louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01841138: Changes of Serum Electrolytes During Bowel Prep With PEG 3350 + Ascorbic Acid - a Prospective Study
Official title: Changes of Serum Electrolytes During Bowel Prep With PEG 3350 + Ascorbic Acid - a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy
Keywords: colonoscopy
bowel preparation
electrolytes
osmolality
water
Lead sponsor: Klinik Bogenhausen
Sponsor class: OTHER
First posted: 2013-04-26
Enrollment: 190
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 an indicaton for colonoscopy

Brief summary: Hypothesis: Patients who undergo bowel preparation with PEG 3350 + ascorbic acid may have significant changes of serum electrolytes.

A new PEG solution (Moviprep = PEG 3350 + ascorbic acid) for colonoscopy reduces the amount of cathartic solution to 2 liters, but requires drinking of additional liquid for optimal results. Ingestion of a high volume of free water bears a risk for severe changes of serum electrolytes, particularly for sodium and potassium.

In this trial, patients undergo regular bowel preparation for standard colonoscopy with Moviprep (2 liters Moviprep split-dose plus ≥2 liters of free liquid until sufficient cleansing is achieved). Blood samples for serum sodium, potassium, chloride, magnesium, phosphate, calcium and serum osmolarity are taken before the beginning of the prep procedure and right before colonoscopy. The interval between both blood samples that will be compared is roughly 24 hours. Additionally, the volume of prep solution and additional liquid is recorded. The quality of bowel preparation is visually rated during colonoscopy with a validated score.

Pre- and postpreparation serum parameters will be compared. Primary outcome measure is the proportion of patients who have a serum sodium beyond the reference values after the completion of bowel preparation. Secondary outcome parameters are the proportion of patients with other serum electrolytes or serum osmolarity beyond the reference. Moreover, changes of serum electrolytes and osmolarity will be correlated with the amount of prep solution and liquid.


Eligibility criteria: Inclusion Criteria:

* indication for colonoscopy
* \>=18 years

Exclusion Criteria:

* \<18 years
* acute inflammatory bowel disease
* previous bowel resection
* high-grade cardiac or renal insufficiency

Primary outcomes:
measure: Proportion of patients with serum sodium concentration beyond the limits of normal after the completion of bowel preparation
timeFrame: within 2 hours before the beginning of colonoscopy
Secondary outcomes:
measure: Proportion of patients with serum potassium or calcium or chloride or magnesium concentration beyond the limits of normal after the completion of bowel preparation
timeFrame: within 2 hours before the beginning of colonoscopy
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum Bogenhausen - Klinikum München GmbH
Study officials:
References:
Clinical trial NCT04031638: Thyroid Cancer Database
Official title: Prospective and Retrospective Thyroid Cancer Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients With a Thyroid Tumor Who Received Radioactive Iodine Treatment
Keywords: Thyroid cancer, Iodine treatment
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 2300
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 a thyroid tumor who received radioactive Iodine treatment in Centre Georges Francois Leclerc, Dijon, France

Brief summary: Thyroid cancer database collects clinical and laboratory data from patients with a thyroid tumor who received radioactive Iodine treatment. This database only records information based on patients' medical files in a structured manner.

Thyroid database is used for retrospective non-interventional research projects.


Eligibility criteria: Inclusion Criteria:

* patients with a thyroid tumor (metastatic or not)
* patients who received radioactive Iodine treatment.
* age \>= 18

Exclusion Criteria:

* Objection to collect medical data records

Primary outcomes:
measure: Patient survival
timeFrame: 10 years
Secondary outcomes:
measure: Collection of patient and treatment characteristics
timeFrame: 10 years
Other outcomes:
Locations:
city: Dijon
country: France
facility: Methodology, Biostatistics and Data Management
Study officials:
References:
Clinical trial NCT04636138: Pharmacogenomic Modulators of Impaired Exercise Adaptation in Statin Users
Official title: Pharmacogenomic Modulators of Impaired Exercise Adaptation in Statin Users
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HMG-CoA Reductase Inhibitor Toxicity
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 5
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) have beneficial effects (prevent stroke, heart attack) but also some bad ones (block some good effects of exercise). Individuals have genetic variations in proteins that metabolize/transport statins. The investigators hypothesize that these variations modulate the relationship between statin use and lack of benefit from exercise. The investigators will test this by having statin-users do supervised exercise for 6 weeks, measuring the cardiorespiratory fitness before/after and correlating this to genetic variations present in the participant.


Eligibility criteria: Inclusion Criteria:

* English-speaking
* Adults (aged 35-65 years)
* Overweight or obese (body-mass index \[BMI\] 25-43)
* Currently taking high-dose atorvastatin (40-80mg once daily) for primary prevention of cardiovascular disease and/or stroke
* Sedentary (\<30 minutes of structured exercise weekly)
* Willing to participate in supervised exercise three times weekly
* Willing to not make intentional changes to their diet during the study period.

Exclusion Criteria:

* Tobacco smokers
* Pregnant or breastfeeding
* Use other medications that affect lipid metabolism (e.g. fibric acid, fish oil)
* Markedly functional debilitated and unable to exert 4 metabolic equivalents (METs) of energy (e.g. unable to climb a flight of stairs without stopping), or who have
* Been advised by a physician to avoid exercise due to comorbid serious cardiovascular disease
* Uncontrolled diabetes (A1c \> 8)
* Uncontrolled thyroid disease
* HIV/AIDS
* Cancer
* History of myocardial infarction or stroke
* History of statin-induced myopathy.

Primary outcomes:
measure: Peak oxygen consumption (VO2max)
timeFrame: 6 weeks
Secondary outcomes:
measure: Resting heart rate
timeFrame: 6 weeks
measure: Resting systolic blood pressure
timeFrame: 6 weeks
measure: Weight
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Daniel J Parente, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05319938: Growth Factors in the Treatment of the Multiple Gingival Recessions
Official title: Clinical Evaluation of Treatment With Micro-surgical Management of Type I Multiple Gingival Recessions Using Coronally Advanced Flap With Either Advanced Platelet-Rich Fibrin or Concentrated Growth Factor: A Comparative Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth Factors, Combined Defect of
Gingival Recession
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare and evaluate the clinical effects of Concentrated Growth Factor (CGF) and Advanced Platelet-Rich Fibrin (A-PRF) applied together with Coronally Advanced Flap (CAF) technique using a microsurgical approach in the treatment of Type I multiple gingival recessions (GR).


Eligibility criteria: Inclusion Criteria:

* Systematically and periodontally healthy non-smokers
* Presence of Cairo Recession type I gingival recession with ≥ 2 mm gingival recession depth, probing depth \<3 mm and gingival thickness (GT) ≥ 0.8 mm on both sides of the maxillary arch
* Width of keratinized gingiva ≥ 2mm
* Presence of identifiable cemento-enamel junction
* Full-mouth plaque index (PI) \< 20 %
* Gingival index (GI) scores =1
* Presence of tooth vitality
* Absence of caries, restorations and furcation involvement in the treated area

Exclusion Criteria:

* Patients who had systemic problems that wound contraindicate for periodontal surgery
* Usage of medications known to interfere with healing and to cause gingival enlargement
* Recession defects associated with demineralization, deep abrasion, previous surgery in the defects area within the past 1 year
* Pregnant or lactating females
* Drug and alcohol abuse

Primary outcomes:
measure: Complete and mean root coverage
timeFrame: Change from baseline at 6 months of the percent of complete and mean root coverage
Secondary outcomes:
measure: Gingival thickness
timeFrame: Change from baseline at 6 months of the gingival thickness
measure: Keratinized gingiva width (WKG)
timeFrame: Change from baseline at 6 months of keratinized gingiva width
measure: Patient esthetic score (PES)
timeFrame: Change from baseline at 6 months of the patient esthetic score
measure: Patient comfort score (PCS)
timeFrame: Change from baseline at 6 months of the patient comfort score
measure: Hypersensitivity score (HS)
timeFrame: Change from baseline at 6 months of the hypersensitivity score
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Figen Öngöz Dede
Study officials:
References:
Clinical trial NCT01626638: Confocal Micro-endoscopy in Head and Neck Cancer/Micro Endoscopie Confocale (MEC)Oto-Rhino-Laryngologie (ORL)
Official title: Clinical Evaluation of Confocal Microscopy in Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Pharyngo Laryngeal Tumors
Pre-malignant Pharyngo Laryngeal Tumors
Keywords: Patients with malignant and pre-malignant pharyngo laryngeal tumors
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2012-06-25
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective is to validate the diagnostic correlation between the intraoperative microendoscopic images and the conventional histological analysis on biopsy and/or surgical specimens on patients with epidermoid carcinoma.


Eligibility criteria: Inclusion Criteria:

* Patients with malignant and pre-malignant pharyngo laryngeal tumors in whom direct laryngoscopy was performed under general anesthesia with biopsies for diagnostic or endoscopic removal
* \> 18 years
* signed ICF

Exclusion Criteria:

* Persons deprived of liberty
* Patients with history of allergy to patent blue
* Pregnant women or breastfeeding women

Primary outcomes:
measure: Diagnostic correlation between confocal micro endoscopy and conventional histology
timeFrame: at an average of 18 months
Secondary outcomes:
measure: Histological diagnostic with confocal micro endoscopy (MEC) VS conventional histological analysis
timeFrame: At the time of the biopsy
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Val De Marne
city: Toulouse
country: France
facility: Institut Universitaire Du Cancer de Toulouse - Oncopole
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Stéphane TEMAM, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Villard A, Breuskin I, Casiraghi O, Asmandar S, Laplace-Builhe C, Abbaci M, Moya Plana A. Confocal laser endomicroscopy and confocal microscopy for head and neck cancer imaging: Recent updates and future perspectives. Oral Oncol. 2022 Apr;127:105826. doi: 10.1016/j.oraloncology.2022.105826. Epub 2022 Mar 19.
Clinical trial NCT06307938: Circulating Tumor DNA in Patients Summoned for Colonoscopy; - a Liquid Biopsy for Detection, Characterization, Individualized Treatment and Follow-up of Colorectal Cancer
Official title: Circulating Tumor DNA in Patients Summoned for Colonoscopy; - a Liquid Biopsy for Detection, Characterization, Individualized Treatment and Follow-up of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Colorectal Adenoma
Keywords: Biomarker
Liquid biopsy
ctDNA
Lead sponsor: Helse Nord-Trøndelag HF
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2024-03-13
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients summoned for colonoscopy at their local public hospital

Brief summary: CoLiQ is a clinical study designed to evaluate the clinical usefulness of circulating tumor DNA (ctDNA) markers found in blood, as a liquid biopsy for diagnosis, prognosis and follow-up of colorectal cancer. The main questions it aims to answer are: 1) Can a panel of ctDNA markers identify CRC patients among the other patients summoned for colonoscopy? and 2) Does the type, number and level of ctDNA markers vary with the subtype and clinical course of CRC? Participants will be asked to answer a questionnaire and give a blood sample at inclusion. In addition, patients with CRC will be asked to give an extra test tube at their routine treatment and follow-up blood sampling.


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years old summoned for colonoscopy
* Patient able to understand and sign written informed consent

Exclusion Criteria:

* Patient \< 18 years old
* Patient unable to understand or give written informed consent
* Patient unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the investigator as unlikely to complete the study

Primary outcomes:
measure: Colorectal cancer
timeFrame: evaluated within 3 months after colonoscopy
measure: Colorectal adenoma
timeFrame: evaluated within 3 months after colonoscopy
measure: Inflammatory bowel disease
timeFrame: evaluated within 3 months after colonoscopy
Secondary outcomes:
measure: Recurrence
timeFrame: Within 5 years following treatment with curative intent for colorectal cancer
measure: Death
timeFrame: Within 5 years following diagnosis of colorectal cancer
measure: Treatment response
timeFrame: Within the 5 years following diagnosis of colorectal cancer
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Nord-Trøndelag Hospital Trust
Study officials:
References:
Clinical trial NCT04733638: ADVANCE- Automated Detection and Volumetric Assessment of ICH
Official title: Automated Detection and Volumetric Assessment of Intracerebral Hemorrhage Using Artificial Intelligence- Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracerebral Hemorrhage
Keywords: Artificial Intelligence
ICH
Lead sponsor: Viz.ai, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients, that meet eligibility criteria, undergoing imaging for a suspected acute stroke or intracranial hemorrhage

Brief summary: To evaluate the performance of the Viz ICH VOLUME algorithm.

Detailed description: To evaluate the performance of the Viz ICH VOLUME algorithm to:

1. detect the presence of ICH on brain imaging,
2. measure the volume of ICH on brain imaging,
3. and to assess the algorithm processing time,
4. and the difference in time to notification, time to treatment, and clinical outcomes in comparison to standard of care.

Eligibility criteria: Inclusion Criteria:

* Adult patients (18 and older)
* Presenting with symptoms suspicious for an acute stroke / intracranial hemorrhage
* Having a complete imaging data set including NCCT +/- MRI, CTA and/or MRA

Exclusion Criteria:

* Subjects with poor or incomplete brain imaging.

Primary outcomes:
measure: Algorithm Performance
timeFrame: Up to 10 minutes
Secondary outcomes:
measure: Algorithm Processing Time
timeFrame: Up to 10 minutes
measure: Time to Notification
timeFrame: Up to 10 minutes
measure: Time to Treatment
timeFrame: up to 1 day (1440 minutes)
measure: Length of Stay
timeFrame: Hospital admit to discharge, up to 30 days
measure: In Hospital Complications
timeFrame: Hospital admit to discharge, up to 30 days
measure: Modified Rankin Scale (mRS) at Discharge and 90 Days
timeFrame: 90 days
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Swedish Medical Center Healthone
state: Colorado
city: New York
country: United States
facility: Mount Sinai Hospital (Neurosurgery)
state: New York
city: Charlotte
country: United States
facility: Presbyterian Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Greenville
country: United States
facility: Prisma Health Upstate
state: South Carolina
Study officials:
affiliation: Director of Clinical Affairs at Viz
name: Moleen Madziva
role: STUDY_DIRECTOR
References:
Clinical trial NCT04056338: Gut Microbiome and ICU Delirium Post Cardiac Surgeries
Official title: Gut Microbiome and Gut Barrier Function in ICU Delirium Post Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit Delirium
Keywords: delirium
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after cardiac surgery and admitted to CSICU are recruited.

Brief summary: ICU delirium are assessed by clinical nurses twice every day. Delirious patients are matched with patients according to their disease, gender and age range(±3 years). Stool samples for gene sequencing are collected. Gut barrier function are studied with several serum biomarkers (endotoxin, etc.). Ecological analyses, regression models and mediation equation will be performed.

Detailed description: ICU delirium are assessed by clinical nurses twice every day using Confusion Assessment Method for the ICU (CAM-ICU). Delirious patients are matched with patients according to their disease, gender and age range(±3 years). Stool samples for gene sequencing are collected within 24 hours after surgeries. Gut barrier function are studied with several serum biomarkers (endotoxin, etc.). Ecological analyses, regression models and mediation equation will be performed.

Eligibility criteria: Inclusion Criteria:

* to have had heart valve surgery or coronary artery bypass grafting (CABG)
* to have no planned transfer to another ward or hospital within 24 hours after surgery
* to have no preoperative cognitive impairment and can speak and read Chinese
* more than 18 years old

Exclusion Criteria:

* to have a hearing or visual impairment that could impact delirium assessment
* to have a history of alcohol or drug abuse
* to have a preoperative intestinal irritation syndrome or history of gastrointestinal disease
* to have received antibiotics or probiotics within 28 days before admission
* to have a life expectancy less than 24 hours
* to have an experience of ICU hospitalization, mechanical ventilation in the past 30 days
* to have a cardiac surgery or hypoxic brain injury in the past 3 months.

Primary outcomes:
measure: Gut microbiome
timeFrame: within 24 hours of delirium
Secondary outcomes:
measure: Gut barrier biomarkers
timeFrame: within 24 hours of matched samples
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: SAHZU
name: Jingfen Jin
role: STUDY_DIRECTOR
References:
Clinical trial NCT00074438: Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis
Official title: Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rituxan
RA
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Roche Pharma AG
First posted: 2003-12-15
Enrollment: 465
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 study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).


Eligibility criteria: Eligibility criteria include, but are not limited to the following:

* Are between the ages of 18 and 80 years.
* Have been diagnosed with rheumatoid arthritis for at least 6 months.
* Have failed treatment (lack of efficacy) with at least 1 but no more than 5 disease-modifying anti-rheumatic drugs or biologics (other than methotrexate).

Primary outcomes:
measure: Proportion of patients with an ACR20 response
timeFrame: 24 weeks
Secondary outcomes:
measure: Proportion of patients with ACR(50,70) responses
timeFrame: 24 weeks
measure: Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Keystone E, Fleischmann R, Emery P, Furst DE, van Vollenhoven R, Bathon J, Dougados M, Baldassare A, Ferraccioli G, Chubick A, Udell J, Cravets MW, Agarwal S, Cooper S, Magrini F. Safety and efficacy of additional courses of rituximab in patients with active rheumatoid arthritis: an open-label extension analysis. Arthritis Rheum. 2007 Dec;56(12):3896-908. doi: 10.1002/art.23059.