louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00261053: Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Official title: A Phase II Exploratory, Open-label Study of the Safety and Efficacy of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Genetic Disorders
Lead sponsor: Pharming Technologies B.V.
Sponsor class: INDUSTRY
First posted: 2005-12-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this single-center study is to explore the efficacy, safety, tolerability and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute attacks in patients with hereditary angioedema.


Eligibility criteria: Main inclusion Criteria:

* Clinical and laboratory diagnosis of HAE
* Plasma level of functional C1INH of less than 50% of normal
* Severe attack of abdominal, facial-oro-pharyngeal, genito-urinary and/or peripheral HAE.

Main exclusion Criteria:

* Acquired angioedema
* Pregnancy or breastfeeding
* Participation in another clinical study within prior 3 months

Primary outcomes:
measure: Primary outcomes: Relief of angioedema symptoms
Secondary outcomes:
measure: Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: For information contact Sonja Visscher
Study officials:
affiliation: Pharming Technologies B.V.
name: Jan Nuijens, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05505253: Alfacalcidol Supplementation on Levator Ani Muscle Strength of Menopausal Pelvic Organ Prolapse Patients
Official title: Alfacalcidol Supplementation on Levator Ani Muscle Strength of Menopausal Pelvic Organ Prolapse Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pelvic Organ Prolapse
Keywords: Alfacalcidol
MyoD expression
pelvic organ prolapse
vitamin D receptorr
levator ani muscle strength
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 48
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study performed to evaluate the role of vitamin D supplementation on the strength of levator ani muscle in menopausal women with pelvic organ prolapse

Detailed description: Forty eight POP women were divided into experimental and control groups in this quasi-experimental study. The experimental group was given 0.5 mcg alfacalcidol orally for three months. We measured levator ani muscle strength, serum 25-hydroxy-vitamin D3 levels, and serum Vitamin D Receptor (VDR) levels at zero months and three months preoperative. Enzyme-linked immunosorbent assay (ELISA) assessed VDR and myoblast determination protein 1 (MyoD) protein expressions in levator ani muscle surgical biopsies.

Eligibility criteria: Inclusion Criteria:

* patients with pelvic organ prolapse stages III and IV who underwent surgery at menopausal age
* normal BMI
* initial serum vitamin D levels \<30 ng/mL

Exclusion Criteria:

* comorbidities (chronic cough, conspitation)
* vitamin D metabolism or immune system interfering diseases or drugs specific routine medications such as anticonvulsants, statin, fibrate or orlistat
* history of vitamin D supplementation within the last month

Primary outcomes:
measure: Vitamin D3 levels
timeFrame: 3 months
measure: Vitamin D receptor levels
timeFrame: 3 months
measure: Levator ani muscle strength
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Universitas Padjadjaran
state: West Java
Study officials:
affiliation: Universitas Padjadjaran
name: RM Sonny Sasotya, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang L, Quan M, Cao ZB. Effect of vitamin D supplementation on upper and lower limb muscle strength and muscle power in athletes: A meta-analysis. PLoS One. 2019 Apr 30;14(4):e0215826. doi: 10.1371/journal.pone.0215826. eCollection 2019.
citation: Latham CM, Brightwell CR, Keeble AR, Munson BD, Thomas NT, Zagzoog AM, Fry CS, Fry JL. Vitamin D Promotes Skeletal Muscle Regeneration and Mitochondrial Health. Front Physiol. 2021 Apr 14;12:660498. doi: 10.3389/fphys.2021.660498. eCollection 2021.
Clinical trial NCT00712153: Follow-up of Coronary Artery Bypass Graft Patency by Multislice Computed Tomography
Official title: Follow-up of Coronary Artery Bypass Graft Patency by Multislice Computed Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: multislice computed tomography
coronary artery bypass grafting
Patients
underwent
surgeries
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2008-07-09
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients underwent CABG and performed MSCT after the surgeries

Brief summary: Coronary artery disease is a major cause of morbidity and mortality across the world and coronary artery bypass surgery (CABG) is the most common surgical procedure for treatment. Patients with recurrent ischemic symptoms after CABG are most likely to have occluded or significantly stenosis in grafts or native coronary arteries. Therefore, there is a need to evaluate the patency of these vessel conduits after CABG. Until now, selective coronary angiography is the traditional gold standard for the assessment of both native coronary arteries and bypass grafts. But it is an invasive procedure that requires x-ray exposure, hospitalization, and includes a risk for complication. However, there is an alternative noninvasive method, multislice computed tomography (MSCT), with high specificity and excellent sensitivity for the detection of the coronary artery disease. It is even cheaper and takes shorter time to perform. Accordingly, the purpose of this study is to use MSCT to evaluate the patency and the quality of all grafts and native coronary arteries after CABG for more than two years. In addition, we will elucidate the relationship of these data and CABG procedures to review our experience.


Eligibility criteria: Inclusion Criteria:

* Patients underwent CABG and performed MSCT after the surgeries

Exclusion Criteria:

* Nil

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00648453: Effect of Plavix on NO (Nitrogen Monoxide) Production of the Endothelial Function
Official title: Effect of Plavix Treatment on NO Production Measured by Laser Doppler Method Referring to Endothelial Function in Patients With Severe Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Keywords: Fontain II-III stage
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-04-01
Enrollment: 39
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine whether in the laser Doppler flowmetric parameters characteristic of endothelial dysfunction at patients with clinically manifest atherosclerosis any change can be detected at plavix (clopidogrel) treatment. Laser Doppler /LD/ measurement combined with iontophoresis evaluates the effect of acetylcholine /ACh/ /endothelium dependent/ and sodium nitroprusside /NSP/ /endothelium independent/ on the microcirculation of the skin


Eligibility criteria: Inclusion Criteria:

* Proven, peripheral arterial disease, Fontain II-III stage, patient submitted to secondary prophylactic thrombocyte aggregation inhibiting treatment
* Doppler index \< 0,8

Exclusion Criteria:

* Hypersensitivity to the active ingredient or one of the components of the drug
* Active pathological bleeding, e.g. gastric ulcer, intracranial bleeding
* Pregnancy, breast-feeding
* Severe, known hepatic insufficiency
* Severe, known renal insufficiency

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Change of the laser Doppler parameters measured after three months clopidogrel /75 mg/day/ treatment compared to the pre-treatment values.
timeFrame: 3 months
Secondary outcomes:
measure: Safety of clopidogrel /75 mg/day/ treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Laszlo Eros
role: STUDY_DIRECTOR
References:
Clinical trial NCT02729753: Clinical Study to Evaluate CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium
Official title: Clinical Study to Evaluate the CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: Pentax Medical
Sponsor class: INDUSTRY
First posted: 2016-04-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the C2 CryoBalloon™ Full and Swipe Ablation Systems for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy for reasons unrelated to the objective of the study

Detailed description: The primary outcomes for the study are the safety and treatment effect of the C2 CryoBalloon™ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed.

Eligibility criteria: Inclusion Criteria:

* Minimum of one 3cm area of non-ulcerated columnar-lined esophagus or squamous-lined tissue suitable for ablation
* Older than 18 years of age
* Requires a clinically necessary esophagectomy for esophageal cancer or other indications.

Exclusion Criteria:

* Patient has esophageal narrowing limiting access to the intended sites of ablation

Primary outcomes:
measure: Safety of the CryoBalloon™ Full and Swipe Ablation System
timeFrame: 2 weeks
measure: Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems
timeFrame: 2 weeks
Secondary outcomes:
measure: Device Performance: Average Procedure Time
timeFrame: Minutes from start to end of procedure
measure: Device Performance: Ease of Deployment of Device
timeFrame: Minutes, from start to end of procedure
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center and Cancer Institute
state: Washington
Study officials:
affiliation: Swedish Medical Center and Cancer Institute
name: Brian Louie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02095353: Comparison of Contrast Agents for MRI Perfusion Analysis in Brain Tumor Patients
Official title: Gadobenate Dimeglumine Compared to Gadobutrol for MRI Perfusion Analysis in Brain Tumor Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Central Nervous System Neoplasms
Keywords: Brain tumor
extraaxial
metastasis
glioma
primary brain tumor
secondary brain tumor
MRI
perfusion
dynamic contrast enhancement
CBV
CBF
ktrans
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 6
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with brain tumors who have had a brain MRI ordered.

Brief summary: This study will compare the use of two contrast agents to analyze blood flow characteristics of brain tumors.

Detailed description: This study will compare contrast agents, gadobenate dimeglumine and gadobutrol, for MRI perfusion analysis in brain tumor patients.

Eligibility criteria: Inclusion Criteria:

* Subjects with brain tumors will be enrolled. These subjects may be newly diagnosed, undergoing treatment or undergoing follow-up. If a subject has undergone surgery or treatment they should have what appears to be residual tumor.

Exclusion Criteria:

* Renal failure (GFR \<45). Subjects will be screened utilizing UNMC gadolinium contrast guidelines.
* Allergic reactions to MRI contrast agents.
* Subjects who do not fit the criteria for the population we are evaluating.
* Subjects should not participate in this study if they have any of the following conditions:

  * Anxiety attacks
  * Panic disorder
  * Claustrophobia
  * Pregnant, or trying to become pregnant
  * Breast feeding
* Subjects should not participate in this study if they have certain kinds of metal in their body, for example: a heart pacemaker, defibrillator, neurostimulator, a metal plate, certain otologic implants, certain types of heart valves, metal slivers in eye, brain aneurysm clips or metal slivers and bullet fragments in or near certain structures in their body. Our standard MRI safety screening will be performed on all subjects.
* If a subject has metal in their body that requires an additional x-ray beyond what is needed for the clinical MRI examination to safely perform the research MRI examination that subject would be excluded.Subjects not being able to return for a follow-up examination

Primary outcomes:
measure: Degree of contrast induced signal changes with dynamic imaging of brain tumors
timeFrame: 2 weeks
Secondary outcomes:
measure: Calculate differences in cerebral blood volume, ktrans and flow in brain tumors
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Unversity of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Matthew White, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06354153: Polarity Management Training Program for First Line Nurse Manager
Official title: Influence of Polarity Management Training Program on First Line Nurse Manager Creativity Behavior and Motivation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervention
Knowledge, Attitudes, Practice
Keywords: Polarity
Management
Training Program
Nurse Managers
Creativity
Motivation
Lead sponsor: Matrouh University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Polarities are vital issues in healthcare systems. Nursing is a profession riddled with polarities. If first-line nurse managers are well trained to manage polarities in the workplace, this could lead to positive outcomes for nurses, nurse managers and organization performance.

Detailed description: Polarities are vital issues in healthcare systems. Nursing is a profession riddled with polarities. If first-line nurse managers are well trained to manage polarities in the workplace, this could lead to positive outcomes for nurses, nurse managers and organization performance. This study aimed to examine the influence of polarity management training program on first-line nurse managers' creative behavior and motivation.

Eligibility criteria: Inclusion Criteria:

First-line nurse managers

* willing to participate in the study
* work in all inpatient care units of Alexandria University hospitals
* Sign a consent

Exclusion Criteria:

First-line nurse managers

* work in outpatient units
* Did not sign a consent
* Absent from training

Primary outcomes:
measure: Questionnaire to measure nurse managers' knowledge
timeFrame: one month
measure: Nursing polarity case study situations to assess first-line nurse manager's ability to differentiate between problems to solve and polarities to manage
timeFrame: one month
measure: Questionnaire to measure creativity behavior of first-line nurse managers
timeFrame: one month
measure: questionnaire to measure intrinsic work motivation among first-line nurse managers
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Marsa Matruh
country: Egypt
facility: Faculty of Nursing, Matrouh University
Study officials:
affiliation: Faculty of Nursing, Matrouh University, Egypt
name: Nagah Abd El-Fattah Mohamed Aly, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Nursing, Matrouh University, Egypt
name: Wael M. Lotfy, Ph.D
role: STUDY_DIRECTOR
affiliation: Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Egypt
name: Safaa M. El-Shanawany, Ph.D
role: STUDY_CHAIR
affiliation: Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Egypt
name: Maha Ghanem, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT01424553: Respiratory Outcome at Adolescence of Very Low Birthweight Infants
Official title: Respiratory Outcome at Adolescence of Very Low Birthweight Infants : the EPIPAGE Cohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Baby 26 to 32 Weeks
Bronchopulmonary Dysplasia
Keywords: Low birthweight
Bronchopulmonary dysplasia
Lung development
Airway obstruction
Asthma
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-08-29
Enrollment: 355
Sex: ALL
Minimum age (years): 14
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: EPIPAGEADO is an observational study. Respiratory symptoms and lung function will be evaluated in very low birth weight and term infants, born in 1997 and included in the French EPIPAGE cohort.

Detailed description: EPIPAGEADO is a multicenter observational study:- to evaluate respiratory symptoms and lung function at adolescence in very low birthweight (VLBW) children, to identify perinatal risk factors for persistent symptoms or impaired lung function tests at adolescence, to assess the exercise tolerance in VLBW children and to search for genetic susceptibility markers associated to impaired lung function.

The main criteria for analysis will be the forced expiratory volume in one seconde (FEV1) The study duration will be 36 months the number of centers will be 4 centers in France (Paris-Necker, Nantes, Lille, Rouen) The number of patients to be included will be 400, including 260 VLBW children without BPD, 40 VLBW children with BPD, 100 control children with birth at term.

Eligibility criteria: Inclusion criteria :

* Children born in 1997, and included at birth in the French EPIPAGE cohort
* Absence of severe neurologic impairment, with impossibility of reliable lung function tests
* Acceptance of the child and his/her parents

Exclusion criteria :

* Severe neurologic impairment, with impossibility of reliable lung function tests
* Absence of child's or parents' acceptance

Primary outcomes:
measure: Forced expiratory volume
timeFrame: Day 0 (at 14 - 15 years old)
Secondary outcomes:
measure: Pulmonary parameters
timeFrame: Day 0 (at 14 - 15 years old)
measure: Standardized questionnaire for respiratory symptoms
timeFrame: Day 0 (at 14-15 years old)
measure: Candidate-gene analysis, with SNPs known to be associated to bronchopulmonary dysplasia (BPD)
timeFrame: Day 0 (at 14-15 years old)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Necker
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Christophe Delacourt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hadchouel A, Rousseau J, Roze JC, Arnaud C, Bellino A, Couderc L, Marret S, Mittaine M, Pinquier D, Verstraete M, Ancel PY, Delacourt C; EPIPAGEADO study group. Association between asthma and lung function in adolescents born very preterm: results of the EPIPAGE cohort study. Thorax. 2018 Dec;73(12):1174-1176. doi: 10.1136/thoraxjnl-2017-211115. Epub 2018 Mar 31.
Clinical trial NCT00634153: The Surgical Gastrointestinal Diseases Registry Protocol
Official title: The Surgical Gastrointestinal Diseases Registry Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Diseases
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2008-03-12
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gastrointestinal diseases.

Brief summary: By placing the medical record information of many subjects into a research registry, researchers will be able to conduct research studies directed at increasing our knowledge about Gastrointestinal Diseases.

Detailed description: Researchers are asking for past, current and future medical record information.

Eligibility criteria: Inclusion Criteria:

* Subjects being seen by the University of Pittsburgh Medical Center for gastrointestinal diseases

Primary outcomes:
measure: Allow researchers to review and study the medical records of many individuals to answer questions about their disease and its treatment.
timeFrame: 1-N/A
Secondary outcomes:
measure: It will help researchers identify and recruit subjects who are eligible for participation in future research studies.
timeFrame: 1-N/A
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Randall E. Brand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00253253: Long-Term Outcome in Congenital Undescended Testis After Surgical Treatment by Orchidopexy
Official title: Long-Term Outcome in Congenital Undescended Testis After Surgical Treatment by Orchidopexy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Undescended Testis
Keywords: orchidopexy, long-term outcome, congenital
Lead sponsor: Medical Center Alkmaar
Sponsor class: OTHER
First posted: 2005-11-15
Enrollment: 181
Sex: MALE
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: The purpose of this study is to determine the long-term outcome in congenital undescended testis after surgical treatment by orchidopexy and to what extent orchidopexy is the treatment for congenital undescended testis.


Eligibility criteria: Inclusion Criteria:

* The orchidopexy has taken place in the Medical Center Alkmaar between 1986-2004
* The indication concerned a congenital undescended testis
* It concerns a first orchidopexy to the concerning testis

Exclusion Criteria:

* Orchidopexy has taken place on an other reason than congenital undescended testis (for example: torsio testis)
* It concerns re-orchidopexy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Medical Center Alkmaar
state: Noord-Holland
Study officials:
affiliation: Department of Pediatrics, Medical Centre Alkmar
name: W.W. M. Hack, MD, PhD
role: STUDY_DIRECTOR
References: