louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04982302: Gut Microbial Changes After Periodontal Treatment
Official title: Evaluation of Salivary and Intestinal Microbiological Response in Patients With Stage III-IV Periodontitis After Non-surgical Periodontal Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Dysbiosis
Intestinal Disease
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be consecutively selected among the patients diagnosed of Stage III-IV periodontitis at the Section of Periodontology of the C.I.R. Dental School of Turin.

Brief summary: Periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. The long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. The present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that non-surgical periodontal treatment may reduce bacterial alpha diversity in stool samples. Fifty patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and 3 months after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls.


Eligibility criteria: Inclusion Criteria:

* periodontitis Stage III or IV
* BMI between 20 and 29 kg/m2
* free diet
* presence of at least 20 teeth

Exclusion Criteria:

* systemic diseases (including diabetes, thyroid, liver, or kidney diseases)
* dietary allergies
* use of antibiotics or probiotics during the previous 30 days
* pregnancy or breast feeding

Primary outcomes:
measure: Changes in microbiome alpha diversity measured from stool samples at 3 months
timeFrame: [Time Frame: Baseline and 90 days]
Secondary outcomes:
measure: Changes in microbiome alpha diversity measured from saliva samples at 3 months
timeFrame: [Time Frame: Baseline and 90 days]
measure: Changes in mean clinical attachment level (CAL) at 3 months
timeFrame: [Time Frame: Baseline and 90 days]
measure: Changes in periodontal pocket depth (PPD) at 3 months
timeFrame: [Time Frame: Baseline and 90 days]
measure: Changes in full mouth bleeding score (FMBS) at 3 months
timeFrame: [Time Frame: Baseline and 90 days]
Other outcomes:
Locations:
city: Turin
country: Italy
facility: CIR Dental School
Study officials:
References:
Clinical trial NCT00051402: Phytoestrogens and Memory Decline in Menopause
Official title: Phytoestrogens and Cognition in Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Memory Loss
Postmenopause
Keywords: Postmenopausal
Memory Loss
Cognition
Phytoestrogens
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-01-15
Enrollment: 96
Sex: FEMALE
Minimum age (years): 62
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether soy-derived phytoestrogens taken as dietary supplements improve memory function in postmenopausal women who have experienced early memory decline.

Detailed description: Accumulating data has indicated that estrogens mediate enhancing effects on cognition and mood and may play a prophylactic role against age- and disease-related cognitive-cerebral decline. Phytoestrogens are plant-derived substances that have demonstrated estrogenic activity, but there is little prospective research regarding their effects on mental function. Mental health practitioners generally do not prescribe phytoestrogens. However, many women experiencing peri- and post-menopausal symptoms use marketed phytoestrogens under the perception of general health benefits, including presumably enhanced mental function. The purpose of this study is to develop preliminary data regarding the efficacy of isoflavone phytoestrogens in improving cognitive function in late middle-aged and elderly postmenopausal women with symptoms of memory impairment.

Participants in this study will be randomized to receive either isoflavone supplementation or placebo. The study will last for 16 weeks, during which participants will take the supplement pill or placebo three times a day. Participants will be assessed at study entry and at Week 16 for changes in basal cortisol levels, mood, and neuropsychological measures of executive function ability and episodic memory.

Eligibility criteria: Inclusion Criteria

* Postmenopausal women
* Mild memory or cognitive decline that does not meet the criteria for probable dementia

Exlcusion Criteria

* Hormone replacement therapy within 2 months prior to study entry
* Psychiatric medications within 30 days prior to study entry

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Robert Krikorian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06713902: Extracellular Vesicles in Fibrin Gel for Cartilage Repair
Official title: Fibrin Gel Loaded with Extracellular Vesicles for the Treatment of Cartilage Lesions in the Joints - GelVex Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Joint Disease
Keywords: Cartilage
Mesenchymal Stromal Cells
Extracellular Vesicles
Platelet Rich Plasma
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Upon signing the Informed Consent, 51 male and female subjects, ≥ 18 years old, attending the IRCCS Galeazzi-Sant'Ambrogio Hospital and matching the inclusion and esclusion criteria will be recruited.

Brief summary: This project aims to produce and study in vitro/ex vivo a platelet rich plasma (PRP)-derived fibrin gel loaded with mesenchymal stromal cells (MSC)-extracellular vesicles (EVs), to combine the positive results on cartilage growth of PRP growth factors and the hyaline cartilage stimulating activity of MSC-EVs. Therefore, the project goal is to provide an advanced option for orthopedic patients with an innovative evolution of a gold standard procedure, making it easy to translate into daily clinical practice for physicians, healthcare professionals and patients.


Eligibility criteria: Inclusion Criteria:

* males and females ≥ 18
* patients undergoing plastic surgery procedures;
* patients undergoing elective joint surgery with a diagnosis of knee or hip osteoarthritis (any Kellgren-Lawrence grade);
* patients undergoing regenerative medicine treatments with PRP with a diagnosis of knee or hip osteoarthritis (any Kellgren-Lawrence grade;
* signed Informed Consent for the study

Exclusion Criteria:

* Positive virological test (HIV, HCV, HBV, TPHA)
* Pregnancy or breastfeeding by self-declaration
* Other conditions that, at the discretion of the investigator or the physician

Primary outcomes:
measure: Confirm the incorporation rate of extracellular vesicles (EV) into platelet-rich plasma (PRP) following the formation of fibrin gel
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
state: MI
Study officials:
References:
citation: Ragni E, De Luca P, Landoni S, Valli F, Mortati L, Palombella S, Talo G, Moretti M, de Girolamo L. High efficiency protocol for platelet derived fibrin gel loaded with mesenchymal stromal cells extracellular vesicles. Regen Ther. 2024 Jul 7;26:442-457. doi: 10.1016/j.reth.2024.06.020. eCollection 2024 Jun.
Clinical trial NCT04428502: Study To Evaluate The Impact Of Anti-Cyclic Citrullinated Peptide(Anti-CCP) For Management With Enbrel In Patients With Psoriatic Arthritis(PsA)
Official title: Correlation of Anti-CCP With Disease Activity and Its Impact on Biological Response in PsA in Iraqi Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 127
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 data from the local Rheumatology Center of Baghdad Teaching Hospital registry

Brief summary: This study is to evaluate the local data in Iraqi patients with psoriatic arthritis on Enbrel treatment with positive Anti-Cyclic Citrullinated Peptide using data from the Rheumatologist in Baghdad Teaching Hospital registry.


Eligibility criteria: Inclusion Criteria:

* Diagnosed PsA patients.
* ≥18 years of age
* Have not received previous biological treatment

Exclusion Criteria:

* Previous use of other biological treatments.
* Etanercept use for less than 1 year duration.

Primary outcomes:
measure: Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 1
timeFrame: Baseline, Month 1
measure: Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 12
timeFrame: Baseline, Month 12
Secondary outcomes:
Other outcomes:
measure: Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12
timeFrame: Month 1, 6 and 12
Locations:
city: Baghdad
country: Iraq
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00172302: Can Intravenous Vitamin C Improve Skin Hyperpigmentation in Long-Term Hemodialysis Patients?
Official title: Can Intravenous Vitamin C Improve Skin Hyperpigmentation in Long-Term Hemodialysis Patients?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Failure, Chronic
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Intravenous vitamin C may improve skin hyperpigmentation in chronic hemodialysis patients

Detailed description: Melanogenesis is caused by enzymatic conversion of tyrosine to melanin pigments.Ascorbic acid has the ability to inhibit peroxidase and may thus inhibit melanin synthesis.

Eligibility criteria: Inclusion Criteria:

* chronic hemodialysis patients

Exclusion Criteria:

* allergic to vitamin C, using steroid, etc

Primary outcomes:
measure: Skin pigmentation extent
Secondary outcomes:
measure: blood anti-oxidant level
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Kao Tze-Wah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01746602: Effect of Topical Glaucoma Therapy on Tear Film Stability in Healthy Subjects
Official title: Effect of Topical Glaucoma Therapy on Tear Film Stability in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Healthy
Keywords: topical lubricants
tear film thickness
anti-glaucoma drugs
break up time
anti-glaucoma treatment
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Long term treatment with anti-glaucomatous drugs has been shown to increase the incidence of dry eye syndrome with all known consequences such as ocular discomfort and epithelial keratitis. Given that thinning of the tear film appears to be a risk factor for the development or the aggravation of dry eye syndrome, the current study seeks to investigate whether tear film thickness is changed after topical treatment with anti-glaucomatous drugs in healthy subjects.

For this purpose, tear film thickness will be measured at baseline and after single instillation of one of 5 study drugs in one randomly chosen eye. In addition, one group of 20 subjects will receive no drug and will serve as a second control. Drug effects on tear film thickness will be compared to the fellow, non-treated eye. In addition, effects on tear film thickness of timolol with preservatives (Timoptic 0.5%) will be compared to timolol without preservatives (Timophtal sine 0.5%) and three lubricants with different viscosity (Genteal HA, Hylo-Comod, Thealoz).


Eligibility criteria: Inclusion Criteria:

* Men and women aged over 18 years
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 6 Dpt.

Exclusion Criteria:

* Regular use of medication (except contraceptives), abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Patients with known hypersensitivity to the study drug or any ingredients
* History or current COPD or asthma
* AV-block grade II or more
* Ametropy ≥ 6 Dpt
* Pregnancy

Primary outcomes:
measure: Tear film thickness
timeFrame: up to 1 hour
Secondary outcomes:
measure: Break up time (BUT)
timeFrame: once on the study day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
References:
citation: Werkmeister RM, Alex A, Kaya S, Unterhuber A, Hofer B, Riedl J, Bronhagl M, Vietauer M, Schmidl D, Schmoll T, Garhofer G, Drexler W, Leitgeb RA, Groeschl M, Schmetterer L. Measurement of tear film thickness using ultrahigh-resolution optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 Aug 15;54(8):5578-83. doi: 10.1167/iovs.13-11920.
Clinical trial NCT02362802: Myocardial Minimal Damage After Rapid Ventricular Pacing
Official title: Myocardial Minimal Damage After Rapid Ventricular Pacing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antitachycardia Pacing
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the impact of antitachycardia pacing ( ATP) on the myocardial tissue with respect to its potential micro damage measured by several myocardial markers, especially by high-sensitive TroponinT.


Eligibility criteria: Inclusion Criteria:

* All patients for de-novo implantation of a transvenous ICD (single chamber, dual chamber or cardiac resynchronization tehrapy) with left pectoral device position and planned apical location of the right ventricular defibrillation electrode.

Exclusion Criteria:

* Resuscitation, cardiac surgical procedure, acute coronary syndrome, acute myocardial infarction, coronary revascularisation, cardioversion or ablation during the past 4 weeks, if baseline high-sensitive Troponin T is elevated
* Known stenosis of coronary vessels with indication for coronary intervention or operative revascularisation
* Intracardiac thrombus or general contraindication against ventricular burst stimulation or intraoperative ICD-testing
* Atypical lead implantation with indication for defibrillation threshold testing by induction of ventricular fibrillation
* Right sided implantation of ICD
* Planned electrical cardioversion
* Lead explantation or -extraction during procedure
* Redo procedure (except of additional implantation of a right ventricular ICD lead)
* Present temporary pacemaker electrode
* ASA \>= IV or NYHA IV
* Cardiogenic shock
* Pulmonary embolism, cerebrovascular insult or dialysis in the past 4 weeks
* Lack of consent of patient
* Minority of patient

Primary outcomes:
measure: High sensitive Troponin
timeFrame: 14-20 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
Study officials:
affiliation: Deutsches Herzzentrum München
name: Christof Kolb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Semmler V, Deutschmann C, Haller B, Lennerz C, Brkic A, Grebmer C, Blazek P, Weigand S, Karch M, Busch S, Kolb C. Myocardial Minimal Damage After Rapid Ventricular Pacing - the prospective randomized multicentre MyDate-Trial. Sci Rep. 2020 Mar 16;10(1):4753. doi: 10.1038/s41598-020-61625-8.
Clinical trial NCT04945902: International Students Intervention
Official title: A Psychosocial Intervention to Protect Purdue International Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Isolation
Keywords: international students
virtual intervention
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The proposed project aims to provide international students on F-1, J-1, or M-1 visas at Purdue additional culturally-relevant support by implementing and testing a psychosocial intervention. The intervention was designed based on the results of a recently published research study (Bhojwani et al., 2020) about international student concerns and needs in the time of COVID-19. This intervention is designed to test the effectiveness of a strengths-based intervention that targets the particular needs of international students during COVID. The intervention was designed based on evidence-based Cognitive-Behavioral and Systemic Therapy (Jafar et. al, 2016; Saravanan et. al., 2017) approaches to addressing stress and anxiety in a culturally-relevant manner and to decrease social isolation.


Eligibility criteria: Inclusion Criteria:

* International students who report being on J-1, F-1, or M-1 visas
* Currently enrolled in classes at Purdue at either the undergraduate or graduate level either remotely or in-person
* 18 years or older

Exclusion Criteria:

• active suicidality and/or homicidality

Primary outcomes:
measure: Change from Baseline of CCAPS-34 scores to Post-intervention
timeFrame: 6 weeks
measure: Change from Baseline of DASC-21 scores to Post-intervention
timeFrame: 6 weeks
measure: Change from Baseline of CCAPS-34 scores to 10 weeks
timeFrame: 10 weeks
measure: Change from Baseline of DASC-21 scores to 10-weeks
timeFrame: 10 weeks
Secondary outcomes:
measure: Social Connectedness Scale (SCS)
timeFrame: through the study completion, an average of 10 weeks
measure: Campus Climate
timeFrame: through the study completion, an average of 10 weeks
measure: Group Session Rating Scale (GSRS)
timeFrame: weekly for 6 weeks
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References:
citation: Bhojwani, J., Joy, E., Hoxsey, A., & Case, A. S. (2020). Being an International Student in the Age of COVID-19. Susan Bulkeley Butler Center for Leadership Excellence and ADVANCE Working Paper Series, 3(2), Special Issue: 47-60.
citation: Zhou X, Zhou AQ., & Sun X. Prevalence of common mental concerns and service utilization among international students studying in the US. Counselling Psychology Quarterly. 2021: 1-21.
Clinical trial NCT04620902: Detection of AD Biomarkers in Tear Fluid
Official title: Detection of AD Biomarkers in Tear Fluid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 69
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 60 patients and nine cognitively healthy age-matched controls (HC) were enrolled in this study.

Brief summary: Detection of AD biomarkers in tear fluid


Eligibility criteria: Inclusion Criteria:

* . Inclusion criteria were an MMSE score ≥ 20 and a CDR score from 0 to 1, thereby including patients across the whole clinical spectrum (i.e. from subjective cognitive disorder to (mild) dementia).

Exclusion Criteria:

* Exclusion criteria at baseline were neurological diseases (such as Normal Pressure Hydrocephalus, Morbus Huntington, brain tumor, epilepsy, encephalitis, recent Transient Ischemic Attack (TIA) or cerebrovascular accident (CVA) (\< 2 years), or TIA/CVA with concurrent (within three months) cognitive decline) and a history of psychiatric disorders (such as schizophrenia, bipolar disorder or psychotic problems, current major depressive disorder (within 12 months), or alcohol abuse).

Primary outcomes:
measure: Level of AD biomarkers in tear fluid
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Academic Hospital Maastricht
Study officials:
References:
Clinical trial NCT04518202: Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy
Official title: Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility, Female
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blinded randomized controlled trial
Primary purpose: PREVENTION

Brief summary: To compare the effectiveness of Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

Detailed description: hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes.

Eligibility criteria: Inclusion Criteria:

* patients with an indication for ofﬁce hysteroscopy

Exclusion Criteria:

* patient refuse to participant
* contraindication for lidocaine patch

Primary outcomes:
measure: Pain intensity will be assessed by visual analogue scale
timeFrame: 10 minutes
Secondary outcomes:
measure: Operative time
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan universirty
name: nahla w Shady, md
role: STUDY_CHAIR
References: