cyrilzakka/clinical-trials huggingface dataset:
Mindfulness Interventions and Chronic Widespread Pain in Adolescents

The primary objective of this study to determine the feasibility and acceptability of a mindfulness intervention for adolescents with juvenile fibromyalgia/ chronic widespread pain and other similar chronic symptoms.

The primary objective is to test the feasibility, safety, tolerability and acceptability of a mindfulness meditation intervention for adolescents with juvenile fibromyalgia/chronic widespread pain.

The purpose of the program is to test how effective an 8-week meditation and stress reduction class is in helping adolescents with chronic symptoms (including but not limited to fibromyalgia or chronic widespread pain, irritable bowel syndrome, joint pain, chronic fatigue, and others).

Participants will attend group sessions led by an instructor experienced in MBSR in an academic setting. The mindfulness meditation group sessions will take place at the Yale School of Medicine.

Participants will attend 90-minute weekly group sessions and a 4-hour retreat with approximately 6-8 other study participants at Yale School of Medicine. Participants are asked to practice at home by listening to pre-recorded 15-20 minute guided meditations.

Eligibility Criteria:
Inclusion Criteria:

* 2010 American College of Rheumatology (ACR) criteria based on the Widespread Pain Index (WPI) and Symptom Severity (SS) checklist.
* Functional Disability Score ≥13 indicating at least moderate disability
* Average pain intensity in the past week ≥ 4 on a 0-10 cm Visual Analog Scale.
* Access to mobile telephone/smartphone with text messaging plan in order to receive survey questions.
* Chronic symptoms such as fatigue, pain, bowel dysfunction, perceived cognitive impairment, or other non-specific symptoms persisting for 3-months or more, severe enough to have led to more than one visit to a medical provider. These symptoms must have not been found to be due to a definable general medical disorder despite adequate evaluation.

Exclusion Criteria:

* Diagnosis of an autoimmune or rheumatologic disease
* Current regular mindfulness meditation activity
* Serious illness (including mental illness/psychopathology) within 90 days prior to screening
* Inability or unwillingness of a parent to give consent/permission or child to assent
* Current use of opioid analgesics
* Current prescription for antidepressant medications
* Screening positive on the Columbia Suicide Screen (CSS)
* Active participation (weekly or more often) in a fibromyalgia or chronic disease support group
Does Core Activation on an Unstable Surface Affect Periscapular Muscle Activation?

The core muscles contain various muscle groups that stabilize the shoulders, pelvis, and spine, and they play an important role as pivot points in extremity movements. It is known that core muscles stabilize the lumbar region and core stabilization affects muscle activation. İn addition conscious abdominal muscle activation during exercise performance is believed to promote greater scapular muscle activation through existing myofascial connections. Studies support the relationship between the scapular region and the core region.

Another aspect of rehabilitation is the use of unstable surfaces with exercise, since it is possible to increase neuromuscular demand without placing further overload on the musculoskeletal system.

Hypothesis originating from the investigation:

H1: Exercises performed with core activation on stable surfaces activate the muscles around the scapula more than exercises performed without core activation.

H2: Exercises performed with core activation on unstable surfaces activate the muscles around the scapula more than exercises performed without core activation.

H3: Exercises performed with core activation on unstable surfaces activate muscle activation around the scapula more than exercises performed on stable surfaces.

H4: Exercises performed without core activation on unstable surfaces activate muscle activation around the scapula more than exercises performed on stable surfaces.

Muscle activation of upper trapezius, middle trapezius, lower trapezius ve serratus anterior will be measured by superficial electromyographic measurement. Muscle activation according to SENIAM for each muscle will be evaluated.

Muscle activations will be measured during 4 different scapula exercises based on the literature. These exercises are: Inferior glide, External rotation in sitting, External rotation with standing elevation, Wall slide.

The specified scapula exercises will be performed on stable and unstable surfaces while the core region muscles are active and inactive. During the exercises, superficial EMG measurements of muscles will be recorded bilaterally.

All measurements will be made in 3 repetitions.

Eligibility Criteria:
Inclusion Criteria:

* Young individuals aged 18 and over
* Body mass index \<30kg/m2

Exclusion Criteria:

* Individuals with previous trauma, neurological or musculoskeletal disorders in the shoulder girdle, upper extremity, spine, or pelvic girdle
* Individuals with a limited or painful range of motion in the shoulder girdle, upper extremity, spine, or pelvic girdle
Registry Study of Thoracic Reirradiation for Non-Small Cell Lung Cancer (NSCLC) Utilizing Proton Beam Therapy or Intensity Modulated Radiation Therapy

The goal of this research study is to learn more about the safety of treating NSCLC with reirradiation using standard methods and to look for ways to lessen side effects and improve therapy. Reirradiation is when radiation is given to an area of the body that has previously received a full dose of radiation.

If you agree to take part in this study, data will be recorded during your therapy. The data to be recorded will include your medical history, the disease, treatments you have received and how you have responded to any treatments, as well as any side effects you may have had.

The data will be stored on a password-protected computer at MD Anderson for use in future research related to cancer.

Your data will be given a code number. No identifying information will be directly linked to your data. Only the researcher in charge of this study will have access to the code numbers and be able to link the data to you. This is to allow medical information related to your data to be updated as needed. Other researchers using your data will not be able to link this data to you.

Length of Study:

After you sign this consent form, your active participation on this study will be over.

This is an investigational study.

Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. History of previous histologically or cytologically documented NSCLC, stage I-IV.
2. Prior course of radiation therapy or concurrent chemoradiation at least 1 month prior to the current course of radiation therapy.
3. Patients eligible to receive a second course of radiation therapy to the thorax, at the discretion of the treating physician.
4. Patients receiving concurrent chemotherapy or targeted agents will be eligible for this protocol.

3.2 Exclusion Criteria:

1. Life expectancy\<3 months
2. Pregnancy.
The Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) Targeting the Right Globus Pallidus Internus (GPi) for Motor Symptoms in Patients With PD

To demonstrate that intervention targeting the right globus pallidus internus (GPi) using transcranial temporal interference stimulation can improve motor symptoms in patients with Parkinson's disease.

Each of patients received either 30-minute or sham tTIS of the right GPi. Before and immediately after the stimulation, participants completed the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III) in the "medication-on" state to assess the motor symptoms. MDS-UPDRS, HAMA and HAMD were assessed on intervention Day 1, Day 10 and 1-month follow-up and clinical efficacy was evaluated by comparing the scale scores before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Meeting the diagnostic criteria for Parkinson's disease in China (2016 version), diagnosed as PD by two neurologists;
2. Hoehn-Yahr stage 1.5-4;
3. Age \> 50 years old;
4. No signs of moderate to severe depression: Beck Depression Inventory-II (BDI-II) score \< 20;
5. No signs of dementia: Mini-Mental State Examination (MMSE) score \> 21;
6. No change in medication regimen in the four weeks prior to enrollment;
7. Right-handed.

Exclusion Criteria:

1. History of other neuropsychiatric disorders;
2. History of alcohol or drug abuse;
3. Previous history of TMS or traditional TES treatment;
4. Presence of non-MRI compatible metal implants in the body, such as deep brain stimulation devices, pacemakers or stents.
Evaluation of a Patient Education Program for Ankylosing Spondylitis

Long term disease management is essential for Ankylosing Spondylitis (AS), a chronic progressive systemic inflammatory disease of the axial skeleton. Extensive information about the disease is a necessary first step. An education program for AS was implemented to improve inpatient medical rehabilitation. In a controlled quasi-experimental multicentric study the efficacy of this program was analysed.


Eligibility Criteria:
Inclusion Criteria:

* Ankylosing Spondylitis (AS) according to modified New York Criteria
* Early diagnosis criteria for AS
* ESSG Criteria for Spondyloarthritis

Exclusion Criteria:

* History of malignant disease during past five years
* Secondary fibromyalgia syndrome
* Group integration deficiencies
* Seminar repeaters
Restoring Hand Function in Patients with Tetraplegia by Intraneural Stimulation of Peripheral Nerves

The aim of the clinical investigation is to evaluate the feasibility, in terms of efficacy and safety, of a prosthetic system, the Regrasp 1 system, based on intraneural stimulation via TIME- 4H electrodes, as an aid device for restoring hand function in tetraplegic patients.

The study involves implanting intraneural electrodes in the nerve used to open and close the hand.

Electrical stimulation will activate the forearm and hand muscles, and thus evoke movements such as opening and closing the fingers of the hand and wrist movements. Electrodes will be implanted temporarily and reversibly within the fascicles so that a more selective and therefore more effective stimulation can be determined. The electrodes will remain implanted for about 6 months.

During this period, the results of the external electrical stimulation will be analysed through experimental sessions that will take place at the Careggi University Hospital. At the end of the study, the electrodes will be removed by surgery under general anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women aged between 18 and 70.
2. Spinal cord injury at the C5-6 level, with complete motor paralysis (ASIA A or ASIA B).
3. Chronic injury (\&gt; 6 months), with stable clinical condition.

Exclusion Criteria:

1. Systemic infections.
2. Central and/or peripheral nervous system comorbidity.
3. Reduced joint flexibility.
4. Severe spasticity of the upper limb (mAS 3).
5. Severe denervation of forearm and hand muscles (as demonstrated by electromyography and electroneurography analysis and intraoperative neural stimulation).
6. Muscles not electrically excitable.
7. Presence of hyperalgesia or allodynia.
8. Wearers of life support devices that could be adversely affected by electromagnetic interference, such as pacemakers, implanted cardioverter defibrillators, etc.
9. Cognitive impairment.
10. Active or history of psychiatric illnesses including major depression, bipolar disorder and personality disorders (borderline or antisocial personality disorder).
11. Pregnancy.
12. History of alcohol or substance abuse.
13. Acquired brain injury with residual deficits.
14. Participation in other clinical trials.
15. Known allergies/hypersensitivity to TIME-4H electrode materials.
16. Life expectancy of less than one year.
17. Contraindications to general anaesthesia (patient refusal, severe aortic stenosis, significant pulmonary disease, etc.).
Effects of Tai Chi on Postural Balance and Quality of Life in the Elderly With Gait Disorder

The goal of this intervention study was to test balance ability and quality of life in older adults with gait problems. The main questions it aims to answer are: 1. Can the balance ability of elderly people with gait disorders be improved through Tai Chi intervention? 2. Whether Tai Chi intervention can improve the quality of life of elderly people with gait disorders.

Participants will be divided into an experimental group and a control group. The experimental group will undergo 12 weeks of Tai Chi intervention, while the control group will maintain daily habits, including simple walking or stretching activities.

The inclusion criteria for potential participants were as follows:

Age ≥ 60 years old Have mild gait problems Can walk independently No Tai Chi training experience or exercise habits

The exclusion criteria for potential participants were as follows:

Age \<60 years old No obvious problems with gait walking with tools Have experience in Tai Chi intervention within three months hearing loss

Outcomes measured: balance, gait, muscle strength, mobility, fall rate, quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years old Have mild gait problems Can walk independently No Tai Chi training experience or exercise habits

Exclusion Criteria:

* Age \<60 years old No obvious problems with gait walking with tools Have experience in Tai Chi intervention within three months hearing loss
Uric Acid Reduction as a Novel Treatment for Pediatric Chronic Kidney Disease

Aim 1. To determine the effect of Allopurinol treatment on renal function (glomerular filtration rate, GFR) in pediatric chronic kidney disease (CKD) patients with high uric acid levels (hyperuricemia).

Aim 2. Establish whether Allopurinol treatment reduces Nlrp3 inflammasome and renal injury biomarkers.

Uric acid levels often rise when kidney function declines. Historically, high uric acid has not been treated unless the uric acid crystallizes in the joint space and causes clinical gout disease, more typically seen in adults. However, new research has shown that high uric acid levels are associated with the development of hypertension, inflammation, and both acute and chronic kidney injury. Adult patients on renal dialysis who have hyperuricemia also have higher mortality rates. In several adult and in one pediatric clinical trial of uric acid lowering therapy (with Allopurinol or Febuxostat), treatment has demonstrated a slower rate of renal function decline and improved blood pressure compared to placebo. The pediatric trial was a 4-month placebo controlled trial of Allopurinol, and showed positive improvement in renal function and blood pressure, but did not adequately control for potential confounders in the outcome. Two known confounders that influence renal function (glomerular filitration rate, GFR) in pediatric CKD are race and glomerular or non-glomerular disease etiology. This study is designed to control for these confounders and establish whether Allopurinol for 6 months of treatment to a goal range of 3-5 mg/dL will improve renal function compared to standard of care. The secondary outcome is to determine whether blood pressure is affected by the treatment and the magnitude of change of serum uric acid. This study will also explore whether Allopurinol treatment alters activation of the Nlrp3 inflammasome or renal injury biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Kidney Disease stage 1-5
* Hyperuricemic (UA \>= 5.5 mg/dL)

Exclusion Criteria:

* Contraindication to Allopurinol
* Elevated baseline liver function tests
* Receiving acute or chronic dialysis
* Primary metabolic disorder
* Sickle cell disease
* Autosomal Dominant Polycystic Kidney Disease
* Cystinosis
* Bartter or Gitelman Disease
* Pregnant or nursing
Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation

This is a single-center, prospective, randomized, double-blind (pharmacotherapy), placebo-controlled, and comprehensive rehabilitation phase II clinical trial to determine the usefulness of pregabalin in a new indication (post-COVID chronic fatigue syndrome).

Patients will be randomized in a 1:1:1:1 ratio to pregabalin (75-300 mg daily in two divided doses), comprehensive rehabilitation with a placebo drug, comprehensive rehabilitation with pregabalin (75-300 mg in two divided doses), or placebo (two divided doses) for 6 months (177-187 days).

There will be 4 outpatient visits to the research center and 12 telephone consultations.

The procedures and assessments performed as part of the study are listed in the study schedule.

It is planned to include 132 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 120 patients (30 in each arm).

Patients will be recruited during an outpatient medical consultation with a general practitioner or neurologist, psychiatrist, psychologist or other specialists, as well as with the use of information materials in the form of leaflets and advertisements on the Internet.


Eligibility Criteria:
Inclusion Criteria:

1. The patient correctly gave written informed consent to participate in the study;
2. Men or women between the ages of 18 and 65 inclusive at the time of signing the informed consent;
3. Patient after a minimum of 6 months from the documented detection of SARS-CoV-2 infection (document confirming the history of the disease, including a positive result of the PCR or antigen test, certificate of convalescence; medical documentation confirming the infection; the condition is also considered fulfilled in the case of documented infection asymptomatic);
4. During the screening, the patient meets the criteria for the diagnosis of chronic fatigue syndrome (CFS) according to the National Academy of Medicine (2015);
5. Women:

   a) incapable of having children (post-menopausal or child-bearing, subjected to permanent sterilization); (b) of childbearing potential with a negative pregnancy test result at screening and using a highly effective method of contraception throughout the IMP use and for 7 days after the last IMP use.
6. The patient agrees to participate in all activities provided for in the study.
7. The patient is able to understand the information presented and give informed consent to participate in the study prior to screening.

Exclusion Criteria:

1. Vital functions disorders;
2. Documented hypersensitivity to pregabalin or any of the excipients of the formulation (i.e., lactose);
3. Moderate or severe depression during treatment or present during psychiatric evaluation at baseline;
4. Concurrent treatment with opioids or other antiepileptic drugs (including tramadol, buprenorphine, morphine, oxycodone, gabapentin, duloxetine);
5. Pregnant or breastfeeding women.
Optimal Regimen in Endovascular Therapy in Ischemic Cerebrovascular Disease Based on Clopidogrel Resistance

1. Clopidogrel resistance is common in patients of ischemic cerebrovascular disease.
2. Genetic polymorphisms are the most important factors to clopidogrel resistance.
3. The purpose of this study is to find the genes which are the related to clopidogrel resistance.
4. Through gene sequencing, we can filter patient of clopidogrel resistance, so another drug maybe used to avoid the undesired efficacy.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic ischemic cerebrovascular disease caused by Intracranial atherosclerotic atherosclerosis research database.
* 90 days had a stroke or transient ischemic attack is defined as symptomatic Intracranial atherosclerotic atherosclerosis
* stenosis ≥ 50% (MRI or CT angiography).
* Intracranial vascular stenosis measured according to the method reported Warfarin aspirin symptomatic intracranial disease research.

Exclusion Criteria:

* diffuse intracranial arterial stenosis.
* cranial magnetic resonance imaging shows lesions as the branch artery blockage caused.
* non-atherosclerotic lesions.
* occurred within 6 weeks of vascular lesions in the region of intracranial hemorrhage.
* potential cardiac thrombus source.
* has concurrent intracranial tumors, intracranial aneurysm or arteriovenous malformation.
* ipsilateral extracranial carotid or vertebral artery stenosis ≥ 50%;
* known to heparin, aspirin, clopidogrel, anesthetics and contrast agents contraindications;
* hemoglobin less than 10g/dL, platelet count \<100000/dL;
* responsibility left after cerebral vascular-related serious neurological dysfunction (mRS ≥ 3);
* international normalized ratio\> 1.5
* there are factors that can not be corrected by bleeding;
* life expectancy \<1 year;
* pregnant or lactating women;
* indications Commission determines that the patient is not suitable for the study treatment.
EyeBag Effectiveness in Meibomian Gland Dysfunction

Meibomian gland dysfunction (MGD) is a common condition that causes the secretion from meibomian glands in the eyelids to become blocked. Normally, the secretion helps to maintain a healthy tear film. In MGD, the tear film becomes unstable and often causes dry eye symptoms. Treatments often involve gently warming the eyelids to melt this blockage which prevents tears from spreading over the eye. Although there has been some research on application of heat with warm moist flannels, the Eye Bags potentially offers a simpler and more effective method of applying heat to the eyelids. This study will test the efficiency of these eyelid warming devices over a period of two weeks use in one eye compared to the other non-treated eye.

Study Design

Contralateral treatment study Randomised eye treated with heated eyebag in the morning and evening each day as per manufacturer's instructions Other eye acts as control with room temperature eyebag overlaid in same manner as treatment eye Investigators masked SMS messaging twice a day for 14 days to remind patients to use eyebag and collect 0-10 comfort score

Eligibility Criteria:
Inclusion Criteria:

* 18 or over
* Have otherwise healthy eyes
* Are prepared not to wear contact lens for the 2 weeks of the trial
* Have a NITBUT \<10s
* OSDI score: greater than or equal to 12
* Symptom frequency at least "some of the time"
* Presence of cloudy fluid expressed from at least 1 of the central 8 glands on the lower/upper lid AND/OR presence of poor expressibility from at least 2-3 of the central 8 glands on the lower lid

Exclusion Criteria:

• Blepharitis
A Single Dose Study Of PF-06291874 In Healthy Adult Subjects

The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers.

The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers. The trial was terminated on Jan 9, 2012, due to undesired pharmacokinetic properties. The decision to terminate the trial was not based on any safety or efficacy concerns.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non childbearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).