louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01689441: Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis
Official title: Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Severe Sepsis or Septic Shock
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Observational studies among critically ill patients have shown strong associations between vitamin D deficiency and adverse outcomes, including increased length of stay, infection, and mortality. It is unknown whether vitamin D deficiency contributes directly to adverse outcomes or whether it is simply a biomarker of severity of illness or overall health status. However, vitamin D plays a key role in host defense, largely by stimulating production of the anti-microbial peptide cathelicidin (LL-37). We will test the hypothesis that administration of activated vitamin D (calcitriol) will increase serum levels of cathelicidin.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18
* Severe sepsis or septic shock
* Central venous catheter (for blood drawing)

Exclusion Criteria:

* Serum calcium ≥ 10.0 mg/dl or phosphate ≥ 6.0 mg/dl, assessed within previous 48 hours
* Current or recent therapy (within previous 7 days) with nutritional vitamin D at doses \>1,000 I.U. per day or activated vitamin D at any dose
* History of solid organ or bone marrow transplant, primary parathyroid disease, metabolic bone disease, or sarcoidosis
* Expected to die or leave the ICU within 48 hours
* History of hypersensitivity or any allergic reaction to calcitriol
* End stage renal disease
* Acute Kidney Injury receiving intermittent renal replacement therapy
* Enrolled in a competing study
* Pregnancy

Primary outcomes:
measure: Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours
timeFrame: 48 hours
Secondary outcomes:
measure: Plasma Interleukin-6 (IL-6) Levels at 48 Hours
timeFrame: 48 hours
measure: Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours
timeFrame: 48 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: David E Leaf, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leaf DE, Raed A, Donnino MW, Ginde AA, Waikar SS. Randomized controlled trial of calcitriol in severe sepsis. Am J Respir Crit Care Med. 2014 Sep 1;190(5):533-41. doi: 10.1164/rccm.201405-0988OC.
Clinical trial NCT06144541: Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type
Official title: Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Skin Pigment
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
First posted: 2023-11-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects, healthy and unhealthy, are eligible to enroll. Subjects from the greater Sacramento region will be enrolled. Subjects must be at least 18 years of age.

Brief summary: The purpose of this study is to correlate subjective skin pigment measurements as reported by patient-responses to the Fitzpatrick Skin Type Scale versus objective classification of skin pigment utilizing Individual Typology Angle (ITA) measurements.

Detailed description: The Fitzpatrick scale is a numerical classification for human skin color developed in 1975 as a way to estimate the response of different types of skin to UV light. It is used by dermatologists to classify skin tone and assess the risk of skin cancer.

The Fitzpatrick scale encompasses six gradings, from I to VI. However, this does not include all skin tones, as there are significantly more not encompassed within the scale. The aim of this study is to incorporate objective measurements when identifying a patient's Fitzpatrick skin type.

Eligibility criteria: Inclusion Criteria:

* Male and females that are 18 years of age and older
* Subjects with all Fitzpatrick skin types I-VI One-third of subjects will be Fitzpatrick I or II skin types, one-third of subjects will be III or IV, and one-third will have V and VI.

Exclusion Criteria:

* Individuals who are pregnant or breastfeeding.
* Prisoners
* Adults unable to consent
* Individuals with open wounds on the nondominant upper inner arm
* Individuals with fibrotic skin disease or other skin conditions or hair growth on the nondominant upper inner arm that could affect skin measurements in the opinion of the investigator
* Individuals with tattoos that cover the site on the nondominant upper inner arm
* Individuals with post-inflammatory hypopigmentation or hyperpigmentation
* Individuals with vitiligo
* Individuals who have used self-tanning products or tanning beds in the last two weeks.

Primary outcomes:
measure: Skin colorimeter derived Individual Typology Angle value correlated against self-reported Fitzpatrick skin type
timeFrame: One time - collected for up to 1 year for the entire study
Secondary outcomes:
measure: Assess Fitzpatrick Skin type based on validated questionnaire
timeFrame: One time - collected for up to 1 year for the entire study
measure: Sun protection habit use
timeFrame: One time - collected for up to 1 year for the entire study
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science & Research
state: California
Study officials:
References:
Clinical trial NCT05605041: Mindfulness in Medical Training
Official title: Mindfulness in Medical Training: Using Headspace to Improve Sleep, Anxiety, and Burnout Among Resident Physicians
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mindfulness, Burnout, Anxiety, Sleep
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Headspace, a smartphone application that provides guided meditation, mindfulness and sleep exercises, will be used as the intervention in improving sleep, anxiety, depression and burnout in all participating individuals selected from the University of Arizona College of Medicine-Tucson residents and fellows.

Detailed description: The intervention of of daily meditation with the Headspace application will be used to determine if this is a possible effective intervention for decreasing the feeling of burnout. It is being proposed that it could improve the subjects' well-being both in the short-term and long term. The primary outcomes will be burnout, anxiety, depression and sleep. This study will use the Maslach Burnout Inventory to assess baseline burnout, as well as at 30 and 90 days post-intervention period. Sleep and anxiety and depression will be assessed using the Epworth Sleepiness Scale and Hospital Anxiety and Depression Scale (HADS) scores at the same intervals.

Eligibility criteria: Inclusion Criteria:

* University of Arizona resident or fellow

Exclusion Criteria:

* none

Primary outcomes:
measure: The Effects on Burnout
timeFrame: 30-90 days
measure: The Effects on Sleep
timeFrame: 30-90 days
measure: The effects on Anxiety and Depression
timeFrame: 30-90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05724641: Arterial Spin Labeling MRI for Assessing Blood Perfusion in the Human Eye Repeatability Study and Clinical Application
Official title: Arterial Spin Labeling MRI for Assessing Blood Perfusion in the Human Eye Repeatability Study and Clinical Application
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retinal Diseases
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The MRI perfusion imaging using arterial spin labeling (ASL)'s non-invasive technique (i.e. without injection of contrast medium) allows, thanks to recent technological improvement of the spatial resolution, measuring several perfusion parameter of the retinal tissue such as the regional Blood Flow (rBF) or the cerebral blood flow (cBF) expressed in ml/100g/min. Reliable application of ASL thus requires the precision and specificity of the MRI protocol to be tested.


Eligibility criteria: Inclusion criteria:

* Carrier of target pathologies: TAO optic neuropathy, inflammatory optic neuropathy, ischemic optic neuropathy.
* no cardiovascular risk factors or other ophthalmological pathology
* adhere to the study protocol after reading the patient information document
* signe the informed consent form to participate in the study
* do not have any contraindications to an MRI examination

Exclusion criteria

* Usual contraindications to MRI (Pacemaker, Metallic foreign body, Cochlear implant,...)
* Severe claustrophobia

Primary outcomes:
measure: Repeatability measurement on volunteers
timeFrame: 2 month
Secondary outcomes:
measure: Mesurement of the retinal perfusion by MRI ASL in patient in acute phase
timeFrame: 4 years
measure: Mesurement of the retinal perfusion by MRI ASLin patient in a chronic phase
timeFrame: 4 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Idil Günes-Tatar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00596141: Pilot Study to Evaluate the Use of OroScience Topical Oral Wound Emulsion in Post Operative Wound Healing
Official title: Pilot Study to Evaluate the Use of OroScience Topical Oral Wound Emulsion in Post Operative Wound Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Surgical Procedures
Pain
Keywords: oral periodontal gingival intraoral mucosal mucoperiosteal
Surgery, Oral
Lead sponsor: OroScience, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Louisiana State University Health Sciences Center in New Orleans
First posted: 2008-01-16
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to determine if Topical Oral Wound Emulsion (TOWE) assists with dental wound healing and relieves pain from oral wounds.


Eligibility criteria: Inclusion Criteria:

* Planned dental treatment includes intraoral surgery involving full thickness mucoperiosteal flaps with at least one vertical releasing incision

Exclusion Criteria:

* Complicated medical history
* History of poor patient compliance
* Presence or placement of materials beneath the suture site

Primary outcomes:
measure: Visible signs of inflammation scored on a scale of 1 to 4 by three (3) blinded investigators.
timeFrame: Three (3) and seven (7) days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: LSU School of Dentistry, Dental Clinics
state: Louisiana
Study officials:
affiliation: Louisiana State University Health Sciences Center in New Orleans
name: Billie G Jeansonne, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06470841: CHG Combined With Venetoclax and Azacytidine in Newly Diagnosed AML
Official title: CHG Regimen Combined With Venetoclax and Azacytidine in Newly Diagnosed Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this phase 2 trial is to test the safety and efficacy of CHG Combined With Venetoclax in treating patients with newly diagnosed AML.

Detailed description: The investigators will evaluate response rate of CHG regimen Combined With Venetoclax in newly diagnosed acute myeloid leukemia. After induction therapy, patients will be given standardized treatment according to risk stratification according to NCCN guidelines. Progression free survival (PFS), Overall survival (OS), and Toxicity will be counted.

Eligibility criteria: Inclusion Criteria:

* The patient should, in the investigator's opinion, be able to meet all clinical trial requirements.
* The patient is willing and able to adhere to the study visit schedule and other protocol requirements.
* The patient should be diagnosed with AML according to the standard criteria of the World Health Organisation (WHO).
* The patient should not have received any prior treatment for AML.

Exclusion Criteria:

* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
* Pregnant or lactating women.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 1 year
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: through study completion, an average of 3 years
measure: Progression Free Survival (PFS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Navy General Hospital
state: Beijing
Study officials:
affiliation: Navy General Hospital, Beijing
name: Liren Qian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00640341: Comparative Performance of PureVision, Acuvue Oasys and O2Optix
Official title: Product Performance of Bausch & Lomb PureVision® Contact Lens When Compared to Johnson & Johnson Acuvue Oasys Contact Lens and the Ciba Vision O2Optix Contact Lens Worn Daily.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-03-21
Enrollment: 510
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 objective of this study is to evaluate the performance of the PureVision Contact Lens compared to Acuvue Oasys Contact lens and O2Optix Contact lens when worn on a daily wear basis.


Eligibility criteria: Inclusion Criteria:

* Subject is myopic
* VA correctable to 0.3 LogMAR or better (driving vision)
* Clear central cornea
* Subject uses a lens care system on a regular basis

Exclusion Criteria:

* Systemic disease affecting ocular health
* Using systemic or topical medications
* Wear monovision, multifocal or toric contact lenses
* Any grade 2 or greater slit lamp findings

Primary outcomes:
measure: Any Slit Lamp Finding > Grade 2
timeFrame: Over all follow-up visits for the 1 month study period
measure: Subjective Responses to Comfort-related Symptoms/Complaints
timeFrame: Over all follow-up visits for 1 month study period
measure: Uncorrected Distance High Contrast Visual Acuity
timeFrame: Over all visits for the 1 month study period
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Anderson & Associates
state: Florida
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Gerard Cairns, MCOptom, PhD
role: STUDY_DIRECTOR
affiliation: Anderson & Associates
name: Bruce Anderson, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02104141: Retrospective/Prospective Data Collection on the LDR ROIA Interbody Fusion Device With VerteBRIDGE Plating
Official title: An Open Label, Multicenter, Clinical Study of the Safety and Efficacy of the LDR Spine ROI-A Interbody Fusion System Using the VerteBRIDGE™ Plating System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Keywords: DDD
lumbar spine
fusion rate
degenerative disc disease
Lead sponsor: LDR Spine USA
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be drawn from community surgeon practices in which the subjects have already received the device and who meet the Inclusion/Exclusion criteria.

Brief summary: The purpose of this combination retrospective and prospective post market study is to examine the short term safety and efficacy of the ROI-A® interbody fusion device with VerteBRIDGE® plates to treat single and two-level degenerative disc disease between L2 and S1, with a focus on fusion rates and patient outcomes.


Eligibility criteria: Inclusion Criteria:

* Subjects must have degenerative disc disease (DDD) of the lumbar spine between L2 and S1
* Subjects may have up to a Grade 1 spondylolisthesis at the involved level(s)
* Subject must have the ROI-A® device at one level or at two contiguous levels between L2 and S1 only
* Subject should have had a minimum of 6 months non-surgical treatment prior to receiving the ROI-A® device
* Subject may have had NO MORE THAN two previous non-fusion surgeries to the lumbar spine at the same levels as the ROI-A®
* Subject must be at least 21 years of age at the time of surgery
* Subject must be willing to signed an informed consent document and return for a 12 month visit

Exclusion Criteria:

* Subject had more than Grade 1 spondylolisthesis at the operated level
* Subject is a prisoner.
* Subject was pregnant at the time of surgery.
* Subject had an active infection or sepsis at the time of surgery.

Primary outcomes:
measure: Number of Participants With Fusion
timeFrame: 12 months after device implantation
Secondary outcomes:
measure: Mean Oswestry Disability Index
timeFrame: 12 months after device implantation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01246141: The Comparison of Tricuspid Replacement and Repair in Patients With Combined Heart Valve Disease
Official title: The Institute of Cardiovascular Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tricuspid Valve Regurgitation
Keywords: tricuspid valve regurgitation
replacement
repair
outcomes
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2010-11-23
Enrollment: 68
Sex: ALL
Minimum age (years): 21
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with aortic valve and mitral valve diseases and functional tricuspid valve regurgitation underwent surgical operations from Nov., 1998 to Dec., 2009 in our institute.

Brief summary: Functional tricuspid regurgitation is common in patients with heart valve disease, replacement and repair both can correct this anomaly. However, there is no data to address which one can bring more benefits to these patients with combined heart valve disease. The investigators retrospectively review patients with two or more heart valve disease and functional tricuspid regurgitation, and assess its long term outcomes.

Detailed description: we reviewed patients who admitted to our hospital due to combined heart valve disease, and underwent tricuspid valve replacement or repair from January,1998 to december,2009. we made a comparison between these two groups, in term of early results after operation and long term results.

Eligibility criteria: Inclusion Criteria:

* Significant disorders in aortic and mitral valves
* Moderate ～ severe tricuspid regurgitation
* Underwent tricuspid repair or replacement operation

Exclusion Criteria:

* Isolate tricuspid valve lesion
* Mild tricuspid valve regurgitation
* Tricuspid valve regurgitation was left without surgical treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Zhang Jinzhou
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: zhang jinzhou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05082441: Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection
Official title: Efficacy of Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Benign Neoplasm
Lead sponsor: Samaritan Health Services
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Liposomal bupivacaine (Exparel) has been used as an adjunct to pain management in the perioperative setting. However, the efficacy of the drug has not bewen studied in patients with benign soft tissue tumor resections. The goal of the study is to see if Exparel controls pain and improves functional outcomes for patients after these procedures compared to the current standard Bupivacaine HCL.

Detailed description: Liposomal bupivacaine (Exparel) has been used as an adjunct to pain management in the perioperative setting. However, the efficacy of the drug has not bewen studied in patients with benign soft tissue tumor resections. The goal of the study is to see if Exparel controls pain and improves functional outcomes for patients after these procedures compared to the current standard Bupivacaine HCL.

Patients will be randomly assigned Exparel or Bupivacaine HCL intraoperatively during the tumor resection. The amount administered is based on the size of wound after tumor resection. The patients are then provided a pain diary in which they record the amount of pain medications taken, VAS pain scores, and musculoskeletal and tumor society score (MSTS) for the first week postoperatively.

The study will end once 140 patients have been enrolled. Data will be analyzed comparing morphine equivalents, pain scores, and functional scores between the groups.

Eligibility criteria: Inclusion Criteria:

* All benign soft tissue tumors greater than one cubic cm
* Adults 18 years and older

Exclusion Criteria:

* Pregnant females
* Women who are breastfeeding
* Less than 18 years old
* Malignant tumors
* Tumors smaller than 1 cubic cm
* Allergy to Exparel
* Patients who are opioid dependent defined as patients on a long acting narcotic or who take more than 30 morphine equivalents per day
* Allergy to amide anesthetics
* bone tumors
* Patients unable to comply with the study standards and follow up

Primary outcomes:
measure: Opioid Use
timeFrame: first 7 days postoperatively
Secondary outcomes:
measure: Pain Score
timeFrame: First 7 days postoperatively
Other outcomes:
measure: Musculoskeletal Tumor Society Score (MSTS score)
timeFrame: First 7 days postoperatively
Locations:
city: Corvallis
country: United States
facility: Good Samaritan Regional Medical Center
state: Oregon
Study officials:
References: