louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04441697: Sleepiness in Parkinson's Patients With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation
Official title: Monitoring of Sleepiness in Patients With Parkinson's Disease Before and During Treatment With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: continous dopaminergic delivery device
deep brain stimulation
sleepiness
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 30
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 the patients refered to the expert Parkinson Center of the Nancy University Hospital, with the diagnosis of Parkinson's disease at the stage of motor fluctuations, and indicated for a continuous dopaminergic delivery device or deep brain stimulation

Brief summary: Sleepiness is frequent in parkinsonian patients, increasing with the duration of disease. By patients with motor fluctuations, continuous dopaminergic delivery devices or deep brain stimulation are justified to improve the motor prognosis. Antiparkinsonian treatments, especially dopaminergic agonists, may worsen the sleepiness and thus affect the quality of life. The investigators aimed to monitor sleepiness in parkinsonian patients before and during treatment with continous dopaminergic delivery device or deep brain stimulation.


Eligibility criteria: Inclusion Criteria:

* patient with Parkinson's disease and motor fluctuations
* and indicated for a continuous dopaminergic delivery device or deep brain stimulation

Exclusion Criteria:

* age \< 18 years
* refusal for the continuous dopaminergic delivery device or deep brain stimulation
* wake-promoting drugs intake
* refusal to participate
* legal protection
* uncontrolled sleep apnea

Primary outcomes:
measure: Mean sleep latency
timeFrame: before continuous antiparkinsonian treatment
measure: Mean sleep latency
timeFrame: 6 months after continuous antiparkinsonian treatment
measure: Mean sleep latency
timeFrame: 12 months after continous antiparkinsonian treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Nancy University Hospital
Study officials:
affiliation: Research and Innovation Department
name: El Mehdi Siaghy
role: STUDY_CHAIR
References:
Clinical trial NCT01957397: Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy
Official title: Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: To investigate the performance and safety of the three 2-piece convex ostomy appliances


Eligibility criteria: Inclusion Criteria:

Subjects interested in participating in the clinical investigation must comply with the following criteria:

1. Are at least 18 years of age and have full legal capacity
2. Have had an ileostomy for at least 3 months.
3. Have used a convex ostomy appliance for the last month
4. Have given written informed consent
5. Have an ileostomy with a diameter of 33mm or less
6. Have experienced leakage (seeping) under the baseplate at least two times over the last two weeks

Exclusion Criteria:

Subjects complying with the following criteria must be excluded from participation in the clinical investigation:

1. Have a loop ostomy (also called double-barrel or ostomy with two outlets)
2. Are pregnant\* or breastfeeding.
3. Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.
4. Currently receiving or have received, within the last month, systemic or local steroid treatment (adrenocortical hormone) in the peristomal area.
5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)).
6. Known hypersensitivity toward any of the test products

   -

Primary outcomes:
measure: Degree of Leakage
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Coloplast A/S
name: Birte P Jakobsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02665897: Pre-eclampsia and Biochemical Markers
Official title: Correlation Between Complications of Pre-eclampsia and Detection of Novel Biochemical Markers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Detection of Preeclampsia Complications
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women after 20 weeks

Brief summary: In view of both endothelial injury in pre-eclampsia, high blood pressure and kidney impairment characteristics, a recent study demonstrated that the serum levels of NGAL increased at the end of the second trimester in women who subsequently developed pre-eclampsia compared to the control group.

This correlates well with the endothelial damage that occurs during pre-eclampsia and thus NGAL can be considered as a promising marker in predicting both early and late onset pre-eclampsia. It may be required to combine one or more biomarker with NGAL to increase the precision, and sensitivity for detection of risk and reliability of using biomarkers for pre-eclampsia.


Eligibility criteria: Inclusion Criteria:

* Age 20-40 years.
* Gestational age \>20 weeks.

Exclusion Criteria:

* Patients with preexisting renal disease,hypertension, diabetes mellitus, gestational hypertension.
* Patients Refuse to participate in the study
* Patients already have complicated preeclampsia.

Primary outcomes:
measure: The level of circulating NGAL
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT00718497: Comparing The Cyberlink Control System to the Manual Letter Board for Communication Purposes in the ALS Patient Population
Official title: Comparing The Cyberlink Control System to the Manual Letter Board for Communication Purposes in the ALS Patient Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Neurodegenerative Disease
Motor Neuron Disease
Keywords: Amyotrophic Lateral Sclerosis
Cerebrospinal Fluid
Neurodegenerative Disease
Motor Neuron Disease
Autonomic Nervous System
Neurodegenerative Diseases
Movement Disorders
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: MDA/ALS Center of Hope
First posted: 2008-07-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALS clinic patients at MDA/ALS Center of Hope.

Brief summary: New technologies are giving people with motor disabilities alternative communication and control channels. The investigators are interested in using the Cyberlink Control System as a hands free means to access a computer for people with Amyotrophic Lateral Sclerosis (ALS). The goal of this project is to determine whether this device is a practical and realistic means for ALS patients to communicate with only the use of facial muscle, brainwave, and eye movements.

The benefit of this study may be of substantial value to many people with severe motor impairment. Additionally, it is hoped that some of the study subjects may benefit by incorporating hands-free computer use into their daily lives.

This study is intended to evaluate the effectiveness of the cyberlink as a tool for daily communication compared to the standard manual letter board.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of definite or possible ALS by the El Escorial Criteria
* Between ages of 18 to 89 years.
* Scored two or less in the ALS FRS category 1 (Speech)
* Scored two or less in the ALS FRS category 4 (Handwriting)
* Cognitively intact with no other neurological diseases
* No unstable medical problems

Exclusion Criteria:

* Any subject not meeting the inclusion criteria
* Patients unable to give informed consent either themselves or via a legally authorized personnel.
* Patients diagnosed with neurological problems other than ALS (upon examination by the principal investigator)

Primary outcomes:
measure: Time Taken to Complete a Sentence
timeFrame: 1 session
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: MDA/ALS Center of Hope
state: Pennsylvania
Study officials:
affiliation: MDA/ALS Center of Hope
name: Terry Heiman-Patterson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04357197: Closed-loop Control Mean Arterial Pressure In Intensive Care Patients
Official title: Closed-loop Control of Vasopressor Infusion in Critically Ill Patients: A Case Series
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single prospective single center study
Primary purpose: TREATMENT

Brief summary: The purpose of this case series is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard hemodynamic monitor (EV1000 Monitor) from Edwards Lifesciences (IRVINE, USA) in critically ill patients

Detailed description: In this protocol, the investigators will report the percentage of case time in hypotension (defined as Mean arterial pressure (MAP) \< 72mmHg) during a two hours study protocol in critically ill patients.

The target MAP will be set at 80 mmHg, and the definition of hypotension is a MAP \< 90% of MAP target ( 80 mmHg - 10% = 72 mmHg)

The investigators want to demonstrate that the closed-loop system can prevent hypotension at this specific set point.

The investigators will test the system in a short series of 10-12 critically ill patients in the ICU setting during a two hours study protocol.

Participants will receive standard patient care

Fluids will be given as a baseline crystalloid administration set at 1-2 ml/kg/h

Eligibility criteria: Inclusion Criteria:

* All patients in the intensive care unit (awake or under sedation)
* Requiring norepinephrine to maintain a MAP of 80 mmHg
* Equiped with an arterial line

Exclusion Criteria:

* Subjects under 18 years of age
* Subject with Atrial Fibrillation
* Subjects who are pregnant

Primary outcomes:
measure: Percentage of case Time in hypotension (MAP <72 mmHg)
timeFrame: During thetwo hours study protocol
Secondary outcomes:
measure: percentage of case time with MAP >88 mmHg with norepinephrine still running
timeFrame: During the two hours study protocol
measure: Amount of vasopressors received
timeFrame: During the two hours study protocol
Other outcomes:
Locations:
Study officials:
affiliation: ERASME
name: Alexandre Joosten, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02390297: Long Term Follow up for the Detection of Delayed Adverse Events in Cal-1 Recipients
Official title: Long Term Follow-up for the Detection of Delayed Adverse Events in Recipients of CD4+ T Lymphocytes and/or CD34+ Hematopoietic Stem/Progenitor Cells Transduced With LVsh5/C46, a Dual Anti-HIV Gene Transfer Construct
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HIV-1 Infection
Receipt of Cal-1 Modified Hematopoietic Cellular Products
Lead sponsor: Calimmune, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligibility for this protocol is dependent on prior exposure to a Cal-1 modified hematopoietic cellular product. The study population will thus consist of individuals with HIV-1 infection, who have met criteria for participation in a Cal-1 phase I/II clinical trial and received a dose of Cal-1 modified hematopoietic cells as part of a previous study

Brief summary: Long term safety follow-up of Cal-1 recipients

Detailed description: Long Term Follow-up for the Detection of Delayed Adverse Events in Recipients of CD4+ T Lymphocytes and/or CD34+ Hematopoietic Stem/Progenitor Cells Transduced with LVsh5/C46 (Cal-1), a Dual Anti-HIV Gene Transfer Construct

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Previous treatment with the Cal-1 modified hematopoietic cellular products

Exclusion Criteria:

* Inability to understand and provide informed consent

Primary outcomes:
measure: Detection of delayed clinical or molecular adverse events related to Cal-1, or the associated delivery procedures
timeFrame: 15 years
Secondary outcomes:
measure: Assessment of the long term survival and activity of Cal-1 modified hematopoietic cells through evaluation of Cal-1 marking and expression in peripheral blood
timeFrame: 15 yars
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA CARE Center
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Ronald Mitsuyasu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02225197: A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors
Official title: A Phase II Study of Fractionated CyberKnife Stereotactic Radiosurgery to Perioptic Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tumor, Benign, Optic Nerve
Keywords: Perioptic
Stereotactic
Radiation
Benign brain tumor
Optic apparatus
Lead sponsor: Community Cancer Center, Normal, Illinois
Sponsor class: OTHER
First posted: 2014-08-26
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out what effects (good and bad) CyberKnife stereotactic radiosurgery has on tumors near the critical structures of the eye (optic apparatus).

The investigators hypothesize that hypofractionated stereotactic radiotherapy via the CyberKnife ® can deliver tumor ablating doses of radiation to perioptic lesions safely and effectively while sparing the adjacent optic apparatus and normal brain tissues from receiving damaging doses of radiation.

Detailed description: The CyberKnife system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.

Eligibility criteria: Inclusion Criteria:

* Perioptic lesion within 2mm of the optic apparatus
* Age \>= 21
* KPS \>= 50
* Planning Target Volume (PTV) \<= 6.0 cm in maximal diameter

Exclusion Criteria:

* Malignant histology
* Age \< 21
* KPS \<= 40
* Planning Target Volume (PTV) \> 6.0 cm in maximal diameter
* Prior whole brain XRT
* Gross total resection

Primary outcomes:
measure: Tumor status
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Normal
country: United States
facility: Community Cancer Center
state: Illinois
Study officials:
affiliation: Community Cancer Center
name: Shermian Woodhouse, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05486897: Periventricular White Matter Hyperintensities in Cerebral Amyloid Angiopathy and Hypertensive Arteriopathy
Official title: Periventricular White Matter Hyperintensities in Cerebral Amyloid Angiopathy and Hypertensive Arteriopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Amyloid Angiopathy
Hypertensive Arteriopathy
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CAA and HA patients, managed at Nîmes University Hospital between January 2015 and March 2022

Brief summary: White matter hyperintensities (WMH) are one of the small vessel disease-related MRI characteristics of both cerebral amyloid angiopathy (CAA) and hypertensive arteriopathy (HA). WMH tend to show a peri-basal ganglia pattern in HA, whereas a multiple subcortical spots pattern can be observed in CAA. Periventricular WMH (PVWMH) have been reported to be posterior predominant using a semiautomated segmentation method and logarithmic transformation, not used in daily clinical practice. In these studies including CAA patients, patients initially presented with haemorrhage-related symptoms. In another study analysing PVWMH and cerebral amyloid evidence in patients with mild cognitive impairment, frontal PVWMH burden was associated with high uptake on florbetapir-PET whereas parietal and occipital PVWMH burden was associated with low CSF-amyloid-beta.

The aim of this study is the descriptive comparative analysis of the distribution of PVWMH between CAA and HA patients with radiological tools available in daily practice.


Eligibility criteria: Inclusion Criteria:

CAA and HA patients, managed at Nîmes University Hospital between January 2015 and March 2022.

Exclusion Criteria:

CAA and HA patients, treated at the CHU of Nîmes between January 2015 and March 2022, not objecting to the use of their health data

Primary outcomes:
measure: Distribution of PVWMH
timeFrame: Base line, Day 0
measure: Distribution of PVWMH - total PVWMH extent.
timeFrame: Base line, Day 0
measure: Corpus callosum (CC) WMH
timeFrame: Base line, Day 0
measure: Corpus callosum (CC) WMH - total CC-PVWMH extent.
timeFrame: Base line, Day 0
measure: Ratios
timeFrame: base line, day 0
measure: Anterior PVWMH
timeFrame: Base line, Day 0
measure: Posterior PVWMH
timeFrame: Base line, Day 0
measure: Total PVWMH
timeFrame: Base line, Day 0
measure: Posterior/anterior PVWMH ratio
timeFrame: Base line, Day 0
measure: anterior CC-PVWMH
timeFrame: Base line, Day 0
measure: Posterior CC-PVWMH
timeFrame: Base line, Day 0
measure: Total PVWMH and posterior/anterior CC-PVWMH ratio
timeFrame: Base line, Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Anissa MEGZARI
role: STUDY_DIRECTOR
References:
Clinical trial NCT01608997: Postoperative Multiparameter Outcomes During the Six Months After Rotator Cuff Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shoulder Pain
Quality of Life
Satisfaction
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-05-31
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Candidates for rotator cuff repair due to shoulder pain and tears

Brief summary: Rotator cuff tears are common amongst 50-60 year olds with no connection to their physical activity. When symptomatic, the injury affects all aspects of general health, quality of life and function. Surgical intervention is recommended only if conservative treatment fails. The purpose of the surgical intervention is to reduce pain, and improve function while improving range of motion and muscle strength around the shoulder. The purpose of the current study is to measure physical, functional, expectation, satisfaction and quality of life outcomes after rotator cuff repair surgery. Another purpose is to learn the reproducibility components of the above outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic tears in supraspinatus and infraspinatus tendon
* Symptoms of up to 12 months
* No relief from conservative treatment
* Complete or almost complete tears of up to 3cm
* Hebrew speakers

Exclusion Criteria:

* Previous trauma
* Shoulder Infection
* Recurrent dislocation
* Avascular necrosis
* Frozen shoulder
* Additional tears
* Otherwise healthy

Primary outcomes:
measure: Shoulder Function
timeFrame: Six Months
measure: Quality of Life
timeFrame: Six Months
Secondary outcomes:
measure: Self-Rated Improvement, Expectations and Satisfaction
timeFrame: Six Months
measure: Range of Motion of the Shoulder
timeFrame: Six Months
measure: Isometric strength around the shoulder
timeFrame: Six months
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References: