louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00950690: Efficacy and Tolerability of Xalatan in Patients
Official title: Observational Study Assessing The Efficacy And Tolerability Of Xalatan™ In Patients With Open Angle Glaucoma And /Or Ocular Hypertension.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Ocular Hypertension
Keywords: observational safety study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-08-03
Enrollment: 1289
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults with glauocma or ocular hypertension

Brief summary: Efficacy data was not collected or analyzed. This study did assess safety and tolerability of Xalatan.

Detailed description: * Efficacy data not collected or analyzed
* Safety and tolerability of Xalatan assessed NA

Eligibility criteria: Inclusion Criteria:

* Patient with ocular hypertension at least 22mg Hg
* Patient must be over 18 years old

Exclusion Criteria:

* None listed in the protocol

Primary outcomes:
measure: Intraocular Pressure
timeFrame: Screening, 10 days, 4 weeks and 12 weeks after beginning treatment
measure: Humphrey Perimetry Visual Field
timeFrame: Visits 1 and 4
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Pfizer Investigational Site
city: Jeddah
country: Saudi Arabia
facility: Pfizer Investigational Site
city: Umm Al Quwain
country: United Arab Emirates
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05933590: Cervical Repositioning Error in Chronic Migraine
Official title: Cervical Joint Repositioning Error in Different Head Positions Among Individuals With Chronic Migraine: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Chronic Migraine
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes individuals aged 18-65 years old, with and without chronic migraine.

Brief summary: This study examines cervical joint position sense in individuals with chronic migraine vs. healthy controls. The ability to reposition the cervical spine after active movement will be evaluated in different head positions. Impaired proprioception and motor control is hypothesized in the migraine group.


Eligibility criteria: Inclusion Criteria:

* Individuals aged 18-65 years old
* Diagnosis of chronic migraine (for the chronic migraine group)
* No history of migraine (for the control group)

Exclusion Criteria:

* History of cervical spine pathology
* Neurological deficits unrelated to migraine
* Current pregnancy

Primary outcomes:
measure: Cervical Joint Repositioning Error Assessment
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_CHAIR
References:
Clinical trial NCT00439790: Sympathetic Nerve Activity and an Implantable Cardioverter Defibrillator in Heart Failure Patients
Official title: Validation of a Prognostic Score to Identify Heart Failure Patients Who Might Need an Implantable Cardioverter Defibrillator Using Muscle Sympathetic Nerve Activity and Autonomic Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Death, Sudden, Cardiac
Keywords: implantable cardioverter defibrillator
Heart failure
Sudden Cardiac Arrest
appropriate shock
Defibrillators, Implantable
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2007-02-26
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patient

Brief summary: The aim of this study is to analyze whether the sympathetic tone, measured indirectly and directly by muscle sympathetic nerve activity recording, is elevated in patients with heart failure receiving an appropriate shock from their implantable cardiac defibrillator (ICD) compared to heart failure patients not receiving a shock from their ICD. All parameters measured in this study will be used to build a risk algorithm able to identify heart failure patients at high risk for sudden cardiac death who could receive an ICD.

Detailed description: We plan to perform an extensive study of the sympathetic nervous system activity in heart failure patients with an ICD. The SNS activity will be measured directly by a recording of the muscle sympathetic nerve activity and indirectly by post processing of 24-hour Holter recording, catecholamine levels assessment, and spontaneous baroreflex sensitivity. A global assessment of the patients status will also be realised. Patients will be followed for one year. During follow up, this cohort will be divided into two groups according to the occurrence or not of an appropriate shock. We assume that an appropriate shock is a surrogate marker for sudden cardiac death. We plan to compare the autonomic nervous system activity in both groups of patients in order to identify a score able to detect heart failure patients at high risk for sudden cardiac death.

Eligibility criteria: Inclusion Criteria:

* Heart failure patient with an ICD

Exclusion Criteria:

* Pregnant patient
* Acute coronary syndrome within the last 3 months
* Peripheral neuropathy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Cardiologie, University Hospital
Study officials:
affiliation: Hospital University Toulouse
name: Atul Pathak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01850290: Imaging Dopamine Function and Its Impact on Outcome After Traumatic Brain Injury (TBI)
Official title: Imaging Dopamine Function and Its Impact on Outcome After Traumatic Brain Injury (TBI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: TBI
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: University of Texas Southwestern Medical Center
First posted: 2013-05-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Traumatic Brain Injury patients in Inpatient Rehabilitation

Brief summary: This study will examine resting dopamine function as well as dopamine response in the brain as it interacts with medicines normally prescribed to subacute Traumatic Brain Injury (TBI) patients.


Eligibility criteria: Inclusion Criteria:

* Non-penetrating TBI
* Age between 18-50 years old
* Admitted to a North Texas TBI Model Systems-affiliated rehabilitation facility within 16 weeks of injury
* Rated at Rancho VI Los Amigos Levels of Cognitive Functioning Scale of less than or equal to Stage V at the time of enrollment
* Disability Rating Scale total score \>/= 7

Exclusion Criteria:

* Central Nervous System disorder resulting in functional disability predating TBI
* Documented diagnosis of disease processes impacted by the dopamine system (e.g., Parkinson's Disease, clinician diagnosed Attention Deficit Hyperactivity Disorder, substance abuse/dependence (excluding marijuana, alcohol, tobacco), or schizophrenia)
* Pre-injury use of dopaminergic pharmaceuticals (i.e., methylphenidate, amantadine, or dopamine receptor blockers such as olanzapine or quetiapine)
* Documented contraindication to use of methylphenidate including allergy
* Uncontrolled epilepsy
* Pregnant
* Medical condition not compatible with use of Methylphenidate
* Recent diagnosis or therapeutic study using radiopharmaceuticals
* Contraindications to the use of Ioflupane
* Allergic to Iodine

Primary outcomes:
measure: Change in Disability Rating Scale
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary outcomes:
measure: John F Kennedy Coma Recovery Scale Revised
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
measure: Functional Independence Measure (FIM)
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
measure: Functional Assessment Measure (FAM)
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
measure: Orientation Log (O-Log)
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
Study officials:
affiliation: Baylor Research Institute
name: Shahid Shafi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Southwestern Medical Center
name: Devous Michael, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02163590: Immediate Effects of Different Rates of Thoracic Mobilization on Pressure Pain Thresholds in Asymptomatic Individuals
Official title: A Preliminary Investigation Into the Immediate Effects of Different Rates of Thoracic Mobilization on Pressure Pain Thresholds in Asymptomatic Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spine Stiffness
Keywords: Spinal mobilisation
Pressure pain threshold
Thoracic spine
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Passive mobilizations of the spine are widely used by physiotherapists in the management of neuromusculoskeletal disorders.

There is a nascent body of work of the mechanical properties of joint mobilizations. Treatment dose is characterized by the direction of force applied, magnitude of force applied, frequency of oscillation, amplitude of displacement, repetition and time. Although the choice of better treatment dose is based on patient complaints and clinical reasoning, the comprehension of the effects of different parameters of joint mobilization will improve the decision making process. The optimal dose of treatment, however, is not already known.

The primary aim of this study is to determine whether different rates of thoracic mobilization are capable to produces hypoalgesic effects, and secondarily investigate if such effects are local or widespread.

Detailed description: Healthy volunteers will be recruited and randomized into 3 groups. A 2Hz mobilisation group, a 0,5Hz mobilisation group and a Placebo group. The pressure pain threshold will be measured before, immediately after and 15 minutes after the intervention.

Eligibility criteria: Inclusion Criteria:

* Healthy asymptomatic subjects
* Manual therapy naive

Exclusion Criteria:

* Any kind of history of trauma or surgery to the spine
* Contraindications or precautions to manual therapy

Primary outcomes:
measure: Pressure pain threshold
timeFrame: Change from baseline imediately after, and 15 minutes after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal de Ciências da Saúde de Porto Alegre
state: RS
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Francisco D Araujo, Pt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02727790: Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose
Official title: Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose Lowering Action in Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-04-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The epidemic nature of type 2 diabetes mellitus, along with the downsides of current treatments, has raised the need for therapeutic alternatives. The aim of this study is to evaluate safety, tolerability, and the glucose-lowering effect of noninvasive peripheral electrical stimulation (PES) as an alternative treatment for diabetes.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with type II diabetes, for at least one year prior to randomization
* Body mass index BMI \< 35 Kg/m2
* Stable glucose lowering drugs regimen for at least one month prior to randomization
* Capable of giving informed consent

Exclusion Criteria:

* Pregnancy, or nursing
* 10\< HbA1c \< 6
* Permanent pacemakers
* Metal prosthesis
* Resting blood pressure \> 160/ 100 mmHg
* Skin disease
* Treatment with steroids or beta-blockers treatment with psychiatric medications

Primary outcomes:
measure: Number of participants with hypoglycemia, and/ or adverse events that are related to treatment
timeFrame: Baseline through 2 months
Secondary outcomes:
measure: Incidence of minor side effects related to treatment
timeFrame: Baseline through 2 months
measure: Changes in mean interstitial glucose levels measured by CGM
timeFrame: Baseline, 1, 2, 5, and 6 weeks
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf-Harofeh Medical Center
Study officials:
References:
citation: Catalogna M, Doenyas-Barak K, Sagi R, Abu-Hamad R, Nevo U, Ben-Jacob E, Efrati S. Effect of Peripheral Electrical Stimulation (PES) on Nocturnal Blood Glucose in Type 2 Diabetes: A Randomized Crossover Pilot Study. PLoS One. 2016 Dec 20;11(12):e0168805. doi: 10.1371/journal.pone.0168805. eCollection 2016.
Clinical trial NCT03867890: Relationship Between Footwear Consumer Behaviour and Lower Extremity Injuries
Official title: Is Consumer Behaviour Towards Footwear Predisposing for Lower Extremity Injuries in Runners and Walkers? A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Risk Factor
Sports Injury
Footwear
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 580
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Leisure-time runners and walkers

Brief summary: A prospective cohort study was set-up in leisure-time walkers and runners. Potential risk factors in consumer behaviour were obtained by means of a baseline questionnaire related to the acquisition of current walking or running shoes. Information on injuries sustained during a 24 week period after the baseline questionnaire was obtained in 104 runners and 104 walkers using a 2-weekly questionnaire.


Eligibility criteria: Inclusion Criteria:

* walk or run at least 10 kilometres per week
* maintain a minimal distance of ten kilometres per week, for a period of 24 weeks
* wear one and the same pair of shoes during walking/running activities during this period

Exclusion Criteria:

* systemic disease, cardiac problems or diabetes
* complaints at the lower extremities in the last two weeks,
* surgery at the lower extremities in the last three years

Primary outcomes:
measure: injury occurence
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Vakgroep Revalidatiewetenschappen
state: Oost-Vlaanderen
Study officials:
References:
Clinical trial NCT04321590: Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against obesity_Pilot Study (OBHEALTH_PS)
Official title: Efficacy of New Products Combining Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity and Associated Dysfunctions (Hyperglycemia and Dyslipemia)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Hydroxycinnamates
Beta-glucan
Green coffee bean extract
Dietary supplement
Lead sponsor: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Sponsor class: OTHER_GOV
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2020-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel, double blind study
Primary purpose: PREVENTION

Brief summary: Randomized, double blind, parallel study to assess the effect of a dietary supplement combining polyphenols (hydroxycinnamates from green coffee) and a soluble dietary fiber (oat beta-glucans) in obese/overweight subjects.

Detailed description: This pilot study intends to select the best combination of beta-glucan and a green coffee bean phenolic extract. Four different supplements were formulated, containing 3 or 5 g of two types of beta-glucan, with 35% and 70% b-glucan content, together with 600 mg of the green coffee bean extract. Blind sachets were prepared containing half the daily dose of the supplement.

60 overweight/obese male and female volunteers (BMI 25-35 kg/m2, 18-60 y old) were recruited and randomly assigned to one of the four intervention groups. Volunteers were instructed to consume one sachet half an hour before lunch and dinner dissolved in 250 mL water daily during 6 weeks.

At the beginning and at the end of the study, volunteers came to the Human Nutrition Unit at the research center after an overnight fast. Urine and blood samples were obtained, blood pressure was measured and anthropometric measurements were performed. Dietary and physical activity records were collected.

Eligibility criteria: Inclusion Criteria:

* Overweight/obese subjects (BMI 25-35 kg/m2)

Exclusion Criteria:

* Smokers
* Pregnant women
* Medication/consumption of vitamins, dietary supplements, etc.

Primary outcomes:
measure: Anthropometric changes
timeFrame: End of 6-week intervention
Secondary outcomes:
measure: Modification in blood lipids
timeFrame: End of 6-week intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Study officials:
affiliation: Research Professor
name: Laura Bravo, Biologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05305690: Natural History and Nonoperative Management of Penetrating Cerebrovascular Injury
Official title: Natural History and Nonoperative Management of Penetrating Cerebrovascular Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Trauma
Keywords: penetrating cerebrovascular injury
nonoperative management
penetrating neck trauma
natural history
antithrombotic therapy
case series
Lead sponsor: Poudre Valley Health System
Sponsor class: OTHER
Collaborators: name: Denver Health Medical Center
First posted: 2022-03-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators are including all adult patients with penetrating cerebrovascular injury since 5/1/2016 to present. Investigators will focus on those managed without operative intervention, but will include cases managed operatively for comparison.

Brief summary: The goal of this study is to evaluate a series of cases of penetrating cerebrovascular injury managed without upfront operation. Investigators focus on patient characteristics, injury details, treatment modalities, serial imaging studies, patient outcomes, and complications. Investigators will compare this patient population to patients managed with upfront operation for context.

Detailed description: Penetrating cerebrovascular injuries (PCVIs) are uncommon, with little data to guide management when emergent operative repair is not performed. Investigators hypothesized that PCVIs may be managed with antithrombotic therapy and directed use of endovascular interventions, but that PCVIs may require enhanced surveillance due to a risk of delayed complications. To perform this study, investigators will review patients with penetrating carotid and vertebral artery injuries managed at an urban Level I trauma center from 2016 to 2022. Patients will be included if they underwent initial nonoperative management (NOM). Patient characteristics, injury details, treatments, serial imaging, outcomes, and complications will be assessed in a retrospective manner using chart abstraction. Investigators will briefly compare these patients to those managed with upfront operations for context.

Eligibility criteria: Inclusion Criteria:

* Penetrating neck trauma
* Carotid or vertebral artery injury

Primary outcomes:
measure: number of patients with stroke
timeFrame: up to one year post-injury
Secondary outcomes:
measure: number of patients with injury progression
timeFrame: up to one year post-injury
measure: number of patients with death
timeFrame: up to one year post-injury
measure: number of patients with bleeding complications
timeFrame: up to one year post-injury
measure: number of patients treated with operative exploration
timeFrame: up to one year post-injury
measure: number of patients treated with arterial embolization or arterial stent placement
timeFrame: up to one year post-injury
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01419990: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of GLPG0634 in Healthy Subjects
Official title: Double-blind Placebo Controlled Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Dosing of GLPG0634 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2011-08-19
Enrollment: 16
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo.

During the course of the study, the amount of GLPG0634 present in the blood (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized.


Eligibility criteria: Inclusion Criteria:

* Healthy male, age 40-60 years
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking

Primary outcomes:
measure: Safety and tolerability
timeFrame: From screening up to 10 days after the last dose
Secondary outcomes:
measure: Pharmacokinetics (PK) and pharmacodynamics (PD)
timeFrame: From first dose up to 10 days after the last dose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS Stuivenberg
Study officials:
affiliation: Galapagos NV
name: Frédéric Vanhoutte, MD
role: STUDY_DIRECTOR
affiliation: SGS Stuivenberg
name: Lien Gheyle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Namour F, Diderichsen PM, Cox E, Vayssiere B, Van der Aa A, Tasset C, Van't Klooster G. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Modeling of Filgotinib (GLPG0634), a Selective JAK1 Inhibitor, in Support of Phase IIB Dose Selection. Clin Pharmacokinet. 2015 Aug;54(8):859-74. doi: 10.1007/s40262-015-0240-z.