louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06179732: Field Evaluations of Innovative Tools for Vector-borne Disease Control in Conflict-affected Communities
Official title: Field Evaluations of Innovative Tools for Vector-borne Disease Control in Conflict-affected Communities:A Cluster Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Childhood ALL
Vector Borne Diseases
Keywords: malaria
cluster randomised trial
children
vector borne diseases
Nigeria
Internally Displaced People camps
Lead sponsor: The Mentor Initiative
Sponsor class: OTHER
Collaborators: name: Liverpool School of Tropical Medicine
name: University of Maiduguri
name: US government
name: SCJohnson
First posted: 2023-12-22
Enrollment: 2400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine the effectiveness of a new spatial repellent (called Mesh) at repelling multiple disease vectors and, reducing clinical malaria rates in temporary shelters and camp settings. The design of the study will be a two-armed cluster randomised trial.

By conducting the research in challenging camp settings in the north of Nigeria, the MENTOR Initiative aims to determine whether Mesh can be effective in harsh camp conditions where communities are living in conflict area temporary shelters.


Eligibility criteria: Inclusion Criteria:

* Shelters with 1 or more children from 6-10 years old
* Shelters with an adult/head of the household

Exclusion Criteria:

* Shelters without children from 6-10 years old

Primary outcomes:
measure: entomological outcome: vector density
timeFrame: 7 months
measure: epidemiological outcome: malaria incidence
timeFrame: 7 months
Secondary outcomes:
measure: feasibility, acceptance and uptake of Mesh
timeFrame: 7 months
Other outcomes:
Locations:
city: Haywards Heath
country: United Kingdom
facility: Sara Estecha Querol
state: West Sussex
Study officials:
affiliation: The Mentor Initiative
name: Richard Allan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00734032: A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
Official title: A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients- A Multicenter, Randomized, Double-blind, Placebo-controlled Study of SB-480848 to Evaluate the Efficacy and Safety -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atherosclerosis
Keywords: SB-480848
Dyslipidaemia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-08-13
Enrollment: 107
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to examine the effects of SB-480848 on plasma lipoprotein associated phospholipase A2 (Lp-PLA2) activity in dyslipidemic patients during a 4-week treatment with SB-480848.


Eligibility criteria: Inclusion criteria:

Dyslipidemic subject who is currently undergoing statin therapy and no change in lipid-lowering therapy or dose during the 4 week prior to randomization

Exclusion criteria:

1. Recent (i.e.,\<6 months prior to screening) CV event and/or vascular procedure defined as:

   A)ST-elevation MI or non-ST-elevation MI B)Unstable angina C)Coronary revascularization \[(percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)\] D)Stroke of any etiology E)Peripheral arterial disease with critical limb ischemia (resting pain or ischemic skin lesions, either ulcers or gangrene) F)Resuscitated cardiac arrest
2. Planned CABG or planned PCI or planned major non-cardiac surgery within study period
3. No measurable Lp-PLA2 activity in plasma (\<10 nmol/min/mL) at screening
4. Change in a lipid-lowering medication, regimen or dosage during the 4 week prior to randomization
5. Poorly controlled dyslipidemia (LDL-c \>=160 mg/dL) at screening

Primary outcomes:
measure: Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity
timeFrame: Baseline (Week 0, Visit 2) and Week 4
Secondary outcomes:
measure: Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time
timeFrame: Baseline (Week 0, Visit 2) up to Follow-up (up to Week 7)
measure: Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up
timeFrame: Baseline (Week 0, Visit 2), Week 1, Week 2 and Follow-up ( Week 7)
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04610632: Home Pregnancy Test Study on BioBank Samples
Official title: Home Pregnancy Test Study Lay User Study on BioBank Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2020-10-30
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General public

Brief summary: This is a non-clinical lay user study using stored clinical samples from the SPD BioBank.

Volunteers recruited into the study and meeting the criteria will test a randomised pregnant or not pregnant urine sample sourced from SPD's biobank with a new home pregnancy test. Volunteers will be required to follow the product instructions for use (IFU).

The order of testing will be randomised prior to execution of the protocol, and each urine sample will only be identifiable by a unique reference number. An independent study technician not involved in study conduct will be responsible for blinding the samples.

Detailed description: Women will be informed of the opportunity to participate in a study in which they will be required to use a home pregnancy test to test a urine sample provided to them. Interested applicants will be invited to join the study.

Volunteers will be advised that the product they will be testing is under investigation and that the volunteer will not be testing their own urine and therefore volunteers will not learn their own pregnancy status.

Volunteers will be required to consent to the study prior to participation. Each volunteer will test only one device, they will be provided with one investigational device and one urine sample. The order of testing will be randomised prior to execution of the protocol, and each urine sample will only be identifiable by a unique reference number.

When ready the volunteer will be required to read the IFU prior to testing the urine sample provided with the investigational device according to the instructions. The volunteer will advise the study technician of the result, who will record this on the result sheet.

Eligibility criteria: Inclusion Criteria:

* Female
* Aged ≥18 years
* Willing to give informed consent

Exclusion Criteria:

* Currently or previously employed by SPD, Abbott, Alere, Unipath, P\&G or affiliates
* Has an immediate relative currently or previously (within last 5 years) employed by SPD, Abbott, Alere, Unipath or P\&G or affiliates
* Is a qualified or trainee Healthcare Professional (HCP)
* Has professional experience of using dipstick type tests or lateral flow devices
* Has previously taken part in this study
* Seen the product within the past 6 months

Primary outcomes:
measure: Agreement with confirmed pregnancy result
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: SPD Development Company Ltd.
state: Bedfordshire
Study officials:
affiliation: SPD Development Company Ltd
name: Sarah Johnson
role: STUDY_DIRECTOR
References:
Clinical trial NCT00708032: Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.
Official title: Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Manchester
First posted: 2008-07-02
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study seeks to evaluate the impact of wearing a new daily disposable soft contact lens on the neophyte population.


Eligibility criteria: Inclusion Criteria:

1. They are of legal age (18 years) and capacity to volunteer.
2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
7. They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
7. They are pregnant or lactating.
8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
10. They have diabetes.
11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Primary outcomes:
measure: Papillary Conjunctivitis
timeFrame: 12 months
Secondary outcomes:
measure: Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.
timeFrame: at 12 months
measure: Visual Acuity After 12 Months of Wear
timeFrame: at 12 months
measure: Subjective Overall Comfort After 12 Months of Daily Wear
timeFrame: at 12 months
measure: Subjective Overall Vision After 12 Months of Daily Wear
timeFrame: at 12 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research, The University of Manchester
state: Greater Manchester
Study officials:
References:
Clinical trial NCT04485832: Telehealth Could Mitigate Disease Progression Compared to Standard of Care in COPD - a Randomized Controlled Trial
Official title: Telehealth Could Mitigate Disease Progression Compared to Standard of Care in COPD - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 168
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of this randomised controlled trial is to test, whether telehealthcare can improve HRQOL and reduce emergency admissions and hospitalisations due to AECOPD. Different outcome parameters as described in the endpoints section will be analysed.


Eligibility criteria: Inclusion Criteria:

* COPD GOLD B-D and age ≥ 40 years

Exclusion Criteria:

* Inability to provide informed consent or to follow trial procedures

Primary outcomes:
measure: Change of COPD assessment test (CAT) at 6 months (slope of the linear regression trend)
timeFrame: 1 year after inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05512832: In-stent Restenosis and Pericoronary Fat Attenuation Index
Official title: Construction and Evaluation of Clinical Prediction Model of In-stent Restenosis After Percutaneous Coronary Intervention by Pericoronary Fat Attenuation Index and Radiomics Characteristics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: In-stent Restenosis
Keywords: pericoronary fat attenuation index
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 126
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with coronary heart disease who have undergone PCI and followed up angiography 9 to 24 months after PCI

Brief summary: This study aims to investigate the predictive value of fat attenuation index (FAI) and related radiomics characteristics of pericoronary fat in patients after percutaneous coronary intervention (PCI) for the occurrence of in-stent restenosis (ISR) during the follow-up period (9 to 24 months). The results of this study are expected to provide an early assessment of the inflammation around the coronary lesion segment in patients after PCI, and provide a basis for early targeted intensive drug therapy in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients with coronary heart disease who have undergone PCI;
* Patients followed up coronary angiography 9 to 24 months after PCI;
* Patients received chest CT examination during inpatient/outpatient follow-up;

Exclusion Criteria:

* Patients with diseases of the immune system;
* Patients with history of tumor diseases;
* Patients with chronic/acute infectious diseases;
* Image quality is not sufficient for analysis;

Primary outcomes:
measure: Fat attenuation index (FAI)
timeFrame: 2022.8.15-2023.8.14
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cardiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Song Ding
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01519232: A Study of Changes in Hepatic Function During Radiation Therapy Using Hepatobiliary Single Photon Emission Tomography (SPECT)
Official title: A Pilot Study of Changes in Hepatic Function During Radiation Therapy Using Hepatobiliary SPECT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2012-01-26
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cancer patients undergoing radiation of the Liver

Brief summary: Radiation-induced liver disease (RILD) is a syndrome characterized by the development of anicteric ascites approximately 2 weeks to 4 months after hepatic irradiation. Previous studies have shown that both the volume of liver irradiated and the dose of radiation delivered are prominent factors for development of RILD. While use of a population-based normal tissue complication probability model allows investigators to limit the risk of RILD to a clinically acceptable level, a test that permits investigators to determine an individual's risk of RILD during the course of treatment may allow for individualized treatment modifications, either to prevent toxicity or increase efficacy.

Detailed description: Early, but subclinical physiologic changes in the liver may be associated with the future development of RILD. There are currently limited data on how a local change in hepatic function associates with regional radiation dose, and how the change of hepatic function during and after radiation therapy (RT) associates with RILD. In the present study, a radiological methodology that is minimally invasive will be used to measure volumetric hepatic functions in patients with intrahepatic malignancies before, during, and after a course of fractioned radiation therapy.

Eligibility criteria: Inclusion Criteria:

* cancer patients undergoing radiation of the Liver
* women and men who agree to avoid pregnancy
* life expectancy of at least 6 months

Exclusion Criteria:

* pregnant women
* breatsfeeding women
* prisoners

Primary outcomes:
measure: Changes in hepatobiliary single photon emission tomography (SPECT) after radiation therapy
timeFrame: 6 months
Secondary outcomes:
measure: measuring values between regional radiation dose and local hepatic function as measured by hepatobiliary SPECT, in normal liver parenchyma
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Mary Feng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04051632: Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)
Official title: Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biomedical Technology
Type 1 Diabetes
Keywords: Medtronic 670G
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 96
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Single institution clinic population.

Brief summary: Observational study of patients at Boston Childrens Hospital with type 1 diabetes (T1D) who elected to treat their diabetes with the Medtronic 670 G hybrid closed loop insulin pump.

Detailed description: Outcome study of 90-100 patients with type 1 diabetes who elected to use the Medtronic 670G.

Major outcome measure was to assess the percent of patients who were able to successfully continue to use the 670G technology over time.

Additional outcome variables included hemoglobin A1c pre and post treatment with the 670G, time in desired glucose range 70-180.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of T1D
* patient of Boston Childrens Hospital diabetes program
* deemed to be adequate candidates for hybrid closed loop technology by their diabetes health care team
* patient received Medtronic 670G training at Boston Childrens Hospital
* patient received follow up diabetes care at Boston Childrens Hospital for at least 3 months after starting on the 670G

Exclusion Criteria:

* patients not trained at Boston Childrens Hospital or self started

Primary outcomes:
measure: Successful implementation of hybrid closed loop technology
timeFrame: 0-24 months
Secondary outcomes:
measure: Impact of hybrid closed loop technology on glycemic control
timeFrame: 0-24 months
measure: Assess impact of hybrid closed loop technology on glycemic control by analysis of sensor glucose data.
timeFrame: 0-24 months.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Childrens Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Gregory Goodwin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05793632: Quetiapine in Prevention of Delirium
Official title: Role of Quetiapine in the Prevention of ICU Delirium in Elderly Patients at a High Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Delirium
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim is to study the effectiveness of Quetiapine in preventing delirium in the elderly patients with multiple risks for delirium.


Eligibility criteria: Inclusion Criteria:

* Patients with anemia
* Sedated patients
* Hypotensive patients
* Immobilized patients
* Patients with visual or auditory impairment

Exclusion Criteria:

* Patients or guardians refuse to participate
* Patients diagnosed with delirium
* Contraindication for delirium

Primary outcomes:
measure: Quetiapine in preventing delirium
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Faculty of medicine, Ain Shams University
name: Walid Kamel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05776732: Effect of CaviionTM Precaution Medical Adhesive-related Skin Injury in Tumor Patients With PICC Catherizaion
Official title: Effect of CaviionTM Precaution Medical Adhesive-related Skin Injury in Tumor Patients With PICC Catherizaion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tumour
Keywords: PICC
medical adhesive-related skin injury
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3M CaviionTM
Primary purpose: PREVENTION

Brief summary: Malignant tumor patients are at high risk of medical adhesive-related skin injury（MARSI）.MARSI can cause local skin ulceration, increase the difficulty of fixation and maintenance frequency, even cause unplanned extubation, and increase the pain and economic burden of the patient's re-installation.Malignant tumor patients with long-term PICC are prone to MARSI.CaviionTM can form a protective film on the skin.Applying CaviionTM before using the adhesive can effectively protect the skin and reduce the occurrence of rash.In China, CaviionTM is mostly used in infants and young children, but adults lack corresponding report and application data.Therefore, it is necessary to carry out corresponding randomized controlled study on adult patients, especially malignant tumors

Detailed description: The incidence of medical viscose-related skin injury after PICC intubation is as high as 33.15%. The main types of injury are mechanical injury, moisture-related skin injury, contact dermatitis 8.02%, folliculitis.After radiotherapy and chemotherapy, patients with malignant tumors interfere with the formation of new damaged skin cells.Large doses of immunosuppressive agents further weaken the skin barrier and are prone to skin metabolism and immune function disorder.In this study, patients with malignant tumor after PICC intubation were randomly assigned.The experimental group uses CaviionTM, and the control group does not use CaviionTM. Observe the skin condition one month after the tube placement

Eligibility criteria: Inclusion Criteria:

* For malignant tumor patients newly implanted with PICC,indwelling catheter for more than 1 month，Conduct catheter maintenance in my hospital during observation

Exclusion Criteria:

* People with skin disease around PICC tube，Psychopath

Primary outcomes:
measure: Incidence of medical viscose-related skin injury
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 石芸
state: ZhwJiang
Study officials:
References: