louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00528476: Risk Factors for Recurrent Urinary Tract Infection in Children
Official title: Role of Clinical and Urodynamic Risk Factors for Recurrent Urinary Tract Infection in 5-18 Years Old Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infection
Pyelonephritis
Cystitis
Keywords: pyelonephritis
cystitis
risk factor
children
urodynamics
Lead sponsor: Kaunas University of Medicine
Sponsor class: OTHER
First posted: 2007-09-12
Enrollment: 161
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to determine clinical and urodynamic risk factors for recurrent urinary tract infection in 5-18 years old children.

Detailed description: It is known, that in the group of young children the most common reason of recurrent UTI is anatomic abnormalities, such as vesicoureteral reflux, hydronephrosis. However, not all recurrent UTI can be explained by anatomic abnormalities. The vast majority of school age children with recurrent UTI have anatomically normal urinary tract. Recent studies discuss about the role of behavioral and functional abnormalities (inadequate fluid intake, stool retention, infrequent voiding, etc.) that can predispose recurrent urinary tract infections. Influence of some these abnormalities for recurrent UTI is controversial. Family history, behavioral and functional abnormalities which predispose to urinary tract infections in children with normal urinary tract are neglected in most protocols of urinary tract infection.

Children in this study receive a careful evaluation including complete history, voiding-drinking diary, bowel questionnaire, physical investigation, sonography, voiding cystourethrogram.

Follow up time - 1 year. Urinalysis once a month and during each episode of fever.

Eligibility criteria: Inclusion Criteria:

* 5-18 years old children, who were treated because of cystitis and pyelonephritis in Kaunas Medical University Hospital

Exclusion Criteria:

* urinary tract malformations
* neurogenic bladder dysfunction
* patients, who received immunosuppressive drugs
* pregnant girls
* children with non bacterial urinary tract infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Kaunas University of Medicine
Study officials:
affiliation: Clinic of Children's Diseases, Kaunas University of Medicine
name: Sarunas Rudaitis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic of Children's Diseases, Kaunas University of Medicine
name: Birute Pundziene, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01937676: LDH as a Biochemical Biomarker to Predict Organ Failure in the Emergency Department Setting
Official title: LDH as a Biochemical Biomarker to Predict Organ Failure in the Emergency Department Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Organ Failure
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2013-09-09
Enrollment: 1250
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: All adult patients admitted to emergency department during study period.

Brief summary: The purpose of this study is evaluate if K3, a novel biomarker, sampled at arrival to the emergency department can be used to predict the development of organ failure measured as SOFA score. K3 consists of lactate dehydrogenase, albumin and magnesium combined.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Admitted to emergency department, Karlstad Central Hospital, Sweden

Exclusion Criteria:

* Not in need of venous blood sample

Primary outcomes:
measure: Development of multiple organ failure
timeFrame: 30 days or complete ICU stay
Secondary outcomes:
measure: Cardiac function
timeFrame: 30 days or complete ICU stay
measure: All cause mortality
timeFrame: 30 days after admission to emergency department
Other outcomes:
Locations:
city: Karlstad
country: Sweden
facility: Karlstad Central Hospital
Study officials:
affiliation: Karolinska
name: Mathias Karlsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska
name: Jan Wernerman, MD, Prof
role: STUDY_DIRECTOR
affiliation: Uppsala University
name: Lars Wiklund, MD, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT06729476: The Effect of Uroshield on Sputum-specimen Bacterial Growth
Official title: The Effect of Uroshield on Sputum-specimen Bacterial Growth and Multidrug Resistant Organisms in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanically Ventilated Patients
Keywords: tracheostomy
mechanical ventilation
biofilm
sputum culture
multi drug resistant organisms
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators retrospectively register the conduct of this study after its completion.

Detailed description: Background: Ventilator-associated pneumonia is a frequent complication of mechanical ventilation, caused by bacterial proliferation and biofilm formation on endotracheal tubes. The UROSHIELDTM is a small device that generates low-energy surface acoustic waves, which transmit energy to the endotracheal tube through a thin cable attached to the tube. Laboratory studies using catheterized urinary tract models have shown a significant reduction in microbial colonization and reduced development of antimicrobial resistance in UROSHIELDTM device treated individuals.

Purpose: To evaluate the impact of a UROSHIELDTM device, adapted for endotracheal tube diameter, on the development of positive sputum cultures in intubated patients.

Methods: The study was prospective, double-blind, interventional and randomized. Included were newly intubated patients, who were randomized at a rate of 1:1 by a physician not involved in the study. Patients, treating staff and study investigators were blinded to whether the patients received true or sham devices. Sputum cultures were taken at baseline and every three days for 15 days.

Eligibility criteria: Inclusion Criteria:

Mechanically ventilated patients

Exclusion Criteria:

Less than 18 years of age, pregnant women

Primary outcomes:
measure: Sputum-specimen bacterial growth
timeFrame: six months
measure: Growth of multidrug resistant organisms from sputum cultures
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shaare Zedek Medical Center
name: Reuven Friedmann, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02016976: Effect of Local Anesthetic EMLA (Lidocaine 2.5% and Prilocaine 2.5%) Cream and Reduction in Dose, Pain and Intravenous Analgesic During Permanent Pacemaker Implantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pacemaker Implantation
Pain
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-12-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators believe that the local anesthetic EMLA (Lidocaine 2.5% and Prilocaine 2.5%) cream will lessen pain and reduce the need for anesthesia and analgesia, when implanting a permanent pacemaker.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing pacemaker implantation

Exclusion Criteria:

* Dementia Patients
* Psychiatric Patients
* Unconscious Patients
* Patients with sensitivity to EMLA

Primary outcomes:
measure: Pain reduction
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT05069376: Effect of Ureteral Stents Length and Location on Related Symptom
Official title: Effect of Ureteral Stents Length and Location on Related Symptom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Overactive Bladder Syndrome
Keywords: Ureteral stent
OAB
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: Intra-ureteral placement of double-J stent Arm 2: Conventional placement of double-J stent
Primary purpose: PREVENTION

Brief summary: This is a prospective randomized clinical trial, evaluating the effect of the intra-ureteral placement of the stent's distal end versus the conventional stent placement on the postoperative LUTS and pain.

Detailed description: Intravesical stent mass has been considered to cause stent-related symptoms, such as LUTS and pain. The current study hypothesized that the total intra-ureteral placement of the stent's distal end could decrease postoperative LUTS and pain. We proposed a prospective randomized trials, investigating the effect of intra-ureteral stent placement versus conventional stent placement. The primary end point was postoperative LUTS. The secondary end points were postoperative pain and quality of life. We used USSQ questionnaire as the assessing tool.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of unilateral ureteral stone
* Plan to undergo unilateral URS lithotripsy
* Adult patients (\>18 years old)

Exclusion Criteria:

* Pre-stented cases
* Distal ureteral stones
* Preoperative urinary tract infection
* With medications known to influence stent-related symptoms, including alpha-blockers, antimuscarinics, beta3-agonist
* Pregnancy
* Other procedures required during the procedure of lithotripsy
* A stent was expected to be indwelled for more than 10 days (ureteral stricture, ureteral tumors/polyps, ureteral trauma, and a large amount of stone fragments)

Primary outcomes:
measure: Lower urinary tract symptom after placement of D-J stent
timeFrame: Before removal of D-J stent
Secondary outcomes:
measure: Pain after placement of D-J stent
timeFrame: Before removal of D-J stent
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Shuang Ho Hospital Taipei Medical University
Study officials:
affiliation: Shuang Ho Hospital Taipei Medical University
name: Chen-Hsun Ho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00973076: Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055
Official title: A Phase I, Open Label, Single-centre Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055 Administered Orally to Japanese Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Solid Tumors
Advanced Solid Malignancies
Keywords: Phase I, cancer
solid tumors
advanced solid malignancies
dose escalation
mTOR Kinase Inhibitor
Japanese
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-09-09
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is to assess the safety and tolerability of AZD8055 in Japanese patients with advanced solid tumours.


Eligibility criteria: Inclusion Criteria:

* Japanese patients with advanced solid tumors for which suitable effective standard treatment does not exist or is no longer effective
* Relatively good overall health other than cancer

Exclusion Criteria:

* Poor bone marrow function (not producing enough blood cells)
* Poor liver or kidney function
* Serious concomitant illness

Primary outcomes:
measure: Assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, coagulation, urinalysis), glucose management (s-glucose, s-insulin, haemoglobin A1c [HbA1c]), vital signs (pulse rate, blood pressure, weight and body temperature)
timeFrame: Laboratory values, vital sign, physical examination every week during Cycle 1 and 2.
Secondary outcomes:
measure: To determine the pharmacokinetic profile of AZD8055 following both single and multiple oral dosing in patients with advanced solid tumours
timeFrame: According to protocol specified schedule, the number of PK samples collected during Cycle 1
measure: To seek preliminary evidence of the anti-tumour activity of AZD8055 in patients with advanced solid malignancies as measured by objective tumour response (according to RECIST criteria)
timeFrame: Every cycle
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Ian Smith
role: STUDY_DIRECTOR
affiliation: National Cancer Center Hospital
name: Tomohide Tamura
role: PRINCIPAL_INVESTIGATOR
References:
citation: Asahina H, Nokihara H, Yamamoto N, Yamada Y, Tamura Y, Honda K, Seki Y, Tanabe Y, Shimada H, Shi X, Tamura T. Safety and tolerability of AZD8055 in Japanese patients with advanced solid tumors; a dose-finding phase I study. Invest New Drugs. 2013 Jun;31(3):677-84. doi: 10.1007/s10637-012-9860-4. Epub 2012 Jul 28.
Clinical trial NCT02853760: Affective Responses in Mountain Hiking
Official title: Affective Responses in Mountain Hiking: A Randomized Controlled Trial Focusing on Differences Between Indoor and Outdoor Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Affect
Lead sponsor: Universitaet Innsbruck
Sponsor class: OTHER
Collaborators: name: Paracelsus Medical University
First posted: 2016-08-03
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Using a within-subject design, 42 healthy participants were randomly exposed to three different conditions: outdoor mountain hiking, indoor treadmill walking, and sedentary control situation (3.5 hours each). Measures included the Feeling Scale, Felt Arousal Scale and a Mood Survey Scale. Univariate ANOVAs were used to analyse differences between the conditions.


Eligibility criteria: Inclusion Criteria:

* voluntary participation

Exclusion Criteria:

* pregnancy
* breast-feeding
* chronic or acute diseases (already existing or diagnosed during the study)
* age below 18 and above 70 years
* unable to be physically active assessed by the Physical Activity Readiness Questionnaire (Shephard, Thomas, \& Weller, 1991)

Primary outcomes:
measure: Change From Baseline Subscales of Mood Survey Scale at 3 Hours
timeFrame: baseline and 3 hours
measure: Change From Baseline Feeling Scale at 3 Hours
timeFrame: baseline and 3 hours after baseline
measure: Change From Baseline Felt Arousal Scale at 3 Hours
timeFrame: baseline and 3 hours after baseline
Secondary outcomes:
measure: Change From Baseline Blood Pressure at 3 Hours
timeFrame: baseline and 3 hours
measure: Change From Baseline Heart Rate Variability at 3 Hours
timeFrame: baseline and 3 hours
measure: Change From Baseline Cortisol at 3 Hours (Saliva Sampling)
timeFrame: baseline and 3 hours
Other outcomes:
Locations:
Study officials:
affiliation: martin.kopp@uibk.ac.at
name: Martin Kopp, Prof.
role: STUDY_DIRECTOR
References:
citation: Niedermeier M, Einwanger J, Hartl A, Kopp M. Affective responses in mountain hiking-A randomized crossover trial focusing on differences between indoor and outdoor activity. PLoS One. 2017 May 16;12(5):e0177719. doi: 10.1371/journal.pone.0177719. eCollection 2017.
citation: Niedermeier M, Grafetstatter C, Hartl A, Kopp M. A Randomized Crossover Trial on Acute Stress-Related Physiological Responses to Mountain Hiking. Int J Environ Res Public Health. 2017 Aug 11;14(8):905. doi: 10.3390/ijerph14080905.
Clinical trial NCT05846360: The Technical and Operational Performance of the QuidelOrtho Savanna RVP4 Analyzer
Official title: The Technical and Operational Performance of the QuidelOrtho Savanna RVP4 Analyzer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Viral Infection
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: School-aged children

Brief summary: The purpose of this study is for the research team to become familiar with and evaluate the technical and operational performance of the QuidelOrtho Savanna RVP4 analyzer by testing 120 archived specimens that were previously tested at the Wisconsin State Laboratory of Hygiene (WSLH) by RT-PCR and multiplex respiratory pathogen panel within the last year.

Detailed description: To test the technical and operational performance of the QuidelOrtho Savanna RVP4 analyzer, the investigator proposes to test samples archived from the ORegon CHild Absenteeism due to Respiratory Disease Study (ORCHARDS) study (HSC 2013-1357), a study that had the goal to "develop and implement a system for daily school-based monitoring of ILI (influenza-like illness) and CLI (COVID-like illness) student absenteeism in kindergarten (K) through grade 12 schools, and assess the system's usability for early detection of accelerated influenza, SARS-CoV-2 and other respiratory pathogen transmission in schools and surrounding communities".

The deidentified paired (WSLH vs. Savanna RVP4) results will be used by QuidelOrtho Corporation to evaluate the technical and operational performance of the analyzer.

Eligibility criteria: Inclusion Criteria:

* Previously collected specimens from the ORCHARDS study.

Exclusion Criteria:

* Specimens not collected as part of the ORCHARDS study.

Primary outcomes:
measure: Number of Samples with Matching Results
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Jonathan Temte, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Temte JL, Barlow S, Goss M, Temte E, Bell C, He C, Hamer C, Schemmel A, Maerz B, Comp L, Arnold M, Breunig K, Clifford S, Reisdorf E, Shult P, Wedig M, Haupt T, Conway J, Gangnon R, Fowlkes A, Uzicanin A. The Oregon Child Absenteeism Due to Respiratory Disease Study (ORCHARDS): Rationale, objectives, and design. Influenza Other Respir Viruses. 2022 Mar;16(2):340-350. doi: 10.1111/irv.12920. Epub 2021 Oct 8.
Clinical trial NCT04389060: Effect of Acute Dietary Supplementation With Grape Seed Extract on Aortic Stiffness, Arterial Pressure, and Blood Vessel Dilation in Collegiate Obese Individuals at Rest
Official title: Effects of Acute Grape Seed Extract Supplementation on Hemodynamics in Obese Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: California Baptist University
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study investigated if elevated BP and aortic stiffness characterized in obese individuals are attenuated following acute grape seed extract supplementation. It is hypothesized that acute dietary supplementation with grape seed extract attenuates aortic stiffness, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and total peripheral resistance and these effects are partially due to reductions in peripheral vasoconstriction

Detailed description: Twenty men (obese = 10; normal body weight (NBW) = 10) participated in this study. Effects of placebo (PL: 600 mg) and GSE (600 mg) on systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (Q), total peripheral resistance (TPR), and AoS were compared 2 h after ingestion of GSE or PL on different days, one week apart. Arterial blood pressure was measured using a sphygmomanometer from a brachial artery at the level of the heart on chair. HR and SV were continuously measured using a non-invasive device (Physio Flow). CO was calculated by HR X SV. TPR was calculated by MAP/CO.

Eligibility criteria: Inclusion Criteria:

* Obesity: body mass index (\>30), Normal body weight: body mass index (25-29)

Exclusion Criteria:

* cardiovascular diseases or consume any antihypertensive medication or supplementation that can affect blood pressure or aortic stiffness

Primary outcomes:
measure: change in heart rate
timeFrame: 2 hours after each supplementation
measure: change in stroke volume
timeFrame: 2 hours after each supplementation
measure: change in cardiac output
timeFrame: 2 hours after each supplementation
measure: change in systolic blood pressure
timeFrame: 2 hours after each supplementation
measure: change in diastolic blood pressure
timeFrame: 2 hours after each supplementation
measure: change in mean arterial pressure
timeFrame: 2 hours after each supplementation
measure: change in total peripheral resistance
timeFrame: 2 hours after each supplementation
Secondary outcomes:
Other outcomes:
Locations:
city: Riverside
country: United States
facility: California Baptist University
state: California
Study officials:
References: