louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01856725: MPP Programming Study
Official title: Evaluation of Programming Strategies for MultiPoint™ Pacing in Cardiac Resynchronization Therapy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-05-17
Enrollment: 40
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: The purpose of this study is to compare the efficacy of cardiac resynchronization therapy (CRT) device programming with hemodynamic measurements to device programming without hemodynamic measurements.


Eligibility criteria: Inclusion Criteria:

* Be scheduled to undergo implant of a St. Jude Medical (SJM) CRT-D system with approved standard indication by ESC/EHRA Guidelines
* Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule

Exclusion Criteria:

* Have high ventricular rate (\>90 bpm) during persistent or permanent atrial fibrillation despite available treatment
* Be in NYHA IV functional class
* Have a recent myocardial infarction within 40 days prior to enrollment
* Have undergone cardiac bypass surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months
* Have had a recent CVA or TIA within 3 months prior to enrollment
* Have had intravenous inotropic support in the last 30 days
* Be less than 18 years of age
* Be pregnant or planning to become pregnant during the duration of the investigation.

Primary outcomes:
measure: end-systolic volume
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital, GVM Care & Research
state: RA
Study officials:
affiliation: Maria Cecilia Hospital, GVM Care & Research
name: Carlo Pappone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04658225: Gingivitis Treated With Chlorhexidine 0.12% Mouthwash in Young Adults
Official title: Gingivitis Treated With Chlorhexidine 0.12% Mouthwash in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age Problem
Keywords: Gingivitis
Periodontal treatment
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Thirty patients with gingivitis ages18 to 30 year with a probing depth of at most 3 mm and at least 20 teeth will select and evaluate at baseline and after 4 weeks. The periodontal clinical parameters will verify: plaque index (PI), gingival index (GI) and Simplified Oral Hygiene Index (OHIS). After evaluation of the clinical parameters, the patients will randomly allocated into two groups of 15 individuals to rinse with antimicrobials twice a day for a period of four weeks. Group A, received 0.12% chlorhexidine antimicrobian in a vial previously identified as solution 1 and group B, received saline solution identified as solution 2.
Primary purpose: TREATMENT

Brief summary: The aim of this study will evaluate the effectiveness of 0.12% chlorhexidine solution as an anti-inflammatory agent and reducing the presence of biofilm in young adults.

Detailed description: Thirty patients with gingivitis ages 18 to 30 year with a probing depth of at most 3 mm and at least 20 teeth will be selected and evaluate at baseline and after 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Presence of gingivitis
* Probing depth (PD) with maximum 3 mm
* Minimum of 20 teeth
* Age between 18 and 30 years old

Exclusion Criteria:

* Patients with periodontal disease (PD ≥ 4mm with clinical attachment loss)
* Diabetes
* Osteoporosis
* Pregnant or lactating females
* Smokers
* Users of immune suppressive medication
* Phenytoin or cyclosporine
* Calcium channel blockers
* Antibiotics
* Nonsteroidal anti-inflammatory drugs
* HIV+ or AIDS

Primary outcomes:
measure: Plaque Index
timeFrame: 30 days
Secondary outcomes:
measure: Gingival Index
timeFrame: 30 days
Other outcomes:
Locations:
city: Nova Friburgo
country: Brazil
facility: Universidade Federal Fluminense
state: Rio De Janeiro
Study officials:
References:
Clinical trial NCT05681325: Evaluation of Antioxidant and Anti-inflammatory Effect of Matcha Tea Intake on Periodontal Health
Official title: Evaluation of Antioxidant and Anti-inflammatory Effect of Matcha Tea Intake on Periodontal Health
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gingival Disease
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study:

This study aims to evaluate the antioxidant and beneficial effects of matcha tea daily intake on periodontal health.

Objectives:

* To evaluate the salivary level of antioxidants (catalase, total antioxidant capacity) after matcha tea intake compared to green tea over a period of one month.
* To evaluate the clinical periodontal parameters including bleeding on probing (BOP), probing pocket depth (PPD) and plaque index (PI) after matcha tea intake compared to green tea over a period of one month.
* To evaluate the salivary levels of IL-1B after matcha tea intake compared to green tea over a period of one month.


Eligibility criteria: Inclusion Criteria:

* • having at least 20 teeth,

  * underwent no medical treatment during the last 3 months before examination and sampling,
  * non-smoker,
  * no history of systemic disease,
  * gingivitis patient (having \>10% bleeding sites with no PPD \>3 mm).

Exclusion Criteria:

* • wore orthodontic appliances,

  * pregnant or currently in the breast-feeding period,
  * periodontitis patient,
  * smoker,
  * has a history of systemic disease.

Primary outcomes:
measure: change in salivary level of antioxidant marker
timeFrame: 30 Days (baseline to one moth of tea intake)
measure: change in salivary level of ant-inflammatory marker
timeFrame: 30 Days (baseline to one moth of tea intake)
Secondary outcomes:
measure: change in percentage of bleeding on probing (BOP)
timeFrame: 30 Days (baseline to one moth of tea intake)
measure: change in plaque index (PI) scores
timeFrame: 30 Days (baseline to one moth of tea intake)
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Universality of Baghdad, College of dentistry
Study officials:
affiliation: University of Baghdad
name: HIND KAREEM, BDS
role: STUDY_DIRECTOR
References:
citation: Zhang Y, Kang N, Xue F, Qiao J, Duan J, Chen F, Cai Y. Evaluation of salivary biomarkers for the diagnosis of periodontitis. BMC Oral Health. 2021 May 17;21(1):266. doi: 10.1186/s12903-021-01600-5.
citation: Kolackova T, Kolofikova K, Sytarova I, Snopek L, Sumczynski D, Orsavova J. Matcha Tea: Analysis of Nutritional Composition, Phenolics and Antioxidant Activity. Plant Foods Hum Nutr. 2020 Mar;75(1):48-53. doi: 10.1007/s11130-019-00777-z.
Clinical trial NCT00515125: Community Oral Nutrition Support Trial
Official title: A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Nutrition in the Community.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Quality of life
Supplement
Care home
Elderly
Malnutrition
Lead sponsor: University of Southampton
Sponsor class: OTHER
First posted: 2007-08-13
Enrollment: 104
Sex: ALL
Minimum age (years): 50
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 determine the best form of dietary intervention to undernourished elderly individuals in care homes.

The research aims to test the null hypothesis that there is no difference between oral nutritional supplements and dietary advice as the first line treatment for malnutrition.

Detailed description: A prospective, randomised, parallel, open-label trial, study in malnourished care home residents, without obvious dementia, to compare the effects of two common forms of nutritional support; dietary advice (DA) and oral nutritional supplements (ONS), on quality of life (QoL) and other outcomes including weight, nutritional intake and appetite. The residents were randomised to receive either DA provided by a dietitian or ONS for a period of 12 weeks. The primary outcome measure was QoL and the secondary outcome measure was dietary intake.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Age \> 50 years
* At risk of malnutrition
* Competent to provide written informed consent and to answer questions
* Able to eat and drink
* Willingness to take part in the trial and to follow the trial protocol

Exclusion Criteria:

* Requirement for tube or parenteral nutrition
* Galactosemia
* Receiving current oral nutritional supplementation
* Palliative care
* Chronic renal disease requiring dialysis
* Liver failure
* Malignancy
* Participation in other studies

Primary outcomes:
measure: The primary outcome measure is Quality of Life
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Care Homes in Hampshire
state: Hampshire
Study officials:
affiliation: University of Southampton
name: Marinos Elia, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parsons EL, Stratton RJ, Cawood AL, Smith TR, Elia M. Oral nutritional supplements in a randomised trial are more effective than dietary advice at improving quality of life in malnourished care home residents. Clin Nutr. 2017 Feb;36(1):134-142. doi: 10.1016/j.clnu.2016.01.002. Epub 2016 Jan 11.
Clinical trial NCT01081925: Congestive Heart Failure: Causes of Sudden Worsening
Official title: Congestive Heart Failure: Causes of Sudden Worsening
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congestive Heart Failure
Keywords: Congestive Heart Failure
Cardiac Failure
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2010-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from sudden worsening of congestive heart failure, who are examined at the Emergency department or admitted to University Hospital

Brief summary: The purpose of the study is to recognize main causes of acute decompensation of chronic congestive heart failure.

Detailed description: Congestive heart failure (CHF) presents a very significant cause of morbidity and mortality. The prevalence of CHF is between 2 and 4% and rises with age (in 70- to 80-year-old people is between 10 and 20%). CHF is the cause of 5% of all acute hospital admissions and accounts for 2% of expenses on health. The most common causes of worsening of the chronic CHF are ischemia, arrhythmias, valvular dysfunction, systemic or pulmonary hypertension, volume overload or fluid retention, high output conditions (infection, anemia, thyrotoxicosis), drugs (NSAIDs, cyclo-oxygenase (COX) inhibitors, thiazolidinediones) and medication nonadherence. The goal of this study is to determine the proportion of various reasons of acute worsening of CHF, using commonly available methods including assessment of serum drug levels.

Eligibility criteria: Inclusion Criteria:

* able to provide informed consent
* aged 19 years or more
* history of heart failure of at least one month
* examined or hospitalized for acute dyspnea at rest or with minimal exertion
* clinical signs of fluid overload defined as at least one of following:
* rales
* jugular venous distension
* peripheral edema
* pulmonary congestion on X-ray
* NT-proBNP above 210 pmo/l

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: University Hospital Hradec Kralove
Study officials:
affiliation: University Hospital Hradec Kralove
name: Radek Pelouch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03537625: Effects of Green Tea on Body Weight Reduction and Gut Microbiota
Official title: Effects of Green Tea and Fermented Green Tea Extract on Obese Adults: a Randomized Double-blind, Placebo-controlled Study Focused on Change of Gut Microbiota and Inflammatory Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Amorepacific Corporation
First posted: 2018-05-25
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators randomly assigned green tea extract, fermented green tea extract, or placebo in adult subjects whose BMI was 25-35 kg/m2. Participants were 40 in each group, and treatment duration was 12 weeks. Primary outcomes were body weight change and fat mass change from baseline to 12 weeks, and secondary outcomes were metabolic parameteres and gut microbiota.

Detailed description: After screening obese subjects who met the inclusion and exclusion criteria, the investigators randomly assigned the two treatment arms and one placebo arm at 1:1:1 ratio. At baseline, anthropometric and biochemical evaluations were conducted including body weight, body composition (DXA and Fat CT), lipid profiles, and liver function test. The tablets were supplied to each participants under double-blind conditions. The investigators obtained blood and stool samples both baseline and final visit at 12 weeks. For improving compliance for treatments, the investigators checked diary for lifestyle and drug compliance every 6 week.

Eligibility criteria: Inclusion Criteria:

* Age 20-60 years
* BMI 25-35 kg/m2
* Abdominal obesity (Waist circumference): Male \>90 cm, Female \>85cm

Exclusion Criteria:

* Cardiovascular events within 3 months
* uncontrolled hypertension (\>160/100 mmHg)
* Diabetes mellitus
* Dyslipidemia under statin therapy
* TSH\<0.1 uU/ml or\>10 uU/ml
* Elevated creatinine level (twice higher than upper normal limit)
* Elevated AST/ALT level (three times higher than upper normal limit)
* Pregnancy, lactation

Primary outcomes:
measure: Body weight
timeFrame: Baseline, and 12 weeks
measure: Body fat
timeFrame: Baseline, and 12 weeks
Secondary outcomes:
measure: Waist circumference
timeFrame: Baseline, 6 weeks, and 12 weeks
measure: Lipid profile
timeFrame: Baseline, and 12 weeks
measure: Inflammatory markers
timeFrame: Baseline, and 12 weeks
measure: Microbiota
timeFrame: Baseline, and 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05520125: Treatment of Patients With Bone Tissue Defects Using Mesenchymal Stem Cells Enriched by Extracellular Vesicles
Official title: Treatment of Patients With Segmental Bone Tissue Defects Using Mesenchymal Stem Cells Enriched by Extracellular Vesicles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Segmental Fracture - Bone Loss
Keywords: bone defects, mesenchymal stem cells, extracellular vesicles
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: Belarusian Medical Academy of Post-Graduate Education
First posted: 2022-08-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of patients with segmental bone tissue defects using mesenchymal stem cells enriched by extracellular vesicles

Detailed description: The aims of the project are to develop a technology for obtaining mesenchymal stem cells extracellular vesicles; to develop biomedical cell product based on mesenchymal stem cells enriched with own extracellular vesicles; to conduct the clinical trials of the biomedical cell product in the treatment of patients with segmental bone tissue defects

Eligibility criteria: Inclusion Criteria:

* age 18-50 years;
* non-union fractures of the tubular bones of the upper limb;
* segmental defects of the bone tissue of the tubular bones of the upper limbs;
* absence of severe comorbidity worsening the patient's prognosis.

Exclusion Criteria:

* pregnancy;
* acute inflammatory processes;
* viral hepatitis B and C, HIV infection, syphilis and other viral and bacterial infections;
* autoimmune diseases;
* allergic reactions in the acute stage, established hypersensitivity to any component of the biomedical cell product;
* mental and behavioral disorders that make it impossible for patients to participate in the study, drug and/or alcohol addiction;
* patients with malignant tumors including a history.

Primary outcomes:
measure: Adverse effects associated with the therapy
timeFrame: 1 year
measure: Adverse effects associated with the therapy
timeFrame: 1 month
measure: Percent of completely recovered patients with segmental bone tissue defects
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study officials:
affiliation: Institute for biophysics and cellular engineering NAS of Belarus
name: Andrei Hancharou, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT01579825: Evaluation of Buffer on Immune Response to Oral Polio Vaccine (OPV) in Bangladesh
Official title: Evaluation of the Effect of Buffer on the Immune Response to Oral Poliovirus Vaccine in Bangladesh: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polio
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: World Health Organization
First posted: 2012-04-18
Enrollment: 300
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypothesis:

The immunogenicity of oral polio vaccine (OPV) will be enhanced in Bangladeshi infants who receive bicarbonate buffer at the time of polio immunization.

Detailed description: The investigators will conduct a study to evaluate the impact of administering bicarbonate buffer on the serologic responses to oral polio vaccine (OPV) in Bangladeshi infants.

Eligibility criteria: Inclusion Criteria:

* infants who are 4-8 weeks old
* residents of study area

Exclusion Criteria:

* received a blood transfusion or any other blood product (such as immune globulin)
* likely to move out of study area within the next four months
* currently enrolled or planning to enroll in another study
* major congenital malformations
* neurologic disorders
* immunodeficiency

Primary outcomes:
measure: Serologic response
timeFrame: 4 weeks after last dose of OPV
Secondary outcomes:
Other outcomes:
Locations:
city: Sylhet
country: Bangladesh
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Neal A Halsey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chandir S, Ahamed KU, Baqui AH, Sutter RW, Okayasu H, Pallansch MA, Oberste MS, Moulton LH, Halsey NA. Effect of buffer on the immune response to trivalent oral poliovirus vaccine in Bangladesh: a community based randomized controlled trial. J Infect Dis. 2014 Nov 1;210 Suppl 1:S390-7. doi: 10.1093/infdis/jiu378.
Clinical trial NCT04654325: Prevalence of SARS-CoV-2 Genome in Tears of Asymptomatic and Moderately Symptomatic COVID-19 Patients
Official title: Prevalence of SARS-CoV-2 Genome in Tears of Asymptomatic and Moderately Symptomatic COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: SARS-CoV-2
Keywords: SARS-CoV-2
COVID19
conjunctiva
tears
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To evaluate the prevalence of SARS-CoV-2 genome in patients with asymptomatic and moderately symptomatic COVID19.

Detailed description: Patients attending to the COVID19 screening facility of Paris South University hospital and willing to participate to the study will have both nasopharyngeal and conjunctival swab for SARS-CV-2 genome detection using PCR. The project will evaluate the prevalence of positive conjunctival swabs in patients with positive nasopharyngeal swab. These results will be corelated to symptoms of disease assessed with a standardized questionnaire.

Eligibility criteria: Inclusion Criteria:

* Patients receiving diagnostic nasopharyngeal PCR for COVID-19 as part of the usual care
* Age ≥ 18.
* Information and signature of consent
* Affiliated with a social security scheme or entitled

Exclusion Criteria:

* Refusal to participate in the study
* Eye surgery less than 3 months old
* Unable to give informed consent
* No coverage through the health insurance system
* Patient under judicial protection
* Patient on AME

Primary outcomes:
measure: presence of SARS-CoV-2 genome in tears
timeFrame: at the end of the study, an average of 1 year
Secondary outcomes:
measure: presence of systemic symptoms evaluated at the time of making an appointment by a systematic standardized interrogation
timeFrame: at the end of the study, an average of 1 year
measure: assessement of viral load levels
timeFrame: at the end of the study, an average of 1 year
Other outcomes:
Locations:
city: Le Kremlin Bicetre
country: France
facility: Hôpital Bicêtre
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Antoine Rousseau, PhD
role: PRINCIPAL_INVESTIGATOR
References: