louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00990093: A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study
Official title: A Randomised, Cross-over, Open-labelled Study Evaluating the Acceptance of Test Catheters Compared to SpeediCath Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2009-10-06
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.

Detailed description: See brief summary

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Has normal/impaired sensation in the urethra
* Self-catheterises at least 4 times per day
* Has used clean self-intermittent catheterisation for at least 14 days
* Is able to open and prepare the catheters for catheterisation
* Has signed the informed consent before any study related-activities.

Exclusion Criteria:

* Has a symptomatic urinary tract infection as assessed by the investigator
* Is mentally unstable as assessed by the investigator

Primary outcomes:
measure: Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hornbæk
country: Denmark
facility: Klinik for Rygmarvsskader
Study officials:
affiliation: Klinik for Rygmarvsskader, Rigshospitalet
name: Fin Biering-Sørensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.
citation: Chartier-Kastler E, Lauge I, Ruffion A, Goossens D, Charvier K, Biering-Sorensen F. Safety of a new compact catheter for men with neurogenic bladder dysfunction: a randomised, crossover and open-labelled study. Spinal Cord. 2011 Jul;49(7):844-50. doi: 10.1038/sc.2011.5. Epub 2011 Feb 22.
Clinical trial NCT00425893: A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households
Official title: A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: influenza
masks
transmission
hand hygiene
non-pharmacologic interventions
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: The University of Hong Kong
First posted: 2007-01-23
Enrollment: 6069
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will test the effectiveness of face masks and hand cleaning in preventing the spread of influenza within households

Detailed description: Randomised controlled trial of surgical masks and alcohol hand wash among approximately 6069 Hong Kong residents who have a household member diagnosed with influenza. Influenza in index member and secondary infection will be documented with rapid influenza tests and PCR. Minimal risk to participants.

Eligibility criteria: Inclusion Criteria:

* Member of family with influenza infected member

Exclusion Criteria:

* Age less than 2 yr

Primary outcomes:
measure: secondary influenza infection
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: University of Hong Kong
state: Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Benjamin J Cowling, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cowling BJ, Chan KH, Fang VJ, Cheng CK, Fung RO, Wai W, Sin J, Seto WH, Yung R, Chu DW, Chiu BC, Lee PW, Chiu MC, Lee HC, Uyeki TM, Houck PM, Peiris JS, Leung GM. Facemasks and hand hygiene to prevent influenza transmission in households: a cluster randomized trial. Ann Intern Med. 2009 Oct 6;151(7):437-46. doi: 10.7326/0003-4819-151-7-200910060-00142. Epub 2009 Aug 3.
citation: Cowling BJ, Fung RO, Cheng CK, Fang VJ, Chan KH, Seto WH, Yung R, Chiu B, Lee P, Uyeki TM, Houck PM, Peiris JS, Leung GM. Preliminary findings of a randomized trial of non-pharmaceutical interventions to prevent influenza transmission in households. PLoS One. 2008 May 7;3(5):e2101. doi: 10.1371/journal.pone.0002101.
Clinical trial NCT01117493: Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis
Official title: Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis
Lead sponsor: Belfast Health and Social Care Trust
Sponsor class: OTHER
Collaborators: name: University of Ulster
First posted: 2010-05-05
Enrollment: 64
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 aim of this exploratory randomized controlled trial was to investigate the efficacy of a disease specific Expert Patient Programme compared to usual care in patients with bronchiectasis. Hypothesis: Disease specific EPP will increase self efficacy compared to usual care.


Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years) with a primary diagnosis of bronchiectasis based on a respiratory physician's assessment including a computed tomography scan were included in the study

Exclusion Criteria:

* Primary diagnosis of cystic fibrosis
* Patients with methicillin-resistant Staphylococcus aureus infection
* Patients with any condition that would have an impact on the assessment procedures (e.g. sensory impairment, pregnancy, language barriers)
* Any factor that would prevent adherence to the self-management programme.

Primary outcomes:
measure: Self-efficacy
timeFrame: 8 months
Secondary outcomes:
measure: Perception of illness
timeFrame: 8 months
measure: Health related quality of life
timeFrame: 8 months
measure: Self rated health
timeFrame: 8 months
measure: Lung function
timeFrame: 8 months
measure: Rate of exacerbation
timeFrame: 8 months
Other outcomes:
Locations:
Study officials:
affiliation: Belfast Health and Social Care Trust & University of Ulster
name: Judy M Bradley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01313871: Assessment of the Disease Severity and Treatment Patterns of Rheumatoid Arthritis in Eastern Europe, Middle East and North African Countries (P08167)
Official title: Cross-sectional Study of Disease Severity and Treatment Patterns of Rheumatoid Arthritis, in Eastern Europe Middle East and North Africa
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Arthritis, Rheumatoid
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-03-14
Enrollment: 0
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: Adults with a confirmed diagnosis of rheumatoid arthritis

Brief summary: The study will assess the disease severity and treatment patterns of rheumatoid arthritis in Eastern European, Middle Eastern, and North African countries.


Eligibility criteria: Inclusion Criteria :

* Confirmed diagnosis of rheumatoid arthritis, preferably based upon criteria established by the American College of Rheumatology (ACR) 1987
* clinical signs \& symptoms
* data obtained from previous laboratory and instrumental examination, which may include but is not limited to: Radiography, Blood tests
* Written informed consent, signed before participation in the study.

Exclusion Criteria :

* Refusal to participate in the study
* Age under 18 years

Primary outcomes:
measure: Number of participants with low, moderate, or high disease activity as assessed by the Disease Activity Score using 28 joint counts (DAS28)
timeFrame: Day of enrollment (Day 0)
Secondary outcomes:
measure: The number of participants with rheumatoid arthritis visiting participating sites in the course of one year
timeFrame: One year
measure: Number of participants with different degrees of disability as assessed by the Health Assessment Questionnaire (HAQ).
timeFrame: Day of enrollment (Day 0)
measure: Number of participants treated with non-steroidal anti-inflammatory drugs (NSAIDs), disease-modifying anti-rheumatic drugs (DMARDS), corticosteroids, and/or biologics
timeFrame: Day of enrollment (Day 0)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00776971: Effect of Carbonated Soft Drinks on Appetite-Regulation
Official title: Carbonated Soft Drinks May Alter Appetite Sensation and Appetite-Regulating Hormone Level and Lead to Increased Energy Intake.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diet
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: LG Life Sciences
First posted: 2008-10-22
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER

Brief summary: Compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation leading to obesity development. Although drinks sweetened with aspartame are available the anticipated positive effect of these drinks on obesity development has not been convincing. However, the mechanisms linking drinks intake to obesity are yet to be clarified.

The investigators aim is to investigate the short-term effects of soft drinks (sugar-sweetened and artificially sweetened (aspartame)), milk and water on the concentration of circulating appetite-regulating hormones, the subjective sensations of hunger and satiety (measured by visual analogue scales) and energy intake. The study is a crossover, intervention trial with 24 overweight, healthy volunteers. The subjects will be tested on four separate days for four hours. Each test day a preload drink (sugar-sweetened soft drink, aspartame-sweetened soft drink, semi-skimmed milk or water) is served.

The investigators expect to clarify the mechanisms linking drinking habits to obesity development and provide scientifically based nutritional guidelines.


Eligibility criteria: Inclusion Criteria:

* Age between 20-50 years;
* BMI between 28-36 kg/m2;
* Weight stabile 3 months prior to the study inclusion;
* Less than 10 hours of weekly exercise.

Exclusion Criteria:

* Diabetes
* Allergic to phenylalanine or milk
* Smoking
* Pregnancy or breast-feeding

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Four hours
Secondary outcomes:
measure: Appetite-regulating hormones, Glucose, Insulin; Energy intake
timeFrame: Four hours
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
Study officials:
affiliation: Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
name: Bjørn Richelsen, Professor
role: STUDY_CHAIR
References:
citation: Maersk M, Belza A, Holst JJ, Fenger-Gron M, Pedersen SB, Astrup A, Richelsen B. Satiety scores and satiety hormone response after sucrose-sweetened soft drink compared with isocaloric semi-skimmed milk and with non-caloric soft drink: a controlled trial. Eur J Clin Nutr. 2012 Apr;66(4):523-9. doi: 10.1038/ejcn.2011.223. Epub 2012 Jan 18.
Clinical trial NCT01664793: From Innovation to Solutions: Childhood Influenza Vaccination Planning
Official title: From Innovation to Solutions: Autodialers, Use of Early Autumn Physicals and Vaccination Assessment as a Vital Sign to Increase Childhood Influenza Vaccination in Diverse Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: influenza
vaccination
strategies
children/adolescents
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2012-08-14
Enrollment: 87665
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to increase childhood influenza vaccination rates using the FDA licensed influenza vaccines according to national guidelines in a randomized cluster trial in which primary care offices are randomized to intervention or control with the control group receiving the intervention in the second year.

Detailed description: The investigators will conduct a stratified, randomized cluster trial of 20 diverse primary care practices to compare influenza vaccination rates in intervention and control sites. Intervention sites will use a package of newly developed and evidence-based techniques that will be tailored to their practice structure and culture, called the 4 Pillars Immunization Toolkit, in addition to receiving donated vaccine for early season vaccination. Control practices will not receive such assistance but will receive the intervention in the second year.

Eligibility criteria: Inclusion criteria:

For children: attendance at the selected health care center within the last year and age \>/=6 months thru 18 years.

Exclusion Criteria:

For children: Severe egg allergy or allergy to influenza vaccine

Primary outcomes:
measure: Primary Outcome
timeFrame: 3/1/2011-2/29/2012
Secondary outcomes:
measure: Effectiveness Score
timeFrame: End of February 2012
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh, School of Medicine, Deparment of Family Medicine and Clinical Epidemiology
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh, School of Medicine, Department of Family Medicine and Clinical Epidemiology
name: Richard Zimmerman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Chyongchiou Lin, PhD
role: STUDY_DIRECTOR
References:
citation: Nowalk MP, Lin CJ, Hannibal K, Reis EC, Gallik G, Moehling KK, Huang HH, Allred NJ, Wolfson DH, Zimmerman RK. Increasing childhood influenza vaccination: a cluster randomized trial. Am J Prev Med. 2014 Oct;47(4):435-43. doi: 10.1016/j.amepre.2014.07.003. Epub 2014 Aug 8.
citation: Zimmerman RK, Nowalk MP, Lin CJ, Hannibal K, Moehling KK, Huang HH, Matambanadzo A, Troy J, Allred NJ, Gallik G, Reis EC. Cluster randomized trial of a toolkit and early vaccine delivery to improve childhood influenza vaccination rates in primary care. Vaccine. 2014 Jun 17;32(29):3656-63. doi: 10.1016/j.vaccine.2014.04.057. Epub 2014 Apr 29.
Clinical trial NCT03414593: Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery
Official title: Prospective, Randomized, Single Blind Trial of Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Preemptive Peripheral Nerve Block
Acute Pain
Keywords: preemptive analgic effect
popliteal sciatic nerve block
Bilateral Hallux Valgus
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who underwent surgery on both feet at the same time. One foot is performed before surgery and the other is performed after surgery.
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to investigate the preemptive effect of ultrasound guided popliteal scistic nerve block on postoperative acute pain in patients with bilateral hallux valgus.

After induction of general anesthesia, the leg to be operated first is decided randomly. After the operation of one leg is completed, PSNB is performed on both legs with 0.2% Ropivacaine and surgery is started on the remaining legs.

When the surgery is over, check to see which foot pain begins first, how strong the pain is, and whether there are any side effects.


Eligibility criteria: Inclusion Criteria:

1. adults between the ages of 20 and 80
2. bilateral hallux valgus surgery on the same day
3. ASA class 1 or 2
4. Patients who have voluntarily agreed in writing to participate in the trial

Exclusion Criteria:

1. Patient with side effects on local anesthetics or steroids
2. Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc.
3. Patients with uncontrolled medical or psychiatric problem
4. Patient does not agree to participate in the study
5. Patients who are pregnant or lactating

Primary outcomes:
measure: Analgesic duration of nerve block
timeFrame: at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1
Secondary outcomes:
measure: Difference of analgesic consumption between both group
timeFrame: at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1
measure: side effect of popliteal sciatic nerve block
timeFrame: at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: Asan Medical Center
name: JongHyuk Lee, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02422693: Aquatic Exercises for Patients With Chronic Low Back Pain
Official title: Aquatic Exercises Versus Aquatic Exercises Associated to Deep Water-running for Patients With Chronic Low Back Pain: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: hydrotherapy
aquatic
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
name: Fundação Araucária
First posted: 2015-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to compare the effect of aquatic exercises (AEG) to the aquatic exercises plus aerobic training (deep-water running) (AEDWRG) on functional status and pain in patients with specific chronic low back pain.

Detailed description: In general, the population will have at least one episode of low back pain during their lifetime, with recurrence in most cases. Several treatments have been proposed for these patients and the evidence is still not clear about the effectiveness of aquatic exercises when compared to other modalities of exercises in the water. This study will be a randomized controlled trial following the Consort-Statement principles. The subjects, aged between 20 and 50 years, after signing the informed consent will be randomly allocated to one group treatment: aquatic exercises (AEG) or aquatic exercises associated to deep-water running (AEDWRG). The duration of the protocol will be set at 12 weeks, 3x-week.

Eligibility criteria: Inclusion Criteria:

* Exclusive diagnosis of chronic low back pain (more than 12 weeks)

Exclusion Criteria:

* Central nervous system disease
* Pregnant
* Fear of water

Primary outcomes:
measure: Change in Roland-Morris Questionnaire
timeFrame: baseline and 9 weeks
Secondary outcomes:
measure: Change in Pain status
timeFrame: baseline and 9 weeks
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Aquatic Physical Therapy Center "Paulo A. Seibert"
state: Paraná
Study officials:
affiliation: Universidade Estadual de Londrina
name: Jefferson R Cardoso, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06819293: IB-T101 Injection for Treatment of Patients with Advanced Clear Cell Renal Cell Carcinoma
Official title: A Phase I, Open Label, Single Center Study Evaluating the Safety and Efficacy of IB-T101 Injection for Treatment of Patients with Advanced Clear Cell Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Clear Renal Cell Carcinoma
Adult
Lead sponsor: Grit Biotechnology
Sponsor class: INDUSTRY
First posted: 2025-02-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, single center, dose escalation, and dose extension IIT study aimed at evaluating the safety, efficacy, and pharmacokinetics of IB-T101 in adult patients with advanced clear renal cell carcinoma


Eligibility criteria: Inclusion Criteria:

1. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;
2. Age ≥18 years old;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
4. Expected survival time of ≥ 3 months;

Exclusion Criteria:

1. CNS dysfunction with clinical significance. For example, seizures, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, cerebral edema, reversible posterior encephalopathy syndrome, or any autoimmune disease involving the CNS.
2. Any form of primary and acquired immunodeficiency (such as severe combined immunodeficiency). Known human immunodeficiency virus (HIV) positive subjects
3. Have experienced myocardial infarction or unstable angina within the 6 months prior to screening
4. Pleural effusion requiring drainage for symptom management within 28 days prior to screening

Primary outcomes:
measure: Objective response rate
timeFrame: 3 years
measure: AEs
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji hospital, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: