louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02089503: Monocentric Retrospective Observational Study on Patients With Macular Degeneration
Official title: Monocentric Retrospective Observational Study Describing the Visual Acuity of Patients With Exudative Age Related Macular Degeneration and Treated by Lucentis® Under Real Conditions of Care.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Exudative Age-Related Macular Degeneration
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 250
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: patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care

Brief summary: Main Objective: The main objective of this retrospective observational study was to describe the evolution of visual acuity measured on ETDRS (Early Treatment Diabetic Retinopathy Study) scale, for patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care, in terms of mean change of the Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).


Eligibility criteria: Inclusion Criteria:

* Patients with exudative-subfove ARMD, regardless the neovessel type or the initial visual acuity; 2 - Patients treated in the department with intra vitreous injection of Lucentis ® during the study period (08/2011 and 02/2013); 3 - If both eyes are eligible, both will be analyzed;

Exclusion Criteria:

1. - Patients who received, for the studied eye, a treatment with a Vascular endothelial growth factor (VEGF) other than Lucentis ® in the three months preceding the start of the study. For those who received combination therapy, the nature of the treatment will be specified and taken into account in the subgroups for statistical analyzes;
2. - Patients with high myopia or neovessel not related to exudative-ARMD;

Primary outcomes:
measure: Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).
timeFrame: measured at 24 months (± 4 weeks)
Secondary outcomes:
measure: the mean change of the BCVA throughout the 24 months of follow-up (FU),
timeFrame: 24 months of follow-up
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Saint Joseph
Study officials:
affiliation: HSJ
name: Maud RIGHINI, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03216603: Health Literacy in People With Chronic Obstructive Pulmonary Disease
Official title: Health Literacy. An Intervention on Organized Information and Health Care for People With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Health literacy
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Norwegian Extra Foundation for Health and Rehabilitation
First posted: 2017-07-13
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Health literacy refers to personal and relational factors affecting a person's ability to acquire, understand and use information about health and health services. In a need assessment study it was found that, the health services need to focus on health literacy factors in the follow up of patients with chronic obstructive pulmonary disease (COPD).

Thus, this project evaluate the effect a of a health literacy partnership health promotion intervention (hospital, municipalities, university) after discharge from hospital with the use of motivational interviewing and tailored follow-ups on re-admission, health literacy, self-management quality of life and cost in people with COPD compared with usual care.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with COPD,
* Above 18 years,
* Admitted to a medical department at the main intervention hospital, l
* Live in the sites belonging to the intervention hospital.

Exclusion Criteria:

* Not diagnosed with COPD,
* Not above 18 years,
* Not admitted to a medical department at the main intervention hospital, and
* Not living in the sites belonging to the intervention hospital.
* Cognitive failure
* Patients that are investigated or treated for cancer

Primary outcomes:
measure: Change of admissions
timeFrame: Eight weeks, six months and one year
Secondary outcomes:
measure: Change of health literacy
timeFrame: Eight weeks, six months and one year
measure: Change of disease specific quality of life
timeFrame: Eight weeks, six months and one year
measure: Change of e-Health
timeFrame: Eight weeks, six months and one year
measure: Change of physical function
timeFrame: Eight weeks, six months and one year
measure: Change of self-management
timeFrame: Eight weeks, six months and one year
measure: Change of psychological stress
timeFrame: Eight weeks, six months and one year
measure: Change of self-efficacy
timeFrame: Eight weeks, six months and one year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lovisenberg Diakonale Hospital
Study officials:
affiliation: University of Oslo and Lovisenberg Diaconal Hospital
name: Christine Borge, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo
name: Astrid K. Wahl, Phd
role: STUDY_CHAIR
References:
Clinical trial NCT00004403: Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Cysticercosis
Keywords: cysticercosis
epilepsy
immunologic disorders and infectious disorders
neurologic and psychiatric disorders
parasitic infection
rare disease
seizures
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine the effect of antiparasitic treatment with albendazole on the severity and duration of epilepsy due to neurocysticercosis.

II. Determine the effect of a short course of albendazole on Taenia solium cysts present in the brain.

III. Determine the natural regression of cerebral T. solium cysts in patients given placebo and their response to treatment at the end of the study.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to receive either albendazole and dexamethasone or placebo.

Patients receive phenytoin daily starting on day 1 and continuing until seizure free for 1 year. Albendazole and dexamethasone or placebo only is administered orally once daily on days 5-15.

Patients are asked to maintain a diary. Patients are followed on day 15 and 30, then every 3 months for 3 years.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Presence of Taenia solium infection as demonstrated by serology and head CT Head CT showing no more than 20 cysts
* At least 2 spontaneous seizures within the last 6 months excluding: Absence seizures Rolandic seizures Bilateral spike wave patterns compatible with genetic epilepsy

--Prior/Concurrent Therapy--

* No prior therapy for cysticercosis

--Patient Characteristics--

* Age: 16 to 65
* Performance status: Not specified
* Hematopoietic: Not specified
* Hepatic: Not specified
* Renal: Not specified
* Neurologic: No focal deficits No motor deficits No cranial nerve lesions History of epilepsy of less than 5 years in duration No head CT evidence of the following: Arteriovenous malformations Trauma Cerebral infarcts or hemorrhages No other focal disease not attributable to cysticercosis No moderate or severe intracranial hypertension No status epilepticus
* Other: No unstable condition due to systemic disease or cysticercosis Not pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Robert H. Gilman
role: STUDY_CHAIR
References:
Clinical trial NCT00874003: The Effects of Mirtazapine Versus Placebo on Alcohol Consumption in Male Alcohol High Consumers
Official title: The Effects of Mirtazapine vs Placebo on Alcohol Consumption in Male Alcohol High Consumers; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Dependence
Keywords: alcohol dependence
anti-depressant
5-HT
NE
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 59
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
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 study the effects of 8 weeks of treatment with mirtazapine on alcohol consumption in alcohol high consuming men. This study is a randomized, double-blind placebo controlled clinical trial with parallel group design(N=59).


Eligibility criteria: Inclusion Criteria:

* 18-65 years of age
* male sex
* alcohol high consumption
* signed informed consent

Exclusion Criteria:

* psychiatric disorders (except nicotine and alcohol dependence)
* severe somatic disorders
* inadequate knowledge of the Swedish language

Primary outcomes:
measure: Alcohol consumption measured by alcohol diary (units/week).
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Addiction Biology Unit
Study officials:
affiliation: Addiction Biology Unit
name: Andrea deBejczy, MD
role: STUDY_DIRECTOR
affiliation: Addiction Biology Unit
name: Bo Söderpalm, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02907203: Clinical Investigation of the GORE® Drug-Coated PTA Balloon Catheter (GORE® DCB Catheter)
Official title: Clinical Investigation of the GORE® Drug-Coated PTA Balloon Catheter (GORE® DCB Catheter) for Conformité Européene (CE) Mark Approval
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: PAD
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2016-09-20
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries of patients with symptomatic PAD.

Detailed description: The primary objective of the clinical investigation is to evaluate the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries (SFA/PA) of patients with symptomatic PAD.

The performance of the GORE® DCB Catheter is superior to a performance goal derived from literature reports of uncoated PTA balloons, measured six months after intervention.

Eligibility criteria: Inclusion Criteria:

* PAD patients with Rutherford Class 2 - 4
* De novo or restenotic lesions, including total occlusions of the SFA/PA
* 1 lesion which may include one or more regions of luminal narrowing ≥70% with a total combined lesion length between 30 - 150mm and a reference vessel diameter of 4 - 6mm
* 1 patent tibial or peroneal artery

Exclusion Criteria:

* Surgical or endovascular access in the Target limb/vessel within the previous 30 days
* Prior treatment of the Target lesion with PTA within 90 days or any prior treatment with drug-coated balloon
* Prior treatment of the Target vessel with stenting or bypass
* Iliac artery inflow lesions that cannot be successfully treated during the Index procedure
* Acute or subacute thrombus or arterial aneurysm in Target limb
* Severe calcification that renders the Target lesion non-dilatable
* Acute or chronic renal dysfunction (serum creatinine ≥2.5 mg/dL)

Primary outcomes:
measure: Late Lumen Loss (LLL)
timeFrame: Six months
Secondary outcomes:
measure: Number of Subjects With Freedom From Major Adverse Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Universitats - Herzzentrum Freiburg
Study officials:
References:
Clinical trial NCT00209703: Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer
Official title: Feasibility Study of mFOLFOX6 (Oxaliplatin Combined With l-Leucovorin (l-LV) and 5-Fluorouracil) in Patients With Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Hokkaido Gastrointestinal Cancer Study Group
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We performed a feasibility study of mFOLFOX6 in advanced colorectal cancer in Japan and to estimate the safety and efficacy of this regimen.

Detailed description: A multicenter Open-label, single-arm feasibility study is conducted on patients with histological stage IV colorectal cancer given oxaliplatin, leucovorin plus fluorouracil. The usefulness of this regimens as therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.

Eligibility criteria: Inclusion Criteria:

1. Histological diagnosis of colorectral adenocarcinoma.
2. Measurable or assessable lesions.
3. Age: 15 \~ 75 years.
4. Performance Status (ECOG): 0 \~ 2.
5. Prior chemotherapy within 2 regimens.
6. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 3.0mg/dl. Creatinine within the upper limit of normal. Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).

(10) Predicted survival for \>8 weeks. (11) Able to give written informed consent.

Exclusion Criteria:

1. Severe pleural effusion or ascites.
2. Metastasis to the central nervous system (CNS).
3. Active gastrointestinal bleeding.
4. Active infection.
5. Uncontrolled ischemic heart disease.
6. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
7. Active multiple cancer.
8. Severe mental disorder.
9. Pregnancy, possible pregnancy, or breast-feeding.
10. Patients with neuropathy ≥ grade 2
11. Judged to be ineligible for this protocol by the attending physician.

Primary outcomes:
measure: Incidence and severity of adverse event
Secondary outcomes:
measure: Determine the clinical response rate, disease-free survival(DFS), overall survival(OS)
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)
state: Hokkaido
Study officials:
affiliation: Hokkaido Gastrointestinal Cancer Study Group
name: Masahiro Asaka, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00073203: A 6 Week Study to Determine the Effectiveness of R228060 in Adult Subjects With Major Depressive Disorder
Official title: A 6- Week, Randomized, Double-Blind, Parallel-Group, Active-and Placebo-Controlled Trial to Assess the Efficacy of R228060 in Adult Subjects With Major Depressive Disorder (MDD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2003-11-19
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to determine the effectiveness of 2 target doses of R228060 in comparison with placebo during 6 weeks of treatment in moderately to severely depressed adult subjects with major depressive disorder.

Approximately 488 subjects will be involved in the study.


Eligibility criteria: * Generally healthy adults on the basis of a physical examination, medical history, ECG and laboratory work-up.
* Subject needs to meet criteria for diagnosis of moderate or severe major depression as defined by the protocol.
* The subject also needs to be an outpatient to participate in this study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Titusville
country: United States
facility: JJ PRD Research Center
state: New Jersey
Study officials:
References:
Clinical trial NCT00110903: Treatment for Subjects With Active Rheumatoid Arthritis (RA)
Official title: Open-Label Study to Assess the Safety of Etanercept Liquid Administered Once Weekly in Subjects With Active Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
RA
etanercept
Immunex
Amgen
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-05-17
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 purpose of this study is to assess the safety of etanercept liquid administered once weekly to subjects with RA.


Eligibility criteria: Inclusion Criteria: - Fulfill the 1987 American Rheumatism Association (ARA) criteria for RA - Active RA at the time of enrollment, receipt of concomitant methotrexate at a dose of up to 25 mg a week is permitted - Screening lab results must demonstrate:

* AST and ALT less than or equal to 2 times the upper limit of normal hemoglobin greater than or equal to 8.5 g/dL;
* Platelet count greater than or equal to 125,000/cm3;
* White blood cell count (WBC) greater than or equal to 3500 cells/cm3;
* Serum creatinine less than or equal to 2 mg/dL - Before any study specific procedure is performed, the subject must provide informed consent for participation in the study Exclusion Criteria: - Previous receipt of etanercept - Receipt of antibody to (tumor necrosis factor) TNF alpha or other TNF inhibitors within 90 days of Day 1 - Currently enrolled in other investigational device or drug trials, or participation in investigational trial within the past 30 days - Receipt of intra-articular corticosteroids within 14 days prior to Day 1 - Receipt of any disease-modifying anti-rheumatic drugs (DMARDs) within 28 days of Day 1 - Receipt of cyclophosphamide within 6 months of Day 1 - Concomitant corticosteroids greater than 10 mg/day of prednisone (or equivalent) during 14 days prior to Day 1 - Dose of nonsteroidal anti-inflammatory drug (NSAID) must be stable for 14 days prior to Day 1 and must not exceed the recommended dose in the product information sheet - Subject is not using adequate contraception - Subject is pregnant or breast-feeding - Subject has significant concurrent medical disease

Primary outcomes:
measure: Proportion of subjects having positive immunoassay response to etanercept liquid during the treatment period.
Secondary outcomes:
measure: Incidence of adverse events, infectious episodes, serious adverse events, serious infectious episodes
measure: Measurements from safety laboratory assessments.
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Dore RK, Mathews S, Schechtman J, Surbeck W, Mandel D, Patel A, Zhou L, Peloso P. The immunogenicity, safety, and efficacy of etanercept liquid administered once weekly in patients with rheumatoid arthritis. Clin Exp Rheumatol. 2007 Jan-Feb;25(1):40-6.
Clinical trial NCT06389903: Subthalamic Nucleus Stimulation Electrode and Psychiatric Lesion Effects in Parkinson's Disease
Official title: Study of Symptoms Related to the Lesion Effect Associated With the Implantation of Electrodes for Stimulation of the Subthalamic Nuclei in the Treatment of Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Brain stimulation
Lead sponsor: Centre Hospitalier du Rouvray
Sponsor class: OTHER_GOV
First posted: 2024-04-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot, prospective, monocentric study concerning 15 Parkinson's disease patients requiring deep brain stimulation implantation.

The primary objective is to evaluate the psychiatric lesion effects of deep brain stimulation in patients with Parkinson's disease, using the Young Mania Rating Scale (YMRS), Big Five Inventory and the Hamilton Depression Rating Scale (HAMD 21).

Detailed description: The patients included were adults suffering from Parkinson's disease (according to ICD-10). They had no severe psychiatric disorders, and no major neurocognitive disorders contraindicating surgery. An initial evaluation will be carried out 72 hours after surgery, then after one month, and finally 3 months after surgery.

Eligibility criteria: Inclusion Criteria:

* Major patient
* Diagnosis of Parkinson's disease (ICD-10)
* L-dopa test must be positive
* Participants who gave their informed, written consent

Exclusion Criteria:

* Severe psychiatric disorder
* Major neurocognitive disorder contraindicating surgery

Primary outcomes:
measure: Assessment of change of mania symptoms
timeFrame: Baseline, 72 hours, 1 month and 3 months after surgery
Secondary outcomes:
measure: Assessment of change of depressive symptoms
timeFrame: Baseline, 72 hours, 1 month and 3 months after surgery
measure: Assessment of change of Behavior
timeFrame: Baseline, 72 hours, 1 month and 3 months after surgery
measure: Assessment of change of Impulsivity
timeFrame: Baseline, 72 hours, 1 month and 3 months after surgery
measure: Assessment of change of Apathy
timeFrame: Baseline, 72 hours, 1 month and 3 months after surgery
measure: Assessment of personality
timeFrame: Baseline
measure: Assessment of executive functions
timeFrame: Baseline, 72 hours, 3 months after surgery
measure: Assessment of confusion
timeFrame: 72 hours and 3 months after surgery
Other outcomes:
Locations:
city: Sotteville Les Rouen
country: France
facility: Marie Desbordes, MD
Study officials:
References: