louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05531383: Effect of Early Memantine Administration on Outcome of Patients With Moderate to Severe Traumatic Brain Injury
Official title: Effect of Early Memantine Administration on Outcome of Patients With Moderate to Severe Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of Early Memantine Administration on Outcome of Participents with Moderate to Severe Traumatic Brain Injury

Detailed description: Studying the effect of memantine on platelet, platelet/lymphocyte ratio (PLR) and C reactive protein (CRP) \& serum NSE levels in participents with moderate to severe TBI as well as outcome.

Investigators evaluate prognostic effect of memantine on participents with moderate to severe TBI. also to estimate which of platelet, platelet/lymphocyte ratio (PLR), C reactive protein (CRP) or serum NSE levels will be affected by administration of memantine in participents with moderate to severe TBI as a predictor of outcome.

Eligibility criteria: Inclusion Criteria:

* Moderate to severe closed TBI with initial GCS of 4-12
* Age from 18 to 65 years of both sexes
* Able to tolerate enteral feeding and drug administration within the first 24 hours of TBI.

Exclusion Criteria:

* Open TBI or patients who would need open craniotomy later on.
* Comorbid illnesses, such as diabetes mellitus, ischemic heart disease, acute myocardial infarction within the past 48 hours, acute or chronic renal insufficiency, hepatic diseases, autoimmune abnormalities, history of epileptic fits and known malignancies.

Patients with chest, cardiac, abdominal trauma or any other trauma requiring mechanical ventilation.

Patients with body mass index (BMI) \<18.5 or \> 34.9 kg/m2.

Primary outcomes:
measure: prognosis of moderate to sever head injury
timeFrame: 7days
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of medecine
state: Minia
Study officials:
affiliation: Minia University
name: Ibrahim Talaat, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02160483: Functional Brain Imaging and Psychological Testing in Women With Chronic Pelvic Pain
Official title: Functional Brain Imaging and Psychological Testing in Women With Chronic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pelvis Pain Chronic
Endometriosis of Uterus
Keywords: Chronic pelvic pain
Endometriosis
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Duke-NUS Graduate Medical School
First posted: 2014-06-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Functional magnetic resonance imaging in women with chronic pelvic pain using arterial spin labelling, functional connectivity, diffusion tensor imaging and magnetic resonance spectroscopy.

Detailed description: Multimodal magnetic resonance neuroimaging will be utilised. Arterial spin labelling is tightly coupled with cerebral metabolism and can be used as a marker of neural activity. Resting state magnetic resonance imaging which measures synchronous activity across the brain, allows detection of functional connectivity of intrinsic brain network. Diffusion tensor imaging detects the anisotropic water diffusion in axonal fibres can provide information on connectivity and fibre tracts. Magnetic resonance spectroscopy would enable the levels of neurotransmitter to be elucidated.

Eligibility criteria: Inclusion Criteria:

* Chronic pelvic pain
* Endometriosis

Exclusion Criteria:

* Contraindication to magnetic resonance imaging

Primary outcomes:
measure: Number of participants with increase in insula anterior cingulate cortex signal on magnetic resonance imaging
timeFrame: 1 hour
Secondary outcomes:
measure: Number of subjects in psychological testing with increased anxiety, depression and pain catastrophizing scores
timeFrame: 1 hour
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Ban L Sng, FANZCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01969383: Comparative Analysis Between Electrical Muscle Activity In Water And Soil
Official title: COMPARATIVE ANALYSIS BETWEEN THE ELECTRICAL ACTIVITY WITH AND WITHOUT MUSCULAR STRENGTH IN WATER AND SOIL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Individuals.
Keywords: healthy
Lead sponsor: Universidade do Vale do Paraíba
Sponsor class: OTHER
First posted: 2013-10-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Muscle activity in the aquatic environment was investigated while performing different exercises by electromyography analysis, due to conflicting results in the literature in relation to the floor. This study evaluated and compared the electrical activity of the rectus femoris and biceps femoris, in aquatic method and on the floor, during flexion and knee extension exercises with and without load.


Eligibility criteria: Inclusion Criteria:

* Age between 18 to 35
* Sedentary (who engage in physical activity more than twice a week).

Exclusion Criteria:

* History of pain, trauma and / or surgery on the knee joint;
* Presence of musculo - skeletal

Primary outcomes:
measure: COMPARATIVE ANALYSIS BETWEEN THE ELECTRICAL ACTIVITY WITH AND WITHOUT MUSCULAR STRENGTH IN WATER AND SOIL
timeFrame: April-October 2013
Secondary outcomes:
Other outcomes:
Locations:
city: São José dos Campos
country: Brazil
facility: Izabela dos Santos Mendes
state: SP
Study officials:
affiliation: Rehabilitation Engineering Laboratory sensorineural motor
name: Fernanda P Silva Lima, Doutora
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05927883: Efficacy of Indigenously Adapted Cognitive Behavioral Therapy for Reducing Gaming Addiction Among Adolescents
Official title: Efficacy of Indigenously Adapted Cognitive Behavioral Therapy for Reducing Gaming Addiction Among Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Internet Gaming Disorder
Lead sponsor: Bahria University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Research evidence identified internet gaming as an emerging problem in youth across the globe and a lot of interventions are being used for managing gaming and associated psychological problems considering cultural aspects. Therefore, the present study aims at investigating the efficacy of Indigenously adapted cognitive behavior therapy for internet gaming addiction among Pakistani Youth. For this purpose, adolescents enrolled in 8th-12th grades in elementary and higher secondary schools in twin cities of Pakistan. Adolescents who scored high on Internet gaming disorder in screening will be included in the study and further detailed investigation will be completed by administering semi-structured Clinical Interviews, Coping inventory, self-control, and social connectedness. Participants will be divided into 2 groups i.e. experimental and control groups.


Eligibility criteria: Inclusion Criteria:

1. Adolescents ranging from 13 - 19 years (WHO, 2013) enrolled in an educational institute in the vicinity of the Federal capital area
2. Playing Internet offline/online games.
3. Excessive users who play more than 5-8 hours per day,40 hours per week will be included.
4. Playing games for at least the past year.
5. No history of major illness or any other psychological disorder.

Exclusion Criteria:

1. Diagnosed prior for any mental or psychological disorder.
2. Receiving any psychotherapy or medication for any particular disorder

Primary outcomes:
measure: Internet Gaming Disorder Scale - short form
timeFrame: 1 year
Secondary outcomes:
measure: Brief Self-Control Scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Bahria University
state: Federal Capital Area
Study officials:
References:
Clinical trial NCT02245061: Cortical Excitability Assessment Using Paired Pulses
Official title: Cortical Excitability Assessment of Pharmacoresistant Focal Epilepsy Using Direct Electrical Stimulation During Stereo-electroencephalography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Focal Epilepsy
Keywords: pharmacoresistant focal epilepsy
cortical excitability
paired pulses
TMS
SEEG
DES
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The identification of the epileptogenic zone (EZ) during pharmacoresistant focal epilepsy presurgical assessment frequently requires intracranial recordings like stereo-electroencephalography (SEEG). Cortical direct electrical stimulation (DES) is commonly used during SEEG for functional mapping or to induce seizure.

However, the recording of seizures is sometimes insufficient to circumscribe the EZ and development of new biomarkers is necessary.

The cortex within the EZ is thought to be hyperexcitable. The "paired pulses" paradigm, using transcranial magnetic stimulation (TMS), allows determining the hemispheric cortical excitability level. The investigators hypothesize that paired pulses DES during SEEG could provide useful information for EZ identification.


Eligibility criteria: Inclusion Criteria:

* Age above 18 years old
* Pharmacoresistant focal epilepsy patients undergoing a stereo-electroencephalographic recording
* Provide written consent to the study after receiving clear information
* Be a beneficiary or member of health insurance plan

Exclusion Criteria:

Patient with contraindication for MRI scanning

* Pregnancy
* Prohibition on participation in other research, apart from any other non-interventional research

Primary outcomes:
measure: Presence of a significant difference between the evoked responses to paired pulses cortical electrical stimulation of epileptogenic zone cortex and of normal cortex
timeFrame: between Day 7 and 21 (End of the stereoelectroencephalographic recordings)
Secondary outcomes:
measure: Presence of a difference of responses patterns between anatomic regions and/or lesion type
timeFrame: between Day 7 and 21 (End of the stereoelectroencephalographic recordings )
measure: Presence of a difference between transcranial magnetic paired pulses stimulations and intracranial paired pulses cortical direct electrical stimulations
timeFrame: Between Day 7 and 21 (End of the stereoelectroencephalographic recordings)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital neurologique de Lyon
Study officials:
References:
Clinical trial NCT02165761: Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients
Official title: Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients Implanted With the GORE® Hybrid Vascular Graft Versus Non-heparin Bonded Synthetic Vascular Grafts.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Hemodialysis
End Stage Renal Disease
Vascular Graft
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2014-06-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 / heparin antibodies (anti-PF4 / H antibodies).


Eligibility criteria: Inclusion Criteria:

* The patient is not a candidate for a native fistula.
* The patient requires the creation of an upper arm vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease.
* The patient has been on hemodialysis for ≥1 month.

Exclusion Criteria:

* The patient is scheduled for a different surgical procedure within 30 days post Index Procedure.
* The patient has a known hypercoagulable disorder or bleeding disorder.
* The patient has had a previous instance of Heparin Induced Thrombocytopenia Type II (HIT type II) or has known sensitivity to heparin.

Primary outcomes:
measure: Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points
timeFrame: 14 days after index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
state: New Jersey
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01350661: Correlation Between Five Asthma Control Questionnaires
Official title: Assessment of Correlation Between Five Asthma Control Questionnaires
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Questionnaires
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2011-05-10
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen at the consultation of pulmonology of a tertiary hospital.

Brief summary: This observational study aims to assess the correlation between many questionnaires designed to assess the level of control of asthma. The five questionnaires will be submitted, at the same time and in a random order, to asthma patients. Some other parameters will be recorded (e.g. lung function, epidemiological data). The hypothesis is that the results of the questionnaires will be the same. If not, we will try to understand why.

The investigators will include 100 patients, stratified with relation to their level of asthma severity (25 patients for each level of severity - described by the GINA guidelines).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma confirmed by a pulmonologist
* Patient have had a lung function testing on the same day than the questionnaires are fulfilled.
* Age equal or upper than 18 years
* Agreement to participate to this study

Exclusion Criteria:

* Age under 18 years
* Refusal to participate to this study

Primary outcomes:
measure: Level of asthma control
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU St Pierre; pulmonology department
Study officials:
References:
citation: Vermeulen F, de Meulder I, Paesmans M, Muylle I, Bruyneel M, Ninane V. Asthma control measurement using five different questionnaires: a prospective study. Respir Med. 2013 Sep;107(9):1314-21. doi: 10.1016/j.rmed.2013.07.003. Epub 2013 Jul 26.
Clinical trial NCT02514161: Respiratory Exercises Versus Manual Therapy and Respiratory Exercises in Moderate Smokers
Official title: Effects of Manual Therapy and Respiratory Muscle Training on the Maximal Inspiratory Pressure in Moderate Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Manual Therapies
Respiratory Muscle Training
Exercise Therapy
Inspiratory Capacity
Keywords: Smokers
Maximum Inspiratory Pressure
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
First posted: 2015-08-03
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess if an intervention of manual therapy and motor control exercises combined with an inspiratory muscle training program is more effective than an inspiratory muscle training program alone in increasing the maximum inspiratory pressure in moderate smokers. In addition, the study pretends to evaluate the changes caused by the intervention regarding possible postural changes and thoracic diameter.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects aged between 18 and 60 years and a current smoking rate ≥ 5 points.

Exclusion Criteria:

* Were excluded participants who presented diagnosis of cardiorespiratory disease, systemic or metabolic disease such as rheumatoid arthritis or cancer, history of thoracic surgery, vertebral fracture, spinal structured musculoskeletal disorders and thoracic region and contraindication to the treatment techniques used (osteoporosis).

Primary outcomes:
measure: Maximum Inspiratory Pressure
timeFrame: Change from Baseline in Maximum Inspiratory Pressure at 4 weeks
Secondary outcomes:
measure: Head posture
timeFrame: Change from Baseline in Head Posture at 4 weeks
measure: Thoracic kyphosis
timeFrame: Change from Baseline in Thoracic kyphosis at 4 weeks
measure: Volumes and lung capacities
timeFrame: Change from Baseline in Volumes and lung capacities at 4 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Centro Superior de Estudios Universitarios La Salle
Study officials:
References:
Clinical trial NCT02636361: A Study of Various Formulations of LY900014 in Healthy Participants
Official title: Pharmacokinetics, Glucodynamics, Safety, and Tolerability of Multiple LY900014 Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-12-21
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the different formulations of LY900014. This study will determine how the different formulations, when injected under the skin, will affect the blood sugar levels in the body, and how safe it is.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
* Must have a body mass index (BMI) of 18.0 to 30 kilogram per square meter (kg/m²) (inclusive) at the time of study screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
* Are non-smokers or have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study
* Have veins suitable for easy blood collection and glucose solution infusion

Exclusion Criteria:

* Have known allergies to insulin lispro or compounds related to these drugs, or any components of the study drug
* Show signs of having an infection or infectious disease at the time of study entry

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro
timeFrame: Predose,5,10,15,20,25,30,35,40,45,50,55,60,70,90,120,150,180,240,300, 360 and 420 minutes postdose
Secondary outcomes:
measure: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp
timeFrame: Predose, every 2.5 minutes for 30 minutes, then every 5 min until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01643161: Guided Self-Help for Functional Neurological Symptoms
Official title: Guided Self-Help for Functional Neurological Symptoms: A Randomized Controlled Efficacy Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Functional Neurologic Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 33
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: Functional (psychogenic or somatoform) symptoms are commonly observed in neurology clinics. There is no known empirically validated treatment approach to functional symptoms. Cognitive Behavioral Therapy (CBT) can be effective, but there are major obstacles to its provision. The investigators will test the hypothesis that adding a CBT-based guided self-help (GSH) as compared to treatment as usual (TAU) improves patient outcomes.


Eligibility criteria: Inclusion Criteria:

* Adult neurology outpatient with functional symptoms not largely explained by neurologic disease.

Exclusion Criteria:

* Unable to use the Guided Self-Help intervention, such as due to significant cognitive impairment or unable to comprehend English.
* Requires specialist psychiatric care.
* Has headache as the only symptom.

Primary outcomes:
measure: CGI
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
References: