louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00646100: Transarterial Chemoembolization for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
Official title: Transarterial Chemoembolization Versus Best Support for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
transcatheter arterial chemoembolization
prospective control study
best support care
survival
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2008-03-28
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transcatheter arterial chemoembolization (TACE) had been proved to improve the survivals for middle stage hepatocellular carcinoma (HCC), but for advanced stage HCC its' efficacy had not been proved. The investigators hypothesize that TACE also improve the survivals for advanced stage HCC. Thus, the investigators carried out this prospective control study to find out if the survivals for patients after TACE better than only best support or not.


Eligibility criteria: Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Tumor size \>7 cm with a portal vein invasion, and the tumor was considered to be unresectable
* No previous HCC directed treatment
* Eastern Co-operative Group performance status 0-1
* Liver function: Child's A

Exclusion Criteria:

* Avascular tumor
* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* underlying serve cardiac or renal diseases
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Diffuse-type HCC
* For patients with main portal vein occlusion, no adequate collateral circulation around the occluded portal vein

Primary outcomes:
measure: survival rates
timeFrame: 6, 12 months
Secondary outcomes:
measure: quality of life
timeFrame: 6, 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Canter Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: cancer canter sun yat-set university
name: jinqing li, MD
role: STUDY_DIRECTOR
References:
citation: Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.
Clinical trial NCT01352000: Relapse-Prevention Booklets as an Adjunct to a Tobacco Telephone Helpline("Quitline")
Official title: Relapse-Prevention Booklets as an Adjunct to a Tobacco Quitline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: self help
smoking cessation
cancer prevention
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Roswell Park Cancer Institute
First posted: 2011-05-11
Enrollment: 3830
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study primary purpose is smoking relapse prevention. This study is a collaboration between researchers who developed the relapse-prevention intervention, at the H. Lee Moffitt Cancer Center in Tampa, Florida, and those associated with the "New York State Smokers' Quitline" (NYSSQL), at Roswell Park Cancer Institute in Buffalo, New York.

Detailed description: In this study, approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call. One-third will be randomized to a Usual Care (UC) condition, which will receive regular quitline services. One-third will be randomized to a Repeated Mailings (RM) condition, which will receive the 8 Forever Free booklets sent by mail at regular intervals over a period of 12 months. And one-third will be randomized to a Massed Mailings (MM) condition, which will receive all 8 booklets in a single mailing.

Eligibility criteria: Inclusion Criteria:

* referrals from the New York State Smokers' Quitline
* at least 18 years of age

Primary outcomes:
measure: 7-Day Point-Prevalence Abstinence at Each Follow-up Point
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Thomas Brandon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03569800: Evaluation of the Clinical and Biological Consequences of Levothyrox® Formula Modification
Official title: Evaluation of the Clinical and Biological Consequences of Levothyrox® Formula Modification
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Thyroid Disorder
Keywords: Levothyrox®
thyroid hormones
bioequivalent
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population refers to outpatients with a thyroid disorder who consult at the Endocrinology department of Hopitaux Universitaires Paris Centre

Brief summary: The purpose of this study is to determine whether the recent excipient modification of Levothyrox® in France for a bioequivalent formula has clinical and biological consequence for the patients. The investigators also plan to describe the patient journey in terms of levothyroxine based drugs since this formula modification of Levothyrox®.

Detailed description: Levothyrox® is a levothyroxine based drug marketed in France in order to substitute a lack of thyroid hormones. Because of a lack of stability during time and because of wide inter-batch variability in terms of active molecule, the National Agency of Safety of Medicaments (ANSM) ask to the market authorization holder to develop a new formula without lactose. This new formula, which has been proven to be bioequivalent has been marketed since march 2017 in France. Some patients were predicted to have their thyroid function imbalance because of this modification. The purpose of the study is to analyse, on the patients treated by Levothyroxine® in how many patients this modification has clinical and biological consequences.

Eligibility criteria: Inclusion Criteria:

* Thyroid disorder treated by Levothyroxine
* Age over 18 year old
* TSH plasma level within the 12 months before formulation modification
* TSH plasma level within the 6 months after formulation modification

Exclusion Criteria:

- Thyroid dysfunction (hypo or hyperthyroidism) despite Levothyroxine treatment, ie TSH plasma level out of normal range within the 6 months before formula modification

Primary outcomes:
measure: Number of abnormal Thyroid Stimulating Hormone (TSH) level after change of levothyrox formulation
timeFrame: 1 day
Secondary outcomes:
measure: Number of patients treated with new formulation of levothyrox
timeFrame: 1 day
measure: Difference betweenTSH plasma levels before and after formulation change
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpitaux Universitaires Paris Centre
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: lionel Groussin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06797700: Risk Factors of Paraspinal Muscles in Degenerative Lumbar Spondylolisthesis
Official title: Prediction of Risk Factors of Paraspinal Muscles in Degenerative Lumbar Spondylolisthesis Based on Spine MRI
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Spine Degeneration
Keywords: degenerative lumbar spondylolisthesis
paraspinal muscles
MRI
Lead sponsor: The First People's Hospital of Yunnan
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone lumbar MRI in our hospital and have been diagnosed with back pain ( including spondylolisthesis or no spondylolisthesis) during the period from 2022 to 2024.

Brief summary: This is a retrospectively observational study. The goal of this observational study is to analyze the risk factors of paraspinal muscles associated with the occurrence of spondylolisthesis in patients with degenerative lumbar spondylolisthesis(DLS) and to construct a predictive model. The main question it aims to answer is: Which paraspinal muscle changes are risk factors for DLS? We will collect the information of patients who have undergone lumbar MRI in our hospital and have been diagnosed with back pain ( including spondylolisthesis or no spondylolisthesis) during the period from 2022 to 2024.The collected data included gender, age, body mass index (BMI), diabetes, hypertension, occupation and imaging parameters. We will then retrospectively analyze the risk factors associated with lumbar spondylolisthesis.


Eligibility criteria: Inclusion Criteria:

* Patients who presented to our hospital with back pain(the diagnosis was spondylolisthesis or no spondylolisthesis);
* Patients older than 50 years;
* Patients with complete clinical data and magnetic resonance imaging (MRI) before surgery.

Exclusion Criteria:

* The patient has previous spinal surgery;
* Patients with lumbar tumor,lumbar infection and lumbar tuberculosis;
* Patients with incomplete MRI sequence.

Primary outcomes:
measure: the MF FCSA
timeFrame: Two weeks before treatment
measure: the ES FCSA
timeFrame: Two weeks before treatment
measure: the MF CSA
timeFrame: Two weeks before treatment
measure: the ES CSA
timeFrame: Two weeks before treatment
Secondary outcomes:
measure: SMI
timeFrame: Two weeks before treatment
Other outcomes:
Locations:
city: Kunming
country: China
facility: The First People's Hospital of Yunnan
state: Yunnan
Study officials:
References:
Clinical trial NCT01227200: The Effect of Adding Pain Relievers to Local Anesthesia Before Preforming Drainage in Peritonsillar Abscess
Official title: The Efficiency of DYPIRON and TRAMADOL in Addition to Local Anesthesia Prior to Incision and Drainage Procedure in Peritonsillar Abscess
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peritonsillar Abscess
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2010-10-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find if adding oral pain relievers as DYPIRON and TRAMADOL in addition to the local anesthesia injection, can help reducing the pain intensity in patients who diagnosed as Suffering from peritonsillar abscess (PTA)and treated by incision and drainage .

Detailed description: Control group: the patient will get local anesthesia injection with Lidocain. After 5 minutes- the DR will preform the incision and drainage of the abscess.

Then the patient will be asked by the vas score, the the pain intensity that he feels.

Intervention group:the patient will get dypiron 4 ml and tramadol 50 mg. after 40 minutes,the patient will get local anesthesia injection with Lidocain. After 5 minutes- the DR will preform the incision and drainage of the abscess.then the patient will be asked by the vas score, the the pain intensity that he feels.

Eligibility criteria: Inclusion Criteria:patients with PTA in ages 18-65, who agreed to join the research -

Exclusion Criteria:cave to dypiron and/or tramadol, pregnant women, mental illness,soldiers.

-

Primary outcomes:
measure: the vas scale
timeFrame: 40 min after giving the oral drugs
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: otolaryngology department, HaEmek mc
city: Afula
country: Israel
facility: Otolaryngology department, HaEmek MC
Study officials:
References:
Clinical trial NCT02380300: Registry Study of Clinical Application of MRI Compatible CIED
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted
Lead sponsor: Biotronik (Beijing) Medical Device Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-05
Enrollment: 2067
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ProMRI CIED implanted，including ProMRI Pacemaker/CRT and ProMRI ICD/CRTD

Brief summary: The purpose of this study is to clear the Safety and Necessity of the Magnetic Resonance Imaging (MRI) in the Presence of CIEDs(Cardiovascular Implantable Electronic Devices).


Eligibility criteria: 1. Inclusion criteria

   * Patient is \>18 years old
   * Patient implanted with a Biotronik MRI compatible CIED (including the pacemaker, cardiac resynchronization therapy, implantable cardioverter defibrillator, and cardiac resynchronization therapy-defibrillator) in the past two months
   * Patient has provided a written informed consent
   * Patient's height is≥140cm
2. Exclusion criteria

   * Have other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, mechanical valves, other active medical devices, non-MRI compatible devices
   * Life expectancy less than 2 years
   * Pregnant and/or breat-feeding females or females who intend to become pregnant in next two years
   * Patient is currently participating in another study
   * In the investigator's opinion patient will not be able to comply with the follow-up requirements

Primary outcomes:
measure: Serious adverse events
timeFrame: two years
measure: The raise of Impedance Threshold of the Atrial and Ventricle
timeFrame: immediate；one month
measure: RA sensing amplitude (daily mean): < 1.5 mV or RV sensing amplitude (daily min.): < 2.0 mV
timeFrame: immediate；one month
measure: The proportion of patients with CIED who need MRI examination
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06986252: Effect of Nurse-led Education on Health, Quality of Life and Sexual Health
Official title: Effect of Nurse-led Education on Health, Quality of Life and Sexual Health for Patients Undergoing Endovascular Intervention for Abdominal Aortic Aneurysm
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abdominal Aortic Aneurysms (AAA)
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main hypothesis is that a nurse-led education provided to patients who received endovascular treatment due to enlarged abdominal aorta would present a difference in perceived health, quality of life and sexual health.

Detailed description: A longitudinal, prospective single-centre randomized control trial to evaluate the effects of a nurse-led educational intervention for patients undergoing endovascular intervention for abdominal aortic aneurysm.

Eligibility criteria: Inclusion Criteria:

* patients who received endovascular treatment for abdominal aortic aneurysm.
* patients who could understand and communicate in Swedish.

Exclusion Criteria:

* cognitive impairment or language impairment that prevents communication and informed consent.
* patients who did not receive endovascular treatment.

Primary outcomes:
measure: Health Education Impact Questionnaire (HeiQ)
timeFrame: from enrollment to 12 month after enrollment
measure: Male Sexual Function-4 Questionnaire
timeFrame: from enrollment to 12 month after enrollment
Secondary outcomes:
measure: EuroQol Five Dimension (EQ-5D-3L)
timeFrame: from enrollment to 12 month after enrollment
measure: Complementary questions for the intervention
timeFrame: from enrollment to 12 month after enrollment
measure: Complementary questions for sexual function
timeFrame: from enrollment to 12 month after enrollment
measure: Laboratory analysis - Cholesterol
timeFrame: from enrollment to 12 month after enrollment
measure: Laboratory analysis - Triglycerids
timeFrame: from enrollment to 12 month after enrollment
measure: Laboratory analysis - High density lipoprotein (HDL)
timeFrame: from enrollment to 12 month after enrollment
measure: Laboratory analysis - Low density lipoprotein (LDL)
timeFrame: from enrollment to 12 month after enrollment
measure: Laboratory analysis - Plasma glucose
timeFrame: from enrollment to 12 month after enrollment
measure: Systolic blood pressure
timeFrame: from enrollment to 12 month after enrollment
measure: Diastolic blood pressure
timeFrame: from enrollment to 12 month after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Göteborg University
name: Monica Pettersson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05578352: The Exploreration of the Management for the Positive IAA in Patients With Type 2 Diabetes After Premix Insulin Therapy
Official title: The Exploreration of the Management for the Positive IAA in Patients With Type 2 Diabetes After Premix Insulin Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Premix insulin is widely used, with high proportion of positive insulin autoimmune antibody in patients with type 2 diabetes. The positive insulin autoimmune antibody may affect blood glucose control. We aim to explore the management for the positive insulin autoimmune antibody and blood glucose control in these patients, and investigate the immune cells changes with the change of different glucose lowering drugs.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes;
* Treated with premix insulin, two or three injections a day, single drug or combination of oral hypoglycemic drugs;
* The treatment regimen was stable for more than 2 months;
* With positive insulin antibody

Exclusion Criteria:

* Patients treated with GLP-1 agonist in the last 3 months;
* Allergic to insulin;
* Impaired liver and renal function (ALT 2.5 times higher than the upper limit of normal value; serum creatinine was 1.3 times higher than the upper limit of normal);
* A history of drug abuse and alcohol dependence;
* Used systemic glucocorticoids therapy in recent 3 months;
* Patients with infection or stress within four weeks;
* Patients who cannot tolerate FGM;
* Pregnant or preparing to become pregnant;
* Considered unsuitable to participate by the investigator.

Primary outcomes:
measure: Insulin autoimmune antibody
timeFrame: 3 month
Secondary outcomes:
measure: HbA1c
timeFrame: 3 month
measure: Time in range
timeFrame: 3 month
measure: Time below range
timeFrame: 3 month
measure: B cell
timeFrame: 3 month
measure: T cell
timeFrame: 3 month
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital, Nanjing Medical Univesity
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Jianhua Ma, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01827852: AVAdeno Study: An Observational Study of First-Line Avastin (Bevacizumab) in Patients With Adenocarcinoma of the Lung
Official title: AVAdeno: Non-interventional Study of Avastin 1st Line Therapy in Adenocarcinoma Patients of the Lung
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-04-10
Enrollment: 1107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with inoperable advanced, metastatic or recurrent predominantly non-squamous adenocarcinoma non-small cell lung cancer

Brief summary: This prospective observational study will evaluate the efficacy and safety of first-line Avastin (bevacizumab) in combination with platinum-based chemotherapy in different age groups (\<60, 60-69, 70-79, \>80 years) in patients with inoperable advanced, metastatic or recurrent adenocarcinoma non-small cell lung cancer. Patients will be followed for 18 months from the start of first-line therapy.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically confirmed inoperable advanced, metastatic or recurrent pre-dominantly non-squamous adenocarcinoma non-small cell lung cancer

Exclusion Criteria:

* Contraindications to Avastin treatment according to the Summary of Product Characteristics

Primary outcomes:
measure: Progression-free survival in 4 different age groups (<60, 60-69, 70-79, >/=80 years)
timeFrame: approximately 4.5 years
Secondary outcomes:
measure: Overall survival in 4 different age groups (<60, 60-69, 70-79, >/=80 years)
timeFrame: approximately 4.5 years
measure: Clinical/demographic patient characteristics at initiation of treatment
timeFrame: approximately 4.5 years
measure: Avastin treatment schedule in routine clinical practice (dosage/duration)
timeFrame: approximately 4 years
measure: Concomitant anti-neoplastic therapy (dosage/duration)
timeFrame: approximately 4.5 years
measure: Safety: Incidence of adverse events in 4 different age groups (<60, 60-69, 70-79, >/=80 years)
timeFrame: approximately 4.5 years
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: