louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06124859: Exercise Tolerance and Lower-limb Muscle Power in Patients With Chronic Respiratory Disease
Official title: Assessment of Exercise Tolerance and Lower-limb Muscle Power in Patients With Chronic Respiratory Disease: a Multicenter Validity Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Fibrosis
Pulmonary Disease, Chronic Obstructive
Keywords: Six minutes stepper test (6MST)
5-times sit to stand test (5STS)
Chronic obstructive pulmonary disease (COPD)
Pulmonary Fibrosis
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: University of Lille Nord de France
First posted: 2023-11-09
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to validate the six minute Stepper Test (6MST) and the 5-repetition chair lift test (5STS) as measures of exercise tolerance and muscle power, respectively, in patients with chronic respiratory disease.

As the reproducibility of the tests has been studied and validated in previous studies, the objective is to investigate the validity of the 6MST and 5STS in comparison with their respective gold standards.


Eligibility criteria: Inclusion Criteria:

* Age 40 and over
* With a diagnosis of chronic obstructive pulmonary disease (GOLD II - IV) or pulmonary fibrosis (\>6 months).
* Able to understand and follow verbal instructions during tests
* Affiliated with a social security scheme
* Willing to participate in the study

Exclusion Criteria:

* Have a neurological, cardiovascular or balance disorder that could impair test performance.
* Having undergone respiratory rehabilitation within the last year.
* With unstable disease (recent exacerbation \< 4 weeks).
* Pregnant and/or breast-feeding women
* Patients under guardianship or curatorship

Primary outcomes:
measure: Oxygen consumption
timeFrame: 19 days
measure: Lower limb muscle power after Five Times Sit to Stand Test (5STS,) calculated by the ratio between STS mean velocity and STS mean force
timeFrame: 19 days
Secondary outcomes:
measure: Heart rate after 6MST
timeFrame: 19 days
measure: Oxygen saturation after 6MST
timeFrame: 19 days
measure: Minute ventilation after 6MST
timeFrame: 19 days
measure: Respiratory rate after 6MST
timeFrame: 19 days
measure: Leg fatigue after 6MST measured by the modified Borg scale
timeFrame: 19 days
measure: Maximum effort test after 6MST
timeFrame: 19 days
measure: Lower limb muscle power after 5STS test
timeFrame: 19 days
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre de Pneumologie Institut universitaire de cardiologie et de pneumologie de Québec
city: Lomme
country: France
facility: Hôpital Saint-Philibert (GHICL)
Study officials:
affiliation: Hôpital Saint Philibert, GHICL
name: Arnaud CHAMBELLAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02395159: Reduction of Groin Wound Infections After Vascular Surgery by Using an Incision Management System (IMS)
Official title: Reduction of Groin Wound Infections After Vascular Surgery in Patients With Risk Factors by the Use a Negative Pressure Wound Incision Management System (KCI Prevena)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections
Keywords: vascular surgery patients
wound management
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2015-03-20
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.

Detailed description: Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.

The aim is to demonstrate that the application of the Prevena™ IMS significantly reduces the incidence of postoperative wound infections. The wound infections will be classified according to Szilagyi.

The treatment phase begins following vascular surgery with wound management using either the Prevena™ IMS or a standard wound dressing, depending on the group to which the patient was randomly assigned. It involves a minimum stay of 7 and maximum 10 days in hospital.

Eligibility criteria: Inclusion Criteria:

* vascular surgery via right or left inguinal approach
* nicotine abuse (active or according to medical condition)
* risk factors:

  1. cardiac risk factors (arterial hypertension, coronary heart disease, status after myocardial infarction)
  2. metabolic disorders (diabetes mellitus type I type II, lipopathy or hyperhomocysteinemia) or chronic or acute renal insufficiency
* previous vascular surgery with inguinal approach
* signed informed consent form
* persons who are legally competent and mentally able to comprehend and follow the instructions of study personnel

Exclusion Criteria:

* local skin infections (fungal infections, acne)
* pregnant and breast-feeding women
* simultaneous participation in another clinical trial
* persons who have been committed to an institution by court or administrative order
* persons in a dependency or employment relationship with the sponsor or investigator

Primary outcomes:
measure: wound infections
timeFrame: 7 days after the surgery
Secondary outcomes:
measure: length of hospital stay
timeFrame: up to 10 days
measure: antibiotic therapy
timeFrame: up to 30 days
measure: revision surgery
timeFrame: up to 30 days
measure: necessity of alternative wound dressings
timeFrame: up to 30 days
measure: prolongation of ambulant treatment
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen, vascular surgery
city: Witten
country: Germany
facility: Marienhospital Wiiten, vascular surgery
Study officials:
affiliation: University Hospital, Aachen
name: Jochen Grommes
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05650359: Study of the Use of Orthopulse Photobiomodulation
Official title: A Randomized and Controlled Study of the Use of Orthopulse Photobiomodulation for Acceleration of Orthodontic Tooth Movement With Fixed Appliances
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthodontics
Lead sponsor: Biolux Technology GmbH
Sponsor class: INDUSTRY
Collaborators: name: medXteam GmbH
First posted: 2022-12-14
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomized, controlled, open-label, multicenter PMCF study.
Primary purpose: TREATMENT

Brief summary: This PMCF study evaluates the safety and performance of OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances.

Detailed description: The purpose of the current clinical investigation performed in form of a post-market clinical follow-up (PMCF) study is to evaluate the performance of OrthoPulse by means of confirming the hypothesis that Subjects in the interventional group (group 1) will have a statistically significant average faster rate of tooth movement during the alignment phase than the average of subjects in the control group (group 2) (estimated 1.8x faster tooth movement) and to substantiate the clinical data for the application of OrthoPulse in case of fixed appliances (brackets).

Eligibility criteria: Inclusion Criteria:

* Age: at least 18 years
* Indication for an orthodontic treatment with fixed appliances
* Presence of a written declaration
* Permanent dentition
* Class I-III malocclusion
* Between 4-10mm of crowding (estimated traditionally) in anterior teeth in mandibular arch (This will depend on the time we choose for the endpoint)

Exclusion Criteria:

* Simultaneous participation in another clinical investigation or study
* Prior participation in this study
* Persons who have been placed in an institution as a result of an administrative or judicial order
* Persons who are dependent on the sponsor, Investigator or the investigation site
* Anterior cross bite
* Spaces between anterior teeth
* Extractions or missing permanent teeth (except for third molars)
* No anticipated requirement of auxiliary appliances and/or elastics during treatment during alignment phase
* Acute oral infection or periodontal disease
* Active caries
* Pregnant patients or patients planning to become pregnant

Primary outcomes:
measure: The primary endpoint of this PMCF study is the rate of tooth alignment.
timeFrame: 42 days after start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Private Practice
state: Arizona
Study officials:
affiliation: Private Practice 1200 W Warner Rd, Chandler, AZ 85224
name: Todd Dickerson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03748459: Rhinoplasty Scar Comparison
Official title: Patient and Observer Graded Rhinoplasty Scar Outcomes: a Randomized-Controlled Trial of Fast Absorbing Versus Permanent Columellar Suture Closure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Incision
Nose Deformity
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients seeking rhinoplasty surgery with one of the investigators.

Brief summary: Traditional suture closure of the columellar scar in rhinoplasty is achieved with permanent skin sutures. These sutures create less inflammation and are thought to lead to improved final scar outcomes. However, permanent sutures require removal which creates pain and inconvenience for the patient. Some surgeons use fast absorbing sutures that do not require removal. The difference in final scar outcome based on suture material used has not been well studied. This study will examine the final scar outcomes of rhinoplasty incisions sutured with traditional permanent suture compared to fast absorbing suture. If scar outcomes are similar between these groups as judged by the patients and blinded observers, rhinoplasty surgeons may be able to preferentially utilize absorbable sutures for incision closure and avoid the pain and inconvenience for the patient during suture removal


Eligibility criteria: Inclusion Criteria

•Adult (age ≥ 18 years) patients undergoing primary open rhinoplasty surgery for any reason with any of the study surgeons.

Exclusion Criteria

* Patients undergoing rhinoplasty for cleft nasal deformity or nasal reconstruction related to cancer resection
* Patients with previous surgery that involved a columellar incision. Patients with history of previous nasal surgery that did not involve an incision on the columella may be included
* Patients with known history of cutaneous disorder that affects scaring such as personal history of keloid formation, collagen vascular disease, or previous radiation to the surgical site
* Inability or unwillingness of subject to give informed consent

Primary outcomes:
measure: Patient Scar Assessment
timeFrame: 12 months after surgery
measure: Clinician Scar Assessment
timeFrame: 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Charleston
country: United States
facility: Ralph Johnson VA Medical Center
state: South Carolina
Study officials:
References:
Clinical trial NCT01651559: The Efficacy Of A Dead Sea Mineral Enriched Body Cream vs Its Carrier as an Adjuvant Treatment For Psoriatic Patients
Official title: A Double Blind Controlled Clinical Trial Comparing The Efficacy Of A Dead Sea Mineral Enriched Body Cream vs Its Carrier as an Adjuvant Treatment For Psoriatic Patients Undergoing Phototherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psoriasis Vulgaris
Keywords: modified PASI
narrow band UVB phototherapy
Dead Sea Minerals
Skin auto-Fluorescence
Skin wash samples
Lead sponsor: Ahava Dead Sea Laboratories
Sponsor class: INDUSTRY
First posted: 2012-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers aged 18-70 diagnosed with moderate to severe chronic stable plaque type Psoriasis for at least 6 months and candidates for phototherapy treatment.

Brief summary: This is a two-center study aimed to assess the efficacy of Dead Sea Minerals in alleviating symptoms of Psoriasis Vulgaris, in 50 patients undergoing phototherapy. A bilateral left right comparison will be made, after using the study product and the placebo, for 8 weeks, twice daily, on each of the body sides (left right). In addition to the clinical evaluations, skin biochemistry will be studied using non-invasive techniques. The latter will be correlated with the clinical results of the patients. These will serve for future development of diagnostic assays and personalized therapies.


Eligibility criteria: Inclusion Criteria:

* Having 2 symetrical (left right)moderate to severe chronic stable plaque type Psoriasis for at least 6 months and candidates for phototherapy treatment

Exclusion Criteria:

* Volunteers with a known allergy to one of the tested materials or to their ingredients.
* Treatment with medication such as anti-inflammatories, anti-histamines, corticosteroids, systemically or topically applied, unless stopped for 4 weeks prior to the trial in the case of systemic treatment and 2 weeks in the case of topical treatment.
* Volunteers in the process of diagnosis or treatment for cancer / kidney disease / liver disease
* Pregnant or lactating women

Primary outcomes:
measure: change from baseline of PASI (Psoriasis Area and Severity Index)
timeFrame: 8 weeks
Secondary outcomes:
measure: change from baseline of the Skin Hydration level
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Michael David, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06461559: Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion
Official title: Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Stoma Ileostomy
Ileostomy; Complications
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study is being conducted to study the effect of infusing your contents from your ostomy bag back into your intestine to re-train them prior to the ostomy takedown operation, which is a surgery to reverse your ostomy to put your intestine back together. Because your intestine past the ostomy hasn't seen any intestinal content for several weeks to months before the takedown operation, it is no longer used to handling the daily work of processing intestinal content and will take time to recover its normal function after surgery. We hope to speed up this process by training them before your planned surgery.


Eligibility criteria: Inclusion Criteria:

* Has a diverting loop ileostomy
* undergoing evaluation for stoma takedown

Exclusion Criteria:

* unable to perform consent
* unable to perform stoma infusion

Primary outcomes:
measure: timing to return of bowel function
timeFrame: 1-5 days
Secondary outcomes:
measure: ease of stoma infusion
timeFrame: 2 weeks prior to surgery to time of surgery
measure: complications
timeFrame: 2 weeks prior to surgery to 30 days post operatively
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
References:
Clinical trial NCT02092259: A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay
Official title: A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay in Patients With Signs and Symptoms of Acute Gastroenteritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Gastroenteritis
Lead sponsor: Luminex Molecular Diagnostics
Sponsor class: INDUSTRY
First posted: 2014-03-20
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All comers

Brief summary: The ARIES Norovirus Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients.

The purpose of this study is to establish the diagnostic accuracy of ARIES Norovirus Assay.

Detailed description: The ARIES Norovirus Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients.

The objective is to establish the diagnostic accuracy of the ARIES Norovirus assay through a multi-site, method comparison on prospectively collected leftover, stool specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement)

Eligibility criteria: Inclusion Criteria:

* The specimen is from a patient with symptoms of acute gastroenteritis.
* The specimen is from a male or female subject who was either hospitalized, admitted to a hospital emergency department or visiting an outpatient clinic.
* The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site.

Exclusion Criteria:

* The specimen is from an individual with known and documented non-infectious conditions such as ulcerative colitis, irritable bowel syndrome and/or Crohn's disease
* The specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor.

Primary outcomes:
measure: Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
timeFrame: Within the first year of sample collection
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Indianapolis
country: United States
facility: Indiana Health
state: Indiana
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Danville
country: United States
facility: Geisinger Medical Laboratories
state: Pennsylvania
Study officials:
affiliation: Luminex Corporation
name: David Himsworth
role: STUDY_DIRECTOR
References:
Clinical trial NCT02646059: The Effective Ways of Recruiting Lapsed Blood Donors: a Stratified Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Donor
Lead sponsor: Guangzhou Blood Center
Sponsor class: OTHER_GOV
First posted: 2016-01-05
Enrollment: 1188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Blood donor recruitment is an important issue in every country, since the blood supply pressure become more and more intense. Donor retention is even more important, because it is easier to recruit an old customers than a new one. Therefore, figuring the most effective ways of recruiting lapsed blood donors and understanding the reasons of not donating blood again is critical and vital for the development of blood donation.


Eligibility criteria: Inclusion Criteria:

* Donated blood at least once between 2009 to 2013, and the blood test result is qualified.

Exclusion Criteria:

* Having donated again before intervened.

Primary outcomes:
measure: Blood donation rate
timeFrame: four to six months
Secondary outcomes:
measure: Reasons of not donating again
timeFrame: 1 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Blood Center
state: Guangdong
Study officials:
References:
Clinical trial NCT04063059: Black Women's Wellness Project
Official title: Women of Color and Family Obesity Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight, Body
Knowledge, Attitudes, Practice
Keywords: Weight Management
Obesity
African American
Women
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 454
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The proposed randomized controlled trial will evaluate an educational self-management intervention in 450 African American women and weight management. It will be the first to use a culturally tailored in-person and telephone approach to address all aspects of wellness and social determinants for African American women to achieve optimal long term wellness for both self and family.


Eligibility criteria: Inclusion Criteria:

* Self-identified African American woman, aged 20-59
* BMI 27.5-57.4
* Ability to walk unrestricted for \> 3 min
* Caretaker of a child -providing a meal at least 50% of days/week
* Caretaker of at least one child aged 5 -12 years
* Resides in Jackson, Saginaw, Ypsilanti, Lansing, Detroit (All cities in Michigan)
* Speaks English fluently

Exclusion Criteria:

* \<12 months postpartum
* Active pregnancy
* Prior or anticipated bariatric surgery
* Non-ambulatory
* History of a severe cardiovascular event (including cerebrovascular accident or myocardial infarction)
* Severe mental illness, neurologic disease and/or cognitive impairment

Primary outcomes:
measure: Weight (lb)
timeFrame: Kick Off Event (Month 0)
measure: Weight (lb)
timeFrame: Closing Event (Month 12)
Secondary outcomes:
measure: Height (inches)
timeFrame: Kick Off Event (Month 0)
measure: Height (inches)
timeFrame: Closing Event (Month 12)
measure: Waist Circumference (inches)
timeFrame: Kick Off Event (Month 0)
measure: Waist Circumference (inches)
timeFrame: Closing Event (Month 12)
measure: Blood Pressure (mmHg)
timeFrame: Kick Off Event (Month 0)
measure: Blood Pressure (mmHg)
timeFrame: Closing Event (Month 12)
measure: Total Cholesterol (mg/dL)
timeFrame: Kick Off Event (Month 0)
measure: Total Cholesterol (mg/dL)
timeFrame: Closing Event (Month 12)
measure: High Density Lipoprotein Cholesterol (mg/dL)
timeFrame: Kick Off Event (Month 0)
measure: High Density Lipoprotein Cholesterol (mg/dL)
timeFrame: Closing Event (Month 12)
measure: Low Density Lipoprotein Cholesterol (mg/dL)
timeFrame: Kick Off Event (Month 0)
measure: Low Density Lipoprotein Cholesterol (mg/dL)
timeFrame: Closing Event (Month 12)
measure: Triglycerides (mg/dL)
timeFrame: Kick Off Event (Month 0)
measure: Triglycerides (mg/dL)
timeFrame: Closing Event (Month 12)
measure: Hemoglobin A1c
timeFrame: Kick Off Event (Month 0)
measure: Hemoglobin A1c
timeFrame: Closing Event (Month 12)
measure: Total Distance Walked (ft)
timeFrame: Kick Off Event (Month 0)
measure: Total Distance Walked (ft)
timeFrame: Closing Event (Month 12)
Other outcomes:
Locations:
Study officials:
References: