louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06540846: Deep Learning for Histopathological Classification and Prognostication of Gynaecologic Smooth Muscle Tumours
Official title: Deep Learning for Histopathological Classification and Prognostication of Gynaecologic Smooth Muscle Tumours
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stump
Keywords: algorithm
diagnostic
pronostic
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 392
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Uterine smooth muscle tumors: leiomyomas, smooth muscle tumors of uncertain malignancy and leiomyossarcomas.

Brief summary: Smooth muscle tumors of the uterus that do not fit the diagnostic criteria of benignity (such as leiomyomas) or malignancy (such as leiomyosarcomas) are called STUMP (smooth muscle tumor of uncertain malignant potential). A potential solution to this problem could be the application of predictive models using artificial intelligence (AI) to aid in the histopathological classification and prognosis of gynecological smooth muscle tumors. Deep learning using convolutional neural networks represents a specific class of machine learning, in which predictive models are trained by considering small groups of pixels in digital images and iteratively identifying salient features. In this study, we aim to develop deep learning models capable of accurately subclassifying and predicting the prognosis of gynecological smooth muscle tumors, based on histopathological features of hematoxylin and eosin (H\&E) slides. The aim is to develop a diagnostic and prognostic algorithm to help pathologists better classify and diagnose uterine smooth muscle tumors and predict their clinical course.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of uterine smooth muscle tumors (leiomyomas, smooth muscle tumors of uncertain malignancy and leiomyosarcomas), registered in the RRePS database and/or treated at Institut Bergonié or one of the participating centers.
* Histopathological material available (kerosene blocks and/or slides).

Exclusion Criteria:

* na

Primary outcomes:
measure: Develop deep learning models that can accurately subclassify gynaecologic smooth muscle tumours
timeFrame: throughout the conduct of the study - an expected average of 6 months after data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonie
Study officials:
References:
Clinical trial NCT00005346: Mechanisms Underlying Abnormal Ambulatory BP Patterns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To understand the mechanism(s) underlying sodium-dependent blood pressure control, and to determine the consequences thereof.

Detailed description: BACKGROUND:

The blood pressure of a significant percentage of the hypertensive population, and the normotensive population at a high risk for the development of hypertension (Blacks and older individuals), is sodium (salt)-dependent. That is to say, increasing the intake of salt will increase blood pressure in these individuals; conversely, and more importantly, decreasing the intake of salt will reduce blood pressure.

DESIGN NARRATIVE:

The investigators believed that the mechanisms responsible for sodium-dependent blood pressure were only indirectly linked to race, sex, and age. Their research was consistent with the hypothesis that sodium-dependent blood pressure control resulted from decreased responsiveness of the renal and adrenal blood pressure regulatory systems. This produced abnormal daily blood pressure patterns, with reduced fluctuation resulting in extended periods of increased blood pressure. The increased cardiovascular load led to the early development of cardiovascular and renal disease, including hypertension. They tested this hypothesis by identifying 'high risk' and 'normal risk' subjects based on renal responses to sodium restriction. The subjects were equal numbers of healthy males and females, Blacks and whites, between the ages of 55-70 years. Using an innovative approach, they then examined the influence of risk status on 24-hour patterns of blood pressure, hormonal activity, and sodium handling. Finally, they determined the clinical significance of the profiles by examining changes in cardiac and renal status at a two-year follow-up.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02590146: Non-Pharmacologic Patient Centered Pain Control Adjuncts During First Trimester Abortion
Official title: Non-Pharmacologic Patient Centered Pain Control Adjuncts During First Trimester Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Termination
Pain Management
Lead sponsor: University of Hawaii
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will examine the use of non-pharmacologic pain control techniques and pain-management counseling as an additional tool for reducing pain during first trimester aspiration abortion.


Eligibility criteria: Inclusion Criteria:

* English speaking, able to read and understand consent form
* Age 18 + (minors eligible with parental consent)
* Seeking in-office aspiration termination of pregnancy
* Gestational age less than 14 weeks

Exclusion Criteria:

* Not able to read or understand English
* Unable to understand consent
* Minors without parental consent
* Requesting narcotic or sedative analgesics
* Currently incarcerated
* Gestational age greater than 14 weeks
* Seeking medication abortion

Primary outcomes:
measure: Difference in overall pain score during procedure between control and intervention group
timeFrame: Collected within 1 minute of procedure completion
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University of Hawaii
state: Hawaii
Study officials:
References:
Clinical trial NCT03920046: Effects of Passive Smoking on Children During Gastrointestinal Endoscopy
Official title: Effects of Passive Smoking on Children During Gastrointestinal Endoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastro-Intestinal Disorders
Keywords: esophagogastroduodenoscopy
laryngospasm
passive smoking
sedation
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 518
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Esophagogastroduodenoscopy patients are included in the study

Brief summary: To evaluate the effect of passive smoking in children during Gastrointestinal Endoscopy.

Detailed description: When the patients and their parents are arrived in the endoscopy unıt about 1 h before the procedure, the anesthetist is obtained a medical history and carried out a physical examination and clinical assesment. Then the parents smoking habits are documented about to detect the magnitude of passive smoking. Endoscopist and anesthesiologist are blinded to the patients passive smoking history. Then the sedation is applied and esophagogastroduodenoscopy procedures performed. Side effects (e.g laryngospasm, coughing) during the study are recorded.

Eligibility criteria: Inclusion Criteria:

* ASA ( American Society of Anesthesiologists) I- ASA II patients
* Aged 1- 18 Year old patients

Exclusion Criteria:

* Smoker patients

Primary outcomes:
measure: laryngospasm ratio
timeFrame: an average of 2 hours
Secondary outcomes:
measure: hypoxia ratio (oxygen saturation < % 90)
timeFrame: an average of 2 hours
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Sibel Seçkin Pehlivan
state: Talas
Study officials:
References:
citation: Chung HK, Lightdale JR. Sedation and Monitoring in the Pediatric Patient during Gastrointestinal Endoscopy. Gastrointest Endosc Clin N Am. 2016 Jul;26(3):507-25. doi: 10.1016/j.giec.2016.02.004.
citation: Rodrigo C. The effects of cigarette smoking on anesthesia. Anesth Prog. 2000 Winter;47(4):143-50.
citation: Tosun Z, Aksu R, Guler G, Esmaoglu A, Akin A, Aslan D, Boyaci A. Propofol-ketamine vs propofol-fentanyl for sedation during pediatric upper gastrointestinal endoscopy. Paediatr Anaesth. 2007 Oct;17(10):983-8. doi: 10.1111/j.1460-9592.2007.02206.x.
citation: Pehlivan SS, Gergin OO, Bayram A, Altay D, Arslan D, Bicer C, Aksu R. The effect of passive smoking on the laryngospasm rate in children sedated during the esophagogastroduodenoscopy. Saudi Med J. 2022 Mar;43(3):275-282. doi: 10.15537/smj.2022.43.3.20210784.
Clinical trial NCT06191146: Factors for Impairment of Renal Graft Function in Intensive Care
Official title: Factors for Impairment of Renal Graft Function in Intensive Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Graft Failure
Dialysis
Chronic Kidney Failure
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: non-dialyzed kidney transplant patient hospitalized in intensive care unit

Brief summary: hypothesis = hospitalization in the intensive care unit (ICU) has an impact on the outcome of the renal graft, due to the therapeutic and exploratory procedures performed.

the aim is to identify risk factors for renal graft degradation in the ICU up to 2 years after hospitalization.

Optimization of renal graft management in the ICU and management by nephrologists after the ICU


Eligibility criteria: Inclusion Criteria:

* kidney graft
* \> 18 years
* first hospitalization in ICU

Exclusion Criteria:

* chronic hemodialysis before ICU
* transfer to intensive care immediately after transplant within 24 hours

Primary outcomes:
measure: composite: return to dialysis, decline in GFR < 15 ml/min, death at 2 years
timeFrame: 2 years after ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: CHU NANCY Central
name: Sébastien GIBOT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004346: Phase II Study of Cholesterol- and Cholestanol-Free Diet, Lovastatin, and Chenodeoxycholic Acid for Cerebrotendinous Xanthomatosis
Official title: Effects of Diet and Medication in Patients With Cerebrotendinous Xanthomatosis (CTX)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cerebrotendinous Xanthomatosis
Keywords: cerebrotendinous xanthomatosis
inborn errors of metabolism
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Oregon Health and Science University
First posted: 1999-10-19
Enrollment: 5
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in patients with cerebrotendinous xanthomatosis before and after a cholesterol- and cholestanol-free diet.

II. Assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in these patients before and after lovastatin and chenodeoxycholic acid.

Detailed description: PROTOCOL OUTLINE: Following a 2-week baseline assessment, patients participate in a feeding study for up to 3 weeks. The diet is free of cholesterol and cholestanol.

For the next 4 weeks, patients return to their typical diet and are medicated with daily lovastatin and chenodeoxycholic acid.

The feeding study is repeated for an additional 3 weeks, with the patient taking either lovastatin or chenodeoxycholic acid.

Eligibility criteria: PROTOCOL ENTRY CRITERIA: Cerebrotendinous xanthomatosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: William Connor
role: STUDY_CHAIR
References:
Clinical trial NCT02984046: Acute Bronchiolitis and Severity Markers: Interest in Protein CC16
Official title: Acute Bronchiolitis and Severity Markers: Interest in Protein CC16
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Bronchiolitis
Keywords: Acute bronchiolitis
RSV
CC16
SP-D
sRAGE
Severity
Biomarkers
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Acute bronchiolitis is a common viral infection in infants mainly due to RSV and rhinovirus.

Biomarkers can be useful for predicting its severity. The serum CC16 is a marker of epithelial aggression. Its rate increase during RSV bronchiolitis in infants less than 7 months. It could be an early predictive biomarker of the severity of acute bronchiolitis, and secondarily for the development of asthma.

Two other markers of airway aggression seem to increase during acute bronchiolitis: serum SP-D protein and serum soluble receptor sRAGE.

Detailed description: Prospective, monocentric, case-control and study Primary end-point: correlation between serum CC16 level and severity of the bronchiolitis, evaluated by a clinical scoring system established at the time of the admission in Paediatric Emergency Unit. Secondary end-points: correlation with urinary CC16; correlation with risk factors for bronchial epithelial aggression, viruses, immediate morbidity and mortality. Study of serum SP-D and sRAGE levels.

Eligibility criteria: Inclusion Criteria:

* Infants under 1 year old hospitalized for acute bronchiolitis

Exclusion Criteria:

* Broncho dysplasia
* Preterm under 34 weeks
* Cystic fibrosis
* Immune deficiency
* Suspicion of primary ciliary dyskinesia
* Congenital heart disease
* Acute renal failure

Primary outcomes:
measure: Serum CC16 rate
timeFrame: at day 1
Secondary outcomes:
measure: Urinary CC16 rate
timeFrame: at day 1
measure: SP-D rates
timeFrame: at day 1
measure: sRAGE rates
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: André LABBE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03791346: Pancreatectomy for NET: External Evaluation of WHO 2017 Grading System
Official title: Outcome After Pancreatectomy for Neuroendocrine Tumor and Evaluation of the WHO 2017 Grading System: a Retrospective Multicentric Analysis of 138 Consecutive Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Surgery
Keywords: neuroendocrine tumor
Survival
WHO 2017 grading system
pancreatectomy
Laparoscopy
Postoperative outcomes
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Department of digestive surgery, Carémeau Hospital, 30900, Nîmes, France
name: Department of oncology, Carémeau Hospital, 30900, Nîmes, France
name: Oncology - Institut du Cancer de Montpellier (ICM), Montpellier, France
name: Digestive & Oncologic Surgery - Institut du Cancer de Montpellier (ICM), Montpellier, France
First posted: 2019-01-02
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective review of collected data including all consecutive patients requiring a pancreatic resection for PanNET at 3 tertiary referral centers for pancreatic surgery in France, between December 1997 and December 2017. The 3 centers were Digestive Surgery Units of Montpellier, Nimes and Institute of Cancer at the University of Montpellier-Nimes.

Brief summary: Aim: The aim of this study was to investigate the clinicopathological factors and to evaluate the prognostic accuracy of the new World Health Organization (WHO) 2017 grading system in pancreatic neuroendocrine tumor (PanNET) patients.

Methods: Data collected between 1997 and December 2017 were analyzed. Histological grading and staging was based on the WHO 2017 grading system. Outcome after surgery and predictors of overall survival (OS) and disease free survival (DFS) were evaluated.


Eligibility criteria: Inclusion criteria:

- patients with histologically proven neuroendocrine tumor located in pancreas who underwent pancreatic resection (by open, laparoscopic or robotic approach) even in case of distant metastasis at time of surgery, with no previous or concurrent malignancy.

Exclusion criteria:

- Patients with tumors diagnosed as adenocarcinoma with scattered neuroendocrine cells or with focal neuroendocrine component were excluded of this study.

Primary outcomes:
measure: Disease-free survival at 5 years
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival at 5 years
timeFrame: 5 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: REGIS SOUCHE
role: STUDY_DIRECTOR
References:
Clinical trial NCT03253146: The Role and Mechanism of Vimentin in Sepsis Patients
Official title: The Role and Mechanism of Vimentin in Sepsis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: Vimentin
sepsis
immune cells
apoptosis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Between july 2016 and december 2017, inpatients were included who were in the Department of critical care medicine of the Peking Union Medical College Hospital.

Brief summary: Sepsis is the most common cause of death in the clinical critically ill patients. We have successfully screened the sepsis biomarkers by clinical proteomics approach and found that Vimentin (VIM) played an important role in the occurrence and development of sepsis. However, the exact mechanism is remaining unclear. In this study, the relationship between the changes of peripheral circulation VIM expression and different stages of sepsis development will be further verified in lager clinical trials, as well as the relationship between VIM expression and apoptosis of immune cells (e.g lymphocytes) will also be clarified. This may indicate that the role of VIM in the cell-mediated immunity apoptosis and inflammation-related pathways. Through the implementation of this study, we can clarify the clinical value of VIM and the mechanism of VIM-mediated immune cell apoptosis during the sepsis development from the molecular level, and determine whether the VIM as a new target for sepsis diagnosis and treatment.


Eligibility criteria: Inclusion Criteria:

Sepsis 3.0 was adopted to selected participants

Exclusion Criteria:

Participants were excluded if they were younger than 18 years of age; contracted acquired immunodeficiency syndrome; had reduced polymorphonuclear granulocyte counts (\<500 μL-1); died within 24 h after admission to the ICU; refused to participate in the study; or declined treatment during the period of observation.

Primary outcomes:
measure: 28-day survival
timeFrame: 28-day
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
citation: Su L, Pan P, Yan P, Long Y, Zhou X, Wang X, Zhou R, Wen B, Xie L, Liu D. Role of vimentin in modulating immune cell apoptosis and inflammatory responses in sepsis. Sci Rep. 2019 Apr 5;9(1):5747. doi: 10.1038/s41598-019-42287-7.
Clinical trial NCT00740246: Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia
Official title: A Multi-Center, Randomized, Blinded, Placebo Controlled, Cross-Over Study to Investigate the Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-22
Enrollment: 594
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia

Detailed description: Evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia

Eligibility criteria: Inclusion Criteria:

* Subjects \> or = 18 years of age and able to give informed consent
* Historical laboratory Hgb indicative of anemia within 3 months prior to screening visit
* Screening Visit laboratory Hgb indicative of anemia
* Screening Visit ferritin indicative of iron deficiency anemia

Exclusion Criteria:

* Known hypersensitivity to VIT-45
* Previously received VIT-45
* Parenteral iron in the 4 weeks prior to screening
* Chronic or serious active infection
* Malignancy history
* Aspartate aminotransferase (AST) or Alanine transaminase( ALT) greater than the upper limit of normal
* Anticipated need for surgery or initiation of dialysis during the study
* Pregnant or sexually active females who are not willing to use an effective form of birth control

Primary outcomes:
measure: Incidence of Treatment-emergent Adverse Events During Each 7-day Study Period
timeFrame: Day 0 to 7
Secondary outcomes:
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Luitpold Pharmaceuticals
state: Pennsylvania
Study officials:
affiliation: American Regent, Inc.
name: David Bregman, MD
role: STUDY_DIRECTOR
References:
citation: Seid MH, Valaoras TG, Barish CF, Dinh Q. Safety Profile of Ferric Carboxymaltose, a New High Dose Intravenous Iron in Patients with Iron Deficiency Anemia. Society for the Advancement of Blood Management 2007.
citation: Seid MH, Mangione A, Valaoras TG, Anthony LB, Barish CF. Safety Profile of Ferric Carboxymaltose, a New High Dose Intravenous Iron in Patients with Iron Deficiency Anemia. Society for the Advancement of Blood Management 2007.