cyrilzakka/clinical-trials huggingface dataset:
High Definition Transcranial Alternating Current Stimulation (HD-tACS) for Post-stroke Aphasia

To investigate the intervention effect of high definition transcranial alternating current stimulation(HD-tACS) in chronic post-stroke aphasia and its underlying neural mechanism by MRI.

Aphasia is one of the most frequent cognitive deficits in poststroke survivor. More than 20% of stroke patients suffered from language impairment. The recovery of language dysfunction after stroke is highly variable. Some patients recover spontaneously in the early phases of stroke, but about two thirds of patients never fully restore language ability. The purpose of this study was to explore the intervention effect of high definition transcranial alternating current stimulation in chronic post-stroke aphasia.

40 patients with language disorder diagnosed by the Aphasia Battery of Chinese (ABC) were recruited from the first affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving HD-tACS. After meeting the inclusion criteria and obtaining informed consent, each participant will complete the clinical evaluation, functional magnetic resonance imaging (fMRI) and HD-tACS treatment conducted by trained researchers at the Neuropsychological Synergetic Innovation Center of Anhui Medical University.

All the participants were randomized (1:1) to receive "real" or "sham" treatment protocol. Stimulation electrodes were arranged in a 4 × 1 ring configuration at F1, F2, C1 ,C2 and FCz, with the central one delivering an alternating current 2 mA and the surrounding 4 electrodes delivering one-fourth of the central electrode's current in the opposite polarity. The average peak-to-peak stimulation intensity across participants was 2 mA for the 6-Hz tACS. In the sham condition, 6-Hz tACS was delivered only during the ramp-up and ramp-down periods (30 s); no current was delivered during the 30-minute intervention. The tACS stimulation lasted 30 minutes, a duration that is common in cognitive neuroscience research. During the tACS, participants sat comfortably in front of a screen, training the speech and comprehension functions to follow a speech therapist.

Before and after the HD-tACS treatment, the patients had receiving a battery measure of neuropsychological tests and Magnetic resonance imaging scan in multimodalities. Neuropsychological assessment included ABC, VFT, Token, MMSE, MoCA, HAMD, HAMA, ADL. Multimodal fMRI includes 3D-T1, rs-fMRI, DTI and ASL.

Neuropsychological evaluation and magnetic resonance imaging data were obtained again 24 hours after the last treatment. The symptoms of the patients were followed up one month after the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* aphasia diagnosed by the ABC.
* 18-75 years old.
* native Chinese speaker.
* right-handed.
* post onset of stroke ≥6months.

Exclusion Criteria:

* mental illness .
* severe dysarthria.
* a history of head injury or surgery.
* alcohol or substance abuse.
* cerebral tumor or abscess.
Gonyautoxin in the Treatment of Chronic Tension-Type Headache

The purpose of this study is to evaluate the clinical efficacy of Gonyautoxin 2/3 epimers in the treatment of patients diagnosed with chronic tensional-type headache in accordance with International Headache Society guidelines

Gonyautoxin are phycotoxins, whose molecular mechanism of action is a reversible block of the voltage-gated sodium channels at neuronal level. They are axonal conduction blockers impeding nerve impulse propagation. In order to evaluate the clinical efficacy of Gonyautoxin 2/3 epimers in the treatment of patients diagnosed with chronic tensional-type headache, the patients were locally injected with placebo versus Gonyautoxin following a painful spots injection standarized protocol

Eligibility Criteria:
Inclusion Criteria:

* Chronic tensional-type headache patients according to the International Headache Society criteria: patients with headache of a pressing or tightening quality with episodic frequency above 15 days a month
* Refractory to conventional treatments such as, orally administered analgesics, systemic muscular relaxant, corticoids and antidepressant like Amytriptiline
* Treated and controlled in the University Hospital Neurology Clinic over 2 years with duration of symptoms over 3 years

Exclusion Criteria:

* Pregnancy
* Use of headache prophylactic treatment a month prior to infiltration
* Myasthenic syndromes
* Muscular dystrophies
* Inflammatory myopathies
* Acute and chronic polineuropathies
* Use of psychotropic substances 24-hour before infiltration
* Anticoagulant treatment
* terminal illnesses (AIDS, cancer)
* drugs or alcohol abuse
The Effect of Primary Care Opioid Taper Plans on Sustained Opioid Taper

The objective of this study is to examine the effects of opioid taper plans as documented in the electronic medical record for Kaiser Permanente Washington (KPWA) patients. The study will compare different types of opioid tapering plans and will report on their effectiveness in producing sustained taper or discontinuation of long-term opioid therapy for chronic non-cancer pain while maintaining adequate pain control. The study population is KPWA patients receiving long-term opioid therapy from 2010 to 2017.

Opioid taper is now encouraged by many health care organizations, but it is unclear if explicit plans for opioid taper by primary care providers are effective at promoting tapering or discontinuation, and if they are effective, which components account for their effectiveness. Patients receiving long-term opioid therapy (LtOT), who are candidates for tapering, often perceive a low risk of overdose and a high risk of increased pain with opioid tapering. They fear opioid withdrawal and lack of effectiveness of non-opioid therapies. For patients with opioid tapering experience, support from family and a trusted health care provider eased opioid tapering. Many patients report improved quality of life following taper.

Little data exists on the optimal opioid taper strategy, including: use of long or short-acting opioids, frequency of clinic visits, use of adjunctive medications and the role of psychological support. Recent initiatives to reduce high-dose opioid use at Kaiser Permanente Washington offer an opportunity to study the effect of opioid taper plans and their components in an integrated care system with an electronic health record including all health encounters and pharmacy dispensing.

This study will report the proportion of LtOT patients who successfully taper compared to a similar group of LtOT patients who don't achieve tapering or discontinuation of tapering. We will also evaluate whether taper plans, defined by the patient's primary care provider, increase the likelihood of successfully tapering comparing the two groups cited above.

Eligibility Criteria:
Inclusion Criteria:

* A cohort of patients enrolled in Kaiser Permanente Washington who were receiving high dose, long-term opioid therapy (LtOT) for treatment of chronic non-cancer pain during 2010-2017. High dose LtOT defined above.
* Patients must be age \>18 years as of cohort entry and enrolled for at least 18 months during the study period.

Exclusion Criteria:

* Patients under 18 years old
* Patients with any cancer diagnosis, hospice, nursing home care, methadone maintenance, buprenorphine for opioid use disorder, cognitive impairment, spinal cord stimulator, or intrathecal opioids.
Polidocanol Sclerotherapy of Pharynges for Obstructive Sleep Apnea (OSA) and Snoring Subjects(SS)

The aim of this prospective study is to evaluate the results of polidocanol sclerotherapy of pharynx for OSAS \& SS,to reduce pharyngeal compliance.

Polidocanol submucous sclerosis in the part of pharynges with 1% polidocanol injection.The injection should be in the retropharyngeal submucosa and lateral pharyngeal bands and lateral pharyngeal submucosa and in front submucosa of soft palate.The injection is multi-point,and each point injection is 0.3\~0.5ml;the total quantity/each time is not more than 5ml.Every patient have to be treated about 1\~2 time.

Eligibility Criteria:
Inclusion Criteria:

* OSAS \& SS which palatopharyngeal collapse.

Exclusion Criteria:

* obstructive sleep apnea syndrome (osas) \& snoring subjects (ss),which anatomic narrow result in.
Study of the Synergistic Effects of Biofeedback and Transcranial Electrical Stimulation in Anxio-depressive Disorders

Anxio-depressive disorders are characterized by a difficulty in regulating the negative or aversive emotions adequately. These dysfunctions have been linked to a deficit in prefrontal cortex activity. The latter has an inhibitory influence on limbic regions -especially the amygdala- involved in the generation of emotions. By this means, the prefrontal cortex intervenes in the control of the sympathetic and parasympathetic branches of the autonomic nervous system whp are responsible for the physiological components of the emotion, including the variations of the cardiac rhythm (HRV: heart rate variability).

In emotionally demanding situations, the activity of the prefrontal cortex is generally associated with an increase in parasympathetic activity that is exerted by stimulation of the vagus nerve. In patients with anxio-depressive disorder, there is a decrease in the activity of the autonomic nervous system whose variability in heart rate is a recognized marker.

Many studies show a beneficial impact of transcranial direct current stimulation (t-DCS) on anxio-depressive symptoms, particularly when a particular area is targeted: the dorso-lateral prefrontal cortex. The impacts of this intervention are multiple and aim in particular to modulate the activity of the autonomic nervous system to promote regulation.

Biofeedback HRV is a technique that allows you to learn how to modulate your heart rate by means of respiratory control exercises. The patient receives an immediate feedback on the effectiveness of his learning (basic principle of bio-feedback). This intervention will allow to act on the parasympathetic activity and to promote a vagal tone adequate to the emotional regulation. Numerous studies have demonstrated the favorable impact of HRV biofeedback on the reduction of anxious and depressive symptoms.

Since the vagus nerve seems to be a primary pathway in physiologically emotional regulation, and considering that vagal tone can be stimulated by both the activity of the prefrontal cortex and through respiratory control, it appears interesting to study the association of t-DCS with HRV biofeedback techniques.

The first objective of this study is to show that HRV biofeedback training coupled with t-DCS is associated with a greater decrease in anxious symptomatology. The secondary objective of the study is to show that a coupling of these two techniques is associated with an increase of the variability of the cardiac rhythm as well as a more important decrease of the depressive symptomatology.


Eligibility Criteria:
Inclusion Criteria:

* Diagnose of anxio-depressive disorder
* Good understanding of French
* High anxiety level (STAI questionnaire score higher to 46) with reported difficulties to manage this anxiety.

Exclusion Criteria:

* Alcohol dependence (assessed by the AUDIT questionnaire)
* Pregnancy
* t-DCS contra indications : traumatic brain injury, epilepsy, known bipolar disease, electronic or metalic implant
* Known cardiac arrhythmia or intake of beta-blockers
Comparing Preoperative Short-course Radiotherapy With or Without Local Boost for Rectal Cancer

A randomized trial comparing weather preoperative short-course radiotherapy with local boost is better than conventional preoperative short-course radiotherapy for local advanced rectal cancer.

The study plans to recruit 100 patients,randomized into study group and control group,patients in study group are given the dose of PTV(planned target volume)-CTV(clinical target volume) 25Gy/5F with a local boost of PTV-GTV(gross tumour volume) 30Gy/5F；patients in control group are given the dose of PTV-CTV 25Gy/5F without a local boost. The other inventions are the same during the whole treatment,after the radiotherapy,they will receive a surgery under TME((total mesorectal excision) principal.Comparing the toxicity of radiotherapy, R0 resection rate,pathological complete remission rate, complications of operation and sphincter retention rate of these two groups to find out weather local boost bringing benefits to patients with local advanced rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Local advanced rectal cancer (TNM Stage ：T3-4NxM0 )diagnosed by biopsy and MRI or Endoscopic ultrasonography .
* distance between tumour and anal edge ≤12cm.
* PS（(Performance Status） score 0-2 or Karnofsky score≥70.
* liver and kidney functions are normal.
* without any treatment before inclusion.

Exclusion Criteria:

* metastasis
* combined with other severe diseases，such as other kind of cancer ,COPD,myocardial infarction,ect.
* include in other clinical trails.
COVID-19 Vaccine Hesitancy Among Rheumatic Diseases Patients

Rheumatological diseases (RD) are an important group of different clinical entities and specific diseases that affect a significant proportion of the world population. In Mexico, the RD have a relevant representation in the adult population. COVID-19 vaccination has been proposed as a measure to contain the COVID-19 pandemic. The vaccines have been shown to be effective and reasonably safe in the population without significant risk factors, which has allowed their approval to attend the health emergency. At present, there is little scientific information that allows a solid recommendation on vaccination for COVID-19 in patients with RD, although most authorities have spoken in favor of vaccination in immunocompromised patients, as are a relevant number of patients with RD. However, it is desirable to achieve herd immunity to facilitate the impact of vaccination on the transmission of SARS-CoV-2 infection. For this, it is required that around 70% -80% of the target population be vaccinated, which implies not only access to the vaccine but also accepting to be vaccinated.

Vaccine hesitancy is defined as the delay or refusal to accept the vaccine when it is available by health services. Sometimes, they conceptualize it as a continuum and also includes the high demand from the population for the vaccine; In this continuum, there are variations in acceptance and rejection and multiple possible combinations, from acceptance with great concern about the decision to rejection of certain vaccines but not others. It is a complex, contextual, changing phenomenon, specific for each vaccine and the referred disease and probably influenced by cultural determinants.

The objectives are:

1. - To measure the phenomenon of vaccine hesitancy in Mexican patients with RD from two Health Institutions in Mexico City.
2. - Translate and adapt the "Oxford Covid-19 vaccine hesitancy scale" to patients with RD and validate this version in a population of patients with RD from two Health Institutions in Mexico City
3. Explore factors associated with the phenomenon of vaccine hesitancy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a rheumatic disease diagnosis according to their primary rheumatologist who agree to participate

Exclusion Criteria:

* Patients with a not confirmed rheumatic disease
A Tool to Help Patients With Muscle Symptoms After Taking a Statin Medication.

The goal of this clinical trial is to learn if an educational website can help patients make an informed decision and engage in shared decision-making with their healthcare provider regarding cholesterol lowering medication use after they have stopped statin therapy due to self-reported muscle symptoms from taking a statin medication. The main questions the trial aims to answer are:

1. Compared to usual care, are patients who engage with the website after experiencing statin-associated muscle symptoms (SAMS) more likely to retry statin therapy?
2. Compared to usual care, are patients who retry statin therapy after engaging with the website more likely to persist on statin therapy?

Researchers will compare people randomized to use the website to those who are receiving usual care to see if statin re-start and persistence rates change.

All participants will take baseline questionnaires and receive usual care as they would if they were not in the study (e.g., visit their doctor, get labs drawn, take medication as prescribed). Patients randomized to the website arm will be asked to engage with content in a website which is anticipated to take most patients approximately 30-minutes. Their clinician will then contact them for a follow-up visit as needed.


Eligibility Criteria:
Inclusion Criteria:

* KPCO member
* Sold a statin from KPCO pharmacy in the previous six months
* Have a gap of \>1.0x the days' supply in refilling their statin
* Patient who stopped therapy (or delayed filling prescription) due to some perceived side effect
* Has email address available in kp.org (and therefore has access to a computer with internet)

Exclusion Criteria:

* Unable to verbalize comprehension of study or impaired decision-making
* Non-English speaking
* Limited life expectancy (e.g. hospice or palliative care)
* Pregnant or planning to become pregnant
* Patients on Kaiser Permanente's "do not call" list for research will also be excluded.
Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating

The purpose of this combined retrospective and prospective clinical study is to examine the clinical outcomes of the ROI-C® anterior cervical interbody fusion device with VerteBRIDGE® plating to treat single level degenerative disc disease between C2 and T1 in the short term, with a focus on fusion rates.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level between C2 and T1.
* The subject can have the ROI-C device at only one level.
* Autograft must have been used with the ROI-C device.
* Subject should have had a minimum of 6 (six) weeks of non-operative treatment prior to surgery.
* Subject must be at least 21 years of age at the time of surgery

Exclusion Criteria:

* No BMP was used in the interbody cage
* Subject was a prisoner at the time of surgery
* Subject was pregnant at the time of surgery
* Subject had an active infection or sepsis at the time of surgery
Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma

The goal of this clinical trial is to develop and evaluate the preliminary efficacy of an intervention to address alcohol use, sexual distress, and sexual assault risk among college women with a history of sexual victimization. The main questions it aims to answer are: 1) what is the feasibility of the recruitment method, research design, interventionist training methods, and delivery of the intervention; 2) does the intervention, relatively to control, the 2- and 6-month follow-up produces reductions in the quantity/frequency of alcohol use and heavy drinking, sexual distress, and sex-related drinking motives, and sexual revictimization. Participants will engage in both individual and group based intervention for alcohol use, sexual distress, and sexual assault risk. Follow-up assessments are completed at 2- and 6-months following program completion. The intervention will be compared to a general health promotion control group.


Eligibility Criteria:
Inclusion Criteria:

1. be between the ages of 18 and 24;
2. speak and comprehend English;
3. report a history of attempted or completed penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via incapacitation or force;
4. report exceeding the national recommended limits for daily drinking (4 or more for women) on two or more occasions in the past month;
5. report past month sexual activity;
6. exceed the clinical cut point on the Female Sexual Functioning Index.

Exclusion Criteria:

1. suicide risk on the Beck Depression Inventory;
2. screen positive on the Alcohol Use Withdrawal Checklist.
Continuous Theta Burst Stimulation as Potential Biomarker of Levodopa-induced Dyskinesias in Parkinson's Disease

The primary endpoint of the study is to identify a neurophysiological biomarker (absence of synaptic depotentiation at primary motor cortex , measured as change in the amplitude of motor evoked potentials recorded at the dorsal first interosseus muscle after administration of neurophysiological cTBS depotentiation protocol) as predictor of the development of Levodopa-induced dyskinesia in patients with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* patients with diagnosis of idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria;
* age between 30 and 80 years;
* ongoing therapy with levodopa;
* fulfillment of requirements for the application of transcranial magnetic stimulation (TMS), assessed by completion of the TMS screening questionnaire.

Exclusion Criteria:

* patients unable to give informed consent;
* cognitive impairment (MMSE ≤ 24);
* history of epilepsy;
* pregnant women.
Ability of Muscle Imaging and Motor Function Measure (MFM) to Detect Changes in Disease Progression in Ambulant Spinal Muscular Atrophy Patients Compared to Healthy Volunteers.

This non-drug, single center, 24-week, longitudinal study in ambulant spinal muscular atrophy (SMA) patients and in age- and gender-matched healthy volunteers will assess the detection of disease progression by magnetic resonance imaging (MRI) and the Muscle Function Measure (MFM) test.

Each participant will be evaluated in three testing sessions: at baseline, at Week 12 and at Week 24. Both patients and volunteers will undergo MRI scans. Patients will additionally undergo testing of motor function and have blood samples taken for Survival of the Motor Neuron (SMN) genes, proteins and mRNA analysis.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, aged \>/= 10 years at screening
* For SMA patients: Confirmed clinical diagnosis of 5q-autosomal recessive SMA, ambulant at time of screening, and prefereably without spinal cord fixation

Exclusion Criteria:

* Previous (3 months or less) or concomitant participation in any other therapeutic trial
* Known or suspected cancer
* Other chronic disease or inadequate renal, liver, or heart function
* Contraindications for MRI scans, including but not limited to: claustrophobia, pacemaker, artifical heart valves, cochlear implants, presence of foreign metal objects in the body, intracranial vascular clips, etc. Any contraindications to MRI found on a standard radiography scan.
Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients

Patients diagnosed with T4 colorectal cancer represent a specific subgroup of colorectal patients, frequently composed of fragile patients whose advanced nature of the disease often requires a multi organ resection by an open surgery approach and frequently leads to higher intra/postoperative complication.Those characteristics makes them to be considered less suitable for ERAS protocol, especially regarding an expected difficult compliance to postoperative items.

The impact of enhanced recovery program on postoperative outcomes in this subset of patients has never been addressed in literature, in fact most of studies either excluded T4 patients due to higher rates of complication or adopted an homogeneous patient sampling analizing all stage colorectal cancer together.

Our aim is to investigate the feasibility of ERAS protocol in T4 colorectal patient, primary outcome was to compare postoperative lenght of stay between T4 colorectal patients treated with ERAS protcol and those treated with standard of care.


Eligibility Criteria:
Inclusion Criteria:

* colorectal cacer
* hystologic diagnosis of adenocarcinoma of the colon/rectum
* clinically staged T4
* written informed consent to surgery obtained

Exclusion Criteria:

* pregnancy
* failure to perform colonic or rectal resection
* synchronous cancer at time of colorectal cancer diagnosis