louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02526641: Macrophages, Portal Hypertension, and Liver Function During AbbVie Treatment of Chronic Hepatitis C
Official title: New AbbVie Direct Acting Antiviral (DAA) Treatment of Chronic Hepatitis C Infection - Effects on the Macrophage Activation Marker Soluble CD163, Portal Hypertension, and Metabolic Liver Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: Direct acting antiviral treatment
sCD163
Portal hypertension
Metabolic liver function
Cirrhosis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: AbbVie
First posted: 2015-08-18
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic hepatitis C patients initiating direct-acting anti-viral therapy.

Brief summary: Investigation of the effects of the new Abbvie direct acting anti-viral (DAA) treatment of chronic viral hepatitis C infection on the macrophage specific activation marker soluble CD163, portal hypertension determined by the hepatic venous pressure gradient (HVPG), and metabolic liver function determined by the galactose elimination capacity (GEC) test and the functional hepatic nitrogen clearance (FHNC).


Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis C genotype 1 or 4 patients initiating the new AbbVie treatment (paritaprevir, ritonavir, ombitasvir og dasabuvir sammen med ribavirin)
* Child-Pugh A liver cirrhosis

Exclusion Criteria:

* Severe liver dysfunction - Child-Pugh klasse B-C
* Life expectancy less than 6 months
* planned liver transplantation or TIPS procedure within 6 months
* non-compliance to treatment or study procedures
* allergy to the DAA drugs used (paritaprevir, ritonavir, ombitasvir, dasabuvir, and ribavirin)
* pregnancy or expected pregnancy during the study (anti-conception has to be used)
* breast feeding
* portal vein thrombosis
* liver cancer or other malignancies
* alcohol consumption

Primary outcomes:
measure: Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 12 weeks
timeFrame: 12 weeks
measure: Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Changes in the levels of the macrophage specific activation marker sCD163
timeFrame: Before, during and after treatment - 60 weeks
measure: Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test
timeFrame: After 12 weeks treatment
measure: Changes in the functional hepatic nitrogen clearance (FHNC)
timeFrame: After 12 weeks treatment
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Hepatology and Gastroenterology, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Henning Grønbæk, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04410341: The DPP-4 Inhibitor Vildagliptin as Adjunct in Major Depressive Disorder Patients
Official title: The DPP-4 Inhibitor Vildagliptin as Adjunct in Major Depressive Disorder Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Sadat City University
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vildagliptin, an antidiabetic drug that inhibits the dipeptidyl peptidase- 4 (DPP-4), increases glucagon-like peptide-1 (GLP-1) and regulates blood glucose levels, favoring weight loss and lowering cardiovascular risk. A retrospective longitudinal study by Rizzo et al. showed that DPP-4 inhibitors administration could have protective effects against cognitive decline in diabetic elderly. Is has been observed that GLP-1 affects brain metabolism, increases neuritic growth, and protects neuronal cells from oxidative stress and death.


Eligibility criteria: Inclusion Criteria:

* Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).
* Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study.

Exclusion Criteria:

* Patients with bipolar I or bipolar II disorder
* Patients with personality disorders
* Patients with eating disorders
* Patients with substance dependence or abuse
* Patients with concurrent active medical condition
* Patients with history of seizures
* Patients with history of receiving Electroconvulsive therapy (ECT)
* Patients with inflammatory disorders
* Patients with allergy or contraindications to the used medications
* Patients with finally pregnant or lactating females
* Cardiovascular disorders
* Severe renal impairment: creatinine clearance of ≤ 25 ml/min
* Moderate or severe hepatic impairment

Primary outcomes:
measure: Effect on Hamilton Depression rating scale score (HAM-D score)
timeFrame: 12 week
Secondary outcomes:
measure: Effect on biological markers
timeFrame: Baseline and 12 week
measure: Interleukin-6
timeFrame: Baseline and 12 week
measure: BDNF
timeFrame: Baseline and 12 week
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT06524141: Review of the Follow-up of Difficult Airway Guidelines
Official title: A Review of the Current Situation in Following Difficult Airway Guidelines: a Survey
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anesthesia
Airway Management
Lead sponsor: Kocaeli City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-07-29
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians who have completed Anesthesiology and Reanimation specialty training

Brief summary: This questionnaire study aimed to ask the participants selected questions from the recommendations of the main guidelines on airway management. Thus, the compliance rate of anesthesiologists with the guidelines in different difficult airway management situations will be investigated. Secondarily, it was aimed to raise awareness about the recommendations of the guidelines.


Eligibility criteria: Inclusion Criteria:

* To be a specialist in Anesthesiology and Reanimation

Exclusion Criteria:

-

Primary outcomes:
measure: Anesthesiologists' adherence to current guidelines in difficult airway management situations.
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli City Hospital
Study officials:
References:
Clinical trial NCT03530241: Fluorescent Cholangiography and Bile Duct Stones
Official title: Sensitivity and Specificity of Fluorescent Cholangiography to Detect Bile Duct Stones in Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gall Stones, Common Bile Duct
Keywords: fluorescence
cholangiography
cholecystectomy, laparoscopic
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Background. X-ray cholangiography has a high sensitivity and specificity of detecting bile duct stones and is the gold standard. There are no studies describing the sensitivity and specificity of IFC for bile duct stone detection.

Research question. What is the sensitivity of IFC to visualize bile duct stones? Method. Prospective study with 40 patients undergoing planned laparoscopic cholecystectomy with preoperative magnetic resonance cholangiopancreatography (MRCP) (gold standard) and intraoperative IFC, X-ray cholangiography and choledochuscopy in that order.

Primary outcome. Sensitivity of visualization of bile duct stone by fluorescent cholangiography and secondary outcome is visualization of anatomy.


Eligibility criteria: Inclusion criteria

* Patients suspected of having bile duct stones by either blood samples, MRCP or medical history (see definitions)
* Patient age ≥ 18 years
* Preoperative MRCP
* Operation performed by a project surgeon

Exclusion criteria

* Open cholecystectomy (including conversion from laparoscopic to open)
* Acute cholecytitis or cholangitis
* Pancreatitis
* Iodine or indocyanine green allergy
* Liver or renal insufficiency
* Thyrotoxicosis
* Cholecystectomy not the primary surgical procedure
* Pregnancy or lactation
* Legally incompetent for any reason
* Withdrawal of inclusion consent at any time

Primary outcomes:
measure: Sensitivity and specificity
timeFrame: 120mins
Secondary outcomes:
measure: Visualization
timeFrame: 120mins
Other outcomes:
Locations:
city: Holte
country: Denmark
facility: Hvidovre University Hospital
state: Danmark
Study officials:
affiliation: Hvidovre University Hospital
name: Lars L Lehrskov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03947541: Utility of Postoperative Bracing
Official title: Utility of Postoperative Bracing: A Single-institution, Randomized-control Trial Comparing Brace to No-brace for Patients Undergoing Long-segment Fusion for Spinal Deformity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Bracing for Spinal Deformity
Keywords: Thoracolumbosacral (TLSO) brace
Lumbosacral orthotic (LSO) brace
Adult spinal deformity
Postoperative Brace
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 14
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: SUPPORTIVE_CARE

Brief summary: The study is being done to assess if the use of bracing helps improve quality of life of patients that are undergoing a spinal fusion for deformity.

If the participant agrees to be in this trial they will be randomly assigned (like the flip of a coin) to receive either brace treatment or non-brace treatment.

Regardless of what treatment group the participants are in, they will undergo surgery as planned. After surgery, patients in both groups will be treated per standard of care.


Eligibility criteria: Inclusion Criteria:

* The principal investigator's new or returning patients
* Adults 18 to 80 years of old
* Undergoing a spinal fusion procedure of greater than or equal to 5 levels for the purpose of correcting idiopathic spinal deformity

Exclusion Criteria:

* Patients who are undergoing a spinal fusion for other reasons besides deformity
* Patients who are unable to provide consent or fill out survey questionnaires
* Patients who have brace-prohibitive body habitus
* Patients who are unable to obtain standing AP and lateral 3-foot standing scoliosis x-rays

Primary outcomes:
measure: Change in Oswestry Disability Index (ODI) score
timeFrame: Baseline, 3 months, 6 months, 12 months and 24 months
Secondary outcomes:
measure: Changes in Scoliosis Research Society Outcomes Questionnaire (SRS-22 and SRS-30)
timeFrame: Baseline, 3 months, 6 months, 12 months and 24 months
measure: Change in Visual Analogue Scale (VAS)
timeFrame: Baseline, 3 months, 6 months, 12 months and 24 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Isaac Karikari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06158217: Effect of Ultrasound Combined With Microbubbles on Blood Perfusion in Invasive Breast Cancer
Official title: Effect of Ultrasound Combined With Microbubbles on Blood Perfusion in Invasive Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Invasive Breast Cancer
Cavitation
Perfusion
Keywords: Contrast-enhanced ultrasound
ultrasound combined with microbubbles
Invasive ductal carcinoma of breast
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 30
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 Invasive breast cancer

Brief summary: Blood perfusion insufficiency and hypoxia are the main causes of drug resistance to chemotherapy in breast cancer. Increasing blood perfusion can improve drug delivery. The cavitation effect of ultrasound-stimulated microbubbles (USMBs) is known to enhance tumor blood perfusion, so we conducted a prospective human study to investigate the effects of USMBs on hemoperfusion in invasive breast cancer (IBC).

Detailed description: patients with IBC were selected from the breast surgery department of our hospital. To induce an enhanced perfusion effect, IBC tumors were treated with SonoVue® microbubbles (MBs) stimulated by ultrasound, with a mechanical index (MI) of 0.2-0.3; 1 mL of SonoVue® MBs were injected at 3.5-min intervals three times for a USMB treatment lasting 10 min. The contrast-enhanced ultrasound (CEUS) parameters peak intensity (PI), area under the curve (AUC), and perfusion area were used to evaluate the changes in blood perfusion.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Invasive Breast Cancer
* patients scheduled to undergo surgical resection
* maximum lesion diameter \< 4 cm
* age over 18 years

Exclusion Criteria:

* patients with allergies to SonoVue®
* patients with severe cardiopulmonary insufficiency,
* patients who had already received neoadjuvant chemotherapy
* pregnant women
* individuals with mental illness
* Patients who refused to participate in the study

Primary outcomes:
measure: changes in peak intensity (PI)
timeFrame: 15 minutes after the USMB procedure
measure: area under the curve (AUC)
timeFrame: 15 minutes after the USMB procedure
measure: percentage increase in the perfusion area (%) of tumor
timeFrame: 15 minutes after the USMB procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
Study officials:
References:
Clinical trial NCT02375217: "Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"
Official title: "Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia Recovery
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective Randomized non inferiority Trial involving adult patients undergoing elective surgery under general anesthesia.56 Patients will be enrolled in 2 groups : full dose sugammadex vs half dose sugammadex for reversal of NMB.

Detailed description: The investigators' aim is to prove that half dose sugammadex in combination with neostigmine 0.05 mg/kg is non-inferior to the recommended dose of sugammadex for the reversal of deep ( absence of Trian of Four response :TOF) or moderate ( TOF 1 or 2 twiches) muscle paralysis in patients undergoing surgery under general anesthesia.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-70
* ASA class I, II, and III
* undergoing surgery under balanced general anesthesia requiring the use of muscle relaxants throughout the surgery

Exclusion Criteria:

* patients undergoing emergency surgeries
* pregnant patients
* patients with end stage renal disease or chronic kidney disease(GFR less than 60)
* patients with allergy to sugammadex or who had previous complications or side effects from previous sugammadex administration
* patients' refusal
* patients with allergy to recuronium

Primary outcomes:
measure: TOF ratio of 0.9
timeFrame: within 5 minutes
Secondary outcomes:
measure: the time to return of TOF ratio to 0.9 and the time till extubation
timeFrame: within 10 minutes
measure: Residual neuro-muscular blockade
timeFrame: within 10 to 180 mins
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: AUBMC
Study officials:
affiliation: American University of Beirut Medical Center
name: Marie Mn Aouad,, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aouad MT, Alfahel WS, Kaddoum RN, Siddik-Sayyid SM. Half dose sugammadex combined with neostigmine is non-inferior to full dose sugammadex for reversal of rocuronium-induced deep neuromuscular blockade: a cost-saving strategy. BMC Anesthesiol. 2017 Apr 11;17(1):57. doi: 10.1186/s12871-017-0348-9.
Clinical trial NCT00496717: Aorta Calcium Scoring
Official title: Measurement of an Abdominal Aorta Calcium Scoring and Its Correlation With Cardiovascular Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: Calcium scoring/aorta/ cardiovascular risk factor/scann
Patients with at least one cardiovascular risk factor
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2007-07-04
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with at least one cardiovascular risk factor in primary prevention. Mainly out patients followed in our cardiology clinic

Brief summary: Calcium scoring of the coronary arteries is use as a predictor of coronary stenosis. The aim of this study is to measure the calcium scoring of the abdominal aorta using an helicoidal fast scan and to correlate this measurement with classical cardiovascular risk factors and newer parameters reflecting vascular rigidity, like pulse velocity measurement.


Eligibility criteria: Inclusion criteria :

* Patients with at least one cardiovascular risk factor
* Ambulatory or hospitalized patients

Exclusion criteria :

* Significant cardiovascular complications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Hypertension, Maladies Vasculaires et Pharmacologie Clinique, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
city: Strasbourg
country: France
facility: Service de Radiologie, Hôpital Civil
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Dominique STEPHAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03168217: Classification of Periodontitis Revisited: A Cluster Analysis
Official title: Classification of Periodontitis Revisited: A Cluster Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis
Keywords: Periodontitis
classification
Cluster analysis
Lead sponsor: University Paris 7 - Denis Diderot
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a retrospective cross-sectional analysis based on a prospectively maintained database of consecutive patients attending the Department of Periodontology at the Rothschild Hospital of Paris (France)

Brief summary: This study aims to identify phenotypic groups of patients with periodontitis by applying a cluster analysis.

Detailed description: This is a retrospective cross-sectional study based on a prospectively maintained database of consecutive patients attending the Departement of Periodontology at the Rothschild hospital. A cluster analysis will help to distinguish clinical and microbiological profils of periodontal patients.

Eligibility criteria: Inclusion Criteria:

* Patients with periodontitis either aggressive or chronic

Exclusion Criteria:

* Patients who had received periodontal therapies or antimicrobial therapy within the 6 months preceding the examination

Primary outcomes:
measure: Clinical Attachment Loss (CAL)
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Paris Diderot University
name: Philippe Bouchard, PhD,DDS
role: STUDY_CHAIR
References:
Clinical trial NCT07008417: A Study on Bioequivalence of Cabergoline Tablets in Human Body
Official title: A Single-center, Randomized, Open-label, Two-formulation, Two-cycle, Two-sequence, Single-dose, Crossover Bioequivalence Study of Cabergoline Tablets Under Fasting and Postprandial Conditions in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Hyperprolactinemia
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-06
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the bioequivalence of the test formulation and reference formulation of cabergoline tablets in healthy Chinese subjects under fasting and postprandial conditions.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects aged 18-45 years (including boundary values), male or female;
* Body mass index: 19-26 kg/m2 (including boundary values), male weight ≥50 kg, female weight ≥45 kg;
* Normal results of physical examination, vital signs, laboratory tests, 12 lead-ECG, chest X-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above.

Exclusion Criteria:

* Received camergoline treatment within the past six months; Those who have a history of allergy to carergoline or any drug component; Those who have had a history of allergy to two or more drugs, foods, etc.
* Those who currently have the following clinically significant diseases, including but not limited to peripheral vascular lesions, orthostatic hypotension, valvular heart disease, fibrous lesions, severe peptic ulcers and other diseases, or have a previous history of related diseases; Or those with other related diseases of the respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, mental and nervous system, otorhinolaryngology, etc., which have been judged by researchers as having clinical significance;

Primary outcomes:
measure: Cmax
timeFrame: : 0 hours-72 hours post-administration
measure: AUC0-72h
timeFrame: 0 hours-72 hours post-administration
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Xiaoshan Hospital
state: Zhejiang
Study officials:
References: