louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01202539: Real-time Assessment of Frameless Intrafraction Motion
Official title: Use of Real-time Infrared Reflective Marker Tracking and Surface Texture Mapping to Assess the Integrity of a Novel Thermoplastic Mask System for Frameless Immobilization
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Brain Tumor
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2010-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential subjects will be recruited by the Oregon Health and Science University study investigators.

Brief summary: The purpose of this study is to assess the ability of a modified thermoplastic mask system in keeping an individual head stationary for a predefined amount of time. The investigators hope to know if the modified mask is study enough, and also if the modification on the mask will allow the investigator see and track the individual's movement underneath the mask by means of a camera that can detect light reflected from the individual. Participants will lay down on their backs and their heads will be held in place with the mask system for approximately 1 hour.


Eligibility criteria: Inclusion Criteria:

* Healthy individual
* Age \> 18 years.
* Males and females of all races and ethnic groups

Exclusion Criteria:

* Severe claustrophobia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: James A. Tanyi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00660439: Treatment Effects of Narrative Exposure Therapy
Official title: Treatment Effects of Narrative Exposure Therapy on Psychiatric Symptoms and Cortisol Levels in Patients With Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Norwegian Center for Violence and Traumatic Stress Studies
First posted: 2008-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study compares Narrative Exposure Therapy with a Waiting list control group, both consists of traumatized patients with diagnosed Posttraumatic Stress Disorder. The main aim is to investigate if the patients psychiatric symptoms and levels of the stress hormone cortisol will improve more after Narrative Exposure Therapy than the Waiting list (i.e. no intervention).

Detailed description: In this study we want to compare Narrative Exposure Therapy (NET) to Waiting list controls. Adult patients with diagnosed Posttraumatic Stress Disorder following different types of trauma, will be included. Clinicians in psychiatric outpatient clinics will treat patients with NET, either immediately after assessment, or after a second assessment 3 months later. All patients will also be assessed 1 and 6 months after treatment completion. All patients will be assessed for psychiatric symptoms by the Mini International Neuropsychiatric Interview (version 5.0.0) and the Clinician-Administered PTSD Scale. Patients will also answer several questionnaires (IES-R, SCL-90, BDI-II, DES and UCL). Baseline level of the stress hormone cortisol will be collected in saliva for measuring the diurnal cycle. We will investigate if patients with Posttraumatic Stress Disorder will show more symptom improvement with NET than those on the waiting list (i.e. no intervention) in addition to measuring potential differences in cortisol between the groups.

Eligibility criteria: Inclusion Criteria:

* Posttraumatic Stress Disorder (PTSD)
* Age above 18 years
* Understands, speaks and writes Norwegian
* Informed, written consent

Exclusion Criteria:

* Active psychosis
* Active suicidality
* Serious self mutilation
* Active alcohol or drug abuse
* Serious dissociative symptoms
* Disease in nervous system or head injury
* Hormonal disease
* Pregnancy

Primary outcomes:
measure: Psychiatric symptoms
timeFrame: 1 and 6 months after treatment
Secondary outcomes:
measure: Cortisol in saliva
timeFrame: 1 and 6 months after treatment
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Western Norway Violence and Traumatic Stress Resource Centre
Study officials:
affiliation: University of Bergen
name: Anne Marita Milde, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01543139: Cytidine- and Creatine-Containing Drug in Treating Bipolar Depression
Official title: A Double-Blind, Placebo-Controlled Trial of Combined Cytidine- and Creatine-Containing Drug and Dietary Supplement in the Treatment of the Bipolar Depression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Bipolar Depression
Keywords: Bipolar Depression
Magnetic resonance spectroscopy
Cytidine-
Creatine-
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This proposed research is aimed to investigate the efficacy and safety of combined cytidine- and creatine-containing drug and dietary supplement in treating bipolar depression and to evaluate changes in relevant brain biochemical metabolism using magnetic resonance spectroscopy.


Eligibility criteria: Inclusion Criteria:

* 19-65 year-old male or female
* Bipolar depression diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV)
* Written informed consent

Exclusion Criteria:

* Present use of drugs for bipolar depression or any psychotropic medication
* Use of psychoactive medication that may affect brain imaging findings
* Diagnosis of any other axis I psychiatric disorder
* Presence of borderline personality disorder or antisocial personality disorder
* Presence of any major physical or neurological illness (e.g., epilepsy, multiple sclerosis, brain tumor, cerebrovascular disease, etc.)
* Hypersensitivity to divalproate, valpromide or diagnosis of porphyria
* Past or current liver disease, current severe liver or pancreas dysfunction
* Currently taking mefloquine
* Presence of alcohol or drug dependence, drug abuse
* Intelligence quotient below 80
* Contraindications to magnetic resonance imaging
* Women who are pregnant, breastfeeding, or planning pregnancy
* Allergy or intolerance to the study drugs

Primary outcomes:
measure: Change from baseline in depressive symptom scores at 4 weeks
timeFrame: Baseline and at 4 weeks
measure: Change from baseline in depressive symptom scores at 8 weeks
timeFrame: Baseline and at 8 weeks
Secondary outcomes:
measure: Changes in brain Glx (glutamate+glutamine) level assessed using magnetic resonance spectroscopy at baseline and 8 weeks
timeFrame: Baseline and at 8 weeks
measure: Number of participants with adverse events
timeFrame: 4 weeks
measure: Number of participants with adverse events
timeFrame: 8 weeks
measure: Changes in brain phosphocreatine level assessed using magnetic resonance spectroscopy at baseline and 8 weeks
timeFrame: Baseline and at 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Medical Center
Study officials:
affiliation: Ewha Womans University
name: In Kyoon Lyoo, MD, PhD, MMS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04420039: Plastic Stent Within a Lumen-Apposing Stent for Malignant Biliary Obstruction
Official title: Is Useful a Coaxial Plastic Stent Within a Lumen-Apposing Metal Stent For The Palliative Management Of Malignant Biliary Obstruction?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Endoscopy
Oncologic Disorders
Therapy Related Neoplasms
Keywords: Malignant biliary obstrucction
Therapeutic endoscopy
Biliary drainage
Lumen apposing stent
Endoscopic Ultrasound
Pancreatic neoplasm
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Hospital Mutua de Terrassa
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Institut d'Investigació Biomèdica de Bellvitge
First posted: 2020-06-09
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Palliative malignant biliopancreatic pathology

Brief summary: There are doubts concerning the possible benefits derived from the insertion of double-pigtail plastic stents (DPS) within the lumen-apposing metal stents (LAMS) in the EUS-guided transmural biliary drainage (BD). The aims was to evaluate the safety of LAMS with and without a coaxial DPS in EUS-BD for the palliative management in malignant biliary obstruction.


Eligibility criteria: Inclusion Criteria:

* Consecutive unresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent EUS-BD after failed ERCP cannulation or inaccessible papilla

Exclusion Criteria:

* Borderline cancer cases
* Others type of biliary stents
* Severe coagulopathy or thrombocytopenia.

Primary outcomes:
measure: Potential benefits
timeFrame: 4 weeks
Secondary outcomes:
measure: Technical success
timeFrame: 24 hours
measure: Clinical success
timeFrame: 4 weeks
measure: Procedure time
timeFrame: 2 hours
measure: Biliary reintervention
timeFrame: 6 months
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua de Terrassa
state: Barcelona, Catalonia
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital de Sant Pau i de la Santa Creu
state: Catalonia
Study officials:
References:
Clinical trial NCT02930239: Gait Rehabilitation Following an Anterior Cruciate Ligament Reconstruction
Official title: Early Initiated Gait Rehabilitation Using the Anti-gravity Treadmill Following an Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Complete Tear, Knee, Anterior Cruciate Ligament
Keywords: ACL-reconstruction
Gait rehabilitation
Anti Gravity treadmill
ACL-rehabilitation
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2016-10-12
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized control trial where subjects following an anterior cruciate ligament reconstruction will be randomized to either a control group who will receive the normal rehabilitation or an experimental group who will perform a 2-week gait rehabilitation using the anti-gravity treadmill in addition to the normal rehabilitation. The intervention will be added to the existing care received at Linkoping University Hospital 2 weeks post-surgery, while the evaluation will be performed in week 5 and 12 post-surgery using: a 3D-gait analysis (with the Qualisys software), self-reported function questionnaires and a clinical examination.


Eligibility criteria: Inclusion Criteria:

* Anterior cruciate ligament injury occurred a minimum of 3 weeks prior to surgery

Exclusion Criteria:

* Previous Anterior cruciate ligament injury
* Other knee injury with restrictions that could interfere with rehabilitation
* Other injury or disease that could interfere with rehabilitation
* Inability to understand the information

Primary outcomes:
measure: 3 dimensional gait analysis
timeFrame: 5 weeks post-surgery
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 5 weeks post-surgery
measure: International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)
timeFrame: 12 weeks post-surgery
measure: 3 dimensional gait analysis
timeFrame: 12 weeks post-surgery
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: Linkoping University
state: Ostergotland
Study officials:
affiliation: Linkoeping University
name: Joanna Kvist, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00018239: Aging and Cellular Mechanism for Insulin Action After Exercise Training
Official title: Aging and Cellular Mechanism for Insulin Action After Exercise Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine whether the metabolic and cellular mechanisms contributing to improved insulin action after aerobic or resistive exercise are different in older, obese, insulin resistant veterans. The hypothesis is that regular exercise, whether aerobic or resistive, will improve whole body insulin action, but the nature and magnitude of changes in skeletal muscle will differ between the two types of exercise.

Detailed description: Veterans will be of comparable body composition and age, and randomly assigned to either aerobic or resistive exercise. They will be instructed in a weight maintenance diet prior to beginning the exercise program, and maintain this diet throughout the study. Metabolic testing will be performed at baseline and after 6 months of exercise training. Testing will include measurement of body composition (anthropometry, dual-energy Xray absorptiometry, computed tomograph scan), maximal oxygen consumption, and muscle strength, glucose tolerance (oral glucose tolerance test), insulin sensitivity (euglycemic-hyperinsulinemic clamp), and muscle biopsies to examine skeletal muscle metabolic characteristics (fiber type distribution, capillary density, oxidative and glycolytic enzyme activities, and levels of key proteins important in insulin signaling and glucose transport). Data will be analyzed using analysis of variance to determine differences between the two exercise groups, and multiple regression analysis to determine the primary adaptations that are associated with the improvements in whole body insulin action.

Eligibility criteria: Males between 50 years and 80 years

Overweight

Non-smoker

Sedentary (no regular exercise for one year)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: VA Maryland Health Care System
state: Maryland
Study officials:
name: Andrew P Goldberg, M.D.
References:
Clinical trial NCT03673839: Comparison of Plant and Animal Proteins on Amino Acid Concentrations
Official title: Randomized Clinical Trial in Healthy Men Evaluating the Impact of Dairy and Plant-based Protein Blends on Plasma Amino Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Resistance-Trained Males
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2018-09-17
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study purpose is to assess various protein blends, which differ in protein quality, and the impact on blood amino acid response in male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy, resistance-trained adult men 18-35 years of age, inclusive, at the screening visit.
* BMI between 18.5 and 29.9 kg/m² inclusive at sceening
* Self-reported resistance training experience of no less than two years , and have participated in resistance training of at least 1h two days per week for the past six months.
* Willing to abstain from any protein supplements for 1 day prior to the study intervention phase (i.e. from the randomised visit, Visit 2)

Exclusion Criteria:

-

Primary outcomes:
measure: Plasma essential amino acids amounts
timeFrame: 4 hours
Secondary outcomes:
measure: Kinetic response of the branch chain amino acids
timeFrame: 4 hours
measure: Maximum amount of plasma branch chain amino acid amounts
timeFrame: 4 hours
Other outcomes:
measure: Time to reach the maximum amount of plasma branch chain amino acid amounts
timeFrame: 4 hours
Locations:
city: Toronto
country: Canada
facility: Glycemic, Index Laboratories, Inc.
state: Ontario
Study officials:
affiliation: Danone North America
name: Jessica BRENNAN
role: STUDY_CHAIR
References:
Clinical trial NCT04993339: Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound
Official title: Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ACL Injury
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
First posted: 2021-08-06
Enrollment: 26
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: The goal of this study is to determine whether the use of injectable osteoinductive/osteoconductive compounds (OOC) during Anterior Cruciate Ligament (ACL) reconstructive surgery, combined with an accelerated rehabilitation protocol (ARP) provides clinical outcomes superior to those attained via traditional ACL reconstruction and delayed rehabilitation protocols.


Eligibility criteria: Inclusion Criteria:

* any adult undergoing a surgical procedure for hamstring ACL reconstruction

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners

Primary outcomes:
measure: Number of Participants With Bone Tunnel Expansion
timeFrame: up to 12 months post-surgery
Secondary outcomes:
measure: Graft Maturation
timeFrame: up to 12 months post-surgery
measure: Number of Participants With Tunnel Ganglion Cyst Formation
timeFrame: up to 12 months post-surgery
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Francesco Travascio
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04343339: Evolution of Psychoactive Substances Consumption in Connection With COVID-19 Containment
Official title: Evolution of Psychoactive Substances Consumption in Connection With COVID-19 Containment - EPILOGUE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Addiction, Substance
COVID-19
Keywords: Risk of overdose on de-confinment
COVID-19 containment will change drugs practices
COVID-19 containment will changes access to care
Addiction is a common disease
Alcohol
Containment
Drug use
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 100
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: Person who lives with an addiction accepting the principle of the study

Brief summary: The current containment linked to COVID-19 will have consequences for people suffering from addiction and there is a risk of overdoses when the containment ends. So the investigators hypothesize that this health crisis is an opportunity to develop risk reduction and access to care for vulnerable people who lives with an addiction.

The main objective of this study is to describe the changes in the psychoactive substances consumption during the containment in people suffering from addiction. The secondary objectives are to describe the evolution at 1 month from the end of the containment of problematic consumption and the level of access to care of these users


Eligibility criteria: Inclusion criteria:

* \>18 years
* Accept study
* live with an addiction

Exclusion criteria:

- not being able to answer the questionnaire

Primary outcomes:
measure: Evolution of consumption
timeFrame: 1 day
measure: Evolution of consumption
timeFrame: 1 month after confinmant
Secondary outcomes:
measure: health care access
timeFrame: 1 day
measure: health care access
timeFrame: 1 month after confinmant
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Hélène Donnadieu-Rigole, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00882739: Safety and Efficacy of Three Different Loading Doses of Clopidogrel, in Patients With Acute Myocardial Infarction
Official title: Safety and Efficacy of Three Different Loading Doses of Clopidogrel, Administered at First Medical Contact in Patients With Acute Myocardial Infarction Undergoing Primary Angioplasty. The LOAD & GO Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Keywords: angiography
percutaneous coronary intervention
Platelet Aggregation Inhibitors
Platelet Function Tests
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
First posted: 2009-04-16
Enrollment: 168
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: The aim of this study is to determine both safety and effectiveness of three different loading dose regimens of clopidogrel in patients with acute myocardial infarction undergoing primary angioplasty.

Detailed description: This study will enroll STEMI patients, who were planned to undergo PCI, and will randomize them to three different clopidogrel loading dose regimens at first medical contact: no pre-treatment, 600 mg or 900 mg. Platelet activity after administration of clopidogrel will be evaluated by VerifyNow™ P2Y12 point-of-care system.

The study is powered to demonstrate significant differences in the primary end point (the rate of TIMI Myocardial Perfusion Grade=3).

Eligibility criteria: Inclusion Criteria:

* ST-elevation myocardial infarction:

  * chest pain lasting more than 30 minutes
  * not responsive to nitrates
  * ST-segment elevation of more than 0.1 mV in two or more leads on the ECG, or new Left Bundle Branch Block
* With indication to primary PCI, presenting within 12 hour from symptoms onset
* Age \> 18 years
* Planned PCI
* Informed Consent

Exclusion Criteria:

* bleeding diathesis
* allergy to study drugs
* pregnancy
* the performance of a rescue PCI after thrombolysis
* known existence of a disease resulting in a life expectancy of \<6 months
* lack of informed consent

Primary outcomes:
measure: TIMI Myocardial Perfusion Grade (TMPG)
timeFrame: post-PCI
Secondary outcomes:
measure: TIMI flow
timeFrame: pre- and post-PCI
measure: Corrected TIMI Frame Count (cTFC)
timeFrame: post-PCI
measure: Major bleedings
timeFrame: 30 days
measure: Major adverse cardiac events (MACEs)
timeFrame: 30 days
measure: Platelet Reactive Units (PRU) as assessed by VerifyNow™ System
timeFrame: pre-PCI
measure: TIMI 2-3 grade flow of the infarct-related artery
timeFrame: pre-PCI
measure: no reflow phenomenon
timeFrame: post-PCI
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Cardiovascular Department, Ospedale S.Donato
state: AR
Study officials:
affiliation: Ospedale San Donato
name: Leonardo Bolognese, MD, FESC
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale San Donato
name: Kenneth Ducci, MD
role: PRINCIPAL_INVESTIGATOR
References: