louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04348162: Food Anthocyanins and Flavanols as a Strategy for a Healthy Ageing: Cardiovascular Health and Cognitive Performance
Official title: Food Anthocyanins and Flavanols as a Strategy for a Healthy Ageing: Cardiovascular Health and Cognitive Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Aging
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
Collaborators: name: Hospital Universitario 12 de Octubre
First posted: 2020-04-16
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study examines the effect of cocoa flavanols, red-berries anthocyanins or a combination of both on markers of cardiovascular health and cognition.

Detailed description: The study examines the effect of cocoa flavanols, red-berries anthocyanins or a combination of both on markers of cardiovascular health and cognition.

Healthy volunteers are recruited to participate in a parallel study (n 30 per group) for 10 to 12 weeks. Markers of cardiovascular health (FMD, markers of inflammation and fatty acid metabolism) and cognition (neuropsychological tests and plasma neurotrophins) are being measured before and after intervention.

Eligibility criteria: Inclusion Criteria:

* Age 50-85
* BMI 20-32 Kg/m2

Exclusion Criteria:

* Mini-mental state examination (MMSE) \< 28
* Systolic blood pressure (SBP) \>139 mmHg
* Diastolic blood pressure (DBP) \> 89 mmHg
* Total cholesterol \> 6.5 mmol/L

Primary outcomes:
measure: Change from baseline of flow-mediated vasodilatation (FMD) of the brachial artery
timeFrame: Over 6 minutes on day 0 and after10 weeks
Secondary outcomes:
measure: Change from baseline STROOP score after 10 weeks intervention
timeFrame: at inclusion and 10 weeks after intervention
measure: Change from baseline Tower of London score after 10 weeks intervention
timeFrame: at inclusion and 10 weeks after intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Institute of Food Science, Technology and Nutrition (ICTAN), Spanish National Research Council (CISC)
Study officials:
References:
Clinical trial NCT01531062: Effect of Nigella Sativa on Lipid Profiles in Elderly
Official title: Effect of Nigella Sativa on Lipid Profiles in Elderly: a Randomized Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Keywords: nigella sativa
dyslipidemia
elderly
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 96
Sex: ALL
Minimum age (years): 60
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 whether Nigella sativa seed extracts are effective in the treatment of dyslipidemia in elderly.

Detailed description: Cardiovascular diseases are still common health problems worldwide. They are major causes of morbidity and mortality in many countries. Dyslipidemia is the main risk factor of cardiovascular events. Despite the invention of many conventional hypolipidemic drugs, the use of traditional medicine remains high, especially in elderly patients. However, evidence of the effectiveness of many herbs or other traditional drugs is lacking. Nigella sativa or black seeds are traditional herbs used for years in Middle East and India. They are believed to cure many diseases, including dyslipidemia. Therefore, a study is needed to prove their effectiveness as their use might improve our strategy to improve patients' compliance.

Eligibility criteria: Inclusion Criteria:

* age of 60 years or more
* having dyslipidemia (total cholesterol \>200 mg/dL or LDL \>100 mg/dL or triglyceride \> 150 mg/dL or HDL \< 40 mg/dL (male) or HDL \< 50 mg/dL (female)

Exclusion Criteria:

* ALT or AST are two times of upper normal limit
* creatinine clearance test is below 30

Primary outcomes:
measure: Decreased level of total cholesterol, LDL, dan triglyceride, and increased level of HDL
timeFrame: 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Internal Medicine Department, Faculty of Medicine, University Indonesia
Study officials:
References:
Clinical trial NCT01664962: Search for Genetic Basis of Vulvodynia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vulvodynia
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2012-08-14
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Vulvodynia, Normal healthy controls

Brief summary: The purpose of this study is to investigate the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).

Detailed description: The short-term goal proposed for the current study was to investigate the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).

Eight polymorphic SNPs in the three different genes suspected to be involved in LPV has been examined as follow:

1. HSPE gene: Four polymorphic SNPs: rs4693608, rs11099592, rs6856901 and rs4364254 that were found to be informative in the Ashkenazi Jewish population
2. TRPV1 gene: Two polymorphic SNPs: rs222747 and rs8065080.
3. NGF gene: A novel T to C SNP in the promoter region at position -198 (rs11102930) and rs6330 which was found to be associated with anxiety-related personality traits and has been suggested to may affect intracellular processing and secretion of NGF.

Eligibility criteria: Inclusion Criteria:o meeting Friedrich's criteria \[50\] for vulva vestibulitis syndrome

* diagnosed by a gynecological examination with LPV
* diagnosed with a severe degree of the syndrome according to Marinoff \[48\]
* classified with the primary type of the syndrome according to an interview
* with both parents of Ashkenazi origin.

Primary outcomes:
measure: Genetic association of Vulvodynia
timeFrame: four years
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee Hospital
Study officials:
References:
Clinical trial NCT04196062: EndoMaster EASE System for Treatment of Colorectal Lesions
Official title: Prospective, Single Arm Study to Assess the Safety and Performance of the EndoMaster EASE System for the Treatment of Colorectal Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Neoplasms
Keywords: Colonic ESD
Robotic Endoscope
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, Single-Arm Study
Primary purpose: TREATMENT

Brief summary: This is a prospective, single arm study to assess the safety and performance of the EndoMaster EASE (Endoluminal Access Surgical Efficacy) System for the treatment of patients with colorectal neoplasms.

Detailed description: Prospective, single arm study to assess the safety and performance of robotically assisted ESD of superficial colorectal lesions, that otherwise cannot be optimally and radically removed by snare-based techniques

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 and ≤ 85;
2. Suspected intramucosal neoplasm of the colon or rectum, including adenocarcinoma and tubular, tubulovillous, or villous adenomas.

Exclusion Criteria:

1. Informed consent not available;
2. Carcinoma of colon or rectum with known involvement beyond the submucosa;
3. Evidence of distant spread of colon cancer;
4. Presence of another active malignancy;
5. Pregnancy;
6. Patients considered unfit for general anaesthesia;
7. The endoscopic platform cannot reach the target site;
8. Current participation in another clinical research study.

Primary outcomes:
measure: Complete (R0) resection
timeFrame: 30 days
Secondary outcomes:
measure: Bleeding during or after the procedure
timeFrame: 30 days
measure: Perforation
timeFrame: 30 days
measure: Adjunctive procedures to control bleeding
timeFrame: 1 day
measure: All cause mortality
timeFrame: 30 days
measure: Infection
timeFrame: 30 days
measure: Impairment of renal function
timeFrame: 30 days
measure: Serious Adverse Events
timeFrame: 30 days
measure: Duration of procedure
timeFrame: 1 day
measure: Operator assessment of device performance
timeFrame: 1 day
measure: Device deficiencies
timeFrame: 1 day
measure: Length of Hospital stay
timeFrame: 30 days
measure: Histology of resected specimen
timeFrame: 30 days
measure: Colonoscopy followup
timeFrame: 6 months, 18 months to 3 years
measure: Cancer status by cross-sectional imaging (MRI / CT)
timeFrame: 12 months and 3 years
measure: Technical Success
timeFrame: 30 days
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Combined Endoscopy Center, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Philip Chiu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00762762: Effectiveness of a Triclosan Containing Toothpaste in Maintaining Periodontal Health in a Type 2 Diabetic Population
Official title: The Effect of Periodontal Treatment and the Use of a Triclosan/Copolymer/Fluoride Toothpaste on Glycaemic Control in Diabetics.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Periodontitis
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical research study to determine the effectiveness of a triclosan/copolymer/fluoride toothpaste in maintaining periodontal health and therefore glycaemic control in a type 2 diabetic population.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes with poor glycaemic control as evidenced by random blood glucose of \>200mg/dl.
* Minimum of 16 teeth
* Chronic periodontitis as indicated by periodontal probing depths \>4mm on at least 6 teeth

Exclusion Criteria:

* Any condition requiring antibiotic cover for dental treatment
* Other serious illness

Primary outcomes:
measure: HbA1c Levels in Blood
timeFrame: 12 months
measure: High Sensitivity CRP (C-Reactive Protein)
timeFrame: 12 months
measure: C-Peptide
timeFrame: 12 months
measure: IL-6 (Interleukin - 6)
timeFrame: 12 months
measure: TNF-α (Tumor Necrosis Factor - Alpha)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Otago University
name: Gregory Seymour, BDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01629862: Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea
Official title: Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Apnea, Obstructive
Diabetes Mellitus
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
name: National Institutes of Health (NIH)
First posted: 2012-06-28
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will examine the possible synergistic effects of obstructive sleep apnea (OSA) and type II diabetes mellitus (DM) on vascular functioning by performing a two-part investigation:

* A cross-sectional study comparing subjects with OSA+DM, OSA only, DM only, and healthy controls.
* A three-month randomized placebo-controlled trial of continuous positive airway pressure (CPAP) in subjects with OSA+DM.


Eligibility criteria: Inclusion Criteria:

* OSA subjects: apnea-hypopnea index \>=10 and \<100
* DM subjects: clinical diagnosis of DM and glycated hemoglobin \< 8.0%

Exclusion Criteria:

* Hematocrit \< 32
* Pregnancy
* Infectious/collagen vascular/hepatic or renal/cardiopulmonary disease

Primary outcomes:
measure: Absolute Change in Brachial Artery Flow-mediated Dilation (FMD).
timeFrame: 3 months (compared to baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Aristidis Veves, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Sanjay R Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bakker JP, Baltzis D, Tecilazich F, Chan RH, Manning WJ, Neilan TG, Wallace ML, Hudson M, Malhotra A, Patel SR, Veves A. The Effect of Continuous Positive Airway Pressure on Vascular Function and Cardiac Structure in Diabetes and Sleep Apnea. A Randomized Controlled Trial. Ann Am Thorac Soc. 2020 Apr;17(4):474-483. doi: 10.1513/AnnalsATS.201905-378OC.
Clinical trial NCT06269562: SPSIPB and CPB on Clavicle Surgeries
Official title: Postoperative Analgesic Efficacy of Clavipectoral Plan Block and Serratus Posterior Superior Intercostal Plane Block Combination in Clavicle Surgeries: A Report of Five Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clavicle Fracture
Postoperative Pain
Analgesia
Keywords: serratus posterior superior intercostal plane block
clavipectoral plane block
clavicle fracture
pain management
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clavicular fractures represent a common occurrence often necessitating effective pain management strategies, particularly following surgical interventions. This study involved a cohort of five patients who underwent clavicular fracture surgery under general anesthesia. A novel analgesic approach combining two distinct nerve block techniques-Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Clavipectoral Plane Block (CPB)-was employed for postoperative pain control. The procedural methodology encompassed the administration of SPSIPB preceding anesthesia induction, followed by CPB subsequent to induction. SPSIPB targeted specific neural regions responsible for sensory blockade within the innervation of the clavicular skin, whereas CPB focused on the clavipectoral fascia. Standard anesthesia protocols were utilized, and postoperative pain levels were evaluated using Numeric Rating Scores (NRS).


Eligibility criteria: Inclusion Criteria:

* Five American Society of Anesthesiologists (ASA) Ⅰ-II- III patients scheduled for clavicle surgery will be included in the study

Exclusion Criteria:

* patients with bleeding disorders
* patients with signs of infection in the block application area
* patients with unstable haemodynamics
* patients with thyroid cardiovascular, renal, hepatic and neuropsychiatric diseases
* patients with vascular disease,
* patients with respiratory distress
* patients whose consent for the study could not be obtained or who did not accept to participate in the study

Primary outcomes:
measure: Numerical Rating Scale
timeFrame: 24 hours after the procedure
Secondary outcomes:
measure: tramadol consumption
timeFrame: 24 hours after the procedure
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
Study officials:
References:
Clinical trial NCT00653562: Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography
Official title: Single Blind, Multi-center, Post Marketing Clinical Study of Zolpidem (Myslee) in Adolescent Patients With Insomnia - Evaluation With Polysomnography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insomnia
Sleep Initiation and Maintenance Disorders
Keywords: polysomnography
zolpidem
Sleep disorders
adolescent
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-04-07
Enrollment: 11
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography

Detailed description: The study consists of two parts. All patients will receive placebo in one part and Zolpidem in the other part in a single blind manner. Efficacy will be measured with polysomnography .

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10

Exclusion Criteria:

* Patients with schizophrenia or manic-depressive illness
* Patients with insomnia caused by physical diseases
* Patients having a history of hypersensitivity to zolpidem
* Patients with attention-deficit hyperactivity disorder

Primary outcomes:
measure: Sleep latency
timeFrame: 2 days
Secondary outcomes:
measure: Total hours of sleep
timeFrame: 2 days
measure: Frequency of intermediate awaking
timeFrame: 2 days
measure: Time of intermediate awaking
timeFrame: 2 days
measure: Patient impression
timeFrame: 2 days
Other outcomes:
Locations:
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyusyu
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT02676362: Methodological Evaluation of Gingival Crevicular Fluid Volume and Elastase Level
Official title: Methodological Evaluation of Gingival Crevicular Fluid Volume and Elastase Levels: Sequential Sampling, Length of Sampling Time And Two Different Sampling Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2016-02-08
Enrollment: 20
Sex: ALL
Minimum age (years): 31
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The mechanisms underlying the formation and composition of gingival crevicular fluid (GCF) and its flow into and from periodontal pockets are not understood very well. The aim of this study was to evaluate the length of sampling time and sequential sampling of GCF neutrophil elastase (NE) enzyme activity by using intracrevicular and orifice methods.

Detailed description: Twenty adults (mean age of 41.8 years. ranged 31-60 years. 18 males. 2 females) with chronic periodontitis were enrolled and all completed the 3-day study. Three-hundred-sixty samples of GCF were harvested from the interproximal sites of each of the two maxillary non-molar teeth according to the orifice method. Each site was sampled three times with 1-min intervals between repeat samples. By using intracrevicular method, the other 360 samples of GCF were collected on the same sites following 10-minutes interval. In first day, 2nd day and 3rd day the length of sampling time in seconds and order were 5. 10. 30; 10. 30. 5 and 30. 5. 10. respectively. GCF elastase activity was determined by hydrolysis of neutrophil specific substrate N-methoxysuccinyl-Ala-Ala-Pro-Val-p-nitroanilide and was expressed as concentration (microU/microl) and total enzyme activity (microU).

Eligibility criteria: Inclusion Criteria:

* no history of systemic disease;
* no history of antibiotics and/or anti-inflammatory drugs within the past 6 months;
* no received any oral hygiene prophylaxis and scaling and root planing within the past 6 months;
* at least 2 interproximal sites exhibiting higher than 5 mm probing depth, radiographic bone loss and gingival index of 2 (with preference of two maxillary non-molar teeth)

Exclusion Criteria:

* with metabolic diseases
* pregnancy, lactation etc.

Primary outcomes:
measure: The length of sampling time of GCF Elastase Levels
timeFrame: 3 days
Secondary outcomes:
measure: The length of sampling time of GCF Volume
timeFrame: 3 days
measure: The length of sequential sampling of GCF Volume
timeFrame: 3 days
measure: The length of sequential sampling of GCF Elastase Levels
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06356662: Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease
Official title: Efficacy and Safety of Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Parkinson Disease
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of tenofovir disoproxil fumarate in the treatment of Parkinson's disease. The changes of motor symptoms and the occurrence of adverse reactions in early Parkinson's disease patients who took tenofovir disoproxil fumarate and did not take Tenofovir disoproxil fumarate at different time points were compared.


Eligibility criteria: Inclusion Criteria:

* 1: Parkinson's disease: Hoehn Yahr= 1 to 2.5 2: MMSE score≥24

Exclusion Criteria:

* 1: essential tremor, stroke, epilepsy and other well-defined neurological disorders

  2: Or have received deep brain stimulation and other brain surgery

  3: Abnormal liver and kidney function

  4: Infected with chronic hepatitis B or AIDS (HIV-1 infection)

  5: Severe depression, schizophrenia, other psychiatric disorders or drug dependence

  6: Other serious physical diseases such as heart, lung, liver, kidney disease, blood disease and malignant tumor

  7: Pregnant or lactating women and seniors over 65 years of age

  8: Allergy or other contraindications to the investigational drug

Primary outcomes:
measure: UPDRS III（Unified Parkinson's Disease Rating Scale part 3）
timeFrame: 1 month、3 month
Secondary outcomes:
measure: Non-Motor Symptom Scale（NMSS）
timeFrame: 1 month、3 month
measure: creatinine(μmoI/L)
timeFrame: 1 month、3 month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Guohua Zhao
state: Zhejiang
Study officials:
References: