louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00930956: Comparison of Different Types of Resistant Starch
Official title: Resistant Starch Type 2 and Cross Linked Resistant Starch Type 4 on Blood Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Keywords: Diabetes
Obesity
Hyperglycemia
Dietary Fiber
Wheat
Grain
Lead sponsor: Kansas State University
Sponsor class: OTHER
First posted: 2009-07-02
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study is to determine whether different types of resistant starch have different effects on blood glucose in healthy adults.

Detailed description: Each volunteer will visit the laboratory in a 10-12 hour fasted state on three occasions over a three-week period, up to two visits/wk, with at least 48 hours between visits. Volunteers will be asked to refrain from vigorous physical activity and the consumption of alcohol the day before each testing visit. Randomization using a Latin Square design was applied to minimize confounding issues associated with the order of administration.

In the morning of each test, a finger-prick capillary blood samples will be collected to determine fasting (baseline) blood glucose levels. The volunteers will then consume the test solution assigned for that trial. Ten minutes will be allowed for the test solution to be consumed. Over the two hours following the start of each test, finger-prick capillary blood samples were collected at 30, 60, 90, and 120 min. Blood glucose levels will be immediately measured in duplicate using an automated blood glucose analyzer (YSI 2300, Yellow Springs, OH). Analysis of the collected sample was repeated if the difference between duplicate samples was greater than 0.1 mmol/L. Once the samples were analyzed, the data was entered and the incremental area under the curve was calculated using the trapezoidal model (GraphPad v5.0, La Jolla, CA).

Eligibility criteria: Inclusion Criteria:

* apparently healthy

Exclusion Criteria:

* diagnosis of any chronic disease
* wheat allergy

Primary outcomes:
measure: Blood glucose
timeFrame: Acute response -- fasting and 30, 60, 90 and 120 minutes post-ingestion
Secondary outcomes:
Other outcomes:
Locations:
city: Manhattan
country: United States
facility: Human Metabolism Laboratory (K-State Univ.)
state: Kansas
Study officials:
affiliation: Kansas State University
name: Mark D Haub, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04126356: VIDEOLARYNGOSCOPY STUDY OF THE LPEC
Official title: Evaluation of the Impact of the Sellick Manoeuvre or Para-tracheal Compression of the Cervical Esophagus on the Displacement of the Laryngeal Mass and the Visualization of the Vocal Cords
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngoscopy
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients undergoing general anaesthesia

Brief summary: Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression.

Detailed description: Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression.

Eligibility criteria: Inclusion Criteria:

* Adults patients undergoing general anaesthesia

Exclusion Criteria:

* pregnant women
* people with facial
* oropharyngeal abnormalities

Primary outcomes:
measure: Distance between oesophagus and trachea
timeFrame: During laryngoscopy procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University of Liege, University Hospital
Study officials:
References:
Clinical trial NCT00378456: Vitamins and Minerals for Children With Downs Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trisiomy 21 (Down Syndrome)
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2006-09-20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 7
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The trial aimed to examine the effects of supplementation with antioxidants and folinic acid on the health, growth and psychomotor development of children with Down syndrome. 156 children with Trisomy 21, less than 7 months of age were recruited and randomised into four groups to receive antioxidants, folinic acid, a combination of antioxidants and folinic acid or a placebo. Blinded outcome assessment was carried out 18 months later.Blood and urine samples were also taken around 12 months of age to examine metabolic effects of supplementation.


Eligibility criteria: Inclusion Criteria:

* Under 7 months of age
* Trisomy 21
* Live in recruitment Area-i.e. London inside M25, in West Midlands or SW England.
* One parent speaks English

Exclusion Criteria:

* No life threatening cardiac disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Institute of Child Health
city: Exeter
country: United Kingdom
facility: Peninsular Medical School
city: London
country: United Kingdom
facility: Institute of Child Health, London
Study officials:
affiliation: Peninsular Medical School, Exeter
name: Stuart Logan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellis JM, Tan HK, Gilbert RE, Muller DP, Henley W, Moy R, Pumphrey R, Ani C, Davies S, Edwards V, Green H, Salt A, Logan S. Supplementation with antioxidants and folinic acid for children with Down's syndrome: randomised controlled trial. BMJ. 2008 Mar 15;336(7644):594-7. doi: 10.1136/bmj.39465.544028.AE. Epub 2008 Feb 21.
citation: Ellis J, Logan S, Pumphrey R, Tan HK, Henley W, Edwards V, Moy R, Gilbert R. Inequalities in provision of the Disability Living Allowance for Down syndrome. Arch Dis Child. 2008 Jan;93(1):14-6. doi: 10.1136/adc.2006.112839. Epub 2007 Mar 7.
Clinical trial NCT04399356: Niclosamide for Mild to Moderate COVID-19
Official title: Niclosamide for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: SARS-CoV-2
Coronavirus
Treatment
Pill
Telehealth
Viral shedding
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded randomized controlled trial.
Primary purpose: TREATMENT

Brief summary: This study will evaluate the antihelmintic drug, Niclosamide, as a potential treatment for mild to moderate coronavirus disease 2019 (COVID-19).

Detailed description: Niclosamide, which has potent antiviral activity against single-stranded RNA viruses including coronaviruses, was proposed as an antiviral during the Severe Acute Respiratory Syndrome (SARS) outbreak in 2002 and has activity including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) where it was found to inhibit SARS coronavirus, SARS-CoV, in in vitro studies and similarly structured RNA viruses (both in vitro and in vivo). The investigators hypothesize that the antiviral activity of Niclosamide may be extended to COVID-19.

Eligibility criteria: Inclusion Criteria:

* Positive SARS-CoV-2 test by PCR
* No requirement of oxygen supplementation
* Ability to take oral medication

Exclusion Criteria:

* Known allergic reactions to any components of Niclosamide medication
* Participation in another trial or use of any experimental treatment for COVID-19, including chloroquine, hydroxychloroquine, remdesivir, and lopinavir/ritonavir
* Hospitalization or requirement of hospitalization at the time of enrollment

Primary outcomes:
measure: Time to Respiratory Viral Clearance
timeFrame: Reduction in viral shedding as measured by oropharyngeal swab on days, 3, 7, 10, 14.
Secondary outcomes:
measure: Time to Fecal Viral Clearance
timeFrame: Reduction in fecal viral shedding as measured by fecal PCR on days, 3, 7, 10, 14 and 21.
measure: Number of Participants With Progression to Severe COVID-19 Disease
timeFrame: Day 1- 30
measure: Number of Days to Resolution of a Fever
timeFrame: Day 1-30
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Harry P Selker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cairns DM, Dulko D, Griffiths JK, Golan Y, Cohen T, Trinquart L, Price LL, Beaulac KR, Selker HP. Efficacy of Niclosamide vs Placebo in SARS-CoV-2 Respiratory Viral Clearance, Viral Shedding, and Duration of Symptoms Among Patients With Mild to Moderate COVID-19: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2144942. doi: 10.1001/jamanetworkopen.2021.44942.
Clinical trial NCT04496856: Effects of Whey and Collagen on FFM, Muscle Strength and Wound Healing in Elderly Surgical Patients
Official title: The Effects of Whey Protein and Collagen on Fat Free Mass, Muscle Strength and Wound Healing in Elderly Patients Undergoing Elective Knee- or Hip Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Arthritis
Sarcopenia
Knee Arthritis
Keywords: Hip Arthroplasty
Collagen
Whey protein
Knee Arthroplasty
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Herlev and Gentofte Hospital
First posted: 2020-08-03
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to compare the effect of whey protein and collagen on fat free mass, muscle strength, functional ability, wound healing and life quality in elderly patients undergoing elective knee- or hip surgery (defined as elective knee- or hip arthroplasty). The patients are admitted at the department of Orthopaedic Surgery at Herlev Gentofte Hospital.


Eligibility criteria: Inclusion Criteria:

* Age 65+ years
* Scheduled elective knee- or hip surgery
* Must be able to understand and speak danish
* Must be able to chew and swallow food with a regular consistency
* Must be able to consume the assigned protein supplementation
* Must be able to consent participation

Exclusion Criteria:

* Vegan
* Demensia
* Critical complications to the surgery which prevents the patient from participating in the rehabilitation program
* Plasma-creatinin above 250 micromol/L
* Palliative patients
* Known intolerance of whey protein and/or collagen
* Patients with a pacemaker

Primary outcomes:
measure: The difference in fat free mass
timeFrame: Weekly for 30 days
Secondary outcomes:
measure: Wound healing
timeFrame: Weekly for 30 days
measure: Redness and infection
timeFrame: Weekly for 30 days
measure: Handgrip strength
timeFrame: Weekly for 30 days
measure: Extension strength of quadriceps femoris
timeFrame: Weekly for 30 days
measure: Life quality
timeFrame: Weekly for 30 days
measure: Difference in functional ability (NMS)
timeFrame: Weekly 30 days
measure: Difference in Chair stand test
timeFrame: Weekly for 30 days
Other outcomes:
measure: Palatability of the protein supplementation
timeFrame: 30 days
measure: Consistency of the protein supplementation
timeFrame: 30 days
measure: Compliance of the protein supplementation intake
timeFrame: Weekly for 30 days
measure: Rapported side effects
timeFrame: 30 days
Locations:
city: Gentofte
country: Denmark
facility: Herlev/Gentofte Hospital
state: Hellerup
Study officials:
References:
Clinical trial NCT00763256: The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
Official title: The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Periodontal Disease
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test effectiveness of dentifrice in maintaining periodontal health.


Eligibility criteria: Inclusion Criteria:

* Poor glycaemic control as evidenced by an HbA1c of \>6.0% for the past 12 months
* Aged 18 to 75 years
* Able to give informed consent
* Minimum of 12 teeth
* Chronic periodontitis as indicated by periodontal probing depths \>5mm on at least 6 teeth

Exclusion Criteria:

* Pregnancy
* Gross dental caries
* Prosthetic heart valves, a history of infective endocarditis or any other condition requiring antibiotic cover for dental treatment (rheumatic fever, mitral valve prolapse with regurgitation)
* Anticoagulant therapy (excluding asprin)

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: Gingivitis Score (GI)
timeFrame: 12 months
measure: P. Gingivalis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Queensland
country: Australia
facility: Logan Hospital Oral Health Clinic
Study officials:
affiliation: University of Otago
name: Gregory Seymour, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03845556: Clinical Study of Titrating PEEP of Different Methods on Right Heart Function
Official title: Clinical Study of Titrating PEEP of Different Methods on Right Heart Function and Pulmonary Artery Pressure in ARDS Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS, Human
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: Zhongda Hospital
First posted: 2019-02-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population admitted to ICU of Zhongda hospital，diagnosed of medium or serious ARDS。

Brief summary: To observe the influence of different methods titrating PEEP on right heart function and pulmonary artery pressure in ARDS patients .

Detailed description: 30 patients who diagnosed as ARDS were included in this study.Then set PEEP with respectively ARDS net 、EIT and Esophageal Pressure in Breathing Machine . Recorded diameter of right and left ventricular TAM TAPSE pulmonary artery pressure.Objective to evaluate the correlation between the level of PEEP in three methods and the right heart function and pulmonary artery pressure in ARDS patients .

Eligibility criteria: Inclusion Criteria:

* Patients admitted to ICU diagnosed of modecate to severe ARDS (Berlin criteria)
* Patients age between 18 years old and 80 years

Exclusion Criteria:

* Patients with chronic respiratory diseases such as COPD.
* Ventilated because of oesophageal surgery in the previous 12months.
* Patients who cannot obtain clear ultrasound images due to thoracic surgery ,massive pleural effusion.
* Oesophageal bleeding in previous 30 days history of oesophageal varices.
* Facial trauma and surgery.

Primary outcomes:
measure: the function of right heart and pulmonary artery pressure
timeFrame: 2018.4-2019.3
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: southeast university
name: Chun Pan, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02328456: Effect of SMS Reminder and Free Eye Drops on Follow-up Adherence After Trabeculectomy Surgery in Rural China
Official title: A Randomized Controlled Trail to Determine the Impact of a SMS Reminder Associated With Free Eye Drops on Follow-up Adherence After Trabeculectomy Surgery in Rural China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Adherence
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Orbis
First posted: 2014-12-31
Enrollment: 209
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the study is to use a randomized controlled design to determine the impact of a SMS messaging associated with free eye drops intervention on the following outcomes among patients after trabeculectomy surgery in rural China.

Detailed description: SMS message reminder is a system which can sent re-visit information to remind the patient about the revisit time and address. The investigators can use the SMS system to find out if it is a useful to reduce the not-attended rate of the revisit appointment among the rural patients.

Eligibility criteria: Inclusion Criteria:

* All the patients after trabeculectomy surgery in 4 cooperated rural hospitals

Exclusion Criteria:

* Both the patient and his/her caretakers don't have cellphone or the one who has cellphone but don't know how to use the SMS function.

Primary outcomes:
measure: Not-attended rate
timeFrame: up to 1 year
Secondary outcomes:
measure: Knowledge and Attitudes about glaucoma, glaucoma surgery and importance of follow-up using a questionnaire
timeFrame: up to 1 year
measure: Additional factors potentially associated with post-operative follow-up using a patient questionnaire
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Blindness Preventment and Treatment Department
state: Guangdong
Study officials:
affiliation: China,Guangdong,Blindness Preventment and Treatment Department,Zhongshan Ophthalmic Center,510060
name: Nathan G Congdon, MD,MPH
role: STUDY_DIRECTOR
References:
citation: Yang K, Jin L, Li L, Zeng S, Wei R, Li G, Man P, Congdon N. Interventions to Promote Follow-up After Trabeculectomy Surgery in Rural Southern China: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Oct 1;134(10):1135-1141. doi: 10.1001/jamaophthalmol.2016.2819.
Clinical trial NCT01097356: The Effect of Probiotics on the Clearance of the Human Papillomavirus and on Cytological Lesions Caused by the Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV-related Cytological Abnormalities on PAP Smear (LSIL)
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2010-04-01
Enrollment: 60
Sex: FEMALE
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: Aim: In this project proposition the investigators would like to examine the effect of immune modulation by probiotics on the clearance of HPV-infections.

This study provides a model for viral infection but also for cancer precursors. This would be an excellent model (and the only possible short-term model) to examine an effect on cancer precursors. Cancer precursors (cytological abnormalities such as L-SIL) are a scientifically accepted surrogate endpoint for cervical cancer, for example in HPV-vaccine studies.

Research question: Does daily intake of probiotics lead to a better immune-response in HPV-infected women, i.e. does it facilitate clearance of the virus and/or regression of cytological lesions?


Eligibility criteria: Inclusion Criteria:

* women with a new LSIL diagnosis an HPV positivity on PAP smear

Exclusion Criteria:

* women over 65
* immunocompromised patients (because of disease or drugs)

Primary outcomes:
measure: 1.proportion of HPV positives in both arms
timeFrame: 6months
measure: 2. proportion of regression of LSIL lesion in both arms
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: Veronique Verhoeven
Study officials:
affiliation: Universiteit Antwerpen
name: veronique verhoeven, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02576756: Retrospective Study in Patients Who Have Had a Difficult Intubation.
Official title: Retrospective Study of the Risk of Aspiration and Postoperative Pulmonary Problems in Patients Who Have Had a Difficult Intubation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aspiration
Pneumonia
Keywords: Risk on aspiration
Postoperative
Difficult Intubation
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patients who had an intubation where another device than a laryngoscope was necessary

Brief summary: The investigator wants to investigate if there is an increased risk of postoperative pulmonary problems in patients who have had an intubation where there was need for more than a laryngoscope.

Detailed description: A difficult intubation is defined as an intubation in which more than a laryngoscope was needed.

Afterwards patient data retrieved from the Clinical Work Station: age, type of operation and time, date, type of anaesthesia, de tools needed for intubation, time needed for intubation and anaesthesia.

In the Clinical Work Station of the Hospital the investigator will search for the following data in these selected patients: preoperative comorbidities, home medication, type of postoperative pulmonary problems and the treatment that was given, time of hospital stay and which department the patient stayed.

Patients with a difficult intubation will be linked to a patient with a corresponding medical history and type of operation but without a difficult intubation. The investigator will look for the same parameters of these patients in the Clinical Work Station.

By means of an odds-ratio the relative risk of a pulmonary complication after a difficult intubation in connection with an easy intubation with different variables can be calculated.

Eligibility criteria: Inclusion Criteria:

* Every patient who had an intubation where another device than a laryngoscope was necessary

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Relative risk for postoperative pulmonary incidents
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Josia B Glissenaar, Med student
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Jan Poelaert, PhD MED
role: STUDY_CHAIR
References: