-morbidities
* respiratory infections at least 6 weeks prior to study enrollment

Primary outcomes:
measure: Inflammatory markers in exhaled breath condensate
timeFrame: Approximately 1-2 months after completion of study procedures in all patients
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw, Banacha Hospital
Study officials:
References:
Clinical trial NCT04943328: Cemented TrendHip® - Multicenter PMCF Study on Total Indications
Official title: Post Market Clinical Follow-Up (PMCF) Study to Evaluate the Performance and Safety of the Cemented TrendHip® Stem in a Prospective Follow-up Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coxarthrosis; Primary
Coxarthrosis; Post-Traumatic
Necrosis, Femur Head
Rheumatoid Arthritis
Fractures, Hip
Hip Dysplasia
Keywords: Total Hip Arthroplasty
Hip Prosthesis
Elderly Patients
Bone Cement
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2021-06-29
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Post Market Clinical Follow-Up (PMCF) study to evaluate the performance and safety of the cemented TrendHip® stem in a prospective follow-up study with patients who underwent a hip arthroplasty with the investigational product (representative of usual clinical practice), at two follow-up examinations


Eligibility criteria: Inclusion: Inclusion criteria

* Patient older than 18 years.
* Patient who undergo / underwent a hip arthroplasty with cemented TrendHip® femoral stem according to the indications for implantation specified in the Instructions for Use.
* Patient not opposing participation in the study.

Exclusion: Exclusion criteria

* Patient with shortened life expectancy.
* The patient is unable to commit to the planned follow-up period.

Primary outcomes:
measure: Change of functional outcome over five year follow-up period (Harris Hip Score)
timeFrame: preoperative (as available) and at two examinations during Follow-Up (1 year postop, 5 years postop)
Secondary outcomes:
measure: Pain Assessment
timeFrame: at two examinations during Follow-Up (1 year postop, 5 years postop)
measure: Patient satisfaction with surgery result
timeFrame: at two examinations during Follow-Up (1 year postop, 5 years postop)
measure: Survival rate (Kaplan-Meier)
timeFrame: at two examinations during Follow-Up (1 year postop, 5 years postop)
measure: Radiological Outcome: Migration of the stem in mm
timeFrame: at two examinations during Follow-Up (1 year postop, 5 years postop)
measure: Radiological Outcome: Evaluation of bony osseointegration or conspicuous features of the stem
timeFrame: at two examinations during Follow-Up (1 year postop, 5 years postop)
measure: Radiological Outcome: Heterotopic Ossification
timeFrame: at two examinations during Follow-Up (1 year postop, 5 years postop)
Other outcomes:
measure: Rate of Adverse and Serious Adverse Events
timeFrame: at two examinations during Follow-Up (1 year postop, 5 years postop)
Locations:
city: Ahlen
country: Germany
facility: St. Franziskus-Hospital
state: Nordrhein-Westfalen
city: Brakel
country: Germany
facility: St. Vincenz Hospital Brakel
city: Mülheim an der Ruhr
country: Germany
facility: St. Marien-Hospital
city: Plettenberg
country: Germany
facility: radprax Krankenhaus Plettenberg GmbH
Study officials:
References: