louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03280576: Validation of Progranulin as a Biomarker for Sepsis
Official title: Sensitivity and Specificity of Progranulin as a Biomarker for Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Postoperative
Dysfunction Following Cardiac Surgery
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: City of Munich
First posted: 2017-09-12
Enrollment: 556
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Sepsis, Patients undergoing cardiac surgery, Healthy volunteers

Brief summary: Progranulin blood concentrations in patients with sepsis will be analysed in relation to disease status in order to validate progranulin as a biomarker for sepsis. Patients undergoing cardiac surgery will serve as controls.

Detailed description: Single nucleotide polymorphisms with known effects on Progranulin plasma concentrations will be assessed in a separate analysis. Expression levels of microRNAs isolated from plasma, circulating exosomes and blood cells will be determined by next-generation sequencing to characterize epigenetic influences on progranulin plasma levels.

Eligibility criteria: Inclusion Criteria:

* Sepsis or Septic Shock defined according to SEPSIS-3 criteria - Age \> 18 years

Exclusion Criteria:

* No informed consent
* Age \< 18 years
* Pregnancy
* Immunosuppression (including transplantation)
* Charlson Comorbidity Index \> 0 (healthy volunteers)

Primary outcomes:
measure: Change in progranulin plasma concentrations during ICU - therapy
timeFrame: ICU admission, day 1, day 4 of ICU therapy
Secondary outcomes:
measure: Change in miRNA expression levels in exosomes, serum and blood cells during ICU - therapy
timeFrame: ICU admission, day 1, day 4 of ICU therapy
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Anesthesiology, LMU Munich
state: Bavaria
city: Munich
country: Germany
facility: Department of Anesthesiology, Klinikum Neuperlach
state: Bavaria
Study officials:
affiliation: Department of Anaesthesiology LMU
name: Gustav Schelling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brandes F, Borrmann M, Buschmann D, Meidert AS, Reithmair M, Langkamp M, Pridzun L, Kirchner B, Billaud JN, Amin NM, Pearson JC, Klein M, Hauer D, Gevargez Zoubalan C, Lindemann A, Chouker A, Felbinger TW, Steinlein OK, Pfaffl MW, Kaufmann I, Schelling G. Progranulin signaling in sepsis, community-acquired bacterial pneumonia and COVID-19: a comparative, observational study. Intensive Care Med Exp. 2021 Sep 3;9(1):43. doi: 10.1186/s40635-021-00406-7.
Clinical trial NCT00607776: Artificial Tears Study in Mild to Moderate Dry Eye Patients
Official title: Artificial Tears Study in Mild to Moderate Dry Eye Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Keywords: dry, eyes
Amelioration of dry eye symptoms
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The mean change in the subjective comfort score from baseline of the test group is at least 2.0 units less than that of the control group.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate dry eye
* over 18

Exclusion Criteria:

* No concurrent ocular disease or meds

Primary outcomes:
measure: Subjective ocular comfort
timeFrame: 1 Month
Secondary outcomes:
measure: Vision quality
timeFrame: 1 Month
Other outcomes:
Locations:
Study officials:
affiliation: Ophthalmic Consultants of Long Island
name: Eric Donnenfeld, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03114176: Effects of Ketogenic Diet in Divers Breathing Enriched Air Nitrox
Official title: Effects of Exercise and Dietary Inatke on Muscle Metabolism and Inflammatory Status Modulated by Oxygen Free Radicals and Cytokines in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Exertion; Excess
Oxygen Toxicity
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 6
Sex: MALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Overweight divers face a challenging activity such as immersions, starting from a higher levels of circulating cytokines and oxidative stress. Ketogenic Diet (KD) is described as effective in weight loss, in countering inflammation and oxidative stress, and used in the control of drug-refractory seizures.

The aim of our pilot study was to evaluate if a ketosis state induced by a specific dietary regime, may have a protective effect on oxidative stress damages and inflammatory status, that accompanies both overweight and diving activities.

Blood and urine samples from six overweight divers were obtained a) before (CTRL) and after a dive breathing Enriched Air Nitrox and performing light underwater exercise (NTRX), b) after a dive (same conditions) performed after 7 days of KD (K-NTRX). We measured urinary 8-isoprostane and 8-OH-2-deoxyguanosine evaluating lipids peroxidation and DNA oxidative damages. Plasmatic IL-1beta, IL-6 and TNF-alpha levels were measured to investigate the inflammatory status.


Eligibility criteria: Inclusion Criteria:

* to be in an overweight state (BMI ≥ 25 kg/m2) and no history of orthopedic, cardiovascular, renal or metabolic disorders.

Exclusion Criteria:

* not to be in an overweight state (BMI ≥ 25 kg/m2) and a history of orthopedic, cardiovascular, renal or metabolic disorders.

Primary outcomes:
measure: Oxidative damage change
timeFrame: Change from Baseline Oxidative damage at twenty days
measure: Pro-inflammatory cytokines change
timeFrame: Change from Baseline Pro-inflammatory cytokines at twenty days
Secondary outcomes:
measure: Weight Loss
timeFrame: Weight was registered before (T0) and after twenty days of no diving activity in which subjects were engaged in a 7-days Ketogenic Diet (T3).
Other outcomes:
Locations:
Study officials:
affiliation: University of Padova
name: Bosco Gerardo, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02800876: Evaluation of Aortic Aneurysms With Focus on Wall Stress and Wall Rupture Risk
Official title: Evaluation of Aortic Aneurysms With Focus on Wall Stress and Wall Rupture Risk by Computational Finite Element Analysis With Dedicated Software
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Aneurysm
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with known aortic aneurysms, who underwent clinical indicated CT during a time period from 01/2004-12/2013

Brief summary: Retrospective study to evaluate the impact of computational wall stress analysis based on computed tomography (CT) of ruptured and not-ruptured aortic aneurysms as an additional predictor for rupture with dedicated software.

Detailed description: In patients with known aortic aneurysm who received clinically indicated CT during a time period from 01/2004-12/2013 the CT data was evaluated with dedicated software, A4clinics, VASCOPS GmbH, Graz, Austria. The following parameters will be evaluated: exterior and luminal diameter, intraluminal thrombus (ILT) thickness, vessel-, luminal- and intraluminal thrombus volume, peak wall stress (PWS), peak wall rupture risk (PWRR), von Mises-stress and rupture risk-index in the ILT.

Eligibility criteria: Inclusion Criteria:

Clinical indicated CT data from patients with known aortic aneurysms.

Clinical indication was:

* Follow up CT examination by known aortic aneurysm
* Patient with known aortic aneurysm with new acute clinical symptoms
* Patients with clinical suspicion of aortic aneurysm

Exclusion Criteria:

* known exclusion criteria for CT examination as known allergy to iodine or contrast media
* known pregnancy

Primary outcomes:
measure: To calculated the rupture risk equivalent diameter (RRED) of the aortic aneurysm and rupture risk-index in the intraluminal thrombus within the aortic aneurysm.
timeFrame: CT Data from 01/2004-12/2013
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References:
Clinical trial NCT04871776: Use of Construal Level Theory to Inform Messaging to Increase Vaccination Against COVID-19
Official title: Use of Construal Level Theory to Inform Messaging to Increase Vaccination Against COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Vaccine Refusal
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-05-04
Enrollment: 3671
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to increase uptake of the COVID booster vaccine through messaging informed by Construal Level Theory. Patients in the Mass General Brigham (MGB) health system aged 18 and older who are eligible for the COVID booster vaccine, but who have not yet received a dose at the time of an upcoming primary care clinic visit, will be randomized to one of three messaging arms: 1) "why" messaging, 2) "how" messaging, or 3) standard of care ("usual care"). Messages will be sent via the electronic patient portal a few days in advance of their office visit. The primary outcome will be the rate of booster vaccination at the targeted visit. The secondary outcome will be the rate of receipt of a COVID booster vaccine within 6 weeks of the targeted visit. Subgroup analyses to assess for any association of patient characteristics with intervention responsiveness will be exploratory.


Eligibility criteria: Inclusion Criteria:

* Patients in the Mass General Brigham system
* Aged 18 and older
* Are eligible for the COVID booster vaccine but have not received a dose at time of upcoming primary care clinic visit

Exclusion Criteria:

* Documented allergy to a COVID vaccine or its components
* Home address outside of Massachusetts
* Did not receive full set of primary COVID-19 vaccination series

Primary outcomes:
measure: Number of Participants Who Received a Booster Vaccination Through the Targeted Visit
timeFrame: 2-5 days
Secondary outcomes:
measure: Number of Participants Who Received a Booster Vaccination Within 6 Weeks of the Targeted Visit
timeFrame: 6 weeks after the target visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mass General Brigham
state: Massachusetts
Study officials:
References:
Clinical trial NCT01259076: Effect of Weight Loss on Breast Density Using Digital Mammography and MRI in Women Who Are At Increased Risk For Breast Cancer
Official title: Effect of Weight Loss on Breast Density Using Both Digital Mammography and Breast MRI
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Healthy, no Evidence of Disease
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Robert H. Lurie Cancer Center
First posted: 2010-12-13
Enrollment: 43
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre-menopausal women between the ages of 30 and 50 who are eligible and undergoing evaluation for gastric bypass surgery

Brief summary: Diagnostic procedures, such as digital mammography and MRI, may help measure how weight loss affects breast density in women who are at increased risk for breast cancer.

Detailed description: OBJECTIVES: I. To determine if weight loss in patients undergoing Roux en Y gastric bypass procedures has any effect on breast density as measured by mammography and breast MRI. OUTLINE: GROUP I: Participants undergo mammography and MRI at baseline and 1 year. Participants also undergo gastric bypass surgery. GROUP II: Participants undergo mammography and MRI at baseline and 1 year. After completion of study treatment, patients are followed up at 1 year.

Eligibility criteria: Inclusion Criteria:

* Women eligible for gastric bypass surgery
* Pre-menopausal women
* All women will have signed an informed consent form prior to participating in study procedures

Exclusion Criteria:

* Women with a history of breast cancer
* Women currently taking exogenous hormone replacement therapy
* Women currently taking a SERM
* Women currently taking an aromatase inhibitor
* Pregnant or lactating women
* Women who have been pregnant or lactating in the past 2 years
* Women who have metallic or other surgical implants
* All subjects will have a determination of their estimated glomerular filtration rate (eGFR) within 24 hours of undergoing any study where gadolinium based contrast agents will be administered
* Subjects should not have a known history of recent onset acute renal dysfunction
* Subjects with a history of stable chronic renal dysfunction may participate in studies using GBCA based on their eGFR, as outlined below
* Subjects should not have severe liver dysfunction, particularly when associated with kidney disease
* Subjects should receive GBCAs in the perioperative period (i.e. within 4 weeks) after renal or liver transplantation

Primary outcomes:
measure: Change in BMI and breast density
timeFrame: At baseline and year 1
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Nora Hansen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03384576: The Effect of Music in the Pediatric Emergency Department Waiting Room on Caregiver Anxiety
Official title: The Effect of Music in the Pediatric Emergency Department Waiting Room on Caregiver Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Music
Emergency
caregivers
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-12-27
Enrollment: 350
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this research study is to examine the effects of playing classical music in the waiting room on caregiver anxiety. People who enter the study will be asked a few identifier questions including age and relation to patient and then will be asked fill out a survey regarding anxiety.

Detailed description: The study investigators will initially screen for participants based on the patient's acuity level. If the patient meets the low acuity requirement and if they have a wait time greater than 20 minutes then the caregiver will be approached to obtain informed consent once they have been placed in a room. If they choose to be included in the study, the patient's medical record number will be recorded, a personal identification number will be assigned, and the patient's information will be entered into the personal identification number key and into our research database. A questionnaire asking participants age and relation to patient and the state-trait anxiety inventory will be administered to the caregiver. An additional question of perceived wait time will also be asked.

Eligibility criteria: Inclusion Criteria:

* Adult caregivers; age \>18 year, accompanying a pediatric patient with acuity level ≥ 4
* Patient must have been in waiting area for at least 20 minutes

Exclusion Criteria:

* Non-english speaking caregivers
* Hearing impaired caregivers
* Caregivers accompanying a patient with an acuity level less than 4

Primary outcomes:
measure: reduction in anxiety score
timeFrame: up to 10 hours
Secondary outcomes:
measure: Perceived waiting time
timeFrame: up to 10 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jennifer M Smedley, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05078476: Rehabilitation of Finger Flexor Tendon Injuries
Official title: Early Active Motion in the Rehabilitation of Flexor Tendon Injuries: Short Splint Versus Relative Motion: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Flexor Tendon Rupture
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 30
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: The primary objective is to compare the two different rehabilitation protocols relative motion flexion and short splint regarding patients'satisfaction in patients with flexor tendon injuries in Zone I and II after 13 and 26 weeks post-surgery.


Eligibility criteria: Inclusion Criteria:

* Informed consent as documented by signature
* ≥ 18 years old
* Understanding of the German language (written and oral)
* Single and multiple finger injuries
* Primary flexor tendon injuries in Zone I-V for the fingers and/ or thumb
* Treated by the hand surgery department at the Inselspital Bern
* Treated with at least a 4-strand core suture

Exclusion Criteria:

* \< 18 years old
* Inability to follow the procedures of the study, e.g. due to language problems, diagnosed psychological disorders or dementia of the patients
* Replantation of the injured finger
* Fracture of the injured finger
* Primary tendon reconstructions

Primary outcomes:
measure: Change in patient satisfaction
timeFrame: 13 and 26 weeks after tendon repair
Secondary outcomes:
measure: Michigan Hand Questionnaire (MHQ)
timeFrame: 6, 13 and 26 weeks after tendon repair
measure: Disabilities of Shoulder, Arm and Hand Questionnaire
timeFrame: 6, 13 and 26 weeks after tendon repair
measure: Range of motion
timeFrame: 6, 13 and 26 weeks after tendon repair
measure: Grip Strength
timeFrame: 13 and 26 weeks after tendon repair
measure: Level of pain
timeFrame: 6, 13 and 26 weeks after tendon repair
measure: Number of therapy sessions
timeFrame: 26 weeks after tendon repair
measure: Ten Test
timeFrame: 6, 13 and 26 weeks after tendon repair
measure: Patients specific function scale
timeFrame: 6, 13 and 26 weeks after tendon repair
measure: Work Productivity and Activity Impairment Questionnaire
timeFrame: 6, 13 and 26 weeks after tendon repair
measure: Rupture rate/ Complications
timeFrame: 26 weeks after tendon repair
measure: Complications
timeFrame: 26 weeks after tendon repair
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospital
Study officials:
affiliation: Inselspital, Bern Universtiy Hospital
name: Bernadette Tobler, Dr. phil.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06050876: Gallbladder Volvulus Diagnosed Intraoperatively: Case Report
Official title: Gallbladder Volvulus Diagnosed Intraoperatively: Case Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gallbladder Volvulus
Keywords: Gallbladder volvulus
Acalculous cholecystitis
Lead sponsor: University of Balamand
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting with signs and symptoms of a calculus cholecystitis

Brief summary: 85-year-old female patient presented with right upper quadrant pain of one day duration, diagnosed with acalculous cholecystitis, and intraoperatively diagnosed with gallbladder volvulus.

Detailed description: 85-year-old female patient presented with right upper quadrant pain of one day duration that is associated with nausea and vomiting, but no fever or jaundice. She was tachycardiac and had severe abdominal right upper quadrant tenderness with positive Murphy's sign. Laboratory results showed only increase in inflammatory markers. Both ultrasound and computed tomography scan of the abdomen were done and acalculous cholecystitis was diagnosed. Open cholecystectomy was done but gallbladder volvulus was noted intraoperatively. Cholecystectomy was done and the patient had smooth postoperative recovery.

Eligibility criteria: Inclusion Criteria:

* any patient presenting with right upper quadrant pain

Exclusion Criteria:

* patients having non gallbladder related pathologies explaining right upper quadrant pain

Primary outcomes:
measure: Gallbladder volvulus
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: University of Balamand
Study officials:
References:
Clinical trial NCT05660876: Fistulotomy Versus Fistulotomy With Marsupialization
Official title: Fistulotomy Versus Fistulotomy With Marsupialization, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fistula in Ano
Lead sponsor: DHQ mardan
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It was a study comparing two standard procedures for fistula in ano

Detailed description: It was a study which compared two standard surgical procedures for fistula in ano

Eligibility criteria: Inclusion Criteria:

* having low lying anal fistula Willing to enroll in study

Exclusion Criteria:

* unfit pts Having uncontrolled diabetes

Primary outcomes:
measure: Comparison of healing time in fistula in ano with and without marsupialization
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Mardan
country: Pakistan
facility: Dhq
state: Kpk
Study officials:
References: