louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02271997: Optimizing Iron Suppletion After Roux-en-Y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Iron Deficiency
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 120
Sex: FEMALE
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: Multicentre randomized controlled trial to evaluate the optimal treatment for patients who developed an iron deficiency after Roux-en-Y Gastric bypass.

Detailed description: Morbid obesity is worldwide a still growing problem. The number of bariatric procedures are still increasing with 9000 bariatric operations in 2009. The golden standard is the Roux-en-Y Gastric bypass (RYGB). The RYGB ensures an excess weight loss of 60-70% in our hospital.

Unfortunately vitamin and mineral deficiencies are a consequence from RYGB. Iron deficiency occurs in 14-66% in the first two years after surgery. Worldwide there are three most used options of treatment for this: treatment with ferrous fumarate, ferrous gluconate and intravenous injection of Ferinject.

Our goal is to determine which treatment is the most effective to normalize ferritin values in the blood and which treatment is the most cost-effective one after a RYGB.

Eligibility criteria: Inclusion Criteria:

* all women who underwent a Roux-en-Y gastric bypass and developed an iron deficiency postoperatively (ferritin\<20microgram/L)

Exclusion Criteria:

* iron deficiency peroperative, blood transfusions during study period, iron containing nutritional supplements except the standard multivitamins after bariatric surgery, decreased renal failure, excessive blood loss due to menstruation, anemia not caused by iron deficiency, accumulation of iron, hypersensitivity for noe of the medicinal products, psychiatric illness, pregnancy

Primary outcomes:
measure: normal value serum ferritin
timeFrame: 1 year
Secondary outcomes:
measure: patients preference for oral or intravenous therapy
timeFrame: 1 year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: OLVG West/ Sint Lucas Andreas Ziekenhuis
state: Noord-Holland
city: Arnhem
country: Netherlands
facility: Rijnstate hospital
city: Beverwijk
country: Netherlands
facility: Rose Kruis Ziekenhuis
Study officials:
References:
citation: Schijns W, Boerboom A, de Bruyn Kops M, de Raaff C, van Wagensveld B, Berends FJ, Janssen IMC, van Laarhoven CJHM, de Boer H, Aarts EO. A randomized controlled trial comparing oral and intravenous iron supplementation after Roux-en-Y gastric bypass surgery. Clin Nutr. 2020 Dec;39(12):3779-3785. doi: 10.1016/j.clnu.2020.04.010. Epub 2020 Apr 21.
Clinical trial NCT02113397: Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis Lung
Official title: Comparative Evaluation of Bacterial Diversity and Richness in CF Lung in Patients Who Use Cycled Every Other Month Tobramycin Inhalation Powder (TOBI™ Podhaler™) Or Continuous Alternating Therapy With Tobramycin Inhalation Powder (TOBI™ Podhaler™) and Inhaled Colistimethate
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis
Microbiome
Sputum
Tobramycin
Colistimethate
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2014-04-14
Enrollment: 1
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with cystic fibrosis who are followed at Dartmouth-Hitchcock Medical Center

Brief summary: The purpose of this study is to characterize bacterial diversity and richness in the sputum of cystic fibrosis patients treated with every-other-month TOBI™ Podhaler™ and continuous alternating therapy with TOBI™ Podhaler and colistimethate (Colistin).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cystic fibrosis confirmed by mutation analysis of the cystic fibrosis transmembrane conductance regulator gene
* Sputum or throat swab culture positive for Pseudomonas aeruginosa at or within 6 months of enrollment
* Age ≥12 years
* Forced expiratory volume in one second (FEV1) 25-90 percent-predicted

Exclusion Criteria:

* Age \<18 years
* Inability to routinely expectorate sputum without induction by hypertonic saline
* Inability to provide or withdrawal of written informed consent
* History of aminoglycoside sensitivity or adverse reaction to inhaled antibiotics
* Serum creatinine ≥ 2.0 mg/dl
* Serum blood urea nitrogen (BUN) ≥40 mg/dl
* Pregnancy or lactating at screening
* History of systemic intravenous anti-Pseudomonal antibiotics within 28 days of enrollment

Primary outcomes:
measure: Simpson Diversity Index
timeFrame: 6 months
Secondary outcomes:
measure: Bacterial Relative Abundance
timeFrame: 6 months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
citation: Filkins LM, Hampton TH, Gifford AH, Gross MJ, Hogan DA, Sogin ML, Morrison HG, Paster BJ, O'Toole GA. Prevalence of streptococci and increased polymicrobial diversity associated with cystic fibrosis patient stability. J Bacteriol. 2012 Sep;194(17):4709-17. doi: 10.1128/JB.00566-12. Epub 2012 Jun 29.
citation: Price KE, Hampton TH, Gifford AH, Dolben EL, Hogan DA, Morrison HG, Sogin ML, O'Toole GA. Unique microbial communities persist in individual cystic fibrosis patients throughout a clinical exacerbation. Microbiome. 2013 Nov 1;1(1):27. doi: 10.1186/2049-2618-1-27.
Clinical trial NCT04414683: Factors Affecting the Prognosis of Early Ovarian Cancer
Official title: Factors Affecting the Prognosis of Early Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with early stage ovarian cancer

Brief summary: To elucidate factors affecting survival of early stage ovarian cancer

Detailed description: To analyze factors affecting survival of early ovarian cancer, such as cell type, cell grade, intraoperative rupture, and laparoscopy vs. laparotomy, etc.

Eligibility criteria: Inclusion Criteria:

* early stage ovarian cancer

Exclusion Criteria:

* Nil.

Primary outcomes:
measure: Factors affecting overall survival of early ovarian cancer
timeFrame: 10 years
Secondary outcomes:
measure: Factors affecting progression-free survival of early ovarian cancer
timeFrame: 10 years
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT01083797: Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate
Official title: Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate: a Comparative Study of the Qualitative and Quantitative Electroencephalogram Pattern
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Other Conditions of Brain
Keywords: Sedation
Electroencephalography
Dexmedetomidine
Chloral hydrate
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Santa Casa de Misericórdia de Belo Horizonte
First posted: 2010-03-10
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Maximum age (years): 38
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the use of dexmedetomidine or chloral hydrate for sedation during electroencephalography in patients with neurological disorders. The hypothesis is that this drugs provides similar changes in EEG pattern.

Detailed description: Patients with chronic neurological disorders such as cerebral palsy or autism need to be sedated during electroencephalography (EEG). However, various sedatives and hypnotics affect the outcome of the review and is not shown. Chloral hydrate (CH) is widely used in children, but in this patients it is less effective.Recently, dexmedetomidine (DEX) has been tested because preliminary data suggests that this drug does not affect the EEG. The aim of the present work was to compare the electroencephalogram (EEG) pattern during CH or DEX sedation, to test the hypothesis that both drugs exert similar effects in EEG.Seventeen patients were evaluated during sedation with DEX or CH on separate occasions.The EEG was subjected to qualitative and quantitative analysis. Clinical variables were also compared.

Eligibility criteria: Inclusion Criteria:

* neurological disorder
* behavior disorder
* epilepsy

Exclusion Criteria:

* cardiac disease
* respiratory disease

Primary outcomes:
measure: electroencephalogram pattern
timeFrame: twenty minutes
Secondary outcomes:
measure: Effective sedative
timeFrame: twenty minutes
measure: Adverse effects
timeFrame: Two hours
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Belo Horizonte
state: Minas Gerais
Study officials:
affiliation: Santa Casa de Misericórdia de Belo Horizonte
name: Magda Fernandes
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Minas Gerais
name: Gomez Renato
role: STUDY_DIRECTOR
References:
citation: Lubisch N, Roskos R, Berkenbosch JW. Dexmedetomidine for procedural sedation in children with autism and other behavior disorders. Pediatr Neurol. 2009 Aug;41(2):88-94. doi: 10.1016/j.pediatrneurol.2009.02.006.
citation: Huupponen E, Maksimow A, Lapinlampi P, Sarkela M, Saastamoinen A, Snapir A, Scheinin H, Scheinin M, Merilainen P, Himanen SL, Jaaskelainen S. Electroencephalogram spindle activity during dexmedetomidine sedation and physiological sleep. Acta Anaesthesiol Scand. 2008 Feb;52(2):289-94. doi: 10.1111/j.1399-6576.2007.01537.x. Epub 2007 Nov 14.
Clinical trial NCT03946397: Impact of Multisensory Hand Massage on the Well-being of Cancer Patients
Official title: Impact of Multisensory Hand Massage on the Well-being of Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators wish to study the impact of a multisensory hand massage on the immediate well-being of cancer patients.


Eligibility criteria: Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Patient treated in the oncology department of CHU Nimes for any form of cancer with an EValuation Immédiate du Bien-Etre (EVIBE) score of 3 or lower

Exclusion Criteria:

* The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient allergic to the massage oil
* Patients with visual or auditory problems
* Patients with an infection resulting in hyperthermia
* Patient with hematoma on the hand
* Patient with dermatological problems or painful areas on the hands
* Patients with an EVIBE score greater than 3

Primary outcomes:
measure: Change in well-being following multisensory massage
timeFrame: 30 minutes
Secondary outcomes:
measure: Well-being following multisensory massage
timeFrame: 2 hours
measure: Well-being following multisensory massage
timeFrame: 4 hours
measure: Well-being following multisensory massage
timeFrame: 6 hours
measure: Well-being following multisensory massage
timeFrame: 8 hours
measure: Patient anxiety
timeFrame: Immediately prior to treatment
measure: Patient anxiety
timeFrame: 30 minutes
measure: Patient anxiety
timeFrame: 8 hours
measure: Satisfaction of staff performing the multisensory massage
timeFrame: End of inclusions (12 months)
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Nadine Houede, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05871697: Multifidus & Gastrocnemius Muscle Thickness & Postural Stability in Spinal Cord Injury Patients: A Correlational Study
Official title: The Relationship Between Multifidus and Gastrocnemius Muscle Thickness With Postural Stability in Patients With Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Cord Injuries
Lead sponsor: Uskudar State Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Başakşehir Çam & Sakura City Hospital
First posted: 2023-05-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have spinal cord injury that gave consent to participate.

Brief summary: This study aims to investigate the relationship between multifidus and gastrocnemius muscle thickness with postural stability in patients with spinal cord injury.

Detailed description: Ultrasound imaging will be used to measure multifidus and gastrocnemius muscle thickness in patients with spinal cord injury. Postural stability will be assessed using the Berg Balance Scale, a clinical balance test consisting of 14 items that evaluate an individual's ability to maintain balance during various functional tasks such as standing unsupported, reaching forward, turning, and standing on one leg. The Berg Balance Scale is a reliable and valid clinical balance test that is commonly used in spinal cord injury patients. Statistical methods, including correlation and regression analysis, will be used to analyze the data and investigate the relationship between the multifidus and gastrocnemius muscle thickness and postural stability.

Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed diagnosis of spinal cord injury at least 6 months prior to study enrollment.
* Patients who are able to follow instructions and comply with study procedures.

Exclusion Criteria:

* Patients with severe cognitive impairment or inability to follow instructions.
* Patients with other medical conditions that may affect muscle thickness or postural stability, such as Parkinson's disease, multiple sclerosis, or severe osteoarthritis.
* Patients with contraindications for ultrasound imaging, such as pregnancy or implanted devices that may be affected by the imaging.
* Patients with severe motor deficits that may limit their ability to perform the study procedures.
* Patients who are unable to tolerate the testing procedures, such as the Berg Balance Scale or ultrasound imaging.

Primary outcomes:
measure: Relationship between multifidus thickness and postural stability
timeFrame: 1 day
measure: Relationship between gastrocnemius muscle thickness and postural stability
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Uskudar State Hospital
name: Mustafa H Temel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00337597: Continuous Regional Analgesia After Total Knee Arthroplasty
Official title: Continuous Regional Analgesia After Total Knee Arthroplasty. Normal Saline or Dextrose 5% in Water as Fluid Medium for Pre-Placement Expansion in Order to Facilitate the Catheter Passing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Analgesia
Keywords: Normal saline
Dextrose 5% in water
neurostimulation
Continuous regional analgesia after total knee arthroplasty
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2006-06-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective, comparative and double blind study is aimed to determine if normal saline or dextrose 5% in water will modify the stimulation during the insertion of the stimulating catheter used for continuous femoral and sciatic blocks in total knee replacement.

Detailed description: The operator is blinded to the medium fluid to expand the perineural femoral and sciatic nerves before threading in the stimulating catheter. He records all the electric data of electrolocation of nerve, which will be compared to determine whether or not a difference in intensity is found between normal saline or dextrose 5% in water.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I and II
* Male or non-pregnant female
* 18 - 80 years of age
* Not allergic to iodine or local anesthetics
* Absence of abnormality of coagulation
* Scheduled for total knee replacement

Primary outcomes:
measure: Characteristics of electrolocation of nerve during insertion of the exploring needle and of the stimulating catheter
Secondary outcomes:
measure: Efficacy of post-operative analgesia
timeFrame: during 48 hours
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: Departemental Hospital of la Roche sur Yon
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes UH
name: Charles Pham Dang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00600197: Biopsychosocial Education and Chronic Low Back Pain
Official title: The Effectiveness of Biopsychosocial Education on Quality of Life and Disability of Individuals Suffering From Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-01-24
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether the biopsychosocial educational program could improve patients' health-related quality of life at 3-6-12-18-24-30 and 36 - month follow up.

Detailed description: Little information exists on biopsychosocial educational program as a multidimensional and interdisciplinary program in which Quality Of Life is as an outcome measure. Thus this educational Program designed in this study is a an outpatient program that used a health education approach to empower participants through a process of assessment, education and skill building in three dimensions of physical,mental and social that leading to improved quality of life. The purpose of this study was to examine to what extent this educational Program could improve low back pain patients' HRQOL.

Eligibility criteria: Inclusion Criteria:

* Low Back Pain lasting more than 12 weeks with or without pain radiating to the legs.
* age 18-70 years.

Exclusion Criteria:

* Osteoporosis
* Newly operation on the back up to 2 years before the beginning of the study
* Fresh vertebral fracture
* Malignancy
* Infection in the back
* spondylolisthesis
* Problem in understanding Farsi Language

Primary outcomes:
measure: SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability
timeFrame: before intervention
Secondary outcomes:
measure: SF-36,Roland Morris Disability Questionnaire, Quebec back pain disability
timeFrame: 3-6-12-18-24-30-36 month after intervention
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
affiliation: Tehran University of Medical Sciences
name: Ahmad Re Jamshidi, MD
role: STUDY_CHAIR
References:
citation: Tavafian SS, Jamshidi AR, Mohammad K. Treatment of low back pain: randomized clinical trial comparing a multidisciplinary group-based rehabilitation program with oral drug treatment up to 12 months. Int J Rheum Dis. 2014 Feb;17(2):159-64. doi: 10.1111/1756-185X.12116. Epub 2013 Jun 21.
Clinical trial NCT03839797: Cadet Healthy Personal Skills Intervention Trial
Official title: Adapting, Developing, And Testing An Evidence-Based Life Skills Training Approach For Sexual Assault Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Skills, Social
Skills, Coping
Lead sponsor: National Health Promotion Associates, Inc.
Sponsor class: INDUSTRY
Collaborators: name: United States Air Force
First posted: 2019-02-15
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Half of the squadrons of incoming cadets were randomized to the CHiPS intervention, the other half were randomized to the control condition
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate a new approach to sexual violence prevention by promoting healthy relationships and personal life skills among incoming Air Force cadets at the United States Air Force Academy.

Detailed description: National Health Promotion Associates (NHPA) adapted the Botvin Life Skills Training (LST) program for incoming fourth class cadets at the United States Air Force Academy (USAFA). The resulting adaptation, called Cadet Healthy Personal Skills (CHiPS), provides cadets with the knowledge, attitudes, and skills to enhance their personal resilience, increase their potential for success, help them develop healthy and rewarding personal relationships, and reduce sexual harassment and assault. The CHiPS program includes ten units, spread across three blocks of content, and each block teaches cadets a range of life skills. All incoming fourth class cadets (N=1,203) were invited to participate in this study, beginning in the Summer of 2017, and of those, 1,098 cadets (91.3%) consented to participate in the trial.Twenty-five facilitators were trained to implement the newly adapted CHiPS program. Half of the incoming class \[four Basic Cadet Training (BCT) squadrons\] was assigned to receive the intervention, while the other half (four BCT squadrons) continued to receive standard trainings already in place at USAFA. All cadets completed a self-report survey at pretest, posttest, and at a 12-month follow-up

Eligibility criteria: Inclusion Criteria:

* incoming cadet at USAFA

Exclusion Criteria:

* None

Primary outcomes:
measure: Self-reported sexual acts without consent
timeFrame: Past 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: White Plains
country: United States
facility: National Health Promotion Associates
state: New York
Study officials:
affiliation: National Health Promotion Associates
name: Kenneth W Griffin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Griffin KW, Williams C, Travis W, Tharp A. Prevention of Unwanted Sexual Contact Among Cadets at the United States Air Force Academy: A Brief Small-Group Intervention. Am J Public Health. 2021 Apr;111(4):672-674. doi: 10.2105/AJPH.2020.306050. Epub 2021 Jan 21.