louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06593301: The Effect of Blood and Blood Products Transfusion Training Based on the Flipped Classroom Model on Nursing Students
Official title: The Effect of Education Based on Flip-Face Classroom Model on Nursing Senior Students' Self-Efficacy Regarding Blood and Blood Products Transfusion; Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-efficacy
Keywords: Blood transfusion
flipped classroom
, student
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Blood is a living tissue with many vital functions that provide perfusion of organs. Therefore, blood transfusion is a tissue transplant and a complicated treatment method that is applied very frequently. Many reactions may develop during transfusion due to application errors. In this direction, it is necessary to increase the knowledge and skills of nursing students regarding safe blood transfusion during their undergraduate education. On the other hand, self-efficacy is a more comprehensive concept that includes the concepts of knowledge and skills, and self-efficacy perception is considered important in terms of indicating a level of professional development. It is important to use effective teaching methods to increase the knowledge and skills of students and to support their self-efficacy. The flipped classroom model is a teaching method that has the potential to change teaching and learning for nursing education. In the light of this information, this study was planned to determine the effect of education based on the flipped classroom model on the self-efficacy of senior nursing students regarding blood and blood product transfusion.

Detailed description: The study is a non-drug clinical randomized controlled trial and was conducted between February and June 2024. The universe of the study consisted of senior nursing students of the faculty where the study was conducted. In terms of reliability of the study, control group data will be collected first. Criteria for inclusion in the study; Being a senior nursing student and being a volunteer.

Eligibility criteria: Inclusion Criteria:

* Being a senior nursing student
* Nursing students who volunteered to participate in the study

Exclusion Criteria:

* There are no exclusion criteria

Primary outcomes:
measure: Self-Efficacy level
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Faculty of Health Sciences
state: Maltepe
Study officials:
affiliation: Maltepe,İstanbul,TÜRKİYE, 34854
name: GÜLŞAH ATAK, Nursing
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00426101: Treatment Protocol for Hemophagocytic Lymphohistiocytosis 2004
Official title: HLH-2004 Treatment Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemophagocytic Lymphohistiocytosis
Keywords: Hemophagocytic lymphohistiocytosis
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Meyer Children's Hospital IRCCS
name: Leiden University Medical Center
name: Children's Hospital Medical Center, Cincinnati
name: Ehime University Graduate School of Medicine
name: Universitätsklinikum Hamburg-Eppendorf
name: Baylor College of Medicine
name: Great Ormond Street Hospital for Children NHS Foundation Trust
name: St. Anna Kinderkrebsforschung
name: Hospital de Cruces
name: Hospital JP Garrahan
First posted: 2007-01-24
Enrollment: 368
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Without therapy HLH is often fatal, and often rapidly fatal. The treatment protocol HLH-94 has improved survival markedly as compared to the survival earlier. We now aim to improve survival further.

Detailed description: The most dangerous period after HLH diagnosis is the first 2 months. In HLH-2004 we provide additional therapy during this period as compared to in HLH-94.

Eligibility criteria: Inclusion Criteria:

* Patients who fulfil the diagnostic criteria of HLH.

Exclusion Criteria:

* Prior cytotoxic or cyclosporin treatment for HLH.

Primary outcomes:
measure: Survival
timeFrame: 1-year after diagnosis
Secondary outcomes:
measure: Late effects
timeFrame: 5-years after diagnosis
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Childhood Cancer Research Unit, Karolinska Hospital
Study officials:
affiliation: Karolinska Institutet
name: Jan-Inge Henter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henter JI, Horne A, Arico M, Egeler RM, Filipovich AH, Imashuku S, Ladisch S, McClain K, Webb D, Winiarski J, Janka G. HLH-2004: Diagnostic and therapeutic guidelines for hemophagocytic lymphohistiocytosis. Pediatr Blood Cancer. 2007 Feb;48(2):124-31. doi: 10.1002/pbc.21039.
citation: Bergsten E, Horne A, Arico M, Astigarraga I, Egeler RM, Filipovich AH, Ishii E, Janka G, Ladisch S, Lehmberg K, McClain KL, Minkov M, Montgomery S, Nanduri V, Rosso D, Henter JI. Confirmed efficacy of etoposide and dexamethasone in HLH treatment: long-term results of the cooperative HLH-2004 study. Blood. 2017 Dec 21;130(25):2728-2738. doi: 10.1182/blood-2017-06-788349. Epub 2017 Sep 21.
citation: Bergsten E, Horne A, Hed Myrberg I, Arico M, Astigarraga I, Ishii E, Janka G, Ladisch S, Lehmberg K, McClain KL, Minkov M, Nanduri V, Rosso DA, Sieni E, Winiarski J, Henter JI. Stem cell transplantation for children with hemophagocytic lymphohistiocytosis: results from the HLH-2004 study. Blood Adv. 2020 Aug 11;4(15):3754-3766. doi: 10.1182/bloodadvances.2020002101.
Clinical trial NCT03290001: The Influence of Anxiety and Depression on Survival in Nasopharyngeal Carcinoma Patients
Official title: The Influence of Anxiety and Depression on Survival in Nasopharyngeal Carcinoma Patients: a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University hospital

Brief summary: This is a prospective, observational cohort study aimed to explore the influence of anxiety and depression to long term survival in nasopharyngeal carcinoma patients.

Detailed description: Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Radiotherapy (RT) and chemotherapy are the mainstays of therapy for NPC because these tumors are biologically highly radiosensitive and chemosensitive. Anxiety and depression symptoms were common psychological symptoms around the time of cancer diagnosis and were often persistent during cancer treatment. Psychological symptoms are associated with prolonged hospital stays, lower quality of life, and worse treatment adherence among patients with cancer. Depressive symptoms have been demonstrated to predict early mortality among patients with some kinds of cancer. But among NPC patients, the influence of anxiety and depression symptoms to long term survival have not be explored. Therefore, this prospective, observational cohort study aimed to explore the influence of anxiety and depression to long term survival in NPC patients.

Eligibility criteria: Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
* Age between 18-70
* Male and no pregnant female
* Patient have signed on the informed consent, and well understood the objective and procedure of this study

Exclusion Criteria:

* The presence of uncontrolled life-threatening illness
* Pregnancy or lactation
* Patient with severe medical condition

Primary outcomes:
measure: Progress-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Anxiety related measure
timeFrame: Baseline, completion of radiation therapy (up to 12 weeks)
measure: Distress related measure
timeFrame: Baseline, completion of radiation therapy (up to 12 weeks)
measure: Overall Survival(OS)
timeFrame: 3 years
measure: Locoregional Relapse-Free Survival(LRFS)
timeFrame: 3 years
measure: Distant Metastasis-Free Survival (DMFS)
timeFrame: 3 years
measure: Complete Response (CR)
timeFrame: completion of radiation therapy (up to 12 weeks)
measure: Weight Loss
timeFrame: Baseline, completion of radiation therapy (up to 12 weeks)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT00669201: Wrist Cartilage - High Resolution in Vivo MR T2 Mapping- a Feasibility Study
Official title: Wrist Cartilage - High Resolution in Vivo MR T2 Mapping- a Feasibility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Keywords: cartilage
osteoarthritis
T2 mapping
MRI
Wrist
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-04-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers, volunteers with known osteoarthritis, routine MR population for wrist investigation

Brief summary: Purpose:Evaluate the feasibility of T2 cartilage mapping on MRI of the wrist and correlate with T2 mapping of knee cartilage.

Study protocol: Phase 1. 10 healthy volunteers, Phase 2. 10 volunteers with osteoarthritis of the wrist, Phase 3. 50 patients for studies for routine MR of the wrist.

MRI protocol: 3 T unit((Signa EXITE HDx),T1, T2 and T2 mapping sequences on axial and coronal orientation.


Eligibility criteria: Inclusion Criteria:

* Phase 1. Age:18-40
* Phase 2: No age limit, known OA on pre-existing X-rays
* Phase 3: No age limit, routine MRI of the wrist

Exclusion Criteria:

* Phase 1, 2: wrist trauma/surgery
* All phases: any contraindication for MR: eg metals, claustrophobia, etc.

Primary outcomes:
measure: wrist bone cartilage thickness can be measured and stratification can be observed on T2 mapping with correlation to T2 mapping of the knee cartilage
timeFrame: Within MRI completion (20 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center , Diagnostic Imaging Dept
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center, Diagnostic Imaging Dept
Study officials:
affiliation: Sheba Medical Center
name: Iris Eshed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Glaser C. New techniques for cartilage imaging: T2 relaxation time and diffusion-weighted MR imaging. Radiol Clin North Am. 2005 Jul;43(4):641-53, vii. doi: 10.1016/j.rcl.2005.02.007.
citation: Recht MP, Goodwin DW, Winalski CS, White LM. MRI of articular cartilage: revisiting current status and future directions. AJR Am J Roentgenol. 2005 Oct;185(4):899-914. doi: 10.2214/AJR.05.0099.
citation: Mosher TJ, Dardzinski BJ, Smith MB. Human articular cartilage: influence of aging and early symptomatic degeneration on the spatial variation of T2--preliminary findings at 3 T. Radiology. 2000 Jan;214(1):259-66. doi: 10.1148/radiology.214.1.r00ja15259.
Clinical trial NCT00365001: A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.
Official title: A Randomized, Open-label Study to Assess the Pharmacokinetics of Simvastatin and Methotrexate in Combination With Tocilizumab in Patients With Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-08-16
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will investigate the pharmacokinetics of simvastatin and methotrexate in combination with tocilizumab to assess any potential drug interactions. Patients will be randomized to receive either tocilizumab (10mg/kg iv infusion on day 8) + methotrexate (10-25mg po /week) or tocilizumab + methotrexate + simvastatin (40mg po on days 1, 15 and 43). Blood samples will be taken for analysis at intervals up to day 44. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-75 years of age;
* rheumatoid arthritis for \>=6 months;
* methotrexate for \>=12 weeks prior to day 1 (stable at 10-25mg/week for 8 weeks).

Exclusion Criteria:

* history of, or current inflammatory joint disease or rheumatic autoimmune disease other than RA;
* concurrent treatment with any DMARD other than methotrexate;
* prior treatment with tocilizumab.

Primary outcomes:
measure: Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite.
timeFrame: Days 1, 15 and 43
Secondary outcomes:
measure: Pharmacokinetic parameters for tocilizumab.
timeFrame: Days 11, 22, 29 and 36.
measure: CRP, IL-6, sIL-6R changes
timeFrame: Throughout study
measure: AEs, laboratory parameters.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Aniston
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Jacksonville
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Royal Oak
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Oklahoma City
country: United States
state: Oklahoma
city: Duncansville
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Christchurch
country: New Zealand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Schmitt C, Kuhn B, Zhang X, Kivitz A, Grange S. Tocilizumab has no clinically relevant effects on methotrexate pharmacokinetics in patients with rheumatoid arthritis. Int J Clin Pharmacol Ther. 2012 Mar;50(3):218-23. doi: 10.5414/cp201613.
Clinical trial NCT01184001: A Study To Evaluate The Effect Of Food On How Tasocitinib (CP-690,550) Is Absorbed And Moves Through The Body Following Oral Administration Of Tasocitinib (CP-690,550) Tablets To Healthy Subjects
Official title: A Phase 1, Randomized, 2-Period, 2-Sequence, Open Label, Single Dose, Cross-Over Study To Evaluate The Effect Of Food On Pharmacokinetics Of Tasocitinib (CP-690,550) Tablets In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Healthy subjects
Food Effect Study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-18
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: In this study, a 10 mg tasocitinib (CP-690,550) tablet will be administered to healthy subjects on two separate dosing occasions. On one occasion the tasocitinib (CP-690,550) tablet will be administered in a fasting condition; On the other occasion the tasocitinib (CP-690,550) tablet will be administered in a fed condition following a standard breakfast meal. The amount of tasocitinib (CP-690,550) in the blood will be measured at various times over 24 hours following each dosing occasion and compared to evaluate for any differences.

Detailed description: To evaluate the effect of food on the pharmacokinetics of tasocitinib (CP-690,550).

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight for males\>50 kg (110 lbs). For females, total body weight \>45 kg (99 lbs).
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

Exclusion Criteria:

* Evidence or history of any clinically significant illness, medical condition, or disease.
* Evidence or history of any clinically significant infections within the past 3 months.
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.

Primary outcomes:
measure: AUCinf and Cmax of tasocitinib (CP-690,550).
timeFrame: PK blood samples out to 24 hours post dose in each of two periods.
Secondary outcomes:
measure: AUClast, Tmax, and t1/2 of tasocitinib (CP-690,550).
timeFrame: PK blood samples out to 24 hours post dose in each of two periods.
measure: Safety: Laboratory tests.
timeFrame: Pre-dose on Day O of Period 1 and post-dose on Day 2 of Period 2.
measure: Safety:Vital signs.
timeFrame: Prior to dosing in Period 1 and 2.
measure: Safety: AE reporting.
timeFrame: Continuous
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06875401: Long-Term Patient-Reported Maternal Outcomes Following Abdominal Cerclage for the Prevention of Preterm Birth
Official title: Long-Term Patient-Reported Maternal Outcomes Following Abdominal Cerclage for the Prevention of Preterm Birth
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cerclage, Cervical
Cervical Insufficiency
Keywords: Patient reported outcomes (PRO)
Quality of life
Preterm birth
Abdominal cerclage
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2025-03-13
Enrollment: 1200
Sex: FEMALE
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: 1. Participants with a TAC compared to controls with no TAC.
2. Participants exposed to short versus longer time spans since TAC insertion.
3. Participants with a TAC and no subsequent birth versus TAC and at least one subsequent birth.

Brief summary: This study aims to explore the maternal patient reported outcomes on pelvic pain sexual health anxiety and depression bladder discomfort foreign body sensation trust in the cerclage, and how these parameters affect the general health perception in the quality of life of women treated with abdominal cerclages in Denmark since 2004.


Eligibility criteria: Inclusion Criteria:

* Transabdominal cerclage

Exclusion Criteria:

* Most recent birth within 6 months

Primary outcomes:
measure: General Health Perception scale - SF-36
timeFrame: At enrollment
measure: Hospital anxiety and depressen scale (HADS)
timeFrame: At enrollment
Secondary outcomes:
measure: Pelvic pain
timeFrame: At enrollment
measure: Foreign body sensation
timeFrame: At enrollment
measure: Trust in the cerclage
timeFrame: At enrollment
measure: Bladder discomfort
timeFrame: At enrollment
measure: Sexual health
timeFrame: At enrollment
measure: SF - 36 QOL
timeFrame: At enrollment
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT00336401: Peri-Operative And Long-Term Cardioprotective Properties Of Sevoflurane In High Risk Patients Undergoing Non-Cardiac Surgery
Official title: Peri-Operative And Long-Term Cardioprotective Properties Of Sevoflurane In High Risk Patients Undergoing Non-Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non Cardiac Surgery
Keywords: anesthesia
non cardiac surgery
cardiac outcomes
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2006-06-13
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Non-cardiac surgery is associated with significant cardiac morbidity and mortality. Volatile anesthetics have a cardioprotective effects which results in preservation of left ventricular function and lower troponin I levels. Lower troponin release has been correlated with better long term event free survival in both cardiac and non cardiac surgery. A recently completed meta-analysis suggests that sevoflurane is a superior volatile agent. The evidence of a cardioprotective effect in non-cardiac surgery is lacking. Base on the current literature, we intend to evaluate the protective potential of sevoflurane versus propofol anesthesia in high risk patients undergoing elective non-cardiac procedures.

Hypothesis: The use of Sevoflurane as a general anesthetic reduces postoperative troponin release, the incidence of myocardial infarction and/or long term morbidity in patients at low to moderate risk of postoperative cardiac complications, who are undergoing noncardiac surgery.


Eligibility criteria: Inclusion Criteria:

Any patient undergoing non-cardiac surgery is eligible if s/he: 1.) is ≥45 years old;2.) Has an expected length of stay ≥48 hours; AND3.) Fulfills any 2 of the six criteria for high cardiac risk as defined by the revised Cardiac Risk Index.(see details in protocol)4.) Informed consent

Exclusion criteria:A patient will be ineligible for this study if s/he:1) Prior adverse reaction to sevoflurane (MH patient) or propofol.2) Previous coronary artery bypass graft (CABG) surgery with complete revascularization in the preceding five years with no evidence of cardiac ischemia since the procedure; or3) Has concomitant life-threatening disease likely to limit life expectancy to \<30 days. -

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
Study officials:
affiliation: Toronto General Hospital, University Health Network
name: Scott Beattie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: