louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00647569: Trial of Collagen Mesh for Prevention of Ventral Hernia After Surgery for Advanced Pelvic Cancer
Official title: Randomized Controlled Trial of Collagen Mesh for Prevention of Ventral Hernia in Patients With Vertical Rectus Abdominis Musculocutaneus Flap for Advanced Pelvic Malignancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Incisional Hernia
Pelvic Cancer
Keywords: vertical rectus abdominis musculocutaneus flap
mesh repair
salvage surgery
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Cook Biotech Incorporated
First posted: 2008-03-31
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the present project is to investigate whether use of biological mesh at the donor site of the rotation flap in closure of the abdominal wall reduce the frequency of incisional hernia formation compared to the usual abdominal wall closure after abdominal rotation flap operation in surgery for advanced pelvic cancer.


Eligibility criteria: Inclusion Criteria:

* Patients operated with a vertical rectus abdominis musculocutaneus flap after abdominoperineal resection for advanced pelvic cancer.

Exclusion Criteria:

* Pre or perioperative knowledge of disseminated malignancy
* Unable to follow the control program
* Known allergy to pig
* Compromised immune defense
* Artificial heart valve or recent (\< 3 months) implanted foreign body
* Age \< 18 years

Primary outcomes:
measure: incisional hernia formation determined by CT scan 1 year postoperative
timeFrame: 1 year postoperative
Secondary outcomes:
measure: postoperative morbidity
timeFrame: 30 days postoperative
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Study officials:
affiliation: Department of Surgery P, Aarhus University Hospital, Denmark
name: Peter Christensen, M.D., Ph.d
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03156569: Salivary Markers in Patients With Xerostomia
Official title: Oral Health and Salivary Markers in Patients With Xerostomia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Xerostomia Due to Hyposecretion of Salivary Gland
Keywords: saliva , dental , oral health
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients Oral Medicine Hospital Morales Meseguer Clinica Odontologica University

Brief summary: The purpose of this study was to investigate the salivary levels of inflammatory and their association with oral health in xerostomía patient

Detailed description: Primary Outcome Measures:

* salivary Proinflammatory and anti-inflammatory cytokines
* questionnaire is provided to the patient for xerostomia characterization

Secondary Outcome Measures:

* Probing pocket depth
* Probing pocket depth and clinical attachment level
* Gingival index
* Plaque index
* Bleeding on probing

Eligibility criteria: Inclusion Criteria:

• The patient must have clinical symptoms of xerostomia (dry mouth)

Exclusion Criteria:

* Head and neck radiotherapy
* Administration anti-inflammatory drugs or antibiotic therapies within the previous 6 months
* Patients who are unable or unwilling to cooperate
* Patient suffering from cancer

Primary outcomes:
measure: saliva flow rate
timeFrame: 2 months
measure: Xerostomia
timeFrame: 2 months
measure: Interleukins
timeFrame: 2 months
Secondary outcomes:
measure: Oral Exam
timeFrame: 4 months
measure: Periodontal evaluation
timeFrame: 4 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Pia Lopez Jornet
city: Murcia
country: Spain
facility: Pia Lopez Jornet
Study officials:
References:
citation: Ohyama K, Moriyama M, Hayashida JN, Tanaka A, Maehara T, Ieda S, Furukawa S, Ohta M, Imabayashi Y, Nakamura S. Saliva as a potential tool for diagnosis of dry mouth including Sjogren's syndrome. Oral Dis. 2015 Mar;21(2):224-31. doi: 10.1111/odi.12252. Epub 2014 May 15.
citation: van den Berg I, Pijpe J, Vissink A. Salivary gland parameters and clinical data related to the underlying disorder in patients with persisting xerostomia. Eur J Oral Sci. 2007 Apr;115(2):97-102. doi: 10.1111/j.1600-0722.2007.00432.x.
citation: Liukkonen J, Gursoy UK, Pussinen PJ, Suominen AL, Kononen E. Salivary Concentrations of Interleukin (IL)-1beta, IL-17A, and IL-23 Vary in Relation to Periodontal Status. J Periodontol. 2016 Dec;87(12):1484-1491. doi: 10.1902/jop.2016.160146. Epub 2016 Aug 19.
citation: Tvarijonaviciute A, Zamora C, Martinez-Subiela S, Tecles F, Pina F, Lopez-Jornet P. Salivary adiponectin, but not adenosine deaminase, correlates with clinical signs in women with Sjogren's syndrome: a pilot study. Clin Oral Investig. 2019 Mar;23(3):1407-1414. doi: 10.1007/s00784-018-2570-3. Epub 2018 Jul 20.
Clinical trial NCT00530569: Evaluation of Clinical Significance of Circulating Markers in Breast Cancer Patients Undergoing Herceptin Therapy
Official title: Evaluation of Clinical Significance of Circulating Markers in Breast Cancer Patients Undergoing Herceptin Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Breast Cancer
Herceptin Therapy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2007-09-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Albertan women with breast cancer who will undergo Herceptin therapy as part of their treatment at some point during a one-year period.

Brief summary: About 30% of breast cancers have higher than normal levels of a cellular marker called HER2. The amount of HER2 is often measured in breast tissue. A higher level of this marker usually indicates a more aggressive type of breast cancer. Cytokeratin is a second cellular marker found in breast cancer cells. Detection of Circulating cytokeratin in the blood could indicate the presence of cancer. The Pathology Department of the Tom Baker Cancer Center is doing this study to see if measuring the levels of circulating HER2 and cytokeratin, through blood testing has clinical significance for patients with breast cancer.

Detailed description: * Single Variate analysis will be performed to correlate variables such as tumour size, grade, stage, ER status, PR status and biopsy HER2 status with soluble HER2 levels.
* Soluble HER2 levels will be analyzed as both a continuous and categorized variable.
* The analysis will attempt to discern the relationship between soluble HER2 levels, HER2 positive circulating epithelial cell level and treatment response.
* This will provide evidence of the effect various treatments have on HER2 levels. HER2 levels both in patients treated with Herceptin and those on other treatment protocols, will be related to clinical disease measures such as time to progression, time to failure, duration of response and duration of survival.
* An initial model of the relationship between these factors and soluble HER2 as a marker will be established from the data.

Eligibility criteria: Inclusion Criteria:

* Albertan women with breast cancer who will undergo Herceptin therapy as part of their treatment at some point during a one-year period.

Exclusion Criteria:

* Greater than 80 years of age
* Previous cancer diagnosis - (other than skin cancer)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: Alberta Health services
name: Bill Kangerloo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04629469: Low Field and High Field Magnetic Resonance Imaging Assessments on Pediatric Patients
Official title: Low Field and High Field Magnetic Resonance Imaging Assessments on Pediatric Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 250
Sex: ALL
Minimum age (years): 0
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Hyperfine Research, Inc. has taken advantage of technological advances and developed an MRI device that is not only portable, but also uses a very-low magnetic field strength, \[less than 0.2 Tesla or approximately 10 times less\] than the field strength of conventional devices. This critical difference allows HRI to address MRI's core challenges by, first, operating at very low magnetic field strengths, eliminating the need for special rooms or shielding. Second, there are minimal safety concerns regarding ferrous metals near the system, as the field strength is too low to attract metal objects. The removal of metal, including items such as jewelry, belts, etc. from clothing and person, prior to being scanned, is unnecessary. Third, the design constraints faced by conventional MRI systems are lifted at low magnetic field and an open device has been designed to minimize anxiety that may come with claustrophobic patients. All of this is possible while still providing image quality that is clinically relevant to a wide variety of fields, including radiology, neurology, pediatrics, emergency medicine, and others.


Eligibility criteria: Inclusion Criteria

Inpatients at CMH Adele Hall ages 0 days to 22 years are eligible for enrollment.

Exclusion Criteria

No additional sedation will be given as part of this study and that sedation, if already administered, will not be altered for study purposes.

Any patient who has a contraindication to having an MRI, such as:

Non-MRI conditional implanted device or device that is not able to be removed for MRI examination

Primary outcomes:
measure: Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US
timeFrame: Through study completion, an average of one year
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Kansas City
name: Sherwin Chan, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sien ME, Robinson AL, Hu HH, Nitkin CR, Hall AS, Files MG, Artz NS, Pitts JT, Chan SS. Feasibility of and experience using a portable MRI scanner in the neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2023 Jan;108(1):45-50. doi: 10.1136/archdischild-2022-324200. Epub 2022 Jul 4.
Clinical trial NCT01908569: Application of MACS and Time-lapse Technology in Good-prognosis Patients
Official title: Application of MACS (Magnetic-activated Cell Sorting) and Time-lapse Technology (Embryoscope) in Assisted Reproduction Patients With Good Prognosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: MACS Technique Efficacy
Keywords: MACS, time-lapse, embryo, spermatozoid, sperm
Lead sponsor: Vida Recoletas Sevilla
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The MACS technique (magnetic-activated cell sorting) is based on the usage of microbeads, magnetic particles with a diameter of 35 nanometers joined to the compound annexin V. Annexin V is a protein with a high affinity for the molecule phosphatidylserine. This system allow us to eliminate those spermatozoids which have begun the apoptosis and have phosphatidylserine residues on their membrane surface. Using this technique, the apoptotic spermatozoids will join the microbeads and consequently be retained in a column applying a magnetic field.

Recent studies show the benefits of spermatozoid selection using MACS and the improvement in mobility, viability, DNA fragmentation and fertilization potential. It has also been observed an improvement in the embryo cells division rate, clinical pregnancy rates and spermatozoid survival after thawing. However, it is necessary to perform new clinical studies in order to evaluate the real potential of this technology and its safety.

The purpose of this study is to evaluate the effect of the MACS technique on the clinical results of good-prognosis patients who are going through IVF/ICSI treatments in order to achieve a pregnancy.

The hypothesis of this study is that the application of the MACS technique in assisted reproduction treatments is associated with a better embryo quality and pregnancy rates.


Eligibility criteria: Inclusion Criteria:

* \<38 years
* \>10 follicles with a diameter of ≥10 mm the day before the follicular puncture

Exclusion Criteria:

* Patients subject to preimplantation genetic diagnosis treatments

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 14 months
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 14 months
measure: Embryo quality
timeFrame: 14 months
measure: Implantation rate
timeFrame: 14 months
Other outcomes:
Locations:
city: Seville
country: Spain
facility: IVI Sevilla
Study officials:
affiliation: Vida Recoletas Sevilla
name: Victor Blasco, MSc
role: STUDY_CHAIR
affiliation: Vida Recoletas Sevilla
name: Rocío Quiroga, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Vida Recoletas Sevilla
name: Cristina González, PhD
role: STUDY_CHAIR
affiliation: Vida Recoletas Sevilla
name: Cinzia Caligara, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02982369: The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain
Official title: The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: Santa Catarina Federal University
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 90
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 aims to investigate the effects of vertebral manipulation and pain education on subjects with neck pain. For this purpose, 90 subjects who present chronic neck pain will be selected and allocated randomly into 2 groups: vertebral manipulation group and pain education group.


Eligibility criteria: Inclusion Criteria:

* Main complaint of Neck Pain for at least six (6) months;
* Score of at least 10 points in NDI (Neck Disability Index);
* Pain and / or restriction of cervical movements;
* Pain reported at least 3 points on the NPRS (Numeric Pain Rating Scale);
* The definition of the term Neck Pain follows the classification of TFNP.

Exclusion Criteria:

* Previous history of rheumatic disease, cervical myelopathy, tumors, vertebrobasilar insufficiency, central or peripheral neurological disorders;
* History of major trauma, fracture or surgery in the neck, shoulder and/or upper limb;
* Signs of nerve root compression as important muscle weakness affecting the upper limbs, reduction, loss or increase of biceps and triceps reflexes, decreased sensation in the dermatomes of the upper limb;
* Red flags contraindicating spinal manipulation.

Primary outcomes:
measure: Pain Intensity
timeFrame: 4 weeks after randomization
Secondary outcomes:
measure: Cytokines
timeFrame: 4 weeks after randomization
measure: Pressure Pain Threshold
timeFrame: 4 weeks and 3 months after randomization
measure: Disability
timeFrame: 4 weeks and 3 months after randomization
measure: Fear Avoidance Beliefs
timeFrame: 4 weeks and 3 months after randomization
measure: Health-related Quality of Life
timeFrame: 4 weeks and 3 months after randomization
measure: Kinesiophobia
timeFrame: 4 weeks and 3 months after randomization
measure: Pain Intensity
timeFrame: 3 months after randomization
Other outcomes:
Locations:
city: Florianopolis
country: Brazil
facility: Santa Catarina Federal University
state: Santa Catarina
Study officials:
affiliation: Santa Catarina Federal University
name: Adair R Soares dos Santos, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00364169: Prevention of Constipation: Systematic Nursing Interventions to Reduce Postoperative Constipation After Thoracic Surgery
Official title: Systematic Nursing Interventions to Reduce Postoperative Constipation After Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Constipation
Keywords: constipation
cancer
surgery
intervention
nursing
postoperative
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Institute of public health, department of nursing sciences, Århus University, Denmark
First posted: 2006-08-15
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to reduce the incidence of postoperative constipation by systematic nurse assessment, interventions and evaluation, in the first month after thoracic surgery.


Eligibility criteria: Inclusion Criteria:

* Patients admitted for planned lung surgery
* Patients are capable
* Able to talk and understand Danish

Exclusion Criteria:

* Patients with colostomy and / or ileostomy
* Neurological or abdominal diseases
* Feed through a tube

Primary outcomes:
measure: Constipation incidence the first month after surgery
Secondary outcomes:
measure: Defecation pattern measured after The Bristol Stool scale.
measure: ADL (after Sallings functional scale)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Cardiothoracic Surgery, The Heart Center, University hospital Rigshospitalet
Study officials:
affiliation: Department of Cardiothoracic Surgery, The Heart Center, University hospital, Rigshospitalet, Copenhagen, Denmark
name: Lene S. Rasmussen, RN,Stud.-MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiothoracic Surgery, The Heart Center, University hospital Rigshospitalet, Copenhagen, Denmark
name: Lene S. Rasmussen, RN,Stud.-MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT04833569: ICG-PDT, Periimplantitis, Diabetes Mellitus
Official title: Clinical, Bacterial, and Inflammatory Outcomes of Indocyanine Green-mediated Photodynamic Therapy for Treating Periimplantitis Among Diabetic Patients: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peri-Implantitis
Keywords: photodynamic therapy*
periimplantitis*
diabetes mellitus*
indocyanine green*
photosensitizer*
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the effect of photodynamic therapy (indocyanine green mediated) on the clinical, biological and inflammatory aspects was assessed in diabetic patients having peri-implantitis


Eligibility criteria: * Inclusion Criteria:

  * adult patients above 45 years of age having type 2 DM
  * HbA1c (≥6.5%) and fasting glucose test
  * probing depth ≥6 mm with bleeding and/or suppuration on at least one site around dental implants that remained in situ
  * On radiographic assessment, the implants exhibited ≥ 3 mm alveolar bone loss apical to the coronal region of the intraosteal portion of the dental implant.
* Exclusion Criteria Patients were excluded if they indicated current or former history of tobacco smoking, any systemic disease other than DM, enrolled in a non-surgical periodontal maintenance program, history of implant repair, pregnancy, and part six months use of antimicrobials, non-steroidal anti-inflammatory drugs, bisphosphonates, or corticosteroids.

Primary outcomes:
measure: Bleeding on probing
timeFrame: 6 months
measure: Plaque index
timeFrame: 6 months
measure: Probing depth
timeFrame: 6 months
measure: Suppuration
timeFrame: 6 months
measure: Crestal bone loss
timeFrame: 6 months
Secondary outcomes:
measure: Microbiological analysis (Porphyromonas gingivalis)
timeFrame: 6 months
measure: Microbiological analysis (Treponema denticola)
timeFrame: 6 months
measure: HbA1c
timeFrame: 6 months
measure: Interleukin-1 beta
timeFrame: 6 months
measure: Interleukin-6
timeFrame: 6 months
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University
name: Nawwaf Labban, BDS MSD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Labban N, Shibani NA, Al-Kattan R, Alfouzan AF, Binrayes A, Assery MK. Clinical, bacterial, and inflammatory outcomes of indocyanine green-mediated photodynamic therapy for treating periimplantitis among diabetic patients: A randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2021 Sep;35:102350. doi: 10.1016/j.pdpdt.2021.102350. Epub 2021 May 24.
Clinical trial NCT01980069: A Double-blind, Randomized, Parallel Design Study to Compare the Effectiveness of Sugammadex Versus Neostigmine in Improving Surgical Condition in Subjects Undergoing Laryngeal Microsurgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Keywords: Sugammadex
Neostigmine
Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators hypothesized that the surgical condition will be improved with the use of sugammadex in patients undergoing laryngeal microsurgery. Investigators will compare the effect of sugammadex and neostigmine on the surgical condition during laryngeal microsurgery.


Eligibility criteria: Inclusion Criteria:

* adult patients of age over 20 years
* scheduled for laryngeal microsurgery under general anesthesia

Exclusion Criteria:

* anticipated difficult intubation, cervical spine disease, neuromuscular disease, acute or chronic renal failure, liver cirrhosis or liver failure
* history of allergy to nondepolarizing muscle relaxant
* history of malignant hyperthermia
* pregnant woman
* body mass index over 35 kg/m2

Primary outcomes:
measure: surgical condition
timeFrame: up to 1 hour after the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Seodaemun-gu
Study officials:
References:
citation: Kim HJ, Lee K, Park WK, Lee BR, Joo HM, Koh YW, Seo YW, Kim WS, Yoo YC. Deep neuromuscular block improves the surgical conditions for laryngeal microsurgery. Br J Anaesth. 2015 Dec;115(6):867-72. doi: 10.1093/bja/aev368.