louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00711061: Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy
Official title: Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Deficiency
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2008-07-08
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Endocrine clinic and community sample

Brief summary: The purpose of this study is to compare the cardiovascular risks of growth hormone deficient young adult males who have completed growth hormone therapy to healthy young adult males.

Detailed description: Adults with growth hormone deficiency are at risk for cardiovascular disease. What age this begins is not known.

The objectives of this study are to compare the following measurements between growth hormone deficient young males 3-7 years post completion of growth hormone treatment and age related healthy controls:

1. Carotid artery imaging
2. Metabolic and cardiac parameters
3. Body composition measurements

Eligibility criteria: Growth Hormone Deficient Inclusion Criteria:

* Males, 18-25 years old
* Completed growth hormone therapy approximately 3-5 years prior to study enrollment
* History of multiple pituitary hormone deficiencies or growth hormone stimulation test \<7 at initiation of growth hormone therapy

Healthy Control Inclusion Criteria:

* Males, 18-25 years old
* No confirmed endocrine diagnosis including Diabetes and thyroid disorders
* BMI - z-score within 2 SD of mean

Exclusion Criteria:

* Known risk factors for cardiovascular disease (eg tobacco use, hypertension, diabetes)
* Family history of early cardiovascular disease (myocardial infarction or stroke \<55years of age) in first degree family members
* Any implanted device
* Medication known to interfere with glucose or lipid metabolism or to influence blood pressure
* Chronic organ illness (eg severe asthma, hepatic or nephritic conditions)

Primary outcomes:
measure: Compare carotid artery intima medial thickness
timeFrame: During study visit
Secondary outcomes:
measure: Compare metabolic parameters and body composition measurements
timeFrame: During study visit
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Childrens Mercy Hospitals and Clinics
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Carol Huseman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01843361: Clopidogrel Response in Acute Ischemic Stroke. The Bochumer CRISP Study
Official title: Prevalence of Low Response to Clopidogrel in Patients After Acute Ischemic Stroke.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: Stroke
Clopidogrel
Aggregometry
Antiplatelet therapy
Platelet function tests
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an acute ischemic stroke admitted to our stroke unit and treated with clopidogrel

Brief summary: The aim of this study was to determine the prevalence rate and risk factors for chemical laboratory clopidogrel low-response (CLR) in the acute phase after an ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* acute ischemic stroke
* admittance to stroke unit
* clopidogrel medication

Exclusion Criteria:

* no consent
* prior bleeding disorders
* severe liver disorders
* current gastrointestinal disorders
* congestive heart failure
* life-threatening malignancies

Primary outcomes:
measure: Result of platelet function test
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Neurology, Ruhr University Bochum
Study officials:
affiliation: Ruhr University Bochum, Department of Neurology
name: Saskia H Meves, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meves SH, Overbeck U, Endres HG, Krogias C, Neubauer H. Dose-dependent effect of early antiplatelet therapy in acute ischaemic stroke. Thromb Haemost. 2012 Jan;107(1):69-79. doi: 10.1160/TH11-06-0436. Epub 2011 Dec 8.
citation: Fong J, Cheng-Ching E, Hussain MS, Katzan I, Gupta R. Predictors of biochemical aspirin and clopidogrel resistance in patients with ischemic stroke. J Stroke Cerebrovasc Dis. 2011 May-Jun;20(3):227-30. doi: 10.1016/j.jstrokecerebrovasdis.2009.12.004. Epub 2010 Jul 10.
Clinical trial NCT03743961: Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia
Official title: Description the Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia : Prospective Descriptive Non-comparative Cohort ( QUALI Cohort)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Systemic Treatment
Metastatic Neoplasia
Elderly Patients
Keywords: quality of life
elderly
metastatic neoplasia
systemic therapies
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 28
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with minimum 75 years old will perform two questionnaires about quality of life and then, according to these scores they will perform a geriatric intervention.

Brief summary: The aim of this study is to describe the impact of : Geriatric intervention contribution on quality of life of elderly patients receiving systemic treatments for metastatic neoplasia

Detailed description: Elderly cancer incidence increases exponentially with advancing age. However, elderly patients are largely underrepresented in cancer treatment trials. The geriatric population presents particular physical, mental, psychological or social specificities that may condition the prognosis especially for patients with metastatic neoplasia. Recently, the measurement of quality of life (QoL) in aging population is being recognized as an important part of clinical decision. It is therefore essential to set up prospective studies to evaluate the impact of oncogeriatric practices on the quality of life of elderly patients with metastatic neoplasia. The main objective of this prospective study is to describe the contribution of geriatric intervention on quality of life for for elderly (\> 75 years) with metastatic solid cancer receiving systemic treatment during the first 6 months of their therapeutic management.

Eligibility criteria: Inclusion Criteria:

* Patient with solid metastatic neoplasia
* 75 years old or more
* Men or women
* ECOG between 0 and 3
* Patient receiving systemic antineoplasic treatment (chemotherapy, hormonotherapy, immunotherapy, targeted therapy)

Exclusion Criteria:

* ECOG 4
* Localized cancer
* Patients already included in a study witch could modify quality of life
* Patient unable to give their consent

Primary outcomes:
measure: Level of quality of life
timeFrame: 6 months
measure: Level of quality of life
timeFrame: 6 months
Secondary outcomes:
measure: number of hospitalizations
timeFrame: 6 months
measure: Duration of hospitalizations
timeFrame: 6 months
measure: Number of toxicities ( grade 3 and 4)
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
Study officials:
affiliation: Institut de Cancérologie Lucien Neuwirth
name: Blandine De Lavigerie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00920361: Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)
Official title: Designated Drug Use Investigation 1 of Follistim Injection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertilization in Vitro
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-06-15
Enrollment: 1664
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japanese 1100 patients

Brief summary: To evaluate dosage and administration method, efficacy and safety of Puregon and the relationship between background factors of patients and dose and administration method.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent IVF

Exclusion Criteria:

* Patients with tumors of ovary, breast, uterus, pituitary or hypothalamus
* Pregnant or possible pregnant women, or lactating women
* Patients with undiagnosed atypical vaginal bleeding
* Patients with a history of hypersensitivity to any of the ingredients of this product.
* Patients with ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease

Primary outcomes:
measure: Number of retrieved oocytes
timeFrame: 2 months, from initiation of treatment to confirmation of pregnancy.
Secondary outcomes:
measure: Pregnancy outcome
timeFrame: 2 months, from initiation of treatment to confirmation of pregnancy.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01669161: Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke
Official title: A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Rehabilitation for Improved Upper Limb Function After Stroke (MicroTransponder's Vivistim System)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Upper
Limb
Deficits
Rehabilitation
VNS
Lead sponsor: MicroTransponder Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients (UK only) at least 6 months post stroke, with upper limb deficits, may enroll. Patients will be randomized to one of two groups - a group implanted with a device that allows pairing VNS with rehabilitation and a group that only receives rehabilitation (no implant). Patients have two baseline evaluations, one evaluation after implant but before initiation of treatment, and then six weeks of rehabilitation or rehabilitation + VNS, followed by post acute therapy evaluations at 1, 7, and 30 days after the 6-weeks of treatment. The intent is to assess safety and provide preliminary effectiveness information for VNS for upper limb functional improvement after stroke. Implanted patients may receive longer-term treatment and follow-up after the acute study.


Eligibility criteria: Major Inclusion Criteria:

1. History of unilateral supratentorial ischemic stroke that occurred at least 6 months prior
2. Age \> 18 years and \< 80 years
3. Right or left sided weakness of upper extremity

Major Exclusion Criteria:

1. Hemorrhagic stroke
2. Any deficits in language or attention that interferes with reasonable study participation
3. Presence of significant apraxia
4. Profound Sensory loss
5. Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including alcohol or drug abuse

Primary outcomes:
measure: Safety
timeFrame: 6-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow, Scotland
country: United Kingdom
facility: U. Glasgow / Western Infirmary
Study officials:
affiliation: U. Glasgow
name: Jesse Dawson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8.
Clinical trial NCT00366561: Neonates With Neurological Complications
Official title: Retrospective Review of Neonates With Neurological Complications Following Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Disorders
Keywords: neonates
neurological complications
surgery
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2006-08-21
Enrollment: 810
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All neonates (newborns \< 30 days of age) from January 1, 2002 through June 20, 2006 at Children's Healthcare of Atlanta who have suffered neurological complications following cardiac surgery.

Brief summary: The purpose of this retrospective study is to identify all neonates (newborns \< 30 days of age) from January 1, 2002 through June 20, 2006 at Children's Healthcare of Atlanta who have suffered neurological complications following cardiac surgery. This retrospective study is important to identify the incidence, care and follow-up of neurological complications at this institution

Detailed description: Studies have shown that between one-quarter and one-half of infants undergoing cardiac surgery will suffer brain injury during surgery (the perioperative period). Some infants with congenital heart disease have neurological injury prior to cardiac surgery as a result of cyanosis, acidosis and abnormal circulation. The spectrum of neurological injury ranges from agitation and subtle disturbances in learning and new memory acquisition to visual and motor development abnormalities, seizures, stroke and encephalopathy.

The patient will be identified from the cardiothoracic surgery database. Their hospital medical records and the neurological database will be reviewed for type of neurological complication (i.e. seizure, stroke), neuro-imaging and any mortality for these patients. We will review the patient outcome data that is available, after the initial surgery, through June 20, 2006. No patients will be contacted.

Eligibility criteria: Inclusion Criteria:

* Children's Healthcare of Atlanta patients
* January 1, 2002 through June 20, 2006
* \< 30 days of age
* neurological complications following cardiac surgery

Exclusion Criteria:

* Those who do not meet inclusion criteria

Primary outcomes:
measure: The purpose of this study was to examine short term outcomes following cardiac surgery in premature neonates.
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Sibley Heart Center Cardiology at Children's Healthcare of Atlanta
name: Janet M Simsic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04045561: Development of a Standardized Reference Guide for Tuning Adherence to Dispense During a Initial Pharmaceutical Consulting (CP ) to the Patient With Multiple Myeloma Oral Chemotherapy Primocure
Official title: Elaboration of a Standardized Referential Guide of the Information to Optimize the Adherence to be Given During an Initial Pharmaceutical Consultation (CP) to the Patient Suffering From Multiple Myeloma in Primocure Chemotherapy Per os
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient is treated for multiple myeloma, is naive to any treatment and begins a chemotherapy protocol with oral therapy and whose course of care includes a stay in the Day Hospital or retrocessions.

Brief summary: The hypothesis is that the implementation of an initial Pharmaceutical Consultation (PC) program based on the provision of standardized information to patients treated for multiple myeloma as a first course of chemotherapy, could optimize their compliance with the delivered per os treatment.

The aim of this study is therefore to develop a standardised reference guide of information to be provided during prostate cancer in order to optimise the compliance of patients treated for multiple myeloma as a first course of chemotherapy per os.


Eligibility criteria: Inclusion criteria

* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 18 years old
* The patient is treated for multiple myeloma, is naive to any treatment and begins a chemotherapy protocol with oral therapy and whose course of care includes a stay in the Day Hospital or retrocessions.

Criteria for non-inclusion

* The subject is participating in another study
* The subject is in an exclusion period determined by a previous study
* The subject is under the protection of justice, guardianship or curatorship
* It is impossible to give informed information about
* The patient is pregnant, parturient, or breastfeeding
* The patient receives a follow-up by a home nurse for the administration of oral medication
* The patient is treated only with oral chemotherapy in the city
* The patient has early dementia.

Translated with www.DeepL.com/Translator

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Primary outcomes:
measure: evaluating the understanding
timeFrame: Day 1
measure: evaluating understanding
timeFrame: Day 1
measure: evaluating the quality of information
timeFrame: Day 1
measure: evaluating quality of information
timeFrame: Day 1
Secondary outcomes:
measure: The time required for the pharmaceutical consultation
timeFrame: Day 1
measure: satisfaction des patients
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06082661: Blood Collection for COM/BSBS
Official title: Blood Collection for Use with Translational, Biomedical Research At UCF College of Medicine and Burnett School of Biomedical Sciences
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Keywords: Blood
Healthy
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study does not specifically target a particular vulnerable population.

Brief summary: The objective of this biospecimen collection protocol is the acquisition of blood from adult volunteers. These biospecimens will be transferred to the College of Medicine (COM)/Burnett School of Biomedical Sciences (BSBS) research scientists and their research teams for testing according to their separate IRB-approved/exempted protocols. These separate IRBapproved protocols cannot be for genetic testing.

Detailed description: Research scientists of the University of Central Florida College of Medicine (COM) and Burnett School of Biomedical Sciences (BSBS) conduct laboratory studies in biomedical and translational research for the purpose of understanding human disease and developing innovative methods for diagnosing, measuring, or treating disease or disease symptoms. The key research divisions are cancer, cardiovascular, immunity and pathogenesis, neuroscience, and molecular microbiology. Frequently, these studies require human blood (or its derivatives) for testing of assays and devices.

Eligibility criteria: Inclusion Criteria:

* Male or female adults
* 18 years old or older
* weigh over 110 pounds
* able to provide informed consent

Exclusion Criteria:

* pregnant/suspect to be pregnant
* prisoners
* have donated blood anywhere in the preceding 16 weeks

Primary outcomes:
measure: Acquisition of blood samples for testing
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
References:
Clinical trial NCT00012961: Improving Health Services for Veterans With Schizophrenia
Official title: Improving Health Services for Veterans With Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Maryland, Baltimore County
First posted: 2001-03-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Schizophrenia exacts a high toll on the lives of patients and their families and constitutes a major health care cost. VISN 5 has placed special emphasis on improving care for veterans with severe mental disorders, an effort recently recognized by the VA as a Program of Excellence in the Care of Seriously Mentally Ill Veterans.

Detailed description: Background:

Schizophrenia exacts a high toll on the lives of patients and their families and constitutes a major health care cost. VISN 5 has placed special emphasis on improving care for veterans with severe mental disorders, an effort recently recognized by the VA as a Program of Excellence in the Care of Seriously Mentally Ill Veterans.

Objectives:

This study is implementing a set of promising QOC methods for assessing QOC for schizophrenia in routine settings, using the evidence-based treatment recommendations developed under the AHCPR/NIMH-sponsored Schizophrenia Patient Outcomes Research Team (PORT).

Methods:

A random sample of 350 persons with a schizophrenia spectrum disorder is being drawn from the VISN 5 sites. Patients must have more than one outpatient contact during the preceding six months. Each subject will participate in two one-hour interviews, one at baseline and another six months later. An informant, psychiatrist, therapist, etc. will also be interviewed to help validate participant response.

Status:

Project work is ongoing.

Eligibility criteria: Inclusion Criteria:

Patients must be adults currently in treatment for an Axis I schizophrenia spectrum disorder (DSM295) at VA.

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Alan S. Bellack, PhD
role: PRINCIPAL_INVESTIGATOR
References: