louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05504824: The Effect of Case-Based Education on the Development of Nursing Students' Clinical Reasoning Skills
Official title: The Effect of Case-Based Education on the Development of Nursing Students' Clinical Reasoning Skills in Critical Illness: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Reasoning
Critical Illness
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Aim: This study was conducted to determine the effect of case-based education on the development of clinical reasoning skills of nursing students in critical illnesses.

Methods: The study was conducted between January 20 and June 30, 2021 using a pilot randomized controlled trial design. In the study, 22 volunteer students were assigned to the experimental and control groups by simple randomization. The experimental group was given case-based education to improve their clinical reasoning skills, and the control group continued the standard education process. Data were collected using a Student Information Form, the Clinical Reasoning Case Form (CRCF), the Student Satisfaction with Education Questionnaire, and a Form for Views on the Education. In the evaluation of data, frequency values, Fisher exact test, Mann-Whitney U, and Wilcoxon tests, Cohen's d coefficient for effect size, ITT analysis, and covariance analysis were used.

Detailed description: Aim of the study This study was conducted to determine the effect of case-based education on the development of nursing students' clinical reasoning skills in critical illnesses.

Research hypotheses H01: There is no difference between the experimental group and the control group in terms of their CRCF scores.

H02: Case-based education on clinical reasoning has no positive effect on student satisfaction.

Eligibility criteria: Inclusion Criteria:

* Having completed the "Medical Nursing" and Surgical Nursing" courses,
* Volunteering to participate in the study,
* Participate in "Case-Based Education"

Exclusion Criteria:

* Not being willing to participate in the study,
* Abandoning the "Case-Based Education" practice
* Not taking one or two of the "Medical Nursing" and "Surgical Nursing" courses at all, or to have taken them but unsuccessfully

Primary outcomes:
measure: Student Information Form
timeFrame: The measurement was collected one week before education.
measure: Clinical Reasoning Case Form (CRCF)
timeFrame: The first measurement was collected one week before education. The second measurement was collected 3 weeks after education.
Secondary outcomes:
measure: Student Satisfaction with Education Questionnaire
timeFrame: The measurement was collected 3 weeks after education.
measure: Form for Views on the Education
timeFrame: The measurement was collected 3 weeks after education.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Nursing
Study officials:
References:
Clinical trial NCT02110524: CVI Drug Coated Balloon First In Human Trial
Official title: Prospective, Controlled, Multi-Center, Open, Single Arm Study for the Treatment of Subjects Presenting De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using a Paclitaxel-Coated Percutaneous Angioplasty Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease
Lead sponsor: Spectranetics Corporation
Sponsor class: INDUSTRY
First posted: 2014-04-10
Enrollment: 80
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: The purpose of this study is to assess safety and the inhibition of restenosis of the CVI Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (SFA) or popliteal arteries.

The primary endpoint for this analysis is late lumen loss at six (6) months.

Detailed description: Prospective, controlled, multi-center, open, single arm study

Main cohort: 50; pre-specified treatment group: 30. Total patients: 80

Eligibility criteria: Inclusion Criteria:

* Subjects with symptomatic leg ischemia, requiring treatment of SFA or popliteal (P1 segment) artery
* De novo or restenotic lesion(s) \>70% within the SFA and popliteal arteries in a single limb which are ≥3 cm and ≤15 cm in cumulative total length (by visual estimation).
* Target vessel reference diameter ≥3 mm and ≤7 mm (by visual estimation).
* Rutherford classification of 2, 3 or 4

Exclusion Criteria:

* Lesion length is \<3 cm or \>15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured.
* Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥ 50% stenosis) may not be treated during the same procedure.
* Treatment of the contralateral limb during the same procedure or within 30 days of the study procedure.

Primary outcomes:
measure: Primary endpoint: Angiographic late lumen loss
timeFrame: 6Month
Secondary outcomes:
measure: Secondary safety endpoint: Major Adverse Event (MAE) rate
timeFrame: 6Months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Jewish Hospital Berlin
Study officials:
affiliation: Jewish Hospital Berlin
name: Henrik Schröder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK, Vermassen F, Zeller T, White R, Ouriel K, Adelman MA, Lyden SP. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. 2019 Oct;140(14):1145-1155. doi: 10.1161/CIRCULATIONAHA.119.040518. Epub 2019 Sep 30.
Clinical trial NCT03869424: Influence of Expectations on Rumination
Official title: Influence of Expectations on Rumination: An Experimental Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study tries to identify whether positive expectations, induced with an active placebo nasal-spray, have effects on rumination.

Detailed description: Healthy volunteers are informed that a new application method for an antidepressant, specialised on protecting from rumination, would be tested. They will randomly be assigned to the treatment group (taking the antidepressant which is in fact an active placebo) or the no treatment control group (not taking a placebo). Then sad mood is induced by mood-suggestive music and negative autobiographic recall. Then participants in the experimental group take the "medication". Afterwards both groups are asked to focus on emotion-focused, symptom-focused and self-focused thoughts to induce rumination (e.g. "Think about what your feelings might mean."). Sadness will be assessed before and after the negative recall task and also after the rumination induction. State Rumination will be assessed before the recall task and after the rumination induction.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* fluent in German language

Exclusion Criteria:

* mental disorders
* allergic to capsaicin
* allergic to sesame oil
* intake of psychopharmacological drugs in the last four weeks
* intake of illegal drugs in the last two weeks
* consumption of alcohol in the last twelve hours
* students in medicine, pharmacy, or psychology
* completed studies in medicine, pharmacy or psychology
* current pregnancy or lactation
* cardio vascular disease
* kidney disease
* liver disease

Primary outcomes:
measure: Change in State Rumination (Fragebogen zur Erfassung aktueller Ruminationsneigung)
timeFrame: At baseline and after the rumination induction. Each assessment is taking 5 Minutes, in total 10 minutes.
measure: Change in Positive and Negative Affect Schedule (PANAS-X)
timeFrame: At baseline, after the negative biographical recall and after the rumination induction, each assessment is taking 3 minutes, in total 9 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps-Universität Marburg
state: Deutschland
Study officials:
affiliation: Philipps-Univeristy of Marburg
name: Winfried Rief, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04172324: Walking in the HIBBOT: is Gait Improved?
Official title: The Effect of a Novel Gait Trainer, the Hibbot, on the Development of Crouch Gait in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cerebral Palsy
Keywords: gait
biomechanics
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the impact of the innovative walking aid HIBBOT on the functions, activity and participation of young children with Cerebral Palsy, in comparison with conventional walking aids.


Eligibility criteria: Inclusion Criteria:

* At risk of or diagnosed with cerebral palsy, based on MRI (uCP 86 - 89 % sensitivity) or HINE (uCP 98% ) or standard motor assessment
* age 18 months - 6 years
* GMFCS level II - IV =with potential (=able to stand and walk when supported by a therapist at the level of the pelvis and lower trunk)
* Sufficient cooperation to complete the tests.

Exclusion Criteria:

* Hip dysplasia
* Fixed contractures in the lower limb
* Botox infiltration \< 6 months prior to inclusion
* Surgery \< 12 months prior to inclusion
* Insufficient understanding of the interventon and tests (based on mental level assessment)
* Refractary epilepsia

Primary outcomes:
measure: Change in Lower limb kinematics during walking in degrees
timeFrame: baseline (at intake, T0) and after the intervention period (3 months, T1)
measure: Change in Muscle activation patterns during gait in microvolts
timeFrame: baseline (at intake, T0) and after the intervention period (3 months, T1)
Secondary outcomes:
measure: Lower limb kinematics during walking in degrees
timeFrame: at follow up (12 months after intake, T2)
measure: Muscle activation patterns during gait in microvolts
timeFrame: at follow up (12 months after intake, T2)
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University of Antwerp
Study officials:
References:
Clinical trial NCT01152424: Usefulness of Exhaled NO in the Differential Diagnosis Acute Eosinophilic Pneumonia and Bacterial Pneumonia
Official title: Usefulness of Exhaled NO in the Differential Diagnosis Acute Eosinophilic Pneumonia and Community Acquired Pneumonia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute
Eosinophilic Pneumonia
Keywords: Acute eosinophilic pneumonia
Exhaled nitric oxide
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who visited the study hospital with bilateral pneumonic infiltration.

Brief summary: Acute eosinophilic pneumonia (AEP) is diagnosed by cell count analysis of bronchoalveolar lavage fluid. However, the performance of bronchoscopy is not easy for patients with AEP, because they usually have hypoxia. Exhaled nitric oxide (FeNO) is usually elevated in the patients with eosinophilic inflammation such as asthma, but there is no previous studies FeNO in the patients with AEP. Investigators hypothesized that FeNO elevated significantly in patients with AEP, and FeNO can be used as non-invasive diagnostic method in patients who are clinically suspected with AEP, especially when the performance of bronchoscopy is difficult.


Eligibility criteria: Inclusion Criteria:

* All patients who visited the study hospital with bilateral pneumonic infiltration.

Exclusion Criteria:

* Patients who do not agree with our study protocol

Primary outcomes:
measure: The difference of FeNO in AEP and Community Acquired Pneumonia
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Armed Forces Capital Hospital
state: Gyeongi
Study officials:
References:
citation: Lee JE, Rhee CK, Lim JH, Lee SM, Shim YS, Lee CT, Won Lee S. Fraction of exhaled nitric oxide in patients with acute eosinophilic pneumonia. Chest. 2012 May;141(5):1267-1272. doi: 10.1378/chest.11-1303. Epub 2011 Oct 20.
Clinical trial NCT05286424: Lipofilling: Optimal Harvesting Techniques for Breast Reconstruction After Mastectomy in Plastic Aesthetic and Reconstructive Surgery
Official title: Lipofilling: Optimal Harvesting Techniques for Breast Reconstruction After Mastectomy in Plastic Aesthetic and Reconstructive Surgery - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Impact of Adipose Tissue Quality on Fat Graft Retention
Keywords: fat graft, adipose tissue
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Joanneum Research Forschungsgesellschaft mbH
First posted: 2022-03-18
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary aim of this project is to standardize the method for lipofilling by identifying the best technique. In this context, the study will investigate the impact of adipose tissue composition and ideal quantity of the injected fat particularly in view of resorption rate. Correlations between adipose tissue composition, amount of transferred fat, already existing subcutaneous fat layer at the grafting site and resorption rate will be made.

The punch biopsy and the non-invasive Lipometer measurements to determine the subcutaneous fat layer thickness in the harvesting and grafting region will be performed in 10 female subjects that undergo elective lipofilling.

The study was registered on Clinicaltrials.gov after start of recruitment.


Eligibility criteria: Inclusion Criteria:

* Women, age 18-70 years (limited upwards due to the indication for lipofilling and the amount of possible secondary diseases)
* History of BRCA1 and BRCA2 - positive breast cancer with following subcutaneous mastectomy
* Planned, elective breast-lipofilling
* Thickness of the skin and subcutaneous fat layer of min. 1 cm (detected via sonography)
* Currently healthy individual, willing to participate in this study

Exclusion Criteria:

* Previous surgery at the harvesting site (e.g. caesarian section)
* Pregnancy or planned pregnancy
* Current or preceded chemotherapy
* Preceded radiatio
* Unable to fully understand study procedures and to provide informed consent

Primary outcomes:
measure: Adipose tissue dependent take rate
timeFrame: 12-24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz
Study officials:
References:
Clinical trial NCT04753424: Semitendinosus Graft as Meniscal Transplant
Official title: Autologous Semitendinosus Tendon Graft as Meniscal Transplant - a Clinical Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patient Satisfaction
Graft Failure
Osteo Arthritis Knee
ACL
Meniscus Tear
Keywords: meniscus transplantation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients, both male and female, 20-50 years of age, with previous subtotal or total meniscectomy, suffering from post meniscectomy symptoms are assessed at the outpatient clinic. If inclusion criteria are met, the patients receive information regarding the treatment.

Brief summary: Removal of meniscal tissue is described to result in poor knee function and a significant risk for future development of osteoarthritis. Different implants have been suggested to substitute a removed meniscus. Meniscal allograft transplantation is not widely available due to costs and availability. The semitendinosus tendon is a known graft with biological properties with potential to remodel and revascularize in an intraarticular environment such as anterior cruciate ligament reconstruction. The objective for this study was to investigate whether the semitendinosus tendon graft could function as a meniscal transplant.


Eligibility criteria: Inclusion Criteria:

* Previous subtotal or total meniscectomy
* Post meniscectomy symptoms
* No osteoarthritic changes on radiography more than Ahlbäck 1
* Knee aligment (hip-knee-angle) +/- 3°
* No persisting ACL insufficiency

Exclusion Criteria:

* Difficulty understanding the instructions
* Current psychiatric diagnosis
* Smoking

Primary outcomes:
measure: Failure
timeFrame: 2 years
Secondary outcomes:
measure: Improved subjective knee function
timeFrame: 2 years
measure: Improved subjective knee function
timeFrame: 2 years
measure: Improved subjective knee function
timeFrame: 2 years
measure: Improved subjective knee function
timeFrame: 2 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: KISÖS
Study officials:
References:
citation: Kohn D. Autograft meniscus replacement: experimental and clinical results. Knee Surg Sports Traumatol Arthrosc. 1993;1(2):123-5. doi: 10.1007/BF01565466.
citation: Johnson LL, Feagin JA Jr. Autogenous tendon graft substitution for absent knee joint meniscus: a pilot study. Arthroscopy. 2000 Mar;16(2):191-6. doi: 10.1016/s0749-8063(00)90035-5.
citation: Ayala Mejias JD, Sciamanna RC, Muniesa MP, Perez-Espana LA. A case report of semitendinosus tendon autograft for reconstruction of the meniscal wall supporting a collagen implant. BMC Sports Sci Med Rehabil. 2013 Mar 28;5:4. doi: 10.1186/2052-1847-5-4.
Clinical trial NCT01763424: Nicotinamide in the Treatment of Psoriasis
Official title: Evaluation of Topical Nicotinamide in Combination With Calcipotriol Compared With Calcipotriol Alone for the Treatment of Mild to Moderate Psoriasis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Psoriasis
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-01-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine if combination of topical calcipotriol and nicotinamide is more effective than calcipotriol alone in treatment of psoriasis.

Detailed description: Current treatment strategies of psoriasis are not completely satisfactorily. By inhibiting inflammatory cytokines, nicotinamide may enhance the effects of current topical treatments. Preliminary studies have shown that nicotinamide, which is a vitamin B derivative, is effective in the treatment of psoriasis. According to lack of data, we will investigate the beneficial effects of adding nicotinamide to calcipotriol for patients with mild to moderate psoriasis.

Eligibility criteria: Inclusion Criteria:

* Men and women of 18 to 65 years old,
* Mild to moderate psoriasis; patients must have had less than 15% of the involved body surface, symmetrical plaques (bilateral lesions) or two plaques at least 5 cm apart on the same side of the body with plaque size greater than 2 × 2 cm, but smaller than 15 × 15 cm.
* Willingness to participate

Exclusion Criteria:

* Those who used any medication or niacin and multi-vitamins two weeks, or anti-psoriatic systemic drugs or beta-blockers one month prior to the study,
* Pregnant women,
* Those with the history of renal, hematologic, liver and major psychiatric diseases,
* Those with only scalp, nail, flexural, palmoplantar, or pustular psoriasis.

Primary outcomes:
measure: Psoriasis severity
timeFrame: Up to 3 months
Secondary outcomes:
measure: Patient's satisfaction
timeFrame: After 3 months
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Skin Diseases and Leishmaniasis Research Center
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Mehdi Khodadadi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levine D, Even-Chen Z, Lipets I, Pritulo OA, Svyatenko TV, Andrashko Y, Lebwohl M, Gottlieb A. Pilot, multicenter, double-blind, randomized placebo-controlled bilateral comparative study of a combination of calcipotriene and nicotinamide for the treatment of psoriasis. J Am Acad Dermatol. 2010 Nov;63(5):775-81. doi: 10.1016/j.jaad.2009.10.016.
Clinical trial NCT04256824: Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds
Official title: Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds; Multi-center, Double Blind, Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Surgical Site Infection
Surgical Wound
Surgical Wound Infection
Lead sponsor: ClinAmygate
Sponsor class: OTHER
Collaborators: name: Misr University for Science and Technology
name: Al Safwa Hospital
name: Al Zohour Hospital
name: Al-Menia Univeristy Hospital
name: MSKMC Univeristy Hospital
First posted: 2020-02-05
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized-controlled study
Primary purpose: PREVENTION

Brief summary: Comparing the incidence of SSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery

Detailed description: Comparing the incidence of surgical site infection (SSI) in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery. Also, comparing the post hospital stay.

Eligibility criteria: Inclusion Criteria:

* age: 18-75
* clean-contaminated wound surgery

Exclusion Criteria:

* Patient has immunodeficiency disorder.
* Patient receiving anti-cancer / immunosuppressive therapy.
* Patients with established pre-operative infection whether community acquired or hospital acquired either at / remote from the operative site.

Primary outcomes:
measure: Incidence of surgical site infection
timeFrame: 30 days
Secondary outcomes:
measure: Hospital stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Misr Univeristy for Science and Technology Hospital
Study officials:
affiliation: ClinAmygate
name: Emad R Issak, Diploma
role: STUDY_DIRECTOR
References:
citation: Ahmed I, Boulton AJ, Rizvi S, Carlos W, Dickenson E, Smith NA, Reed M. The use of triclosan-coated sutures to prevent surgical site infections: a systematic review and meta-analysis of the literature. BMJ Open. 2019 Sep 3;9(9):e029727. doi: 10.1136/bmjopen-2019-029727.