louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05522686: The Effect of Different Education Methods Before Invasive Urodynamics
Official title: The Effect of Different Education Methods Before Invasive Urodynamics on Patients' Anxiety, Pain, Readiness for the Procedure, and Satisfaction Levels: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urologic Diseases
Urodynamics
Keywords: pain
anxiety
satisfaction
readiness
patient education
nursing
urodynamics
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Clinical Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: This study was carried out to compare the effects of different education methods utilized before a urodynamic testing procedure on patients' pain, anxiety, readiness for the procedure, and satisfaction.

Background: Urodynamic testing is an invasive procedure that causes pain and anxiety. Patient education is an evidence-based nursing intervention that relieves pain and anxiety and increases patient satisfaction.

Design: The study is a single-center, randomized controlled clinical trial. Method: Participants (n=80) were randomly assigned to four groups. While patients in the control group were provided with routine clinical information, patients in the intervention group were given education with brochures, videos, and brochure-supported videos. The research data were collected by using a Data Collection Form with items about participants' descriptive characteristics, the State Anxiety Inventory, and the Visual Analog Scale.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years of age,
* Had urodynamics for the first time,
* Had no communication problems,
* Volunteered to participate in the study

Exclusion Criteria:

* Had major hearing, vision, and speech impairments,
* Used antidepressants, or anxiolytic drugs,
* Had an indwelling urinary catheter,
* Used any analgesic in the 24 hours before coming to the urodynamic laboratory

Primary outcomes:
measure: Change from Anxiety
timeFrame: baseline (before education), pre-urodynamics and immediately after urodynamics
measure: Change from Pain
timeFrame: baseline (before education), pre-urodynamics and immediately after urodynamics
measure: Change from Readiness for the Procedure
timeFrame: baseline(before education) and pre-urodynamics.
measure: Satisfaction management
timeFrame: immediately after urodynamics
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Esra Özden
Study officials:
affiliation: Gulhane Training and Research Hospital
name: esra özden
role: STUDY_CHAIR
References:
Clinical trial NCT01574586: Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience
Official title: A Multicenter, Randomized Trial to Compare 2 Link Nobori and 3 Link Xience Stents in Bifurcation Stenting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Stenosis
Keywords: True Bifurcation stenosis
Lead sponsor: Kurashiki Central Hospital
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to make a comparison of safety and efficacy of DESs with different link number (2-link Nobori and 3-link Xience) in patients with de novo true bifurcation lesions.

The minimum lumen diameter of the side branch ostium in bifurcation at 8 months and the MACE rate until one year after PCI will be assessed in both groups.


Eligibility criteria: Inclusion Criteria:

1. Patient eligible for percutaneous coronary intervention
2. Patient or substitute decision-maker willing to provide written informed consent, which is approved by the Institutional Review Board or its equivalence
3. De novo stenosis at coronary bifurcation with up to two vessels (visually estimated diameter stenosis ≥50%)
4. Second vessel at coronary bifurcation treatable with trial device during the procedure
5. True coronary bifurcation, ≥50% diameter stenosis in both the main and side branches, belonging to the Medina classes 1.1.1, 1.0.1, and 0.1.1,
6. Visually estimated target lesion reference vessel diameter, 2.5-5.0 mm in the main branch, ≥2.25 mm in the side branch
7. Target lesion treatable with one or two stents in both the main and side branches
8. Consensus of PCI after discussion between cardiologists and cardiac surgeons for the lesion in the left main coronary artery
9. Thrombolysis in Myocardial Infarction grade ≥1 flow in both the main and side branches

Exclusion Criteria:

A. General restrictions

1. Unable to be followed by the implementing medial institution
2. Life expectancy \<1 year
3. Acute myocardial infarction (\<1 week)
4. Left ventricular ejection fraction \<30%
5. Scheduled for elective treatment requiring antiplatelet drug Withdrawal
6. Deemed as unsuitable by the investigator or subinvestigator
7. Serum creatinine level ≥2.0 Mg/dl

B. Vascular morphological restrictions

1. Lesion proximal to coronary artery bypass graft anastomotic site (visual estimation ≤5.0 mm) or including a part of coronary artery bypass grafting
2. In-stent restenosis
3. Severe calcification

Primary outcomes:
measure: Minimum lumen diameter of the side branch ostium in bifurcation
timeFrame: 8 months
Secondary outcomes:
measure: Incidence of MACE
timeFrame: in-hospital, 30 days, 8 months, 1 year
Other outcomes:
Locations:
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
Study officials:
References:
Clinical trial NCT05380986: Camrelizumab Combined With Apatinib Mesylate
Official title: A Real World Study of Camrelizumab Combined With Apatinib Mesylate in Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solid Tumor
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2022-05-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to observe the safety of camrelizumab combined with apatinib mesylate in the treatment of solid tumors

Detailed description: According to current studies, the combination of camrelizide and apatinib mesylate has significant efficacy and controllable toxicity in the treatment of solid tumors.

This study adopted camrelizumab combined with apatinib mesylate in the treatment of solid tumors, aiming to further explore the safety of camrelizumab combined with apatinib mesylate in the treatment of solid tumors and provide more research data for the treatment of solid tumors.

Eligibility criteria: Inclusion Criteria:

1. Age: ≥18 years old, male or female;
2. ECOG score is 0\~2;
3. Patients with solid tumors confirmed by pathology or histology;
4. At least one measurable lesion (according to RECIST V 1.1);
5. For patients who have failed first-line or second-line treatment or who cannot tolerate standard treatment regimens for solid tumors.
6. Estimated survival ≥3 months;
7. Patients who have used immunosuppressants or antiangiogenic drugs in the past are not excluded;
8. For women who have not undergone menopause or surgical sterilization, agree to abstain from sex or use an effective contraceptive method during treatment and for at least 7 months after the last dose given in study treatment;
9. Researchers think they can benefit;
10. Voluntarily participate in the study and sign the informed consent;

Exclusion Criteria:

1. Pregnant or lactating women;
2. Except patients with contraindications to camrelizumab and/or apatinib mesylate, that is, those allergic to camrelizumab and its excipients; Allergic to apatinib mesylate should be prohibited; It should be contraindication for patients with active bleeding, ulcers, intestinal perforation, intestinal obstruction, hypertension beyond drug control within 30 days after major surgery, class III-IV cardiac insufficiency (NYHA standard), and severe hepatic or renal insufficiency (Class 4).
3. Those deemed unsuitable for inclusion by doctors;
4. The researchers determined there was a high risk that the tumor would invade important blood vessels and cause fatal hemorrhages during the follow-up study

Primary outcomes:
measure: AE
timeFrame: up to 2 years
Secondary outcomes:
measure: Objective response rate
timeFrame: up to 2 years
measure: Disease control rate
timeFrame: up to 2 years
measure: Overall survival
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Henan
country: China
facility: Henan Tumor Hospital
Study officials:
References:
Clinical trial NCT02013986: Effects of Etomidate on Postoperative Circadian Rhythm Changes of Salivary Cortisol in Children
Official title: Phase 1 Study of Circadian Rhythm of Salivary Cortisol in Health Children ;Phase 2 Study of Circadian Rhythm of Salivary Cortisol of Children Undergoing Surgery Using Etomidate or Not Using Etomidate.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Congenital Hydronephrosis
Congenital Choledochal Cyst
Fracture
Keywords: salivary cortisol
circadian rhythm
children
etomidate
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Etomidate is an unique drug used for induction of general anesthesia and sedation. Adrenal cortical inhibition by etomidate has received much attention. However wether the circadian rhythm and pulse secretion pattern of cortisol in children are the same as that in adults is not known. Moreover, the effect of etomidate on circadian rhythm changes and clinical outcomes has never been carefully studied in children undergoing surgery. Our hypothesis is that etomidate can relieve the changes of circadian rhythm of salivary cortisol in children for 24-48 hours，and this does not make clinical outcomes worse postoperatively.

Detailed description: * Sample size assessment: Using formula to calculate the total number is 30.
* Statistical analysis: ANOVA
* Reporting for adverse events: During the period of study, if there is any severe adverse event happening, such as severe infection, severe low cortisol concentration threatening the patient's life we will stop the trial.

Eligibility criteria: Inclusion Criteria:

* 3-12 years old who are plan to undergo surgery

Exclusion Criteria:

* endocrine disease, blood infusion, having fever, ulcer or bleeding in the oral cavity

Primary outcomes:
measure: Change from baseline in salivary cortisol at the operative day
timeFrame: baseline(8am), 8pm
measure: Change from baseline in salivary cortisol at the first day after surgery
timeFrame: baseline(8am), 8pm
Secondary outcomes:
measure: Numbers of Acquired Infection Events
timeFrame: up to 10 days after surgery
measure: Numbers of using inotropic drugs
timeFrame: within 3 days
measure: Days of stay in intensive care unit (ICU) after surgery
timeFrame: up to 10 days after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: department of anesthesia of Xinhua Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Wng Y Wei, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02888886: Role of Systemic Inflammation in Increase of Cardio-vascular Risk in Chronic Obstructive Pulmonary Disease
Official title: Role of Systemic Inflammation in Increase of Cardio-vascular Risk in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: systemic inflammation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 89
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose is to study the correlation between systemic inflammation (serum levels of CRP, IL-1beta, IL-6 and TNF-alpha) or hyperhomocysteinemia and the increase of mortality, in a representative cohort of patients with chronic obstructive pulmonary disease (COPD).

Secondary purposes are:

1. To confirm the increase of cardiovascular mortality and the importance of cardiovascular morbidity in patients with COPD,
2. To establish the role of various genetic polymorphisms in the correlation between systemic inflammation and cardiovascular disorders observed in COPD,
3. To search for acceleration of aging of cardiovascular system evaluated with carotid intima-media thickness when systemic inflammation markers are increased,
4. To study the correlation between COPD risk factors (tobacco and other food factors), change of respiratory functional data and cardiovascular morbi-mortality. In this study cardiovascular morbi-mortality is defined by following disorders: ischemic cardiopathy, left-sided heart failure, cardiac arrhythmia and cerebrovascular accident. Diagnosis is confirmed with standard techniques and independently of this study. Results of clinical examination, ECG, echocardiography and /or brain scanner will be collected.


Eligibility criteria: Inclusion Criteria:

* Actual or past active smoking of at least 20 packets/year
* FEV1/FVC \< 70%

Exclusion Criteria:

* Co-morbidity except essential arterial hypertension controlled by treatment, stable coronary disease, type 2 diabetes and/or degenerative arthropathy (non-inflammatory rheumatic disorder)
* Acute disorder during 8 weeks before inclusion, especially COPD worsening
* Long-term corticosteroid or non-steroid anti-inflammatory treatment

Primary outcomes:
measure: Mortality
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Service des Maladies Respiratoires et Réanimation Respiratoire- Hôpital de Brabois- CHRU de Nancy
name: Ari CHAOUAT, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00556686: Salivary Catecholamines in Aphthous Stomatitis (Canker Sores)
Official title: Salivary Catecholamines in Aphthous Stomatitis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Canker Sore
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2007-11-12
Enrollment: 0
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: All subjects will be sampled from the community.

Brief summary: The purpose of this study is to examine how compounds produced in patients with canker sores affect wound healing.

Detailed description: The purpose of this study is to determine if salivary catecholamines are elevated in patients with the disease aphthous stomatitis. The results of this study will be combined with those performed in collaboration with a co-Investigator to understand the effects of catecholamines on mucosal wound healing and oral epithelial cell migration.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older, both genders
* History of recurrent aphthous ulcers with 4 or more episodes per year

Exclusion Criteria:

* History of salivary gland disease including Sjogren's disease, parotitis, and sialolithiasis
* History of benign or malignant salivary gland tumor
* History of celiac disease, ulcerative colitis or Crohn's disease
* Patients on medications that affect salivary flow such as anti-depressants and anti-cholinergic medications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Davis
name: Nasim Fazel, MD, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01301586: A Novel Combination Oral Agent to Treat Acne Vulgaris
Official title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL ORAL ACNE TREATMENT FOR THE TREATMENT OF ACNE VULGARIS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: ACNE VULGARIS
Lead sponsor: Nexgen Dermatologics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate a novel, combination product for the treatment of acne vulgaris in females


Eligibility criteria: Inclusion Criteria:

* Healthy females 13 years of age or older
* Non-pregnant, non-lactating females
* Signed written informed consent form
* Must be able to understand and be willing to follow all study instructions
* Have a clinical diagnosis of acne vulgaris

Exclusion Criteria:

* Female subjects who are pregnant or nursing
* Any concomitant dermatologic condition that may affect outcome measures
* Concurrent use of any other medication to treat acne vulgaris
* Have a history or clinical evidence of any other active acute or chronic medical disease or condition considered by the principal investigator as unsuitable for the study
* Are currently using any other investigational agent or device
* Have participated in any other clinical study within 90 days prior to enrollment
* Employees or family members of sponsor or research site

Primary outcomes:
measure: The mean number of Inflammatory Lesions on the face at the beginning and end of treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: The mean number of Comedones will be evaluated at the beginning and end of treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rolling Hills Estates
country: United States
facility: Palos Verdes Dermatology Associates
state: California
city: Boynton Beach
country: United States
facility: Berlin Center
state: Florida
Study officials:
affiliation: Study Protocol, Inc.
name: Joshua M Berlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00242086: Comparison of Triphasic CT, PET and MR Tumour With Pathological Findings in Colorectal Cancer Liver Metastases
Official title: Comparison of Triphasic CT, CT/PET and MR Defined Gross Tumour With Pathological Findings in Patients With Colorectal Cancer Liver Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Metastases
Colorectal Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-10-19
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to correlate the MRI CT and PET appearances of colorectal liver metastases to pathologic appearance ot better understand the accuracy of imaging to determine tumor size.

Detailed description: The purpose of this study is to correlate the MRI CT and PET appearances of colorectal liver metastases to pathologic appearance ot better understand the accuracy of imaging to determine tumor size.

Eligibility criteria: Inclusion Criteria:

* liver metastases from colorectal cancer undergoing liver resection

Exclusion Criteria:

* contraindication to CT, MRI or PET

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Masoom Haider, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02745886: Metformin Induces a Dietary Restriction-like State in Human
Official title: Chronic Metformin Treatment Induces a Dietary Restriction-like State in Overweight Human
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Overweight Subjects
Metformin
Aging
Lead sponsor: Wuhan General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The fact that metformin treatment has been associated with reduced risk of cancer and cardiovascular disease raises the possibility of a beneficial role of metformin for other age-related diseases. The actions of metformin resemble the effects of calorie restriction (CR) to some extent, and microarray analyses have shown that metformin induces a gene expression profile that aligns with that of CR in animal. The aim of the study is to investigate whether metformin treatment can induce dietary restriction-like state in human.

Sixty overweight subjects will be included in this study, and participants will be divided 3 groups (20 cases in each group)including metformin group (0.85, twice daily), standard diet group, and CR group. All subjects will be treated 6 months. At the end of this study, blood samples and muscle samples will be obtained.

Detailed description: Blood samples will be obtained from all individuals. blood lipids, inflammation markers, insulin, glucose, leptin,adiponectin, ala aminotransferase, asp aminotransferase, creatine phosphokinase,lactate dehydrogenase, alkaline phosphatase,bilirubin, cyclo-oxygenase, citrate synthase, renal function, leukocyte telomere length ratio, and telomerase activity will be measured before and after the treatments.Also, hyperinsulinemic-euglycemic clamp will be performed before and after the treatments. Muscle samples will be obtained by biopsy for 9 individuals (3 cases from each group) at the end of the study. Microarray analysis will be performed for the gene expression profile from the muscle samples. Other protein expressions such asadenosine monophosphate-activated protein kinase (AMPK), peroxisome proliferator-activated receptor coactivator 1a (PGC-1a) activity,will be checked by Western blot.

Eligibility criteria: Inclusion Criteria:

* Overweight
* Male

Exclusion Criteria:

* Female
* Obesity
* Using any other drugs
* \< 18 years old
* \> 60 years old
* Mental disorders
* Surgery history for abdomen

Primary outcomes:
measure: The differences of gene expression profile among 3 groups.
timeFrame: 6 months
Secondary outcomes:
measure: The differences of insulin sensitivity in 3 groups
timeFrame: 6 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhang Jiajia
state: Hubei
Study officials:
affiliation: Wuhan General Hospital
name: Guangda Xiang, MD,PhD
role: STUDY_CHAIR
References: