louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05489289: A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection
Official title: A Randomized, Double-blind, Phase III Clinical Study on the Efficacy and Safety of AK104 Versus Placebo as Adjuvant Therapy for Hepatocellular Carcinoma With High Risk of Recurrence After Curative Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2022-08-05
Enrollment: 570
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 efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.


Eligibility criteria: Inclusion Criteria:

1. Pathological diagnosis of HCC without any metastasis;
2. Receiving radical resection as the only anti-tumor treatment;
3. No evidence of residual cancer found during or after the operation;
4. Presence of any high risk factor of postoperative recurrence;
5. Child-Pugh grade: A;
6. ECOG score: 0;
7. Controlled underlying causes of HCC.

Exclusion Criteria:

1. Fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc;
2. Any anti-tumor treatment other than radical surgery before randomization;
3. Precarious liver function indicated by severe complications;
4. Recent procedures or medications leading to high risk of bleeding;
5. Poorly controlled or symptomatic hypertension, congestive heart failure, arrhythmia, etc;
6. Failure of performing enhanced CT or MRI scans of the liver;
7. Recent severe infections or systemic antibiotics use;
8. Active autoimmune diseases;
9. History of other incurable malignant tumors;
10. History of transplantation;
11. Pregnancy.

Primary outcomes:
measure: Recurrence free survival (RFS) by BICR
timeFrame: Up to 48 months
Secondary outcomes:
measure: 12-months recurrence free survival (RFS-12)
timeFrame: 12 months
measure: 24-months recurrence free survival (RFS-24)
timeFrame: 24 months
measure: Time to recurrence (TTR)
timeFrame: Up to 48 months
measure: Overall survival (OS)
timeFrame: Up to 48 months
measure: Types and proportions of adverse events (AEs)
timeFrame: Up to 48 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jia Fan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00913289: Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells
Official title: Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Liver Cirrhosis
Keywords: Liver Cirrhosis
Lead sponsor: Kanazawa University
Sponsor class: OTHER
First posted: 2009-06-04
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mesenchymal stem cells have the capability to differentiate into hepatocytes and will be useful for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cells compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will receive autologous adipose tissue derived stromal cells which include such mesenchymal stem cells.

Detailed description: The population of the liver cirrhosis patients is enormous in Japan and the only radical treatment for them is liver transplantation. However, the number of giving donors is extremely limited. Mesenchymal stem cells have been capable to differentiate into mesodermal-lineage cells as well as endodermal-lineage cells such as hepatocytes. They reside in the mesenchymal tissues such as bone marrows as well as adipose tissues. The latter tissues are relatively enriched with mesenchymal stem cells compared to bone marrow cells. In this study, the cirrhotic patients will receive autologous adipose tissue derived stromal cells which contains substantial number of mesenchymal stem cells.

Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis patients
* Platelets count in peripheral blood: over 7.0x10\^4/microliter
* Serum creatinine: less than 1.5 mg/dl
* Capable of understanding the features of this clinical trial

Exclusion Criteria:

* Associated with risky gastroesophageal varices for bleeding
* Severe portal hypertension
* Complicated with severe heart failure
* Renal disease
* Respiratory disease
* Hematological disease
* Coagulation disturbance and judged to be excluded by doctors
* Associated with malignancy
* Past history of the following:

  * malignancy
  * ischemic heart disease
  * cerebrovascular disease (cerebral infarction, cerebral hemorrhage)
  * decompensated status of liver cirrhosis
* Pregnant, or possibility of pregnancy
* Infected with HIV
* Under mediation with adrenal corticoid steroid, anti-histamine drug
* Anticipated with difficulty of follow-up observation
* Anticipated with inconsistency of following the protocol
* Addiction of alcohol drinking and unable to stop drinking
* Other candidates who are judged to be not applicable to this study by doctors

Primary outcomes:
measure: all cause harmful events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
Study officials:
affiliation: Kanazawa University
name: Shuichi Kaneko, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02421289: Influence of Cytochrome P2B6 on Efavirenz Dose in HIV-infected Thai Patients
Official title: Influence of Cytochrome P2B6 on Efavirenz Dose in HIV-infected Thai Patients in a Prospective Randomized Controlled Trial: a Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cytochrome P-450 CYP2B6
Efavirenz
HIV
Keywords: CYP2B6 polymorphism
efavirenz
Thai
HIV-infected patient
pharmacogenomic
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-04-20
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Genetic polymorphisms of cytochrome P450 2B6 (CYP2B6) are associated with lower rate of EFV metabolism and lead to high exposure, as well as a higher risk of neuropsychiatric adverse event especially homozygous variant CYP2B6 \*6/\*6. This trial was designed to compare the proportion of patients who had undetectable HIV RNA at 24 weeks after ART initiation between patient who did CYP 2B6 guided EFV dose and who did not.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old
* Anti-HIV positive
* Naïve to antiretroviral drugs
* Meet the criteria to start ART to Thai National guidelines
* Sign inform consent

Exclusion Criteria:

* Body mass index (BMI) \>25 kg/m²
* Pregnant women or breastfeeding
* Received drugs that may have interaction with EFV e.g. rifampicin, fluconazole (400-800 mg), ergot alkaloid, midazolam, triazolam, ritonavir, carbamazepine, phenytoin, phenobarbitone, St John's Wort
* Having active opportunistic infections e.g. tuberculosis, cryptococcosis, histoplasmosis, penicillosis
* Hepatic dysfunction as indicated by:
* Transaminases \>5-10 × the upper limit of normal
* ALP \>5-10 × the upper limit of normal
* Total bilirubin \>2.5-5 × the upper limit of normal

Primary outcomes:
measure: HIV RNA
timeFrame: 24 weeks
Secondary outcomes:
measure: Neuropsychiatric adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of medicine Ramathibodi Hospital
Study officials:
affiliation: Faculty of medicine Ramathibodi Hospital
name: Pansachee Damronglerd, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02690389: Electro-acupuncture and Flumazenil's Effect on Sedation
Official title: The Sedation Effect of Electro-acupuncture on Bilateral Zusanli (ST 36) and Neiguan (PC 6) in General Anesthesia May Not be Mediated by the Benzodiazepines- GABA Pathway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acupuncture
General Anaesthesia
Sedation
Keywords: Acupuncture
Flumazenil
Narcotrend
General Anaesthesia
Sedation
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
Collaborators: name: Sichuan Cancer Hospital and Research Institute
First posted: 2016-02-24
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Object: To explore the mechanism of the electro-acupuncture (EA) induced sedation effect in general anaesthesia through investigating the role of the Benzodiazepines-GABA system.

Method: 80 patients undergoing abdominal surgery were randomly divided into four groups (n=20): C group (propofol only group), F group (propofol + flumazenil group), EA group (propofol + electro-acupuncture group), and EA+F group (propofol + electro-acupuncture + flumazenil group). Before induction, acupuncture needles were inserted at the points of Zusanli (ST 36) and Neiguan (PC 6) bilaterally to elicit"DeQi". Target-controlled infusion (TCI) of propofol was used for the induction and maintenance of anaesthesia. After 15minutes, equilibrium of Narcotrend Index (NT index) was achieved, patients were then assigned to receive different interventions. In EA group and EA+F group, patients received EA for 30 minutes under general anaesthesia, and flumazenil with the dosage of 0.1mg/kg was added in the latter at the end of EA. In C group and F group, patients didn't receive EA, and flumazenil with the dosage of 0.1mg/kg was administered in F Group at the same time point with EA+F group. HR, MAP and NT index were recorded at different time points up to 30 minutes after the end of EA.


Eligibility criteria: Inclusion Criteria:

* 80 abdominal surgical patients
* aged 30 to 60 years old,
* weighing 50-70Kg,
* ASA I-Ⅱ, who scheduled to receive general anaesthesia were enrolled to this trial.

Exclusion Criteria:

* Hypertension or severe heart and lung diseases,
* Conditions that might affect the consciousness or NT index, such as seizures, psychosis, brain lesions, and treatment with sedative drugs,
* Contraindications to acupuncture, such as severe hemorrhagic disease, hyper-sensitive patient, and tumor or ulcer exist on the skin of the acupuncture points.

Primary outcomes:
measure: depth of general anaesthesia
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
Study officials:
affiliation: Sichuan University
name: yin liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01893489: Visualization of Carotid Atherosclerosis by 68Ga-MSA
Official title: Phase I Study to Evaluated the Safety of Noninvasive Molecular Imaging for the Detection of Inflammation in Carotid Atherosclerotic Lesions by Using Ga-68-NOTA-MSA in Healthy Volunteers and Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atherosclerosis
Carotid Atherosclerosis
Noninvasive Imaging of Atherosclerosis
Keywords: positron emission tomography
macrophage
neomannosyl human serum albumin
Lead sponsor: Korea University
Sponsor class: OTHER
Collaborators: name: SHIN JIN MEDICS
First posted: 2013-07-09
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Until now, no specific atherosclerosis-targeting agent labeled with positron emitter is not yet available. Investigators developed neomannosyl human serum albumin(MSA) for the terminal mannose residues of MSA binding with the mannose receptors of macrophages in atherosclerosis, and investigators investigate whether 68Ga-MSA can be a novel agent for non-invasive molecular imaging of carotid atherosclerotic lesion in PET.


Eligibility criteria: Inclusion Criteria:

* •coronary artery disease patients with carotid plaques

  * control without carotid plaque

Exclusion Criteria:

* •pregnancy, allergy to albumin, any acute or chronic inflammatory disease, hematologic disease, liver disease, renal disease

Primary outcomes:
measure: side reactions at MSA injection site of the skin
timeFrame: with 2 hours after MSA injection
measure: unstable changes of vital signs and development of abnormal biochemical parameters
timeFrame: 24 hours after MSA injection
Secondary outcomes:
measure: standard uptake unit(SUV) at carotid arteries
timeFrame: baseline
measure: SUV at aorta and iliac arteries
timeFrame: baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Nuclear Medicine, Institute of Radiation Medicine,
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References:
Clinical trial NCT01372189: Molecular Imaging of Epidermal Growth Factor Receptor in Colorectal Neoplasia Using Confocal Laser Endomicroscopy
Official title: In Vivo Molecular Imaging of Epidermal Growth Factor Receptor in Patients With Colorectal Neoplasia Using Confocal Laser Endomicroscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Colorectal Adenoma
Keywords: molecular imaging
epidermal growth factor receptor
colorectal neoplasia
confocal laser endomicroscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2011-06-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients known to have large polypoid lesions in colon or rectum from previous examinations from outpatients and inpatients at Qilu Hospital were enrolled into the study

Brief summary: The study aims to:

1. Achieve molecular imaging of EGFR in patients with colorectal neoplasia in vivo using confocal laser endomicroscopy.
2. Compare the results of in vivo EGFR-specific molecular imaging with CLE and ex vivo immunohistochemistry .

Detailed description: Various kinds of tumor markers have been shown to be over-expressed in colorectal cancer, including epidermal growth factor receptor(EGFR). The conventional detection method of EGFR expression in colorectal neoplasia is immunohistochemistry which is time-consuming, and the immunoreactivity can be affected by storage and fixation of tissues. Confocal laser endomicrosopy is a newly developed device which could identify the cellular and subcellular structures clearly with the magnification at×1000, making it possible to explore the physiological and pathological molecular mechanism of the gastrointestinal tract. So the study aims to achieve molecular imaging of EGFR in colorectal neoplasia in vivo using confocal laser endomicroscopy.

Eligibility criteria: Inclusion Criteria：

●Patients known to have large polypoid lesions in colon or rectum from previous examinations from outpatients and inpatients at Qilu Hospital were enrolled into the study

Exclusion Criteria:

* Patients who are allergic to fluorescein sodium
* Patients with impaired cardiac, liver or renal function
* Patients who are unwilling to sign or give the informed consent form
* Patients with giant tumors or obvious GI tract bleeding which make it hard or impossible to observe the lesions
* Patients with coagulopathy
* Patients with pregnancy or breastfeeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology, Qilu Hospital
name: Yanqing Li, PhD. MD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01101789: Triclosan Coated Suture Wound Closure for Peripheral Vascular Surgery: a Prospective Multicenter Study
Official title: Triclosan Coated Suture Wound Closure for Peripheral Vascular Surgery: a Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infection
Keywords: surgical wound infection
triclosan-coated suture
Lead sponsor: North Karelia Central Hospital
Sponsor class: OTHER
First posted: 2010-04-12
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized multicenter study which purpose is to determine whether triclosan-coated sutures for wound closure after lower limb vascular surgery would reduce the incidence of surgical wound infections.


Eligibility criteria: Inclusion Criteria:

* patient undergoing peripheral vascular surgery procedure

Exclusion Criteria:

* patients refusal

Primary outcomes:
measure: surgical wound infection
timeFrame: one month after surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: North Carelia central hospital
Study officials:
affiliation: North Karelia Central Hospital
name: Johanna Turtiainen, MD
role: STUDY_DIRECTOR
affiliation: Kuopio University Hospital
name: Kimmo Makinen
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Maarit Venermo
role: PRINCIPAL_INVESTIGATOR
affiliation: South Carelia Central Hospital
name: Eija Saimanen
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Ilkka Uurto
role: STUDY_DIRECTOR
References:
Clinical trial NCT06595589: Effect of Caries Conceptualizing and Residential University Life
Official title: The Effect of Dental Caries Conceptualizing and the Residential University Life on the Caries Prevalence and Caries Prevention Practice of Egyptian Dental Students: Observational Cross-Sectional Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Caries, Dental
Keywords: caries prevalence
residential students
dental students
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2024-09-19
Enrollment: 303
Sex: ALL
Minimum age (years): 20
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young Adult 4th year Dental students

Brief summary: The study aims to detect the conceptualization of dental caries among dental student and compare the caries prevalence in residential and non residential dental student

Detailed description: A face-to-face meeting will be held with the target student group, illustrating the study set up and seeking the participation approval. The students who will accept to participate in the study will receive a questionnaire including the caries conceptualization assessment inquiry, the caries prevention practice as well as the residential habits. All the participating students will be scheduled for dental examination to record their DMFT index. The digital responses will be coded, analyzed and correlated with the clinical findings.

Eligibility criteria: Inclusion criteria will be:

* Students already taught a dental cariology in 4th year of university.
* Students registered in the Galala dental program science year one.
* Medically free students.
* Students having at least 1year clinical practice.

Exclusion criteria will be:

* First, second-, and third-year students.
* Non dental students.

Primary outcomes:
measure: Caries Prevalence
timeFrame: At base line Immediately after collecting the data
Secondary outcomes:
measure: caries conceptualization in relation to the Caries preventive behavior of the students.
timeFrame: At base line
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05814289: The Association of Telephone Head Tilt With Cervical, Thoracic, and Lumbar Spine Mobility and Disorders in Young Adults
Official title: The Association of Telephone Head Tilt With Cervical, Thoracic, and Lumbar Spine Mobility and Disorders in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Forward Head Posture
Keywords: Head tilt
Lumbar spine
Spine
Cervical spine
Thoracic spine
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To determine the relationship between telephone head tilt and cervical, thoracic, and lumbar spine mobility and disturbances in young adults.

Detailed description: Today, the fact that smartphones are easily portable and can be used for many purposes such as playing games, surfing the Internet, accessing information, shopping, and listening to music has made them widespread at an unexpected rate. This situation has brought the issue of device addiction to the agenda. Smartphone addiction can lead to many physical ailments such as visual impairment, numbness, and tingling in the hands, neck, back, hip, and knee pain. In the studies conducted, smartphone addiction was determined in university students and this situation was found to be associated with musculoskeletal pain. Considering the smartphone usage rates, durations, and smartphone usage postures of young adults, it can be predicted that spinal mobility may be adversely affected and may cause spine-related disorders. This study aims to determine the relationship between telephone head tilt and cervical, thoracic, and lumbar spine mobility, and disorders in young adults. In addition, it is aimed to examine the relationship between these parameters with quality of life.

Eligibility criteria: Inclusion Criteria:

* Using smartphone,
* Not having any diagnosed chronic disease,
* No past or present mental illness,
* Individuals who can speak, read and write Turkish.

Exclusion Criteria:

* Having any neurological, psychiatric or cognitive disorder,
* Individuals who cannot speak, read or write Turkish.

Primary outcomes:
measure: Telephone head tilt
timeFrame: 1 day
measure: Cervical, Thoracic, and Lumbar Spine Mobility
timeFrame: 1 day
measure: Core Outcome Measurement Index
timeFrame: 1 day
measure: General quality of life assessed by Nottingham Health Profile
timeFrame: 1 day
measure: Japanese Orthopedic Association Back Pain Evaluation Questionnaire
timeFrame: 1 day
measure: The Bournemouth Questionnaire
timeFrame: 1 day
measure: The Spine Functional Index
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Tokat Gaziosmanpasa University
state: Tokat
Study officials:
References: