louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04441320: Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture
Official title: Efficacy and Safety of Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture, A Prospective, Mutlcenter and Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ureteral Stricture
Hydronephrosis
Radiation Exposure
Keywords: radiation induced ureteral stricture
coated metal ureteral stent
safety
efficacy
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, multicenter and controlled study to observe the efficacy and safety of coated metal ureteral stent in the treatment of radiation induced ureteral stricture.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of ureteral stricture and hydronephrosis.
2. Previous history of radiation therapy.
3. Must be able to tolerate surgery.

Exclusion Criteria:

1. Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter).
2. Colon resection surgery patients.

Primary outcomes:
measure: Patency rate
timeFrame: Up to 36 months
measure: Indwelling time
timeFrame: Up to 36 months
measure: Device related serious adverse events
timeFrame: Up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peiking university people's hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06234020: Frequency of Vertebrospinal Anomalies in Patients Presenting With Anorectal Malformations
Official title: Frequency of Vertebro-spinal Anomalies in Patients Presenting With Ano-rectal Malformations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorectal Malformations
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 106
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting in OPD, Emergency and admitted in ward.

Brief summary: To determine the frequency of different vertebrospinal anomalies in patients with ARM

Detailed description: 106 pediatric patients presenting in Department of Neonatal and Paediatric Surgery, The Children Hospital, PIMS from date of approval up to 6 months with diagnosis of anorectal malforatioms will be enrolled in the study using non-probability convenience sampling technique. In this way, 106 patients will be included in the study. Patient selection will be made in the light of aforementioned exclusion and inclusion criteria of the study. Guardians of all patients will be explained about the study and informed consent will be obtained from them. Baseline data of enrolled patients will be recorded in the clinical questionnaire after careful history and examination. All patients born in our setup go through initial Xray of Lumbar spine and sacrum and ultrasound of spine which will be observed. Findings in the imaging will be noted in the clinical performa. It will be ensured that data is collected after approval of the synopsis and patient's confidentiality would not be breeched. Patients would have the autonomy to withdraw from study whenever they want.

Eligibility criteria: Inclusion Criteria:

* I.Neonates and Paediatric patients from age 1 day to 12 years II.Presenting in Department of Paediatric Surgery with Anorectal Malformation III.Both Pre and Post Op

Exclusion Criteria:

* Patients who have not consented for further investigations

Primary outcomes:
measure: To determine the frequency of different vertebrospinal anomalies in patients with ARM
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Shaheed Zulfiqar Ali Bhutto Medical University/PIMS
Study officials:
References:
Clinical trial NCT05720520: Effect of Game-Based Phone Application on Nursing Students' Knowledge and Skills on Intestinal Stoma and Peristomal Care
Official title: Effect of Game-Based Virtual Reality Phone Application on Nursing Students' Knowledge and Skills on Intestinal Stoma and Peristomal Skin Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Nursing Education
Nursing Student
Phone Application
Stoma Care
Peristomal Skin Care
Virtual Reality
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: Purpose: The purpose is to determine effect of game-based virtual reality phone application on nursing students' knowledge and skills on intestinal stoma and peristomal skin care.

Material and methods:This study will be conducted as a single-blind randomized controlled experimental study between March-April 2023. The students in the experimental group will play the developed mobile game on stoma and peristomal skin care as much as they want for 5 days, while the students in the control group will perform skills on stoma and peristomal skin care on the model in the skill laboratory for only one day. After performing the inteventions, the skills and knowledge measurements of the students in both groups will be measured by the researcher through the forms prepared in accordance with the literature. After four weeks, the permanence levels of the students in both groups regarding stoma and peristomal skin care will be measured and the data collection process of the study will be terminated.


Eligibility criteria: Inclusion Criteria:

* To register for the Nursing Fundamentals Course for the first time,
* Participating in theoretical lessons and group work,
* Participating in knowledge and skill assessments on stoma and peristomal skin care,
* Having an Android phone,
* Having internet access,
* Volunteer to participate in the research.

Exclusion Criteria:

* Have any previous training in stoma and peristomal skin care

Primary outcomes:
measure: Stoma and Peristomal Skin Care Skill Form
timeFrame: 1 day
Secondary outcomes:
measure: Stoma and Peristomal Skin Care Knowledge Form
timeFrame: 1 day
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant Izzet Baysal Univercity
Study officials:
References:
Clinical trial NCT06627374: Study of Thoracic Ultrasound As a Response to the Closure of Hemodynamically Significant Patent Ductus Arteriosus in Premature Infants
Official title: The Predictive Value of Thoracic Ultrasound As a Response to the Closure of Hemodynamically Significant Patent Ductus Arteriosus in Premature Infants: an Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patency of the Ductus Arteriosus
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 50
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Full-term and preterm neonates admitted to the aforementioned operational unit after birth, undergoing closure of the hsPDA (hemodynamically significant Patent Ductus Arteriosus) according to standard clinical practice.

Brief summary: The diagnostic hypothesis is based on the evidence that, while the functional closure of the PDA (Patent Ductus Arteriosus) occurs within a few hours after birth, anatomical closure may take several weeks. The functional closure of the PDA can be extremely sensitive to variations in blood oxygen tension and the hemodynamic instability of preterm infants. Therefore, echocardiographic evaluation and ductal diameter at a single point in time (such as during PDA echocardiography) may not correlate with transductal blood flow. Assessing the variation in the amount of pulmonary interstitial fluid using LUS (lung ultrasound score) could be an early predictive parameter for the closure or non-closure of hsPDA (hemodynamically significant PDA).


Eligibility criteria: Inclusion Criteria:

* Neonates under 28 days of life
* Patients eligible for hsPDA closure treatment according to standard clinical practice

Exclusion Criteria:

* Neonates with congenital heart diseases (except for PDA and patent foramen ovale)
* Neonates with pneumothorax
* Neonates with pulmonary hemorrhage

Primary outcomes:
measure: Lung ultrasound score variability
timeFrame: From enrollment to the end of treatment on average of 3 - 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References:
Clinical trial NCT06724874: Online Web-Based Deep Relaxation Exercise Applied to Pregnant Women on Maternal Fetal Attachment and Pregnancy Perception
Official title: The Effect of Online Web-Based Deep Relaxation Exercise Applied to Pregnant Women on Maternal Fetal Attachment and Pregnancy Perception: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Maternal Fetal Attachment Pregnancy Perception
Pregnancy Perception
Lead sponsor: Çankırı Karatekin University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned as a pre-test post-test randomized controlled study in order to determine the effects of an online web-based deep relaxation exercise applied to pregnant women on maternal-fetal attachment and pregnancy perception. The study is planned to be conducted with pregnant women reached through social media (such as Facebook, Messenger, Instagram). The study is planned to be conducted between December 15, 2024 and June 15, 2025. The universe of the study will consist of pregnant women who volunteer to participate in online deep relaxation exercises and share their contact information. When the power analysis was performed, the sample size was calculated as a total of 80 pregnant women (40 experimental, 40 control), assuming that the web-based deep relaxation exercise applied would increase the mean maternal-fetal attachment score (72.25±7.16) (Güney and Uçar, 2019) by four and a half points at a 5% error level, a two-sided significance level, a 95% confidence interval, and an 80% ability to represent the universe (https://www.stat.ubc.ca/\~rollin/stats/ssize/n2.html). Pregnant women to be included in the groups will be selected from the relevant population using the improbable random sampling method.


Eligibility criteria: Inclusion Criteria:

* Women with internet access,
* Women expecting a single baby,
* Women whose pregnancy is 12-24 weeks

Exclusion Criteria:

* Women with a history of physical and/or psychological illness and those taking any psychiatric medication
* Women who answered the survey questions incompletely.

Primary outcomes:
measure: Effect of online web-based deep relaxation exercise applied to pregnant women on maternal-fetal attachment
timeFrame: Four months
Secondary outcomes:
measure: The effect of online web-based deep relaxation exercise applied to pregnant women on pregnancy perception
timeFrame: Four months
Other outcomes:
Locations:
Study officials:
References:
citation: Kumcağız H, Ersanlı E, Murat N. The Development of a Self-perception of Pregnants Scale and its Psychometric Features.Journal of Psychiatric Nursing 2017;8(1):23-31
citation: Golbasi Z, Ucar T, Tugut N. Validity and reliability of the Turkish version of the Maternal Antenatal Attachment Scale. Jpn J Nurs Sci. 2015 Apr;12(2):154-61. doi: 10.1111/jjns.12052. Epub 2014 Jun 24.
Clinical trial NCT06987474: Capella Scientia Development Study
Official title: Capella Scientia (SCDX) Development Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2025-05-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from clinical sites located in India, Spain, and the Philippines.

Brief summary: This study involves collecting biometry and aberration data using the next generation biometer, Unity DX.

Detailed description: In this prospective, noninterventional, single-arm, unmasked, multicenter study, 4 different subject cohorts will be enrolled simultaneously to collect biometry and aberrometry data using Unity DX. This study will be conducted in India, Spain, and the Philippines.

Eligibility criteria: Inclusion Criteria:

* Able to understand and sign an IRB/IEC approved consent form;
* Willing and able to attend study visit(s) as required by the protocol;
* Consenting age at the jurisdiction of study site;
* Other group-specific, protocol required inclusion criteria may apply.

Exclusion Criteria:

* Women of child-bearing potential;
* Unable to fixate due to nystagmus or other eye movement abnormality (e.g., significant strabismus);
* Unclear optical media preventing data capture from all devices in the study;
* Contraindicated for pupil dilation (e.g., narrow angles, allergies) per investigator's clinical judgment;
* Any ocular disease and/or condition that, in the investigator's clinical judgment, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study;
* Other group-specific, protocol required exclusion criteria may apply.

Primary outcomes:
measure: Manifest Refraction Spherical Equivalent (MRSE)
timeFrame: Group 1 and Group 4: Day 0; Group 2 and Group 3: Screening (Day -30 to Day -1), Day 30 to 60 postoperative, Day 70 to 100 postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Principal II, Clinical Trial Operations, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT06743074: Effectiveness of Different Exercise Programmes in Individuals With Dynamic Knee Valgus
Official title: Effectiveness of Different Exercise Programmes in Individuals With Dynamic Knee Valgus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Valgus
Keywords: knee
exercise
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dynamic knee valgus (DDV) is an erroneous movement pattern of the lower limb that occurs in multiple planes. It results from a combination of hip joint adduction, femoral anteversion, knee abduction and external tibial torsion .

Detailed description: Dynamic knee valgus (DDV) is an erroneous movement pattern of the lower limb that occurs in multiple planes. It results from a combination of hip joint adduction, femoral anteversion, knee abduction and external tibial torsion . DDV is also referred to as a mechanism in which the knee joint moves medially relative to the hip and foot with the centre fixed to the ground.

Eligibility criteria: Inclusion criteria:

* Age between 18-50 years.
* Absence of any lower extremity pain.
* Having a frontal plane projection angle of 10 and above in the descent phase of squatting on one leg.
* Having active or regular physical activity.
* Volunteering to participate in the study.

Exclusion criteria:

* Active knee pain.
* History of patellar instability.
* Presence of rheumatic diseases such as osteoarthritis, rheumatoid arthritis.
* History of trauma or injury causing ligament laxity in the ankle, hip or knee.
* Having a neurological disease that may impair the ability to perform any lower limb movement.
* Having undergone any lower extremity surgery before.
* Having received physiotherapy from hip, knee and ankle in the last 6 months.
* To be benefiting from another treatment during the study.

Primary outcomes:
measure: Frontal Plane Projection Angle (FPPA)
timeFrame: 6 weeks
measure: Lower Extremity Clinical Measurements
timeFrame: 6 weeks
measure: Balance Evaluation
timeFrame: 6 weeks
measure: Proprioception Assessment
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: bahcesehır University
state: None Selected
Study officials:
affiliation: Bahçeşehir University
name: aleyna zeynep karcıoğlu
role: STUDY_CHAIR
References:
Clinical trial NCT04755374: Clinical Characteristics and Discharge Assessment of Patients From Palliative Care
Official title: Clinical Characteristics and Discharge Assessment of Patients in a Recent Founded Palliative Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: Critical illness
Palliative care
Length of stay
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-02-16
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a critical ilness/conditions

Brief summary: The number of people having chronic diseases and the demand for palliative care has increased. The factors that have an impact on length of stay and discharge of patient who were admitted to palliative care center will be investigated.

Detailed description: Adult patients admitted to the Diskapi Yildirim Beyazit Teaching and Research Hospitals Palliative Care Unit between August 2018 and September 2020 and discharged to their home will be retrospectively evaluated.

Patient's age, gender, diagnosis, conditions/comorbidities, Karnofsky Performance Scale, discharge status (death, intensive care unit or at home), gastrostomy status, presence of tracheostomy and/or mechanical ventilation, nutritional status (total parenteral nutrition or enteral nutrition), pressure ulcers, the lowest and highest recorded hemoglobin concentration, white blood cell count and serum sodium concentration and the education level of the patient and the caregiver will be recorded. Patients will be grouped according to length of stay (LOS) as Group 1: discharged in equal or less than 21 days or Group 2: Prolonged discharged in longer than 21 days and analysed accordingly

Eligibility criteria: Inclusion Criteria:

• Adult patients admitted to the palliative care unit

Exclusion Criteria:

• Patients not consenting to participate the study

Primary outcomes:
measure: Length of stay
timeFrame: 24 hours after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Teaching and Research Hospital
Study officials:
affiliation: Ministry of Health
name: Gulten Utebey, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gomes B, Higginson IJ. Where people die (1974--2030): past trends, future projections and implications for care. Palliat Med. 2008 Jan;22(1):33-41. doi: 10.1177/0269216307084606.
citation: Lau F, Downing GM, Lesperance M, Shaw J, Kuziemsky C. Use of Palliative Performance Scale in end-of-life prognostication. J Palliat Med. 2006 Oct;9(5):1066-75. doi: 10.1089/jpm.2006.9.1066.
citation: Kelly A, Conell-Price J, Covinsky K, Cenzer IS, Chang A, Boscardin WJ, Smith AK. Length of stay for older adults residing in nursing homes at the end of life. J Am Geriatr Soc. 2010 Sep;58(9):1701-6. doi: 10.1111/j.1532-5415.2010.03005.x. Epub 2010 Aug 24.
Clinical trial NCT01905774: Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox
Official title: Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thalassemia
Iron Overload
Keywords: Renal Function
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 36
Sex: ALL
Minimum age (years): 1
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Thalassemia Major or Intermedia treated by Iron chelators or by blood transfusions without treatment with iron chelators

Brief summary: Thalassemia Major patients developed Iron Overload due to blood transfusions and intestinal iron absorption. Renal function caused by Iron overload was studied in a previous study and shows principally tubular disfunction. In this previous study the Iron chelator used was Deferrioxamine. In the last five years an oral Iron chelator was introduced and approved by the FDA, Deferasirox, (Novartis, Switzerland and USA). The purpose of this study is to assess the renal function in Thalassemia Major patients treated with this new oral iron chelator and compare the results with our previous study.

Detailed description: Patients with Thalassemia Major. The laboratory tests that will be studied are: Urine dip stick, Urea, Creatinine, Na, K, Uric Acid, Calcium, Phosphorus in serum and urine, and N acetyl-b-D-glucosaminidase in Urine.Blood gases will be also taken in serum samples.

The overall iron accumulation will also be calculated based in the amount of Packed Cells Units transfused. The total iron burden will also assessed by measurement of Transferrin saturation and Serum Ferritin.

Eligibility criteria: Inclusion Criteria:

* Patients with Thalassemia Major or Intermedia treated by Iron chelators or by blood transfusions without treatment with iron chelators

Exclusion criteria:

None relevant

Primary outcomes:
measure: Renal function in Thalassemia patients treated by Deferasirox
timeFrame: One year study
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Ha'Emek Medical Center
Study officials:
affiliation: Ha'Emek Medical Center, Afula, Israel
name: Ariel Koren, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smolkin V, Halevy R, Levin C, Mines M, Sakran W, Ilia K, Koren A. Renal function in children with beta-thalassemia major and thalassemia intermedia. Pediatr Nephrol. 2008 Oct;23(10):1847-51. doi: 10.1007/s00467-008-0897-8. Epub 2008 Jun 25.