louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04340726: Periimplant Bone Changes in Different Abutment Heights and Insertion Timing in Posterior Mandibular Areas
Official title: Periimplant Bone Changes in Different Abutment Heights and Insertion Timing in Posterior Mandibular Areas: Results From a Randomized Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Failed
Lead sponsor: Universidade Católica Portuguesa
Sponsor class: OTHER
First posted: 2020-04-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the influence of the abutment height and insertion timing on early marginal bone loss (MBL) in posterior mandibular partial implant-supported restorations.

Material and methods: The study was planned as a prospective, randomized, controlled parallel group including subjects in need of two implants for the restoration of an edentulous posterior mandibular area. Data were gathered on age, gender, attached gingiva height, bleeding on probing (BoP), smoking habits and previous periodontitis. The patients were allocated into three groups: Group A implants were immediately connected to 2 mm height abutments; Group B implants were immediately connected to 1 mm height abutments; Group C implants were left to heal in a sub-mucosal position and 2 mm abutments were inserted in a second stage surgery. Peri-apical radiographs were taken at the implant surgery (baseline), 4 weeks after surgery (T1), 16 weeks after implant placement at the final restoration delivery (T2) and 1-year after implant placement (T3).


Eligibility criteria: Inclusion Criteria:

* patients age \> 18 years;
* American Society of Anaesthesiologists (ASA) status I;
* no systemic medication or condition known to potentially alter bone metabolism; - absense of acute periodontal condition.

Exclusion Criteria:

* lack of primary stability at implant surgery;
* need for bone regeneration procedures during surgery;
* inability to correct place the implant in accordance with the prosthetic requirements.

Primary outcomes:
measure: Marginal bone changes
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Viseu
country: Portugal
facility: Universidade Católica Portuguesa
Study officials:
References:
Clinical trial NCT05924126: Empiric Antibiotic Treatment for Septic Patients in the Intensive Care Unit
Official title: Empiric Antibiotic Treatment for Septic Patients in the Intensive Care Unit: Appropriateness and Therapeutic Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Septic Patients Admitted to the ICU
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: septic patients admitted to the ICU

Brief summary: Sepsis is one of the most common causes of ICU admission. About 5-15% of patients admitted to the hospital with an infection will have sepsis, and about 30-40% of them will have septic shock. About 34% of septic patients and about 53% of patients with septic shock will die within 28 days of admission. Broad-spectrum empiric antibiotic treatment (depending on the source of infection and patient risk factors) is one of the cornerstones of sepsis management. According to the recommendations of the surviving sepsis campaign, empiric antibiotic treatment should be given within one hour of the patient's arrival for patients with sepsis or septic shock. Administration of inappropriate antibiotics in the first 24 hours of admission was found in 34% of septic patients in various studies, and administration of inappropriate antibiotics (or when administered in delay) was found to be associated with increased morbidity and mortality.

In this study, we will assess the proportion of patients who were admitted to the ICU due to sepsis or septic shock and received empiric antibiotic treatment which, in retrospect, according to the growth in the cultures later on, was inappropriate. We will also assess the therapeutic results in these patients - mainly significant morbidity and mortality within 28 days, and compare them to the group of patients who received appropriate antibiotic therapy. We would also like to assess what were the possible reasons for inappropriate empiric antibiotic treatment, in order to draw conclusions to reduce the rate of these cases.


Eligibility criteria: Inclusion Criteria:

* All patients admitted to the general ICU due to sepsis or septic shock between 1/1/20 and 31/12/20

Exclusion Criteria: Patients who were admitted due to other non-infectious etiologies

-

Primary outcomes:
measure: Proportion of septic patients who recieved inappropriate empiric antibiotic therapy
timeFrame: January 2020-December 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT03790826: Chronic Indwelling Foley and Catheter Associated Trauma (CIF-CAT) Study
Official title: Chronic Indwelling Foley and Catheter Associated Trauma (CIF-CAT) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Infections and Inflammations
Keywords: bladder mucosal trauma
Lead sponsor: Nellie Medical, LLC
Sponsor class: INDUSTRY
First posted: 2019-01-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To determine whether an indwelling low profile Kohli Atraumatic Catheter causes less macro-morphologic inflammation and edema to the bladder mucosa than a traditional indwelling Foley catheter as assess by computerized image analysis.

Detailed description: The Kohli Atraumatic Catheter similarly aims to reduce bladder mucosal trauma with its low profile pancake shaped balloon versus the ovoid balloon of a traditional Foley catheter. The Kohli Atraumatic Catheter has a short, opened-ended tip that minimally protrudes through a patented low-profile donut-shaped balloon. The combination of the low profile and reduced tip length prevents the catheter from contacting the bladder walls and thereby minimize disruption of the bladder surface mucus layer and trauma to the urothelium - theoretically reducing the chance of bacterial invasion. A trial in which sheep were randomized to a traditional indwelling Foley catheter or a prototype Kohli Atraumatic Catheter demonstrated a dramatic reduction in both bladder wall trauma and edema. The ulcerated area dropped from 7.2% to 1.8% (75%) and the edema from 26.9% to 13.0% (52%).

Statistical Analysis To compare the effects of 2 catheter types, data will be analyzed using the general linear models tools from SAS/STAT software and presented as means ± standard error of the mean. The model will include 2 catheter types, inflamed vs non-inflamed areas, and their interactions.

Eligibility criteria: Inclusion Criteria:

* Men or Women older than age 18
* Indwelling Foley urinary catheter for at least 30 days prior to entry with anticipation for continued indwelling urinary catheterization for at least 30 days after entry into the study.

Exclusion Criteria:

* Inability to provide informed consent
* Unwilling or medically inappropriate for cystoscopy

Primary outcomes:
measure: Bladder mucosa damage assessment via computerized image analysis
timeFrame: 30 days
Secondary outcomes:
measure: Bladder mucosa damage urologist visual assessment
timeFrame: 30 days
measure: Patient discomfort via Numeric Pain Rating Scale
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01069926: To Assess the Pharmacokinetics of AZD1656 and Its Metabolite in Type 2 Diabetes Mellitus Patients
Official title: A Phase I, Multi-center, Open-label, Single Dose Study, to Assess the Pharmacokinetics of AZD1656 and Its Metabolite in Type 2 Diabetes Mellitus Patients With or Without Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glucose Lowering
Keywords: Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To assess the pharmacokinetics of AZD1656, and its metabolite, in type 2 diabetes mellitus patients with varying degrees of renal impairment and to compare the results with those in patients with normal renal function.


Eligibility criteria: Inclusion Criteria:

* Patients with a clinical diagnosis of T2DM for at least 1 year, treated with any OAD or insulin
* Calculated MDRD GFR based on S-creatinine at enrollment should fall within any of the 4 categories: mild , moderate, severe normal

Exclusion Criteria:

* Clinically significant progression of current disease or clinically relevant trauma, as judged by the Investigator, within 2 weeks before the first administration of the IP
* Clinically significant neuropathy according to the Investigator. However subjects with diabetic neuropathy which is not clinically significant according to the Investigator may be included.

Primary outcomes:
measure: Change-from-baseline variables will be calculated for the safety variables listed below, as the post-treatment value minus the value at baseline
timeFrame: The baseline values will be as follows:
Secondary outcomes:
measure: To evaluate the safety of AZD1656 in T2DM patients with various degrees of renal impairment. To describe the pharmacodynamics of AZD1656 in T2DM patients with various degrees of renal impairment by assessment of 24-hours glucose profile
timeFrame: blood samples will be collected for up to 48 hours postdose and urine samples for up to 12 hours postdose for measurement of plasma and urine concentrations of AZD1656 and its metabolite
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
Study officials:
affiliation: University of Tennessee Medical Center
name: William Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00500526: Effects of Singing in Chronic Obstructive Pulmonary Disease
Official title: Effects of Singing on Dyspnea, Quality of Life and Pulmonary Function Parameters of COPD Patients in Stable Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Pulmonary function
Respiratory muscle
Dyspnea
Quality of life
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2007-07-12
Enrollment: 43
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of the practice of singing for a long period of time on pulmonary function data, quality of life, and dyspnea sensation of patients with COPD in stable clinical conditions. As singing is a type of respiratory training, the study hypothesis is that singing would improve maximal respiratory pressures, dyspnea sensation, and overall quality of life of these patients.

Detailed description: Thirty COPD patients in stable clinical conditions are going to be randomized in two groups: the first one is going to have singing classes for six months; the other one is going to have classes of general manual arts for a similar period of time. The patients of both groups are going to perform spirometry, measurements of maximal respiratory pressures and answer the health related quality of life questionnaires SF-36 and Saint George's before the beginning of practice and after 6 months.Both singing and manual arts practices are going to be administered one hour a week by specialized teachers.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD according GOLD criteria
* Stable clinical conditions for the previous two months

Exclusion Criteria:

* Severe comorbidities other than COPD
* Hypoxemia with partial arterial oxygen pressure lower than 50 mmHg
* Incapacity to come to the research center in a weekly basis.

Primary outcomes:
measure: Forced vital capacity, forced expiratory volume, functional residual capacity, inspiratory capacity, maximal respiratory pressures
timeFrame: 6 months
Secondary outcomes:
measure: General quality of life score: SF-36 questionnaire.Specific quality of life score : Saint George's Questionnaire; Basal dyspnea index
timeFrame: 6 months
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas de Ribeirão Preto
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: José B Martinez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonilha AG, Onofre F, Vieira ML, Prado MY, Martinez JA. Effects of singing classes on pulmonary function and quality of life of COPD patients. Int J Chron Obstruct Pulmon Dis. 2009;4:1-8. Epub 2009 Apr 15.
Clinical trial NCT03558126: Silicone Tube for the Surgical Treatment of Glaucoma
Official title: Silicone Tube Miniature Drainage Device Implanted Under Scleral Flap for the Surgical Treatment of Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma, Open-Angle
Keywords: silicone tube
miniature drainage device
POAG
IOP
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The biocompatible silicone tube miniature drainage device is a small, non-valved implant to shunt aqueous humor underneath the conjunctiva to control the intraocular pressure. Efficacy and safety were evaluated with a minimum follow-up of 12 months.

Detailed description: Patients were examined postoperatively at 1 day, 1 week, 1, 3, 6, 12, 18, 24 months or more frequent when required. IOP, BCVA and slit lamp biomicroscopy were observed at every visit. History of all medication details and postoperative complications were recorded. One-way analysis of variance (ANOVA) with repeated measures was used to analyze the other differences over time in IOP and BCVA. Nonparametric K-related samples test was used to analyze the difference of medications number at different time points. Success rates were evaluated using Kaplan-Meyer survival analysis curves.

Eligibility criteria: Inclusion Criteria:Eligible patients were at least 18 years of age and presented with medically uncontrolled POAG requiring incisional surgery for IOP (intraocular pressure) reduction.

-

Exclusion Criteria:Exclusion criteria included narrow angles, normal tension glaucoma, previous eye surgery (except cataract surgery), neovascular glaucoma, uveitis, any ocular abnormality that would preclude accurate IOP assessment, and inability to comply with the follow-up program or unwillingness to participate in this study.

-

Primary outcomes:
measure: IOP
timeFrame: 3 years
Secondary outcomes:
measure: Number of anti-glaucoma medication
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04574726: Study of Balance Reactions in a Virtual Environment Compared to a Real Environment
Official title: Study of Balance Reactions in a Virtual Environment Compared to a Real Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Pôle Saint Hélier
Sponsor class: OTHER
Collaborators: name: Hopital La Musse
First posted: 2020-10-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, multicenter, controlled, randomized, intervention study with minimal risks and constraints (RIPH2) on healthy volunteers.
Primary purpose: SCREENING

Brief summary: Validate a virtual environment by demonstrating a non modification of the characteristics of postural reaction and displacement of the body's center of pressure between a real environment and the same environment in immersive virtual reality.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer, men and women over 18 years old

Exclusion Criteria:

* Severe visual disorders which couldn't enable immersive virtual reality experience
* Immobilisation of one of the upper limbs (restraint splint)
* Orthopedic problems and pain in the lower limb
* MSSQ upper than 25
* Pregnant women
* Person under legal protection

Primary outcomes:
measure: Area of CoP (Center of pression)
timeFrame: Immediately after inclusion
Secondary outcomes:
measure: Total distance covered by the CoP during the balance test (in mm)
timeFrame: Immediately after inclusion
measure: Simulator Sickness Quantifying (SSQ)
timeFrame: Immediately after the balance test
Other outcomes:
Locations:
city: Rennes
country: France
facility: Pole Saint-Hélier
state: Bretagne
city: Saint-Sébastien-de-Morsent
country: France
facility: Hôpital la Musse
Study officials:
References:
Clinical trial NCT00926926: Effects of Oxybutynin Topical Gel on Gastric Emptying
Official title: Effect of Oxybutynin Chloride Topical Gel on Gastric Emptying, Using the Acetaminophen Absorption Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteer
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-06-24
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study explores the effect of oxybutynin topical gel on gastric emptying


Eligibility criteria: Inclusion Criteria:

* Adult, healthy, post-menopausal females

Exclusion Criteria:

* Patients for whom OTG or acetaminophen is contraindicated.
* Abnormality of the GI tract.
* Taking drugs that affect gastric motility.

Primary outcomes:
measure: The effect of oxybutynin chloride topical gel administration on gastric emptying will be assessed by comparing the single dose relative bioavailability of acetaminophen
timeFrame: After 7 days of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: St. Charles
country: United States
state: Missouri
Study officials:
affiliation: Watson Laboratories
name: Scott Olsen, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT02369757: Patients Navigator for Organized Colorectal Cancer Screening
Official title: Patients Navigator for Organized Colorectal Cancer Screening in Underserved Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
Collaborators: name: Gustave Roussy, Cancer Campus, Grand Paris
name: University of Lyon
name: Centre Georges Francois Leclerc
First posted: 2015-02-24
Enrollment: 40774
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective is to evaluate the impact of the recruitment and training of a peer-navigator on the participation rate of colorectal cancer screening among underserved area. The role of the navigator is to establish an intervention culturally-tailored to the inhabitants in order to promote the Fecal Occult Blood test (FOBT) and accompany the inhabitants to complementary exams, if needed.


Eligibility criteria: Inclusion Criteria:

* person living in the IRIS intervention zones
* person invited by the local management structure to participate in colorectal cancer screening

Exclusion Criteria:

* person not living in the IRIS intervention zone
* person not invited by the local management structure to participate to colorectal cancer screening

Primary outcomes:
measure: Participation rates
timeFrame: 24 months
Secondary outcomes:
measure: Percentage of patients primary care peers take care of
timeFrame: 24 months
measure: Qualitative analysis
timeFrame: 1 hour
Other outcomes:
Locations:
city: Saint-Priest-en-Jarez
country: France
facility: Institut de cancérologie Lucien Neuwirth
Study officials:
affiliation: Institut de Cancérologie Lucien Neuwirth
name: Franck Chauvin, PhDMD
role: STUDY_CHAIR
References:
citation: Allary C, Bourmaud A, Tinquaut F, Oriol M, Kalecinski J, Dutertre V, Lechopier N, Pommier M, Benoist Y, Rousseau S, Regnier V, Buthion V, Chauvin F. ColoNav: patient navigation for colorectal cancer screening in deprived areas - Study protocol. BMC Cancer. 2016 Jul 7;16:416. doi: 10.1186/s12885-016-2469-9.
Clinical trial NCT01104857: Respiratory Muscle Dysfunction in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Mechanical Ventilation
Keywords: Respiratory muscle
Myosin
Mechanical ventilation
Lead sponsor: University Medical Center Nijmegen
Sponsor class: OTHER
First posted: 2010-04-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Respiratory muscle dysfunction in critically ill patients is associated with elevated morbidity, including prolonged weaning from mechanical ventilation. The causes for respiratory muscle dysfunction in these patients is poorly understood and no effective treatment is available.

The general hypothesis of the present study is that in critically ill mechanically ventilated subjects respiratory muscle dysfunctions results from loss of myosin induced by activation of proteolytic cascades.


Eligibility criteria: Inclusion Criteria:

* Severe sepsis / septic shock
* Clinical reason for laparotomy
* \> 18 years

Exclusion Criteria:

* No informed consent
* Medical history of myopathy
* Unintended weight loss before ICU admission
* Pregnancy
* Chronic use of corticosteroids

Primary outcomes:
measure: Diaphragm muscle myosin content
timeFrame: 1 day
measure: Markers for inflammation
timeFrame: 1 day
measure: Markers for activation of proteolytic pathway in the diaphragm
timeFrame: 1 day
Secondary outcomes:
measure: length of ICU stay
timeFrame: 6 months
measure: Length of mechanical ventilation
timeFrame: 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud Universtity Nijmegen Medical Centre
Study officials:
References: