cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of a Protease Activated Receptor-4 Antagonist Being Tested to Reduce the Chances of Having Additional Strokes or "Mini Strokes"

The purpose of this study is to determine whether BMS-986141 is effective in reducing the recurrence of stroke in people who recently had a stroke, or a transient ischemic attack (known as a TIA or "mini stroke") and are receiving acetylsalicylic acid (also known as aspirin or ASA) to treat the stroke or TIA.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Male or female, age 18 or older
* Must have had a very recent stroke or transient ischemic attack ("mini stroke") that can be confirmed by the study doctor
* Able to be assigned to a study group no later than 48 hours after the stroke occurred
* Has an image of the brain that confirms that the stroke was not caused by hemorrhage or other reason that could explain symptoms

Exclusion Criteria:

* A suspicion by the study doctor that the transient ischemic attack or stroke was caused by a blood clot that formed in the heart; examples of this include history of an abnormal heart rhythm known as atrial fibrillation or a ventricular aneurysm or defect of the heart.
* Any condition requiring treatment with an anticoagulant
* History of intracranial hemorrhage ("bleeding in the brain")
* Gastrointestinal ("stomach or intestinal") bleeding in the last 3 months that required treatment
* Planned or anticipated invasive surgery or procedure during the study
* Unable to tolerate MRI procedures.
Effectiveness of a Handwriting Intervention

The purpose of the study was to examine the effectiveness of an occupational therapy led handwriting intervention for special education and at-risk kindergarten students.

In spite of the increased use of computers and tablets by children of younger and younger ages, handwriting remains an important skill for school success and continues to be a critical skill for elementary school students to acquire. Beginning writers still do most of their composing by hand, and difficulties with handwriting can have far-reaching effects on a child's self esteem and academic success.

This study examined the effectiveness of an occupational therapy led handwriting intervention for special education and at-risk kindergarten students. There is a tremendous need for studies examining the outcomes of handwriting instruction provided to the at-risk population, in order to determine whether outcomes are similar to those seen in the typically developing population. There is also a need for studies that examine outcomes in "real world" settings, in addition to those settings manipulated for experimental research. Such studies may not be as "clean" as those in classic experimental research, however it is imperative to examine outcomes in the settings that are occurring in today's schools. At-risk children are increasingly being provided intensive interventions under an RtI model, and children receiving special education services are increasingly being integrated into less restrictive settings, thus creating classroom environments with a wide variety of students needs.

The purpose of this study was to examine the outcomes of a handwriting intervention, the Size Matters Handwriting Program (SMHP), provided to kindergarten children currently receiving IEP or RtI interventions. This study attempted to answer the following research questions:

1. Will at-risk kindergarteners (those children receiving IEP or RtI support) participating in a 16 week, occupational therapy led handwriting SMHP intervention group demonstrate significantly greater improvements in handwriting legibility than children who do not receive the intervention?
2. Will at-risk kindergarteners, participating in a SMHP handwriting intervention, make significantly greater gains in the pre-reading skills of letter-name recognition and letter-sound recall, than students who do not receive the intervention?

The study incorporated a two group pre and post-test design. Both groups consisted of kindergarten students receiving IEP and/or RtI support. An occupational therapist provided biweekly group handwriting instruction using the Size Matters Handwriting Program to students in the intervention group (n = 23), while the control group (n=12) received the standard handwriting instruction.

Eligibility Criteria:
* Inclusion Criteria:

  * Kindergartners receiving educational support in the form of IEP and/or RtI tier 2 interventions
  * Must be in a support classroom where services are delivered
* Exclusion Criteria:

  * Children not in kindergarten
  * Children not receiving IEP or Rtl tier 2 interventions
Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty

Total knee arthroplasty(TKA) is an effective modality for the treatment of advanced osteoarthritis of the knee joint with excellent outcomes. With 719,000 cases being performed as of 2010, the incidence is expected to increase up to 3.48 million procedures annually by 2030.

There have been several studies regarding efficacy of peri articular infiltration. IPACK block is a novel technique gaining popularity where one injects local anesthesia safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.

There have been no studies till date comparing the efficacy between IPACK block and Periarticular Infiltration (PAI).

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiology) class I-IV
* age 18-75.

Exclusion Criteria:

* ASA class V
* morbid obesity
* patient refusal
* patients with chronic pain or on pain medication
* allergy to LA
* patients receiving any additional regional techniques
* coagulopathy
* patients receiving systemic anticoagulation
* local infection and procedures anticipated to last more than 5 hours.
Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers

Treatment of insomnia in caregivers is needed given that 60% of Alzheimer disease caregivers report sleep complaints, and insomnia may add to the burden of AD caregiving and contribute to morbidity and mortality risk. This is the first intervention trial in AD caregivers to target insomnia and also evaluate two mechanisms of chronic disease risk, inflammation and cellular aging

This randomized controlled trial aims to evaluate the non-inferiority of Mindful Awareness Practices for Insomnia (MAP-I ) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I) on outcomes of insomnia, cellular and genomic markers of inflammation, and cellular aging in older adult AD spousal caregivers with insomnia (N=150) over one-year follow-up. The specific aims of this project are:

Primary Aim 1: Determine the effects of MAP-I vs. CBT-I on subjective and objective dimensions of insomnia.

Secondary Aim 1: Evaluate the effects of MAP-I vs. CBT-I on cellular and genomic markers of inflammation.

Secondary Aim 2: Evaluate the effects of MAP-I vs. CBT-I on markers of cellular aging.

Exploratory Aim 1: Explore moderating effects of caregiver stress (Stress and Adversity Inventory, STRAIN, number \& experienced intensity of stress exposure) on insomnia outcomes, and effects of MAP-I vs. CBT-I on caregiver stress, health functioning, chronic medical morbidity and related medication use at follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Alzheimer or other dementia caregivers
* Older than 45 years of age
* Self-identified as the principal person taking care of the patient with Alzheimer or other dementia
* Diagnostic and Statistical Manual Criteria - 5 for Insomnia

Exclusion Criteria:

* Psychiatric disorders including current major depressive disorder or other current DSM-5 psychiatric disorder (e.g. substance dependence) with the exception of anxiety disorder;
* Psychotic symptoms;
* Acute suicidal or violent behavior or history of suicide attempt within the last year
* Other sleep disorders including current or lifetime history of sleep apnea, nocturnal myoclonus, phase-shift disorder as identified by SCID-5 and Duke Structured Interview for Sleep Disorders (DSISD)
* Medical conditions such as acute or uncontrolled medical illness (e.g., major surgery, metastatic cancer, Class III heart failure, inflammatory disorder)
* Chronic infections
* Obesity with body mass index (BMI) \>35
* Use of hormone containing medications including steroids or immune modifying drugs
* Daily use of analgesics such as opioids;
* Daily us of sedative hypnotic medications
* Cognitive impairment as evidenced by DSM-5 interview and/or Mini-Mental Status Exam (MMSE \< 26)
* Actively practicing a mind body intervention.
The Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation for Upper-limb Motor Function Recovery in Subcortical and Brainstem Stroke

The purpose of this study is to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation applied with an electromagnetic therapy stimulator 'ALTMS-A' for upper-limb motor function recovery with the sham control group for those who need upper-limb rehabilitation treatment for subcortical and brainstem stroke

After low-frequency repetitive transcranial magnetic stimulation (rTMS) over the contralesional motor cortex (M1), the score of the Box and Block test increased immediately, especially in patients without cortical involvement.

Eighty-eight patients will be recruited and divided into two groups. Each group will receive 10 sessions of the real rTMS or sham rTMS over the contralesional primary motor cortex. Each rTMS session consists of low-frequency (1Hz) 1800 stimulations.

The objective of this study is to evaluate the efficacy and safety of rTMS for upper-limb motor function in patients with subcortical and brainstem stroke.

Eligibility Criteria:
Inclusion Criteria:

* 19-80 years old
* Radiologically confirmed ischemic stroke with subcortical and brainstem lesions within 90 days
* Fugl-Meyer assessment scale (upper extremity) \> 15
* Mini-mental status exam (the Korean version) \> 14 with appropriate cognitive function
* Written informed consent

Exclusion Criteria:

* Fugl-Meyer assessment scale (wrist) \< 1 or Fugl-Meyer assessment scale (hand) \< 1
* Hemorrhagic stroke or traumatic brain injury
* Cerebellar stroke
* Previous history of stroke
* Traumatic brain injury
* Previous history of brain surgery
* Need for intensive care due to complications associated with stroke (e.g. pneumonia, infection, hemodynamic instability)
* History of psychological or neurological diseases
* History of pain or muscular weakness of upper limbs which may interfere with rehabilitation
* History of seizure or epilepsy
* Aphasia
* Skin lesions in the stimulation site of scalp
* Intracranial metal implant
* Inability to receive regular physical or occupational therapy
* Disagreement to use contraception in women of childbearing age
Combined SAPB in MICS

Minimally invasive cardiac surgery (MICS) has begun to be performed frequently in recent years. Compared to sternotomy, MISC reduces the risk of mediastinitis, leaves a more aesthetic scar, facilitates postoperative rehabilitation, and shortens the hospital stay. MICS requires a thoracic incision in the right 4th or 5th intercostal space. This incision causes intense and long-lasting pain in the postoperative period. Pain is exacerbated by breathing movements, coughing, and respiratory physiotherapy.

Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in any type of cardiothoracic surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. This prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity.

In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, thoracic epidural analgesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. SAPB is one of them. SAPB can be applied in three ways. While deep SAPB (DSAPB) is applied under the serratus anterior muscle, superficial SAPB (SSAPB) is applied above the serratus anterior muscle. Combined SAPB (CSAPB) is applied both below and above the serratus anterior muscle. These blocks can be performed with a single injection anywhere between the second and seventh ribs on the lateral chest wall.

In this study, the analgesic effects of ultrasound-guided CSAPB application in patients undergoing MICS will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years old
* American Society of Anesthesiologists (ASA) physical status I-II-III
* BMI 18 to 40 kg/m2
* Elective Minimally Invasive Cardiac Surgery (MICS)

Exclusion Criteria:

* Patient refusing the procedure
* Emergency surgery
* History of chronic opioid or analgesic used
AMG 529 First in Human Study

A study to assess the safety and tolerability of AMG 529 following single, ascending doses administered subcutaneously (SC) or intravenously (IV) in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women ≥ 18 to ≤ 55 years old with no history or evidence of clinically relevant medical disorders
2. Body mass index (BMI) between 18 and 32 kg/m², inclusive, at screening
3. Women must be of non-reproductive potential as defined in protocol
4. Other inclusion criteria may apply

Exclusion Criteria:

1. Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives (whichever is longer), since ending treatment on another investigational device or drug study(s) prior to receiving the first dose of investigational product
2. Women who are lactating/breastfeeding or who plan to breastfeed while on study through 90 days after receiving the dose of investigational product
3. Men with partners who are pregnant or planning to become pregnant while the subject is on study through 90 days after receiving the dose of investigational product
4. Positive pregnancy test at screening or day -1
5. Other exclusion criteria may apply
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice (UK)

This prospective cohort study will provide information about: characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed Warfarin for the first time, the occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.


Eligibility Criteria:
Inclusion Criteria:

* All male and female patients who have been prescribed for the first time either Rivaroxaban or standard of care from the date of market authorization of rivaroxaban to Dec 31, 2017

Exclusion Criteria:

- Patients who have any record of being prescribed their index drug prior to the enrolment period or who qualify as members of both cohorts on the same day, will be excluded
Upper Extremity Recovery Post Stroke Using Virtual Occupations

The purpose of this study is to explore the efficacy of the SaeboVR rehabilitation system for improving functional outcomes related to upper extremity motor recovery in stroke survivors.

The specific objectives are:

1. To explore the participants' level of performance and satisfaction with their performance in self-identified problem areas of daily functioning following a 4-week intervention using the SaeboVR rehabilitation system.
2. To evaluate the efficacy of an intervention protocol that emphasizes task-specific and goal-oriented virtual practice, reflecting the participants' self-identified goal priorities.

This study will employ a multiple single-subject pre-post experimental design, with multiple pre and post measures, to evaluate the potential efficacy of a virtual reality-based treatment using the SaeboVR rehabilitation system in stroke survivors. Comprehensive measurement during the baseline and post-treatment phases will be completed, with each individual to serve as their own control. Participants will make 3 separate visits to the laboratory (approximately 2 days apart) on the Bannatyne Campus at the University of Manitoba prior to the 4 week intervention and again after the intervention. The Arm Activity Measure (ArmA) and the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) will be used both pre and post intervention as well as the Canadian Occupational Performance Measure (COPM) to measure participants' performance on self-identified occupational performance issues and their level of satisfaction with their performance. Two participants will be recruited upon discharge from inpatient stroke rehabilitation at the Riverview Health Centre, Winnipeg, Manitoba, and upon entry into this study, will receive one-to-one treatment and supervision using the SaeboVR rehabilitation system for approximately 1 hour per session, 2 to 3 times per week for 4-weeks.

Eligibility Criteria:
Inclusion Criteria:

* adults aged 18 or over with upper extremity deficits post stroke
* admitted to Riverview Health Centre (Winnipeg, Canada) for stroke rehabilitation and are being discharged to home locations within the city of Winnipeg
* referred to outpatient Occupational Therapy at the Health Sciences Centre (Winnipeg, Canada) for additional upper extremity retraining post-stroke
* have a premorbid fully functional upper extremity
* have anti-gravity strength of the affected elbow to at least 45 degrees of active flexion when in an upright seated position
* have anti-gravity strength of the affected shoulder to at least 30 degrees of active flexion and active abduction/adduction when in an upright seated position
* have active internal and external shoulder rotation of the affected shoulder to at least 15 degrees when in an upright seated position
* able to speak and understand English
* able to follow verbal instructions
* have normal visual acuity with corrective lenses
* have no noted visual neglect

Exclusion Criteria:

* have a history of seizure
* have arthritis or pain restricting repetitive training of the affected upper extremity
App-based Psychosocial Intervention to Enhance Quality of Life in Arabic-speaking Refugees Residing in Switzerland

The ongoing warfare and economic instability in the Middle East and in North Africa causes many people to leave their home countries. Arrived in a host countries, in this example, in Switzerland, they face a lot of structural and psychosocial hurdles. Particularly in the first years, building up a certain quality of life is complicated and challenging. To support this process, the Swiss Red Cross and the University of Bern have developed the Sui app. It contains structural and social information as well as low-intensity psychological tools to provide support to the everyday life of Arabic-speaking people in Switzerland.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Arabic as native or second language
* Good knowledge of reading, writing and speaking Arabic
* Have lived in Switzerland for no longer than 5 years
* Give written consent
* Have access to a smartphone and an internet connection
* Indicate an emergency contact whom they could contact in event of a crisis

Exclusion Criteria:

* Indicate an increased risk of self-harm or suicide at baseline
* Indicate having been diagnosed with psychosis or bipolar disorder
* Be participating in a similar study at baseline
* Have a lack of written and spoken Arabic skills
Bioavailability of Ubiquinol in Huntington Disease

The death of brain cells in Huntington Disease (HD) is thought to be associated with a lack of normal cell energy and harmful brain substances called free radicals. Coenzyme Q10 (CoQ) is a marketed nutritional supplement that may prove useful in HD because it increases cell energy and combats free radicals.

Most studies of CoQ have looked at only one formulation of CoQ ("ubiquinone") in HD. The purpose of the study is to find out if people that switch from the common formulation of CoQ ("ubiquinone") to a different formulation ("ubiquinol") have higher levels of CoQ in their blood after taking the same dose. The investigators also want to find out if this different formulation is tolerable for individuals with HD.


Eligibility Criteria:
Inclusion Criteria:

* Have manifest Huntington disease
* Be 18 years of age or older
* Be taking an oxidized formulation of CoQ for at least 30 days prior to the baseline visit
* Be on a steady dose of all concomitant medications for at least 30 days prior to the baseline visit

Exclusion Criteria:

* Have a history of intolerability of sensitivity to CoQ
* Have an unstable medical or psychiatric illness
* Be pregnant or breastfeeding; women of childbearing age must use reliable contraception
Exercise and Breast Cancer Related Lymphedema: Influence of Muscle Group and Sequence on Volume Change in Swollen and Normal Arms

Arm exercise influences arm volume and symptoms in breast cancer related lymphedema.


Eligibility Criteria:
Inclusion Criteria:

* unilateral arm lymphedema as a result of breast cancer treatment
* completion of breast cancer treatments
* arm lymphedema onset 3 months or more after surgery and persistent for at least 6 months
* in the maintenance phase of lymphedema treatment

Exclusion Criteria:

* women with recurrent cancer
* intercurrent diseases affecting the swollen arm
* lack of understanding of the Hebrew language
Effect of Acupuncture Dry Needle in Treatment of Chronic Mechanical Low Back Pain

Low back pain affects about 60% to 90% of the working-age population in modern industrial society. Chronic mechanical low back pain (CMLBP) is the most common problem of the working-age population in modern industrial society; it causes a substantial economic burden due to the wide use of medical services and absence from work. The purpose of this trial was to evaluate the short-term effect of acupuncture dry needle in treatment of chronic mechanical low back pain.

Low back pain affects about 60% to 90% of the working-age population in modern industrial society. Chronic mechanical low back pain (CMLBP) is the most common problem of the working-age population in modern industrial society; it causes a substantial economic burden due to the wide use of medical services and absence from work. The purpose of this trial was to evaluate the short-term effect of acupuncture dry needle in treatment of chronic mechanical low back pain. Thirty patients their age ranged from 20 - 45 years participated in our study and divided randomly into two equal groups suffering from nonspecific low back pain. The first group (A) consist of 15 patients receiving acupuncture dry needle over trigger points of back muscles followed by stretching and strengthening exercises for back muscles, the second group (B) consist of 15 patients receiving only stretching and strengthening exercises for back muscles. The following parameters including pain severity, functional disability and lumbar range of motion (flexion, extension, right side bending and left side bending) were measured before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age ranges from 20 to 45 years old.
2. Pain of at least 30 mm to 70 mm on a visual analogue scale (VAS) from 0 mm (no pain) to 100 mm (worst imaginable pain).
3. Presence of MTrPs at least in 4 muscles on any side.
4. Patients had lower back myofascial pain syndrome for at least 3 months ago.

Exclusion Criteria:

A history of previous back surgery, neurologic deficit, current lower extremity symptoms, cardiopulmonary disease with decreased activity tolerance, rheumatologic conditions, polyarticular osteoarthritis, rheumatoid arthritis and advanced lumbar degenerative disease, patients receiving other treatment in the form of physical therapy or medication for the duration of the study that may interfere with the results of this study.