louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00869076: Pharmacists Management of Diabetes
Official title: Pharmacist Management of Diabetes Mellitus: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Pharmacist
Lead sponsor: Advantage Health Physician Network
Sponsor class: OTHER
Collaborators: name: Doran Foundation
name: Michigan Pharmacist Foundation
name: Priority Health
name: Western Michigan Society of Health System Pharmacists
First posted: 2009-03-25
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The hypothesis is that patients with poorly controlled diabetes would have greater improvement in their blood sugar control when managed by a clinical pharmacist than when managed with usual medical care. Patients with poor control are randomized to pharmacist management or to usual medical care for one year.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* A1c greater than or equal to 9.0

Exclusion Criteria:

* Not expected to live for the duration of the study
* Managed by an endocrinologist
* Unwillingness to participate and attend pharmacist visits

Primary outcomes:
measure: Hgb A1c change
timeFrame: 1 year
Secondary outcomes:
measure: HgbA1c change based on ethnicity
timeFrame: one year
measure: percent of patients with a 1 point or greater decrease in A1c
timeFrame: one year
measure: Percent of patients with a 1 point decrease in A1c by ethnicity
timeFrame: one year
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Advantage Health Physican Network
state: Michigan
Study officials:
References:
Clinical trial NCT05889676: Validation of a Simultaneous Ocular/Cervical VEMP With Mastoid Vibration by B250
Official title: Validation of a Simultaneous Ocular/Cervical VEMP With Mastoid Vibration by B250
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vertigo
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2023-06-05
Enrollment: 120
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: all adult patients attedning the balance laboratory at Karolinska University Hospital after written consent.

Brief summary: A Validation study in which the standard separate cVEMP and oVEMP will be compared with a new protocol in which the cVEMP and oVEMP can be recorded simultaneously in response to a mastoid vibration by bone transducer B250


Eligibility criteria: Inclusion Criteria:

-) dizzy patients attending the balance laboratory -

Exclusion Criteria:

-) age \< 18 years old

Primary outcomes:
measure: response rate
timeFrame: during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Hearing and Balance Unit
Study officials:
References:
Clinical trial NCT00939276: Macular Edema Incidence/Severity Reduction With Nevanac
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetic Retinopathy
Keywords: cataract surgery
macular edema
prevention
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-07-14
Enrollment: 175
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: The purpose of this study is to evaluate NEVANAC in patients with diabetic retinopathy who developed macular edema (ME) within 90 days following cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens (IOL) into the lens capsule.
* History of Type 1 or Type 2 diabetes.
* History of nonproliferative diabetic retinopathy (NPDR), mild, moderate, or severe, in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale.
* Able to understand and sign an informed consent approved by an IRB/IEC.
* Central subfield macular thickness less than or equal to 320 μm in the study eye prior to cataract surgery.
* Absence of clinically significant macular edema in the study eye as detected by clinical exam.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by the reading center or Investigator.
* Current or previous ocular disease other than diabetic retinopathy in the study eye that, in the opinion of the Investigator, would have confounded the assessments of the macula, the retina, or central vision.
* Planned multiple procedures for the study eye during the cataract/IOL implantation surgery (eg, trabeculoplasty, corneal transplant).
* Corneal transplant in study eye.
* Baseline cumulative corneal fluorescein staining score (ie, sum of scores for all 5 corneal regions) for the study eye greater than or equal to 5, or baseline corneal fluorescein staining score in any single region for the study eye greater than or equal to 3.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percentage of patients who develop macular edema within 90 days following cataract surgery
timeFrame: Time to event
Secondary outcomes:
measure: Mean change in best-corrected visual acuity (BCVA) from baseline to Day 90
timeFrame: Baseline, Day 90
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center For Trial Locations
state: Texas
Study officials:
References:
citation: Pollack A, Staurenghi G, Sager D, Mukesh B, Reiser H, Singh RP. Prospective randomised clinical trial to evaluate the safety and efficacy of nepafenac 0.1% treatment for the prevention of macular oedema associated with cataract surgery in patients with diabetic retinopathy. Br J Ophthalmol. 2017 Apr;101(4):423-427. doi: 10.1136/bjophthalmol-2016-308617. Epub 2016 Jul 7.
Clinical trial NCT01781676: Safety Study of Kudiezi(Yueanxin,a Chinese Medicine Injection)Used in Hospitals in China
Official title: Registry Study Intensive Hospital Monitoring Protocol of Kudiezi Injection ( Yueanxin ) 's Clinical Safety
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Angina Pectoris
Stroke
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Longhua Hospital
First posted: 2013-02-01
Enrollment: 30000
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: An anticpcipated sample size was caculated in this study,about 30000.Patients using Kudiezi injection from 2012 to 2014 in more than 20 hospital.

Brief summary: This study was advocated by institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences in October 2011.

It was funded by China major scientific and technological specialized specialized project for 'significant new formulation of net drugs'.

Kudiezi(Yueanxin) is kind of Chinese Medicine injiection used for treating corinary heart diswese、angina pectoris and stroke in many Chinese hospitals.

The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.

Detailed description: It is very common that Chinese Medicine Injection used in hospitals in mainland China.However safety problems rose in recent years.There could be many uncertain factors influence Chinese Medincine Injection in clinical practice.

Safety surveillance on Chinese Medincine injection is an important problem that needs to be sorted out through large sample observational dtudy.

A registry study for Kudiezi(Yueanxin) injection safety surveillance with 30000 patients will be conducted form Jan.2012 to Dec.2015.

Eligiblity crteria Patients who will use Kudiezi(Yueanxin) injection in selected hospitals.

Date will be collected in four aspects by four different forms as following:

Form A(blue):demographic information ;Form B(yellow):adverde drug events/reaction;Form C(white):extracted information from hodpiral information system and laboratory information system.

Eligibility criteria: Inclusion Criteria:

Patients using Kudiezi(Yueanxin) injection from 2012 to 2014

Exclusion Criteria:

none

Primary outcomes:
measure: Number of participants with adverse events;incidence of Kudiezi(Yueanxin)'ADRs and identify factors that contributed to the occurrence of the adverse reaction
timeFrame: to assess Kudiezi(Yueanxin)'s 'adverse event' and 'drug adverse reaction' during patients' hospital stay,administration information of Kudiezi will be registered every day.The registry procedure will last 3 years only for patients using Kudiezi.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Basic Research in Clinical Medicine
state: Beijing
Study officials:
affiliation: China Academy of Chinese Medical Sciences
name: Xie Y Ming, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03580876: Addition of Azathioprine in IBD Patients With Immunogenic Failure
Official title: Addition of Azathioprine to the Switch of Anti-TNF Drug in IBD Patients in Clinical Relapse With Undectectable Anti-TNF Trough Levels and Anti-drug Antibodies : a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Clinical Failure After Switch
Lead sponsor: Védrines, Philippe, M.D.
Sponsor class: INDIV
First posted: 2018-07-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two strategies
Primary purpose: TREATMENT

Brief summary: Loss of response under anti-TNF is frequent. 20% of patients with clinical relapse present an immune mediated pharmacokinetic failure. In the last AGA recommendations, switch to another anti-TNF drug is suggested with no indication of immunosuppressive agent. In a recent study, 70% of patients with an immunogenic failure to a first anti-TNF agent developed a new immunogenic failure to the second anti-TNF drug using alone.

Detailed description: The aim of the study in these patients with an immune mediated pharmacokinetic failure was to compare two strategies:

Switch to a second anti-TNF alone or switch to a second anti-TNF with addition of azathioprine

Comparing rates of clinical failure, rates of immunogenic failure and finally adverse events during a follow-up of 24 months

Eligibility criteria: Inclusion Criteria:

* IBD Patients in clinical failure under anti-TNF (Infliximab (IFX) or Adalimumab (ADA) in monotherapy at the optimal dose) ADA: 40mg/7 days, IFX: 10mg/kg/8 weeks Active disease CD: HBI \> 5 with Calprotectin \> 250 µg/g stool UC: Total Mayo Score \> 4 with an endoscopic subscore \> 1 Anti-TNF monotherapy for at least 4 months and optimization for at least two months
* Patients with an immune mediated PK failure Undetectable rates of anti-TNF and high Ab against anti-TNFs \> 20ng/mL for ATI and AAA (Elisa Theradiag) on two consecutive samples
* Patients who have agreed to and signed the consent form

Exclusion Criteria:

* Unclassified colitis
* Pregnant woman
* Crohn's disease CD with a exclusive anoperineal phenotype
* Contraindication or intolerance to azathioprine
* Primary non-responder patients To the first anti-TNF or After the switch to a - second anti-TNF
* Ostomy

Primary outcomes:
measure: clinical failure
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montbrison
country: France
facility: Clinic of Montbrison
state: Loire
Study officials:
References:
Clinical trial NCT00155376: Intravenous-Morphine and Glucagon-Usage Enhanced MR Cholangiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Morphine can induce constriction of sphincter of oddi and glucagon can facilitate bile secretion and dilatation of bile duct. We conduct this randomized double blinded study to evaluate the effect of enhancement in MRCP using intravenous morphine and glucagon.

Detailed description: Morphine can induce constriction of sphincter of oddi and glucagon can facilitate bile secretion and dilatation of bile duct. We conduct this randomized double blinded study to evaluate the effect of enhancement in MRCP using intravenous morphine and glucagon.

Eligibility criteria: Inclusion Criteria:

* normal volunteer
* living liver donor

Exclusion Criteria:

* COPD
* chronic liver disease
* hypersensitive to glucagon
* DM
* insulinoma
* glucagonoma
* pregnancy

Primary outcomes:
measure: MRCP visibility
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: province of Taiwan
Study officials:
affiliation: National Taiwan University Hospital
name: Hon-Man Liu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04152876: Functional Genomics of Rare Genetic Diseases: Realization of Innovative Tools With High Diagnostic Power
Official title: Functional Genomics of Rare Genetic Diseases: Realization of Innovative Tools With High Diagnostic Power
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rare Diseases
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
Collaborators: name: Institute of Genetics and Biophysics CNR
First posted: 2019-11-05
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be selected from the Center for rare diseases of the IRCCS Neuromed, and at IGB CNR according to specific inclusion criteria. Approximatey 300 subjects, recruited with a family-based approach, will be included in the study.

Brief summary: The project aims to improve the understanding of a significant group of rare diseases both from a genetic/diagnostic and clinical/experimental point of view and aims to develop one or more diagnostic protocols.

The study will be conducted through the application of complementary experimental strategies, ranging from the clinical, genetic and molecular characterization of the pathology to the search for rare variants and the development of cellular disease models.

Detailed description: 1. Clinical evaluation of patients and relatives
2. High throughput analysis of genetic variants in genome exomes
3. Genotype-phenotype association testing
4. Identification of genetic risk variants for rare diseases

Eligibility criteria: Inclusion Criteria:

* Patients affected by: SLA, Incontinentia Pigmenti type II, Rett Syndrome, Paget Disease, Pompe Disease, Immunodeficiency, Centromeric instability and Facial anomalies, Cortical malformations and malignant epileptic encephalopathies

Exclusion Criteria:

* none

Primary outcomes:
measure: Identification of genetic variants responsible for rare diseases
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCCS Neuromed
Study officials:
affiliation: Head of Neurology Unit
name: Diego Centonze, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01304576: Orientation Agnosia: Clinical and Anatomical Study
Official title: Orientation Agnosia: Neuropsychological Evaluation, Associated Symptoms, Clinical and Anatomical Correlations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Disorders
Brain Lesions
Keywords: stroke
parietal lesions
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The area of the brain responsible of visuospatial processing data and more specifically the orientation of an object or image is located in parietal lobe, especially on the right side. A dysfunction of this region would result in a disorder of recognition of the orientation of objects and images that the investigators call orientation agnosia. Several isolated cases are reported in the literature but to the investigators knowledge deficit has never been systematically searched, or put into perspective compared to other neuropsychological deficits. Moreover, the precise location of the lesion responsible for such a disorder remains uncertain. The objectives of this study are (1) detect the existence of orientation agnosia in case of right parietal lesion, and (2) to improve the understanding of such a deficit allowing better management of this disorder.

Detailed description: Idem

Eligibility criteria: Inclusion Criteria:

* age between 18 and 80 years
* french language
* right parietal lesion on cerebral imaging (CT-scan is sufficient), including stroke,arterial malformation, isolated tumoral lesion
* informed consent

Exclusion Criteria:

* previous neurological history except non complicated migraine and stabilized epilepsia without seizure since 5 years
* previous psychiatric history except depression without hospitalization \> one week or anxiety with maximum one anxiolytic treatment
* drug or alcohol abuse
* severe cranial traumatism
* other severe chronic pathology
* psychotropic medication other than a hypnotic or an anxiolytic at low doses without dose modification for at least one month
* visual impairment
* motor or sensory deficit sufficient to render impossible neuropsychological tests
* patient without judicial or administrative liberty
* measure of legal protection or no capable to express their consent
* pregnancy or breastfeeding

Primary outcomes:
measure: orientation agnosia evaluation
timeFrame: 1 week to 6 months (average)
Secondary outcomes:
measure: associated clinical symptoms especially apraxia
timeFrame: 1 week to 6 months (average)
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU de Rouen - Hôpitaux de Rouen
state: Haute-Normandie
Study officials:
affiliation: Service de neurologie et centre mémoire de ressources et recherche
name: Olivier MARTINAUD, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03604276: Neuroinflammatory Response and Headache Control in Patients After Subarachnoid Hemorrhage
Official title: Neuroinflammatory Response and Headache Control in Patients After Subarachnoid Hemorrhage (HASH4-CSF) - An Observational Trial
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Headache
Subarachnoid Hemorrhage
Keywords: Headache
Subarachnoid hemorrhage
Neuroinflammation
Lead sponsor: MaineHealth
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible patients are patients with a non-traumatic subarachnoid hemorrhage who are treated with an external ventricular drain for symptomatic hydrocephalus.

Brief summary: The purpose of this study is to determine the relationship between the Neuroinflammatory response and headache pain after subarachnoid hemorrhage.

Detailed description: Persistent headache is a significant medical issue that affects 20% of patients who survive an aneurysmal subarachnoid hemorrhage (SAH). This headache may last years, severely affecting quality of life. Laboratory evidence suggests that the persistent headache may be a result of a maladaptive neuroinflammatory response to the hemorrhage injury that is more vigorous than necessary. The goal of this study is to measure key immunomodulators in the blood and the cerebrospinal fluid of these patients in order to determine the magnitude and dynamics of their neuroinflammatory response. In addition, the investigators will collect and analyze observational data about the success of medications to treat headache, with a specific focus on the anti-inflammatory agent dexamethasone, in managing acute headache pain and preventing the development of persistent headaches in patients after SAH.

Eligibility criteria: Inclusion Criteria:

* Non-traumatic subarachnoid hemorrhage
* Age \> 18 years
* Treated with external ventricular drainage

Exclusion Criteria:

* Pregnancy or lactation
* Age \< 18 years
* Traumatic SAH

Primary outcomes:
measure: Characterization of the neuroinflammatory response in the CSF and blood of patients with non-traumatic SAH.
timeFrame: 10 days
measure: Determination of correlation between the neuroinflammatory response and severity/presence of headache pain.
timeFrame: 10 days
measure: Determination of correlation between the neuroinflammatory response and development of chronic headache.
timeFrame: 1 year
Secondary outcomes:
measure: Comparison of the neuroinflammatory response in the CSF and blood in patients treated with dexamethasone versus other analgesics post SAH.
timeFrame: 10 days
measure: Comparison of dexamethasone versus other analgesics in their ability to improve measures of quality of life.
timeFrame: 1 year
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
Study officials:
affiliation: MaineHealth
name: Elizabeth K Glisic, PharmD
role: PRINCIPAL_INVESTIGATOR
References: