louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05044793: A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System
Official title: A Multicenter Clinical Study To Assess The Long-Term Safety And Effectiveness Of The OMNI® Surgical System In Combination With Cataract Surgery In Eyes With Open Angle Glaucoma (GEMINI 2.0)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Lead sponsor: Sight Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-16
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who received treatment and completed Protocol #06213

Brief summary: The purpose of this study is to evaluate the long-term safety and effectiveness of the OMNI® Surgical System in subjects who were treated under protocol #06213


Eligibility criteria: Inclusion Criteria:

• Participated in, received treatment, and completed Protocol #06213

Exclusion Criteria:

* Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits
* Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate washout, place the subject at risk of significant vision loss during the study period (e.g., wet age macular degeneration (AMD), corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits)

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Change in Intraocular Pressure (IOP)
timeFrame: 12 months
measure: Change in Hypotensive Medications
timeFrame: 12 months
measure: Number of Participants With ≥20% Reduction in IOP From Baseline to 36 Months
timeFrame: 12 months
measure: Number of Participants With Intraocular Pressure (IOP) Between 6 and 18mmHg Inclusive.
timeFrame: 12 months
Locations:
city: Wichita
country: United States
facility: Grene Vision Group
state: Kansas
city: Oklahoma City
country: United States
facility: Oklahoma Eye Surgeons
state: Oklahoma
city: Jenkintown
country: United States
facility: Northern Ophthalmics
state: Pennsylvania
city: El Paso
country: United States
facility: El Paso Eye Surgeons
state: Texas
Study officials:
References:
Clinical trial NCT00233493: Spread of Dermatophytes Among Families
Official title: Demonstration of the Spread of Dermatophytes Through Casual Contact Among Family Household Members
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Onychomycosis
Tinea Pedis
Keywords: dermatophytes
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2005-10-05
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study Design-Households with at least 2 residents and 1 individual (index person \[IP\]) with tinea pedis and/or onychomycosis were identified by screening. Infection was confirmed clinically and mycologically (potassium hydroxide \[KOH\] and culture positive) in the IP; then other members within the same household were examined for tinea pedis and/or onychomycosis using the same criteria. All participants with confirmed fungal infections were referred to their primary care physicians for appropriate treatment.

Brief summary: The objective is to demonstrate person-to-person spread of dermatophytes of the skin and nails among family members, as measured by fungal culture and DNA typing of the dermatophytes isolated.

Detailed description: Enrolled families consist of at least two members over the age of 14. Once the index person is examined and a dermatophyte is isolated from either toenail or foot scale, other family members are examined and cultured. All dermatophyte isolates obtained from each family unit are compared using DNA typing and restriction length polymorphism (RFLP) to determine whether family members share the same organism or were infected by an outside source.

Eligibility criteria: Inclusion Criteria: positive dermatophyte culture

-

Exclusion Criteria:

* use of antifungal agents, either oral or topical

Primary outcomes:
measure: Dermatophyte Species Distribution
timeFrame: Baseline
Secondary outcomes:
measure: Dermatophyte Strain Types Among All Enrolled Households
timeFrame: Baseline
measure: Number of Households With Dermatophyte Infection Spread
timeFrame: Baseline
measure: Number of Participants Affected by the Association of Spread of Infection and History of Tinea Pedis or Onychomycosis
timeFrame: Baseline
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: Center for Medical Mycology, University Hospitals Cleveland Medical Center
name: Mahmoud A Ghannoum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02781493: Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopyp
Keywords: Prucalopride
Polyethylene Glycol
bowel preparation
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Binzhou People's Hospital
name: Tai'an People's Hospital
name: Linyi People's Hospital
First posted: 2016-05-24
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prucalopride based bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.

Detailed description: Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost.Unfortunately, despite advances in bowel preparation methods, up to one-third of all colonoscopies are reported to have an inadequate bowel preparation.

Prucalopride can accelerate colonic transit and has been demonstrated to be efficient in constipation.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older,
* scheduled to undergo elective outpatient colonoscopy,
* and were able to provide informed consent.

Exclusion Criteria:

* history of colorectal surgery
* severe colonic stricture or obstructing tumour
* dysphagia
* compromised swallowing reflex or mental status
* significant gastroparesis or gastric outlet obstruction
* known or suspected bowel obstruction or perforation
* severe chronic renal failure (creatinine clearance\<30 ml/min
* severe congestive heart failure (New York Heart Association class III or IV)
* uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg)
* dehydration
* disturbance of electrolytes
* pregnancy or lactation
* haemodynamically unstable
* unable to give informed consent.

Primary outcomes:
measure: Difference of scores rating by Boston Bowel Preparation Scale between 2 groups.
timeFrame: 9 months
Secondary outcomes:
measure: Polyp detection rate between 2 groups.
timeFrame: 9 months
measure: rate of adverse events between 2 groups.
timeFrame: 9 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Li Yanqing, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04067271: LUEbeck Registry of Intensive Care Patients - Characterization of the Patients Intestinal MICROBIOME
Official title: LUEbeck Registry of Intensive Care Patients - Characterization of the Patients Intestinal MICROBIOME
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ICU Patients
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who receive treatment on ICU.

Brief summary: The purpose of the current study is to analyze the effects of ICU-care on changes in microbiome and the influence of intestinal microbiome changes on short-term and long-term morbidity and mortality of ICU patients.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* All patients receiving intensive medical care
* A written informed consent from the patient or two independent doctors or legal guardians.

Exclusion Criteria:

* Age \<18 years

Primary outcomes:
measure: Modification of the microbiome
timeFrame: Day 0
Secondary outcomes:
measure: ICU intensive care unit stay
timeFrame: Day 0
measure: Hospital stay
timeFrame: Month 12
measure: Hospital stay
timeFrame: Month 6
measure: Survival
timeFrame: Month 6
measure: Survival
timeFrame: Month 12
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: Medical Clinic II-UKSH Campus Lübeck
state: Schleswig-Holstein
Study officials:
References:
Clinical trial NCT04731493: Effect on the Quality of Life of a Therapeutic Education Program in Patients With Marfan Syndrome
Official title: Effect on the Quality of Life of a Therapeutic Education Program in Patients With Marfan Syndrome: an Observational, Prospective and Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Marfan Syndrome
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 25
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Marphan Syndrom

Brief summary: This is a before-after, observational, prospective, multicenter cohort study. The study will consist of 2 phases: an initial observational phase of a minimum of 3 months before the Therapeutic Education Program (TEP) intervention, then a phase of evolution analysis of at least 3 months.

Detailed description: During the first observational phase, the quality of life assessment will be carried out 3 months apart without intervention. The data obtained during this first phase will make it possible to characterize the functional impact in patients, to verify the reproducibility of our evaluations, and to evaluate the spontaneous evolution of the parameters over a period of 3 months.

During the second phase of evolution analysis, the quality of life will be assessed at 3 month intervals (M9, M12) after the therapeutic Education Program (M6). The comparison between the evolution during the two phases, before and after the TEP will allow us to assess the benefits of the TEP.

Eligibility criteria: Inclusion Criteria:

* Patient aged between 7 and 25 years old with Marfan Syndrome or related according to Ghent criteria
* For minors, no oral opposition from the holders of parental authority and consent of the minor.
* For adults, no oral opposition collected
* Patient affiliated to a social security scheme or equivalent

Exclusion Criteria:

* Inability of the patient to understand the content of the TEP sessions or the questionnaire about quality of life (non-French speaking, severe intellectual disability)
* Patient who has already participated in a TEP session for his pathology.
* Protected adult: patient under legal guardianship or curator protection

Primary outcomes:
measure: quality of life of children and young adults with Marfan
timeFrame: Base line
measure: quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP),
timeFrame: 3 months
measure: quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP),
timeFrame: 9 months
measure: quality of life of children and young adults with Marfan syndrome after therapeutic education program (ETP),
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UHToulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Yves DULAC, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01872793: Validation of BIVA for Nutritional Assessment in Cirrhotic Patients
Official title: Validation of Bioelectrical Impedance Vector Analysis for Nutritional Assessment in Patients With Cirrhosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Malnutrition
Keywords: bioelectrical impedance vector analysis
nutritional assessment
nutritional status
mortality
complications
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 250
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: The participants will be recruited from the Gastroenterology Department of a tertiary care setting.

Brief summary: Despite the importance of nutritional status in patient's outcome, there is no gold standard for nutritional assessment. Traditional techniques used in healthy subjects to assess nutritional status cannot be used in cirrhotic patients due especially to ascites and peripheral edema, and altered rates of biochemical markers due to liver failure.

Bioelectrical impedance vector analysis has emerged as a useful method to assess body composition and nutritional status especially in patients at the extremes of body weight (fluid overload, excess of adipose tissue, etc.).

With previous results from our research group, BIVA showed to be useful for evaluating cirrhotic patients.

The aim of this study is to validate our previous results and validate BIVA for nutritional assessment in patients with liver cirrhosis


Eligibility criteria: Inclusion Criteria:

Diagnose of liver cirrhosis by two or more of the following criteria:

* Albumin \< 3.4 g/dL
* INR ≥ 1.3
* Total bilirubin ≥ 2 mg/dL
* Portal hypertension (esophageal varices, splenomegaly, ascites, etc.)
* Liver biopsy
* Ambulatory patients

Exclusion Criteria:

* Personal history of surgery in the last four weeks
* Thyroid disorders without replacement therapy
* Pregnancy
* Active alcoholism with alcohol ingest in the previous 6 months.
* Acute or chronic renal failure
* Hepatic or renal transplant

Primary outcomes:
measure: Changes in nutritional status
timeFrame: At the time of inclusion, every six months up to 36 months
Secondary outcomes:
Other outcomes:
measure: Evaluation of mortality
timeFrame: Through study completion, an average of 36 months.
Locations:
city: Mexico city
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Study officials:
affiliation: Instituto Nacional de Nutrición y Ciencias Médicas "Salvador Zubirán"
name: Aldo Torre, MD, MSc
role: STUDY_CHAIR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Astrid Ruiz-Margain, BSc, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Ricardo Macías-Rodriguez, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02397993: Serum Parameter Prior and After EUS-guided Fine Needle Aspiration of the Pancreas
Official title: Serum Lipase, Amylase and CA 19-9 Prior and After EUS-guided Fine Needle Aspiration of the Pancreas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatitis
Lead sponsor: Helios Albert-Schweitzer-Klinik Northeim
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with independent indication for endoscopic ultrasound-guided fine needle aspiration of the pancreas due to pancreatic disease (e.g. pancreatitis, pancreatic masses) no volunteers accepted

Brief summary: Endoscopic ultrasonography (EUS ) -guided fine needle aspiration (EUS -FNA ) of focal pancreatic lesions is an essential diagnostic procedure with high therapeutic effect in clinical routine.

The aim of this study is to determine the levels of serum lipase, serum amylase and the tumor marker CA 19-9 prior and after EUS-FNA. In animal experiments on dogs, an increase of all three parameters was observed after surgery on the pancreas. For humans, these clinically important data are not yet available .

It is assumed that the probability of pancreatitis with increased activity of lipase and amylase will rise with the number of puncture procedures as well as the size of the puncture needle. In addition, the post-interventional assessment of the tumor marker CA 19-9 could result in a false positive assumption of malignant neoplastic pancreatic lesion.


Eligibility criteria: Inclusion Criteria:

* independent indication for pancreatic EUS-FNA
* age ≥ 18 years
* patient able to give informed consent

Exclusion Criteria:

* Contraindications for EUS-FNA
* pregnancy
* no informed consent available
* known stenosis of esophagus or duodenum
* relevant coagulation disorders

Primary outcomes:
measure: Serum lipase
timeFrame: up to 24h prior to EUS-FNA and 4 hours after EUS-FNA
Secondary outcomes:
measure: Serum amylase
timeFrame: up to 24 hours prior to EUS-FNA
measure: Serum amylase
timeFrame: 4 hours after EUS-FNA
measure: CA 19-9
timeFrame: up to 24 hours prior to EUS-FNA
measure: CA 19-9
timeFrame: 4 hours after EUS-FNA
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: Department of Gastroenterology, University Medical Center
state: Lower Saxony
city: Northeim
country: Germany
facility: HELIOS Albert-Schweitzer Hospital Northeim
state: Lower Saxony
city: Bielefeld
country: Germany
facility: Department of Gastroenterology, Klinikum Bielefeld
state: North-Rhine Westphalia
Study officials:
affiliation: Helios Albert-Schweitzer-Klinik
name: Tobias Meister, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Bielefeld
name: Jan Heidemann, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Göttingen
name: Volker Ellenrieder, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03244293: Bispectral Index (BIS) for Classification of Procalcitonin (PCT) Sepsis Grades in Critically Ill Patients With Sepsis
Official title: Sensitivity and Specificity of Bispectral Index (BIS) for Classification of Procalcitonin (PCT) Sepsis Grades in Critically Ill Patients With Sepsis, Severe Sepsis and Septic Shock and Multiple Organ Failure (MOF)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis, Severe
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critical Care patients with all grades of Sepsis monitored with bispectral index

Brief summary: To evaluate the discriminative power of BIS monitoring to classify the degree of mental state associated with the PCT graded sepsis cascade, and to assess its utility for monitoring the improvement or deterioration of sepsis.

Detailed description: To evaluate the discriminative power of BIS monitoring to classify the degree of mental state associated with the PCT graded sepsis cascade, and to assess its utility for monitoring the improvement or deterioration of sepsis. The primary endpoint of our study was to use an artefact-free 10-min mean BIS value to classify the degree of sepsis. As secondary endpoints, we correlated the mean BIS value to various mental state and sepsis parameters; PCT, C-reactive protein (CRP), Glasgow coma scale, and sequential organ failure assessment (SOFA) score. In a longitudinal study, patients' PCT sepsis grades were reassessed at a later time point and a second artefact-free 10-min mean BIS value was recorded to evaluate BIS evolution within the same patient.

Eligibility criteria: Inclusion Criteria: patients with sepsis

* patients with sepsis

Exclusion Criteria:

* Patients who received drugs that would interfere with BIS monitoring

Primary outcomes:
measure: Bispectral Index (BIS)-Electroencephalography (EEG) derived parameter correlated to the severity of Sepsis as indicated by Procalcitonin (PCT) biomarker.
timeFrame: Time point 1= On CCU admission, Time point 2= day 3 of CCU admission, Time point 3= on release from CCU.
Secondary outcomes:
Other outcomes:
Locations:
city: Dalian
country: China
facility: Dalian Medical University
state: Dalian
Study officials:
affiliation: Suez Canal University
name: Ashraf Dahaba, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02387593: Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study
Official title: Usefulness of Endocuff in the Adenoma Detection Rate. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Canceer
Keywords: Adenoma
Colonoscopy
Screening
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2015-03-13
Enrollment: 300
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: Colorectal cancer (CRC) is one of the leading causes of cancer death worldwide. The cumulative risk of developing CRC is about 6% lifelong.

The benefit of screening colonoscopy depends on the detection and removal of all adenomas, however, some of these may be difficult to detect.

The "endocuff" (EC) is a polymer sleeve which joins the tip of the colonoscope to improve the image viewing of the mucosa during colonoscopy procedure.

There is insufficient evidence of the usefulness of endocuf

Detailed description: All patients requiring colonoscopy for screening and who agree to participate in the study will be included and randomized them to make an standard colonoscopy or colonoscopy with endocuff, for randomization system will be used in balanced blocks of 4, created on the page randomization.com.

Eligibility criteria: Inclusion Criteria:

* Healthy adult patients,
* Aged 18,
* Who would come to colonoscopy for colon cancer screening without prior colonoscopy studies

Exclusion Criteria:

* Boston colonic preparation \<5 points
* Suspected Lynch syndrome or familial adenomatous polyposis (FAP)

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 30 minutes
measure: Measurement of the polyp detection rate
timeFrame: 30 minutes
Secondary outcomes:
measure: Cecal intubation rate
timeFrame: 30 minutes
measure: ileal intubation rate
timeFrame: 10 minutes
measure: Difficulty performing polypectomy
timeFrame: 10 minutes
measure: Complications during colonoscopy
timeFrame: One week
Other outcomes:
Locations:
city: México
country: Mexico
facility: Rafael Barreto
state: Tlalpan
Study officials:
affiliation: Department of Endoscopy
name: Rafael Rafael, MD
role: PRINCIPAL_INVESTIGATOR
References: