louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04068961: New Strategies of Genetic Study of Patients With Oculocutaneous Albinism
Official title: New Strategies of Genetic Study of Patients With Oculocutaneous Albinism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oculocutaneous Albinism
Mutation
Keywords: CGH array chip
Homozygosity mapping
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 64
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 having been examined during a genetic consultation, with Oculocutaneous Albinism

Brief summary: The oculocutaneous albinism is an autosomal recessive condition associated with mutations in 4 genes. In 20% of patients no mutation is identified. The optimization of genetic analysis methods and the search for new genes involved will help improve the diagnosis in these patients.

Detailed description: The oculocutaneous albinism is an autosomal recessive condition associated with mutations in 4 genes. In 20% of patients no mutation is identified. The optimization of genetic analysis methods and the search for new genes involved will help improve the diagnosis in these patients.

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Eligibility criteria: Inclusion Criteria:

-Oculocutaneous albinism (diagnosis validated by a clinician at the initial genetic consultation and did not show mutations of the TYR, OCA2, TYRP1, SLC45A2 genes)

Exclusion Criteria:

None

Primary outcomes:
measure: Presence of a genetic anomaly
timeFrame: At the screening
measure: Identification of a genetic mutation
timeFrame: At the screening
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Fanny MORICE-PICARD, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01337661: A Study of the Inflammatory Pathways Associated With Chronic Obstructive Pulmonary Disease Exacerbations
Official title: An Exploratory Study of the Cellular Inflammatory Mechanisms Associated With Chronic Obstructive Pulmonary Disease Exacerbations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Acute Exacerbation of COPD
AECOPD
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2011-04-19
Enrollment: 26
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects referred to the hospital clinic with AECOPD

Brief summary: The purpose of this study is to observe how the inflammatory pathways differ in subjects with chronic obstructive pulmonary disease (COPD) during an acute exacerbation of COPD (AECOPD).

Detailed description: This is an observational study in adult male and female subjects with COPD to collect blood, endobronchial tissues and BAL to investigate the inflammatory genes/pathways associated with AECOPD at the time of exacerbation (ie, active disease) and at 6 weeks later (ie, stable disease).

Eligibility criteria: Inclusion Criteria:

* Physician-diagnosed acute exacerbations of chronic obstructive pulmonary disease
* Current or ex-smoker with a tobacco history of 15 or more pack years
* Females of childbearing potential must use birth control for the duration of the study.

Exclusion Criteria:

* Evidence or history of clinically significant disease
* Subjects with asthma
* Subjects taking anti-leukotriene medications

Primary outcomes:
measure: Identification of how inflammatory pathways differ in COPD subjects
timeFrame: 6 weeks
Secondary outcomes:
measure: Biomarker Sample Repository
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Research Site
Study officials:
affiliation: MedImmune Ltd
name: Rene van der Merwe, MBChB, MFPM
role: STUDY_DIRECTOR
affiliation: BCF Diagnostics
name: Prof. Connor Burke
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00922961: Research for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer
Official title: Research for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: brachytherapy, late cutaneous toxicity
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 25
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 25 patients, treated by brachytherapy in a phase II study "Mammosite" (from 2003 to 2005), will be asked to attend a clinical exam in order to evaluate the late cutaneous toxicity due to brachytherapy.

During this consultation, a blood sample will be taken for analysis ( rate of CD8 T-Lymphocyte Apoptosis)

Detailed description: This is an interventional study for the french law

Eligibility criteria: Inclusion Criteria:

* All patient treated by exclusive per-operative brachytherapy in the prior study Mammosite for breast cancer
* Patient with social security

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Assessment of the rate of Radiation-Induced CD8 T-Lymphocyte Apoptosis
timeFrame: Blood sample during a consultation
Secondary outcomes:
measure: Assessment of the rate and scores of late fibrosis related to irradiation by mammosite
timeFrame: During a consultation with 2 physicians
measure: Assessment of the rate of telangiectasia
timeFrame: During a consultation with 2 physicians
measure: Assessment of the rate of sequellar pain
timeFrame: During a consultation with 2 physicians
measure: Assessment of the rate of seroma collection
timeFrame: During a consultation with 2 physicians
measure: Assessment of the breast esthetic score
timeFrame: During a consultation with 2 physicians
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: Yazid BELKACEMI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06432361: Resource Allocation for Alcohol
Official title: Resource Allocation for Alcohol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-05-29
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A total of 150 young adults (ages 21-29) will be randomized to receive a brief alcohol intervention (intended to reduce alcohol-related resource allocation (e.g., time and money spent on alcohol), alcohol consumption, and alcohol related consequences) or an assessment only control condition.

All participants will complete a 3 week monitoring period of daily surveys assessing time spent in various domains, alcohol use, personal goals, and money spent on alcohol and substance-free activities. Those in the intervention condition will receive weekly personalized information summarizing the previous week's resource allocation.

All participants will complete a 1 and 3 month follow up survey. Participants can earn up to $126 for completing all study components.


Eligibility criteria: Inclusion Criteria:

* 1)21-29 years old, 2) reside within WA state, 3) report drinking 2+ days per week, on average, in the last six months, 4) report 4+ heavy drinking episodes (4+/5+ for women/men) in the past month,

Exclusion Criteria:

* 1) currently enrolled in a 4-year college, 2) currently in or seeking treatment for alcohol use

Primary outcomes:
measure: Standard drinks containing alcohol-
timeFrame: past 1 month
measure: Alcohol-related problems
timeFrame: past 1 month
measure: Alcohol Demand
timeFrame: past 1 month
measure: Time allocation
timeFrame: past 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Jennifer Cadigan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00120861: Valopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard Therapy
Official title: A Randomized, Phase IIb Clinical Trial to Evaluate the Safety and Antiviral Activity of NM283 and the Combination of Pegylated Interferon Plus NM283, in Patients With Chronic Hepatitis C Who Have Previously Failed to Respond to Standard Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: Genotype-1
Previously failed treatment
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-07-19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to compare the safety, effectiveness and tolerance of valopicitabine (NM283) when used alone and when valopicitabine is used together with pegylated interferon in hepatitis C treatment failure patients. These results will be compared against the results of treatment with pegylated interferon plus ribavirin, the current standard therapy for treatment of hepatitis C viral infection.


Eligibility criteria: Inclusion Criteria:

* Documented clinical history compatible with chronic hepatitis C and compensated liver disease
* Failed response to previous hepatitis C therapy of pegylated interferon/ribavirin

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient is co-infected with hepatitis B or HIV

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: New York
country: United States
state: New York
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT02755961: Efficacy of Dietary Education and Education on Phosphate Binder Use in Hemodialysis Patients
Official title: A Randomized Controlled Trial to Evaluate the Efficacy of Reducing High-Phosphate Containing Diet Education and Proper Phosphate Binder Intake Education to Serum Phosphate Level Among Maintenance Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperphosphatemia
End-stage Renal Disease
Keywords: End-stage renal disease
Phosphate binders
Hyperphosphatemia
Dietary education
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 70
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: Hyperphosphatemia is an independent risk factor for mortality among dialysis patients. And most phosphate in human is derived from the food. The purpose of this study is to evaluate the efficacy of nutritional consultation and education on phosphate binder among dialysis patients.

Detailed description: Hyperphosphatemia is an independent risk factor for mortality among dialysis patients. Hyperphosphatemia is associated with increased incidence of cardiovascular diseases, and is a mediator to the development of hyperparathyroidism and mineral bone disorder. Phosphate is usually obtained by food intake, and it can be removed by hemodialysis. However, the efficacy of removal is limited, so that dietary education and proper intake of phosphate binder is essential.

Eligibility criteria: Inclusion Criteria:

* End-stage renal disease patients whose dialysis vintage is more than 3 months

Exclusion Criteria:

* Patients with liver cirrhosis
* Pregnant patients
* Patients with alimentary tract malabsorption diseases
* History of recent alcohol or drug abuse
* Patients receiving chemotherapy for solid organ tumor
* History of mental illness (major depressive disorder, bipolar disorder, schizophrenia, etc.)
* Patients having difficulty communicating with our medical team (dementia, mental retardation, etc.)

Primary outcomes:
measure: The proportion of patients who reached Ca x P product lower than 55
timeFrame: 2-3 month
Secondary outcomes:
measure: Changes of MMAS-8 score
timeFrame: 1 month, 2-3 month
measure: Changes of bioequivalent dose of phosphate binder
timeFrame: 2-3 month
measure: Changes of PG-SGA
timeFrame: 2-3 month
measure: Amount of change in dietary phosphorus intake
timeFrame: 2-3 month
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Assistant Professor
name: Jong Cheol Jeong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00947661: Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open Angle Glaucoma
Ocular Hypertension
Keywords: glaucoma latanoprost
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2009-07-28
Enrollment: 578
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: A single-blind , 12-week, parallel group clinical study is planned to evaluate the efficacy and safety of SPARC0912 and Reference0912. SPARC0912 is an experimental drug having similar active ingredient but containing a different preservative as that in Reference0912. Patients with open angle glaucoma or ocular hypertension will be enrolled and randomly assigned to receive either product. One drop will be instilled to the study eye nightly at 8:00 PM.


Eligibility criteria: Inclusion Criteria:

* Men and women aged ≥ 18 years.
* Diagnosis of ocular hypertension (OHT) or primary open angle glaucoma (POAG).
* Unmedicated IOP ≥ 22 mmHg in one or both eyes.
* Given informed consent.
* Women of child bearing potential practicing an acceptable method of birth control with a negative urine pregnancy test.

Exclusion Criteria:

* Known lack of ocular hypotensive response to topical ophthalmic, prostaglandin analogs (in the opinion of the investigator).
* Intraocular conventional surgery or laser surgery within the past six months.
* Refractive surgery in study eye (e.g., radial keratotomy, PRK, LASIK, etc.) within the past 3 months.
* Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy.
* Ocular trauma within the past 3 months.
* Progressive retinal or optic nerve disease apart from glaucoma.
* Concurrent infectious/non infectious conjunctivitis, keratitis, or uveitis in either eye.
* Any abnormality preventing stable applanation tonometry.
* Use of contact lens for the duration of the study.
* Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber.
* Clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications is not judged safe.
* Clinically significant systemic disease which might interfere with the study.
* History of non-compliance to medical regimens or unwilling to comply with the study protocol.
* Participation in another clinical study within the last thirty (30) days.

Primary outcomes:
measure: Change in Intraocular Pressure From Baseline to Week 12
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: High Point
country: United States
facility: SPARC study site
state: North Carolina
Study officials:
References:
Clinical trial NCT05172661: Effects of Physical-Cognitive Training With Different Task Models in Parkinson's Disease With Mild Cognitive Impairment
Official title: Effects of Physical-Cognitive Training With Different Task Models on Dual-Task Walking in Parkinson's Disease With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Parkinson Disease
Keywords: Dual-task walking training
Parkinson's disease
Mild cognitive impairment
Electroencephalography
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study will characterize exercise model effects (integrated model vs. consecutive model) of physical-cognitive exercise on dual-task walking control in Parkinson's disease with mild cognitive impairment.


Eligibility criteria: Inclusion Criteria:

* a diagnosis of idiopathic Parkinson's disease
* have decreased cognitive functions but do not interfere with functional independence
* Montreal Cognitive Assessment (MoCA): 21-25
* able to walk independently without walking devices for at least 10 meters and with the ability to turn 180°

Exclusion Criteria:

* a diagnosis of dementia
* other diseases that may influence cognitive functions or walking performance
* a history of brain surgery
* modification of the medication during the exercise intervention

Primary outcomes:
measure: Change from baseline dual-task walking performance at 8 weeks
timeFrame: 8 weeks
measure: Fall frequency
timeFrame: 20 weeks
measure: Change from baseline Montreal Cognitive Assessment (MoCA) score at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
References:
Clinical trial NCT00733161: Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure
Official title: Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Congestive Heart Failure
Endothelium-derived Factors
Elderly
Keywords: passive leg exercise
congestive heart failure
endothelium-derived factors
elderly
Lead sponsor: Kyoto University
Sponsor class: OTHER
First posted: 2008-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of passive exercise on systemic endothelial function in elderly patients with chronic heart failure.

Detailed description: Endothelial function is known to be impaired in patients with chronic heart failure (CHF) and impaired endothelial function has been reported to be associated with an increased mortality risk in those subjects. Although systemic exercise training has been demonstrated to improve endothelial dysfunction in patients with CHF, elderly patients with severely impaired exercise capacity could not engaged in usual exercise training using ordinal ergometer. Those patients are able to join stretching or very light resistance training. On the other hand, passive pedaling using strength ergometer has been reported to be useful in patients with severely impaired exercise capacity, but the safety and the efficacy of passive pedaling on endothelial function in old patients with CHF has not been previously reported.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic heart failure
* Elderly patients aged ≧65 years
* Patients with severely reduced exercise capacity and cannot continue exercise with usual cycling ergometer for 5 minutes

Exclusion Criteria:

* Unstable hemodynamic status (uncontrolled arrhythmia, uncontrolled congestion, uncontrolled hypertension)
* Active infectious disease
* Malignancy
* Chronic obstructive pulmonary disease
* Dialysis
* Severe aortic valve disease
* With any hip, knee, ankle joint pain
* Hemiplegia
* Current smoker

Primary outcomes:
measure: Endothelial function
timeFrame: 2 weeks
Secondary outcomes:
measure: Left ventricular systolic and diastolic function
timeFrame: 2 weeks
measure: Six-minute walk distance
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Study officials:
affiliation: Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
name: Takeshi Kimura, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ozasa N, Morimoto T, Bao B, Shioi T, Kimura T. Effects of machine-assisted cycling on exercise capacity and endothelial function in elderly patients with heart failure. Circ J. 2012;76(8):1889-94. doi: 10.1253/circj.cj-11-1113. Epub 2012 May 16.
Clinical trial NCT01162161: Role of Sphingolipids in Pulmonary Edema
Official title: Role of Sphingolipids in Pulmonary Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Edema
Keywords: sphingolipid
ceramide
sphingomyelinase
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2010-07-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 3 groups

first group: patients with a lung oedema because of a pneumonia (about 30 patients)

second group: patients with a lung oedema because of cardiac insufficiency (about 25 patients)

third group: patients without any lung oedema (about 15 patients)

Brief summary: In this mono-center prospective study, the impact of changes in the sphingolipid metabolism in patients with pulmonary edema will be investigated.

Detailed description: There will be three groups of patients:

1. hydrostatic pulmonary edema
2. toxic pulmonary edema
3. not ventilated patients without any pulmonary edema

Samples of a routine bronchoalveolar lavage and EDTA-blood will be analysed in respect of sphingolipids, ceramide, sphingomyelin-phosphodiesterase and several cytokines.

Eligibility criteria: Inclusion Criteria:

* above the age of 18

Exclusion Criteria:

* taking steroids

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Medical Clinic I, University Hospital Aachen
state: Nordrhein-Westfalen
Study officials:
affiliation: RWTH Aachen University
name: Stefan Krüger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: