louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04787497: The Effect of Extra Virgin Olive Oil in People With Multiple Sclerosis
Official title: The Neuropsychological Effects of Extra-Virgin Olive Oil in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Cyprus
Sponsor class: OTHER
Collaborators: name: World Olive Center for Health
name: Ellis-Farm, Eliama Daily Value
First posted: 2021-03-08
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is an open label feasibility trial to examine the effect of a complementary treatment with High Phenolic Extra Virgin Olive Oil (HPEVOO) on the cognitive and mental health of people with Multiple Sclerosis (MS), while receiving their standard medical treatment.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of MS
* Must be between 18 to 65 years of age
* Both males and females are eligible for participation
* Must have at least five years of education
* Must be fluent in Greek language

Exclusion Criteria:

* Other neurological, psychiatric or chronic condition
* Enrollment in other trials/drug studies
* Experiencing side effects from previous treatments
* Inadequate visual and auditory acuity

Primary outcomes:
measure: Symbol Digits Modalities Test (SDMT)
timeFrame: baseline, 6-months, 12-months
measure: California Verbal Learning Test-Second Edition (CVLT-II)
timeFrame: baseline, 6-months, 12-months
measure: Brief Visuospatial Memory Test-Revised (BVMT-R)
timeFrame: baseline, 6-months, 12-months
measure: Wisconsin Card Sorting Test (WCST)
timeFrame: baseline, 6-months, 12-months
measure: Trail Making Test (TMT)
timeFrame: baseline, 6-months, 12-months
measure: The Vocabulary and Block Design from the Wechsler Adult Intelligence Scale (WAIS)
timeFrame: baseline
measure: The Digit Span Test (DST) from WAIS
timeFrame: baseline, 6-months, 12-months
measure: Word List Generation (WLG) Test
timeFrame: baseline, 6-months, 12-months
measure: Faux Pas Recognition (FPR) Test
timeFrame: baseline, 6-months, 12-months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline, 6-months, 12-months
measure: Health Status Questionnaire (SF-36)
timeFrame: baseline, 6-months, 12-months
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: baseline, 6-months, 12-months
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Private medical office
Study officials:
References:
Clinical trial NCT01352897: Registry On Efficacy and Safety Of Rosuvastatin, and Atorvastatin and Simvastatin In Hypercholesterolaemia
Official title: A Registry to Collect Data of Efficacy and Safety Between Rosuvastatin, and Atorvastatin and Simvastatin In Subjects With Type IIa and IIb Hypercholesterolaemia Under Real Clinical Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolaemia
Keywords: Cholesterol
rosuvastatin
retrospective
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-05-12
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from primary care and specialist clinics

Brief summary: The objective of this follow-up retrospective study is to evaluate the long term efficacy and safety of rosuvastatin in reducing lipid parameters in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Primary hypercholesterolemia
* Subjects from first rosuvastatin Registry study

Primary outcomes:
measure: Percentage of patients who maintain US NCEP ATP III LDL-C target goals after long-term therapy
timeFrame: Up to 8 years
Secondary outcomes:
measure: LDL-cholesterol levels
timeFrame: Up to 8 years
measure: HDL-cholesterol levels
timeFrame: Up to 8 years
measure: Proportion of patients having raised levels of serum CK or ALT
timeFrame: Up to 8 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Research Site
Study officials:
affiliation: ARTHUR TAN HEART CLINIC, GLENEAGLES MEDICAL CENTRE
name: DR ARTHUR TAN, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01905397: Negative Pressure Wound Therapy to Reduce Surgical Site Infection
Official title: Evaluation of Negative Pressure Wound Therapy for Reduction of Postoperative Surgical Site Infection in Patients Undergoing Colorectal and Hepatopancreatobiliary Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Undergoing Hepatopancreatobiliary Surgery
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Kinetic Concepts, Inc.
First posted: 2013-07-23
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the rate of surgical site infection between traditional wound care and negative pressure wound therapy. Wounds will be assessed 4-5 days after surgery and at the first clinic visit after surgery.


Eligibility criteria: Inclusion Criteria:

* Female and male patients 18 years of age or older
* Scheduled for an elective surgery in either open CRS or open HPBS. This includes, but is not limited to: ileocecectomy, right hemicolectomy, extended right hemicolectomy, transverse colectomy, left hemicolectomy, sigmoidectomy, proctectomy, low anterior resection, or abdominoperineal resection gastrectomy, hepatectomy, bile duct reconstruction, duodenectomy, pancreatectomy, pancreaticoduodenectomy, or pancreatic duct reconstruction

Exclusion Criteria:

* The need for emergency surgery.
* The need for use of only laparoscopic surgery.
* Presence of bowel obstruction, strangulation, peritonitis or perforation.
* The presence of local or systemic infection preoperatively.
* ASA class ≥4.
* Inability to provide informed consent and authorization.
* Known allergy or hypersensitivity to silver.
* Any clinically significant condition that, in the investigator's opinion, would significantly impair the subject's ability to comply with the study.

Primary outcomes:
measure: Participants With a Surgical Site Infection
timeFrame: 30 days after surgery; assessed at 4-5 days and 30 days post-operation
Secondary outcomes:
measure: Number of Surgical Site Infections by Type
timeFrame: 30 days post-surgery
measure: Length of Hospital Stay
timeFrame: Up to 62 days post-surgery
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Dan Blazer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05460897: Health Behaviour Change in Brazilians
Official title: Health Behaviour Change in Brazilians - Effectiveness of a Pan-Canadian English-language Program, Translated Into Brazilian Portuguese, to Increase Healthy Behaviours
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Inactivity
Eating Behavior
Smoking
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2022-07-15
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chronic diseases are the leading health problem in Brazil and Canada. Such diseases share common risk factors in common, such as physical inactivity, poor diet, and smoking. This context requires a comprehensive approach to change these behavioural risk factors, aiming at the promotion of healthy lifestyles and the prevention of diseases. Although Brazil and Canada have significant differences, particularly in terms of socioeconomic factors, some similarities in the health domain allow both countries to mutually benefit from an exchange of knowledge. For instance, the newest version of Canada's dietary guidelines has incorporated several aspects presented in the pioneering evidence-based dietary guidelines for the Brazilian population, launched in 2014. Similarly, Brazil can greatly benefit if the country follows the Canadian lead in prioritizing investment in physical activity initiatives. The present project aims to verify the effectiveness of a Canadian program to change health behaviours, specifically physical inactivity, poor diet, and smoking, adapted for Brazilians. The project consists of a 12-week randomized controlled trial, based on education and behaviour change techniques focusing on physical activity, healthy eating habits, and smoking cessation. Pre-, post, and 3-month follow-up health and fitness assessments will evaluate respectively the initial condition of the participants, eventual changes and if the changes persist.


Eligibility criteria: Inclusion Criteria:

Brazilians who speak Brazilian Portuguese fluently, and present at least one of the following risk factors:

* physical inactivity (\<150 min of MVPA per week)
* unhealthy diet (consumption of fewer than five fruits/vegetables per day)
* smoking (any amount of personal tobacco use)

Exclusion Criteria:

* unstable clinical conditions
* inability to participate fully in the program due to mental or physical limitations
* concurrently participation in other studies of intensive health behaviour modification

Primary outcomes:
measure: Physical activity
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: Professor
name: Darren Warburton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02213497: Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer
Official title: Phase I Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Esophageal Cancer
Keywords: Esophageal Cancer
Neoadjuvant
Proton Beam Radiotherapy
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2014-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: Patients with esophageal cancer to be treated with concurrent preoperative proton therapy along with carboplatin and paclitaxel.

Detailed description: 1. To identify the maximally tolerated radiation dose (MTD) of dose-escalated proton radiotherapy in combination with carboplatin/paclitaxel in the preoperative setting for esophageal cancer.
2. To estimate pathologic response rates by esophagectomy surgical specimens after escalated doses of chemoradiotherapy.
3. To assess the utility of circulating tumor cells and tumor vesicles as biomarkers to predict treatment response to chemoradiotherapy

Eligibility criteria: Inclusion Criteria:

* Patients with a histologic diagnosis of adenocarcinoma of the esophagus located distal to the carina
* Patients with AJCC 7th edition clinical stage IIB-IIIC
* Patient must be \>18 years of age.
* Patients must have an ECOG Performance Status of 0-1
* Patients must be able to provide informed consent.
* Patients must be surgical candidates with adequate hematologic, renal, hepatic and pulmonary function
* serum AST and ALT \< 2 times the upper limit of normal
* Patients must have bilirubin \< 1.5 × normal.
* WBC \> 3000/mm3, platelets \> 100,000 mm3.
* Hemoglobin \> 10 g/dL serum creatinine \< 1.5 times the upper limit of normal
* Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented.

Exclusion Criteria:

* Patients with primary tumors exceeding 8 cm in length or 5 cm in width ( length should be measured by endoscopic findings, width should be measured by diagnostic CT or CT portion of PET/CT)
* Patients with primary tumors located at or above the carina
* Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
* Pregnant women, women planning to become pregnant and women that are nursing

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: John Plastaras, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04899297: Quality of Life in Parents of Adolescents With Spinal Deformities: Development of a New Questionnaire.
Official title: Quality of Life in Parents of Conservatively Treated Adolescents With Spinal Deformities: Development of a New Questionnaire.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Quality of Life
Spinal Deformity
Scoliosis; Adolescence
Keywords: Scoliosis
Quality of life
Spinal Deformity
Lead sponsor: Istituto Scientifico Italiano Colonna Vertebrale
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of adolescents with spinal deformities treated in a tertiary referral outpatient center.

Brief summary: This study aims to develop a new instrument capable of providing an efficient measure of the quality of life of parents of conservatively treated patients with spinal deformity. The development of a questionnaire in a Rasch environment and specifically developed for parents of conservatively treated patients will ensure greater sensitivity and specificity of the questionnaire.


Eligibility criteria: Inclusion Criteria:

* have at least one child between the ages of 10 and 18 with adolescent idiopathic scoliosis of 10 degrees or more, or with Scheuermann's kyphosis or idiopathic hyperkyphosis
* prescription of a brace or specific exercises for the child's vertebral deformity.

Exclusion Criteria:

* Child with a history of spinal surgery
* Child with a history of significant diseases with possible impact on the quality of life of the parents
* Child with a history of spinal trauma
* Child with positive neurological evaluation

Primary outcomes:
measure: Parents' quality of life
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: ISICO
state: Mi
Study officials:
affiliation: Istituto Scientifico Italiano Colonna Vertebrale
name: Fabio Zaina, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00484497: Evaluation of a Food Supplement on Sleep Quality
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial for the Evaluation of a Food Supplement on Sleep Quality in Primary Insomnia Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Sleep quality
food supplement
randomized controlled trial
actigraphy
Leeds
Volunteers presenting moderate primary insomnia
Lead sponsor: Persee Medica
Sponsor class: INDUSTRY
First posted: 2007-06-11
Enrollment: 105
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer aged between 25 to 65 years
* Patient diagnosed for primary Insomnia (threshold for inclusion: 10 on the ISI scale)
* Healthy volunteer without diurnal sleep (total score for inclusion must be less than 10 on the Epworth scale)
* Patient affiliated to the French Social Security
* Patient who gave written informed consent

Exclusion Criteria:

* Secondary insomnia
* History of severe psychiatric disorder, assessed by the MINI test
* Resistance to Hypnotic drugs
* Anxiety, depression, suicide, detected by the Beck Depression Inventory
* Acute Pathology during the precedent three years
* Breast feeding and pregnancy women
* Non compliant volunteer
* Hypersensibility to treatment composant

Primary outcomes:
measure: Sleep quality assessed by the Leed Sleep Evaluation Questionnaire, measured after one month of treatment
Secondary outcomes:
measure: Sleep quality assessed by the Leed Sleep Evaluation - Questionnaire, measured 15 days after treatment withdrawal
measure: Sleep quality assessed by a Sleep diary completed each day during all the study period by the participants
measure: Sleep efficiency measured by ambulatory actigraphy (2 period)
measure: Evolution of melatonin/6sulfatoxymelatonin ratio (before and after treatment)
measure: Clinical General Impression of the clinician, before and after treatment.
measure: Safety of the treatment (adverse event reporting)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinical Research Center- Hopital Cardiologique
Study officials:
affiliation: Clinical Research Center
name: Catherine Cornu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cornu C, Remontet L, Noel-Baron F, Nicolas A, Feugier-Favier N, Roy P, Claustrat B, Saadatian-Elahi M, Kassai B. A dietary supplement to improve the quality of sleep: a randomized placebo controlled trial. BMC Complement Altern Med. 2010 Jun 22;10:29. doi: 10.1186/1472-6882-10-29.
Clinical trial NCT01963897: Duchenne Muscular Dystrophy < 18y in Norway: Genotype/Phenotype, Growth, Puberty, Bone Health and Quality of Life.
Official title: Duchenne Muscular Dystrophy in Norway. Genotype/Phenotype in Patients Younger Than 18 Years, With a Main Focus on Growth, Puberty, Bone Health and Quality of Life.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne Muscular Dystrophy
Keywords: Genotype/phenotype correlations
Growth
Bone health
Puberty
Quality of life
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: University Hospital of North Norway
First posted: 2013-10-16
Enrollment: 73
Sex: MALE
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with Duchenne muscular dystrophy under 18 years in Norway

Brief summary: The study will give a consent based epidemiological overview of Norwegian patients with Duchenne muscular dystrophy younger than 18 years of age. Genotype of the population will be described. Longitudinal development of growth, bone health, and , when applicable, puberty over a two year period will be studied. Questionnaires regarding quality of life will also be an important part of the study.

Detailed description: The participants who are not regularly seen at our regional hospital, are recruited via their local neuropediatrician. Patients who do not come to our region hospital will be seen at their local hospital.Each participant will be seen up to three times with one year between each visit. The visits include clinical examination, DXA scan, x-ray for bone age, and blood tests including several parameters related to bone health, growth and puberty. Standardized questionnaires regarding quality of life (patients and parents) will be used, and certain questions regarding the importance of achieving normal height and puberty will be added. Additional anamnestic data will be retrieved from the patients' medical records.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Duchenne muscular dystrophy
* Age under 18 years
* Residing in Norway

Exclusion Criteria:

-

Primary outcomes:
measure: Genotype
timeFrame: 1 day (At first visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Magnhild Rasmussen, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05131997: A Study to Evaluate the Efficacy and Safety of AD-221 and AD-221A
Official title: A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy and Safety of Administrated AD-221 and AD-221A in Patients With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Hypercholesterolemia
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-23
Enrollment: 290
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 evaluate the efficacy and safety of AD-221 and AD-221A

Detailed description: The purpose of this study is to evaluate the efficacy and safety of AD-221 and AD-221A in patients with primary hypercholesterolemia

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Subjects with primary hypercholesterolemia

Exclusion Criteria:

* Patient with secondary dyslipidemia
* Other exclusions applied

Primary outcomes:
measure: Low density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline, Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Hospital
state: Seodaemun-gu
Study officials:
affiliation: Yonsei University Hospital
name: Sang Hak Lee, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: