louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05592080: Exploring Liver and Muscle Fat Content Using MRI
Official title: Exploring Liver and Muscle Fat Content in Overweight and Obese Polycystic Ovary Syndrome Using Magnetic Resonance Imaging Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: (1) subjects with other causes of irregular menstrual cycles or androgen excess including hyperprolactinemia, uncontrolled thyroid disease, congenital adrenal hyperplasia, Cushing's disease, androgen secreting tumor, or pregnancy; (2)subjects with abnormal liver function test results (ALT level 2.5 times higher than the upper limit of the normal range); (3) subjects with renal insufficiency (eGFR \< 60 ml/min/1.73 m2); (4) subjects with a history of chronic liver diseases such as alcoholic liver disease, viral hepatitis, autoimmune liver disease, drug-induced liver disease, genetic metabolic liver disease; (5) subjects experiencing alcoholism (weekly alcohol intake \> 100 g) subjects experiencing smoking within the past 3 months and engaging in high-intensity exercise; (6) subjects with a history of cancer; (7) subjects with active infection; subjects who were pregnant or breastfeeding.

Brief summary: The aim of our study was to compare the difference of fatty infiltration in liver and muscle using magnetic resonance imaging (MRI) between overweight as well as obese polycystic ovary syndrome (PCOS) cases and body mass index (BMI)-matched women without PCOS, identifying the possible influence factors.


Eligibility criteria: Inclusion Criteria:

(1) subjects with a body mass index (BMI) ≥ 24 kg/m2; (2) subjects aged between 18 and 40 years; (3) subjects who had not received any prescription or non-prescription drugs that affect insulin sensitivity or ovarian function, including hormonal contraceptives and metformin, within three months before the trial; (4) PCOS diagnosis fulfills the Rotterdam 2003 criteria phenotype B with hyperandrogenism (HA) and oligo-/anovulation \[29\]; (5) subjects who had not received medication that impacts lipid metabolism (fibrates, statins, antioxidants and diuretic) in the recent 3 months; (6) subjects who did not intend to become pregnant and use barrier contraception; (7) subjects who did not change their lifestyle, including physical activity and eating habits, during the study period.

Exclusion Criteria:

-

Primary outcomes:
measure: liver fat fraction
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
Study officials:
References:
Clinical trial NCT01664780: Acoustic Radiation Force Impulse Imaging (ARFI) in Patients After Liver Transplantation
Official title: Acoustic Radiation Force Impulse Imaging (ARFI) in Patients After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplantation
Keywords: standard
values
share
wave velocity
in ARFI imaging
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2012-08-14
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after orthotopic liver transplantation

Brief summary: Aims: Prospective evaluation of the applicability of acoustic radiation force impulse(ARFI) imaging to assess liver fibrosis in patients after orthotopic liver transplantation.

Material and methods: We prospectively assess the performance of ARFI imaging in planned 100 patients after orthotopic liver transplantation. We evaluate shear wave velocity of the left and right liver lobe with the convex array (6C1HD)ultrasound transducer and compare the results with clinical data and B-mode criteria.

ARFI elastometry is an increasingly popular non-invasive method for the assessment of hepatic fibrosis and cirrhosis. To date, ARFI technology has not been applied systematically in patients after orthotopic liver transplantation. Therefore we want to establish standard values in this population.


Eligibility criteria: Inclusion Criteria:

* Patients after orthotopic liver transplantation.

Exclusion Criteria:

* Patients without status after orthotopic liver transplantation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital of Erlangen, Dep. of Medicine 1
Study officials:
affiliation: Dep. of Medicine 1, University of Erlangen-Nuremberg
name: Dane Wildner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02201680: Anxiety Level of Child and Parents During Preoperative Anesthesia Evaluation
Official title: Anxiety Level of Child and Parents During Preoperative Anesthesia Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety State
Parent
Child
Keywords: anxiety
preoperative
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2014-07-28
Enrollment: 117
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children planned to undergo surgical procedures or diagnostic procedures under general anesthesia

Brief summary: 1. Appreciation of preoperative anxiety in children is important for the anesthesiologist.
2. Several factors defined to effect the anxiety levels preoperatively in children such as , age, previous medical encounters , education level and parental anxiety. 3. This information was tested for Turkish children during the preoperative anesthetic evaluation.

Detailed description: 1. Before the planned surgery all children accompanying parents filled a questionnaire about the demographics, marital status, economical conditions, education level and other diseases and operations in the family.
2. Both the parent and child filled State and Trait Anxiety tests specially prepared for adults Spielberger Anxiety tests and children defined and validation tests had already been proven.

Statistical analysis performed for evaluation.

Eligibility criteria: Inclusion Criteria:

* Legible

Exclusion Criteria:

* Illegible due to lack of education or eye diseases

Primary outcomes:
measure: children state anxiety
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University Cerrahpaşa Medical Faculty
name: Rovnat Babazade, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Practice
name: Levent Kayaalp, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Gurcan Gungor, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Burak Dogangun, Asoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06307080: Clinical Study of Multimodal Ablation Remodeling Immunosensitized PD-1 in the Treatment of Pancreatic Cancer With Liver Metastasis
Official title: Clinical Study of Multimodal Ablation Remodeling Immunosensitized PD-1 in the Treatment of Pancreatic Cancer With Liver Metastasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Keywords: liver metastases
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Clinical evaluation of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.
2. Construction of a combined treatment system of multimodal ablation therapy combined with immunotherapy and chemotherapy.
3. Transformation and clinical application of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.


Eligibility criteria: Inclusion Criteria:

1. age 18-70 years old, gender is not limited;
2. Newly diagnosed pancreatic cancer with liver metastasis confirmed by pathology or consistent with clinical diagnosis, and no metastases to organs other than the liver;
3. Imaging evaluable tumors with safe access to puncture;
4. The number of half liver tumors ≤3 and the size of each tumor ≤3 cm;
5. ECOG PS score ≤2 points, expected survival \> 3 months.

Exclusion Criteria:

1. Liver function Child-Pugh grade C, severe jaundice, especially obstructive jaundice;
2. The liver is significantly atrophy, the tumor is too large, and the ablation range needs to reach one-third of the liver volume;
3. Expected survival \< 3 months;
4. serious heart, lung, liver and kidney dysfunction and coagulation dysfunction;
5. Uncontrolled co-morbidities, including poorly controlled hypertension or diabetes, persistent active infections, or mental illness or social conditions that may affect participants' compliance with the study;
6. refractory ascites, pleural fluid or bad fluid;
7. Pregnancy or breastfeeding;
8. The researcher considers that there are any other factors that are not suitable for inclusion or affect the participant's participation in the study.

Primary outcomes:
measure: Safety and efficacy assessment
timeFrame: Up to 1 year after the treatment
Secondary outcomes:
measure: Survival benefit
timeFrame: Up to 1 year after the treatment
Other outcomes:
measure: The application of medical-mechanical combination therapy mode
timeFrame: Up to 1 year after the treatment
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Long Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00862680: 4D PET/CT in Diagnosing Participants With Lung and Colorectal Cancer With Liver and Lung Metastasis
Official title: 4D PET/CT Imaging in Lung and Colorectal Cancer With Liver Metastasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Malignant Neoplasm in the Liver
Metastatic Malignant Neoplasm in the Lung
Stage IV Colorectal Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Stage IVA Colorectal Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8
Stage IVB Colorectal Cancer AJCC v8
Stage IVB Lung Cancer AJCC v8
Stage IVC Colorectal Cancer AJCC v8
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-03-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER

Brief summary: This trial studies how well 4 dimensional (D) positron emission tomography/computed tomography (PET/CT) works in diagnosing participants with lung or colorectal cancer that has spread to the liver and lung. Diagnostic procedures, such as PET/CT, may help find and diagnose disease and find out how far the disease has spread. But the motions made by breathing can reduce the image quality of the scan. Adjusting the scanner to 4D may allow for more breathing motion may improve the quality of the PET/CT images.

Detailed description: PRIMARY OBJECTIVES:

I. Study the impact of 4D positron emission tomography/computed tomography (PET/CT) imaging on the evaluation and staging of lung and colorectal cancer.

OUTLINE:

Participants undergo 4D PET/CT scan over up to 12 minutes.

Eligibility criteria: Inclusion Criteria:

* Patients with suspected colorectal cancer with nodules in the lung or liver (1-2 cm in diameter) will be eligible for this study.
* Patients with suspected lung cancer with nodules in the lung or liver (1-2 cm in diameter) will be eligible for this study.

Exclusion Criteria:

* Patients that cannot tolerate being scanned for an additional 12 minutes with arms above their head will be excluded.

Primary outcomes:
measure: Maximum lesion standardized uptake value (SUVmax) for gated and ungated positron emission tomography/computed tomography (PET/CT) scans
timeFrame: Up to 10 years
measure: Impact of the difference in SUVmax on the lesion detectability and staging of the evaluated patients
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Osama Mawlawi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04432480: NIPE Monitoring Values During Routine Pediatric Anesthesia
Official title: Parasympathetic Activity Evaluation by Newborn Infant Parasympathetic Evaluation (NIPE) Monitor (MDMSTM, Loos, France) During Routine General Anesthesia in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Nociceptive Pain
Keywords: General anesthesia
Nociceptive Pain
Monitoring
Pediatric anesthesia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Fondation Apicil
First posted: 2020-06-16
Enrollment: 90
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children in the pediatric surgical wardof:

* Lille University hospital (Lille, France)
* Armand Trousseau Hospital (Paris, France)

Brief summary: Description of the standard values and fluctuations of the new NIPE index during routine pediatric anesthesia. NIPE monitor connected to anesthesia monitor, displays an instantaneous value ranging from 0 to 100. NIPE values described at different time points during anesthesia: beginning of induction, intubation, extubation, skin incision, opioid administration, vasopressors or atropine administration, transfusion, volume expansion. In addition, NIPE values during hemodynamic events (heart rate or blood pressure increase greater than 20%) will be recorded.


Eligibility criteria: Inclusion Criteria:

* Surgery under general anesthesia
* Absence of analgesic treatment in the 24 hours before the intervention

Exclusion Criteria:

* Central or peripheral neuropathy
* Non sinus arrythmia, pace maker
* Cardiac surgery
* Analgesic medication within 24 hours before surgery
* Anti cholinergic or anti arrythmic chronic medication
* Opposition of the legal tutor or of the child

Primary outcomes:
measure: Variation of the instantaneous NIPE index after opioid administration
timeFrame: 5 minutes after opioid administration
Secondary outcomes:
measure: the area under the ROC curve of NIPE value
timeFrame: Baseline and 5 minutes before the first hemodynamic event.
measure: Variation of the instantaneous NIPE index after skin incision
timeFrame: 5 minutes after skin incision
measure: Variation of the instantaneous NIPE index after insertion of airway control device
timeFrame: 5 minutes after insertion of airway control device
measure: Variation of the instantaneous NIPE index after removal of airway control device
timeFrame: 5 minutes after removal of airway control device
measure: Variation of the instantaneous NIPE index after anesthetic induction
timeFrame: 5 minutes after anesthetic induction
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Anne LAFFARGUE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03031080: BOND Study: the Benefit Of Night Splinting in Dupuytrens'
Official title: The Effectiveness of Night Splinting After Collagenase Injection for Dupuytren's Contracture
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dupuytren Contracture
Keywords: Collagenase, Night-splinting, Dupuytrens, Contracture
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2017-01-25
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial - Block Randomisation
Primary purpose: SUPPORTIVE_CARE

Brief summary: The BOND study is a prospective, randomised single blinded controlled trial to assess the effect of night splinting in patients who have had collagenase injection and manipulation therapy for Dupuytren's Contracture.

Detailed description: This trial will assess the effectiveness of night splinting in Dupuytrens' contracture on functional and quality of life outcomes.

Eligibility criteria: Inclusion Criteria:

1. Single digit contractures greater than 30 degrees
2. No prior surgery for their contractures.
3. Successful collagenase and manipulation therapy (contracture reduced to within 10 degrees of full extension).

Exclusion Criteria:

1. Multiple digit contractures
2. Prior surgery for their contractures.
3. Failure of collagenase and manipulation therapy (contracture not reduced to within 10 degrees of full extension).
4. Inability to consent to treatment.

Primary outcomes:
measure: Range of motion
timeFrame: At 0 weeks, 12 weeks and 52 weeks
Secondary outcomes:
measure: PEM Questionnaire
timeFrame: At 0 weeks, 12 weeks and 52 weeks
measure: URAM Questionnaire
timeFrame: At 0 weeks, 12 weeks and 52 weeks
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Royal Liverpool & Broadgreen University Hospitals NHS Trust
state: Merseyside
Study officials:
affiliation: Consultant Hand Surgeon
name: Graham Cheung, MBBCh FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02691780: Study to Evaluate the Safety and Efficacy of Sorafenib, in Subject With Refractory Solid Tumors
Official title: Study to Evaluate the Safety and Efficacy of Sorafenib, in Subject With Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Refractory Solid Tumors
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a single arm, pilot study of Sorafenib in patient with BRAF mutation Refractory solid tumor and specific sensitivity to Sorafenib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.

To investigate the efficacy and safety of Sorafenib in patient with Refractory solid tumor.


Eligibility criteria: Inclusion Criteria:

* Provision of fully informed consent prior to study specific procedures.
* Patients must be \>= 19 years of age
* BRAF mutation, Refractory solid tumor and/or specific sensitivity to Sorafenib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
* ECOG Performance status0-2
* Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
* Adequate Organ Function Laboratory values

  * Absolute neutrophil count \>= 1.5 x 109/L, Hemoglobin \>= 9g/dL, Platelets\>=100x 109/L Bilirubin \<= 1.5 x upper limit of normal AST/ALT \<= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine\<= 1.5 X UNL
* Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
* Adequate heart function

Exclusion Criteria:

* Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for \<= 5 years.
* Has known active central nervous system(CNS) metastases
* Has an active infection requiring systemic therapy
* Pregnancy or breast feeding
* Patients with cardiac problem
* Any previous treatment with Sorafenib

Primary outcomes:
measure: Progression Free survival
timeFrame: 24 months
Secondary outcomes:
measure: Overall Response Rate
timeFrame: 24 months
measure: Time to progression
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
measure: Number of subjects with Adverse Events as a measure of safety
timeFrame: 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul, Korea, Republic Of
Study officials:
References:
Clinical trial NCT01825980: Proof of Concept Study to Determine the Safety and Antiviral Effect of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus Infected Patients
Official title: Double-blind, Randomized, Placebo-controlled, Multi-center Trial to Determine the Safety and Antiviral Effect of 3 Days of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus (HCV) Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatitis C
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-04-08
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To evaluate the antiviral activity of 3 days of BZF961. To determine safety and tolerability of BZF961 in HCV patients. To evaluate pharmacokinetics of BZF961 in HCV patients.


Eligibility criteria: Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed Male \& female treatment naive subjects, age 18-60 years of age with Hepatitis C genotype-1. Subjects must weight at least 50kg to participate in the study, and must have a body mass index (BMI) within the range of 18-36 kg/m2 Able to communicate well with the investigator, to understand and comply with the study requirements.

Exclusion Criteria:

* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer: or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.

Subjects that were previously treated for HCV infection.

Primary outcomes:
measure: HCV viral load
timeFrame: Day 3
Secondary outcomes:
measure: Number of participants with adverse events as a measure of safety
timeFrame: 2 weeks
measure: Total BZF961 concentration in plasma
timeFrame: Day 4
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: Orlando
country: United States
facility: Novartis Investigative Site
state: Florida
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: