louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05424120: Thoracentesis QI Study
Official title: Thoracentesis Quality Improvement (QI) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Effusion
Keywords: pleural effusion
thoracentesis
wall suction
manual aspiration
vacuum bottle drainage
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled, non-blinded, single-center, quality improvement study to determine which method of standard of care thoracentesis (wall suctioning, manual aspiration, or vacuum drainage) has the shortest procedural time.
Primary purpose: TREATMENT

Brief summary: Researchers will compare 3 standard of care methods of pleural fluid drainage during therapeutic thoracentesis. Patients are randomized to manual aspiration, vacuum bottle drainage or wall suction methods. Primary outcome is procedural time with secondary outcomes of pain and dyspnea scores.


Eligibility criteria: Inclusion Criteria:

* Age \>18
* Evidence of pleural effusion on imaging
* Clinical indication for thoracentesis

Exclusion Criteria:

* Age \<18
* Standard contraindication for thoracentesis procedure
* Patients on positive pressure ventilation
* Patients who have opted out of research in EPIC

Primary outcomes:
measure: Procedural time to 500mL
timeFrame: Through study completion, an average of 24 hours
measure: Procedural time to 750mL
timeFrame: Through study completion, an average of 24 hours
measure: Procedural time to 1L
timeFrame: Through study completion, an average of 24 hours
measure: Pain and dyspnea scores- Baseline
timeFrame: Immediately prior to starting the thoracentesis
measure: Pain and dyspnea scores- Cath
timeFrame: Through study completion, an average of 24 hours
measure: Pain and dyspnea scores- Post-fluid
timeFrame: Through study completion, an average of 24 hours
measure: Pain and dyspnea scores- Post-cath
timeFrame: Immediately after removing the thoracentesis catheter
measure: Pain and dyspnea scores- 5m post
timeFrame: 5 minutes post-procedure
measure: Pain and dyspnea scores- 24h post
timeFrame: 24 hours post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Roy Cho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06899620: BC179 Against Alcohol-Induced Damage
Official title: Protective Effect of Probiotic BC179 on Alcohol-Induced Damage: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess the effectiveness and safety of probiotic strain BC179 in reducing alcohol absorption in the gut, thereby lowering health risks, as measured by participants' hangover scores.


Eligibility criteria: * Inclusion Criteria:

  1. A history of long-term heavy alcohol consumption, equivalent to ethanol intake ≥40g/day for over 1 year. The conversion formula is: ethanol (g) = volume of ethanol-containing beverage (mL) × ethanol content (%) × 0.8 (specific gravity of ethanol);
  2. Body Mass Index (BMI) between 18kg/m² and 25kg/m²; Voluntarily signed a written informed consent form, agreeing to participate in this study;
  3. Agreed to comply with the study protocol and restrictions;
  4. Subjects (including male participants) have no plans for conception from 14 days prior to screening until 6 months after the end of the trial and voluntarily agree to use effective contraception.
* Exclusion Criteria:

  1. Patients with various types of viral hepatitis, autoimmune liver disease, drug-induced liver damage, vascular liver disease, genetic metabolic liver disease, or primary liver cancer;
  2. Individuals who have recently consumed substances with similar functions to the tested product, potentially affecting the study results;
  3. Patients with severe allergies or immune deficiencies;
  4. Pregnant, breastfeeding, or women with plans for pregnancy;
  5. Individuals with severe diseases of vital organs such as cardiovascular, pulmonary, hepatic, renal conditions, or those with diabetes, severe thyroid disorders, metabolic diseases, malignant tumors, or severe immune system disorders;
  6. Individuals who have used antibiotics within the past two weeks;
  7. Participants who did not comply with the required consumption of the tested product or missed follow-ups, making it impossible to evaluate the effectiveness;
  8. Other participants deemed unsuitable by the researchers.

Primary outcomes:
measure: Alcohol Absorption Rate Assessment
timeFrame: 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Luoyang
country: China
facility: Wu Ying
state: Henan
Study officials:
References:
Clinical trial NCT00756574: Randomized Control Trial to Study the Efficacy of the Surgical Mask Versus the N95 Respirator to Prevent Influenza
Official title: A Randomized Control Trial of Surgical Masks vs N95 Respirators to Prevent Influenza in Health Care Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: N95
Respirator
mask
influenza
efficacy
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Health Canada
First posted: 2008-09-22
Enrollment: 447
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to compare the efficacy of the surgical mask to the N95 respirator in protecting nurses from influenza in the hospital setting. The investigators propose a non-inferiority randomized controlled trial whereby nurses are randomized to either a surgical mask or an N95 respirator when caring for patients with febrile respiratory illness during the influenza season. The hypothesis is that the surgical mask offers similar protection against influenza to that of the N95. The specific objective of the study is to assess whether the rates of influenza (laboratory-confirmed by PCR and HAI assay), as well as secondary outcomes (influenza-like illness, work-related absenteeism, physician visits for respiratory illness, and lower respiratory infection), are similar among nurses using a surgical mask compared to those using an N95 respirator.


Eligibility criteria: Inclusion Criteria:

* Nurses who work in emergency departments and medical units
* Nurses expected to work full time (defined as \> 37 hours per week)

Exclusion Criteria:

* Nurses who were not fit tested
* Nurses who could not pass a fit test

Primary outcomes:
measure: Laboratory-confirmed Influenza Infection
timeFrame: one year
Secondary outcomes:
measure: Physician Visits for Respiratory Illness
timeFrame: one year
measure: Influenza-like Illness
timeFrame: Over entire study period
measure: Absenteeism
timeFrame: over study period
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Science
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences - McMaster University
name: Mark Loeb, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loeb M, Dafoe N, Mahony J, John M, Sarabia A, Glavin V, Webby R, Smieja M, Earn DJ, Chong S, Webb A, Walter SD. Surgical mask vs N95 respirator for preventing influenza among health care workers: a randomized trial. JAMA. 2009 Nov 4;302(17):1865-71. doi: 10.1001/jama.2009.1466. Epub 2009 Oct 1.
Clinical trial NCT01977274: Predictive Clinical and Biological Parameters in Gynecological Cancer
Official title: Predictive Clinical and Biological Parameters in Gynecological Cancer - GC-BIO-IPC 2013-010
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Endometrium Cancer
Cervix Cancer
Keywords: ovarian, endometrium, cervix cancer
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Research of predictive clinical and biological factors in breast cancer : genomic, proteomic, mutation


Eligibility criteria: Inclusion Criteria:

* gynecological cancer suspicion
* age \> 18
* signed informed consent

Exclusion Criteria:

- emergency

Exclusion criteria after histological exam Any diagnosis that is not a gynecological cancer (ovarian, cervix, endometrium).

Primary outcomes:
measure: molecular alteration in gynecological cancer
timeFrame: average of 4 weeks after diagnosis
Secondary outcomes:
measure: relation between molecular alteration and clinical and histological characteristics
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
References:
Clinical trial NCT01154374: A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)
Official title: A Phase II, Randomized, Controlled, Two-Center Pilot Study of the Safety and Efficacy of Topically Applied MEBO® Wound Ointment Compared to Standard of Care in Subjects With Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Foot Ulcers
Keywords: Diabetic Foot Ulcers (DFUs)
Lead sponsor: Skingenix, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).

Detailed description: This is a phase II, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of MEBO in the treatment of subjects with DFUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC.

Eligibility criteria: Inclusion Criteria:

* Male or female ≥18 years of age
* Able and willing to provide informed consent
* Able and willing to comply with protocol visits and procedures
* Target ulcer duration of ≥4 weeks

Exclusion Criteria:

* Ulcer of a non-diabetic pathophysiology
* Known or suspected allergies to any of the components of MEBO
* Malignancy on target ulcer foot
* Non-compliance in the screening or run-in period

Primary outcomes:
measure: The incidence of complete healing of the target ulcer.
timeFrame: 8 weeks of treatment period
Secondary outcomes:
measure: Time required to achieve complete healing (days).
timeFrame: 8 weeks treatment period
measure: Absolute and percentage change in ulcer surface area from baseline to endpoint.
timeFrame: 8 weeks treatment period
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Blume Podiatry Group, P.C.
state: Connecticut
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
Study officials:
affiliation: University of Miami
name: Robert S Kirsner, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00004374: Study of Systemic Amyloidosis Presentation and Prognosis
Official title: Study of Systemic Amyloidosis Presentation and Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amyloidosis
Keywords: amyloidosis
arthritis & connective tissue diseases
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Indiana University School of Medicine
First posted: 1999-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Analyze prospectively the course of amyloid deposition in patients with primary, secondary, myeloma-associated, and hereditary amyloidosis.

II. Determine abnormalities of humoral and delayed-type hypersensitivity in these patients.

III. Identify prognostic factors in hereditary amyloidosis and develop tests for genetic defects associated with systemic amyloidosis.

IV. Diagnose familial amyloidotic polyneuropathy (FAP) prior to symptom onset. V. Validate the correlation of low serum prealbumin and retinol binding protein levels with amyloidosis in patients with FAP.

Detailed description: PROTOCOL OUTLINE: Patients receive a comprehensive evaluation with an emphasis on identifying prognostic and diagnostic factors. Assessments include gastrointestinal, renal, hematologic, dermatologic, cardiac, and serologic studies. Immunologic studies include antinuclear antibody, latex fixation, and serum and urine electrophoresis.

Genetic trees are constructed using detailed family history data; blood and urine samples are routinely collected from relatives. Family members of patients with familial amyloidotic polyneuropathy type II (Indiana type) undergo a flexor retinaculum biopsy of the wrist.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Systemic amyloidosis, i.e.: Primary, myeloma associated Secondary, e.g., associated with the following conditions: Rheumatoid arthritis Inflammatory bowel disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Merrill D. Benson
role: STUDY_CHAIR
References:
Clinical trial NCT03623074: Control of Myopia Using Novel Spectacle Lens Designs
Official title: Efficacy and Safety Study of Novel Spectacle Lens Designs to Control of Myopia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Juvenile Myopia
Keywords: Myopia
Lead sponsor: SightGlass Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-09
Enrollment: 266
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, controlled, multisite, subject-and observer-masked, 3-arm parallel group clinical trial of 36-month duration to evaluate the safety and efficacy of a novel spectacle lens design in reducing the progression of juvenile myopia.


Eligibility criteria: Inclusion Criteria:

* Children 6-10 years of age (day prior to 10th birthday) at time of informed consent/assent
* SER error between -0.75 and -4.50 D
* SER power between the two eyes must be less than or equal to 1.50 D
* Willingness to participate in the trial for 3 years without content lens wear

Exclusion Criteria:

* Previous or current use of contact lenses
* Previous or current use of bifocals, progressive addition spectacles lenses
* Previous or current use of myopia control treatment
* Astigmatism worse then -1.25 DC in either eye

Primary outcomes:
measure: Axial length
timeFrame: 36 Months
measure: Spherical equivalent refraction
timeFrame: 36 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Golden Optometric Group
state: California
city: Longwood
country: United States
facility: Sabal Eye Care
state: Florida
city: Pensacola
country: United States
facility: Visual Performance Center
state: Florida
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: West Monroe
country: United States
facility: Eye Associates of Northeast Louisiana (DBA Haik Humble Eye Center) Research Dept
state: Louisiana
city: Raytown
country: United States
facility: Advanced Eyecare, PC
state: Missouri
city: New York
country: United States
facility: SUNY School of Optometry
state: New York
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Wantagh
country: United States
facility: Dept of Clinical Research, South Shore Eye Care, LLP
state: New York
city: Dakota Dunes
country: United States
facility: Dunes Eye Consultants
state: South Dakota
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
city: Houston
country: United States
facility: University of Houston College of Optometry
state: Texas
city: Salt Lake City
country: United States
facility: William J Bogus, OD, FAAO
state: Utah
city: Waterloo
country: Canada
facility: Center for Ocular Research & Education, School of Optometry, University of Waterloo School of Optometry & Vision Science
state: Ontario
Study officials:
affiliation: SightGlass Vision, Inc.
name: Joseph Rappon, OD, MS, FAAO
role: STUDY_CHAIR
References:
Clinical trial NCT00851474: Measurement of Cardiac Output and Blood Volumes
Official title: Measurement of Cardiac Output and Blood Volumes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cardiac Output
Keywords: COstatus(R)
Ultrasound Dilution
Cardiac Output
Blood Volumes
Comparison of COstatus(R) cardiac output with other methods
Lead sponsor: Transonic Systems Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (older than 18 years of age) in the Intensive Care Unit with arterial and central venous catheters in place.

Brief summary: Cardiac Output (amount of blood pumped by the heart in one minute) will be measured using the new COstatus(R) system and these values will be compared with cardiac output values measured by other methods such as thermodilution. Blood volumes measured by the COstatus(R) system will also be recorded.


Eligibility criteria: Inclusion Criteria:

* Adult patients (older than 18 years of age)
* Should have both arterial and central venous catheters already in place

Exclusion Criteria:

* Patients who do not have either the arterial or central venous catheters.

Primary outcomes:
measure: Compare cardiac output measured by COstatus(R) with other methods such as PA Thermodilution
timeFrame: 5-8 minutes minimum
Secondary outcomes:
measure: Measure blood volumes
timeFrame: 5-8 minutes minimum
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: Wayne State University
name: Lawrence Diebel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.
Clinical trial NCT06607874: Self-Collection for Cervical Cancer Screening and HPV Vaccination for Cancer Prevention Among Women in Emergency Care in Northeast Florida
Official title: Eligibility and Participation Characteristics of a Pilot Study of Self-Collection for Cervical Cancer Screening and HPV Vaccination for Cancer Prevention
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Human Papillomavirus-Related Cervical Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients recruited after previous ED visits

Brief summary: Human Papilloma Virus (HPV) is a cause of cervical cancer in women. This study is being done to identify sites for cervical cancer screening and education regarding HPV vaccination outside of the traditional settings of primary care and gynecologic clinics. Identifying non-traditional cancer screening settings may increase cancer screening completion and HPV vaccination among women with limited health care knowledge and access who are vulnerable to health disparities.


Eligibility criteria: Inclusion Criteria:

* Adults assigned as female at birth age 18-65 with a Mayo Clinic medical record number

Exclusion Criteria:

* Adults assigned as female at birth age 0-17
* Adults assigned as female at birth age \> 65
* Adults assigned as male at birth
* Adults assigned as female at birth without a Mayo Clinic medical record number

Primary outcomes:
measure: Human Papilloma Virus (HPV) sample self-collection following Emergency Department (ED) presentation
timeFrame: Baseline
measure: HPV vaccination following ED presentation
timeFrame: One month
measure: Interviews of women who decline self-collection
timeFrame: Baseline
measure: Interviews of women who consent to self-collection but do not complete the self-collection
timeFrame: Up to 6 weeks
measure: Interviews of women who complete the self-collection
timeFrame: Up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Christopher C. DeStephano, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00917774: A Gender-Specific Posterior Cruciate-Substituting High-Flexion Knee Prosthesis Does Not Improve Fit and Function
Official title: A Gender-Specific Posterior Cruciate-Substituting High-Flexion Knee Prosthesis Does Not Improve Fit and Function Compared With a Standard Posterior Cruciate-Substituting High-Flexion Knee Prostheis A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis of the Knee
Female
Keywords: gender specific knee
osteoarthritis
total knee arthroplasty
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2009-06-10
Enrollment: 88
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare functional and radiographic results, range of motion of the knee, patient satisfaction, femoral component, revision and complication rates in patients receiving either a standard posterior cruciate substituting-flex (LPS-flex) or gender-specific posterior cruciate substituting-flex (LPS-Flex) total knee prosthesis.

Detailed description: Recently much debate and discussion has focused on the effect of gender-specific total knee arthroplasty. The purpose of this study was to compare functional and radiographic results, range of motion of the knee, patient satisfaction, femoral component, revision and complication rates in patients receiving either a standard posterior cruciate substituting-flex (LPS-flex) or gender-specific posterior cruciate substituting-flex (LPS-Flex) total knee prosthesis.

Eligibility criteria: Inclusion Criteria:

* End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease, in female patients

Exclusion Criteria:

* Male patient
* Inflammatory disease
* patient with other Lower extremity disease which may affect functional outcome
* Neurologic disease effecting patients lower extremity
* Revision surgery

Primary outcomes:
measure: knee function
timeFrame: 2 years
Secondary outcomes:
measure: implant fit to patient
timeFrame: 2 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Yoowang Choi, MD
role: PRINCIPAL_INVESTIGATOR
References: