louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02185495: Screening for Early Lung Cancer in Shanghai, China
Official title: Screening and Diagnosing for Early Lung Cancer in Shanghai Communities With Imaging Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Shanghai Pulmonary Hospital, Shanghai, China
name: Fudan University
name: Ruijin Hospital
name: Shanghai Public Health Clinical Center
First posted: 2014-07-09
Enrollment: 3000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Imaging procedures including chest X-ray and low-dose computed tomography may be effective in lung cancer early detection. Yet it is unknown whether low-dose computed tomography combined with computer aided detection （CAD) is more effective than LDCT in screening of early lung cancer.

Detailed description: The randomized clinical trial is to investigate and compare the effectiveness of CAD-guided low-dose computed tomography and low-dose computed tomography in lung cancer screening for community individuals in Shanghai, China. Thus, an imaging protocol which can detect early lung cancer in asymptomatic high risk patients will be proposed.

Eligibility criteria: Inclusion Criteria:

* Age of 55 to 74 years; smoking history of at least 30 pack-years; and if former smoker, have quit within 15 years
* Age 50 or older ,20 or more pack-year history of smoking, and one additional risk factor (occupational exposure, residential radon exposure, cancer history, family history of lung cancer, history of lung disease)
* Age 35 and one additional risk factor
* Ability to accept LDCT examination and sign informed consent form

Exclusion Criteria:

* Individuals with any symptoms suggestive of lung cancer （e.g., vigorous coughing, chest pain, weight loss, blood-stained sputum）
* Individuals with acute pulmonary abnormalities or those in poor health conditions or those have metallic implants or devices in the chest or back will be excluded due to the potential impact on the results as well as difficulty of acquiring the images.
* Pregnant women

Primary outcomes:
measure: The sensitivities of low-dose computed tomography and low-dose computed tomography with computer aided detection in detecting early lung cancer
timeFrame: 24months
Secondary outcomes:
measure: The false positive rates between low-dose computed tomography and low-dose computed tomography with computer aided detection will be compared
timeFrame: 24months
measure: Nodule detection rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changzheng Hospital
state: Shanghai
Study officials:
affiliation: Radiology Department of Shanghai Changzheng Hospital
name: Shiyuan Liu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03265795: Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation
Official title: Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillary Cyst
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 8
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Surgical ablation of large maxillary cysts usually results in considerable hard and soft tissue deficits that ultimately affect the final esthetic and functional outcomes. Reconstruction of such defects; whether primarily or secondarily; offers much better long-term outcomes. However, primary bony reconstruction becomes potentially complicated in many cases of such large cysts encroaching or involving the maxillary sinus where a communication with the maxillary sinus lining may be unavoidable.

Reconstruction of such defects can be accomplished using either vascularized or; more commonly; non-vascularized autogenous bone grafts. Different bone substitutes remain to be another viable option. The simultaneous use of titanium meshes provides physical three-dimensional support for the bone graft contained within as well as the overlying soft tissues. However, the drawbacks of titanium meshes in such defects remain to be mainly the difficulty in adequately shaping the mesh and the lack of proper isolation of the mesh contents from the maxillary sinus cavity.


Eligibility criteria: Inclusion Criteria:

1. Age of patients from 15 to 60 years old.
2. Patients with unilateral maxillary lesion encroaching maxillary sinus.
3. Dentulous or edentulous patients.
4. Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.

Exclusion Criteria:

1. Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders, neuromotor disorders and autoimmune diseases (may affect normal healing).
2. Patients with bilateral maxillary lesions.
3. Children under 15 years old.

Primary outcomes:
measure: oral health related quality of life
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gellrich NC, Schramm A, Hammer B, Rojas S, Cufi D, Lagreze W, Schmelzeisen R. Computer-assisted secondary reconstruction of unilateral posttraumatic orbital deformity. Plast Reconstr Surg. 2002 Nov;110(6):1417-29. doi: 10.1097/01.PRS.0000029807.35391.E5.
citation: Eckardt A, Swennen GR. Virtual planning of composite mandibular reconstruction with free fibula bone graft. J Craniofac Surg. 2005 Nov;16(6):1137-40. doi: 10.1097/01.scs.0000186306.32042.96.
citation: Lethaus B, Kessler P, Boeckman R, Poort LJ, Tolba R. Reconstruction of a maxillary defect with a fibula graft and titanium mesh using CAD/CAM techniques. Head Face Med. 2010 Jul 19;6:16. doi: 10.1186/1746-160X-6-16.
Clinical trial NCT04217395: Quality of Life and Autonomy in Health of Overweight or Obese People Receiving Reinforced Support
Official title: Implementation and Effectiveness of a Reinforced Support Program for People Who Are Overweight or Obese to Improve Their Autonomy in Health and Quality of Life
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity
Keywords: Obesity
Overweight
Empowerment
Autonomy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects are the overweight or obese care health users followed-up byincluded in the X-Ailes program.

Brief summary: This mixed-methods prospective cohort study aims to evaluate a recently implemented reinforced support program named "X-ailes program".

The X-Ailes program is a face-to-face or telephone-based support program by health-system navigators/case-managers, funded by the French Ministry of Health (program for empowerment of care users). X-Ales is developed by an patients and public association to support overweight or obese care users facing difficulty to access to care or resources regarding the management of their health situation.

The subjects of the present study are the overweight or obese care-users followed-up by the X-Ailes program.

The aim of the study Eval-X-ailes is to assess the effect of the support program X-Ailes on quality of life, autonomy and literacy of overweight or obese care users at 12 months.


Eligibility criteria: Inclusion Criteria:

* People aged 18 or more, male or female
* Body mass index equal or over 25
* Resident Living in one of the 2 territories covered by the X-ailes program (Lyon Metropolitan Area or Puy-de-Dôme County)
* Starting Included in the X-ailes program support (1st phone contact to initiate follow-up)
* Not objecting to participating in the evaluation of the X-ailes program

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: Quality of life at 12 months, measured by the specific questionnaire Quality of life, Obesity and Dietetics (QOLOD, Ziegler et al. 2005)
timeFrame: month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: metropolitan area of Lyon
Study officials:
References:
Clinical trial NCT04312295: ACP Simulation-based Communication Training Program for Nurses Discussing ACP With Chronic Kidney Disease Patients
Official title: The Effects of an ACP Simulation-based Communication Training Program for Nurses Discussing ACP With Chronic Kidney Disease Patients: A Longitudinal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was to evaluate the effects of ACP simulation-based communication training program (ACP-SCT program) for nurses to discuss ACP with chronic kidney disease patients

Detailed description: The ACP-SCT program was including three stages, as follows Stage I: To discuss ACP knowledge and law Objective: Opportunity to share experiences, and develop a mutual understanding of the the challenge of ACPdiscussing with CKD patients.

Stage II: communication skills section and Feedback section Objective: 1. To provide a structured approach to managing ACP discussions. 2. Opportunity to practice communication skills in a safe environment 3. Opportunity to discuss their experiences of the training program, and reflect future on their own practice and experience.

Eligibility criteria: Inclusion Criteria:

* Participants were nephrology nurses and worked at least one year

Exclusion Criteria:

* Non-nephrology nurses

Primary outcomes:
measure: ACP Knowledge Scale
timeFrame: pretest (before training program), Immediate test (after training program), post-test (3 month after training program)
measure: ACP Confidence Scale
timeFrame: pretest (before training program), Immediate test (after training program), post-test (3 month after training program)
Secondary outcomes:
Other outcomes:
Locations:
city: Pingtung
country: Taiwan
facility: Tajen University
state: Yanpu Township
Study officials:
affiliation: Tajen University
name: Jui-O Chen, Mater
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen JO, Chang SC, Lin CC. The development and pilot testing of an ACP simulation-based communication-training program: Feasibility and acceptability. PLoS One. 2021 Aug 24;16(8):e0254982. doi: 10.1371/journal.pone.0254982. eCollection 2021.
Clinical trial NCT05025995: The Effect of a Serious Health Game on Children's Eating Behavior
Official title: Can Garfield Make Children Eat Healthier? A Cluster-randomized Controlled Trial to Examine the Effect of a Serious Health Game on Children's Eating Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behavior
Lead sponsor: Tilburg University
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 157
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Background: Currently the dietary intake patterns of children do not meet the prescribed dietary guidelines. Consequently childhood obesity is one of the most serious health concerns. Therefore, innovative methods need to be developed and tested in order to effectively improve the dietary intake of children. Learning children how to cope with the overwhelming number of unhealthy food cues could be conducted effectively by serious health games.

Objective: The main aim of this study was to examine the effect of a serious health computer game on young children's eating behavior and attitudes towards healthy and unhealthy foods.

Methods: A cluster-randomized controlled trial with a between-subject design was conducted (N=157; 8-12 years), whereby children played a game that promoted a healthy lifestyle or were in the control condition. Children in the control condition attended regular classes and did not play a game. The game was designed in collaboration with researchers and pilot-tested before conducting the experiment among a group of children repeatedly. After one week of playing, attitudes towards food snacks and actual intake was assessed, whereby children could eat at libitum from fruits or energy-dense snacks.


Eligibility criteria: Inclusion Criteria:

* primary school between group 5 and 8

Exclusion Criteria:

* n.a.

Primary outcomes:
measure: calorie intake of energy dense snacks (candy) and fruits (bananas and apples)
timeFrame: 1 week after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Tilburg
country: Netherlands
facility: Tilburg School of Humanities and Digital Sciences
Study officials:
References:
citation: Folkvord F, Haga G, Theben A. The Effect of a Serious Health Game on Children's Eating Behavior: Cluster-Randomized Controlled Trial. JMIR Serious Games. 2021 Sep 2;9(3):e23050. doi: 10.2196/23050.
Clinical trial NCT02544295: Based-virtual Reality Diagnosis for Neuropsychiatric Diseases and Sleep/Wake Disorders
Official title: Based-virtual Reality Diagnosis for Neuropsychiatric Diseases and Sleep/Wake Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Addiction
Attention Deficit Disorder With Hyperactivity
Sleep Disorders
Anxiety
Depression
Attention Deficit
Lead sponsor: University of Bordeaux
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 590
Sex: ALL
Minimum age (years): 7
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The objective of this research is to develop original virtual reality scenarios and/or new virtual reality equipments to evaluate or diagnose pathologies, such as attention deficit disorders or neuropsychiatric pathologies, addiction, anxiety or depression or pathologies interfering with sleep/wake disorders.

Detailed description: Nature of the trial: without direct individual benefit study conducted in healthy volunteers, patients with attention disorders : ADHD (Attention Deficit Disorder / Hyperactivity) and cognitive aging, addictive disorders, anxiety disorders, depressive disorders or pathologies that interfere with sleep/wake cycle. The duration of the study is 8 years.

Type of trial: Comparison of two parallel groups of healthy volunteers and patients with attention disorders, addictive, anxious, depressive or interfering with sleep/wake cycle.

Study design:

* standardized clinical interview with a sleep specialist, psychiatrist, or psychologist and rating scales,
* a virtual reality task. The primary outcome is to evaluate the diagnosis accuracy and the acceptability of the virtual tool to the referent standard (clinical interview and scales).

The secondary outcomes are:

* The comparison of healthy subjects and patients performances
* Tolerance, acceptability to exposure to virtual scenarios.

Eligibility criteria: Inclusion Criteria:

* Being aged between 7 and 75 years
* Having signed written informed consent

Exclusion Criteria:

* Having participated to a clinical trial in the previous 3 months

Primary outcomes:
measure: Presence or absence of the disease
timeFrame: 1 day
Secondary outcomes:
measure: Sleepiness scale
timeFrame: 1 day
measure: BDI-II questionnaire
timeFrame: 1 day
measure: IDS-R questionnaire
timeFrame: 1 day
measure: Acceptability scale
timeFrame: 1 day
measure: ASRS
timeFrame: 1 day
measure: Physiological parameters: Polysomnography (total sleep time (min))
timeFrame: 1 night
measure: Physiological parameters: Polysomnography (sleep structure (stage %))
timeFrame: 1 night
measure: Physiological parameters: Polysomnography (Apnea/Hypopnea index and Periodic movements index (events/hr))
timeFrame: 1 night
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital of Bordeaux
Study officials:
affiliation: University of Bordeaux
name: Pierre PHILIP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02523495: The Clinical Outcome and the Exploration of Related Biomarkers of Target Therapy in Metastasis Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neoplasms, Therapy-Associated
Keywords: Molecular Targeted Therapy
metastasis colorectal cancer
biomarker
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Metastasis colorectal cancer patients in Chinese Han population

Brief summary: Through clinical observation and data statistics, conclude the clinical outcome of target therapy in metastasis colorectal cancer and explore some biomarkers that relate to target therapy.

Detailed description: 1. Establish a clinical database of patients who are diagnosed with metastasis colorectal cancer in tongji hospital.
2. Build a biological specimen banks of metastasis colorectal cancer through collecting blood samples from those patients who have reached an agreement with us.
3. Through clinical observation and data statistics, conclude the clinical outcome of target therapy in metastasis colorectal cancer.
4. To extract DNA from the blood and explore some biomarkers that related to target therapy in metastasis colorectal cancer.

Eligibility criteria: Inclusion Criteria:

1. Metastasis colorectal cancer confirmed by histologically and radiography
2. Receive target therapy over half a year
3. Have a measurable lesions

Exclusion Criteria:

1. A history of other malignant tumors in five years

Primary outcomes:
measure: overall survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT05798195: Traditional Chinese Medicine or Low-dose Dexamethasone in COVID-19 Pneumonia
Official title: Traditional Chinese Medicine or Low-dose Dexamethasone in Symptomatic Patients With Post-COVID-19 Parenchymal Lung Abnormalities: a Randomized Controlled Trial Three Arm, Parallel Group, Single Blind, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19 Pneumonia
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 420
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: The goal of this type of clinical trial is to learn about symptomatic patients with post-COVID-19 parenchymal lung abnormalities. The main questions it aims to answer are: the efficacy and safety of low-dose dexamethasone or traditional Chinese medicine in symptomatic patients with post-COVID-19 parenchymal lung abnormalities.

Participants will be divided into three parallel groups：controlled group with conventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc. dexamethasone group: dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine. Chinese medicine group: Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of COVID-19 pneumonia；
* 3 to 8 weeks after the onset of the first symptoms of COVID-19 infection;
* Modified Medical Research Council (mMRC) score ⩾2 or hypoxemia;
* Imaging severity assessment of pneumonia: CT severity scores (CTSS):≥5；
* Signed the informed consent.

Exclusion Criteria:

* Participants still admitted to intensive care unit at the time of enrollment;
* Known prior structural lung disease, including pulmonary fibrosis, severe COPD, severe bronchiectasis, and lung destruction;
* Taking glucocorticoids or immunosuppressants because of other chronic diseases;
* Contraindications of glucocorticoid;
* Heart failure(NYHA III or IV);
* Participants with renal replacement therapy;
* Psychiatric disorders or cognitive impairments;
* The expected survival time is less than six months due to diseases other than COVID-19 pneumonia.

Primary outcomes:
measure: Lung CT scan
timeFrame: 1 month
Secondary outcomes:
measure: Lung CT scan
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: Department of Respiratory and Critical Care Medicine
name: Zhenguo Zhai, Dcotor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04278495: The Effect of Losartan on the Recoverability of Renal Function in Anuric and Oliguric Patients With Unilateral Obstructed Kidney
Official title: The Effect of Losartan on the Recoverability of Renal Function in Anuric and Oliguric Patients With Unilateral Obstructed Kidney: A Double Blind Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Losartan Adverse Reaction
Uropathy
Uropathy Obstructive
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 96
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: Previous experimental studies concluded that angiotensin receptor blockers can ameliorate the harmful inflammatory and histological changes after relief of obstruction. Nevertheless, these witnessed effects have not been yet translated into the clinical practice.


Eligibility criteria: Inclusion Criteria:

* anuric and oliguric patients
* calculuar ureteral obstruction

Exclusion Criteria:

* anomalous kidney
* bilateral obstructed kidney
* history of recent use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors
* ASA score of \>3

Primary outcomes:
measure: Renographic glomerular filtration rate of the affected kidney.
timeFrame: 3 months
Secondary outcomes:
measure: Serum creatinine change
timeFrame: 3 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and nephrology center
state: Outside U.S./Canada
Study officials:
affiliation: Mansoura University
name: Ahmed Shokier
role: STUDY_CHAIR
References: