louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02370147: Very Brief Smoking Reduction Intervention
Official title: The Effect of Very Brief Smoking Reduction Intervention in Smokers Who Having no Intention to Quit: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking reduction intervention
no intention to quit
randomized controlled trial
telephone follow-up intervention
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2015-02-24
Enrollment: 500
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: HEALTH_SERVICES_RESEARCH

Brief summary: A two-arm randomized controlled trial for smokers who are not intent to quit smoking will be proposed in outpatient department clinics of People's Liberation Army General Hospital in Beijing, China. Smoking reduction intervention arm (SRI) consisting of a very brief face-to-face individual smoking reduction intervention lasted about one minute, and five follow-up interventions lasted for about minute each. Control arm (EDA) consisting of a very brief face-to-face individual exercise and dietetic advices lasted for the same intervention time as SRI, and also five follow-up interventions lasted for one minute each with different intervention contents.


Eligibility criteria: Inclusion Criteria:

1. Aged ≥18 years old;
2. Smoked more than 10 cigarettes per day in the past month.
3. Have no intent to smoking cessation now.
4. Agreed to participate in the follow-up, offer telephone number and signed an informed consent form.

Exclusion Criteria:

1. Smoked less than 10 cigarettes per day in the past month.
2. Had some diseases that let the physician think that it would be unethical not to advise him to quit smoking as soon as possible.
3. Cognitively impaired (such as those with deafness or who could not understand and complete the questionnaire reliably).
4. Pregnant females.

Primary outcomes:
measure: self-reported 7-day point prevalence quit rate
timeFrame: at 12 months follow-up
measure: prolonged abstinence quit rate
timeFrame: at 12 months follow-up
Secondary outcomes:
measure: smoking reduction rates
timeFrame: baseline and at 12 months follow-up
Other outcomes:
Locations:
Study officials:
References:
citation: Wu L, He Y, Jiang B, Zhang D, Tian H, Zuo F, Lam TH, Cheung YT. The effect of a very brief smoking-reduction intervention in smokers who have no intention to quit: study protocol for a randomized controlled trial. BMC Public Health. 2015 Apr 25;15:418. doi: 10.1186/s12889-015-1749-7.
Clinical trial NCT05972447: Ultra-wide Diameter Implants in Mandibular Molars
Official title: Evaluation of Immediately Placed Ultra-wide Diameter Implant Placed in Mandibular Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Keywords: UWD implants
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this \[clinical trial\] is to \[To evaluate both the clinical and radiographical outcome on osteointegration and peri-implant bone density when using ultra wide diameter implant placed immediately in molar extraction socket\]

Detailed description: the aim of this study is to evaluate the clinical and radiographical outcomes on osseointegration and peri-implant bone density when using 12 ultrawide diameter dental implants placed immediately in 12 patients after atraumatic extraction of non-restorable mandibular molars without raising a flap or using bone grafts.

Eligibility criteria: Inclusion Criteria:

Adult patients ranging from 20-40 years.

* Adequate bone beyond teeth apices without jeopardizing any anatomical structure.
* Non-restorable mandibular molar teeth.
* Available bone with adequate width and buccolingual dimensions.
* Peri-implant bone defect should be 2mm or lesser.

Exclusion Criteria:

* Smokers.
* Medically compromised patients like uncontrolled diabetes and coagulation disorders.
* Tooth with periapical pathosis or bony defects.

Primary outcomes:
measure: the mean value of implant stability
timeFrame: up to 6months
measure: the mean value of peri-implant bone density
timeFrame: up to 9 months
measure: the mean value of Marginal bone loss
timeFrame: up to 9months
measure: the mean of peri-implant probing depth
timeFrame: up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
affiliation: Alexandria University
name: Gaafar N Elhalawani
role: STUDY_DIRECTOR
References:
Clinical trial NCT06531447: First-line Gemcitabine Plus Cisplatin in Locally Advanced (IIIC Stage) Breast Cancer Patients
Official title: First-line Gemcitabine Plus Cisplatin in Locally Advanced (IIIC Stage) Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast cancer
TUBB3 gene
ERCC1 gene
RMM1 gene
Prognosis and predictive
Lead sponsor: The National Center of Oncology, Azerbaijan
Sponsor class: OTHER_GOV
First posted: 2024-08-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the study is to investigate of the prognostics and predictive role of TUBB3 expression in locally advanced breast cancer

Detailed description: Using combination of gemcitabine plus cisplatine as first line treatment patients with locally advanced breast cancer with high TUBB3 expression

Eligibility criteria: Inclusion Criteria:

IIIC stage breast cancer patients

Exclusion Criteria:

Other stages breast cancer patients

Primary outcomes:
measure: Clinical tumor regression rate
timeFrame: 4 months
Secondary outcomes:
measure: Increasing PFS and OS
timeFrame: 5 years and 10 years
Other outcomes:
Locations:
city: Baku
country: Azerbaijan
facility: Elchin Mansurov
Study officials:
affiliation: The National Center of Oncology
name: Elchin Mansurov, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02992847: Evaluation of Potential Accumulation of Gadolinium (Dotarem and Multihance) in the French Observatory of Multiple Sclerosis (Www.Ofsep.Org/)
Official title: Evaluation of Potential Accumulation of Gadolinium (Dotarem and Multihance) in the French Observatory of Multiple Sclerosis (Www.Ofsep.Org/)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Gadolinium based contrast agent
MRI
Dentate nucleus
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Guerbet
First posted: 2016-12-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the French observatory of multiple sclerosis (www.ofsep.org/)

Brief summary: Several recent studies have shown an increase in the signal intensity of the unenhanced T1-weighted magnetic resonance images in the brain of patients with normal renal functions and a breakdown of the blood-brain barrier. This hyper-intensity was specifically related to an accumulation of gadolinium based contrast agent. These studies were mainly conducted in patients with primary or secondary brain tumor. Multiple sclerosis is a particular model since it involves patients with a break of the blood-brain barrier, a long life expectancy, and who received many injections of contrast enhancing agents. In this context, it appears fundamental to know whether contrast agents accumulate in the brain for this disease. The French Observatory of Multiple Sclerosis is particularly suited to test this hypothesis, with homogeneous MRI data over several centers in France, and optimized sequences of 3D-T1 without injection. The purpose of this study is to evaluate the accumulation of two commonly used gadolinium based contrast materials (Dotarem and Multihance) in patients with multiple sclerosis, who received at least 5 injection of exclusively one of these contrast material.


Eligibility criteria: * Inclusion Criteria:
* Clinical diagnosis of Multiple sclerosis
* At least 5 MR imaging with the same Gadolinium based contrast agent (either Dotarem or Multihance)
* Have performed an unenhanced T1-weighted image before Gadolinium based contrast agent injection according to the OFSEP protocol
* Exclusion Criteria:
* Never experienced other contrast agent then the one specified by the group to which they belong (either Dotarem, or Multihance)

Primary outcomes:
measure: Mean signal intensity in the dentate nucleus, pons, globus pallidus, and thalamus on unenhanced T1-weighted images after unenhanced MRI (magnetic resonance imaging), (no measurement unit)
timeFrame: 12 months after last injection of contrast material for enhanced MR acquisition
Secondary outcomes:
measure: EDSS (Expanded Disability Status Scale) score
timeFrame: 12 months after last injection of contrast material for enhanced MR acquisition
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02671747: Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder
Official title: Pilot Testing for Mind Over Matter: Healthy Bowels, Healthy Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Fecal Incontinence
Accidental Bowel Leakage
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 56
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study is to pilot-test an innovative, combined urinary/bowel continence workshop in two Wisconsin communities. Between 8-15 women with incontinence will be enrolled in each of the two pilot communities and will complete three 90-minute workshop sessions over a 6 week period.

Detailed description: The pilot study will use mixed methods to compare pre- and post-workshop data about urinary and bowel incontinence symptoms and care-seeking from workshop participants as well as information about workshop acceptability from workshop participants and community partners. The study is expected to last 6 months from initial IRB approval through data analysis and workshop revision. This research will provide preliminary data for a larger test of this workshop in four diverse Wisconsin Communities, followed by a randomized, controlled trial and subsequent dissemination research study.

Eligibility criteria: Inclusion Criteria:

* qualifying symptoms in 3 months prior to enrollment

Exclusion Criteria:

* receiving new treatment for qualifying symptoms in 3 months prior to enrollment

Primary outcomes:
measure: urinary incontinence symptoms for participant with bladder symptoms
timeFrame: 3 months after workshop completion
measure: bowel incontinence symptoms for participant with bowel symptoms
timeFrame: 3 months after workshop completion
Secondary outcomes:
measure: geriatric self-efficacy score for urinary incontinence
timeFrame: 3 months after workshop completion
measure: barriers to care-seeking for urinary incontinence
timeFrame: 3 months after workshop completion
measure: barriers to care-seeking for accidental bowel leakage
timeFrame: 3 months after workshop completion
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Heidi Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06584747: Study of Cerebral Vascular Reserve Using Pharmacological Testing With Acetazolamide: A Non-Inferiority Study of PET Method Compared to Conventional Reference Scintigraphy
Official title: Study of Cerebral Vascular Reserve Using Pharmacological Testing With Acetazolamide: A Non-Inferiority Study of PET Method Compared to Conventional Reference Scintigraphy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebrovascular Circulation
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study compares two methods for assessing brain blood flow. PET scan will be use with a drug called Acetazolamide and compare its effectiveness to the standard scintigraphy method. The goal is to see if the PET scan is just as good as the traditional method in measuring how well the brain's blood vessels respond to the drug.


Eligibility criteria: Inclusion Criteria:

* Chronic stenosing cerebral vascular pathology (stenosis \> 70% on Doppler examination or angiography).
* Patient aged over 18 years.
* Patient who has voluntarily agreed to participate in the study and has signed the written informed consent.
* Patient affiliated with a social security system.

Exclusion Criteria:

* Patient with stenosis less than 70% on Doppler examination or angiography.
* Patient with a contraindication to 18F-FDG PET examinations: severe claustrophobia, poorly controlled diabetes during 18F-FDG PET examinations (fasting capillary blood glucose ≥ 11 mmol/L).
* Patient with a contraindication to scintigraphy.
* Patient with an allergy to sulfonamides (Acetazolamide DIAMOX®).
* Patient enrolled in another clinical study with a specified exclusion period.
* Minor patient.
* Patient unable to give informed consent.
* Vulnerable individuals

Primary outcomes:
measure: diagnostic performance of the 18F-FDG PET
timeFrame: 12 months
Secondary outcomes:
measure: contribution of late 18F-FDG PET metabolic information
timeFrame: 12 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine Lacassagne
Study officials:
References:
Clinical trial NCT00842647: Diagnosis of Hepatic Tumors in Cirrhosis: Prospective Validation of the Noninvasive Diagnostic Criteria for Hepatocellular Carcinoma
Official title: Diagnosis of Hepatic Tumors in Cirrhosis: Prospective Validation of the Noninvasive Diagnostic Criteria for Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: Sensitivity
specificity
positive rate
negative rate
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, China
First posted: 2009-02-12
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between July 2006 and July 2009

1. All the patients who receive hepatomy in our department
2. Diagnose as HCC
3. Diagnosis of HCC is confirmed by noninvasive criteria for HCC as used by the American Association for the Study of the Liver guidelines
4. No history of previous treatments
5. No pathological diagnosis before treatment

Brief summary: This study prospectively evaluates the accuracy of the noninvasive diagnostic criteria for hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

1. All the patients who receive hepatomy in our department
2. Diagnose as HCC
3. Diagnosis of HCC is confirmed by noninvasive criteria for HCC as used by the American Association for the Study of the Liver guidelines
4. No history of previous treatments
5. No pathological diagnosis before treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
citation: Bruix J, Sherman M. Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005;42:1208-1236 Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108. Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, et al. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol 2001;35:421-430. Fattovich G, Stroffolini T, Zagni I, Donato F. Hepatocellular carcinoma in cirrhosis: incidence and risk factors. Gastroenterology 2004;127:S35- S50.
Clinical trial NCT01227447: Investigation of the Suburothelial Myofibroblast Network and of Smooth Muscle Function and Control in the Human Urinary Outflow Tract
Official title: Investigation of the Suburothelial Myofibroblast Network and of Smooth Muscle Function and Control in the Continent and Incontinent Human Urinary Outflow Tract
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Incontinence, Overactive Bladder, Stress Urinary Incontinence
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2010-10-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Human tissue from the urinary outflow tract (bladder base and urethra) of patients undergoing cystectomy or radical prostatectomy (for cancer treatment) with pre-operatively documented voiding disorders/incontinence - in particular SUI

Brief summary: The aim is to find out if adreno-muscarinic synergy is present also in human tissues of the urinary outflow tract that have a dual adrenergic-muscarinic receptor fitting. To further characterise morphology and function of the suburothelial myofibroblast network in the human bladder outlet.


Eligibility criteria: Inclusion Criteria:

Tissue will be collected from the operation theatre only after having obtained the patient´s consent and in strictest accordance with histopathological requirements, i.e. after assessment of resection margins. It might be necessary to retrieve the tissue from the pathologist after first pathological assessment is completed. Tissue will be placed in Tyrode´s solution, gassed with 95 % O2 and 5 % CO2, for functional and RT-PCR or Western blot experiments, or in OCT (optimal cutting temperature) compound, snap-frozen in liquid nitrogen, and stored in a -80°C freezer until cutting for immunohistochemical experiments.

Exclusion Criteria:

None.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig Maximilians University Munich, Dep Urology
Study officials:
affiliation: LMU Munich
name: Alexander Roosen, PD Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walther S, Strittmatter F, Hennenberg M, Gratzke C, Stief CG, Roosen A. Adreno-muscarinic synergy in the male human urinary outflow tract. Neurourol Urodyn. 2018 Sep;37(7):2128-2134. doi: 10.1002/nau.23578. Epub 2018 Apr 20.
Clinical trial NCT01051947: Impact of Nebivolol on Central Aortic Pressure
Official title: Impact of Nebivolol on Central Aortic Pressure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Central Aortic Pressure
Keywords: Nebivolol
Metoprolol
central aortic pressure
hypertension
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2010-01-20
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, cross-over, single-blind study to compare the effects of nebivolol and metoprolol on central aortic pressure and peripheral brachial pressure in patients with stable cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* Subjects with history of hypertension
* Subjects who have received metoprolol for a minimum of 3 months

Exclusion Criteria:

* Patients who have had an acute myocardial infarction, coronary revascularization or who have been hospitalized for heart failure or cardiac arrhythmia in the past 6 months

Primary outcomes:
measure: Stable blood pressure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: The Cardiac Center at Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Jennifer Campbell, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04889547: Randomized Controlled Trial Assessing the Effect of Dexamethasone on Postoperative Function After Distal Radius Fixation
Official title: Randomized Controlled Trial Assessing the Effect of Intraoperative Dexamethasone in the Management of Postoperative Analgesia and Stiffness After Distal Radius Fixation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Distal Radius Fracture
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is designed to assess the use of intraoperative dexamethasone on postoperative analgesia and stiffness after open reduction and internal fixation of distal radius fractures. The idea is that the dexamethasone will aid in reducing postoperative swelling which will then improve pain control as well as overall function.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Willingness to comply with study procedures and
* Male or female greater than 18 years old
* American Society of Anesthesia class I/II/III
* Ability to take oral medicine in order to assess opioid regimen postop
* Distal radius open reduction and internal fixation surgery with single incision and volar plate
* Ability to consent for and receive a preoperative upper extremity nerve block by anesthesia

Exclusion Criteria:

* Chronic opioid users
* Prescriptions for selective-serotonin reuptake inhibitors, gabapentin, duloxetine within 3 days of surgery
* History of diabetes and A1C \> 8
* Systemic glucocorticoids within 1 month of study enrollment
* Inability to take ibuprofen or acetaminophen due to allergy or condition
* History of hepatitis
* Pregnancy or lactation
* Allergic to opioids
* Known allergic reactions to components of IV dexamethasone

Primary outcomes:
measure: Patient rated wrist evaluation
timeFrame: 48 hours, 1 week, 2 weeks
Secondary outcomes:
measure: Finger-to-palm distance
timeFrame: 48 hours, 1 week, 2 weeks
measure: Visual analog scale
timeFrame: 48 hours, 1 week, 2 weeks
measure: Total opioid consumption
timeFrame: 48 hours, 1 week, 2 weeks
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
References: