louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00236977: Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia
Official title: Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: CKD
iron
anemia
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.

Detailed description: The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure patients receiving or not receiving erythropoietin. After an extensive enrollment period, patients were randomized to receive oral iron (ferrous sulfate, 325mg three times daily (TID) for 56 days) or IV iron sucrose (total 1000mg, 500mg X 2 OR 200mg X 5 within two weeks). Erythropoietin schedule was to remain unchanged during the 56 day study.

Eligibility criteria: Inclusion Criteria:

* Hemoglobin \< or = 11.5 gm/dL
* Stable dose or not receiving EPO
* Renal Anemia

Exclusion Criteria:

* IV iron with last 6 months
* Chronic infection, malignancy,major surgery within last month
* Blood Transfusion with last two months
* Significant blood loss within last 3 months
* Concomitant sever diseases of the liver

Primary outcomes:
measure: Patients With an Increase in Hemoglobin >= 1gm/dL.
timeFrame: Change from Baseline up to Day 56
Secondary outcomes:
measure: Number of Subjects With a Clinical Response
timeFrame: Change from Baseline up to Day 56
measure: Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56
timeFrame: Change from Baseline up to Day 56
measure: Highest Change From Baseline in Ferritin (ng/mL) up to Day 56
timeFrame: Change from Baseline up to Day 56
measure: Mean Change in Ferritin (ng/mL) From Baseline to Day 56
timeFrame: Change from Baseline at Day 56
measure: Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56
timeFrame: Change from Baseline at Day 56
measure: Mean Change From Baseline in Hemoglobin (g/dL) at Day 56
timeFrame: Change from Baseline at Day 56
Other outcomes:
Locations:
city: Valley Forge
country: United States
facility: Luitpold Pharmaceuticals
state: Pennsylvania
Study officials:
affiliation: American Regent, Inc.
name: Mark A Falone, MD
role: STUDY_DIRECTOR
References:
citation: Van Wyck DB, Roppolo M, Martinez CO, Mazey RM, McMurray S; United States Iron Sucrose (Venofer) Clinical Trials Group. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int. 2005 Dec;68(6):2846-56. doi: 10.1111/j.1523-1755.2005.00758.x.
Clinical trial NCT02488577: Outcomes of TAMIS-Total Mesorectal Excision Versus Transanal Loco-regional Excision for T2 Low Rectal Cancer
Official title: Outcomes Comparison of TAMIS-TME Versus Transanal Minimally Invasive Locoregional Resection for T2 Low Rectal Cancer: an Open Label Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Rectal Cancer
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Cases with stage T2 N0 low rectal cancer will undergo either Transanal minimally invasive total mesorectal excision or transanal minimally invasive locoregional resection.


Eligibility criteria: Inclusion Criteria:

* T2 N0 low rectal cancer

Exclusion Criteria:

* patients unfit for laparoscopic resection
* Unwilling to share in the study

Primary outcomes:
measure: Overall percent of postoperative complications.
timeFrame: 30 days
Secondary outcomes:
measure: Hospital stay
timeFrame: 30 days
measure: Recurrence.
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Professor of surgical oncology Mansoura university
name: Sherif Kotb, M.D., PhD.
role: STUDY_DIRECTOR
affiliation: surgical oncology Mansoura university
name: Osama Eldamshety, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: surgical oncology Mansoura university
name: Adel Fathi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03722277: Variable Resistance Training in Patients With Osteoarthrosis of the Knee
Official title: Variable Resistance Training Versus Conventional Rubber Band Training: Effects on Functional Capacity and Strength in Patients With Osteoarthrosis of the Knee
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Resistance Training
Lead sponsor: University College South Denmark
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial investigating the effect of variable load training in patients with knee osteoarthrosis.

The intervention will consist of resistance training with variable load in knee extension- and flexion. The control group will receive conventional strength training with rubber band.

Outcome measures will be the Knee Osteoarthrosis Outcome Score, functional capacity measured in a sit to stand test, 30m. pace walk and a 9 step stair climb test. Additionally isometric strength in knee flexion- and extension will be measured.


Eligibility criteria: Inclusion Criteria:

* Knee pain and minimum three of the following
* \>50 years
* morning stiffness \< 30 min
* crepitation
* bone tenderness
* bone osteophytes
* absence of inflammation

Exclusion Criteria:

* Other causes of symptoms to the knee

Primary outcomes:
measure: Change in self reported knee function
timeFrame: At baseline and 10 weeks follow up
Secondary outcomes:
measure: Change in functional capacity
timeFrame: At baseline and 10 weeks follow up
measure: Change in isometric strength
timeFrame: At baseline and 10 weeks follow up
measure: Change in functional capacity
timeFrame: At baseline and 10 weeks follow up
measure: Change in functional capacity
timeFrame: At baseline and 10 weeks follow up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03893253: Early or Late Booster in Basic Life Support for Health Care Professionals
Official title: Does an Early Booster Session Improve Performance and Retention of Basic Life Support Skills Compared to a Late Booster in Health Care Professionals? A Simulation-based Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Basic Life Support
Lead sponsor: Hopital Montfort
Sponsor class: OTHER
Collaborators: name: Institut du Savoir Montfort
First posted: 2019-03-28
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomized to one of three groups : early booster, late booster, or no booster (control group)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Attrition of skills after basic life support (BLS) training is common. Psychology studies have established that for basic memory recall tasks, spaced learning strategies improve retention. Spaced learning is often organized as a refresher or 'booster' course after initial training. This study aims to investigate if this principle holds true for BLS skills, which require rapid memory recall and efficient deployment of procedural skills while under time pressure.

Detailed description: Health care professionals who have not received BLS training in the 6 months leading up to the date of participation will be recruited from local health care institutions in the greater-Ottawa area. Participants will be randomized into one of three groups: early booster, late booster, or no booster (control). Currently, no booster is the educational standard. The early booster group will receive a booster at 3 weeks, the late booster at 2 months, and no booster for the control. All participants will undergo BLS training, an immediate post-test, and a retention post-test at 4 months. Post-tests involve a simulated cardiac arrest scenario. Raters will be blinded to the group allocation and simulation test order.

Eligibility criteria: Inclusion Criteria:

-Healthcare professionals who interact with patients and have not received any BLS training or practice in the 6 months leading up to the date of their participation will be recruited.

Exclusion Criteria:

* under 18 years of age
* non healthcare professionals
* healthcare professionals who don't interact directly with patients
* healthcare professionals who have completed Basic Life Support training in the previous six months

Primary outcomes:
measure: Basic Life Support Performance
timeFrame: 4 months
Secondary outcomes:
measure: Time to start chest compressions
timeFrame: 4 months
measure: Time to defibrillation
timeFrame: 4 months
measure: Quality of CPR
timeFrame: 4 months
measure: Overall BLS performance
timeFrame: 4 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Institut du Savoir Montfort
state: Ontario
Study officials:
affiliation: Hôpital Montfort
name: Richard Waldolf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05832853: A Study of the Intervention Effect of a Hybrid Exercise Program on Frail Elderly
Official title: Hybrid Exercise Program is Frail Elderly Need: Effectiveness on the Physical Abilities and Clinical Assistance From White Box Modeling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Keywords: frailty
exercise intervention
Lead sponsor: Northeast Normal University
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 181
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The declining physical condition of frail elderly is becoming an ugent problem. Although the exercise intensity of Wu Qin Xi appears to be low, it is highly effective in the older individuals. Inspired by the characteristics and functions of Wu Qin Xi, we designed a brand new exercise intervention training program among frail older people, which incorporates Wu Qin Xi, strength exercises and endurance exercises to improve physical fitness, and even reverse the condition of frailty. Furthermore, to improve utility in clinical practice, we innovatively employed machine learning simulations to infer the condition of older adults and predict their level of frailty after the intervention.


Eligibility criteria: Inclusion Criteria:

1. a Fried frailty phenotype score of 3-5 points;
2. could walk for at least 6 min without support;
3. had not been able to walk in the past year other training.

Exclusion Criteria:

1. people who have a past mental illness or serious psychological issues which make it difficult to obey orders;
2. people who have had neurological disorders within the last six months;
3. people who must regularly participate in other training programs during the study period;
4. people who struggle to walk normally due to significant muscle and skeletal injuries and continuous joint discomfort.

Primary outcomes:
measure: Assessing the endurance of frail older adults using the six-minute walk test
timeFrame: Month 6
measure: Assessing the speed of frail older adults using the ten-meter maximum walk speed
timeFrame: Month 6
measure: Using handgrip strength tests to assess strength in frail older adults.
timeFrame: Month 6
measure: Assessment of balance in frail older adults using Time Up and Go Test.
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: Chinese Center of Exercise Epidemiology
state: Jilin
Study officials:
References:
Clinical trial NCT04298853: Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
Official title: Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neonatal Abstinence Syndrome
Neonatal Opioid Withdrawal
Neonatal Opioid Withdrawal Syndrome
Keywords: morphine
Finnegan
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 17
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence syndrome.


Eligibility criteria: Inclusion Criteria:

* newborn greater than or equal to 35 weeks gestation
* intrauterine opioid exposure
* signs and symptoms of opioid withdrawal

Exclusion Criteria:

* congenital anomalies or suspected genetic condition
* co-morbid conditions that require sedation or analgesia due to clinical condition
* ongoing need for respiratory support

Primary outcomes:
measure: Enrollment Rate
timeFrame: Prior to second dose of morphine, within 4 hours
measure: Drop Out Rate
timeFrame: Through final follow-up call at 6 weeks of age
measure: Number of Study Group Subjects Switched to Standard Arm
timeFrame: 24 hours
Secondary outcomes:
measure: Length of Hospital Stay From Birth to Discharge
timeFrame: Until discharge, up to 6 weeks
measure: Total Cumulative Morphine Exposure
timeFrame: Until discharge, up to 6 weeks
measure: Peak Morphine Dose
timeFrame: Until discharge, up to 6 weeks
measure: Length of Morphine Treatment
timeFrame: Until discharge, up to 6 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
Study officials:
References:
Clinical trial NCT05022953: The Effect of Digital Storytelling on Nursing Students' Compliance
Official title: The Effect of Digital Storytelling on Nursing Students' Compliance With Isolation Precautions and Their Knowledge Levels: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education
Isolation
Nursing Students
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 109
Sex: ALL
Minimum age (years): 21
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study investigated the effect of digital storytelling on nursing students' compliance with isolation precautions and their knowledge levels.This was a pretest-posttest open-label randomized controlled trial. The nursing department of the faculty of health sciences of a university in the eastern Black Sea region of Turkey. The sample consisted of 109 fourth-year nursing students divided into groups of experimental (n=66) and control (n=43). Data were collected using a demographic characteristics questionnaire, an Isolation Knowledge Test (IKT), a Questionnaire of Students' Opinions on Digital storytelling (QSODS), and the Scale of Compliance with Isolation Precautions (SKIP). The experimental group attended a digital storytelling activity (intervention), while the control group received an education based on the curriculum. The data were analyzed using the Mann-Whitney U test, the Wilcoxon test, the Analysis of variance (ANOVA), and the Spearman correlation test.


Eligibility criteria: Inclusion Criteria:

* Being voluntary
* Having access to the Internet

Exclusion Criteria:

* Not attending the digital storytelling activity (intervention)
* Not taking the posttest

Primary outcomes:
measure: Distribution of students according to descriptive characteristics.
timeFrame: 1 month
Secondary outcomes:
measure: The difference between the pre, post and follow-up knowledge scores of the control and experimental group students
timeFrame: 1 month
measure: The difference between the control and experimental group scores according to the total and sub-dimensions of the scale
timeFrame: 2 months
measure: The following are quotations from the experimental group participants about digital storytelling.
timeFrame: 2 months
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Sule BIYIK BAYRAM
Study officials:
affiliation: Kırıkkale University
name: Emel Gulnar, PhD
role: STUDY_CHAIR
affiliation: Gazi University
name: Nurcan Caliskan, PhD
role: STUDY_CHAIR
affiliation: Karadeniz Teknik University
name: Cigdem Torun Kılıc, Msc
role: STUDY_CHAIR
References:
Clinical trial NCT02517853: Efficiency of Neurostimulation of Tibial Nerve in the Treatment of Low Anterior Resection Syndrome
Official title: Prospective and Randomized Study to Evaluate the Efficiency of Percutaneous Neurostimulation of Posterior Tibial Nerve in the Treatment of Low Anterior Resection Syndrome (LARS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Surgery
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2015-08-07
Enrollment: 41
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: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the efficiency of the Neuroestimulation of the Posterior Tibial Nerve for the treatment of this syndrome.

A multicentric, prospective, randomized study will be performed in patients affected with severe LARS symptoms. Patients will be randomized in two groups:

1. Control group- placebo
2. Treatment group: neuroestimulation of the posterior tibial nerve


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 and under 75 years who have been undergone anterior resection of the rectum with sphincter preservation for rectal cancer
* Patients with LARS score \> 29

Exclusion Criteria:

* Patient with intestinal inflammatory disease
* Patients with known irritable colon disease
* Pregnancy patients
* Patients with others intestinal resection segments different from the rectum
* Patients with metastatic disease
* Patient with previous history of posterior tibial neurostimulation or sacral nerve stimulation

Primary outcomes:
measure: Tibial nerve stimulation efficacy measured by LARS score
timeFrame: 1 month
measure: Tibial nerve stimulation efficacy measured by LARS score
timeFrame: 3 months
measure: Tibial nerve stimulation efficacy measured by LARS score
timeFrame: 6 months
measure: Tibial nerve stimulation efficacy measured by LARS score
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
References:
citation: Marinello FG, Jimenez LM, Talavera E, Fraccalvieri D, Alberti P, Ostiz F, Frago R, Blanco A, Pellino G, Espin-Basany E. Percutaneous tibial nerve stimulation in patients with severe low anterior resection syndrome: randomized clinical trial. Br J Surg. 2021 Apr 30;108(4):380-387. doi: 10.1093/bjs/znaa171.
Clinical trial NCT00861653: Atherosclerotic Plaque Characterization
Official title: Atherosclerotic Plaque Characterization Using Multispectral, Multicontrast High Resolution Cardiovascular Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Keywords: Atherosclerosis
Subjects diagnosed with atherosclerosis
Lead sponsor: Piedmont Healthcare
Sponsor class: OTHER
First posted: 2009-03-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnosed with atherosclerosis

Brief summary: The purpose of this study is to utilize high-resolution CMR carotid imaging for the characterization of carotid wall volumes and plaque content in patients with clinical significant carotid atherosclerosis. Patients who are scheduled to undergo an imaging procedure will be recruited from the cath lab. Upon enrollment, blood samples conventional and genetic profiling will be collected. For patients undergoing a carotid endarterectomy, tissue from the carotid vessel will be collected during their procedure. Comparison of the MR images with tissue and/or blood samples will be made. Length of time in the study will be approximately 1 day. There will be no study-related patient follow-up.


Eligibility criteria: Inclusion Criteria:

* Age range \>17 years of age
* Surgical carotid artery disease
* Provide written informed consent and Authorization for Use/Disclosure of PHI

Exclusion Criteria:

* History of carotid trauma
* History of middle or large vessel vasculitis
* Refusal to provide written informed consent and Authorization for
* Use/Disclosure of PHI

Primary outcomes:
measure: Characterization of plaque that is found in the carotid walls of patients who have atherosclerosis
timeFrame: 2 years post study initiation
Secondary outcomes:
measure: To evaluate the effectiveness of MR imaging in identifying these plaque characteristics
timeFrame: 2 Years Post Study Initiation
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
Study officials:
affiliation: Piedmont Healthcare
name: Sarah Rinehart, MD
role: PRINCIPAL_INVESTIGATOR
References: