louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05862948: Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy
Official title: Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy - ACCENDO-Colo Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenoma Colon
Colonic Adenoma
Keywords: ADR
CADe
Endo-AID
Lead sponsor: Fondazione Poliambulanza Istituto Ospedaliero
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 1160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Participants undergoing colonoscopy will be randomized in a 1:1 ratio to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy (CC). Researchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years or ≤85
* Patients undergoing screening, follow-up, or diagnostic colonoscopy

Exclusion Criteria:

* Suspected or known inflammatory bowel disease
* Colonic resection
* Taking anticoagulants or antiaggregants that contraindicate the performance of therapy
* Patients with incomplete colonoscopy
* Patients with inadequate preparation using the Boston Colonic Preparation Scale (BBPS). A cleaning quality of less than 2 points in any of the 3 colonic sections will be considered inadequate.
* Inability to provide informed consent.

Primary outcomes:
measure: Adenoma detection rate (ADR)
timeFrame: 1 years
Secondary outcomes:
measure: Polyp detection rate (PDR)
timeFrame: 1 years
measure: Polyp per colonoscopy (PPC)
timeFrame: 1 years
measure: Adenoma per colonoscopy (APC)
timeFrame: 1 years
measure: Sessile serrated lesion detection rate (SSLDR)
timeFrame: 1 years
measure: Advanced adenoma detection rate (AADR)
timeFrame: 1 years
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
state: Bs
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
Study officials:
References:
Clinical trial NCT06804148: MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry
Official title: MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will be treated with Myval TAVR are included in the registry.

Brief summary: Rational of the Myval THV - Prospective German Multicenter Registry is to evaluate the performance of this relatively new but very promising TAVR valve in a consecutive real-word, all-comers registry and to assess the long-term durability and efficacy of the Myval THV.


Eligibility criteria: Inclusion Criteria:

* Patient is going to be treated with Myval THV
* Age ≥ 18 years
* Ability to give informed consent

Exclusion Criteria:

* Pregnant and lactating women
* Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.
* Patients in whom anti-platelet and/or anticoagulant therapy are contra-indicated.
* Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the registry

Primary outcomes:
measure: It is a composite of: - All-cause mortality - All stroke - Moderate or severe paravalvular regurgitation
timeFrame: 5 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck
state: Schleswig-Holstein
Study officials:
References:
Clinical trial NCT03524248: Development of Real-time Image-guided Radiotherapy
Official title: Development of Real-time Image-guided Radiotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lung Cancer
Skin Cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal is to achieve the maximal radiotherapy tumor dose while sparing the health tissue and critical structures. On-board cone-beam CT (CBCT) scans are routinely acquired prior to dose delivery and matched with simulation CT at the planned treatment positions. Thus, setup or motion errors can be detected and corrected. However, CBCT is not available for situations with gantry collisions such as WBI and TSEB. More importantly, CBCT cannot reveal any irregular respiration or body movement during beam-on time. Thus, it is essential to develop a real-time image system that can detect organ/body motion during beam-on time, and correlate simulation-planning images with prior treatment CBCT images.In this proposed clinical trial, we will cooperate with a 3D camera company (Xigen LLC) to develop novel 4D video imaging techniques and validate the feasibility and accuracy of 4D video image guidance in correlation with 4D CT/CBCT useful for advanced IGRT.


Eligibility criteria: Inclusion Criteria:

* All patients benefit from advanced IGRT can participate to the study except for those emergent and pediatric patients (age \<18 years) who require special care or there is no time for the setup the 4D video systems
* The patient population would be selected according to the technical progress and clinical needs

Exclusion Criteria:

* None

Primary outcomes:
measure: Develop real-time 4D video imaging guidance with combination use of cone-beam computerized tomography (CBCT) useful for daily setup and target motion tracking in advanced image-guided radiotherapy (IGRT).
timeFrame: 12 years
Secondary outcomes:
measure: To correlate real-time 4D surface images with the internal structures shown in daily XVI volumetric images
timeFrame: 12 years
Other outcomes:
measure: To synchronize the 4D CBCT with real-time stereovisions that would allow us to track any irregular respiration motion useful for gated or target tracked radiotherapy
timeFrame: 12 years
measure: To validate accuracy and precision of the patient position in special procedures such as stereotactic body radiotherapy (SBRT), total skin electron beam therapy (TSEB), IMRT of H&N cancer, and whole-breast irradiation (WBI) under breast holding
timeFrame: 12 years
measure: To determine delivery dose distribution by correlating real-time surface images with the planning volumetric images and dose distribution for radiotherapy
timeFrame: 12 years
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01752348: Effects of Free Fatty Acids and 3-hydroxybutyrate on Protein, Glucose, Lipid Metabolism and Intracellular Signals.
Official title: Effects of Free Fatty Acids and 3-hydroxybutyrate on Protein, Glucose, Lipid Metabolism and Intracellular Signals; a Study on Muscle Wasting and Metabolism During Acute Inflammation and Potential Anabolic Mechanisms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Inflammatory Response Syndrome
Keywords: sepsis
cytokine release
fever
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators hypothesize that the investigators can detect protein-sparing effects of administration of the ketone 3-hydroxybutyrate and free fatty acids during simulation of an acute inflammatory disease. The investigators use the infusion of endotoxin, US standard reference E.coli in healthy subjects as a model for inflammation / infection and to evaluate the effect on protein metabolism using different tracers and the investigators can measure the various intracellular signaling pathways of selected muscle and adipose tissue.


Eligibility criteria: Inclusion Criteria:

* 20 \< body mass index \< 30 kg/m2.
* written and orally informed consent before enrollment.

Exclusion Criteria:

* participation in other studies using radioactive tracers or other exposure to radiation (X-rays, scintigraphy etc).
* allergy to soy products or eggs
* diabetes, any type
* epilepsy
* ongoing infection
* immune deficiency
* cardiovascular disease
* dysregulated hypertension
* primary muscles disease, congenital or acquired

Primary outcomes:
measure: Protein metabolism
timeFrame: 6 hours intervention period
Secondary outcomes:
measure: Activated intracellular signalling pathways
timeFrame: study day
Other outcomes:
measure: Other systemic metabolic effects
timeFrame: 6 hours of intervention
Locations:
city: Aarhus C
country: Denmark
facility: Medical Research Laboratory, Department of Internal Medicine and Endocrinology
Study officials:
affiliation: Institute of Clinical Medicine, Aarhus University, Denmark. Department of Internal Medicin and Endocrinology, Aarhus university hospital, Aarhus, Denmark.
name: Niels Møller, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomsen HH, Rittig N, Johannsen M, Moller AB, Jorgensen JO, Jessen N, Moller N. Effects of 3-hydroxybutyrate and free fatty acids on muscle protein kinetics and signaling during LPS-induced inflammation in humans: anticatabolic impact of ketone bodies. Am J Clin Nutr. 2018 Oct 1;108(4):857-867. doi: 10.1093/ajcn/nqy170.
Clinical trial NCT06748365: Serum Ferritin and Prognosis of DKA
Official title: Role of Ferritin in the Clinical Presentation and Short-Term Prognosis of Diabetic Ketoacidosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Ketoacidosis
Keywords: serum Ferritin
Diabetic Ketoacidosis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with DKA admitted to the emergency department or intensive care units of Sohag university Hospital

Brief summary: the aim of this study is to: evaluate the association between serum ferritin levels and the clinical presentation and short-term prognosis of patients with DKA. Specifically, the correlation between its level and the severity of DKA at presentation and determine its prognostic value in predicting short-term outcomes.

Detailed description: Ferritin studies and correlation to acute events like stroke or Mi was done before, however some studies have found a correlation with the degree and prognosis of these diseases and others not. However no study was tried on DKA patients before so the investigators are trying to find if Ferritin would have a relation with patients of Dka and could be used as a prognostic tool (for example we found in this study when level is less than "200" patients mostly has good prognosis) this is just an example or (serrum ferritin turned out to be irrelevant to DKA prognosis as patients would have good prognosis despite number value) and this will be in selected patients according to criteria to exclude any chronic condition in the investigators hospital care units.

Eligibility criteria: Inclusion Criteria:

-

All patients with DKA :

1. Adult Aged 18 years old or older .
2. Type 1 DM , type 2 DM
3. Diagnosis of DKA based on the American Diabetes Association criteria: blood glucose \>250 mg/dL, arterial pH \<7.3, serum bicarbonate \<18 mEq/L,

Exclusion Criteria:

1. Patients age less than 18 years old
2. Iron deficiency anemia and iron overload
3. Chronic Inflammatory Diseases: Conditions such as rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease
4. Acute and chronic infections, including bacterial, viral, and fungal infections
5. Pt presented with other acute complication (MI,stroke)
6. CKD patients
7. Patients with chronic liver diseases
8. Patients with malignancy
9. Pregnant women.

Primary outcomes:
measure: evaluate the association between serum ferritin levels and the clinical presentation and short-term prognosis of patients with DKA. Specifically, the correlation between its level and the severity of DKA at presentation and determine its prognostic value
timeFrame: Through the study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospitals
Study officials:
References:
Clinical trial NCT03292965: Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery
Official title: Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery: Comparison of Neostigmine and Sugammadex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Block, Residual
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Compare the reversal effect of neostigmine and sugammadex using quantitative neuromuscular monitoring

Detailed description: At the end of surgery, decide the dosage of reversal referring to quantitative neuromuscular monitoring value (TOF). After the administration of reversal, the anesthesiologist who are going to manage the participant should not check the quantitative neuromuscular monitoring and determine the timing of extubation only with his (or her) judgement. After entering post-anaesthesia care unit (PACU) measure the TOF value and check the incidence of TOF ratio \> 0.9 between the neostigmine group and sugammadex group.

Eligibility criteria: Inclusion Criteria:

* patients aged over 18 years, planned to undergoing elective laparoscopic surgery under general anesthesia

Exclusion Criteria:

* Obesity BMI over 30 kg/m2
* Impairment of renal or/and liver function
* Allergy to rocuronium, sugammadex
* (Familial) history of malignant hyperthermia
* Taking medicines which is affecting neuromuscular function

Primary outcomes:
measure: the incidence of postoperative residual curarization
timeFrame: Immediately after entering PACU
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Department of anesthesiology and pain medicine
name: AhYoung Oh, M.D Ph. D
role: STUDY_CHAIR
References:
citation: Lee YJ, Oh AY, Koo BW, Han JW, Park JH, Hong JP, Seo KS. Postoperative residual neuromuscular blockade after reversal based on a qualitative peripheral nerve stimulator response: A randomised controlled trial. Eur J Anaesthesiol. 2020 Mar;37(3):196-202. doi: 10.1097/EJA.0000000000001157.
Clinical trial NCT04929665: Thoracic Paravertebral Block, Erector Spinae Plane Block, and in Combined Paravertebral-erector Spinae Block
Official title: Comparison of Ultrasound-guided Thoracic Paravertebral and Erector Spinae Plane Block Alone and in Combination on Analgesia After Video-assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Thoracic Surgery, Video-Assisted
Thoracic Paravertebral Block
Erector Spinae Plane Block
Keywords: Erector spinae block, Thoracic paravertebral block, VATS
Lead sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 75
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: Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block and erector spina plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. Generally, comparisons are made between ESPB and TPVB in studies and the analgesic effect is evaluated. However, no research could be found in the literature combining ESPB and TPVB. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, it may be possible to obtain a more effective analgesic effect in patients by combining the mechanism of action of TPVB and ESPB, as in the multimodal analgesia method. This study seeks to evaluate the effect of TPVB, ESPB and combined TPVB-ESPB pain after VATS.


Eligibility criteria: Inclusion Criteria:

* 18 to 80 years old
* ASA physical status I-II-III
* BMI 18 to 30 kg/m2
* Elective video assisted thoracoscopic surgery

Exclusion Criteria:

* Patient refusing the procedure
* Emergency surgery
* Chronic opioid or analgesic use

Primary outcomes:
measure: Pain scores [ Time Frame: 24 hours after the surgery]
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kecioren
country: Turkey
facility: Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
state: Ankara
Study officials:
affiliation: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
name: Musa Zengin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00912665: Regulation of Optic Nerve Head Blood Flow During Combined Changes in Intraocular Pressure and Arterial Blood Pressure
Official title: Regulation of Optic Nerve Head Blood Flow During Combined Changes in Intraocular Pressure and Arterial Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Optic Nerve Head Blood Flow
Intraocular Pressure
Regional Blood Flow
Ocular Physiology
Optic Disk
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance to changes in perfusion pressure. In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. In the optic nerve head only few data are available. Large scale studies have shown that reduced ocular perfusion pressure is an important risk factor for the prevalence, the incidence and the progression of primary open angle glaucoma.

Former studies that investigated ocular blood flow autoregulation only measured choroidal blood flow. For the optic nerve head only few data are available, although it seems likely that it underlies similar autoregulatory mechanisms.

The primary goal of the present study is to gain more insight into these phenomena in humans.

The present study aims to investigate the pressure/flow relationship as a measure for optic nerve head autoregulation during combined changes of intraocular pressure and arterial pressure. Intraocular pressure will be increased by the use of a suction cup technique, mean arterial pressure will be increased by squatting. During the whole procedure, optic nerve head blood flow will be measured continuously.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 18 and 35 years, nonsmokers
* Men and women will be included in equal parts
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal findings in the laboratory testings unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia less than 1 diopter

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug (except oral contraceptives)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks

Primary outcomes:
measure: Optic nerve head pressure-flow relationship
timeFrame: in total 3x on 2 study days
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
References:
Clinical trial NCT03179865: Evaluation of Early Mucosal Healing During Clinical Remission in Pediatric Ulcerative Colitis
Official title: Evaluation of PUCAI Score at Assessment for Mucosal Healing During Clinical Remission in Pediatric Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-06-07
Enrollment: 28
Sex: ALL
Minimum age (years): 4
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients could be included if they have establish ulcerative colitis, while they are on clinical remission

Brief summary: Establishing that mucosal healing (MH) has occurred after therapy is an important treatment goal, and the gold standard is endoscopic evaluation. In UC it is unclear if clinical parameters are adequate. The pediatric ulcerative colitis activity index (PUCAI) has demonstrated good correlations for clinical remission and disease severity, but its role for establishing mucosal healing after therapy has not been validated . The ability to predict mucosal healing may be different for patients in long term remission compared to assessment after obtaining clinical remission. No previous study has prospectively validated the use of PUCAI as a proxy for MH specifically during clinical remission after therapy.

Detailed description: All pediatric patients ≤ 19 years old and at the Wolfson Medical Center pediatric IBD center who enter clinical remission are routinely assessed by colposcopy or sigmoidoscopy assess. This is an analysis of prospectively collected data regarding PUCAI and endoscopic Mayo score at the time of assessment of mucosal healing by endoscopy. Patients could be included if they have establish ulcerative colitis, while they are on remission for at least 3 months after treatment of flare. For this study, complete clinical remission was absence of abdominal pain, and no diarrhea or bleeding (PUCAI\<10). sigmoidoscopy will be performed between 12-24 weeks after remission was documented.

Eligibility criteria: Inclusion Criteria:

1. Ulcerative Colitis patient
2. clinical remission (PUCAI\<10) for at least 3 months.
3. Sigmoidoscopy for assessment mucusa healing after therapy performed between 12-24 weeks after remission was documented

   -

   -

Primary outcomes:
measure: Mucusa healing according to the MAYO score
timeFrame: cross sectional study, the data will be reported during 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: The Wolfson Medical Center
Study officials:
References: