louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05651217: Clinical Study on Disposable Sterile Urinary Catheter
Official title: A Multicenter, Prospective, Randomized Controlled Clinical Study to Evaluate the Safety and Effectiveness of Disposable Sterile Urinary Catheter
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Catheters
Urinary Tract Infection
Lead sponsor: Shandong Branden Med.Device Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2022-12-14
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, randomized controlled study, with the urinary tract infection rate at the time of catheter insertion for 1 week as the primary end point. By comparing the clinical safety and effectiveness of two kinds of urethral catheters, to evaluate the clinical application effect of one kind of urethral catheters.


Eligibility criteria: Inclusion Criteria:

* 18-80 year old patients;
* Retained catheter ≥ 7 days;
* Patients who were conscious and had good communication skills and volunteered to participate in the study.

Exclusion Criteria:

* Pregnant and lactating female patients;
* Diabetes patients;
* Patients allergic to sulfadiazine, silica gel and stainless steel;
* Urethral malformation, acute urethral injury, prostate disease, intermittent catheterization, suprapubic cystostomy and other patients who are not suitable for catheterization;
* Patients who have used urinary catheters for a long time or had catheters retained within one week;
* Patients who are participating in other clinical trials that interfere with this trial.

Primary outcomes:
measure: Urinary tract infection rate
timeFrame: one week
Secondary outcomes:
measure: Success rate of catheterization
timeFrame: 10 minutes after catheterization
measure: level of urethral irritation
timeFrame: 10 minutes after catheterization
measure: level of urethral irritation
timeFrame: 72 hours
measure: level of urethral irritation
timeFrame: one week
measure: Incidence of device related adverse events
timeFrame: 72 hours
measure: Incidence of device related adverse events
timeFrame: one week
measure: time of catheter duration
timeFrame: one week
measure: rating of operation convenience
timeFrame: 10 minutes after catheterization
measure: rate of packaging integrity
timeFrame: 10 minutes after catheterization
measure: rate of device defect rate
timeFrame: 10 minutes after catheterization
Other outcomes:
Locations:
city: Dalian
country: China
facility: Liaoning Cancer Hospital & institute
state: Liaoning
Study officials:
References:
Clinical trial NCT01822717: Nonvisual Foot Inspection for People With Visual Impairment
Official title: Nonvisual Foot Inspection for People With Visual Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Visual Impairment
Keywords: Diabetes
Visual Impairment
Blindness
Foot Care
Self-Management
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: Kent State University
First posted: 2013-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to find out whether a method of nonvisual foot inspection, using the senses of touch and smell, helps people with diabetes and visual impairment to find new foot problems when they are in early, easily-treated stages. All people in the study had regular foot inspections by podiatrists. The results include how people feel about the method, whether they actually did check their feet it, and whether the method helped them to discover foot problems themselves.

Detailed description: Data gathered over the course of 1 year:

* bimonthly phone calls to ask about foot care practices at home over the last week
* a baseline comprehensive foot evaluation and 4 additional comprehensive evaluations every 3 months

Qualitative data:

- Focus groups immediately after comprehensive diabetes self-management education, and 1 year later, to determine acceptability of foot care procedures and patient perceptions about effectiveness

Eligibility criteria: Inclusion Criteria:

* Over age 18
* Diagnosed with diabetes (either type 1 or type 2)
* Having visual impairment

Exclusion Criteria:

* Self-reported numbness in hands
* Inability to pass a brief screening for decisional capacity

Primary outcomes:
measure: Days per week participants performed foot inspection
timeFrame: every 2 months for 1 year
Secondary outcomes:
measure: Number of foot problems discovered
timeFrame: every 3 months for 1 year
Other outcomes:
measure: Acceptability
timeFrame: 1 year
Locations:
city: Cleveland
country: United States
facility: Cleveland Foot and Ankle Institute
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Ann S Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams A. Appraising the Multi-SAFE approach to low vision and diabetes: a simple technique for saving feet. Diabetes Voice 56(Special Issue 1):14-17, 2011
Clinical trial NCT06995417: Discontinuation of Tobacco Dependence in Smoking Patients With Squamous Cell Carcinoma of the Head-neck District: Multicenter Prospective Observational Study
Official title: Discontinuation of Tobacco Dependence in Smoking Patients With Squamous Cell Carcinoma of the Head-neck District: Multicenter Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer of Head and Neck
Keywords: Cancer Head&amp;Neck
Smoker
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 200
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: The study population will be patients with SCCHN who are active smokers, or have quit smoking for less than 30 days, at the time of initiation of the process (visits and instrumental examinations) that led to the cancer diagnosis

Brief summary: The primary objective of our study is to evaluate the effectiveness of a standardized clinical practice counseling strategy for promoting post-diagnosis smoking cessation among patients with SCCHN. Efficacy will be measured as the percentage of patients who succeed in sustained smoking cessation ("sustained quitters," see below) at 6+1 months after enrollment, i.e., after the initiation of anti-smoking counseling.


Eligibility criteria: Inclusion criteria.

* Patients with SCCHN tumors of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, and paranasal sinuses.
* Patients older than 18 years of age with SCCHN of these sites who are candidates for surgical/radiotherapy (RT)/radiochemotherapy (RTCT) treatment with curative intent (primary treatment).
* Patients with SCCHN who are active smokers, or have quit smoking for less than 30 days, at the time of initiation of the process (visits and instrumental tests) that led to the diagnosis of cancer

Exclusion criteria

* Patients with SCCHN cancer who have quit smoking for more than 30 days at the time of initiation of the diagnostic process.
* Patients using only e-cigarettes at the time of initiation of the treatment process.
* Patients with non-SCCHN cancer in recurrent metastatic stage and not eligible for curative purpose therapy.

Primary outcomes:
measure: Effectiveness of a standardized counseling strategy in clinical practice to promote smoking cessation
timeFrame: 6+1 months from enrollment, i.e., initiation of anti-smoking counseling.
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Azienda Ospedaliera Careggi
state: Firenze
Study officials:
affiliation: Aou Careggi
name: LORENZO LL LIVI, MEDICAL DOCTOR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00182117: Pilot Bleeding Study: Risk and Protective Factors Associated With Bleeding in the Hemodialysis Population
Official title: Pilot Bleeding Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bleeding
End Stage Renal Disease
Keywords: bleeding
end stage renal disease
antiplatelet therapy
anticoagulant therapy
hemodialysis
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
First posted: 2005-09-16
Enrollment: 490
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: This study is examining the risk and protective factors associated with bleeding in the hemodialysis population.


Eligibility criteria: Inclusion Criteria:

* Patient is undergoing hemodialysis

Exclusion Criteria:

* This is an observational study. No exclusion criteria required.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
Study officials:
affiliation: Assistant Professor, Medicine
name: Christian G Rabbat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05045417: IL17 in Systemic Lupus Erythematosus Patients: Association With Disease Activity and Organ Damage
Official title: IL17 in Systemic Lupus Erythematosus Patients: Association With Disease Activity and Organ Damage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * The study will include 110 patients with SLE :

  * 40 with lupus nephritis
  * 40 with interstitial lung disease
  * 30 SLE patients without internal organ affection)
* In addition to 30 sex and age matched healthy individuals as a control group

Brief summary: Many laboratory markers can be measured for assessment of Lupus activity as aberrant manufacturing and imbalance of the cytokines of T-helper cell which already have been implicated within autoimmunity pathogenesis as IL-18 and IL-10 levels are usually elevated in lupus sufferers and correlated with SLEDAI score IL-17 has been linked to immune-mediated organ damage in several autoimmune diseases and recently it has been linked to pathogenesis of a murine model of lupus and human lupus Diverse cytokine abnormalities which common in lupus patients may skew T cells differentiation into IL-17-producing CD4+ and double negative T cells. This could promote the autoimmune process by activation of immune cells \&stimulation of proliferation of B-cell and production of antibody


Eligibility criteria: Inclusion Criteria:

* SLE will be diagnosed according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE
* Age ≥ 18 years.
* Patients who are able and willing to give written informed consent

Exclusion Criteria:

-Any other autoimmune disease rather than SLE. -

* Systemic diseases
* Malignancy
* pregnancy

Primary outcomes:
measure: SLE disease activity index (SLEDAI)
timeFrame: 18 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Crispin JC, Tsokos GC. IL-17 in systemic lupus erythematosus. J Biomed Biotechnol. 2010;2010:943254. doi: 10.1155/2010/943254. Epub 2010 Apr 6.
citation: Garrett-Sinha LA, John S, Gaffen SL. IL-17 and the Th17 lineage in systemic lupus erythematosus. Curr Opin Rheumatol. 2008 Sep;20(5):519-25. doi: 10.1097/BOR.0b013e328304b6b5.
citation: Su DL, Lu ZM, Shen MN, Li X, Sun LY. Roles of pro- and anti-inflammatory cytokines in the pathogenesis of SLE. J Biomed Biotechnol. 2012;2012:347141. doi: 10.1155/2012/347141. Epub 2012 Feb 15.
Clinical trial NCT02995317: Who is Falling? - Fall Risk Prediction Among Community Dwelling Elderly.
Official title: The ≥65 Years NOrthern Jutland Cohort of Fall Risk Assessment With Objective Measurements (the NOCfao Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Accidental Fall
Keywords: Aged
Gait
Postural Balance
Accelerometry
Physical Activity
Lead sponsor: University College of Northern Denmark
Sponsor class: OTHER
Collaborators: name: Aalborg Municipality
name: Aalborg University
First posted: 2016-12-16
Enrollment: 600
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be undertaken in Aalborg Municipality at different activity-centers and nursing homes in collaboration with care workers, nurses and staff at the activity centers, all employed at the Department of Elderly and Health. Furthermore the project manager arranges briefing meetings with groups of employees in order to provide clarification of the project and encourage support of the recruitment of the study-population. Participants satisfying the inclusion and exclusion criteria is contacted by the project group, to ensure that they fully understand what it takes to participate. Subsequently, an appointment for completion of the baseline data is made.

Brief summary: The purpose of this study is to investigate if the level of physical activity, selected physical and psychological risk factors can predict risk of falling in older (≥65) community dwellers.


Eligibility criteria: Inclusion Criteria:

* Home dwelling
* Manage body transfer independently
* Walking ability for at least 10 meters with or without assistive devices

Exclusion Criteria:

* Progressive neurological or rheumatologically illness
* Diagnosed vestibular problems
* Experienced pain in a substantial degree, limiting or obstructing everyday living
* Known uncorrected visual or hearing problems.
* Serious difficulties in speaking, understanding or reading Danish.
* Cognitive impairment equivalent to Mini Mental State Examination \< 23

Primary outcomes:
measure: Self-reported number of falls confirmed by monthly phone calls
timeFrame: One year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: University College of Northern Denmark
Study officials:
affiliation: University College of Northern Denmark
name: Bo Grarup
role: PRINCIPAL_INVESTIGATOR
References:
citation: Villumsen M, Grarup B, Christensen SWMP, Palsson TS, Hirata RP. "Study protocol for the >/=65 years NOrthern jutland Cohort of Fall risk Assessment with Objective measurements (the NOCfao study)". BMC Geriatr. 2020 Jun 8;20(1):198. doi: 10.1186/s12877-020-01535-6.
Clinical trial NCT03917017: The Evaluation of Surgical Decisions and Prognosis of the Radiomics and Watson Artificial Intelligence in Patients With Hepatocellular Carcinoma
Official title: The Evaluation of Surgical Decisions and Prognosis of the Radiomics and Watson Artificial Intelligence in Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Resection
Keywords: radiomics
Watson artificial intelligence
hepatocellular carcinoma
surgical decisions
prognosis
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the surgical decisions and prognosis of the radiomics and Watson artificial intelligence in patients with hepatocellular carcinoma.

Detailed description: Hepatectomy is an effective treatment for patients with hepatocellular carcinoma, but liver failure after hepatectomy may lead to increased postoperative mortality.Therefore, it is very important to make preoperative surgical decisions, evaluate the safety of the operation and identify which patients are likely to suffer from liver failure.Imaging omics is a newly emerging research method in recent years, which has great potential in cancer diagnosis and treatment, and can monitor treatment and predict the prognosis of patients, so as to better realize accurate diagnosis and treatment of diseases.The artificial intelligence platform developed by IBM Watson for Watson tumor treatment decisions can provide treatment decisions and corresponding theoretical basis to guide surgical decisions based on the key clinical data of liver cancer patients.

Eligibility criteria: Inclusion Criteria:

1. 18 years≤ Age ≤80 years
2. Compling with the diagnosis criteria of complex hepatic carcinoma.
3. Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled
4. Preoperative liver function is Child - Pugh grade A or B.
5. The patients are volunteered for the study.

Exclusion Criteria:

1. Patients with mental illness.
2. Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.)
3. The patients refused to take part in the study.
4. There are other co-existed malignant tumors.
5. Benign liver diseases.
6. Indocyanine green allergy

Primary outcomes:
measure: Postoperative survival
timeFrame: 5 years
Secondary outcomes:
measure: Disease-free survival
timeFrame: 5 years
Other outcomes:
measure: Intraoperative blood loss
timeFrame: intraoperative
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: China, Guangdong Zhujiang Hospital of The Southern Medical University
name: Chihua Fang, M.D;Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00828217: Adapted Physical Activity, Health-related Quality of Life and Satisfaction With Care in Hospitalized Children
Official title: ACTIVHOP: Adapted Physical Activity, Health-related Quality of Life and Satisfaction With Care in Hospitalized Children; a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hospitalization
Keywords: adapted physical activity
hospital
health-related quality of life
satisfaction with care
child
adolescent
randomized controlled trial
physical activity
quality of life
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: University of Nancy
name: Association pour la promotion du sport chez l'enfant malade (APSEM)
First posted: 2009-01-23
Enrollment: 312
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study is to assess the efficacy of adapted physical activity intervention on health-related quality of life and satisfaction with care in hospitalized children and adolescents.

This is a randomized controlled study. The hypothesis is that children practicing adapted physical activity during their hospitalization present a higher health-related quality of life and satisfaction with care than those who do not.


Eligibility criteria: Inclusion Criteria:

* Length of hospital stay (more than 3 days)
* Children or parents able to understand and read French
* No medical contra-indications to physical activity
* Children hospitalized in 3 specific departments at Nancy Children's Hospital:

  * Médecine Infantile 1 et 3(paediatrics)
  * Médecine Infantile 2 (haematology-oncology, immunology department)
  * Chirurgie orthopédique et Brûlés (orthopaedic surgery and Burned)
* Children and parents being agree to participate in the study

Exclusion Criteria:

* No written informed consent
* Children hospitalized less than 3 days
* Medical contra-indication to physical activity
* Children already included in that study (former hospitalization)

Primary outcomes:
measure: health-related quality of life measurement
timeFrame: 2 points: on the first and last day of hospitalization
Secondary outcomes:
measure: satisfaction with care measurement
timeFrame: 1 point: 15 days after hospital discharge
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: University Hospital, Children's Hospital
Study officials:
affiliation: University Hospital of Nancy, Children's Hospital
name: Pascal Chastagner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nancy-University, Paul Verlaine Metz University, Paris Descartes University, EA4360 Apemac, Nancy, France
name: Serge Briançon, Pr
role: STUDY_CHAIR
affiliation: Nancy-University, Paul Verlaine Metz University, Paris Descartes University, EA4360 Apemac, Nancy, France
name: Anne Vuillemin, PhD
role: STUDY_CHAIR
affiliation: APSEM
name: Aline Herbinet, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06519617: Study on Optimization and Evaluation of Integrated Chinese and Western Medicine for pSS Glandular Damage
Official title: Study on Optimization and Evaluation of Integrated Chinese and Western Medicine for Primary Sjogren's Syndrome Glandular Damage
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Primary Sjögren Syndrome
Keywords: randomized controlled trial
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The treatment group received an optimized program combining Chinese and Western medicine for pSS glandular injury, while the control group received a conventional program for pSS glandular injury.
Primary purpose: TREATMENT

Brief summary: ChatGPT In a randomized controlled trial, 136 patients with primary Sjögren's syndrome (pSS) meeting the inclusion criteria were enrolled and randomly divided into two groups of 68 each. The treatment group received an optimized program combining Chinese and Western medicine for pSS glandular injury, while the control group received a conventional program for pSS glandular damage. The primary efficacy endpoint was the 12-week non-stimulated salivary flow rate (UWS) score. Secondary efficacy endpoints included the glandular damage Visual Analog Scale (VAS) scores, the European Sjögren's Syndrome Patient Reported Index (ESSPRI), among others. The treatment course lasted 12 weeks. The efficacy and safety of the optimized program for pSS glandular injury were evaluated by comparing within and between groups before and after treatment.


Eligibility criteria: Inclusion Criteria:

* 1. clinical diagnosis of pSS and qi and yin deficiency ; 2.Sign the informed consent form.

Exclusion Criteria:

* 1. pSS activity system damage (ESSDAI score ≥5); 2. Combined connective tissue diseases other than pSS; 3. Pregnant or lactating women; 4. severe cardiovascular and cerebrovascular diseases, liver and kidney failure, and severe malignant tumors; 5. taking psychotropic drugs; 6. assessed by the investigator to be ineligible for enrollment.

Primary outcomes:
measure: UWS score
timeFrame: 12 weeks after treatment
Secondary outcomes:
measure: VAS score
timeFrame: 12 weeks after treatment
measure: ESSPRI
timeFrame: 12 weeks after treatment
measure: Schirmer test
timeFrame: 12 weeks after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan friendship hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Qingwem Tao
role: STUDY_CHAIR
References: