louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05431647: Sensory Integration for Infants With Cortical Visual Impairment
Official title: The Effectiveness of Sensory Integration Interventions on Motor and Sensory Functions in Infants With Cortical Vision Impairment and Cerebral Palsy: A Single Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensory Integration Disorder
Keywords: Cerebral Palsy
Cortical Visual Impairment
Sensory Integration
Motor Function
Early Intervention.
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 34
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our study examines the effect of sensory integration training on sensory, motor and oculomotor skills in infants with cortical vision impairment .

Detailed description: Cortical vision impairment (CVI) and Cerebral Palsy (CP) lead to decrement in sensory and motor functions of infants. The current study examined the effectiveness of sensory integration interventions on sensory, motor, and oculomotor skills in infants with cortical vision impairment. Thirty-four infants with CVI and CP aged 12-18 months were enrolled to the study. The infants were randomly divided into 2 groups as the control and intervention groups. The intervention group took sensory integration intervention 2 days a week for 8 weeks in addition to conventional physiotherapy two days a week for eight weeks. The control group only received the conventional physiotherapy program 2 days a week for 8 weeks. The duration of the treatment sessions were 45 minutes for both interventions. Before and after the intervention, sensory processing functions were evaluated with the Test of Sensory Functions in Infants (TSFI) and motor functions were evaluated with the Alberta Infant Motor Scale (AIMS).

Eligibility criteria: Inclusion Criteria

* Cerepral palsy
* Cortical visual impairment
* 12-18 months

Exclusion Criteria

* Not participating in treatment regularly

Primary outcomes:
measure: Test of Sensory Functions in Infants (TSFI)
timeFrame: 30 minute
measure: Alberta Infant Motor Scale (AIMS)
timeFrame: 30 minute
Secondary outcomes:
measure: Test of Sensory Functions in Infants (TSFI)
timeFrame: 30 minute
measure: Alberta Infant Motor Scale (AIMS)
timeFrame: 30 minute
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Occupational Therapy Department
state: Çankaya
Study officials:
affiliation: hacettepe üniversitesi
name: mustafa cemali, Phd. student
role: STUDY_DIRECTOR
References:
Clinical trial NCT03797547: Real Life Study in Myopic Neovascularization
Official title: Real Life Study in Myopic Neovascularization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopic Choroidal Neovascularisation
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Active mCNV among:
* Naïve patients.
* Patients with previous history of laser photocoagulation or PDT, with no history of anti-VEGF.
* Patients with previous history of other anti-VEGF treatments.including ranibizumab or bevacizumab, with sustaining mCNV activity, who did not receive injection since the last 3 month

Brief summary: This is a multi centre, single arm, prospective observational phase 4 study in naive or pretreated patients with myopic neovascularization. The patients will be treated with intravitreal injections of Aflibercept following a real life protocol.

This sudy aims to evaluate the visual acuity during a 36 months period of time.


Eligibility criteria: Inclusion Criteria:

* Man or woman aged 18 years and more under reliable method of contraception for woman with childbearing potenteial (hormonal or any intrauterine devices).
* High myopy defined by refractive error ≤ -6 D or History of high myopia among pseudophakic patient or patient treated with refractive surgery
* Patient with active CNVm
* • Patients naïve or Patients pretreated with previous history of laser photocoagulation or PDT or by other anti-VEGF treatments who did not receive injection since the last 3 month

  * with OCT or angiography examination

Exclusion Criteria:

* Treatment with an anti VEGF administrated by intravitreal injection within 1 months prior to baseline in the study eye.
* Treatment with PDT or laser administrated within 6 months prior to baseline in the study eye.
* History of vitrectomy in the study eye
* History of any other retinal disease
* VA less than 20/250

Primary outcomes:
measure: visual acuity measurement
timeFrame: 6, 12, 24 and 36 months
Secondary outcomes:
measure: visual acuity measurement in naive patient
timeFrame: 12, 24 and 36 months
measure: visual acuity measurement after other treatment such as laser, pdt visudyneor other IVT treatment
timeFrame: 6, 12, 24 and 36 months
measure: pourcentage of patients who gain more than or equal of 15 letters
timeFrame: 6,12,24 and 36 months
measure: Anatomics parameters by oct
timeFrame: 6, 12, 24 and 36 months
measure: Anatomics parameters by color photographs
timeFrame: 6, 12, 24 and 36 months
measure: Anatomic parameters by fluoresceine angiography or angiography oct
timeFrame: 6, 12, 24 and 36 months
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Chu de Poitiers
Study officials:
References:
Clinical trial NCT06629077: Brain Blood Vessel Responses to Changes in Blood Flow
Official title: Cerebrovascular Responses to Acute Hypoperfusion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Magnetic Resonance Imaging
Cerebrovascular Circulation
Keywords: Magnetic Resonance Imaging
Brain Blood Flow
Lower Body Negative Pressure
Carbon Dioxide
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2024-10-08
Enrollment: 36
Sex: ALL
Minimum age (years): 55
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Brain blood flow will be measured during a simulated postural change test and while breathing increased levels of carbon dioxide using magnetic resonance imaging.

Detailed description: Global cerebral blood flow (CBF) decreases with advancing age; however, some adults have accelerated declines in CBF, placing them at a greater risk of cognitive impairment. However, there is a lack of human studies that investigate the cause or consequence of altered blood flow regulation in the brain. This study will systematically address this gap in knowledge by examining cerebrovascular control in adults during acute physiological challenges (simulated postural change test and breathing increased carbon dioxide) that stimulate a change in CBF.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 55-69 years
* Have a BMI ≤34.5 kg/m2
* Nonsmoker
* Females must be postmenopausal

Exclusion Criteria:

* Diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's disease (AD)
* History or evidence of hepatic disease, hematological disease, or peripheral vascular disease; severe kidney injury requiring hemodialysis
* History of cardiovascular disease including: severe congestive heart failure, coronary artery disease, ischemic heart disease (stents, coronary artery bypass grafts) and tachycardia
* Uncontrolled hypertension
* History of clinically significant ischemic or hemorrhagic stroke, or significant cerebrovascular disease
* Severe untreated obstructive sleep apnea
* History of diabetes with HbA1c greater than 9.5%
* Major neurologic disorders other than dementia (e.g., MS, ALS, brain surgery, etc.)
* Current or recent (\&amp;lt;1 year) major psychiatric condition (Axis I) or addictive disorders
* Significant surgical history
* Other significant medical conditions at investigators' discretion
* Contraindications to MRI
* Prescribed medications that interfere with prazosin
* Lactose allergy

Primary outcomes:
measure: Change in blood flow
timeFrame: Two study visits, up to 240 minutes
measure: Change in blood velocity
timeFrame: Two study visits, up to 240 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT00100477: Use of Topotecan in Patients With Refractory Acute Leukemia
Official title: Study of Topoisomerase Inhibition in the Treatment of Acute Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Leukemia
Keywords: Multiple Myeloma
Lymphoma
Leukemia
Etoposide
Drug Therapy
Clinical Trials
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Immunex Corporation
name: SmithKline Beecham
name: Amgen
First posted: 2004-12-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to identify the highest tolerated doses in drugs used to treat aggressive leukemia, lymphoma or multiple myeloma not responding to standard chemotherapy treatment. The drugs being used in this study include drugs frequently used in treating such diseases (mitoxantrone and etoposide) as well as a newer drug that has also been shown to be effective (topotecan).

Detailed description: The purpose of this study is to identify the highest tolerated doses in drugs used to treat aggressive leukemia, lymphoma or multiple myeloma not responding to standard chemotherapy treatment. The drugs being used in this study include drugs frequently used in treating such diseases (mitoxantrone and etoposide) as well as a newer drug that has also been shown to be effective (topotecan).

Eligibility criteria: Inclusion Criteria:

Patients in the following disease categories will be considered eligible for this study:

* Any acute leukemia beyond an initial attempt to induce a remission or after relapse
* Chronic Myelogenous Leukemia in Blast Phase
* Refractory Multiple Myeloma
* Refractory non-Hodgkin's and Hodgkin's Lymphoma
* Patients must be more than 14 days beyond prior myelotoxic chemotherapy
* Several other eligibility criteria apply.

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System
name: Mark Mainwaring
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04519177: Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ...
Official title: Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep Disorder
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

Brief summary: The investigators have shown that sleep health education and sleep disorders screening improve health and safety of employees. There is potential to increase the benefits of the sleep health education and screening program if more firefighters are evaluated, diagnosed and referred for treatment. Investigators will evaluate whether firefighters in stations randomized to participate in the Sleep Health and Education Program (SHEP) intervention will have improved health and safety outcomes as compared to firefighters in stations randomized to the control condition.


Eligibility criteria: Inclusion Criteria:

* Firefighters working in one of the two fire departments selected for study

Exclusion Criteria:

* None

Primary outcomes:
measure: Evaluation of sleep disorder
timeFrame: 12 months (on end-of-year questionnaire)
measure: Diagnosis of sleep disorder
timeFrame: 12 months (on end-of-year questionnaire)
measure: Treatment of sleep disorder
timeFrame: 12 months (on end-of-year questionnaire)
measure: Injuries
timeFrame: Over 12 months (The number of injuries as documented in the fire department database)
measure: Disability days
timeFrame: Over 12 months (The number of injuries as documented in the fire department database)
Secondary outcomes:
measure: Motor vehicle crashes
timeFrame: Over 12 months, reported on monthly surveys
measure: Near crashes
timeFrame: Over 12 months, reported on monthly surveys
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03476577: Bariatric Surgery and Pharmacokinetics of Ibuprofen
Official title: Bariatric Surgery and Pharmacokinetics Ibuprofen: BAR-MEDS Ibuprofen
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Ibuprofen
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-03-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on ibuprofen are investigated.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Ibuprofen concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01709877: EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach
Official title: Randomised Non-inferiority Trial of Laparoscopic Cholecystectomy Performed With EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach Using Clinical, PROMS and Health Economic Endpoints
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gallstones
Keywords: Multiport laparoscopy
Single Port Laparoscopy
Symptomatic Gallstones
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
Collaborators: name: Regione Toscana
name: Scuola Superiore Sant'Anna di Pisa
name: Università di Pisa
First posted: 2012-10-18
Enrollment: 300
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: Its main objective is to evaluate the clinical outcome (including patient reported outcomes) and health economic assessment (HTA) of a new re-usable system for Single Port Laparoscopic Surgery - ENDOCONE SYSTEM developed by Prof Cuschieri by undertaking a randomised controlled prospective clinical trial (RCT) on specific operations performed (on a random allocation basis) by either the traditional multi-port laparoscopic approach or the Single Port- ENDOCONE system by Karl Storz. To this effect, 300 patients meeting the trial inclusion criteria will be randomised over a three year period to have the operation by either of the two approaches.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic gallstone disease
* ASA I/II
* Age between 18 and 80 years

Exclusion Criteria:

* ASA III or more
* significant co-morbid cardiovascular, neurological diseases, diabetics and chronic obstructive airway disease
* patients with previous history of invasive cancer
* patients with previous surgery
* patients requiring urgent/emergency interventions

Primary outcomes:
measure: Conversion rate
timeFrame: During the intervention
measure: Morbidity
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Postoperative course
timeFrame: 1 week
measure: Duration of hospital stay
timeFrame: 6 days
measure: Return of bowel function
timeFrame: 12, 24, 48 hours
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Ospedale San Donato
state: AR
city: Lucca
country: Italy
facility: Ospedale Campo di Marte
state: LU
city: Pisa
country: Italy
facility: Ospedinale di Cisanello
state: PI
city: Pontedera
country: Italy
facility: Ospedale Felice Lotti
state: PI
Study officials:
affiliation: AOUP
name: Franco Mosca, Prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scuola Superiore Sant'Anna di Pisa
name: Alfred Cuschieri, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01172977: Neurological Complications at Stroke Patients With Diabetes Mellitus
Official title: Neurological Complications at Stroke Patients With Diabetes Mellitus During the First Six Months After a Cerebral Ischemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Diabetes Mellitus
Keywords: Diabetes mellitus
Stroke
Lead sponsor: Evangelisches Krankenhaus Bielefeld gGmbH
Sponsor class: OTHER
First posted: 2010-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients on the Stroke Unit with hyperglycemia with cerebral ischemia within the last 24 hours

Brief summary: It is to be investigated if a correlation exist between the development of the HbA1c value and the complication rate is following a stroke.

Detailed description: The immediate objective of the study is to find out if a correlation between blood sugar control in diabetics and the incidence of complications after a stroke exists.

The study has a high practical importance because any consequences in the treatment of diabetes mellitus can be implemented without affecting costs.

Eligibility criteria: Inclusion Criteria:

* Stroke patients on the Stroke Unit with hyperglycemia with cerebral ischemia within the last 24 hours

Exclusion Criteria:

* Patients with intracerebral hemorrhage
* Pregnant patients
* Patients with sensory aphasia

Primary outcomes:
measure: Functional outcome six months after the cerebral ischemia
timeFrame: six months
Secondary outcomes:
measure: Additional cerebral ischemia
timeFrame: six months
measure: Mortality
timeFrame: sixt months
Other outcomes:
Locations:
city: Bielefeld
country: Germany
facility: Evangelisches Krankenhaus
Study officials:
affiliation: Evangelisches Krankenhaus Bielefeld, Germany
name: Cristian Barzu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05712577: Psychological Support in Adult Patients With Marfan Syndrome
Official title: Psychological Help in Patients With Marfan Syndrome: the Role of Quality of Life, Coping Mechanisms, Psychosocial Aspects and Self-esteem Levels
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rare Diseases
Marfan Syndrome
Psychology, Social
Keywords: Marfan syndrome
Psychological support
Self-report
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with MFS who have requested psychological support/psychotherapy and patients who have never requested psychological support/psychotherapy.

Brief summary: The goal of this observational study is to identify key factors leading to psychotherapy or psychological support in adult subjects with Marfan syndrome (MSF). the main questions it aims to answer are:

* Understand and define which internal variables of the individual drive this request for psychological support;
* To learn about verify the impact that the clinical manifestations of MSF have on psychosocial aspects, self-esteem, subjective perception of the disease and coping mechanisms.

Detailed description: Patients following psychological interview during follow-up visits will be enrolled in the study.

The following self-report questionnaires will be used in understanding the impact the syndrome has on mental health and quality of life:

* Rosenberg Self- Esteem: 10 item Likert scale for assessing self-esteem;
* SF 36: 36 item scale assessing eight domains: physical functioning physical role limitations; bodily pain; general health perceptions; energy/vitality; social functioning; emotional role limitations and mental health;
* Cope NVI: to test measures coping behaviors as potential responses to stressors like social support, avoidance strategies, positive attitude, problem orientation and transcendent orientation;
* OQ45.2: measure of general psychological distress.

Eligibility criteria: Inclusion Criteria:

* Subjects affected by Marfan syndrome;
* Subjects currently in follow-up at Cardiovascular Genetic Centre, IRCCS Policlinico San Donato;
* Signed informed consent.

Exclusion Criteria:

* Subjects with cognitive deficits

Primary outcomes:
measure: Questionnaire performance
timeFrame: 8 Months
measure: Questionnaire performance
timeFrame: 8 Months
measure: Questionnaire performance
timeFrame: 8 Months
measure: Questionnaire performance
timeFrame: 8 Months
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Lombardia
Study officials:
affiliation: Cardiovascular-Gentic Centre, IRCCS Policlinico San Donato
name: Alessandro Pini, MD
role: PRINCIPAL_INVESTIGATOR
References: