louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02043782: Investigation of a New 1-piece Convex Ostomy Product
Official title: Investigation of a New 1-piece Convex Ostomy Product in Subjects With Ileostomy and Colostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Ileostomy
Stoma Colostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2014-01-23
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the investigation was to investigate the performance and safety of a new ostomy product


Eligibility criteria: Inclusion Criteria:

* Are at least 18 years of age and have full legal capacity.
* Have had an ileostomy/colostomy for more than 3 months
* Have used a 1-piece flat ostomy product for the last 1 month
* Has given written Informed Consent and signed the letter of authority
* Have an ileostomy or colostomy with a diameter of 33 mm or less
* Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
* Are evaluated to be suitable for a soft convex product
* If having a colostomy: changes their product on average 2 times pr. 24h or more
* Currently uses a bag of size medi/midi or maxi

Exclusion Criteria:

* Have a loop ostomy (also called double-barrel or ostomy with two outlets).
* Are pregnant or breastfeeding
* Currently receiving or have within the past 2 month received radio- and/or chemotherapy
* Currently receiving or have within the past month received systemic or local steroid treatment in the peristomal area
* Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
* Known hypersensitivity toward any of the test products
* Participating in other interventional clinical investigations or have previously participated in this investigation
* Use irrigation during the investigation (flush the intestine with water)
* Have a fistula in the peristomal area or less than 2 cm from the edge of the baseplate
* If subject has a colostomy: empties the bag

Primary outcomes:
measure: Degree of Leakage
timeFrame: 14 +/- 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Søborg
country: Denmark
facility: TFS
Study officials:
affiliation: Coloplast A/S
name: Birte P Jakobsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04517682: COVID-19 and SARS-CoV-2 Detection in Saliva
Official title: SARS -CoV-2 Detection in Saliva Samples: A Test Validation Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: RNA Virus Infections
Keywords: Detection
Lead sponsor: Ambry Genetics
Sponsor class: INDUSTRY
Collaborators: name: The Saratoga Hospital
name: St. Joseph Hospital of Orange
name: Crozer-Keystone Health System
First posted: 2020-08-18
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be comprised of individuals age 18 years or older who are willing and able to provide verbal consent to provide a saliva sample AND a NP swab. The number of participants required is estimated to be 300 individuals whose infection status is unknown or 50 infection positive individuals and 50 infection negative individuals. The population will generally be symptomatic for, or at high risk of COVID-19 disease by criteria set forth in local testing sites. In addition, investigators will collect paired NP swabs and saliva from an equivalent size cohort of individuals known or suspected to NOT be infected with SARS-CoV-2.

Brief summary: This study aims to validate the use of human saliva as a substrate for an assay to detect SARS-CoV-2 and define accuracy, analytical sensitivity and specificity of the TaqPath RT-PCR test.

Detailed description: Investigators will carry out validation of a laboratory assay to detect SARS-CoV-2 nucleic acids in human saliva samples. Data for the validation will include the test results from standard nasopharyngeal (NP) swabs (controls) AND matched saliva samples (experimental group) of individuals who are either known to be infected or at high risk of being infected. Investigators hypothesize that the performance of an assay designed specifically for saliva will not perform differently, as defined by a predetermined margin, from the standard assay performed on NP and other respiratory samples

Eligibility criteria: Inclusion Criteria:

* Reads and understands English or Spanish
* Willing and able to provide consent
* Diagnosed with COVID-19 or at high risk of disease based on objective criteria

Exclusion Criteria:

* Unwilling or unable to provide consent.
* Pregnant female

Primary outcomes:
measure: Detection of COVID-19 SARs-CoV-2 in saliva samples versus nasopharyngeal samples
timeFrame: up to 7 days
Secondary outcomes:
Other outcomes:
measure: Reason for testing
timeFrame: Baseline
measure: Current symptom status
timeFrame: Baseline
measure: Current symptoms
timeFrame: Baseline
measure: Prior symptoms
timeFrame: Baseline
measure: Date of first symptom or number of days since first symptom.
timeFrame: Baseline
measure: Previous test for COVID-19 and date of test.
timeFrame: Baseline
Locations:
city: Aliso Viejo
country: United States
facility: Ambry Genetics
state: California
Study officials:
affiliation: Ambry Genetics
name: Brigette Tippin Davis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02765282: Automated Deep Brain Stimulation Programming Using Functional Mapping
Official title: Automated Deep Brain Stimulation Programming Using Functional Mapping
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Deep brain stimulation (DBS)
Kinesia
Lead sponsor: Great Lakes NeuroTechnologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Wake Forest University Health Sciences
name: Ohio State University
name: Wake Forest University
First posted: 2016-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Participants will undergo DBS programming guided by the DBS-Expert system and by a clinician per standard care.


Eligibility criteria: Inclusion Criteria:

* The ability to provide informed consent
* Clinical diagnosis of idiopathic Parkinson's disease (PD)
* Implanted deep brain stimulation (DBS) system for tremor and/or bradykinesia

Exclusion Criteria:

* Significant medical or psychiatric illness or dementia as evidenced by a score less than 26 on the Montreal Cognitive Assessment
* Not capable of functioning independently
* Individuals so symptomatic as to compromise safety

Primary outcomes:
measure: Programming time when programmed using Kinesia-based assessment (DBS-Expert) compared to programming time when programmed by a clinician
timeFrame: Up to 2 hours (from start of programming session until end of programming session)
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Great Lakes NeuroTechnologies Inc.
name: Dustin A Heldman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04580082: ADHOC Mindfulness-Based Research
Official title: ADHOC Mindfulness-Based Research - An Intervention to Address Loneliness Among Older People Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Loneliness
Depression
Anxiety
Lead sponsor: Mazonson & Santas Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 202
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The AMBR Study (ADHOC Mindfulness-Based Research Study) is a randomized controlled trial that examines the effectiveness of teaching mindfulness-based techniques through online lessons to combat loneliness, anxiety, and depression among people living with HIV over the age of 50. It is a substudy of the ADHOC study (ClinicalTrials.gov identifier NCT04311554).

Detailed description: The AMBR Study is a randomized controlled trial that examines the effectiveness of teaching mindfulness-based techniques through online lessons to combat loneliness, anxiety, and depression among people living with HIV who are over the age of 50 and enrolled in ADHOC (ClinicalTrials.gov identifier NCT04311554). The intervention consists of 14 mindfulness audio lessons, each approximately 20-minutes long. The mindfulness lessons are designed to develop three core skills: concentration (the ability to maintain focus on present-moment experiences), clarity (the ability to pinpoint exactly what you are experiencing in each moment), and equanimity (openness to experience).

Eligibility criteria: Inclusion Criteria:

* ADHOC participant with a score of 4 or higher on the 3-item Loneliness Questionnaire from their ADHOC profile
* Clinical diagnosis of HIV
* Able to read and write in English
* Able and willing to provide online informed consent and complete study activities online
* Access to a smartphone or computer

Exclusion Criteria:

- Acute medical problem(s) requiring immediate inpatient treatment

Primary outcomes:
measure: Loneliness
timeFrame: Baseline and follow-up, 25 days
Secondary outcomes:
measure: Anxiety
timeFrame: Baseline and follow-up, 25 days
measure: Depression
timeFrame: Baseline and follow-up, 25 days
Other outcomes:
Locations:
city: Larkspur
country: United States
facility: Mazonson & Santas Inc
state: California
Study officials:
affiliation: Mazonson & Santas Inc.
name: Peter Mazonson, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06229782: Orbital Artery Doppler Ultrasound in Brain Death
Official title: Orbital Artery Doppler Ultrasound as an Ancillary Test for Diagnosing Brain Death: a Prospective, Single Blind Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Death
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-01-29
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Brain death is the irreversible loss of all activity in the brain, brainstem, and cerebellum, the part of the central nervous system that remains inside the skull.

The clinical diagnosis of brain death should be supported by ancillary tests that provide information about cerebral blood flow or electrical activity in the brain. Some of the ancillary tests that evaluate cerebral blood flow include transcranial Doppler ultrasonography (TDUS), computed tomography (CT) angiography (CTA), and catheter-based cerebral angiography.

This study hypothesized that Orbital Doppler ultrasonography (ODUS) alone is more effective than TDUS in detecting intracranial blood flow in diagnosing brain death. To this end, the investigators examined the results of ODUS in patients diagnosed as brain dead who underwent CT angiography.


Eligibility criteria: Inclusion Criteria:

* suspected brain death

Exclusion Criteria:

* eye surgery,
* uncontrolled diabetes mellitus,
* facial trauma,
* hypothermia,
* hypotension (systolic pressure \< 100 mm Hg)
* endocrine-metabolic coma

Primary outcomes:
measure: ODUS
timeFrame: 30 minutes
measure: Resistive index (RI)
timeFrame: 30 minutes
Secondary outcomes:
measure: Transcranial Doppler ultrasound (TDUS)
timeFrame: 30 minutes
measure: Cerebral blood flow (CTA)
timeFrame: 40 minutes
measure: Optic nerve diameter
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,
Study officials:
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: Korgün Ökmen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01705782: The Effects of Amino Acid Supplement During Acute Inflammation.
Official title: Metabolic Effects of Endotoxin Induced Acute Inflammation in Healthy Young Men With and Without Supplement of Amino Acids.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Febrile Illness Acute
Inflammation
Metabolic Diseases
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 8
Sex: MALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the metabolic effects during acute inflammation with and without the nutritional supplement of amino acids.

E. Coli Endotoxin (LPS, lipopolysaccharide) is used to initiate an inflammatory response.

The study is an interventional randomized placebo study including 8 healthy male subjects. Each subject participates 3 times (different days) and are given one of following interventions:

* Placebo (NaCl)
* Endotoxin, US standard reference E.Coli + Placebo (NaCl)
* Endotoxin, US standard reference E.Coli + Amino acids (intravenously)

It is our hypothesis that the nutritional intervention during acute inflammation plays an important role in lipid and protein metabolism.


Eligibility criteria: Inclusion Criteria:

* male gender
* 20\<BMI\<30
* Age \> 25 years old
* Written consent before starting the study

Exclusion Criteria:

* Allergy for soya products ore egg
* Diabetes
* Epilepsy
* Infection
* Immune defects
* Heart disease
* Dysregulated hypertension
* Participating in other trials using radioactive tracers or x-rays the last year.

Primary outcomes:
measure: Protein catabolism during acute illness
timeFrame: After 6 hours intervention
Secondary outcomes:
measure: The local effects on muscle and fat tissue
timeFrame: At 2 hours and 4,5 hours
measure: Other systemic metabolic effects during acute illness
timeFrame: 6 hours
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Medical Department MEA, NBG, Aarhus University Hospital
state: Jylland
Study officials:
References:
citation: Vladimirova YV, Molmer MK, Antonsen KW, Moller N, Rittig N, Nielsen MC, Moller HJ. A New Serum Macrophage Checkpoint Biomarker for Innate Immunotherapy: Soluble Signal-Regulatory Protein Alpha (sSIRPalpha). Biomolecules. 2022 Jul 4;12(7):937. doi: 10.3390/biom12070937.
citation: Rittig N, Bach E, Thomsen HH, Pedersen SB, Nielsen TS, Jorgensen JO, Jessen N, Moller N. Regulation of Lipolysis and Adipose Tissue Signaling during Acute Endotoxin-Induced Inflammation: A Human Randomized Crossover Trial. PLoS One. 2016 Sep 14;11(9):e0162167. doi: 10.1371/journal.pone.0162167. eCollection 2016.
citation: Rittig N, Bach E, Thomsen HH, Johannsen M, Jorgensen JO, Richelsen B, Jessen N, Moller N. Amino acid supplementation is anabolic during the acute phase of endotoxin-induced inflammation: A human randomized crossover trial. Clin Nutr. 2016 Apr;35(2):322-330. doi: 10.1016/j.clnu.2015.03.021. Epub 2015 Apr 9.
Clinical trial NCT04812782: Dietary Fat and Endothelial Function in Type 1 Diabetes
Official title: Influence Of Extra Virgin Olive Oil and Butter on Endothelial Function in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Endothelial function
FMD
gastric emptying
post prandial glycemia
dietary fat
EVOO
butter
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross-over, interventional, controlled study.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effects of the add-on of extra vergin olive oil or butter to a high glycemic index meal on endothelial function in subjects with type 1 Diabetes and healthy subjects.

Detailed description: Impaired endothelial function is an early manifestation of atherosclerosis and predictor of incident cardiovascular events. Diabetes affects arterial vasodilation by reducing the bioavailability of NO and more in general affecting the balance between the atheroprotective and atherothrombotic properties of the endothelium. A consistent number of studies has so far documented that Mediterranean-style diet associates with reduced risk of cardiovascular diseases and diabetes. Intake of extra virgin olive oil (EVOO), that is a common but not necessary ingredient of the Mediterranean diet, seems to further enhance the beneficial cardiovascular effect and reduce the incidence of diabetes. We have designed the present study to test whether EVOO supplementation acutely influences endothelial function in T1DM. EVOO supplementation wil be compared to butter supplementation in the context of a high glycemic index (GI) meal that is known to increase PP glycemic burden.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years,
* diagnosis of type 1 diabetes since at least 1 year,
* HbA1c \<8.5% (69 mmol/mol),
* stable insulin therapy for at least 3 months before the enrolment into the study

Exclusion Criteria:

* pregnancy, celiac disease, history of cardiovascular diseases, hypertension, hyperlipidemia, retinopathy, nephropathy, neuropathy, and ongoing treatment with vasoactive drugs.

Primary outcomes:
measure: Change of Endothelial function from pre meal to post meal period
timeFrame: before meal, 1 hour, 3 hour, 5 hour after meal
Secondary outcomes:
measure: Serum glucose
timeFrame: before meal, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour after meal
measure: Gastric emptying rate
timeFrame: before meal, 15, 90, 120, 180, 240, 300 minutes after meal
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: University Magna Graecia
Study officials:
References:
Clinical trial NCT02711982: Surgery for Traumatic Optic Neuropathy
Official title: Clinical Treatment of Traumatic Optic Neuropathy: Optic Nerve Decompression Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Optic Neuropathy
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
First posted: 2016-03-17
Enrollment: 2
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The pathophysiology of Traumatic Optic Neuropathy (TON) include a primary and secondary mechanism of injury. At present, no studies validate a particular approach to the management of TON. There are three management lines for these patients that include 1)observation only;2)medical treatment with high or megadoses of methylprednisolone; and 3)surgical intervention. Studies have shown that forces applied to the frontal bone and malar eminences are transferred and concentrated in the area near the optic canal. The tight adherence of the optic nerve's dural sheath to the periosteum within the optic canal is also thought to contribute to this segment of the nerve being extremely susceptible to the deformative stresses of the skull bones. In this study, investigators aim to make a randomized controlled trial to certify the efficiency of optic nerve canal decompression for TON patients.

Detailed description: surgical intervention's efficiency and outcome for TON patients will be clearly present after this randomized controlled trial study.

Eligibility criteria: Inclusion Criteria:

* Patients with the history of Traumatic Brain Injury or Craniofacial Trauma
* Optic nerve compression（intraneural edema, nerve sheath hematoma or canal fracture with impingement)
* Amplitude and latency abnormal or Ratio of amplitude of abnormal to normal side.

Exclusion Criteria:

* Glasgow Coma Scale，Score\<8
* Patients with good Visual Acuity and Visual Evoked Potential amplitude ratio more than 50%
* Other Contraindications for surgery

Primary outcomes:
measure: Amplitude and Latency of Visual-Evoked Potential
timeFrame: from trauma day to 60 days after trauma
Secondary outcomes:
measure: Vision level of Visual Acuity
timeFrame: from trauma day to 60 days after trauma
Other outcomes:
Locations:
city: ShangHai
country: China
facility: Department of Neurosurgery,ShangHai ChangZheng Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Lijun Hou, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05616182: Application of LARS Ligament in Bone Prosthesis Replacement
Official title: A Prospective, Real-world, Single-center, Cohort Study of LARS Ligaments in Bone Tumors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Malignant Tumor
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2022-11-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing LARS ligament and bone prosthesis replacement

Brief summary: This is a single-center, prospective, real-world observational study designed to enroll all patients eligible for enrollment. Basic data, treatment methods, postoperative complications and limb function were collected. The differences in postoperative complications, postoperative limb function and so on between patients who underwent LARS ligament implantation and bone prosthesis replacement (ligament group) and patients who underwent bone prosthesis replacement (control group) were compared.

Detailed description: This is a single-center prospective real-world observational study of 100 eligible patients with bone tumors who are scheduled to undergo LARS ligament implantation and/or bone prosthesis replacement in Henan Cancer Hospital in the next 10 years. Basic data, treatment methods, postoperative complications and limb function were collected. The differences in postoperative complications, postoperative limb function and so on between patients who underwent LARS ligament implantation and bone prosthesis replacement (ligament group) and patients who underwent bone prosthesis replacement (control group) were compared.

Eligibility criteria: Inclusion Criteria:

Men and women of all ages are welcome.

Pathologically confirmed in our hospital as a subtype of malignant tumor.

He received LARS ligament and bone prosthesis replacement at our hospital.

Exclusion Criteria:

Not Applicable.

Primary outcomes:
measure: Postoperative complications
timeFrame: From surgery to 24 months after surgery
measure: Limb function
timeFrame: Patients were enrolled until 24 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Department of Bone and Soft Tissue ,Henan Cancer Hospital
state: Henan
Study officials:
References: