louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00567060: Efficacy and Safety of Piracetam Taken for 12 Months in Subjects Suffering From Mild Cognitive Impairment (MCI)
Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of 9600 and 4800 mg/Day Piracetam Taken for 12 Months by Subjects Suffering From Mild Cognitive Impairment (MCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Memory Disorders
Keywords: Piracetam
Nootropil
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-12-04
Enrollment: 676
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to explore in a more documented way the relative potential and efficacy of piracetam 9600 and 4800 mg daily.


Eligibility criteria: Inclusion Criteria:

* male/female between 50 and 89 years (inclusive)
* declining cognitive function of at least 3 months duration interfering with complex activities of daily living
* normal basic activities of daily independent living
* Clinical Dementia Rating scale score equal to 0.5
* score at least one point above the lowest possible score on 7 out of 8 tests in the cognitive battery at both Selection Visit and Baseline Visit

Exclusion Criteria:

* general anesthetics within 3 months of selection visit
* history of severe allergic drug reaction(s)
* history of drug or alcohol dependence (DSM IV defined) within the last 12 months
* any drug prescribed to activate cerebral metabolism, taken within 1 week of screening or/and concomitantly
* concomitant intake of anticoagulent medications
* concomitant intake or intake within 1 week before screening of drug that might affect cognitive function or central nervous system
* history of dementia, psychiatric or neurological disorders, mental retardation, learning disabilities and stroke
* current depression
* impaired renal function, thyroid function or neurological degeneration
* any gastrointestinal dysfunction that might interfere with the absorption or elimination of the study drug
* insulin-dependant diabetes mellitus
* bleeding disorders or disturbance in hemostatic function.

Primary outcomes:
measure: Cognitive Battery Composite Score over a 52-week period
Secondary outcomes:
measure: safety of piracetam for 12 months
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Jelic V, Kivipelto M, Winblad B. Clinical trials in mild cognitive impairment: lessons for the future. J Neurol Neurosurg Psychiatry. 2006 Apr;77(4):429-38. doi: 10.1136/jnnp.2005.072926. Epub 2005 Nov 23.
Clinical trial NCT01220960: Art Therapy Intervention for Breast Cancer Patients
Official title: A Mixed Methods Approach to Evaluating How Art Therapy Can Benefit Women Recently Diagnosed With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: art therapy
breast cancer
women
young women
older women
quality of life
meaning making
support group
art making
art symbols
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: The Cedars Cancer Institute
First posted: 2010-10-14
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: As studies continue to debate the effects of quality of life on survival, increased attention is being focused on investigating complementary alternative therapies to boost overall total health in cancer patients . Art therapy is an interesting growing field, which has shown promise to positively influence quality of life in the pediatric and adult oncology population alike. As there is a paucity of well controlled complete studies in this field, the investigators propose to study the impact of art therapy sessions in women with breast cancer with quantitative and qualitative analysis of emotional health and physical symptoms.

The results of the investigators study will have widespread applicability to oncology programs that wish to offer/implement such sessions to their palliative and non-palliative outpatients in an effort to address the important concept of whole person care.


Eligibility criteria: Inclusion Criteria:

1. Any woman 18-years or older
2. Stage I to III breast cancer (first time diagnosis)
3. Minimum of 6 weeks Post Operative status

Primary outcomes:
measure: Quality of Life (emotional distress, physical symptoms,self-efficacy and well-being)
timeFrame: 8 weeks
Secondary outcomes:
measure: Ability to find and create meaning after the psychosocial impact of a breast cancer diagnosis
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Cedars Breast Centre\ Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: Cedars CanSupport
name: Katherine L Laux, MA Art Therapy
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Virginia Lee, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars CanSupport
name: Sharon Wexler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Monisha Sudarshan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MUHC Cedars Breast Centre
name: Sarkis Meterissian, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03527576: Block Duration After Spinal Block and iv Dexamethasone.
Official title: Block Duration After Spinal Block and iv Dexamethasone: a Randomized Controlled Double-blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lower Limb Injury
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 50
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: It has been largely demonstrated that iv dexamethasone prolongs the duration of analgesia after peripheral nerve block. However, data are missing regarding the duration of analgesia after spinal block. The objective of this randomized controlled double-blinded trial is to assess whether intravenous dexamethasone administered after a spinal block, before the surgery would prolong sensory block characteristics without impacting the motor block duration.


Eligibility criteria: Inclusion Criteria:

* Patient with ASA I-III status ;
* Patient scheduled for an osteosynthesis surgy of the lower limb

Exclusion Criteria:

* Polytrauma patient
* Pregnancy
* Contraindication to spinal anesthesia
* Contraindication to dexamethasone administration
* Patient with chronic pain

Primary outcomes:
measure: Duration of sensory block (minutes)
timeFrame: Postoperative day 0
Secondary outcomes:
measure: Highest dermatoma reached (level)
timeFrame: Postoperative day 0
measure: Onset time between injection and highest dermatoma (minutes)
timeFrame: Postoperative day 0
measure: Total duration of the sensory block (minutes)
timeFrame: Postoperative day 0
measure: Total duration of the motor block (minutes)
timeFrame: Postoperative day 0
measure: Time to the first analgesic request (minutes)
timeFrame: Postoperative day 0
measure: Cumulative consumption of morphine (mg)
timeFrame: Postoperative days 0, 1 and 2
measure: Pain score
timeFrame: Postoperative days 0, 1 and 2
measure: Rate of postoperative nausea and vomiting
timeFrame: Postoperative day 0, 1 and 2
measure: Rate of pruritus
timeFrame: Postoperative day 0, 1 and 2
measure: Rate of urinary retention
timeFrame: Postoperative day 1 and 2
measure: Satisfaction level
timeFrame: Postoperative day 2
measure: Length of stay
timeFrame: up to 14 days
measure: Persistent pain
timeFrame: 3 and 6 postoperative months
measure: Pain score if persistent pain
timeFrame: 3 and 6 postoperative months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois and University of Lausanne
state: Vaud
Study officials:
References:
Clinical trial NCT01877876: Assessing the Accuracy of the RevK Sensor
Official title: Assessing the Accuracy of the RevK Sensor for Non-Invasive Hemoglobin Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Undergoing Spine Surgery
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-06-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing spine surgery

Brief summary: Evaluation of a new generation of sensors for monitoring blood hemoglobin. The newest version is RevK.

Detailed description: Evaluation of a new generation of sensors for monitoring blood hemoglobin with the Masimo non-invasive hemoglobin monitor. The newest sensor version is RevK.

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female
* American Society of Anesthesiology Classification 1, 2 or 3
* Scheduled to undergo spine or hip surgery

Exclusion Criteria:

* Pregnant or nursing
* Patients who in the study investigators clinical judgement would not be suitable for research

Primary outcomes:
measure: To assess the accuracy of the RevK sensor for measuring blood hemoglobin compared to a laboratory-derived hemoglobin value.
timeFrame: Intermittently during spine surgery
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ronald D Miller, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05907876: Test-Retest Reliability Of UULEX In Patients With Stroke
Official title: Karabuk University
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: STROKE
UULEX
UPPER EXTREMITY
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with stroke receiving rehabilitation services in a rehabilitation centre

Brief summary: Hemiplegia refers to a complete paralysis involving one side of the arm, trunk and leg. Stroke causes loss of ability and leads to loss of functionality of daily life activities of individuals. Changes in the anatomy of the joint should be analysed for a better understanding of upper extremity problems, especially shoulder problems and pain after stroke. In recent years, the prevalence of shoulder pain in haemiplegic patients has ranged between 5% and 84%. Shoulder pain makes movements of the upper limb difficult and affects gait. Lack of active movement and spasticity is an important cause of shoulder pain. Pain and changes in muscle tone affect upper limb functionality by 30-66%. Improvement in shoulder pain with the recovery of upper extremity functions is important in returning the person to active life independently, as well as obtaining effective hand function. There are many clinical tests used to evaluate upper extremity functionality after haemiplegia. One of them, the Unassisted Upper Extremity Exercise Test (UULEX), is a performance test that evaluates upper extremity performance. The unsupported upper extremity exercise test (UULEX) is a simple, inexpensive field test developed to measure upper arm exercise capacity, but there are no reports on its reliability for use in patients with hemiplegia. The aim of our study was to determine the test-retest reliability of the UULEX in stroke patients.


Eligibility criteria: Inclusion Criteria:

* Having had a stroke
* Diagnosis of haemiplegia after a previous stroke
* Being between 18-78 years old
* Volunteering to participate in the study

Exclusion Criteria:

* Presence of pain in the upper limbs or neck
* Cognitive disorders
* Presence of comorbidity affecting upper extremity and hand functions (carpal tunnel syndrome, trigger finger, impingement syndrome, thoracic outlet syndrome, lateral and medial epicondylitis)
* History of upper extremity surgery

Primary outcomes:
measure: Upper Limb Functionality
timeFrame: First Day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Karabuk University
name: Fatma Hale Altınkaya
role: STUDY_CHAIR
References:
Clinical trial NCT01244776: Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer
Official title: Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Corneal Ulcer
Lead sponsor: Shaanxi Aierfu Activtissue Engineering
Sponsor class: INDUSTRY
Collaborators: name: Shenzhen AiNear Cornea Engineering Company Limited
name: Air Force Military Medical University, China
name: Engineering Technology Center for Tissue Engineering of Xi'an
name: Beijing Tongren Hospital
name: West China Hospital
name: Henan Provincial People's Hospital
name: Wuhan Union Hospital, China
name: Southwest Hospital, China
First posted: 2010-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to develop a lamellar keratoplasty method for corneal ulcer using acellular corneal matrix (ACM) and to make an analysis among patients for its therapeutic effect.

Detailed description: Infections, chemical injury, and other diseases result in acute or chronic corneal ulcer, which may damage corneal stroma and may lead to permanent corneal scars and blindness. Corneal transplantation is standard method for corneal ulcer, but severe shortage of donor corneas limits its application. Acellular porcine corneal matrix is similar to the native cornea, especially with the biological property and microstructure. Recently, this matrix has been proved to be safe when transplanted to animal subjects and will not be rejected by the recipient. In animal lamellar keratoplasty experiments, acellular corneal matrix showed that they can integrate into the corneal wound bed and help reconstruction of the lamellar integrity of corneal stroma. This study will investigate its healing effect on human corneal ulcer. It will provide a potential corneal substitute for this disease.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 75 yrs.
* Corneal ulcer.
* Informed consent.

Exclusion Criteria:

* Corneal perforation.
* Other ocular diseases.
* The presence of systemic connective tissue diseases
* Severe allergic constitution
* Pregnancy
* The presence of chronic disease, such as significant cardiovascular illness
* The patients who received clinical experiments for other medicine or medical devices within 3 months prior to the transplantation.
* Any patient that is not suitable for recruitment, in the judgment of the investigator.

Primary outcomes:
measure: Rejection evaluation
timeFrame: 30 days following transplantation
Secondary outcomes:
measure: Corneal wound healing
timeFrame: 90 days following transplantation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital
name: Liuhe Zhou, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04099576: The Effect of Therapeutic Neuroscience Education on Chronic Low Back Pain
Official title: Physiotherapy Combined With Therapeutic Neuroscience Education Versus Physiotherapy Alone for Patients With Chronic Low Back Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: therapeutic neuroscience education
chronic low back pain
kinesiophobia
pain
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 31
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: Ongoing fear and catastrophization in people with chronic low back pain (CLBP) causes increased pain, disability and kinesiophobia, and decreased endurance of trunk muscles. Nowadays, recurrent low back pain complaints are increasing day by day. Besides the use of electrophysical agents and exercise in the treatment of chronic low back pain, education methods used to reduce the negative effects of psychosocial factors are important for healing.

Although there were studies about the combination of Therapeutic Neuroscience Education (TNE) with exercise in CLBP, there are no studies that combine electrophysical agents, exercise and TNE methods in the literature. Therefore, in this study, we aimed to investigate whether TNE combined with physiotherapy consisting of electrophysical modalities and home program exercise is superior to only physiotherapy in patients with CLBP.


Eligibility criteria: Inclusion Criteria:

The inclusion criteria were:

* aged between 18-60 years
* to have CLBP ˃ 3 months duration
* to have independent walking ability
* to be literate in Turkish.

Exclusion Criteria:

* to have vertebral compression fractures
* to have transitional vertebrae
* to have an underlying tumoral, rheumatologic or inflammatory disease
* to have trauma, surgical history
* to be pregnant or less than six months postpartum period

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 1 minute
measure: Tampa Kinesiophobia Scale
timeFrame: Five minutes
Secondary outcomes:
measure: partial curl-up
timeFrame: 1 minute
measure: modified Sorensen tests
timeFrame: Five minutes
measure: Roland Morris Index
timeFrame: Five minutes
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University Medical Ethics Committee
Study officials:
References:
citation: Walti P, Kool J, Luomajoki H. Short-term effect on pain and function of neurophysiological education and sensorimotor retraining compared to usual physiotherapy in patients with chronic or recurrent non-specific low back pain, a pilot randomized controlled trial. BMC Musculoskelet Disord. 2015 Apr 10;16:83. doi: 10.1186/s12891-015-0533-2.
Clinical trial NCT00599976: Comparison of Pulmonary Vein Isolation Versus AV Nodal Ablation With Biventricular Pacing for Patients With Atrial Fibrillation With Congestive Heart Failure (PABA CHF)
Official title: Randomized Controlled Trial of Pulmonary Vein Antrum Isolation vs. AV Node Ablation With Bi-Ventricular Pacing for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure (PABA CHF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Congestive Heart Failure
Lead sponsor: Azienda Policlinico Umberto I
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
First posted: 2008-01-24
Enrollment: 81
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: For patients with atrial fibrillation and heart failure, current treatment can include AV nodal ablation with biventricular pacing. Pulmonary vein isolation (PVI) is a new procedure for this patient population which attempts to restore sinus rhythm. This trial is a randomized controlled trial of AVN ablation with biventricular pacing versus PVI for atrial fibrillation patients with congestive heart failure.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic atrial fibrillation with NYHA II-III symptoms despite the use of anti-arrhythmic medications.
* Ejection fraction was required to be ≤ 40%.
* Patients were required to be on a heart failure regimen that included beta-blockers and ace-inhibitors or angiotensin receptor blockers for all patients and spironolactone for NYHA III patients.
* Patients were required to complete a 6-minute walk test and to be ≥ 18 years of age.

Exclusion Criteria:

* Reversible causes of AF and heart failure (HF) such as pericarditis, hyperthyroidism, valvular heart disease and tachycardia-induced cardiomyopathy.
* Post-operative AF, previous MAZE or MAZE-like surgery, previous left atrial instrumentation
* Life expectancy ≤ 2 years
* Likely cardiac transplant within the next 12 months
* Contraindication to anti-arrhythmic medications and/or anticoagulation
* Severe pulmonary disease
* Documented intra-atrial thrombus
* Tumor or other abnormalities which preclude catheter introduction
* Cardiac surgery, MI or PCI within the past three months.

Primary outcomes:
measure: composite of EF, 6-minute walk distance and MLWHF score
timeFrame: 6 months
Secondary outcomes:
measure: freedom from AF and left atrial size
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Khan MN, Jais P, Cummings J, Di Biase L, Sanders P, Martin DO, Kautzner J, Hao S, Themistoclakis S, Fanelli R, Potenza D, Massaro R, Wazni O, Schweikert R, Saliba W, Wang P, Al-Ahmad A, Beheiry S, Santarelli P, Starling RC, Dello Russo A, Pelargonio G, Brachmann J, Schibgilla V, Bonso A, Casella M, Raviele A, Haissaguerre M, Natale A; PABA-CHF Investigators. Pulmonary-vein isolation for atrial fibrillation in patients with heart failure. N Engl J Med. 2008 Oct 23;359(17):1778-85. doi: 10.1056/NEJMoa0708234.
Clinical trial NCT05439876: Getting SMART for Pediatric Epilepsy
Official title: Getting SMART for Pediatric Epilepsy (Sleep, Melatonin, and Research Trial, SMART)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Epilepsy in Children
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.

Detailed description: Sleep disturbances are more prevalent in children with epilepsy whose sleep can be disrupted by seizures occurring during the night and/or during the day. Melatonin is a naturally occurring hormone produced in the pineal which regulates sleep-wake cycles and facilitates quality sleep. Therefore, the purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.

Eligibility criteria: Inclusion Criteria:

- Children aged between 1 and 18 years with a confirmed diagnosis of epilepsy and with sleep problems

Exclusion Criteria:

* Children who are bedridden with limited mobility
* Children with liver or kidney dysfunction
* Children on medication for sleep or mood problems within 4 weeks before the baseline clinic visit
* Adolescent girls who are pregnant or breastfeeding
* Adolescent girls who have sexual activities but cannot take effective contraceptive measures during the trial

Primary outcomes:
measure: Sleep quality
timeFrame: 4 weeks
Secondary outcomes:
measure: Behavioral profile
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Wang-Tso Lee
role: PRINCIPAL_INVESTIGATOR
References: