louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05771870: Pediatric Nursing Students' Self-efficacy Regarding Pediatric Medication Administration and, Clinical Comfort and Worry: A Study on a Two-group Pre-post-test Design Comparing Nurse and Peer Mentoring
Official title: Pediatric Nursing Students' Self-efficacy Regarding Pediatric Medication Administration and, Clinical Comfort and Worry: a Study on a Two-group Pre-post-test Design Comparing Nurse and Peer Mentoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Administration
Mentoring
Comfort
Keywords: medication administration
mentoring
nursing students
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Children are a particularly vulnerable population to medication mistakes, and it is critical to improve the self-efficacy, clinical comfort, and worry levels of student nurses who will care with them. As a result, the purpose of this study was to investigate the effects of postgraduate nursing students' and clinical nurses' mentoring practice on pediatric nursing students' self-efficacy in pediatric medication administration, clinical comfort, and worry levels. The nurse mentoring group finished the study with 70 students, while the peer mentoring group (postgraduate nursing students) completed the study with 73 students, for a total of 143 students. For data collection, the "Participant Information Form," the "Medication Administration Self-Efficacy Scale in Children for Nursing Students," and the "Pediatric Nursing Students Clinical Comfort and Worry Tool" were utilized. The data is still being analyzed.


Eligibility criteria: Inclusion Criteria:

* Third-year student at Department of Nursing
* Taking a Child Health and Disease Nursing course
* Successful completion of the Pharmacology course in the first year (2nd semester)
* Participating in research as a volunteer

Exclusion Criteria:

- Failure in the pharmacology course

Primary outcomes:
measure: Change from medication administration self-efficacy scale in children for nursing students mean score at one semester (14 weeks).
timeFrame: Medication Administration Self-Efficacy Scale in Children for Nursing Students was used before the mentoring practice and when the mentoring practice ended (14 weeks later).
measure: Change from pediatric nursing students' clinical comfort and worry tool mean score at one semester (14 weeks).
timeFrame: Pediatric Nursing Students Clinical Comfort and Worry Tool was used before the mentoring practice and when the mentoring practice ended (14 weeks later).
Secondary outcomes:
Other outcomes:
Locations:
city: Karabuk
country: Turkey
facility: Karabuk training and research hospital
Study officials:
References:
Clinical trial NCT00446875: Analgesic Properties of Oral Sucrose During Immunizations
Official title: Efficacy of Oral Sucrose and Maternal Contact During Routine Immunizations in Postnatal Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Pain
Keywords: Pain
Procedural pain
Sucrose
Infant
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2007-03-13
Enrollment: 98
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the analgesic properties of oral sucrose during routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will significantly decrease the objective measures of acute pain during routine immunizations.

Detailed description: The purpose of this study is to examine the analgesic properties of oral sucrose during routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will significantly decrease the objective measures of acute pain during routine immunizations.

Acute pain during early life may alter infant pain responses, cognitive development and behavioral outcomes. Infants respond to immunizations with significant pain and distress. This study will examine the analgesic properties of oral sucrose and maternal holding in postnatal infants.

Comparison: Administration of oral sucrose, sterile water and maternal contact 2 minutes before routine immunizations.

Eligibility criteria: Inclusion Criteria:

1. Currently between 4 and 11 months of age;
2. Between 37 and 42 weeks' completed gestation at birth;
3. Birth weight greater than 2.5 kg; and
4. No evidence of acute or chronic disease

Exclusion Criteria:

1. Fed 30 minutes prior to immunization;
2. Received analgesic/sedative the day of the immunizations;
3. Parent wishes to feed the infant during the immunizations;
4. Infant is diagnosed with a major congenital disorder where the behavioral responses to painful stimuli may be altered; or
5. Language barriers preclude the process of obtaining parental consent.

Primary outcomes:
measure: Behavioral pain response
timeFrame: Baseline, and then at 2 and 5 minutes post DTaP, IPV, and Hep B vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: University Pediatric Associates, Penn State Children's Hospital
state: Pennsylvania
Study officials:
affiliation: The Penn State University
name: Linda A Hatfield, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01466075: Study of an Investigational Glucose Meter System
Official title: Clinical Study of the Apollo Evolution BGMS With Tatsu Blood Glucose Test Strips
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2011-11-06
Enrollment: 207
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 purpose of this study is to demonstrate that untrained subjects who have diabetes or pre-diabetes can operate the investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of diabetes or pre-diabetes.
* Be 18 years of age or older
* Be able to speak, read and understand English and understand the Informed Consent document.
* Be willing to complete study procedures

Exclusion Criteria:

* Pregnancy
* Infections or skin disorders at the site of the venipuncture (at the discretion of the phlebotomist).
* Hemophilia, bleeding disorder, or clotting problems. Persons taking aspirin (81 mg or 325 mg) daily or Plavix® are not reason for exclusion.
* Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGM (at the discretion of the site professional staff).
* A condition, in the opinion of the Investigator, would put the subject at risk or influence the conduct of the study or interpretation of the results. The reason for exclusion will be documented by the professional staff.
* Previously participated in a blood glucose monitoring study using a similar device or use a similar device for personal use when monitoring blood glucose.
* Working for a competitive medical device company or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company
* Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors

Primary outcomes:
measure: Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
Secondary outcomes:
measure: Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
measure: Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
measure: Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction
timeFrame: 1 hour
Other outcomes:
Locations:
city: Mishawaka
country: United States
facility: Bayer HealthCare LLC, Diabetes Care
state: Indiana
Study officials:
affiliation: Ascensia Diabetes Care
name: David Simmons, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06898775: Passive Safety Surveillance Data of Dengue Vaccine, Qdenga (TAK 003) in Private Vaccination Sites in Buenos Aires, Argentina.
Official title: Retrospective Analysis of Passive Safety Surveillance Data of Dengue Vaccine, Qdenga (TAK 003) At Private Vaccination Centers, During 2023 and 2024 Dengue Season in Buenos Aires, Argentina
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dengue Vaccines
Keywords: Dengue
vaccine
safety
passive surveillance
AEFI
TAK-003
Argentina
Lead sponsor: Fundación Vacunar
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 112345
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People vaccinated with dengue vaccine, TAK-003 at private vaccination centers in Buenos Aires, Argentina

Brief summary: The TAK-003 vaccine, Qdenga, developed by Takeda, was approved by ANMAT in April 2023 and has been available in Argentina since November 2023 for individuals from 4 years old and without limit of age. Clinical trials demonstrate that Qdenga has a favorable safety profile, adequate immunogenicity for all four serotypes, and efficacy in preventing severe dengue in seropositive and seronegative subjects. However, there are currently limited real-world safety studies on TAK-003, particularly for adults over 60 years old.

The aim of this study is to evaluate Adverse Events Supposedly Attributed to Vaccination and Immunization (AEFI) for TAK-003 vaccine in vaccinated people at private vaccination centers in Buenos Aires metropolitan area.


Eligibility criteria: Inclusion Criteria:

* All individuals who were vaccinated with Qdenga at Vacunar centers since November 2023 still 1st November 2024, from 4 years of age with no upper limit in accordance with ANMAT approval and for whom safety data is available through the Vacunar centers passive surveillance systems.

Exclusion Criteria:

* Reports with insufficient information to characterize the AEFI will be excluded from the analysis.

Primary outcomes:
measure: Incidence of AEFI
timeFrame: 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Fundación Vacunar
Study officials:
References:
Clinical trial NCT02153775: Progressive Muscle Relaxation and Cigarette Craving
Official title: Preliminary Study of Effects of Progressive Muscle Relaxation on Cigarette Craving and Withdrawal Symptoms of Experienced Smokers in Acute Cigarette Abstinence : A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Addiction
Keywords: Progressive muscle relaxation
Cigarette
Smoking
Craving
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 34
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: Cigarette craving usually occurs with unpleasant feelings, including stress. Progressive Muscle Relaxation (PMR) may reduce level of cigarette craving and/or withdrawal symptoms.

Detailed description: The study reports on a study investigating the acute effects of a one-time application of progressive muscle relaxation on craving for cigarettes in smokers who were instructed to abstain from cigarettes for 3 hours.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or more
* Daily cigarette smokers

Exclusion Criteria:

* Hospitalization
* Participating in cigarette dependency treatment or trying to quit smoking with other methods
* Uncontrolled blood pressure
* Current other substance users (except alcohol)

Primary outcomes:
measure: Craving
timeFrame: Immediately after a 20-minutes session of progressive muscle relaxation
Secondary outcomes:
measure: Cigarette withdrawal-related and non-withdrawal related feelings
timeFrame: Immediately after a 20-minutes session of progressive muscle relaxation
Other outcomes:
measure: Blood pressure
timeFrame: Immediately after a 20-minutes session of progressive muscle relaxation
measure: Pulse rate
timeFrame: Immediately after a 20-minutes session of progressive muscle relaxation
Locations:
city: Bangkok
country: Thailand
facility: Department of Psychiatry, Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Thatsanee Limsanon, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Limsanon T, Kalayasiri R. Preliminary effects of progressive muscle relaxation on cigarette craving and withdrawal symptoms in experienced smokers in acute cigarette abstinence: a randomized controlled trial. Behav Ther. 2015 Mar;46(2):166-76. doi: 10.1016/j.beth.2014.10.002. Epub 2014 Nov 7.
Clinical trial NCT02329275: HPV as a Possible Cause of Azoospermia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV in Testis Tissue
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Group 1: Unselected azoospermic men referred to the fertility clinic Group 2: Proven fertile men referred for vasectomy

Brief summary: Azoospermia is found in 5-20% of all men suffering from infertility, and in more than 20% azoospermia remains unexplained. The investigators suggest, that HPV may be an etiological factor in azoospermia and reduced sperm production.

The investigators plan to examine the occurrence of HPV in testicular tissue from 100 azoospermic men and to compare with the HPV occurrence in testicular tissue from a control group of 40 normal, healthy men undergoing vasectomy. Since HPV, in a recent Danish study, was detected on sperm in 16% of 188 randomly selected semen donors, the investigators also plan to examine the occurrence of HPV on sperm ejaculated during the last week before vasectomy. If HPV should be found in testicular tissue from men belonging to the control group, it will be highly relevant to compare with the HPV occurrence on sperm ejaculated from the men in concern.

A Linear Array HPV Genotyping Kit from Roche will be used for detection of HPV in testicular tissue and ejaculates. In total, with this test kit 37 HPV genotypes are examined for, including 13 high risk types.


Eligibility criteria: Inclusion Criteria:

* Men with azoospermia (Group 1) and proven fertile men undergoing vasectomy (Group 2)

Exclusion Criteria:

* Men with testicular abnormalities (Group 2)
* Men who do not understand the purpose and possible consequences of the study (both groups)

Primary outcomes:
measure: HPV DNA in testicular tissue
timeFrame: Two years
Secondary outcomes:
measure: HPV DNA in ejaculates
timeFrame: Two years
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Fertility Clinic, Odense University Hospital
Study officials:
References:
Clinical trial NCT06952075: GR1803 Injection in Patients With RRMM
Official title: Single-Arm, Open, Multi-Center Phase II Clinical Trial of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma Complicated by Extramedullary Plasmacytoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Multiple Myleoma
Lead sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-30
Enrollment: 30
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: All subjects will receive GR1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 2 years or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.


Eligibility criteria: Inclusion Criteria:

* 1、ECOG score 0-2 2、≥18 years of age 3、Multiple myeloma must be Complicated by Extramedullary Plasmacytoma.

Exclusion Criteria:

* 1、Prior treatment with any BCMA-targeted therapy 2、Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma 3、Known allergies, hypersensitivity, or intolerance to the study drug (teclistamab) or its excipients 4、Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.

Primary outcomes:
measure: ORR
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 2 years
measure: AE
timeFrame: 2 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT03721575: Randomized Trial on Scarpa Fascia Preservation During Hernio-abdominoplasty
Official title: Scarpa Fascia Preservation Versus Removal During Hernio-abdominoplasty: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 50
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: This randomized trial aimed to assess the efficacy of preservation of Scarpa's fascia during hernio-abdominoplasty in reducing the volume of postoperative drainage, accelerating time to drain removal and recovery, and reducing complication rate.


Eligibility criteria: Inclusion Criteria:

* Patients with complex ventral hernia that are fit for surgery (ASA class I and II) (Saklad, 1941).
* Patients with class III, IV according to Pitanguy's classification of abdominal deformities (Pitanguy, 1995).

Exclusion Criteria:

1. Patient with ASA class III, IV, and V.
2. Morbid obesity (BMI \> 40).
3. Recurrent incisional hernias after mesh hernioplasty.
4. Strangulated hernias.
5. Isolated small paraumbilical hernias.
6. Patients with abdominal organomegaly and/or ascites.
7. Patients with coagulopathy,
8. Patients who are heavy smokers, patients with pulmonary problems, and patients with uncontrolled diabetes.

Primary outcomes:
measure: Volume of postoperative drainage
timeFrame: Two weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mansoura University
name: Sameh H Emile
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04553575: CoViD-19 Patient in Reims University Hospital in March to April 2020
Official title: Follow-up CoViD-19 Patients Hospitalized in Reims University Hospital Between the 01/03/2020 and 30/04/2020
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infections
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 127
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient hospitalized for CoViD-19 infection during the health crisis, in a short-stay service of Reims University Hospital and included in Covid-19 Cohort

Brief summary: Medical context: Follow-up of a retrospective cohort of 499 cases of CoViD-19, hospitalized at the University Hospital of Reims during the health crisis, prospectively up to two years of follow-up.

Possible intervention for serological monitoring, leading to a change from category 3 to category 2 (French law on human person research)

Aim of the study: To know the factors of gravity of CoViD-19, to know its prognostic factors, to see how the evolution of the treatments implemented have influenced the fate of the patients.

Material and methods:

Type of study: cohort study Population: Patients in the CoViD-19 cohort - Reims Calendar: September 2020 - July 2022

Expected results: Better knowledge of the cares of patients with CoViD-19


Eligibility criteria: Inclusion Criteria:

* Patient hospitalized for CoViD-19 infection during the health crisis, in a short-stay service of Reims University Hospital and included in Covid-19 Cohort
* Age \> 18 years
* Patient who benefit from the national health insurance coverage
* patient agree for participation (consent form signed)

Exclusion Criteria:

* Patient protected by law

Primary outcomes:
measure: Health status in the 2 years after CoViD-19 diagnosis
timeFrame: 2 years follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References: