louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01089920: Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans
Official title: Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2010-03-19
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Coffee and green tea are 2 widely consumed beverages. Both contain polyphenol antioxidant compounds (chlorogenic acids for coffee and catechins for tea). The bioavailability of catechins is somewhat known and has been referenced in the literature. However, bioavailability data from tea infusion is non-existent, even though it reflects better how consumers drink this beverage. In addition, bioavailability of coffee chlorogenic acids is less understood and no dose response study has been reported so far in the literature. Thus, there is a great need to understand and reinforce our knowledge on the bioavailability of coffee and tea polyphenol compounds.


Eligibility criteria: Inclusion Criteria:

* 18 - 65 years, male and female
* Healthy as determined by the medical questionnaire and the medical visit
* Normal weight: BMI 18 - 25
* Coffee drinkers with an average consumption of 2-5 cups per day
* Having given informed consent

Exclusion Criteria:

* Intestinal or metabolic diseases / disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer
* Have had a gastrointestinal surgery, except appendicectomy
* Difficulty to swallow
* Have a regular consumption of medication
* Have taken antibiotic therapy within the last 6 months
* Alcohol consumption \> 2 units a day
* Smokers (more than 5 cigarettes per day)
* Have given blood within the last 3 weeks
* Volunteers who cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial during the last 3 weeks

Primary outcomes:
measure: Compare plasma Area under the curve (AUC) of highest and lowest dose of coffee for chlorogenic and phenolic acid metabolites
timeFrame: Measurements done over 24h after ingestion
Secondary outcomes:
measure: Compare Area under the curve (AUC), Maximum plasma concentration (Cmax), Time to reach maximum plasma concentration (Tmax) and half-life (T1/2) of all three doses of coffee for chlorogenic and phenolic acid metabolites
timeFrame: Measurements done over 12h after ingestion
measure: Compare AUC, Cmax, Tmax and T1/2 of all three doses of green tea for catechin metabolites
timeFrame: Measurements done over 12h after ingestion
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Nestle Research Center
Study officials:
affiliation: Nestec
name: Maurice Beaumont, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00289120: Effect of Cola on Urinary Stone Risk Factors
Official title: Effect of Cola on Urinary Stone Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Stone
Keywords: urolithiasis, cola
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2006-02-09
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Examine the effects of cola on risks of kidney stones

Detailed description: Prospective crossover study examining the risks of cola on stone risk factors.

Eligibility criteria: Inclusion Criteria:

* urolithiasis, healthy volunteer

Exclusion Criteria:

-

Primary outcomes:
measure: The Plasma and Urine Parameters
timeFrame: at the end of each 6-day intervention in Cola and Water Phase
measure: The Plasma and Urine Parameters
timeFrame: at the end of 6-day intervention of Cola and water phase
measure: The Plasma Osmolarity
timeFrame: at the end of 6-day intervention of cola and water phase
measure: The Plasma and Urine Parameters
timeFrame: at the end of 6-day intervention of Cola and water phase
Secondary outcomes:
measure: Total Urine Volume
timeFrame: at the end of each 6-day intervention in Cola and Water Phase
measure: Urinary pH
timeFrame: at the end of each 6-day intervention in Cola and Water Phase
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Kenneth Ogan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herrel L, Pattaras J, Solomon T, Ogan K. Urinary stone risk and cola consumption. Urology. 2012 Nov;80(5):990-4. doi: 10.1016/j.urology.2012.07.003. Epub 2012 Sep 25.
Clinical trial NCT06096220: Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts
Official title: Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts - Randomized, Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Odontogenic Keratocyst
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 50
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 goal of this clinical trial is to compare surgical treatment outcomes of odontogenic keratocysts (OKC) treated with enucleation and local application of Carnoy's solution or 5% 5-fluorouracil. The main questions it aims to answer are:

1. What is the recurrence rate of OKC treated with enucleation and local application of 5% 5-fluorouracil cream in the period of three and five years after the treatment
2. What is the recurrence rate of OKC treated with enucleation and local application of Carnoy's solution in the period of three and five years after the treatment
3. Is there a difference in the recurrence rate between these two groups
4. What is the frequency of sensitivity disorders in the innervation zone of inferior alveolar and infraorbital nerves in both groups

Participants will be assigned to one of two groups after Histopathological verification (HP verification).They will be treated with enucleation and local application of Carnoy's solution or 5% 5-fluorouracil depending on group. After surgical treatment they will be monitored in accordance to standard treatment protocols for patients with OKC.


Eligibility criteria: Inclusion Criteria:

* Histologically verified OKC of the upper or lower jaw;
* Indicated surgical treatment of OKC

Exclusion Criteria:

* Hypersensitivity to 5-fluorouracil and Carnoy's solution;
* Pathological fracture of the jaw in OKC region.
* Nevoid basal cell carcinoma

Primary outcomes:
measure: Recurrence rate
timeFrame: 5 years
Secondary outcomes:
measure: Sensitivity disorders
timeFrame: Immediately after the surgery up to one month
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: School of Dental Medicine
Study officials:
affiliation: University of Belgrade, School of Dental Medicine
name: Miroslav Andric
role: STUDY_CHAIR
References:
Clinical trial NCT04352920: Vacuum Myofascial Therapy Device in Treatment of Muscle Fibrosis
Official title: Vacuum Myofascial Therapy Device in Treatment of Muscle Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Injury
Keywords: negative pressure
cupping
physical therapy modalities
Lead sponsor: University of Cadiz
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 1
Sex: MALE
Minimum age (years): 24
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Medical Doctor diagnosed muscle fibrosis
Primary purpose: TREATMENT

Brief summary: We present the case of a 24-year-old professional soccer player, with no personal history of interest, who came to the X-Ray diagnosis service due to severe pain in the right quadriceps muscle after a 10-month evolution of muscle rupture occurred during sports practice.

Detailed description: PHYSIUM System® provides standardized negative pressure massage for 15 minutes with the analgesic program and 15 minutes with the trigger points program at 80 millibars with eight adjustable arms, both in the entire muscle and in muscle fibrosis.

Seven days later, after PHYSIUM System® session with the same parameters of the previous treatment, ultrasound elastography was performed.

Eligibility criteria: Inclusion criteria.

* 24-year-old professional soccer player.
* No personal medical history of interest

Primary outcomes:
measure: The intensity of pain in muscle fibrosis
timeFrame: Baseline
Secondary outcomes:
measure: The intensity of pain in muscle fibrosis
timeFrame: Two weeks
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: Manuel Rodríguez Huguet
state: Cádiz
Study officials:
affiliation: University of Cádiz
name: Manuel Rodriguez Huguet, Physiotherapy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bhatia K, Tong CS, Cho CC, Yuen EH, Lee J, Ahuja AT. Reliability of shear wave ultrasound elastography for neck lesions identified in routine clinical practice. Ultraschall Med. 2012 Oct;33(5):463-8. doi: 10.1055/s-0032-1325330. Epub 2012 Oct 15.
citation: Ekstrand J, Askling C, Magnusson H, Mithoefer K. Return to play after thigh muscle injury in elite football players: implementation and validation of the Munich muscle injury classification. Br J Sports Med. 2013 Aug;47(12):769-74. doi: 10.1136/bjsports-2012-092092. Epub 2013 May 5.
citation: Hallen A, Ekstrand J. Return to play following muscle injuries in professional footballers. J Sports Sci. 2014;32(13):1229-36. doi: 10.1080/02640414.2014.905695. Epub 2014 May 1.
citation: Fousekis K, Tsepis E, Poulmedis P, Athanasopoulos S, Vagenas G. Intrinsic risk factors of non-contact quadriceps and hamstring strains in soccer: a prospective study of 100 professional players. Br J Sports Med. 2011 Jul;45(9):709-14. doi: 10.1136/bjsm.2010.077560. Epub 2010 Nov 30.
Clinical trial NCT06893120: Cognitive Exercise Therapy Approach (BETY) in Parkinson's Disease
Official title: Investigation of the Effectiveness of Cognitive Exercise Therapy Approach (BETY) in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Biopsychosocial model
depression
disease management
exercise
Parkinsons' Disease
quality of life
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Considering the impact of motor and non-motor findings on movement problems in the disease management of people living with PD, biopsychosocial evaluation and treatment approaches are essential. However, there are not many studies investigating the impact of a biopsychosocial-based exercise approach on the biopsychosocial characteristics of individuals in PD management.

The Cognitive Exercise Therapy Approach (BETY), an innovative exercise approach based on the biopsychosocial model, has been developed with the participation of individuals with rheumatism in exercise sessions for many years. This study investigated the effects of the BETY, a supervised biopsychosocial model-based exercise intervention, on cognitive status, physical activity, balance, and biopsychosocial status in people living with PD.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with idiopathic Parkinson's disease
* between 1-3 at home according to Modified Hoehn and Yahr Staging (MH\&Y)

Exclusion Criteria:

* Individuals who were diagnosed with dementia before Parkinson's diagnosis
* Had undergone deep brain stimulation
* Diagnosed with psychiatric or additional neurological diseases
* Had limited physical activity due to orthopedic problems or previous neurological diseases
* Had communication problems

Primary outcomes:
measure: BETY-Biopsychosocial Questionnaire
timeFrame: Three months
Secondary outcomes:
measure: Beck Depression Scale (BECK-D)
timeFrame: Three months
measure: International physical activity questionnaire-Short (IPAQ-Short)
timeFrame: Three months
measure: Berg Balance Scale (BBS)
timeFrame: Three months
measure: 8-Item Parkinson's Disease Questionnaire (PDQ-8)
timeFrame: Three months
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: Three months
measure: Montreal Cognitive Assesment: MoCA
timeFrame: Three months
measure: Modified Hoehn & Yahr Staging Scale (MH&Y)
timeFrame: Three months
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Alaaddin Keykubat University
state: Alanya
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altındağ
Study officials:
References:
Clinical trial NCT03770520: Graft Patency of QFR-guided Versus Angio-guided Coronary Artery Bypass Grafting
Official title: The Clinical Effect of QFR-guided Coronary Artery Bypass Grafting: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Ischemic Heart Disease
Keywords: Quantitative Flow Ratio
Coronary Artery Bypass Grafting
Graft patency
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2018-12-10
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Coronary artery bypass grafting(CABG) is the golden standard for severe coronary artery disease(CAD), the current surgery strategy is mainly based on coronary angiography(CAG), but many trials of PCI have shown that visually stenosis in CAG may not have functional significance. The aim of this study is to investigate if the Quantitative Flow Ratio (QFR) can be adopted in CABG and achieve a better graft patency.

Detailed description: CABG is the major treatment of three vessels or left main disease. CAG is the main basis on choosing the vessels to graft, however, some of the grafts occluded shortly after surgery due to competitive flow, these vessels may not be significantly stenosis in functional assessment such as Fractional Flow Reserve (FFR). Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Comparing to FFR, there is no need for pressure wire or ATP when performing QFR. This study plan to investigate the clinical effect of QFR in CABG, all patients included will be allocated 1:1 into two groups: QFR-guided and Angio-guided, QFR-guided group will be performed a CABG based on the result of QFR, the other group will be based on heart team discussion of CAG, CTA will be adopted to evaluate the 1 year graft patency.

Eligibility criteria: Inclusion Criteria:

* patients with evidence of angina pectoris
* left main or three vessels disease, have the indication for CABG after discussion of the heart team
* at least one main vessels stenosis on 40%-70%

Exclusion Criteria:

* former cardiac surgery patients
* need to perform other cardiac or major surgery( i.e. valve surgery, carotid endarterectomy
* emergent CABG
* acute myocardial infarction time less than 7 days
* life expectancy less than 3 years

Primary outcomes:
measure: The rate of graft patency
timeFrame: 12 months
Secondary outcomes:
measure: Major adverse cardiovascular event(MACE)
timeFrame: 12 months
measure: The rate of angina relief
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Ran Dong, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03855020: Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients
Official title: Serial Epstein-Barr Virus DNA Surveillance During Treatment in Non-metastatic Nasopharyngeal Carcinoma Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Keywords: plasma EBV DNA
nasopharyngeal carcinoma
longitudinal surveillance
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically confirmed, non-metastatic, previously untreated nasopharyngeal carcinoma (NPC) will be invited to join this study.

Brief summary: Endemic nasopharyngeal carcinoma (NPC) is invariably associated with Epstein-barr virus (EBV) infection. Plasma EBV DAN detected by polymerase chain reaction (PCR)-based assays can provide important informations of disease screening, disease relapse, and risks classification. In this study, the investigators will explore the impact of serial plasma EBV DNA during chemotherapy and radiotherapy on initial tumor response and long-term survival in patients with non-metastatic nasopharyngeal carcinoma


Eligibility criteria: Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type)
2. No evidence of distant metastasis (M0)
3. Receive standard radical treatment
4. Not exhibiting overt psychopathology, and willing to participate and written informed consent was obtained

Exclusion Criteria:

1. WHO type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
2. Treatment with palliative intent
3. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
4. Severe intercurrent disease

Primary outcomes:
measure: Progression-free survival
timeFrame: 3 years
Secondary outcomes:
measure: overall survival
timeFrame: 3 years
measure: Distant metastasis-free survival
timeFrame: 3 years
measure: locoregional failure-free survival
timeFrame: 3 years
measure: EBV DNA clearance rate
timeFrame: during the first month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT01537120: Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2)
Official title: Evaluation of Continuous Glucose Monitoring as a Tool to Measure Glucoregulatory Effects of a Twice Daily Oral Insulin Secretagogue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-02-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This trial will attempt to develop the use of Continuous Glucose Monitoring (CGM) as a tool for the evaluation of both new and existing pharmacological treatments for type 2 diabetes, using the twice daily administered dipeptidyl peptidase-4 (DPP4) inhibitor, vildagliptin as a probe. The primary hypothesis is that two weeks of treatment with 50 mg of oral Vildagliptin, twice daily will lead to a statistically significant decrease in 24 hour weighted-mean glucose (WMG) relative to placebo.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes mellitus on a clinical regimen that is metformin alone, up to a maximum of 3 gram per day, on a background of lifestyle measures, and has a Hemoglobin A1C at screening of \> 7%.
* If on antihyperglycemic therapy with both metformin and sulfonylurea with a Screening Visit/Visit 1 Hemoglobin A1C of \>= 6.5% and =\< 7.5%, should then discontinue sulfonylurea usage and undergo washout of sulfonylurea.

Exclusion Criteria:

* History of either stroke, chronic seizures or major neurological disorder within the last 6 months.
* Untreated hypertension with a blood pressure of \> 160/95 mmHg.
* History of neoplastic disease within the past 5 years.
* History of hypersensitivity to vildagliptin or other DPP4 inhibitors.
* Had major surgery, or donated or lost 1 unit (500 mL) of blood, or participated in another investigational study within 4 weeks prior to screen.
* Used any illicit drug or abusively used alcohol within the past 3 months.

Primary outcomes:
measure: 24 Hour Weighted Mean Glucose (WMG) At 2 Weeks
timeFrame: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment
Secondary outcomes:
measure: Hemoglobin A1C (HbA1C) At 2 Weeks
timeFrame: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment
measure: HbA1C At 12 Weeks
timeFrame: At 2 weeks after Placebo treatment and again at 12 weeks after Vildagliptin treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02523820: Nebulized Corticosteroid for Post Extubation Stridor in Children
Official title: Nebulized Corticosteroid for Post Extubation Stridor in Children: A Randomized Double Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stridor
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 144
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy and adverse effect of nebulized corticosteroid to prevent post-extubation stridor in children.

Detailed description: The guideline for prevention and treatment of post-extubation stridor in children is inconclusive include Nebulized epinephrine and intravenous corticosteroid. Nebulized corticosteroid is alternative treatment for viral croup. the rationale of this study to evaluate the efficacy of nebulized fluticasone propionate to prevent pediatric post-extubation stridor

Eligibility criteria: Inclusion Criteria:

* Children age between 1 month old - 18 year old who was intubated

Exclusion Criteria:

* Palliative care
* Anatomical abnormalities of airway; subglottic stenosis
* Neuromuscular disease with negative inspiratory force \< - 30 mmHg
* Need positive pressure after extubation

Primary outcomes:
measure: post-extubation stridor
timeFrame: 6 hours
Secondary outcomes:
measure: treatment failure
timeFrame: 24 hour
measure: adverse events
timeFrame: 24 hour
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pediatric,Ramathibodi Hospital
Study officials:
affiliation: Ramathibodi Hospital, Mahidol University
name: Nattachai Anantasit, Assist Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prasertsan P, Nakju D, Lertbunrian R, Chantra M, Anantasit N. Nebulized Fluticasone for Preventing Postextubation Stridor in Intubated Children: A Randomized, Double-Blind Placebo-Controlled Trial. Pediatr Crit Care Med. 2017 May;18(5):e201-e206. doi: 10.1097/PCC.0000000000001124.