louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00676494: The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions
Official title: A Prospective, Single Arm, Multi-Center Study to Assess Performance of the Pathway PV Atherectomy System During Percutaneous Peripheral Vascular (PV) Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: Pathway Medical Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-13
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in peripheral vasculature.

This is a prospective, single arm, multi-center study to obtain safety and performance data for the Pathway PV Atherectomy System when used as a primary or adjunctive therapy for percutaneous intervention to remove atherosclerotic disease, debris, and thrombus from the lower limb peripheral vasculature.


Eligibility criteria: Inclusion Criteria:

* Documented symptomatic atherosclerotic peripheral vascular disease
* Target lesion(s) is/are located in a superficial femoral, popliteal and/or infrapopliteal arteries
* The patient has been informed of the nature of the study and has provided informed consent
* The patient agrees and has capability to meet study requirements and be present at the follow-up clinic visits

Exclusion Criteria:

* Target lesion is located in the iliac artery.
* Target lesion stenosis is \< 70%.
* Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
* Patient is unable to participate for the duration of the study.
* Patient is currently participating or has participated in a study with another investigational medical device or medication.

Primary outcomes:
measure: Major Adverse Events (MAEs) Within 30 Days
timeFrame: 30 days
Secondary outcomes:
measure: Average Rutherford Classification Score at 6 Months
timeFrame: 6 months
measure: Average Ankle Brachial Index (ABI) at 6 Months
timeFrame: 6 months
measure: Freedom From Target Lesion Revascularization (TLR) at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Herz Zentrum Bad Krozingen, Germany
name: Thomas Zeller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leipzig
name: Dierk Scheinert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeller T, Krankenberg H, Steinkamp H, Rastan A, Sixt S, Schmidt A, Sievert H, Minar E, Bosiers M, Peeters P, Balzer JO, Gray W, Tubler T, Wissgott C, Schwarzwalder U, Scheinert D. One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial. J Endovasc Ther. 2009 Dec;16(6):653-62. doi: 10.1583/09-2826.1.
Clinical trial NCT04762394: Epidemiology of Psychiatric Disorders in Children and Adolescent at Egypt
Official title: Epidemiology of Psychiatric Disorders Among Preschool and School Children and Adolescent in Egypt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Behavior Disorders
Child Mental Disorder
Adolescent Behaviour Disorder
Keywords: child
adolescent
psychiatry
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 400
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This is study will take part in community study( nursery and schools).

Brief summary: Pediatric, developmental and mental health problems are more common than renal, cardiac and renal problems.

Compartmental problems were often conceptualised across two broad spectrums: internalising intrapersonal problems like anxiety, depression and withdrawal and externalising problems such as Interpersonal problems such as hyperactivity and aggression.

Mental disorders with long-term consequences can result in children and adolescents, undermining health compliance and reducing societies' ability to be safe and productive. As, children and adolescent have long-term deteriorating effects of mental health problems are often serious.

Early detection and identification of problems are in the best interest of children, adolescents, their families, and the community as a whole. All three are important.

how epidemiology can help our understanding of children and adolescent mental health: the burden of the community, measurement and tracking highly significant.

This study will display the first large-scale study of psychiatric disorders in children and adolescents in the Egypt . to provide services, including prevention and intervention based on evidence of mental health, a population-representative child survey and adolescent mental estimates disorders were needed urgently


Eligibility criteria: Inclusion Criteria:

1. age of children (2-18 years)
2. both males and females.
3. living in Egypt.

Exclusion Criteria:

* unwilling parent to recruited in the study.

Primary outcomes:
measure: measure the prevalence of DSM 5 psychiatric disorders in the community sample of school children in Assiut government.
timeFrame: through study completion, an average of 1 year
measure: measure of risk factor of DSM 5 psychiatric disorders in the community sample of school children in Assiut government.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: gellan Ahmed
Study officials:
References:
Clinical trial NCT01044394: Same-day, Reduced Volume Bowel Preparation
Official title: Evaluating the Effectiveness of a Same-day, Reduced Volume Polyethylene Glycol + Electrolyte Solution (PEG-ELS) Bowel Preparation for Afternoon Colonoscopies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Bowel Preparation
Keywords: colonoscopy
bowel preparation
polyethylene glycol
Quality in endoscopy
Bowel Preparation for colonoscopy
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2010-01-07
Enrollment: 0
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: We seek to evaluate whether a same day, reduced liquid volume (2liters) polyethylene glycol (PEG-ELS) bowel preparation can achieve adequate colon cleansing in patients scheduled for afternoon colonoscopies. The primary outcome will be adequacy of the bowel preparation. Secondary outcomes will include Boston Bowel Preparation Scale score, patient compliance with completing the preparation, tolerability of the preparation, willingness to repeat the preparation, side effects, duration of procedure (endoscope insertion and withdrawal times), and polyp detection.

Detailed description: The diagnostic accuracy of colonoscopy depends on the quality of the preparation. The adequacy of the preparation determines whether complete visualization of the mucosa and identification of pathologic lesions is achieved. For reasons that are not entirely clear, colonoscopies scheduled in the afternoon have been identified as a risk factor for having an inadequate preparation. Standard bowel preparation regimens at BMC include polyethylene glycol- electrolyte solutions (PEG-ELS) in full (four liters) and reduced (two liters) forms. These laxatives are typically administered either the evening prior to the colonoscopy or in "split dose" (a portion the evening before and a portion the morning of the colonoscopy). The percent of failed colonoscopies due to a fair/poor preparation in our endoscopy unit is 17-20%. Our trial seeks to establish the efficacy and safety of a reduced volume PEG-ELS laxative given on the day of the colonoscopy.

Eligibility criteria: Inclusion Criteria:

* English speaking patients referred for colonoscopy.

Exclusion Criteria:

* Age \< 18,
* Pregnancy,
* History of bowel resection,
* Allergy to PEG-ELS, and
* Inability to provide informed consent.

Primary outcomes:
measure: Primary outcome: adequacy of bowel preparation.
timeFrame: 1 year
Secondary outcomes:
measure: Boston Bowel Preparation Scale scores, subject compliance, subject tolerability, adverse events, colonoscopy insertion & withdrawal time, number of repeat procedures needed due to inadequate bowel preparation, polyp detection, and adenoma detection.
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medicial Center Gastroenterology Department
name: Brian Jacobson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05151094: Registry of Hospitalized Patients in University Hospital Dubrava Respiratory Center
Official title: Registry of Hospitalized Patients in University Hospital Dubrava Respiratory Center
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Covid19
Thrombosis
Bleeding
Sepsis
Mechanical Ventilation Complication
Inflammatory Response
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 6000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that were hospitalized in our institution due to the COVID-19 infection

Brief summary: Aim of this project is to understand clinical features, clinical outcomes and efficacy and safety profiles of different therapies by analyzing a cohort of COVID-19 patients hospitalized and treated in a tertiary-level institution, University hospital Dubrava. Patients' clinical and laboratory characteristics, drug exposure and outcomes are obtained by analysis of written and electronical medical records.

Detailed description: University Hospital Dubrava has been completely repurposed during the COVID-19 pandemic to become high volume COVID-19 tertiary institution. Establishment of hospital registry project is necessary to properly understand disease characteristic, related outcomes and real-life treatment patterns. Registry provides a fundamental framework for future upgrading with emerging or retrogradely obtained specific data that will substantially facilitate understanding of COVID-19 in the context of other specific diseases, therapies and procedures. Large comprehensive database will provide sufficient statistical power to allow for investigation of large number of subgroups and existence of interactions between different variables. Assessment of large number of clinically important outcomes (mortality, occurrence of venous and arterial thromboses, major bleeding, bacteriemia, incidence of mechanical ventilation and intensive care unit admission) is necessary to put any investigated parameter in the proper efficacy and safety context.

Eligibility criteria: Inclusion Criteria:

* all hospitalized patients positive for COVID-19

Exclusion Criteria:

* none

Primary outcomes:
measure: Mortality
timeFrame: At 30-days from hospital admission
Secondary outcomes:
measure: Incidence of venous or arterial thrombotic events
timeFrame: At 30-days from hospital admission
measure: Incidence of major bleeding
timeFrame: At 30-days from hospital admission
measure: Incidence of bacteriemia
timeFrame: At 30-days from hospital admission
measure: Incidence of mechanical ventilation
timeFrame: At 30-days from hospital admission
measure: Incidence of intensive care unit admission
timeFrame: At 30-days from hospital admission
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
state: Grad Zagreb
Study officials:
affiliation: University Hospital Dubrava
name: Marko Lucijanic, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01602094: Immunity to Measles Virus in the Thai Population Age 18-30 Years and Predictive Factors
Official title: Immunity to Measles Virus in the Thai Population Age 18-30 Years and Predictive Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Measles
Keywords: measles
antibody
prevalence
predictors
Donor of National Blood Centre, The Thai Red Cross Society who age 18-30 years old
Measles antibody levels
Predictors of adequate measles antibody levels and inadequate measles antibody levels
Lead sponsor: Queen Saovabha Memorial Institute
Sponsor class: OTHER
First posted: 2012-05-18
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health Thai participant age 18-30 years old.

Brief summary: Prevalence of participants who have protective immunity to measles virus is less than ninety percent.

Predictor of adequate measles antibody levels include the following :

* History of measles infection
* History of complete measles primary immunization( 2 doses with at least 1 month interval after age of 9 months)
* History of measles exposure

Predictor of inadequate measles antibody levels include the following :

* Born outside Thailand
* History of staying outside Thailand for long time in childhood
* Living in the rural area for a long period in childhood
* Fail to participate school system on time


Eligibility criteria: Inclusion Criteria:

* Age 18-30 years old

Exclusion Criteria:

* Last measles vaccination less than 10 years of age
* Immunocompromised host including congenital immune defect, splenectomy or splenic dysfunction, history of suspect HIV exposure, taking immunosuppressant
* Receiving blood or blood product within 3 months
* Receiving others vaccinations or immunoglobulins or any medication that possibly decrease immune response

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Queen Saovabha Memorial Institute
Study officials:
affiliation: Queen Saovabha Memorial Institute
name: Jaruboot Angsanakul, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01362894: Clinical Comparison of Two Daily Disposable Toric Lenses
Official title: Clinical Comparison of Two Daily Disposable Toric Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-06-01
Enrollment: 240
Sex: ALL
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 trial was to compare the performance of two contact lenses commercially available for people with astigmatism.

Detailed description: This trial compared the performance of two commercialized daily disposable contact lenses in Germany.

Eligibility criteria: Inclusion Criteria:

* Sign written informed consent.
* Germany: Be of legal age.
* Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in an ophthalmic clinical trial.
* Wears contact lenses overnight while sleeping.
* Habitual daily disposable contact lens wearer.
* Monovision correction during the study.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Overall Vision
timeFrame: 1 week, replacing lenses daily
measure: Overall Comfort
timeFrame: 1 week, replacing lenses daily
measure: Overall Handling
timeFrame: 1 week, replacing lenses daily
measure: Overall Satisfaction
timeFrame: 1 week, replacing lenses daily
Secondary outcomes:
measure: Ease of Selecting Final Lens Power
timeFrame: Day 0
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06820294: Retrospective WGS Study
Official title: Assessing the Clinical Benefits of Whole Genome Sequencing for Children With Neoplasms
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cancer
Pediatric Cancer
Neoplasm
Lead sponsor: The Wellcome Sanger Institute
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children and young people (up to the age of 21 years) diagnosed with a neoplastic disorder

Brief summary: This retrospective case series reviews clinical notes to assess whether NHS whole genome sequencing provides tangible benefits for paediatric tumours.

Detailed description: The NHSE-commissioned whole genome sequencing programme went live at the end of 2020. It remains as yet unproven, whether this whole genome sequencing programme for children with cancer can deliver tangible benefits in real-time. There is an urgent need, therefore, to assess whether children with tumours who are receiving NHS whole genome sequencing are actually benefiting from this additional assay. This is a retrospective case series. The principal methodology is that of reviewing clinical notes to assess whether children with tumours have benefited from NHSE whole genome sequencing. Apart from the contribution of our work to the scientific literature, this research will inform government on the potential benefits, or lack thereof, of the live NHSE whole genome programme and has the potential to influence policy on whether this programme should be continued.

Eligibility criteria: Inclusion Criteria:

* All children and young people (up to the age of 21 years) diagnosed with a neoplastic disorder who have been offered NHSE whole genome sequencing.

Exclusion Criteria:

* Anyone not offered NHSE whole genome sequencing
* Individuals beyond the age of 21
* Individuals without a neoplastic disorder.

Primary outcomes:
measure: The proportion of children clinically benefiting from whole genome sequencing
timeFrame: 5.5 years
Secondary outcomes:
measure: Relation between mutation data and disease phenotypes
timeFrame: 5.5 years
Other outcomes:
measure: The cost of whole genome sequencing
timeFrame: 5.5 years
Locations:
city: Cambridge
country: United Kingdom
facility: Wellcome Sanger Institute
Study officials:
References:
Clinical trial NCT01006694: Paraprofessional Treatment of Depression in Vietnam
Official title: Paraprofessional Treatment of Depression in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Keywords: depression
collaborative care
Vietnam
behavioral activation
Lead sponsor: Vietnam Veterans of America Foundation
Sponsor class: OTHER
Collaborators: name: RAND
name: Vanderbilt University
First posted: 2009-11-03
Enrollment: 473
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: Trained para-professional health care workers will implement a stepped-care model of depression care in commune health stations in Vietnam.

Detailed description: This project focuses on evaluation of a collaborative care system for treatment of depression in Vietnam. This system involves training para-professional health care workers in a stepped-care model system of depression care to be implemented in commune health stations in Vietnam.

Eligibility criteria: Inclusion Criteria:

1. Age \>=18
2. Depression Diagnosis

Exclusion Criteria: active psychosis, mania, substance abuse, suicidal behaviors, cognitive impairment.

Primary outcomes:
measure: Change across time (random effects slope) in depressive symptoms, as assessed by the PHQ-9 questionnaire
timeFrame: 0, 6, 12, 24 weeks
Secondary outcomes:
measure: Change across time (random effects slope) in anxiety symptoms, as assessed by the GAD-7 questionnaire
timeFrame: 0, 6, 12, 24 weeks
measure: Change across time (random effects slope) in physical health, as assessed by the SF-12 questionnaire, Physical Health subscale
timeFrame: 0, 6, 12, 24 weeks
measure: Change across time (random effects slope) in mental health, as assessed by the SF-12 questionnaire, Mental Health subscale
timeFrame: 0, 6, 12, 24 weeks
measure: Change across time (random effects slope) in behavioral activation skills and behaviors, as assessed by the BADS questionnaire.
timeFrame: 0, 6, 12, 24 weeks
measure: "Substantial improvement" in depressive symptoms, as assessed by the PHQ-9
timeFrame: 6, 12, 24 weeks
measure: "Depression remission", as assessed by the PHQ-9
timeFrame: 6, 12, 24 weeks
Other outcomes:
Locations:
city: Nha Trang
country: Vietnam
facility: Khanh Hoa Provincial Hospital
state: Khanh Hoa
city: Danang
country: Vietnam
facility: Danang Psychiatric Hospital
Study officials:
affiliation: RAND
name: victoria ngo, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01750294: A Pilot Study of Chlorthalidone Among Patients With Poorly Controlled Hypertension and CKD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Poorly-Controlled Hypertension
Keywords: hypertension
kidney disease
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 14
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: It is estimated that in the United States there are approximately 8 million individuals with moderate to severe chronic kidney disease (CKD), not on dialysis. Volume expansion plays an important role in the pathogenesis of hypertension in patients with CKD. For this pilot study, the investigators hypothesize that administration of chlorthalidone among patients with moderate to severe CKD will improve blood pressure (BP).


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years.
* Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2 but ≥20 mL/min/1.73m2.
* Poorly controlled blood pressure by 24-hour ambulatory blood pressure (BP) monitoring.
* Treated hypertension: use of at least one antihypertensive drug. One of the drugs should be either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). If these are contraindicated then use of a beta-blocker is required.

Exclusion Criteria:

* Use of thiazide or thiazide-like drugs in the previous 3 months.
* Use of furosemide in a dose \>200 mg/d.
* Ambulatory BP of either ≥160 systolic or ≥100 mmHg by 24-hour ambulatory BP monitoring.
* Expected to receive renal replacement therapy within the next 3 months.
* Vascular event such as myocardial infarction, heart failure hospitalization, or stroke within 3 months prior to randomization.
* Pregnant or breastfeeding women or women who are planning to become pregnant or those not using a reliable form of contraception (oral contraceptives. condoms and diaphragms will be considered reliable).
* Known hypersensitivity to thiazide or sulfa drugs.
* Organ transplant recipient or therapy with immunosuppressive agents. Nasal or inhaled corticosteroids will be permitted.

Primary outcomes:
measure: Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks
timeFrame: Baseline and 12 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush VAMC
state: Indiana
Study officials:
affiliation: Indiana University
name: Rajiv Agarwal, MD FASN FAHA
role: PRINCIPAL_INVESTIGATOR
References: