louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06187051: Type 1 Endoleak : Fenestrated Custom Made Endograft (FEVAR) Versus Open Surgery Explantation (OSR) : What's the Best
Official title: FEVAR or Open Repair to Treat Type 1 Endoleak : A French Multicentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aorta Aneurysm
Lead sponsor: University Paul Sabatier of Toulouse
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient presenting a type 1A endoleak after EVAR for AAA during the follow up

Brief summary: Proximal type 1A endoleak is a worrying complication after endovascular repair of an abdominal aortic aneurysm (EVAR). The ideal solution is not obvious between relining by FEVAR and endograft explantation.

A retrospective french multicentric study was performed between 2010 and 2023 to compare the outcomes and the efficiency of both technics and propose a decision algorithm for the management of type 1A endoleak after EVAR.


Eligibility criteria: Inclusion Criteria:

* Type 1A endoleak after EVAR

Exclusion Criteria:

* no

Primary outcomes:
measure: Post operative mortality
timeFrame: day 30 post operative
measure: Major adverse cardiovascular event (MACE) post operative
timeFrame: day 30 post operative
measure: Redo surgery after type 1A endoleak surgery
timeFrame: 30 day, 6 months, 12 months, 24 months
Secondary outcomes:
measure: Efficiency of the treatment
timeFrame: 30 day, 6 months, 12 months, 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01526551: A Study to Compare the Impact of a School Based HPV Program on Vaccination Uptake and Completion Rates
Official title: A Study to Compare the Impact of a School Based HPV Vaccination Program on Vaccination Uptake and Completion Rates Among High School Students in Rural, Southeastern Kentucky
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus
Keywords: Human Papillomavirus
Lead sponsor: Lake Cumberland District Health Department
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-02-06
Enrollment: 935
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the impact of a school-based Human Papillomavirus (HPV) vaccination program to determine if the combination of increased disease and vaccine education coupled with the removal of barriers will positively impact the HPV vaccination uptake and completion rates among students.

Detailed description: The purpose of this study is to evaluate the impact of a school-based HPV vaccination program. The intervention will consists of: provision of HPV vaccine information and consent forms for parents delivered in the back-to-school packets; school-nurse delivered student education; removal of barriers (scheduling, transportation and parental presence); changing of social norms; and the provision of free HPV vaccine.

Eligibility criteria: Inclusion Criteria:

* Must have not completed three dose series of HPV vaccine
* Must be a student at Wayne County or Monticello High School in KY

Exclusion Criteria:

* Completed three dose series
* Pregnant
* Contraindication to vaccine ingredients

Primary outcomes:
measure: Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program
timeFrame: August 2012-June 2013
measure: Number of Students Who Completed HPV Vaccination as a Result of the School-based Program
timeFrame: August 2012 -- June 2013
Secondary outcomes:
Other outcomes:
Locations:
city: Monticello
country: United States
facility: Monticello High School
state: Kentucky
city: Monticello
country: United States
facility: Wayne County High School
state: Kentucky
Study officials:
affiliation: Lake Cumberland District Health Department
name: Christine Weyman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02717351: 18841- Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment- Darkening Dose.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-03-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment DArkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04107051: Post-Marketing Surveillance Study of Nalmefene Hydrochloride Hydrate in Patients with Alcohol Dependence
Official title: Nalmefene Hydrochloride Hydrate Tablets 10mg Specified Drug-use Results Survey (the Safety and the Prognosis After Achieving Reduced Alcohol Intake)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Dependence
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-27
Enrollment: 533
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with alcohol dependence who are planned to be newly started on nalmefene hydrochloride hydrate for the treatment of reduction of alcohol consumption.

Brief summary: The purpose of this study is to investigate the safety and the prognosis after achieving reduced alcohol intake in patients with alcohol dependence who received treatment for the reduction of alcohol intake in the routine clinical setting in Japan.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Alcohol Dependence
* Must agree to follow-up during the first year of prescription and publication of survey results
* Patients whose goal of treatment for Alcohol Dependence is to reduce alcohol consumption
* Patients receiving psychosocial treatment aiming to promote treatment adherence and reduction of alcohol consumption
* Patients who have chronic heavy drinking
* Patients who have confirmed that they are willing to receive treatment to reduce their alcohol consumption

Exclusion Criteria:

* Patients who has ever been treated with nalmefene hydrochloride hydrate
* Patients who are contraindicated

Primary outcomes:
measure: Alcohol Use Disorders Identification Test-Consumption(AUDIT-C)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Otsuka Pharmaceutical Co., Ltd.
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Yasuhiko Fukuta, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04404751: Quadruple Fortified Salt Clinical Trial
Official title: Effectiveness of Quadruple Fortified Salt in Improving Hemoglobin Levels Among Anemic Women of Reproductive Age (18-49 Years) in Rural Low Resource Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Lead sponsor: Haydom Lutheran Hospital
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: Tanzania Food and Drugs Authority
First posted: 2020-05-27
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Anaemia is the world leading cause of disability and is responsible for about more than 115,000 maternal deaths and 591,000 perinatal deaths per year, of which 3/4 occur in Africa and Asia. Despite the fact that there are several causes of anemia, the most important causes are due to micronutrients deficiency, namely iron, Folic acid and Vitamin B12. Low intakes of these micronutrients consequently affect a woman's health, pregnancy outcome and the nutritional status of breast-fed children. With these in mind we wish to test the effectiveness of salt fortified with these four micronutrients (Iodine, Iron, Folic acid and vitamin B12) in raising the Hemoglobin levels among the non-pregnant and non-lactating women of reproductive age.

Detailed description: Anaemia is the low level of Haemoglobin based on the location. As per WHO a woman is termed anaemic if has HB \<11g/dl but in high attitude is =\<13g/dl

Eligibility criteria: Inclusion Criteria:

* Adult with relative low haemoglobin (Hb level 8g/dl to 13g/dl)
* Able to eat food cooked with salt
* Able to give consent

Exclusion Criteria:

* Planning to become pregnant within the study period,
* chronically ill,
* have haematological diseases during study time,
* restricted to use salt in food

Primary outcomes:
measure: Haemoglobin level
timeFrame: 10 months of consuming fortified salt
Secondary outcomes:
measure: Iron store replenishment
timeFrame: 10months of intervention
Other outcomes:
Locations:
city: Manyara
country: Tanzania
facility: Haydom Lutheran Hospital
Study officials:
References:
Clinical trial NCT02920151: Effects of Balance Exercises Circuit in Patients With Hip or Knee Arthroplasty
Official title: Effects of Balance Exercises Circuit in Patients With Total Hip or Knee Arthroplasty (BECA): A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Replacement
Knee Replacement
Postural Balance
Lead sponsor: Grupo de Estudos e Pesquisas Sobre Atividade Física Para Idosos
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 65
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of balance circuit in patients with more than one year of postoperative total hip or knee arthroplasty. Patients were randomized between intervention group (IG) (balance exercise circuit ) and control group (CG) (usual routine). The evaluations were conducted by blind examiners.

Detailed description: Balance Exercise Circuit (BEC) program, includes exercise that specifically challenge sensory inputs from mechanoreceptors as well as from the visual and vestibular systems. It is composed of 13 stations, involving static and dynamic balance exercises, including tandem walking, forward-backward stepping, wide-stance gait, functional reach, heel lift, toe press, balance on unstable surfaces, and standing on one leg. The BEC lasts 50 min, two times per week for a total of 12 weeks. Progression of exercises occurred every 3 weeks and was closely supervised to ensure safety. Each BEC session comprised of warm-up and stretching (10 min), exercise circuit (30 min), and cool-down (10 min).

Eligibility criteria: Inclusion Criteria:

* more than one year of postoperative total hip or knee arthroplasty

Exclusion Criteria:

* total hip AND knee arthroplasty
* other surgeries of the lower limbs and spine
* autoimmune disease
* contraindication for physical exercise

Primary outcomes:
measure: Berg Balance Scale
timeFrame: three months
Secondary outcomes:
measure: QuickScreen scale
timeFrame: three months
measure: Falls Efficacy Scale
timeFrame: three months
Other outcomes:
measure: static balance
timeFrame: three months
measure: Timed Up and Go
timeFrame: three months
Locations:
Study officials:
affiliation: Grupo de Estudos e Pesquisas Sobre Atividade Física Para Idosos
name: Marisete P Safons
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03437954: Outcomes of Post-operative Diet in Children Following Tonsillectomy and Adenoidectomy
Official title: Outcomes of Post-operative Diet in Children Following Tonsillectomy and Adenoidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Tonsillitis
Sleep Disordered Breathing
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 86
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This research is being done because it is not known which dietary recommendations are best to help patients recover after a tonsillectomy and/or adenoidectomy. The purpose of this study is to determine how diet after tonsil/adenoid surgery affects bleeding, pain, and oral intake.

Detailed description: Currently it is not known which dietary recommendations are best to help patients recover after a tonsillectomy and/or adenoidectomy. Traditional standard of care is to recommend that patients be restricted to a soft diet post-operatively. However, the investigators believe that there may be benefit in allowing patients to eat a restriction-free diet. In this study, the investigators will compare the current standard of care verse a non-restricted diet. The purpose of this study is to determine how diet after tonsil/adenoid surgery affects bleeding, pain, and oral intake.

Eligibility criteria: Inclusion Criteria:

* Patients 3-12 years undergoing tonsillectomy and/or adenoidectomy.

Exclusion Criteria:

-

Primary outcomes:
measure: Bleeding
timeFrame: From time of surgery through postoperative day 10.
Secondary outcomes:
measure: Pain
timeFrame: From time of surgery through postoperative day 10.
measure: Days missed from normal activity
timeFrame: From time of surgery through postoperative day 10.
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
Study officials:
affiliation: MedStar Georgetown University Hospital
name: Earl Harley, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00854854: Efficacy Study of TKcell in Advanced Gastric Cancer
Official title: Evaluating the Safety and Efficacy of Combination Therapy With FOLFOX-4 and TKcell Therapy Versus FOLFOX-4 Alone in Patients With Recurrent, Unresectable and Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Advanced Gastric Cancer
Keywords: NKCell
FOLFOX-4
gastric cancer
Lead sponsor: Binex
Sponsor class: INDUSTRY
First posted: 2009-03-03
Enrollment: 94
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine efficacy of NKCell combined FOLFOX-4 chemotherapy in gastric cancer


Eligibility criteria: Inclusion Criteria:

* Written informed consent.
* Diagnosis of histologically confirmed adenocarcinoma of the gastric
* ECOG performance status of 0 - 2
* At least one definite measurable lesion(s): ≥ 1 cm on spiral CT scan or ≥2cm in physical examination
* Adequate liver, renal, bone marrow functions as evidence by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 7.5 x 109/L; Bilirubin less than 2 mg/dL ASAT and/or ALAT \< 5 UNL; serum creatinine ≤ 2 ULN
* Minimum life expectancy of 12 weeks
* Effective contraception for both male and female subjects if the risk of conception exists

Exclusion Criteria:

* Brain metastasis and/or leptomeningeal disease (known or suspected)
* Previous chemotherapy for gastric cancer except adjuvant treatment with progression of disease documented \> 6 months after end of adjuvant treatment.
* Previous oxaliplatin-based chemotherapy
* Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization and chemotherapy
* HIV antibody (+), Chronic hepatitis
* Uncontrolled infection
* Concurrent or previous chronic systemic immune therapy, targeted therapy, hormonal therapy not indicated in the study protocol except for contraception
* Clinically relevant coronary artery disease, history of myocardial infarction, high risk of uncontrolled arrhythmia
* Known hypersensitivity reaction to any of the components of the treatment.
* Pregnancy (absence to be confirmed by ß-hCG test) or lactation period
* Participation in another clinical study within the 30 days before randomization
* Significant disease which, in the investigator's opinion, would exclude the subject from the study

Primary outcomes:
measure: Determine response rate
timeFrame: within study period
Secondary outcomes:
measure: Determine safety of combination,time to treatment failure, overall survival time
timeFrame: within study period
Other outcomes:
Locations:
city: Banpo-Dong
country: Korea, Republic of
facility: The catholic University of korea
state: Seoul
Study officials:
affiliation: The Catholic Medical Center
name: Seok-Goo Cho, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03488654: CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography
Official title: The Heart in Systemic Lupus Erythematosus - a Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lupus Erythematosus, Systemic
Coronary Artery Disease
Myocardial Disease
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with diagnosed SLE

Brief summary: In systemic lupus erythematosus (SLE), cardiac manifestations, e.g. coronary artery disease (CAD) and myocarditis are leading causes of morbidity and mortality. The prevalence of subclinical heart disease in SLE is unknown. We studied whether a comprehensive cardiovascular magnetic resonance (CMR) protocol may be useful for early diagnosis of heart disease in SLE patients without known CAD


Eligibility criteria: Inclusion Criteria:

* diagnosis of SLE, as defined by the American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus

Exclusion Criteria:

* age under 18 years
* known coronary artery disease
* impaired renal function with an estimated glomerular filtration rate less than 30 ml/min, estimated by the Modification of Diet in Renal Disease Study Group (MDRD) formula (45)
* devices as pacemakers, implantable cardioverter-defibrillators, insulin pumps and others
* metallic foreign bodies in the eyes, ferromagnetic implants labeled MR unsafe
* allergy against CMR contrast media or adenosine
* presence of chronic atrial fibrillation, 2nd or 3rd degree Atrioventricular (AV)-block, trifascicular block, asthma and severe chronic obstructive pulmonary disease

Primary outcomes:
measure: Prevalence of cardiovascular pathologies identified by CMR in patients with SLE
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Thilo Burkard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01937754: Study of the Effects of an Oral Nitric Oxide Supplement on Blood Pressure in Prehypertensive Adults
Official title: Study of the Effects of an Oral Nitric Oxide Supplement on Functional Capacity and Blood Pressure in Healthy Adults With Prehypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Prehypertension
Keywords: Prehypertension
Nitric Oxide
Blood Pressure
Functional Capacity
Quality of Life
Lead sponsor: Neogenis Laboratories
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Oral supplementation of Neo40(TM), a nitrate lozenge, will reduce blood pressure in healthy adults with clinical prehypertension.


Eligibility criteria: Inclusion Criteria:

* Adults between the ages of 18 to 80 years
* Two blood pressure readings of \>/=135/80 mmHg at rest, thus representing prehypertension
* Informed consent

Exclusion Criteria:

* Existence of any significant internal or cardiovascular disease;
* Current use of any antihypertensive medication.
* Inability to give informed consent, or fill out standard questionnaires or inability to follow up clinically.

Primary outcomes:
measure: Reduction in Systolic and Diastolic Blood Pressure Readings
timeFrame: 30 days
Secondary outcomes:
measure: Improvement in Functional Capacity
timeFrame: 30 days
Other outcomes:
measure: Improvement in Quality of Life
timeFrame: 30 days
Locations:
city: Beverly Hills
country: United States
facility: California Medical Institute
state: California
Study officials:
affiliation: California Medical Institute, Cedars Sinai Medical Center
name: Ernst Schwarz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: