louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01475396: The Effect of Physical Activity on the Brain
Official title: Clinical Study on the Effect of Physical Activity on Cognition and Memory in the Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Aerobic Exercise
Anaerobic Exercise
Unchanged Condition
Keywords: exercise
physical activity
cognition
brain
aging
BDNF
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2011-11-21
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Physical activity is thought to increase overall body functions and to decrease cardiovascular and stroke risk factors. Now the question arose, wether enhanced exercise could also exert positive influence on cognition in the aging brain. Therefore, 50 to 80 years old healthy subjects take part in a prospective study with regular sports activity during 6 months. Cognitive functions are detected with sensitive neuropsychological outcome measures, further investigations include MRT of the head, lactat- and other physical measures as well as detailed serum profiles. As a hypothesis, enhanced physical activity is suggested to predict better cognitive performance.


Eligibility criteria: Inclusion Criteria:

* 50-80 years old
* healthy
* lesser activity

Exclusion Criteria:

* regular physical activity
* diabetes
* stroke
* heavy smoking, drinking,
* BMI \< 20
* MMSE \< 25

Primary outcomes:
measure: Change of reaction times in ms in a motor learning task after 6 months of intervention/control condition
timeFrame: 6 months
measure: Change of delayed memory scores in #of words in a Verbal learning task after 6 months of intervention/control condition
timeFrame: 6 months
measure: Change of performance in ms in a reaction time task after 6 months of intervention/control condition
timeFrame: 6 months
measure: Change of relative regional grey matter volumes in % measured by T1-weighted MRI after 6 months of intervention/control condition
timeFrame: 6 months
Secondary outcomes:
measure: Change of physical measurements (ECG)/fitness assessments (lactate) after 6 months of intervention/control condition
timeFrame: 6 months
measure: Change of BDNF blood serum levels in ng/dl after 6 months of intervention/control condition
timeFrame: 6 months
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University Hospital of Muenster
state: NRW
Study officials:
affiliation: University Hospital of Muenster
name: Agnes Flooel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Muenster
name: Stefan Knecht, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02504996: IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia
Official title: IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia in Patients Presented With Sciatalgia to Emergency Department: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sciatica
Keywords: sciatalgia
emergency department
paracetamol
morphine
Lead sponsor: Akdeniz University
Sponsor class: OTHER
Collaborators: name: Pamukkale University
name: Antalya Training and Research Hospital
name: University of Gaziantep
name: Ataturk University
First posted: 2015-07-22
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Siatalgia is one of the main symptoms related to emergency department presentations. Patients with sciatalgia are seeking for immediate pain relief and little known regarding the pain management of these patients in emergency department. This study aim to trial the effect of intravenous paracetamol and morphine in patients presented with sciatalgia to emergency department.

Detailed description: Siatalgia is one of the main symptoms related to emergency department presentations. Patients with sciatalgia are seeking for immediate pain relief and little known regarding the pain management of these patients in emergency department. Neuronal compression is the main cause of pain in sciatalgia rather than inflammation which also differ sciatalgia from the other type of pains in emergency department. Sciatalgia is a kind of neuralgia and there is not so much option in the pain management of these patients. Intravenous paracetamol and morphine is commonly used analgesics in various kind of pain in emergency department. So, this study aim to trial the effect of intravenous paracetamol and morphine in patients presented with sciatalgia to emergency department.

Eligibility criteria: Inclusion Criteria:

* Patients with pain radiating to the sciatic nerve path
* Pain within the last one week
* Patients with positive straight leg raise
* Patients over 21 and lower than 65 years old

Exclusion Criteria:

* Pain score lower than 40 mm in visual analogue scale score
* Neurological deficit
* Allergy to the study drugs
* Unstable vital signs
* History of malignancy or rheumatological diseases or arthritis
* History of chronic pain syndrome
* Receiving pain killer, steroid, anti-depressant, anti-convulsant and musculorelaxant within the last six hours.
* Drug or alcohol addiction
* Pregnancy or breast feeding
* Fewer more than 37.9 Celsius degrees.

Primary outcomes:
measure: Visual Analogue Scale Score to measure pain reduction
timeFrame: 30 minutes
Secondary outcomes:
measure: Rescue drug need questionnaire
timeFrame: 30 minutes
measure: Adverse effects
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University Hospital
Study officials:
affiliation: Pamukkale University
name: Mustafa Serinken, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05428696: Safety and Tolerability, PK, and PD Study of Single and Multiple ALXN2080 Doses in Healthy Participants
Official title: A Randomized, Double-blind, Placebo-controlled First-in-Human Study of Single and Multiple Doses of ALXN2080 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ALXN2080
Complement system
Pharmacokinetics
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2022-06-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ALXN2080 in healthy adult participants.

Detailed description: Participants will be assigned to 10 different cohorts (6 SAD cohorts and 4 MAD cohorts), each with 8 participants on active treatment with ALXN2080 and 2 participants on placebo. ALXN2080 will be administered under fasted conditions throughout this study, except for the last SAD Cohort 6 in which ALXN2080 will be given with food to evaluate the effect of food on the single-dose pharmacokinetics of ALXN2080.

Eligibility criteria: Inclusion Criteria:

* Healthy is defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
* Body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg. BMI max is 32 kg/m2.
* Male or female; female of childbearing potential and male participants agreed to follow protocol specified contraception guidance.

Exclusion Criteria:

* Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
* History of hypersensitivity to any ingredient contained in the study intervention.
* Evidence of active infections, history of meningococcal infection, unexplained, or recurrent infection.
* Known or suspected history of drug or alcohol abuse or dependence.
* Current tobacco users or smokers.
* Diseases or conditions or previous procedures known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
* For females: pregnant, breastfeeding, or intending to conceive during the course of the study.

Primary outcomes:
measure: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 through up to Day 28
Secondary outcomes:
measure: Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) Of Single Dose ALXN2080
timeFrame: Up to 168 hours postdose
measure: Maximum Observed Plasma Concentration (Cmax) of Single Dose ALXN2080
timeFrame: Up to 168 hours postdose
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Clinical Trial Site
Study officials:
References:
Clinical trial NCT00812396: Biomarkers of Muscle Anabolism (MK-0000-082)
Official title: A Randomized, Single-Blind, Placebo-Controlled, Fixed-Sequence, Single-Dose, Parallel Design Study to Utilize Comparative Proteomics to Identify Early Biomarkers of Muscle Anabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Muscle Anabolism
Keywords: Biomarkers of muscle anabolism
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-12-22
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate the ability of comparative proteomics to identify early biomarkers of muscle anabolism.


Eligibility criteria: Inclusion Criteria:

* subject is a healthy male between 18 and 40 years old
* subject's weight is stable over the past 3 months
* subject agrees to refrain from consuming alcohol during study
* subject agrees to consume no caffeine while in the CRU
* subject agrees to follow meat-free diet
* subject is willing to avoid strenuous activity
* subject has been a nonsmoker for at least 6 months

Exclusion Criteria:

* subject is a regular user of illicit drugs
* subject has taken androgenic steroids in the past 12 months
* subject has participated in sports events, resistance training, or moderate to heavy endurance training in the past month
* subject has prostate cancer
* subject has HIV and/or hepatitis B or C

Primary outcomes:
measure: comparative proteomics on proteins present in the vastus lateralis or plasma
timeFrame: 1 week
Secondary outcomes:
measure: mRNA or miRNA expression in the vastus lateralis or in peripheral blood
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Chen F, Lam R, Shaywitz D, Hendrickson RC, Opiteck GJ, Wishengrad D, Liaw A, Song Q, Stewart AJ, Cummings CE, Beals C, Yarasheski KE, Reicin A, Ruddy M, Hu X, Yates NA, Menetski J, Herman GA. Evaluation of early biomarkers of muscle anabolic response to testosterone. J Cachexia Sarcopenia Muscle. 2011 Mar;2(1):45-56. doi: 10.1007/s13539-011-0021-y. Epub 2011 Feb 26.
Clinical trial NCT02707796: Correlation Between Partial Oxygen Pressure and Oxygen Reserve Index
Official title: Evaluation of the Correlation Between Partial Oxygen Pressure and Oxygen Reserve Index, and Sensitivity and Specificity of Oxygen Reserve Index in Patients Undergoing Hemicolectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COLON CANCER
Keywords: oxygen reserve index, partial oxygen pressure, hemicolectomy
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Oxygen reserve index (ORI) measured by multiple wave pulse co-oximeter is a new technological development in medical science. Our aim in this study is to identify the correlation between arterial oxygen pressure (PaO2) and ORI, and to identify the specificity and sensitivity of ORI as a tool to prevent hypoxia and hyperoxia in abdominal surgery patients.

Detailed description: Patients aged between 20-55 years old,American Society of Anesthesiologists physical status 1-2 who will have hemicolectomy will be included to the study. If hemodynamic instability or a sudden decrease in oxygen saturation by pulse oximetry (SpO2) occurs, arterial blood gas analysis will be taken from the patient and ORI, SpO2, PaO2, and arterial oxygen saturation (SaO2) will be recorded. The primer endpoint of the study is to identify the correlation between PaO2 and ORI, seconder end-point is to identify the specificity and sensitivity of ORI as a detector of PaO2. Pearson test for correlation, regression analysis for sensitivity and specificity will be performed. The study will include 240 patients according to power analysis

Eligibility criteria: Inclusion Criteria:

* Patients aged between 20-55 years old
* American Society of Anesthesiologists physical status I-II
* Patients undergoing hemicolectomy

Exclusion Criteria:

* Chronic obstructive and restrictive pulmonary disease
* Diabetes Mellitus
* Ischemic heart disease
* Peripheric artery disease.
* Operations longer than 200 minutes, requirement transfusion of more than 1 U erythrocyte suspension, and requirement of vasopressor or inotrope infusion will be excluded from the study

Primary outcomes:
measure: Evaluation of the correlation between partial oxygen pressure in arterial blood sample and oxygen reserve index calculated by pulse co-oximetry, and sensitivity and specificity of oxygen reserve index in patients undergoing hemicolectomy
timeFrame: oxygen reserve index and peripheric oxygen saturation will be recorded before and after induction of anesthesia, and every 5 minutes and arterial partial oxygen pressure in every 30 minutes during hemicolectomy.
Secondary outcomes:
measure: Sensitivity and specificity of oxygen reserve index
timeFrame: During Hemicolectomy
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cigdem Akyol Beyoglu
Study officials:
References:
Clinical trial NCT01237496: Analysis of HBV-Specific Immune Response in Patients With HBeAg Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a (40KD)) - Immunology Sub-Study of ML18253
Official title: Longitudinal Analysis of HBV-specific T Cell Responses in Patients With HBeAg-negative Chronic Hepatitis B (CHB) Treated With Pegylated Interferon Alfa-2a (40 KD) (Pegasys - RO258310). Immunology Sub-study of ML18253
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-11-09
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate immune responses in patients with HBeAg-negative chronic Hepatitis B treated with Pegasys (peginterferon alfa-2a). Eligible patients will have been randomized in study ML18253 to receive Pegasys 180 mcg subcutaneously for 48 or 96 weeks. Sample collection period for each patients will occur in the first 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients 18-55 years of age
* Chronic HBeAg negative hepatitis B
* Liver disease consistent with chronic hepatitis documented by liver biopsy within 18 months prior to enrollment
* Participation in study ML18253.

Exclusion Criteria:

* Interferon-based or any systemic anti-HBV therapy \</= 12 months prior to first dose of study drug
* Antiviral, anti-neoplastic, or immunomodulatory treatment \</= 12 months prior to first dose of study drug
* Nonresponders to previous interferon therapy and resistant to lamivudine
* Co-infection with hepatitis A, C or D, or with human immunodeficiency virus (HIV)
* Hepatocellular cancer
* Compensated (Child A, score 6) or decompensated liver disease (Child B or C)
* History or evidence of medical condition associated with chronic liver disease other than HBV

Primary outcomes:
measure: CD4 and CD8 mediated immune response: Interferon-y (ELISPOT analysis, flow cytometry)
timeFrame: 24 weeks
measure: CD4 and CD8 mediated immune response: Interleukin-2 production (Flow cytometry)
timeFrame: 24 weeks
measure: CD4 and CD8 mediated immune response: Cytokine profile analysis by supernatant culture
timeFrame: 24 weeks
measure: CD4 and CD8 mediated immune response: Proliferative response upon T-cell stimulation
timeFrame: 24 weeks
measure: CD8 response in HLA-A2 positive patients
timeFrame: 24 weeks
Secondary outcomes:
measure: Profile of proinflammatory cytokines: analysis of cytokines in serum
timeFrame: 24 weeks
measure: HBV viremia (HBV RNA assessed by COBAS PaqMan HCV test)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
city: Brescia
country: Italy
city: Milano
country: Italy
city: Parma
country: Italy
city: Reggio Emilia
country: Italy
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT00272896: Hemodynamic and Headache-Inducing Effect of Intravenous Vasoactive Intestinal Peptide in Migraineurs
Official title: Hemodynamic and Headache-Inducing Effect of Intravenous Vasoactive Intestinal Peptide (VIP) in Migraineurs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Migraine
Vasoactive Intestinal Peptide
Ultrasonography, Doppler, Transcranial
Keywords: Migraine
VIP
Transcranial Doppler
Headache
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2006-01-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: We hypothesized that infusion of VIP may induce headache/migraine in migraineurs and that VIP-induced headache may be associated with dilation of intra- and extracranial vessels. To test this hypothesis, we performed a double blind placebo-controlled crossover study in migraineurs and studied the effect on headache and cerebral and systemic hemodynamic parameters.

Detailed description: We hypothesized that infusion of VIP may induce headache/migraine in migraineurs and that VIP-induced headache may be associated with dilation of intra- and extracranial vessels. To test this hypothesis, we performed a double blind placebo-controlled crossover study in migraineurs and studied the effect on headache and cerebral and systemic hemodynamic parameters. The subjects were randomly allocated to the infusion of 8pmol/kg/min VIP or placebo (isotonic saline), duration 25min. Headache intensity, mean velocity of blood flow in the middle cerebral artery (VmMCA), superficial temporal artery diameter, end-expiratory CO2 and vital signs were recorded at baseline and then every 10 min until 120 min after start of the infusion. The patients received a headache diary for the following 12 hours after infusion.

Eligibility criteria: Inclusion Criteria:

* migraineurs

Exclusion Criteria:

* cerebrovascular disorders, pregnancy, nursing

Primary outcomes:
measure: Headache
measure: Intra- and extracranial vasodilation
Secondary outcomes:
measure: arterial blood pressure
measure: heart rate
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup Hospital
Study officials:
affiliation: Danish Headache Center, Glostrup, Denmark
name: Jes Olesen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03966196: Validation and Characterization of Signal Decrease on an Oximeter in COPD (They Have Chronic Obstructive Pulmonary Disease) Patients During Deep Inhalation (
Official title: Validation and Characterization of Signal Decrease on an Oximeter in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
Copd
Keywords: COPD
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: half healthy subject, half COPD patients
Primary purpose: DIAGNOSTIC

Brief summary: The objective is to verify that there is a decrease in the pulsed oxygen saturation with the digital sensor. That is, the drop in oxygen saturation in COPD patients during inhalation is real and not due to an artifact of the measuring tool, because oximeters need a quality pulsatile signal to properly measure oxygen saturation


Eligibility criteria: healthy arm

Inclusion Criteria:

* Healthy adults volunteers are recruited from students with normal lung function.

Exclusion Criteria:

* abnormal lung function

COPD Arm

Inclusion Criteria:

* Adults with Chronic Obstructive pulmonary disease

Exclusion Criteria:

* cardiovascular disease

The subjects selected are selected on a voluntary basis among the patients coming to the pulmonary consultation. They have Chronic Obstructive Pulmonary Disease.

Primary outcomes:
measure: drop in oxygen saturation during deep inspiration in COPD
timeFrame: from the intervention to 3 minutes after the start of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Giuseppe Liistro, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04116996: Globus Pallidus Stimulation to Treat Insomnia
Official title: Stimulation of the External Pallidal Segment for Insomnia in Patients with Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Researchers are to determine if turning on an additional unilateral DBS (deep brain stimulation) electrode with stimulation to the globus pallidus externa (GPe) region of the brain will improve insomnia (sleep).


Eligibility criteria: Inclusion Criteria:

* 40-80 years of age
* Symptomatic with Parkinsonism for 7-20 years
* Severe insomnia based on ISI score

Exclusion Criteria:

* Clinically significant dementia (MMSE \<23)
* Hoehn \& Yahr \[Hoehn, 1967 #1839\] stage I or V disease
* Other significant neurological or psychiatric disease
* Previous pallidotomy or thalamotomy
* Previous placement of other implantable devices
* Secondary parkinsonism (non-idiopathic parkinsonism)
* Inability to travel to Jacksonville for post-operative study visits
* Severe sleep apnea
* Insomnia due to pain or untreated mood disorder
* Contraindications to 3T MRI
* Circadian rhythm sleep disorders.
* Current use of hypnotics

Primary outcomes:
measure: Change in Insomnia Severity Index
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Change in Parkinson's Sleep Scale (PDSS)
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Pablo Castillo, MD
role: PRINCIPAL_INVESTIGATOR
References: