louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04210297: Development and Validation of an Noninvasive Model for Predicting High Risk Esophageal Varices in Cirrhosis
Official title: Development and Validation of an Noninvasive Model for Predicting High Risk Esophageal Varices in Cirrhosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal and Gastric Varices
Keywords: noninvasive
portal hypertension
radiomics
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Jinan Central Hospital
First posted: 2019-12-24
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We queried the cirrhotic patients treated in Qilu Hospital Affiliated to Shandong University and Jinan Central Hospital Affiliated to Shandong University.

Brief summary: The aim of the study is to develop and validate a new noninvasive method based on routine examination during clinical practice for predicting high risk esophageal varices in cirrhosis.

Detailed description: Portal hypertension is the main consequence of cirrhosis. Variceal bleeding is the principal and life-threatening complication of portal hypertension. Endoscopic screening is the golden standard to detect esophageal varices. However, endoscopy is limited by its invasiveness, cost and the discomfort it imposes on patients. With the goal of circumventing these disadvantages, we intend to develop an noninvasive method for predicting high risk esophageal varices.

Eligibility criteria: The inclusion criteria:

1. patients who were diagnosed with liver cirrhosis.
2. patients who underwent the abdominal contrast-enhanced CT examination.
3. patients who received endoscopic screening.
4. patients with written informed consent.

The exclusion criteria:

1. patients who previously underwent endoscopic therapy, transjugular intrahepatic portosystemic shunt (TIPS), splenectomy, partial splenic embolization (PSE), hepatectomy, balloon-occluded retrograde transvenous obliteration, or liver transplantation.
2. patients with liver cancer.
3. patients with severe ascites or hepatic encephalopathy.
4. lacks abdominal contrast-enhanced CT within 1 month of endoscopy.

Primary outcomes:
measure: Accuracy
timeFrame: through study completion, up to 2 years
measure: sensitivity
timeFrame: through study completion, up to 2 years
measure: specificity
timeFrame: through study completion, up to 2 years
Secondary outcomes:
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: Yanjing Gao, PhD.MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin Y, Li L, Yu D, Liu Z, Zhang S, Wang Q, Li Y, Cheng B, Qiao J, Gao Y. A novel radiomics-platelet nomogram for the prediction of gastroesophageal varices needing treatment in cirrhotic patients. Hepatol Int. 2021 Aug;15(4):995-1005. doi: 10.1007/s12072-021-10208-4. Epub 2021 Jun 11.
Clinical trial NCT05826197: Prediction of Axillary Lymph Node Metastasis Status in Breast Cancer Based on PET/CT Radiomics
Official title: A Study on the Construction of a Comprehensive Predictive Model for Axillary Lymph Node Metastasis in Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer undergoing PET/CT at our hospital.

Brief summary: Patients with suspected breast cancer undergoing PET/CT at our hospital. The PET/CT center's chief physician and senior attending physician reviewed the films together and disagreement, if any, was resolved by consensus. The lesion was visually identified. A 3D region of interest(ROI) of the lesion was automatically outlined using the 40% threshold method, and PET metabolic parameters were measured . Breast lesions with radionuclide concentrations greater than those in normal breast tissue are considered to be breast cancer lesions, while lymph nodes with radionuclide concentrations greater than those in muscle tissue are considered to be metastatic lymph nodes.

Image segmentation: Image segmentation was performed using ITK-SNAP software (4) (version 3.6.0, http://www.itksnap.org/), Brush Style: circular, Brush Size: 10, Brush Options: 3D. The entire tumor volume was outlined on the PET image as ROI for segmentation.

An open source Python package (PyRadiomics version 3.0.1(5)) was used to extract the radiomics features from the ROI.

Univariate and multivariate binary logistic regressions were used to construct model for predicting lymph node metastasis in breast cancer.


Eligibility criteria: Inclusion Criteria:

* 1) 18F-FDG PET/CT for breast occupancy; 2) adult female patients with pathologically confirmed breast cancer (age ≥18 years); 3) no history of surgery, radiotherapy, or chemotherapy before 18F-FDG PET/CT; and 4) interval between 18F-FDG PET/CT and puncture/surgery ≤2 weeks.

Exclusion Criteria:

* 1) multifocal, bilateral, or occult breast cancer; 2) incomplete clinical or pathological data; 3) poor PET/CT image quality, when metabolic tumor volume(MTV) cannot be automatically segmented; and 4) concomitant malignant tumors.

Primary outcomes:
measure: Radiomics score
timeFrame: 1 day During the inspection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05571397: Expanding Use of CGM in Critical Care: Impact on Nurse Work Patterns and Patient Outcomes
Official title: Expanding Use of Continuous Glucose Monitoring Beyond COVID in Critical Care: Impact on Nurse Work Patterns and Patient Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hyperglycemia
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: CGM will be used by 100 MICU patients with glycemic control comparison with matched 100 MICU historical controls
Primary purpose: TREATMENT

Brief summary: The primary objective of this implementation study is to assess the feasibility of real time continuous glucose monitoring (CGM) implementation using a CGM plus (+) point-of-care (POC) protocol among patients on IV insulin or those with hyperglycemia (\>250mg/dl) in the critical care hospital environments.

Detailed description: This study analyzes the feasibility of inpatient real time CGM implementation through the use of a CGM + POC protocol as routine care for glycemic monitoring among patients on IV insulin or those with hyperglycemia (\>250mg/dl). The investigators will examine the effects on medical intensive care (MICU) patient's (N=100) glycemic control compared to matched historical control patients (N=100) from the MICU who received fingerstick POC.

Eligibility criteria: Inclusion Criteria:

* adults \>18 years old,
* admitted to Ohio State University Wexner Medical Center MICU and
* have hyperglycemia (glucose \>250mg/dl) or are currently on IV insulin.

Exclusion Criteria:

* Current COVID-19 infection,
* Refractory shock (Levophed dose \>0.5 mcg/kg/min or equivalent)
* Actively being treated for diabetic ketoacidosis (DKA)
* Actively being treated for hyperosmolar non-ketoacidosis (HONK)
* Pitting edema, anasarca, blue or purple discoloration to left upper extremity
* Treated with high dose acetaminophen (\>1 gram Q6 hours)
* Treated with hydroxyurea
* Are pregnant, patients
* Using home insulin pump therapy during hospitalization, or
* Reside in a corrections institution.

Primary outcomes:
measure: Time in Range
timeFrame: Daily during MICU admission; MICU length of stay to be determined by patient medical needs
Secondary outcomes:
measure: Time in hypoglycemia
timeFrame: Daily during MICU admission; MICU length of stay to be determined by patient medical needs
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: EILEEN FAULDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01663597: Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes
Official title: Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Errors
Axial Length, Eye
Corneal Wavefront Aberration
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-08-13
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants will be selected by the Department of Clinical Pharmacology

Brief summary: Aberrations play a significant role in the visual process and can be divided in lower-order and higher-order aberrations. The former can be measured using the commercially available IOL Master (Carl Zeiss Meditec AG, Germany) and have profound influence on visual acuity. Higher-order aberrations do not significantly influence visual acuity but affect the quality of vision and can cause halos, double vision, and night vision disturbances.

Background Cataract surgery has become a routine procedure in the developed countries. During this surgery, a foldable intraocular lens is usually inserted into the capsular bag. However, these lenses do not account for individual optical biometry data or aberrations. Therefore, it is important to provide data for ametropic and emmetropic eyes as this information might improve future intraocular lens design and lead to individually adapted lenses for yielding optimal visual acuity and quality results.

The aim of the present study is to clarify the correlation between refractive errors/axial eye length and spherical aberrations of the cornea.


Eligibility criteria: Inclusion Criteria:

* men and women aged between 40 and 60 years
* normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* normal ophthalmic findings unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* presence of any corneal or retinal disease
* Dry eye syndrome
* high astigmatism (\>1 diopter)
* history of refractive surgery
* abuse of alcoholic beverages
* participation in a clinical trial in the 3 weeks preceding the study
* symptoms of a clinically relevant illness in the 3 weeks before the study day
* pregnancy

Primary outcomes:
measure: Axial eye length
timeFrame: 1 day
Secondary outcomes:
measure: Refractive error
timeFrame: 1 day
measure: Corneal radius
timeFrame: 1 day
measure: Pupil diameter
timeFrame: 1 day
measure: Anterior chamber depth
timeFrame: 1 day
measure: Anterior corneal topography
timeFrame: 1 day
measure: Corneal thickness map
timeFrame: 1 day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
References:
Clinical trial NCT05971797: Rational-emotional Behavioral Therapy (REBT) in Patients With Osteoarthritis and Concomitant Diseases Before Arthroplasty
Official title: Rational-emotional Behavioral Therapy in Patients With Osteoarthritis and Concomitant Diseases Before Knee or Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Pain
Keywords: Depression
Anxiety
Rational Emotive Behavior Therapy
Arthroplasty
Osteoarthritis
Comorbidities
Lead sponsor: Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
Sponsor class: OTHER
Collaborators: name: Chuvash State University named after I.N. Ulyanov
First posted: 2023-08-02
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomized clinical trial in patients with depression or anxiety identified at prior psychological counseling prior to joint replacement surgery with or without comorbidities
Primary purpose: TREATMENT

Brief summary: The objective of this study was evaluation of the effectiveness of REBT on the emotional state of orthopedic patients with comorbidities before and after arthroplasty.

Detailed description: The studies assessed depression or anxiety in orthopedic patients by using Spielberger State-Trait Anxiety Inventory (STAI) and Hospital Anxiety and Depression Scale (HADS) before and after athroplasty. The comorbid background studied. The orthopedic patients with comorbidities were divided into several groups: arterial hypertension, chronic pyelonephritis , varicose veins, cardiovascular disease and atherosclerosis, diabetes mellitus, infection diseases, gastrointestinal diseases, obesity, neurological disorder, cerebrovascular accident, iron deficiency anemia, chronic bronchitis, hyperthyroidism, cardiac arrhythmia, other diseases. Patients with high levels of anxiety and depression underwent Rational Emotive Behavior Therapy before surgery. Patients without comorbidities and patients with comorbidities but without exposure considered as a control.

Eligibility criteria: Inclusion Criteria:

* Patients enrolled for the primary knee or hip arthroplasty (M15.0, M16, M17) before operation.

Exclusion Criteria:

* Other types of psychiatric pathology
* Reluctance to undergo psychological correction
* Failure to pass pre-test
* Ongoing follow-up with a psychologist or psychiatrist

Primary outcomes:
measure: STAI
timeFrame: 2 days after surgery
measure: HADS
timeFrame: 2 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cheboksary
country: Russian Federation
facility: Federal Center for Traumatology, Orthopedics and Endoprosthetics
state: Chuvashia
Study officials:
References:
Clinical trial NCT01502397: Risk of Hepatitis B Reactivation in Patients With Prior HBV Exposure Undergoing Rituximab-containing Chemotherapy: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exposure to Hepatitis B Virus
Keywords: hepatitis B
anti-HBc
HBsAg
rituximab
occult HBV
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2011-12-30
Enrollment: 70
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 B-cell lymphomas or chronic lymphocytic leukaemia referred to Queen Mary Hospital for rituximab-containing chemotherapy

Brief summary: The purpose of this study is to determine whether preemptive nucleoside analogue therapy or regular virologic monitoring is the preferred method in management patients with prior exposure to hepatitis B vius (HBV) and undergoing rituximab-containing chemotherapy.

Detailed description: Occult hepatitis B virus (HBV) reactivation has been documented in patients undergoing rituximab-containing chemotherapy who are hepatitis B surface antigen (HBsAg)-negative but with serologic evidence of prior exposure to HBV. However detailed prospective studies documenting the incidence of reactivation and the virologic and serologic kinetics of reactivation are lacking. The investigators prospective study proposes to follow-up 70 such patients with all serologic and virologic parameters monitored every 4 weeks. Patients with detectable HBV DNA will be started on nucleoside analogue therapy. The optimal method and duration of monitoring will also be determined from our study.

Eligibility criteria: Inclusion Criteria:

* Documented HBsAg-negative with or without antibody to hepatitis B surface antigen (anti-HBs)
* Documented anti-HBc (total)-positive

Exclusion Criteria:

* Concomitant liver diseases including chronic hepatitis C and D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis.
* Significant alcohol intake (\>30 grams per day)

Primary outcomes:
measure: HBV reactivation (defined as detectable HBV DNA > 20 IU/mL)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Medicine, The University of Hong Kong, Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Man-Fung Yuen, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00565097: Lanreotide as Treatment of Polycystic Livers
Official title: Long-Acting Lanreotide as a Volume Reducing Treatment of Polycystic Livers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Polycystic Liver Disease
Hepatomegaly
Liver Diseases
Polycystic Kidney, Autosomal Dominant
Keywords: Polycystic Liver Disease
Autosomal Dominant Polycystic Kidney Disease
Liver cyst
Lanreotide
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Ipsen
First posted: 2007-11-29
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of lanreotide in controling total liver volume in patients with polycystic livers this study will be performed. A minimum of 38 patients will be recruited and randomized (1:1) to receive either verum or placebo. Lanreotide is already used in other disease states and found to be safe and non-toxic.


Eligibility criteria: Inclusion Criteria:

* 18 yrs-of age
* Multiple cysts \> 20
* Cooperating patient
* Is willing and able to comply with the study drug regimen and all other study requirements
* Willingness to give written informed consent

Exclusion Criteria:

* Use of oral anticonceptives or estrogen suppletion
* Females who are pregnant or breast-feeding
* History or other evidence of chronic pulmonary disease associated with functional limitation
* History of severe cardiac disease
* History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
* Symptomatic gallstones
* Renal failure requiring hemodialysis

Primary outcomes:
measure: Reduction of total liver volume as determined by CT scan
timeFrame: 6 months
Secondary outcomes:
measure: Reduction of liver volume and individual cyst volume on CT scan.
timeFrame: 6 months
measure: Change of kidney volume and individual cyst volume on CT scan
timeFrame: 6 months
measure: Symptom evaluation by (validated) questionnaires
timeFrame: 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
Study officials:
affiliation: Radboud University Medical Center Nijmegen
name: Joost PH Drenth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center Nijmegen
name: Loes van Keimpema, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Gasthuisberg, University of Leuven
name: Frederik Nevens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05836597: Functional Dyspepsia Treatment Using Virtual Reality
Official title: Effectiveness and Safety of Virtual Reality for the Treatment of Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Dyspepsia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of using virtual reality to treat gastrointestinal symptoms related to functional dyspepsia.


Eligibility criteria: Inclusion Criteria:

* Symptoms of dyspepsia thought to represent functional dyspepsia, meeting Rome IV criteria
* Had an upper endoscopy and assessment for Helicobacter pylori; if a patient is found to have H. pylori, treatment with confirmed eradication (by stool antigen test or urea breath test) will be required before the patient is eligible for study inclusion.
* Patients will be considered for the study if they have undergone a complete history and physical examination during a previously scheduled consultation/evaluation visit with a gastroenterologist in the Mayo Clinic Florida General GI or Motility clinic.

Exclusion Criteria:

* Symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, type I diabetes, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), or patients have known uncontrolled GERD, esophagitis, eosinophilic esophagitis, or untreated H. pylori.
* Patients with gastroparesis or cyclic vomiting syndrome.
* Patients with prior surgery to the esophagus, stomach or duodenum.
* Patients taking opioids.
* Patients with motion sickness, vertigo, or a seizure disorder
* IBS symptoms are not predominant.

Primary outcomes:
measure: Change in abdominal pain scores
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Overall PAGI-SYM scores
timeFrame: Baseline, 8 weeks
measure: Change in nausea/vomiting
timeFrame: Baseline, 8 weeks
measure: Change in bloating
timeFrame: Baseline, 8 weeks
measure: Change in post-prandial fullness
timeFrame: Baseline, 8 weeks
measure: Change in heartburn
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: David Cangemi
role: PRINCIPAL_INVESTIGATOR
References: