louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06380114: Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination
Official title: Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hpv
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2024-04-23
Enrollment: 16000
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Each year in the U.S., ≥20,000 women and 14,000 men are affected by HPV-related cancers, including cervical and oropharyngeal cancer. However, in 2020, only 59% of U.S. adolescents aged 13-17 were up-to-date for HPV vaccination, and rates for 11-12 year olds, the primary target age group for HPV vaccination (when the immune reaction is better and before exposure to HPV infection), are even lower. Standing orders (written protocols that authorize designated members of the healthcare team to vaccinate without first obtaining a patient-specific physician order) have been shown to work in inpatient settings and for adults, but have not been evaluated for HPV vaccine, which some parents consider controversial. Also, the ways in which organizational readiness for change (resources, motivation, staff attributes, leadership support and culture) moderate the effect of standing orders has not been studied. A physician's recommendation is correlated with HPV vaccine acceptance, and the investigators have developed a successful online, interactive, communication education program that will be adapted to train nurses and staff in addition to physicians. The investigators propose testing standing orders for HPV vaccine in an Accountable Care Organization (ACO) in Western New York, and assessing which provider and practice factors moderate the effect of standing orders. Advantages of this setting include a diverse group of rural, urban and suburban practices, and the ACO provides data infrastructure and analytics that allow practices to evaluate vaccination rates in real time.

Using a 2-arm cluster randomized trial (n=40 practices), the investigators will assess the effectiveness of standing orders (SO) + HPV communication education (intervention arm) relative to HPV communication education alone (control arm) on HPV vaccination for 9-17 year-olds.


Eligibility criteria: Inclusion Criteria:

* active patient in AHP practice

Exclusion Criteria:

* patient belonging to a practice with \>80% UTD baseline HPV vaccination rate for ages 13-17
* patient belonging to a practice with \<20 11-12 year-olds eligible for an HPV dose

Primary outcomes:
measure: Patient-Level Captured Opportunities for HPV Vaccination
timeFrame: 12-month baseline compared to 12-month intervention compared to 12-month maintenance (control arm vs intervention arm)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center (URMC)
state: New York
Study officials:
References:
Clinical trial NCT00922714: Scandinavian Intensive Care Unit (ICU) Glutamine Study
Official title: Glutamine to Intensive Care Patients - a Prospective, Double-Blind, Placebo-Controlled Multicenter Study in the Scandinavian Countries
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: ICU Patients
Keywords: Glutamine
ICU patients
Critically ill
Nutrition
Lead sponsor: Scandinavian Critical Care Trials Group
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective double-blinded placebo-controlled block randomized study in intensive care patients comparing intravenous glutamine supplementation to placebo. The hypothesis is an improvement of clinical outcome. The primary endpoint is a reduction in the Sequential Organ Failure Assessment (SOFA) score on day 7 of treatment.

Detailed description: This is a prospective double-blinded placebo-controlled block randomised study in intensive care patients comparing intravenous glutamine supplementation (0.285 g/kg body weight/24 h) to placebo. Inclusion criteria are patients treated for more than 3 days. Primary endpoint is a reduction in SOFA-score on day 7 of treatments. Secondary endpoints are: ICU-mortality, 6-months mortality, length of ICU stay, organ failure free days as well as reduction in SOFA-score on day 10 of treatment. Nutrition will be standardised so that not less than 80% of the target which is basal energy expenditure according to Harris \& Benedict is given daily. Enteral nutrition is preferred, but a combination of enteral and parenteral nutrition is recommended to achieve the nutritional target. For statistical comparison non-parametric rank order statistics will be used. To detect a 0.75-point difference in the reduction of SOFA-score on day 7 of treatment, a total of 1,000 patients will be needed.

Eligibility criteria: Inclusion Criteria:

* admission to the ICU
* decision to give the patient full nutrition
* APACHE II score \> 10 at admission
* age 18-85 years

Exclusion Criteria:

* readmission to the ICU after a previous ICU-stay in which the patient has been included into the study
* subjects with any condition which in the opinion of the attending physician makes the subject unsuitable for inclusion
* no informed consent

Primary outcomes:
measure: A reduction in SOFA-score
timeFrame: Day 7 of treatment
Secondary outcomes:
measure: Mortality
timeFrame: ICU stay and 6 months
measure: Length of ICU stay
timeFrame: ICU stay
measure: Organ failure free days
timeFrame: ICU stay
measure: Reduction in SOFA-score
timeFrame: Day 10 of treatment
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Intensive Care Unit, Karolinska University Hospital Huddinge
Study officials:
affiliation: Dept Anesthesiology and Intensive Care Medicine, KArolinska University Hospital Huddinge, Stockholm, Sweden
name: Jan Wernerman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05397314: DNA Fragmentation - Effect on Pregnancy Rate
Official title: DNA Fragmentation - Effect on Pregnancy Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Male
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Punalpin, an antioxidant, has a positive impact on DNA fragmentation in spermatozoa in male fertility patients with increased amount of DNA fragmentation in their spermatozoa. Secondary purpose is to investigate whether there is any positive effect on the subsequent pregnancy rates from the fertility treatment.


Eligibility criteria: Inclusion Criteria:

* Male fertility patients with increased amount of DNA fragmentation in their spermatozoa

Exclusion Criteria:

-

Primary outcomes:
measure: Sperm DNA fragmentation
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06564181: The Relation Between Serum Zinc and Lupus Nephritis
Official title: The Relation Between Serum Zinc and Lupus Nephritis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lupus Nephritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patient with lupus nephritis .
* patients with sex and age matching health control ( control group)

Brief summary: The goal of this observational study is to investigate the relation between serum zinc and lupus nephritis by search Prevalence of hypozincemia in lupus nephritis and Association between serum zinc and urea, serum creatinine, hemoglobin, estimated glomerular filtration rate (eGFR).

Detailed description: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease affecting various organs including the skin, joints, kidneys, brain and heart...

Lupus nephritis (LN) is one of the most common severe organ manifestations of SLE . LN is clinically evident in 50-60% of patients with SLE , and it is histologically evident in most SLE patients, even those without clinical manifestations of kidney disease.

LN is associated with significant morbidity and mortality in SLE patients, as up to 20% of patients progress to end-stage renal disease (ESRD). The clinical manifestations of LN are variable, ranging from asymptomatic proteinuria to a myriad of manifestations associated with nephritic and nephrotic syndromes and ESRD.

Zinc is a vital micronutrient involved in numerous physiological processes including immune function, antioxidant defense, and cellular repair. It is a cofactor for over 300 enzymes and plays critical roles in DNA synthesis, protein production, and cell division. Zinc deficiency can impair immune function, increase oxidative stress, and hinder tissue repair, which are all relevant factors in autoimmune diseases like SLE, making its study in the context of LN particularly relevant.

However, further research is needed to fully understand the mechanisms and to develop evidence-based guidelines for zinc supplementation in lupus nephritis patients.

Eligibility criteria: Inclusion Criteria:

* Patients with lupus nephritis

Exclusion Criteria:

* other patients with other renal diseases .
* patients with other autoimmune diseases.
* patients on dialysis.
* patients with Diabetes mellitus.
* patients with liver diseases.

Primary outcomes:
measure: Prevalence of hypozincemia in lupus nephritis Correlation between hypozincemia and urea , S. Creatinine and eGFR
timeFrame: 1/9/2024 - 1/9/2025
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Yasser Abdel Mawgoud, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT00920881: Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System
Official title: Protocol #TS05-066 Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Continuous glucose monitoring
Accuracy
Continuous glucose-error grid analysis
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2009-06-15
Enrollment: 58
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: Subjects recruited from clinical research centers which specialize in diabetes-related therapies.

Brief summary: To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard.


Eligibility criteria: Inclusion Criteria:

* History consistent with type 1 diabetes
* At least 18 years of age
* Available and capable of following the protocol instructions provided by the healthcare professional
* Signed and dated informed consent form

Exclusion Criteria:

* Pregnancy
* Type 2, gestational, or secondary diabetes
* Known allergy to medical grade adhesives
* Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin
* Seizure disorder
* Myocardial ischemia
* History of stroke
* Severe hypoglycemia unawareness
* Other concomitant medical conditions that in the opinion of the investigator, would affect the evaluation of device performance and/or safety

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Clinic
state: Texas
city: Renton
country: United States
facility: Ranier Clinical Research
state: Washington
Study officials:
affiliation: Abbott Diabetes Care
name: Joe Bugler
role: STUDY_DIRECTOR
References:
citation: Weinstein RL, Schwartz SL, Brazg RL, Bugler JR, Peyser TA, McGarraugh GV. Accuracy of the 5-day FreeStyle Navigator Continuous Glucose Monitoring System: comparison with frequent laboratory reference measurements. Diabetes Care. 2007 May;30(5):1125-30. doi: 10.2337/dc06-1602. Epub 2007 Mar 2.
citation: McGarraugh G, Bergenstal R. Detection of hypoglycemia with continuous interstitial and traditional blood glucose monitoring using the FreeStyle Navigator Continuous Glucose Monitoring System. Diabetes Technol Ther. 2009 Mar;11(3):145-50. doi: 10.1089/dia.2008.0047.
Clinical trial NCT02916381: The Analgesic Efficacy of the Pectoral Block After Mastectomy
Official title: The Analgesic Efficacy of the Pectoral Block After Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Unilateral mastectomy is associated with moderate to severe postoperative pain. A new regional anaesthetic technique has been recently described, call the PEC block. This technique consists of injecting local anaesthetic between different muscles of the chest in order to relieve postoperative pain. The investigators aim to verify that this technique has a clinical relevant postoperative analgesic effect. For that purpose, the investigators will randomise 50 patients scheduled to undergo unilateral mastectomy into two groups: one group will receive a PEC block after the induction of the general anaesthesia under ultrasound guidance, while the other group will not have this regional procedure.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I-III
* Age ≥ 18
* Patients undergoing unilateral mastectomy

Exclusion Criteria:

* Contraindications to regional block
* Pregnancy
* Inability to give informed consent
* History of alcohol or drug dependence/abuse
* History of long term opioid intake or chronic pain disorder

Primary outcomes:
measure: Intravenous morphine consumption during the first 24 postoperative hours (mg)
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Intravenous morphine consumption on postoperative day 2 (mg)
timeFrame: Postoperative day 2
measure: Intravenous morphine consumption in phase 1 recovery (mg)
timeFrame: 2 postoperative hours
measure: Pain scores at rest in phase 1 recovery (visual analogue scale, 0 - 10)
timeFrame: 2 postoperative hours
measure: Pain scores at rest on postoperative day 1 (visual analogue scale, 0 - 10)
timeFrame: Postoperative day 1
measure: Pain scores at rest on postoperative day 2 (visual analogue scale, 0 - 10)
timeFrame: Postoperative day 2
measure: Postoperative nausea and vomiting (yes/no)
timeFrame: Postoperative day 1
measure: Postoperative nausea and vomiting (yes/no)
timeFrame: Postoperative day 2
measure: Pruritus (yes/no)
timeFrame: Postoperative day 1
measure: Pruritus (yes/no)
timeFrame: Postoperative day 2
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
state: Vaud
Study officials:
affiliation: CHUV
name: Eric Albrecht
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01184781: Project PREVAM : Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy
Official title: Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy for the Detection of Adenomatous Polyps and Cancer in a High Risk Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenomatous Polyps
Cancer
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2010-08-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to perform a prospective, multicenter research comparing capsule endoscopy with the video colonoscopy in the detection of the adenomatous polyps and cancer specifically in a high risk population (sensibility, specificity, NPV, PPV and diagnostic accuracy). The investigators will used the Pillcam II™ colon capsule (second generation) and a high resolution colonoscope (with high definition). Both procedures will be perform in the same day with an adapted bowel preparation.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Patient with 40 years old and first degree relative affected by colo rectal cancer at age ≥ 60 ans
* Patient with 40 years old or ten years before the age at affected disease in case or first deree relative colo rectal cancer before 60 years old.
* Fecal occult blood test positive
* Personal history of adenomatous polyps
* Personnal history of acromegaly
* Patient with social insurance
* Persons already participating in another clinical trial..
* Signature of informed consent

Exclusion Criteria:

* Pregnancy or breast feeding woman
* Déficience mentale du sujet rendant sa participation à l'essai impossible
* Pacemaker or all electronic devices implanted
* Patient with swallowing disorder, or digestive stricture know or suspected by the investigator
* Previous history of intestinal surgery, radiotherapy or inflammatory bowel disease
* Previous history of polyadenomatous congenital disease, Lynch syndrome
* Intolerance with dompéridon and/or bisacodyl
* Intolerance with oral intake of NaP, polyethylen glycol (PEG) or macrogol
* Colonoscopy contre indication for anesthesiologic reasons

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 7 days
Secondary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: 7 days
Other outcomes:
Locations:
city: Nice
country: France
facility: Digestive department - Archet hospital
city: San Remo
country: Italy
facility: Gastro entérology department
Study officials:
affiliation: Digestive department
name: HEBUTERNE Xavier, PU-PH
role: STUDY_DIRECTOR
References:
citation: Parodi A, Vanbiervliet G, Hassan C, Hebuterne X, De Ceglie A, Filiberti RA, Spada C, Conio M. Colon capsule endoscopy to screen for colorectal neoplasia in those with family histories of colorectal cancer. Gastrointest Endosc. 2018 Mar;87(3):695-704. doi: 10.1016/j.gie.2017.05.023. Epub 2017 May 26.
Clinical trial NCT04140981: Comparison of Ultrasonographic and Anthropometric Measurements in Difficult Airway Evaluation
Official title: Evaluation of Ultrasounographic Measurements and Anthropometric Measurements as Predictors of Difficult Direct Laryngoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Difficult Airway Intubation
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA 1-2-3, 18-75 aged, patients undergoing general anesthesia

Brief summary: In this study, anthropometric measurements (clinical measurements) will be applied in all patient groups; expected (to be difficult to provide airway patency as a result of detailed history, physical examination and evaluation tests performed by an experienced anesthesiologist), and unexpected (although it was not predicted that a difficulty was encountered). And ultrasounographic measurements will be applied in all patients. The aim of this study is to evaluate the predictive accuracy of ultrasonographic measurements.

Detailed description: In the preoperative period, the following clinical tests will be performed before the patient arrives in the operating room and when the patient arrives, the measurements will be made by ultrasonography.

1. Mallampati classification
2. Determination of mouth opening (interinsizer distance)
3. Thyromental distance
4. Sternomental distance

Preoperative evaluation of the patients and clinical results of the airway tests (mentioned above) will be recorded. The cervical soft tissue thickness will be measured and recorded at 3 levels (thyrohyoid membrane, vocal cord, hyoid bone) with the help of ultrasonography (mentioned above). In addition, since all patients will be under general anesthesia, laryngoscopic images (laryngoscopic evaluation according to Cormack Lehane classification) routinely recorded on the anesthesia follow-up sheet will be recorded.

Eligibility criteria: Inclusion Criteria:

* patients under general anesthesia
* ASA 1-2-3

Exclusion Criteria:

* Patients who will undergo emergency surgery,
* pregnant women,
* children,
* patients who may have difficulty in airway management due to cervical instability,
* patients with trauma or malignancy in the neck region

Primary outcomes:
measure: Cormack Lehane classification
timeFrame: during the intubation period
Secondary outcomes:
measure: ultrasonographic measurement
timeFrame: 15 min before the operation
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale Univercity Faculty of Medicine Hospital
Study officials:
affiliation: Kırıkkale University Faculty of Medicine
name: Kevser Peker
role: PRINCIPAL_INVESTIGATOR
References: