louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04522388: Examining the Effect of Nutritional Supplementation on Skeletal Muscle Mass in Patients Awaiting Lung Transplant
Official title: A Pilot Study Examining the Effect of Nutritional Supplementation on Skeletal Muscle Mass in Patients Awaiting Lung Transplant
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Transplant; Complications
Keywords: pre-hab
nutrition
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Abbott Nutrition
First posted: 2020-08-21
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Ensure Enlive, Nutritional shake, twice a day
Primary purpose: TREATMENT

Brief summary: This non-randomized pilot study aims to investigate whether a protein rich nutritional shake (Ensure Enlive) given to patients pre-transplant will decrease skeletal muscle loss (measured by quadriceps ultrasound) and improve nutritional state (measured by Nutritional Risk Index). A nutritional supplement would be a cost-effective solution to treat malnutrition, a known risk factor implicated in poor outcomes for lung transplant recipients.


Eligibility criteria: Inclusion Criteria:

* Subjects 18 years or older who are listed for single or double lung transplant
* Subject provides written informed consent to participate in this study

Exclusion Criteria:

* Subject with history of Galactosemia
* Subject with history of milk protein allergy
* Subject with history of soy protein allergy

Primary outcomes:
measure: Effect of nutritional supplementation on skeletal muscle mass as assessed by ultrasound of the quadriceps
timeFrame: Pre-transplant
Secondary outcomes:
measure: Effect of nutritional supplementation on Nutritional Risk index as assessed by serum albumin level
timeFrame: Pre-transplant
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Errol Bush, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu J, Krishnan A, Lin CT, Shah PD, Broderick SR, Higgins RSD, Merlo CA, Bush EL. Sarcopenia of the Psoas Muscles Is Associated With Poor Outcomes Following Lung Transplantation. Ann Thorac Surg. 2019 Apr;107(4):1082-1088. doi: 10.1016/j.athoracsur.2018.10.006. Epub 2018 Nov 14.
citation: Chamogeorgakis T, Mason DP, Murthy SC, Thuita L, Raymond DP, Pettersson GB, Blackstone EH. Impact of nutritional state on lung transplant outcomes. J Heart Lung Transplant. 2013 Jul;32(7):693-700. doi: 10.1016/j.healun.2013.04.005. Epub 2013 May 9.
Clinical trial NCT03848988: Descriptive Analysis: STarT Back Screening Tool: Cross-sectional Survey & Chart Review
Official title: A Descriptive Analysis of Back Pain Patient's Seeking Care at Chiropractic Academic Teaching Clinics Using the STarT Back Screening Tool: Cross-sectional Survey and Chart Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Back Pain
Keywords: Chiropractic
Screening tool
Teaching
Lead sponsor: Parker University
Sponsor class: OTHER
Collaborators: name: Baylor Scott and White Health
name: Private Practitioner
First posted: 2019-02-21
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New LBP patients presenting to a chiropractic teaching clinic in Dallas, TX

Brief summary: Keele STarT Back SCreening Tool (KSB) is a practical and validated bio-psychosocial questionnaire that stratifies lower back pain patients into 3 risk groups (low, medium, high), with suggested treatment guidelines for each grouping. The 9-question KSB has been used in chiropractic practice to help guide medical decision making, but its use in chiropractic teaching environments has been limited.

Detailed description: All new LBP patients between the ages of 18-65 years presenting to a chiropractic teaching clinic in Dallas, TX between March 05, 2018 and April 06, 2018 were asked to complete the KSB questionnaire. No introduction of the KSB was given to students or faculty. For all patients that completed the KSB, a chart review of the first 4 weeks of care was completed to retrieve patient follow-up information and treatment provided, including: self-reported LBP on a 10-point numerical rating scale (NRS), region of spinal manipulation therapy (SMT), and active rehabilitation provided.

Eligibility criteria: Inclusion Criteria:

* Patients between the age of 18-65 years old.

Exclusion Criteria:

* None

Primary outcomes:
measure: Chiropractic care Questionnaire
timeFrame: 4 weeks
Secondary outcomes:
measure: Low back pain self reported
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parker University
state: Texas
Study officials:
References:
Clinical trial NCT00004288: Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ankylosing Spondylitis
Keywords: ankylosing spondylitis
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Rochester
First posted: 1999-10-19
Enrollment: 4
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Assess the safety and efficacy of olsalazine, a dimer of 5-aminosalicylic acid, in men with ankylosing spondylitis unresponsive to nonsteroidal anti-inflammatory drugs and physiotherapy.

Detailed description: PROTOCOL OUTLINE: Patients are treated with daily olsalazine. The dose is increased each week until the protocol dose is reached.

Supplemental acetaminophen is allowed; nonsteroidal anti-inflammatory drugs continue unchanged. Concurrent sulfasalazine is prohibited.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Meets modified New York diagnostic criteria
* Active disease, i.e., morning stiffness for more than 30 minutes
* Failed or experienced nonlife-threatening reaction to prior sulfasalazine
* No significant hematologic, hepatic, or renal disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester
name: Samuel H. Zwillich
role: STUDY_CHAIR
References:
Clinical trial NCT05891288: Sealing of Initial Occlusal Caries Using Fissure Sealants
Official title: Sealing of Initial Occlusal Caries in Fissures of Permanent Molars Using Bioactive Versus Fluoride Releasing Fissure Sealants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries; Initial
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing resin based pits and fissure sealant in initial carious lesions of fissures in posterior molars in patients at risk of caries. Visual tactile examination and VistaCAM will be used for evaluation.

Detailed description: SmartCap™ Technology, which is used in the novel bioactive fissure sealant, is based on proprietary semi-permeable resin microcapsules. The rechargeable SmartCap microcapsules in BioCoat are packed with ionic fluoride, calcium, and phosphate solutions that diffuse in and out of the sealant. It is hypothesized that fluoride uptake is increased in the presence of calcium and phosphate ions.

With little evidence-based information in the literature about using bioactive fissure sealants to seal initial carious lesions, it was determined that a randomized controlled trial would be beneficial in testing the null hypothesis that bioactive resin pits and fissure sealant will have the same clinical performance as fluoride releasing resin-based pits and fissure sealant in fissures with initial caries.

Eligibility criteria: Inclusion Criteria:

* Patients with bilateral initial carious fissures in molars showing no signs of caries.
* Co-operative patients approving to participate in the trial.

Exclusion Criteria:

* Sound fissures.
* Pregnancy.
* Disabilities.
* Systemic disease or severe medical complications.
* Rampant caries.
* Heavy smoking.
* Xerostomia.
* Lack of compliance.
* Evidence of severe bruxism, clenching, or tempromandibular joint disorders.

Primary outcomes:
measure: Retention of sealant
timeFrame: 2 years
Secondary outcomes:
measure: Caries incidence
timeFrame: 2 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
state: El Manial
Study officials:
affiliation: Lecturer, Department of Conservative Dentistry
name: Omar Shaalan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03133988: Margetuximab Expanded Access Program
Official title: An Expanded Access Program Providing Margetuximab in the Treatment of HER2+ Metastatic Breast Cancer in Single, Individually-approved Patients
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: HER2-positive Breast Cancer
HER2-positive Carcinoma
Lead sponsor: TerSera Therapeutics LLC
Sponsor class: INDUSTRY
First posted: 2017-04-28
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of the Expanded Access program is to provide margetuximab to patients with pretreated HER2+ breast cancer for whom potential benefit justifies potential treatment risks.

Detailed description: TerSera Therapeutics LLC (TerSera) will consider, on a case-by-case basis, requests by treating physicians to file a single patient investigational new drug application for expanded access to margetuximab and for TerSera to supply margetuximab for single patient use.

Eligibility criteria: Inclusion Criteria:

* TerSera may consider requests on a case-by-case basis from treating physicians for patients not otherwise eligible for margetuximab clinical studies.
* Treating physicians should consider approved therapies for a patient's disease, as well as ongoing clinical studies, before seeking expanded access use with an investigational agent.

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06521788: Artificial Intelligence Assisted Breast Ultrasound in Breast Cancer Screening
Official title: Application Research of B-ultrasound Assisted by Artificial Intelligence in Breast Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Screening
Keywords: Cancer epidemiology
Artificial intelligence
Ultrasound
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 21790
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: AIBU is a randomized, open-label study assessing the effectiveness of an articificial intelligence-assisted breast ultrasound breast cancer screening strategy compared to standard screening (according to the current local guidelines in each participating area) in detecting late-stage breast cancers.

Detailed description: we enrolled asymptomatic women Women From January 2021 to December 2022, and then followed up for the next 1 year. The main study endpoint will be measured at the end of the one year after intervention.

Eligibility criteria: Inclusion Criteria:

* Women aged 35-70 who participated in breast cancer screening (Shanghai Rural Women "Women two cancer screening project", national major public health service project "Rural women breast cancer screening Project" and "Gynecological diseases and breast diseases screening project for retired and living difficult women") in Shanghai district

Exclusion Criteria:

* 1. Personal history of breast carcinoma, either invasive or ductal carcinoma in situ (DCIS); 2. Personal history of any types of malignant neoplasms; 3. Known condition or suspicion of severe cardiopulmonary insufficiency, liver and kidney insufficiency and other systemic diseases; 4. Known condition or suspicion of serious comorbidities and average life expectancy less than 5 years; 5. History of lateral or bilateral mastectomy; 6. Disagree to participate in the study and follow-up interviews.

Primary outcomes:
measure: Incidence rate of early breast cancer in each arm
timeFrame: 4 years
Secondary outcomes:
measure: Sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods
timeFrame: 4 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Maternal and Infant Healthy Centre of Hongkou District, Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Shanghai Pudong New Area Healthcare Hospital For Women & Children
Study officials:
affiliation: Fudan University
name: Ying Zheng
role: STUDY_CHAIR
References:
Clinical trial NCT00439088: Try Walking a Mile in These Shoes: Activity Level of Lower Extremity Amputees
Official title: Comparison of the Patient Activity Monitor to a Pedometer During Ambulation Monitoring of Transtibial Amputees
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputee
Keywords: Ambulation
Ambulatory Monitoring
Activities of Daily Living
Pedometer
Validation Studies [PT]
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2007-02-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to compare the accuracies of the Patient Activity Monitor to that of a standard pedometer during a walking task and some day-to-day activities in a simulated apartment setting.

Detailed description: The ability to accurately measure daily activity levels in lower extremity amputee patients is important for a better understanding of their use of prosthetic limbs. Most studies have shown that patients often report their activity level inaccurately. More objective data on activity levels will not only provide information helpful for determining the appropriate prosthetic components for an individual, it will also be helpful when assessing the effects that medical illness have on activity levels and in objectively determining the benefits of rehabilitation. In addition, being able to measure activity accurately will allow further verification of currently developed clinical surveys designed to determine amputee activity in a practical form.

Until more recently a practical, accurate and affordable means of monitoring lower extremity amputee activity has not been available for use. Currently a monitoring device designed specifically for this task is available for research use. It is called the Patient Activity Monitor (PAM). Many different models of more generic activity monitoring devices, called pedometers, also exist and need to be further tested in the amputee population.

The objective of our study was to measure and compare the step count and ambulation distance accuracies of a Yamax Digi-Walker pedometer and the PAM in transtibial amputees at the K3 Level within a simulated apartment setting and during relatively continuous gymnasium walking.

Eligibility criteria: Inclusion Criteria:

* Unilateral transtibial amputees who were identified as community level ambulators (K-Level 3)

Exclusion Criteria:

* Malfunction of prosthesis; or
* New medical co-morbidities that impacted on ambulation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Rehabilitation Centre
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Meridith B Marks, M.D., M.ed
role: STUDY_DIRECTOR
References:
Clinical trial NCT00636688: Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial
Official title: Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Keywords: Obesity
Lifestyle changes
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2008-03-14
Enrollment: 110
Sex: MALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Healthy lifestyle factors are associated with maintenance of erectile function in men. To determine the effect of weight loss and increased physical activity on erectile and endothelial functions in obese men.

Randomized, single-blind trial of 110 obese men without diabetes, hypertension, or hyperlipidemia, who had erectile dysfunction that was determined by having a score of 21 or less on the International Index of Erectile Function (IIEF).

The 55 men randomly assigned to the intervention group received detailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity. Men in the control group (n = 55) were given general information about healthy food choices and exercise.


Eligibility criteria: Inclusion Criteria:

* Obese, sedentary (\<1 hour per week of physical activity) men with erectile dysfunction (a IIEF score lower than 22)and no evidence of participation in diet reduction programs within the last 6 months

Exclusion Criteria:

* Diabetes mellitus or impaired glucose tolerance (plasma glucose levels of 140-200 mg/dL \[7.8-11.1 mmol/L\] 2 hours after a 75-g oral glucose load)
* Impaired renal function, including macroalbuminuria, pelvic trauma, prostatic disease, peripheral or autonomic neuropathy
* Hypertension (blood pressure \>140/90 mm Hg)
* Cardiovascular disease
* Psychiatric problems
* Use of drugs or alcohol abuse (500 g of alcohol per week in the last year).

Primary outcomes:
measure: IIEF (International Index Erectile Function)
timeFrame: two years
Secondary outcomes:
measure: Endothelial function, Circulating inflammatory markers
timeFrame: two years
Other outcomes:
Locations:
Study officials:
affiliation: Department of Geriatrics and Metabolic Diseases, SUN Naples, Italy
name: Dario Giugliano, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Bacon CG, Mittleman MA, Kawachi I, Giovannucci E, Glasser DB, Rimm EB. Sexual function in men older than 50 years of age: results from the health professionals follow-up study. Ann Intern Med. 2003 Aug 5;139(3):161-8. doi: 10.7326/0003-4819-139-3-200308050-00005.
citation: Esposito K, Giugliano F, Di Palo C, Giugliano G, Marfella R, D'Andrea F, D'Armiento M, Giugliano D. Effect of lifestyle changes on erectile dysfunction in obese men: a randomized controlled trial. JAMA. 2004 Jun 23;291(24):2978-84. doi: 10.1001/jama.291.24.2978.
Clinical trial NCT00992888: Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis
Official title: Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis. A Pato-etiological Study With Focus on the Endotoxin Pathway.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholic Hepatitis
Keywords: Alcoholic Hepatitis
Alcohol
Endotoxin
LPS
Liver dialysis
Innate immunity
Toll Like receptors
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2009-10-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the role of endotoxins and the endotoxin mediated immune activation pathway in patients with alcoholic hepatitis. Also, to determine the effect of Liver assist (liver dialyses) intervention on these parameters in patients with severe alcoholic hepatitis.


Eligibility criteria: Inclusion Criteria:

Patients with alcoholic hepatitis based on the following criteria

* Alcohol intake for 6 consecutive months above 40g /day, at admission or 3 months earlier.
* Serum bilirubin level above 80 mmol/l
* exclusion of other types of liver disease.
* Liver biopsy when diagnosis is unclear.

Exclusion Criteria:

* Heart failure
* Pregnancy
* non fluent danish speakers

Primary outcomes:
measure: Serum endotoxin levels
timeFrame: one year
Secondary outcomes:
measure: Endotoxin activation pathway proteins
timeFrame: 1 year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Medicine V, Aarhus University Hospital
Study officials:
affiliation: Department of Medicine V, Aarhus University Hospital
name: Hendrik Vilstrup, Prof
role: STUDY_DIRECTOR
References:
citation: Stoy S, Dige A, Sandahl TD, Laursen TL, Buus C, Hokland M, Vilstrup H. Cytotoxic T lymphocytes and natural killer cells display impaired cytotoxic functions and reduced activation in patients with alcoholic hepatitis. Am J Physiol Gastrointest Liver Physiol. 2015 Feb 15;308(4):G269-76. doi: 10.1152/ajpgi.00200.2014. Epub 2014 Dec 11.
Clinical trial NCT05974488: The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE
Official title: The Efficacy of Distal Pharyngeal Airway in Enhancing Oxygenation During Transesophageal Echocardiography (TEE) in Patients Sedated with Propofol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Airway Obstruction
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 50
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 purpose of this study is to investigate the effect of using the McMurray Enhanced Airway (MEA) which is a flexible extended-length distal pharyngeal airway on improving oxygen delivery compared to standard nasal cannula.


Eligibility criteria: Inclusion Criteria:

* Age \> or = 18 years old
* Patients willing to participate and provide an informed consent
* Patients scheduled to undergo an elective TEE procedure.

Exclusion Criteria:

* Patients with history of uncontrolled gastroesophageal reflux disease
* Patients with anatomical airway obstruction
* Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements

Primary outcomes:
measure: Incidence of hypoxia
timeFrame: during procedure (up to 60 minutes)
Secondary outcomes:
measure: Incidence of subclinical hypoxia
timeFrame: during procedure (up to 60 minutes)
measure: Incidence of severe Hypoxia
timeFrame: during procedure (up to 60 minutes)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Fouad G Souki, MD
role: PRINCIPAL_INVESTIGATOR
References: