louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05403216: Relationship Between Oral Lichen Planus and Autoimmune Thyroid Diseases
Official title: Clinical Value of the Relationship Between Oral Lichen Planus and Autoimmune Thyroid Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oral Lichen Planus
Lead sponsor: The Dental Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Oral lichen planus (OLP) patients

Brief summary: On the basis of previous studies, a validation cohort will be established to explore the relationship between oral lichen planus and autoimmune thyroid diseases, and a disease efficacy prediction strategy can be formed.

Detailed description: For oral lichen planus patients, the prevalence of Hashimoto's thyroiditis will be investigated and the relationship between levels of anti-TG, anti-TPO antibodies and severity of oral lichen planus will be determined.

Besides, for patients with Hashimoto's thyroiditis, the prevalence of oral lichen planus will be investigated and the relationship between levels of anti-TG, anti-TPO antibodies and severity of oral lichen planus will be determined.

Eligibility criteria: Inclusion Criteria:

* OLP patients without systemic disease

Exclusion Criteria:

* OLP patients with severe periodontal disease

Primary outcomes:
measure: Oral lichen planus (OLP) lesions record
timeFrame: 1 year
measure: Level of thyroid function and antibody
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Stomatology Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Qianming Chen, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT02831816: Clinical Evaluation of Patient Preoperative Prep
Official title: Clinical Evaluation of ZP, A Patient Preoperative Skin Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Skin Preparation
Lead sponsor: Zurex Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-13
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study is to demonstrate the antimicrobial efficacy of the ZP Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects of any race.
* Subjects in good health.
* Minimum skin flora baseline requirements on abdomen and groin.
* Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area.

Exclusion Criteria:

* Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics.
* Subjects with a history of skin sensitivity, skin allergies, or skin cancer.
* Subjects who are pregnant, attempting pregnancy, or nursing.

Primary outcomes:
measure: Bacterial Reduction
timeFrame: 10 minutes post product application
measure: Bacterial Reduction - Abdomen
timeFrame: 10 minutes post product application
Secondary outcomes:
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: BioScience Laboratories, Inc.
state: Montana
Study officials:
References:
citation: Edmiston CE, Lavin P, Spencer M, Borlaug G, Seabrook GR, Leaper D. Antiseptic efficacy of an innovative perioperative surgical skin preparation: A confirmatory FDA phase 3 analysis. Infect Control Hosp Epidemiol. 2020 Jun;41(6):653-659. doi: 10.1017/ice.2020.27.
Clinical trial NCT06834516: ClearSight Baby Cuff
Official title: Early Feasibility Data Collection Using ClearSight on Children Less Than Two Years Old
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2025-02-19
Enrollment: 15
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be less than 2 years of age with blood pressure monitoring as part of routine care.

Brief summary: A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients.

Detailed description: A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients under 2 years old

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Age \< 2 years
3. Availability of a standard blood pressure measurement as part of standard of care

Exclusion Criteria:

1. Any significant disfigurement or prior injury to a participant's finger that is intended to be used for monitoring with the prototype finger cuff
2. Inability to place finger cuffs appropriately due to subject anatomy, condition, or obstructive paraphernalia
3. Known sensitivities to system materials
4. Broken or open skin located at the site of the finger cuff
5. Proven left-right difference in blood pressure
6. Cardiac problems that can cause a difference in blood pressure between the two arms, including aortic coarctation
7. Extreme contraction of the smooth muscles in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease

Primary outcomes:
measure: Proper cuff fit
timeFrame: 30 minutes of monitoring with study devices during scheduled surgery procedure
measure: Cuff remains properly fitted for the duration of the study measurement
timeFrame: 30 minutes of monitoring with study devices during scheduled surgery procedure
measure: Measurement with monitor started without errors
timeFrame: 30 minutes of monitoring with study devices during scheduled surgery procedure
measure: Measurement stability within 10 mins
timeFrame: 30 minutes of monitoring with study devices during scheduled surgery procedure
measure: Early feasibility accuracy
timeFrame: 30 minutes of monitoring with study devices during scheduled surgery procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
Study officials:
affiliation: Edwards Lifesciences
name: Tina Abdelnour, MS, BSN
role: STUDY_DIRECTOR
References:
Clinical trial NCT05009316: Impact of Social Support and Coping Strategies on Post-Surgical Pain
Official title: Impact of Social Support and Coping Strategies on the Development and Evolution of Post-Surgical Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Support
Coping Behavior
Post-Surgical Pain, Chronic
Keywords: Pain, Chronic
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2021-08-17
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the impact of social support and pain coping strategies in the development and evolution of post-surgical pain.

Detailed description: This is a longitudinal study. After giving their informed consent, patients will answer online questionnaires assessing pain and different psychosocial variables at these time points: before surgery, one to three days after surgery, and one, three, and six months after surgery.

The psychosocial variables evaluated are the following ones :

* Depression,
* Anxiety,
* Stress,
* Pain Coping Strategies,
* Social Support,
* Couple Support.

Eligibility criteria: Inclusion Criteria:

* Aged over 18 years of age.
* Capacity to understand and voluntarily sign an informed consent form in French.

Exclusion Criteria:

* Insufficient French language skills.
* History of psychotic disease.
* History of neurodegenerative pathology.
* History of neurological disease (e.g. stroke)
* Pre-existing pain condition related to the reason for surgery

Primary outcomes:
measure: Intensity of acute post-surgical pain
timeFrame: Three days after surgery
measure: Development of Persistent post-surgical pain, 3 months
timeFrame: 3 months after surgery
measure: Persistent post-surgical pain, 6 months
timeFrame: 6 months after surgery
measure: Pain interference
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institute of NeuroScience (IONS) - UCLouvain
Study officials:
affiliation: Université Catholique de Louvain
name: André Mouraux, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT06835816: Amino Acid Supplementation in Continuous Renal Replacement Therapy
Official title: Amino Acid Supplementation in Continuous Renal Replacement Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 30
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: ICU patients treated with continuous renal replacement therapy is recruited prior to start of treatment.

Blood samples are drawn and then dialysis start without amino acid supplementation. After a few hours samples are drawn from blood and dialysate. Then patients are given amino acid supplementation (33.5g/24hrs) for 20-24 hours. New samples are drawn and amino acid supplementation is increased to 67g/24hrs and new samples are drawn after additional 24 hours. Then CRRT will continue with the full amino acid supplementation (standars of care).


Eligibility criteria: Inclusion Criteria:

* Dialysis where amino acid supplementation is planned by treating physician

Exclusion Criteria:

* Liver failure
* Muscle disease
* Neurodegenerative disease

Primary outcomes:
measure: Balance of amino acids
timeFrame: After 3 days of dialysis
Secondary outcomes:
measure: Amino acid concentration in plasma
timeFrame: After 3 days of dialysis
measure: Concentration of vitamins and trace elements
timeFrame: After 3 days of dialysis
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Jonathan Grip, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01482416: Vascular Effect of Estrogens Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
Official title: Flow-mediated Evaluation of the Brachial Artery of Climacteric Women Using Estradiol and Placebo. Randomized, Double Blinded, Placebo Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unspecified Injury of Brachial Artery, Left Side, Initial Encounter
Keywords: hormone replacement therapy
Doppler velocimetry
Flow-mediated dilation
menopause
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2011-11-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the vascular effects of estrogens on climacteric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.

Detailed description: The interruption of the secretion of sex steroids that occurs after menopause, determines a change in vascular pattern at various levels. As a result, several side effects might appear and interfere with women's quality of life and health. The use of hormone replacement therapy has contributed to the improvement in these effects. It has been observed vascular beneficial effects of sex steroids in premenopausal women, and of hormone replacement therapy (HRT) in climacteric women, on the central retinal arteries. The objective of this study is to evaluate the effects of conjugated equine estrogen on flow-mediated dilation of the brachial artery.

Eligibility criteria: Inclusion Criteria:

* Women without menstrual cycles within the last 12 months and FSH \> 30IU/L
* Healthy women
* Women that were not using drugs with potential vascular effect within the last 1 year
* Women that never used hormone replacement therapy

Exclusion Criteria:

* Smoking
* Blood Pressure \> 160/90 mm Hg.
* Breast and or endometrial cancer
* History of acute myocardial infarction
* Diabetes
* Vaginal bleeding of any origin
* Hepatic disease
* Thrombophlebitis or thromboembolic disorders

Primary outcomes:
measure: Flow-mediated dilation of the brachial artery
timeFrame: one month after treatment started
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital das Clinicas - Universidade Federal de Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Medical School of Universidade Federal de Minas Gerais
name: Selmo Geber, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Faria AF, de Souza MA, Geber S. Vascular resistance of central retinal artery is reduced in postmenopausal women after use of estrogen. Menopause. 2011 Aug;18(8):869-72. doi: 10.1097/gme.0b013e31820cc60c.
citation: Hurtado R, Celani M, Geber S. Effect of short-term estrogen therapy on endothelial function: a double-blinded, randomized, controlled trial. Climacteric. 2016 Oct;19(5):448-51. doi: 10.1080/13697137.2016.1201809. Epub 2016 Jul 16.
Clinical trial NCT05399316: Inulin and the Gut Microbiota in Healthy Adults
Official title: The Effect of the Prebiotic Fiber INulin on metaboLITE Production of the Gut Microbiota in Healthy Adults- a Randomized, Double Blind Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Microbiota Dysbiosis and Nutrition
Lead sponsor: Experimental and Clinical Research Center
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this study the effects of a fibre dietary supplement on the gut microbiome in healthy adults will be investigated. For this purpose, a 14-day dietary supplementation with inulin or placebo (maltodextrin) will be carried out in healthy adults. The main objective of the study is to investigate inulin-induced changes in gut bacterial composition, bacterial gene expression, bacterial metabolite production and associated immune system changes.

Detailed description: Healthy volunteers between the age of 18 and 60 will be recruited. In the first week of the study baseline blood and stool sampleswill be collected and nutritional information recorded. The participants will then take 15g of inulin or maltodextrin twice per day for 14 consequetive days. Blood and stool samples will be collected daily during the inital phase of the intervention and again at the end of the intervention.

From the stool samples bacterial nucleic acids will be isolated and used for metagenomic and transcriptomic analysis. The blood samples will be used to analyse for markers of barriere function and for analysis of immune cells.

Eligibility criteria: Inclusion Criteria:

* Men and women in a 1:1 ratio
* Age 20 - 60 years
* Body Mass Index 18.5 - 34.9 kg/m2

Exclusion Criteria:

* Arterial hypertension, diabetes mellitus, known cardiovascular disease requiring treatment (e.g. coronary heart disease, stroke).
* Known end-organ damage to the brain, heart or kidneys
* Chronic kidney disease, need for dialysis
* Diseases or functional disorders that, in the opinion of the study doctor, preclude participation in the study
* Acute infections
* Malnutrition
* Antibiotics in the previous 4 weeks
* Regular consumption of probiotics or prebiotics
* Allergies
* Change in bodyweight of more than 2 kg in the previous 3 months
* Inability to uderstand the studie aims and study procedures
* Drug or alcohol abuse

Primary outcomes:
measure: Metabolite associated bacterial gene expression
timeFrame: 12 months
Secondary outcomes:
measure: serum butyrate
timeFrame: 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Experimental and Clinical Research Center
Study officials:
affiliation: Charite University
name: Nicola Wilck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University
name: Hendrik Bartolomaeus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ECRC
name: Victoria McParland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05297916: Delayed vs Early Enteral Feeding After Anterior Sagittal Anorectopexy
Official title: Early Versus Delayed Postoperative Enteral Feeding to Reduce the Incidence of Perineal Wound Infection Following Anterior Sagittal Anorectoplasty of Congenital Recto-vestibular Fistula
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Onset of Perineal Wound Infection
Keywords: recto-vestibular fistula,
early enteral feeding
peripheral parenteral nutrition
perineal wound infection
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 55
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: delayed enteral feeding ingroup 1 early enteral feeding in group 2
Primary purpose: PREVENTION

Brief summary: to study the effect of early vs delayed enteral feeding following ASARP in females with congenital recto-vestibular fistula

Detailed description: congenital Recto vestibular fistula represents the commonest type of anorectal malformation in females. The treatment of this anomaly is mainly approached either through anterior or posterior sagittal ano-rectoplasty approach. Several perioperative factors may affect the outcome. One of major postoperative complications is the occurrence of wound infection.

Purpose: we aimed to study the effect of delayed vs early postoperative enteral feeding on the occurrence of postoperative wound infection and dehiscence.

Patients and methods:

A prospective randomized trial included 55 infants with recto-vestibular fistula. All infants were managed by single stage anterior sagittal anorectoplasty at an age ≥ 3 months. Patients were divided into two groups. group A included infants who started oral intake on the 5th postoperative day and group B included infants who started oral intake on the 2nd postoperative day. The primary outcome was the onset of perineal wound infection. Group A infants were kept on peripheral parenteral nutrition during fasting period.

Eligibility criteria: Inclusion Criteria:

* All female infants with congenital rectoperineal fistula

Exclusion Criteria:

* patients with major anomalies, patients who have staged repair

Primary outcomes:
measure: perineal wound infection
timeFrame: WITHIN TWO WEEKS POST OPERATIVE
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
Study officials:
References:
Clinical trial NCT02337816: Role of Metabolomics in the Diagnosis of Endometriosis
Official title: Role of Metabolomics in the Diagnosis of Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: Endometriosis
Metabolomics
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women of childbearing age , patients of the University Hospital , suffering from benign gynecological disease

Brief summary: Endometriosis is one of the most common benign gynecological, affecting about 10% of premenopausal women. The pathophysiology of this disease is still not completely clear. Despite its prevalence, there is no blood test available for the diagnosis of endometriosis and the average delay time to diagnosis is 9.4 years.

Metabolomics is a scientific discipline that studies changes in metabolites related to the pathophysiology of the disease.

Aim of the study is to identify an alteration in the expression of the metabolites in women with endometriosis


Eligibility criteria: Inclusion Criteria:

* women of childbearing age ;
* written consent to laparoscopic surgery;
* written consent to the study .

Exclusion Criteria:

* Suspicion or diagnosis of malignant disease
* Inability or unwillingness to provide written consent

Primary outcomes:
measure: Plasma and urine concentration of metabolites
timeFrame: At least one month after discontinuation of hormonal therapies , before laparoscopic surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Murgia F, Angioni S, D'Alterio MN, Pirarba S, Noto A, Santoru ML, Tronci L, Fanos V, Atzori L, Congiu F. Metabolic Profile of Patients with Severe Endometriosis: a Prospective Experimental Study. Reprod Sci. 2021 Mar;28(3):728-735. doi: 10.1007/s43032-020-00370-9. Epub 2020 Nov 10.
Clinical trial NCT04218916: Rhodiola Rosea for Coronary Microvascular Disease
Official title: The Efficacy and Safety of Rhodiola Rosea in Patients With Coronary Microvascular Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Coronary Microvascular Disease
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 114
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effects of rhodiola rosea on coronary flow reserve and symptoms in patients with microvascular angina pectoris, and to evaluate adverse drug reactions. Long-term clinical follow-up of 1 to 3 years was conducted to evaluate the effect of rhodiola rosea on long-term adverse cardiovascular events in patients with coronary microvascular disease.


Eligibility criteria: Inclusion Criteria:

1. Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;
2. Coronary normal or stenosis \< 20%;
3. Ischemic depression in ST segment during resting or exercise;
4. Blood flow reserve (CFR) of the anterior descending coronary artery \< 2.0;
5. Subjects or their guardians agreed to participate in this study.

Exclusion Criteria:

1. Previous myocardial infarction or PCI or CABG treatment;
2. A history of heart failure or LVEF \< 50%;
3. Severe arrhythmia;
4. Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy;
5. A history of stroke within half a year;
6. Diabetes difficult to control;
7. Refractory hypertension or hypertension accompanied by left ventricular wall thickness \> 12 mm;
8. Familial hypercholesterolemia;
9. Takayasu arteritis, Kawasaki disease or coronary artery malformation;
10. Pregnant or nursing, or having the intention to give birth within one year;
11. Hepatic or renal dysfunction;
12. Other diseases which may cause serious risks to patients;
13. Requiring warfarin anticoagulant therapy; Taking potassium channel opener, CCB, ACEI drugs or traditional Chinese medicines;
14. Allergic to contrast agents or blood products;
15. Patients who participated in clinical research of other drugs within 3 months before being selected.

Primary outcomes:
measure: Changes of Coronary Flow Reserve
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: