louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02462902: Comparison And Outcomes Of Fluid Resucitation With 0.9% Normal Saline And 5% Albumin In Cirrhosis Patients With Sepsis Induced Hypotension
Official title: Comparison And Outcomes Of Fluid Resucitation With 0.9% Normal Saline And 5% Albumin In Cirrhosis Patients With Sepsis Induced Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis With Septic Shock
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 300 consecutive patients with cirrhosis of any aetiology admitted with features of sepsis and sepsis induced hypotension to the intensive care unit, the emergency department and the step down units of Institute of Liver and Biliary Sciences, New Delhi, who fulfil the inclusion criteria.

This study will be a single centre prospective randomized comparative trial. Patients will be randomized into two groups. Group A will receive crystalloid, 0.9% sodium chloride solution (total of 30ml/kg over 30 minutes) and Group B will receive colloid, 5% albumin (250 ml over 15 minutes).


Eligibility criteria: Inclusion Criteria:

1. Cirrhotic patients of any aetiology with Infection - suspected or documented and Mean arterial pressure less than 65 mm of Hg

Exclusion Criteria:

1. Cirrhosis patients in septic shock who are already on vasopressors and/or inotropes
2. Cirrhosis patients in septic shock with structural heart disease
3. Cirrhosis patients in septic shock with chronic renal failure/dialysis dependent/volume overloaded state
4. Cirrhosis patients in shock, caused by other reasons, other than septic shock
5. Cirrhosis patients in septic shock in whom contraindication to internal jugular or subclavian line insertion is present
6. Age less than 18 years
7. Previous episode of septic shock during the same hospital stay
8. Pregnant or lactating women
9. Patients in need for emergent surgical interventions
10. Cirrhosis patients in septic shock with chronic obstructive lung disease and right heart failure
11. Cirrhosis patients in septic shock with associated upper gastrointestinal bleed or coagulopathy related bleed with a haemoglobin of less than 8g/dL or requiring urgent transfusions of blood and blood products
12. A previous adverse reaction to human albumin solution

Primary outcomes:
measure: Total number of patients with MAP (Mean Arterial Pressure) ≥ 65
timeFrame: 3 hours
Secondary outcomes:
measure: Change in lactate dynamics
timeFrame: 3 hours
measure: Total number of patients with Urine output >/= 0.5mL/kg/hr.
timeFrame: 3 hours
measure: Mortality
timeFrame: 7 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT02175602: Study of Drug Combination on Pharmacokinetics in Healthy Volunteers
Official title: Effect of a Combination of Daclatasvir, Asunaprevir, and BMS-791325 on the Pharmacokinetics of Selective Serotonin Reuptake Inhibitors in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C Infection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-06-26
Enrollment: 41
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the effect of Daclatasvir, Asunaprevir, and BMS-791325 on the pharmacokinetics of selective serotonin reuptake inhibitors.


Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent Form

   a) Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's IRB or IEC before the initiation of any protocol-required procedures.
2. Target Population

   a) Healthy subjects as determined by no clinically significant deviation from normal in medical history, psychiatric history, physical examination findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results.
3. Age and Reproductive Status

   1. Males and females, ages 25 to 55 years, inclusive.
   2. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
   3. Women must not be breastfeeding.

Exclusion Criteria:

1. Any significant acute or chronic medical illness.
2. Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug (appendectomies with no complications are allowed at the investigator's discretion).
3. Any major surgery within 4 weeks of study drug administration.
4. Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to the start of study drug administration).
5. Any other sound medical, psychiatric, and/or social reason as determined by the investigator.

Primary outcomes:
measure: Serial blood samples for plasma SSRI (selective serotonin reuptake inhibitor) of escitalopram or sertraline
timeFrame: Before dosing (0 hour) through 24 hours after SSRI administration on day 7 and day 29
measure: Serial blood samples for determination of plasma concentrations of DCV (daclatasvir), ASV (asunaprevir), BMS-791325, and the metabolite BMS-794712
timeFrame: Before dosing (0 hour) through 12 hours after SSRI administration on day 22 and day 29
Secondary outcomes:
measure: Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
timeFrame: Two to three months
Other outcomes:
Locations:
Study officials:
affiliation: PPD Development, LP
name: Ikenna Ogbaa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06612502: The Effect of Percussion Massage Therapy on the Recovery of DOMS in Physically Active Young Men Delayed Onset Muscle Soreness = DOMS
Official title: The Effect of Percussion Massage Therapy on the Recovery of Delayed Onset Muscle Soreness in Physically Active Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delayed Onset Muscle Soreness (DOMS)
Keywords: Delayed Onset Muscle Soreness
Percussion massage therapy
Stretching
Recovery
Lead sponsor: Shanxi Normal University
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn the effect of percussion massage therapy (PMT) on the recovery of delayed onset muscle soreness (DOMS) in physically active young men.

The main question it aims to answer is:

Compared with static stretching, Do 25 minutes and 40 minutes of PMT can decrease pain and increase the rang of motion of knee of low limb DOMS in physically active young men? Compared with static stretching, Do 25 minutes and 40 minutes of PMT sessions can increase power and improve the neuromuscular electrophysiology of low limb DOMS in physically active young men?

Researchers will compare 25 minutes and 40 minutes of PMT to a static stretching to see if different times of PMT are better to treat DOMS.

Participants will： Undergo squats to induce low limb DOMS. Receive static stretching, 25 minutes and 40 minutes of PMT, respectively for three times.

Visit the lab for four times in one week for tests.


Eligibility criteria: Inclusion Criteria:

Regularly participate in physical activity, have no contraindications to exercise, and volunteered to participate in this study

Exclusion Criteria:

Participants consumed alcohol and exercised vigorously throughout the formal experiment or they underwent interventions other than those planned for the experiment.

Primary outcomes:
measure: Muscle pain
timeFrame: From enrollment to the end of treatment for 3 days
measure: Knee joint ROM
timeFrame: From enrollment to the end of treatment for 3 days
measure: CMJ
timeFrame: From enrollment to the end of treatment for 3 days
measure: Surface EMG
timeFrame: From enrollment to the end of treatment for 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Shanxi Normal University
state: Shanxi
Study officials:
References:
Clinical trial NCT05814302: Treatment Of Fever In The Emergency Department
Official title: Treatment Of Fever And Associated Symptoms In The Emergency Department: Which Drug To Choose?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever
Keywords: Fever
Paracetamol
Paracetamol/Ibuprofen
Emergency Department
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults \> 18 years old with fever and associated symptoms accessing the ED

Brief summary: Fever is a frequent cause of admission to the Emergency Department (ED) around the world. While it can be caused by a wide range of conditions, the most effective treatment based on its etiology is still undetermined. This observational, prospective, single-center study enrolled adult patients who accessed the ED for fever, with the aim to define the most effective treatment for them.

Detailed description: Physicians were free to administer paracetamol 1000 mg (P), the combination paracetamol 500 mg/ibuprofen 150 mg (PI) or Ibuprofen 600 mg (I).The primary endpoint was both 1-degree and 1-point reduction in body temperature for all associated symptoms on the Numeric Rating Scale (NRS) after 1 hour (T1). Secondary endpoint was the reduction of at least 2 points on the NRS after two hours (T2). Adverse events, the needing of a rescue therapy and the response based on the underlying etiology (bacterial, viral, or immune/neoplastic) were also evaluated.

Eligibility criteria: Inclusion Criteria:

* fever with/without associated symptoms
* adults who had given their consent to participate in the study.

Exclusion Criteria:

* age \< 18 years old
* contraindications or allergies to Paracetamol, Ibuprofen or to the combination Paracetamol/Ibuprofen
* patients unable to take oral drugs
* patients who did not express their consent to participate to the study

Primary outcomes:
measure: body temperature
timeFrame: 1 hour
measure: Numerical Rating Scale (NRS)
timeFrame: 1 hour
Secondary outcomes:
measure: the reduction of at least 2 points on the Numerical Rating Scale (NRS) after two hours (T2) after the drug administration
timeFrame: 2 hours
measure: rescue therapy
timeFrame: 2 hours
measure: adverse events
timeFrame: 2 hours
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
Study officials:
References:
Clinical trial NCT00420602: DHA Supplementation in Patients With STGD3
Official title: Clinical Interventions Against Stargardt Macular Dystrophy: DHA Supplementation in Patients With STGD3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dominantly Inherited Stargardt's Disease (STGD3)
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2007-01-11
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: We have found that biomarkers of long-term elevated dietary intake of omega-3 fatty acids such as DHA and EPA are inversely associated with severity of disease phenotype in STGD3 patients. Therefore, the purpose of this study is to follow STGD3 patients as they supplement their diets with DHA/EPA.


Eligibility criteria: Inclusion Criteria:

* All Moran Eye Center patients with STGD3

Exclusion Criteria:

* All others

Primary outcomes:
measure: ERG
timeFrame: 1 year
Secondary outcomes:
measure: Visual acuity
timeFrame: 1 year
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Moran Eye Center, University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Paul S. Bernstein, MD Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00538421: Opioid-potentiated Volative Anaesthetic Vs. Remifentanil And Propofol During Abdominal Aortic Aneurysm Surgery
Official title: Opioid-potentiated Volative Anaesthetic(Sevoflurane)Compared to Remifentanil and Propofol During Abdominal Aortic Aneurysm Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aortic Diseases
Abdominal
Aneurysm
Surgery
Keywords: propofol
Anaesthesia
Sevoflurane
Abdominal
Aortic
Aneurysm
Lead sponsor: Sykehuset i Vestfold HF
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2007-10-02
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing 2 different anaesthetic methods during abdominal aortic aneurysm surgery. The patients will be followed up 30 days postoperative. Number of patients included will be 200. Perioperative details will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Patients who are planned for open, elective abdominal aortic aneurysm surgery.
* ASA group 1-4.

Exclusion Criteria:

* Patients below 18 years.
* Patients who are included in other pharmaceutical studies.
* Opioids-, benzodiazepins-, antiepileptic drugs-, alcohol- and α2-agonists abuse.
* Pregnant and breastfeeding women.
* Patients with familiar history of malignant hyperthermia.
* Patients with known hypersensitivity for opioids, propofol or volative anaesthetics.
* Patients with considerable arrythmia (atrial fibrillation /atrial flutter is acceptable). Uncontrolled hypertension, serious psychiatric disease.
* Patients with unstable angina pectoris or myocardial infarction last month before inclusion.
* Acute abdominal aortic surgery. Acute dissection or rupture.
* Planned laparoscopic abdominal aortic aneurysm surgery.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tonsberg
country: Norway
facility: Sykehuset i Vestfold HF
Study officials:
affiliation: Sykehuset i Vestfold HF
name: Espen Lindholm, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01937221: Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease
Official title: Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Mild to Moderate Cognitive Impairment
Keywords: mild cognitive impairment
mild to moderate cognitive impairment
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Institute for Brain Sciences
name: Alzheimer's Association
name: Duke-NUS Graduate Medical School
First posted: 2013-09-09
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal controls and patients with mild, mild to moderate cognitive impairment

Brief summary: The goal of this study is to create new retinal imaging processing software useful for the development of novel retinal biomarkers of cognitive impairment associated with Alzheimer's disease (AD).


Eligibility criteria: Inclusion Criteria:

1. Result of the standard neuropsychological assessment
2. Are men or postmenopausal women, at least 55 years of age. Postmenopausal women are defined as women who have had a hysterectomy and/or bilateral oophorectomy; or who have been amenorrheic for at least 2 years;
3. Fluency in English
4. Participants in mild cognitive impairment (MCI)/prodromal and mild-to-moderate dementia groups must assign a surrogate for purposes of informed consent and help with protocol compliance.

Exclusion Criteria:

1. Known or suspected diagnosis of non-AD, associated dementia;
2. Major ophthalmologic comorbidities: Ruptured globe, retinal vascular occlusive disease, retinal artery occlusion, anterior ischemic optic neuropathy, media opacification due to corneal abnormalities or cataract that prevent ocular and OCT examination, glaucoma, wet (neovascular) age-related macular degeneration, history of intravitreal injections, and macular edema. If two eyes satisfy the inclusion criteria, both eyes will be included in the study.

Primary outcomes:
measure: Nerve fiber layer/ganglion cell layer (NFL/GCL) abnormality score
timeFrame: Baseline
measure: NFL/GCL abnormality score
timeFrame: 12 months
Secondary outcomes:
measure: Drusen/plaque score
timeFrame: Baseline
measure: Drusen/plaque score
timeFrame: 12 months
measure: Total drusen area
timeFrame: Baseline
measure: Total drusen area
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Heather Whitson, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Eleonora Lad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00479921: Annual Study to Investigate Influenza Vaccine Due to New Virus Strains for the 2007/2008 Influenza Season in Europe
Official title: Immunogenicity and Reactogenicity of Trivalent Influenza Subunit Vaccine Influvac® for the Season 2007/2008. An Open, Baseline-Controlled Multi-Center Study in Two Groups of Healthy Subjects: Adults and Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Volunteers
Keywords: Influenza
Vaccine
CHMP criteria
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-05-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of healthy subjects: subjects aged \>= 18 and \<= 60 years and subjects \>= 61 years of age (elderly).


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent.
* Healthy and aged \>= 18 and \<= 60 years or \>= 61 years of age.
* Mental health good enough to understand the study and the informed consent form and to fill in the questionnaire.

Exclusion Criteria:

* Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
* Having fever and/or presenting with an acute infectious episode of the upper and/or lower respiratory airways.
* Having experienced a serious systemic and/or local reaction after previous influenza vaccination.
* Having an auto-immune disorder (e.g. RA, SLE, auto-immune thyroid disorders) or other disorders affecting the immune system, taking immunosuppressive medication (such as systemic corticosteroids) including the four weeks preceding the start of the study (date of informed consent), or having a disease in a terminal stage.
* Having received vaccination against influenza within the previous six months before Visit 1.

Primary outcomes:
measure: Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2007/2008
Secondary outcomes:
measure: HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP)
Other outcomes:
Locations:
city: Tessenderlo
country: Belgium
facility: Site 1
city: Hamburg
country: Germany
facility: Site 2
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT02961621: Multi-tasking to Hyper-tasking: Investigating the Impact of Next Generation 911
Official title: Multi-tasking to Hyper-tasking: Investigating the Impact of Next Generation 911
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 323
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Emergency call centers across the country are preparing for the Next Generation 911 (NG911) initiative, which will allow citizens to place 9-1-1 "calls" using digital technologies such as text messaging, email, Skype or instant messaging, and will expand emergency information sources to also include streaming video, photo uploads, and automatic crash notifications. The impact of these new information and communication technologies on those tasked with using them in time-sensitive emergency situations is unknown. Our study is designed to address the following hypotheses: 1) We hypothesize that NG911 implementation will have a significant effect on telecommunicator stress levels and 2) A resiliency training tailored to the needs of telecommunicators will mitigate the impact on NG911 implementation on stress levels. We will test these hypotheses through the following specific aims:

Aim 1: Measure levels of stress, job satisfaction and job performance among 9-1-1 telecommunicators before and after the NG911 implementation.

Aim 2: Develop and test the efficacy of an evidence-based resiliency training and worker support intervention to improve psychological well-being and job performance of 9-1-1 telecommunicators.

Aim 3: Build an ABM tool of 9-1-1 call centers to improve 9-1-1 telecommunicator workforce training and smooth transitions to future call center innovations.


Eligibility criteria: Inclusion Criteria:

* subjects must be 9-1-1 telecommunicators (call receivers and dispatchers) who work at participating call centers and consent to participate.

Exclusion Criteria:

* We will exclude subjects who do not consent to participate
* We will exclude subjects who do not confirm that they are 21 or older.

Primary outcomes:
measure: Calgary Symptoms of Stress Inventory
timeFrame: Baseline, immediately post intervention and 3 months post intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Hendrika Meischke, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kerr DC, Ornelas IJ, Lilly MM, Calhoun R, Meischke H. Participant Engagement in and Perspectives on a Web-Based Mindfulness Intervention for 9-1-1 Telecommunicators: Multimethod Study. J Med Internet Res. 2019 Jun 19;21(6):e13449. doi: 10.2196/13449.
citation: Meischke H, Lilly M, Beaton R, Calhoun R, Tu A, Stangenes S, Painter I, Revere D, Baseman J. Protocol: a multi-level intervention program to reduce stress in 9-1-1 telecommunicators. BMC Public Health. 2018 May 2;18(1):570. doi: 10.1186/s12889-018-5471-0.