louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00659932: Dealing With Anxiety: A Cognitive Behavioural Program for Diabetes
Official title: Dealing With Anxiety: A Pilot Cognitive Behavioural Program for Diabetic Clinic Outpatient Attendees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Keywords: diabetes
cognitive behavioural therapy
Lead sponsor: Hunter and New England Health
Sponsor class: OTHER
First posted: 2008-04-17
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to assess whether a cognitive behavior therapy (CBT) program for diabetes clinic patients was acceptable, improved quality of life and produced measurable change in levels of depression, anxiety and stress.

Detailed description: Having co-morbid anxiety or depression makes it difficult to carry out the activities for diabetes selfcare. Psychological interventions have been shown to result in improvements in HbA1C and depression. Reports on psychosocial outcomes are conflicting and there are no studies of quality of life. Our diabetes outpatient population has a higher prevalence of anxiety and depression compared to the general public and this led to the development of a group CBT intervention designed to reduce anxiety as a co-morbidity of diabetes.

Eligibility criteria: Inclusion Criteria:

* Consenting attendees of the Hunter Area Diabetes Services RNH Diabetes Outpatient Clinic

Exclusion Criteria:

* Accessibility problems including:

  * limited English
  * developmental disability
  * physical immobility
  * geographical distance
  * extreme age/frailty

Primary outcomes:
measure: Hemoglobin A1C (HbA1C)
timeFrame: 6 months
Secondary outcomes:
measure: Depression Anxiety Stress Scale (DASS)
timeFrame: 6 months
measure: Diabetes Quality of Life (ADDQoL)
timeFrame: 6 months
Other outcomes:
Locations:
city: Newcastle
country: Australia
facility: Royal Newcastle Hospital
state: New South Wales
Study officials:
References:
Clinical trial NCT05178732: The Effect of Menstrual Cycle Phase and Protein Dose on Muscle Protein Synthesis
Official title: The Effect of Menstrual Cycle Phase and Protein Dose on Muscle Protein Synthesis in Response to Exercise in Young Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Protein Synthesis
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: P.volve
First posted: 2022-01-05
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Adaptation to resistance exercise requires maximal rates of muscle protein synthesis, which can be achieved with post-exercise ingestion of \~20g of protein. These recommendations are based on studies in males and responses in females may vary.

Muscle recovery is related to the ability to build new muscle protein from amino acids (muscle protein synthesis). This response is thought to be impacted in females by hormones that fluctuate across different phases of the menstrual cycle. However, the effect of menstrual cycle phase on muscle protein synthesis is not known.


Eligibility criteria: Inclusion Criteria:

* BMI between 18 and 30
* Recreationally active
* Regular menstrual cycle

Exclusion Criteria:

* Smoking
* Metabolic disease
* Any motor disorder
* Use of over-the-counter pharmaceuticals, during the study.
* Pomegranate, milk or lidocaine allergy
* Taken contraceptives in the past 3 months
* Irregular menstrual cycle (less than 9 cycles per year and a length not between 21-35 days)
* Post-menopausal women
* Pregnancy and lactation

Primary outcomes:
measure: Muscle protein synthesis
timeFrame: 7.5 hours
Secondary outcomes:
measure: Plasma amino acid kinetics
timeFrame: 7.5 hours
measure: Serum insulin concentrations
timeFrame: 7.5 hours
measure: Blood flow
timeFrame: 7.5 hours
measure: Sex hormone concentrations
timeFrame: 5 minutes
measure: Gene expression
timeFrame: 7.5 hours
measure: Blood glucose
timeFrame: 7.5 hours
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
state: Devon
Study officials:
affiliation: University of Exeter
name: Francis Stephens
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01664832: Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?
Official title: Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: Premature Infants
snychronized ventilation
non-invasive ventilation
RDS
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2012-08-14
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is the examination of the hypothesis that synchronized nasal IMV as compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants immediately after extubation when recovering from Respiratory distress syndrome (RDS).

Another objective is to examine the effects for synchronized non-invasive mechanical ventilation on gas exchange and cerebral oxygen saturation.

Detailed description: In this study the investigators plan to test the hypothesis that synchronized nasal IMV (S-NIMV) as compared to non-synchronized nasal IMV (NIMV) will decrease breathing effort in preterm infants immediately after extubation when recovery from RDS, as measured by phasic esophageal pressure deflection.

Furthermore, the investigators plan to evaluate the effects of synchronized NIMV on gas exchange and brain oxygenation, and to evaluate the reliability of a newly developed abdominal pressure sensor device for the S-NIMV mode in a newly designed commercially available ventilator device.

Eligibility criteria: Inclusion Criteria:

Preterm infants recovering from respiratory failure with the following criteria were eligible for this study.

* Gestational age \<32 wks, those who are on invasive mechanical ventilation, recovering from RDS, and ready for extubation as judged by the clinical team.
* Informed consent available.

Exclusion Criteria:

• Infants with major congenital anomalies involving the CNS, lung (i.e. lung hypoplasia, active air leaks) or the heart (ASD, VSD allowed), or known neuromuscular disease.

Primary outcomes:
measure: phasic esophageal pressure deflection
timeFrame: 4 hours
Secondary outcomes:
measure: Cerebral oxygen saturation
timeFrame: 4 hours
measure: Arterial oxygen saturation
timeFrame: 4 hours
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Children's Hospital University of Ulm
state: Baden-Wüttemberg
Study officials:
affiliation: University of Ulm
name: Hummler Helmut, Prof. Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03717532: Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome
Official title: Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of blood restriction therapy by comparing increase in muscle mass and strength in patients that receive blood restriction therapy to patients who receive a placebo.


Eligibility criteria: Inclusion Criteria:

* ASA class I-II
* Diagnosed with patellofemoral pain syndrome

Exclusion Criteria:

* Patients with confirmed radiographic evidence explaining knee pain
* Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
* Younger than 18 years of age or older than 65
* Any patient considered a vulnerable subject
* Patients with impaired circulation, peripheral vascular compromise, Previous revascularization of the extremity, or severe hypertension
* Patients with Sickle cell anemia or venous thromboembolism
* Patients with Sickle cell anemia or venous thromboembolism
* Patients with cancer or Lymphectomies
* Patients with increased intracranial pressure

Primary outcomes:
measure: Increase in Muscle Mass Measured by Biodex
timeFrame: 6 Weeks
measure: Decrease in Pain measured by Visual Analog Scale (VAS)
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Guillen Gonzalez-Lomas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00351832: A Study To Compare the Effect of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With Vildagliptin (50mg qd, 50mg Bid, 100mg qd) to Placebo in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
Vildagliptin
Hemoglobin A1c
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-07-13
Enrollment: 236
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is to evaluate the effect of vildagliptin 50mg qd, 50mg bid or 100mg qd compared to placebo in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 diabetes
* Patients who have been placed on dietary therapy/exercise therapy without achievement of glycemic control
* Outpatients

Exclusion Criteria:

* Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
* Significant cardiovascular disease
* Significant diabetic complications

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline on HbA1c at 12 weeks
Secondary outcomes:
measure: Change from baseline on fasting plasma glucose at 12 weeks
measure: Change from baseline on HOMA B at 12 weeks
measure: Change from baseline on HOMA IR at 12 weeks
measure: Change from baseline in body weight at 12 weeks
measure: Change from baseline on fasting lipids at 12 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04600232: TB-LAM in the Diagnosis of TB
Official title: Clinical Utility of TB-LAM in the Diagnosis of Active TB in Hospitalized HIV-infected Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Tuberculosis
Non-Tuberculous Mycobacterial Pneumonia
Lead sponsor: Shanghai Public Health Clinical Center
Sponsor class: OTHER_GOV
First posted: 2020-10-23
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Tuberculosis (TB) is still the leading cause of death in HIV-infected patients. Early diagnosis of TB substantially improves the survival of HIV-infected patients. Urine based detection of lipoarabinomannan (LAM) provides promising methods for quick diagnosis of TB in HIV-infected patients. However, the sensitivity and specificity of TB-LAM is still not well established, especially in area where non-tuberculosis mycobacterium is also prevalence. Here we aimed to evaluate the clinical utility of TB-LAM in diagnosis of active TB in hospitalized HIV-infected patients.


Eligibility criteria: Inclusion Criteria:

* Hospitalized HIV-infected patients.
* Willing to participate into the study.

Exclusion Criteria:

* Already diagnosed with active TB
* Received any anti-tuberculosis drugs and/or quinolone for more than 7 days.

Primary outcomes:
measure: Sensitivity against microbiological reference standard
timeFrame: 2 months
measure: Specificity against microbiological reference standard
timeFrame: 2 months
Secondary outcomes:
measure: Sensitivity against composite reference standard
timeFrame: 2 months
measure: Specificity against composite reference standard
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04812132: RCT Comparing OAGB and Long Limb Roux Gastric Bypass
Official title: A Multicentre Randomized Controlled Trial Comparing Outcome of Laparoscopic One-anastomosis Gastric Bypass and Laparoscopic Long Biliopancreatic Limb Roux Gastric Bypass for Treatment of Morbid Obesity.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: OAGB
Long biliary limb Roux gastric bypass
Metabolic surgery
Obesity
Lead sponsor: Tartu University Hospital
Sponsor class: OTHER
Collaborators: name: North Estonia Medical Centre
name: Fertilitas (private clinic)
First posted: 2021-03-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective multicenter randomized controlled trial to compare the outcomes of one-anastomosis gastric bypass to long biliary limb Roux gastric bypass.

We plan to enroll up to 500 patients from three different clinics in Estonia. Outcomes are excess weight loss %, impact on type 2 diabetes, hypertension, hyperlipidemia and obstructive sleep apnea.

Other outcomes are nutritional deficiencies, occurrence of reflux disease and impact on quality of life.

There are planned outpatient visits 1, 5 and 10 years after the surgery to measure the impacts.

There are a lot of studies comparing OAGB to standard Roux gastric bypass but non comparing it to long biliary limb gastric bypass.


Eligibility criteria: Inclusion Criteria:

* BMI over 35 and obesity related disease
* BMI over 40
* age between 18-60 years
* agrees to participate in the study

Exclusion Criteria:

* age under 18 years or over 60 years
* abundant adhesions discovered during the surgery
* active upper gastrointestinal ulcer disease
* prior bariatric surgery
* active symptomatic reflux disease
* active psychiatric disease (eg psychosis)

Primary outcomes:
measure: Excess weight loss %
timeFrame: 10 years
measure: Impact on type 2 diabetes mellitus
timeFrame: 10 years
measure: Impact on type 2 diabetes mellitus
timeFrame: 10 years
measure: Impact on hypertensive disease
timeFrame: 10 years
measure: Impact on total cholesterol
timeFrame: 10 years
measure: Impact on hyperlipidemia
timeFrame: 10 years
measure: Impact on hyperlipidemia
timeFrame: 10 years
measure: Impact on hyperlipidemia
timeFrame: 10 years
measure: Impact on hyperlipidemias
timeFrame: 10 years
Secondary outcomes:
measure: Nutritional deficiencies: anemia
timeFrame: 10 years
measure: Nutritional deficiencies
timeFrame: 10 years
measure: GERD
timeFrame: 10 years
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
Study officials:
References:
Clinical trial NCT06166732: The Effect of Music-Based Mindfulness to Cope with Acculturative-Related Stress
Official title: The Effect of Music-Based Mindfulness on Acculturative Stress and Attention in East Asian International Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the effect of music-based mindfulness on stress reduction among East Asian international students.


Eligibility criteria: Inclusion Criteria:

* Being 18 years of age or older
* Pursuing an undergraduate/graduate degree with an F-1 visa
* Originating from regions including China, Hong Kong, Taiwan, North Korea, South Korea, and Japan
* Living in the United States for no more than 3 years
* Having less than one year of mindfulness practice

Exclusion Criteria:

• Individuals not meeting inclusion criteria

Primary outcomes:
measure: Change in Spielberger State-Anxiety Inventory
timeFrame: 5 minutes before intervention and 5 minutes post intervention
measure: Change in researcher-designed attention scale
timeFrame: 5 minutes before intervention and 5 minutes post intervention
measure: Change in Trail Making Test, Part A and B
timeFrame: 5 minutes before intervention and 5 minutes post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami, Volpe 206
state: Florida
Study officials:
affiliation: University of Miami
name: Teresa Lesiuk, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01589432: A Randomized, Double-blind, Placebo- and Active-controlled Study of the Electric Current Effects of ABT-639 on the Spontaneous Activity of Pain Sensory Receptors in Patients With Diabetic Peripheral Neuropathy
Official title: A Randomized, Double-blind, Placebo and Active-controlled Study of the Electrophysiological Effects of ABT-639 on Spontaneous Activity in C-Nociceptors in Patients With Painful Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Neuropathic Pain
Keywords: Diabetic peripheral neuropathy
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-05-02
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.


Eligibility criteria: Inclusion Criteria

* Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months.
* Subject must have an average score of greater than or equal to 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.

Exclusion Criteria

* Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from diabetic neuropathic pain or interfere with the pain assessments of diabetic neuropathic pain.
* A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with diabetic neuropathic pain assessments or other functions.
* Subject has clinically significant abnormalities in clinical laboratory tests.

Primary outcomes:
measure: Spontaneous activity in peripheral c-nociceptors
timeFrame: 10 minute intervals over 180 minutes
Secondary outcomes:
measure: Pain intensity measurements
timeFrame: hourly for 4 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 68882
Study officials:
affiliation: AbbVie
name: Rita Jain, MD
role: STUDY_DIRECTOR
References:
citation: Serra J, Duan WR, Locke C, Sola R, Liu W, Nothaft W. Effects of a T-type calcium channel blocker, ABT-639, on spontaneous activity in C-nociceptors in patients with painful diabetic neuropathy: a randomized controlled trial. Pain. 2015 Nov;156(11):2175-2183. doi: 10.1097/j.pain.0000000000000249.
Clinical trial NCT01312532: Comparing Fixed-bearing Versus Mobile-bearing Prosthesis in Total Knee Arthroplasty: A Prospective Randomized Trial
Official title: Study of Prosthesis in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Total knee arthroplasty
Fixed-bearing
Mobile-bearing
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-03-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which prosthesis is better in total knee arthroplasty

Detailed description: Theoretical advantages of mobile-bearing devices led surgeons to use these prostheses instead of fixed-bearing devices as traditional implants. This study was designed to compare Fixed-bearing versus Mobile-bearing Prosthesis in Total Knee Arthroplasty through a five-year follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients with expected primary total knee arthroplasty

Exclusion Criteria:

* Mediolateral instability
* Infective arthritis
* Severe deformity
* Revision

Primary outcomes:
measure: Knee Society Scoring
timeFrame: five years after surgery
Secondary outcomes:
measure: Pain
timeFrame: five years after surgery
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Al-zahra university hospital
Study officials:
affiliation: Isfahan University of Medical Sciences
name: mohammad dehghani, A.Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01437332: Molecular Mediators of Nerve Injury Signaling
Official title: Molecular Mediators of Nerve Injury Signaling
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Nerve Injury
Chronic Neuropathic Pain
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgical procedures at Rambam Health Care Campus wherein the surgeon and PI determine appropriateness for study

Brief summary: Specific proteins and other signaling molecules are increased and decreased following nerve injury. Some of these are important in producing pain or explaining why pain persists after traumatic nerve injuries or in disease states such as diabetes. In this study, the investigators hypothesize that it is possible to detect changes in specific signaling molecules and that these will provide insights into novel treatment strategies. The patients to be included are those who are undergoing the removal of tissue during surgery. The tissues that would otherwise be discarded will be included in the study as appropriate.


Eligibility criteria: Inclusion Criteria:

* patients undergoing surgery where tissue removal is anticipated

Exclusion Criteria:

* age younger than 18

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
References:
citation: Ebenezer GJ, McArthur JC, Thomas D, Murinson B, Hauer P, Polydefkis M, Griffin JW. Denervation of skin in neuropathies: the sequence of axonal and Schwann cell changes in skin biopsies. Brain. 2007 Oct;130(Pt 10):2703-14. doi: 10.1093/brain/awm199.