cyrilzakka/clinical-trials huggingface dataset:
Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury

Spaulding Rehabilitation Hospital is conducting a research study evaluating the effectiveness of the brain-training product, MUSE, an EEG-guided neurofeedback device designed to assist in cultivating a relaxed, attentive state of mind during meditation. The investigators study aims to evaluate whether such a tool could be useful in treating persistent traumatic brain injury symptoms such as inattention, impulsivity, irritability, or dysregulated mood.

Twenty subjects in total will participate in this study. Subjects will be randomized to focused-attention meditation training with or without the neurofeedback device, MUSE. Subjects will be asked to practice \~10 min of daily meditation for 6-8 weeks. Neuropsychological testing will be performed at the beginning of the study and after six weeks of training. At this time point, those randomized to the non-MUSE group will be given a device and asked to train for an additional two weeks. At the conclusion of the study, all subjects will also undergo a brief telephone or in-person exit interview regarding their experiences using the MUSE device.

Primary endpoint: change in Neurobehavioral Symptom Inventory

Secondary endpoints: change in the following: Wechsler Adult Intelligence Scale-IV Digit Span and Symbol-Digit Coding, Trail-Making Test, Beck Anxiety Inventory, Beck Depression Inventory, Cognitive and Affective Mindfulness Scale-Revised, percentage of EEG activity associated with alpha, beta, or theta activity.

Eligibility Criteria:
Inclusion Criteria:

1. history of mild-moderate traumatic brain injury
2. impaired attention or concentration
3. \>1 year since traumatic brain injury
4. ability to participate in neurofeedback and mindfulness meditation
5. daily access to a smart phone
6. on stable dosage of neuropsychological medications with no significant changes planned for the duration of the study
7. no prior history of a meditation practice

Exclusion Criteria:

1. severe mental illness or psychological symptoms (severe depression, suicidality, disabling anxiety, PTSD, psychosis, dissociation)
2. significant pre-morbid learning disability
3. current or recent (in past year) history of significant drug or alcohol abuse
4. medical illness severe enough to result in an attentional disorder
5. neurodegenerative disease
6. non-fluency in English.
Primary Ovarian Insufficient Patients

The Prospective Cohort Study for Primary Ovarian Insufficient Patients was set up to investigate the short- and long-term health consequences in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, China.

Premature ovarian insufficiency (POI) is a rare cause of infertility in women affecting 1% of the population. It is characterized by amenorrhea, hypoestrogenism and elevated gonadotrophin levels in women younger than 40 years of age. Other than the reproductive outcome of these patients, the short- and long-term health consequences are still unknown.

Since last decade, Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD) has been used in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, and Henan Province Key Laboratory for Reproduction and Genetics. Information of patients (POI, PCOS, Endometriosis, azoospermia, ect) were recorded comprehensively. The current project plans to recruit POI participants in our center. Biological samples, questionnaires and short/long term health data will be collected. The study is aimed to provide evidence for POI prognosis.

Eligibility Criteria:
Inclusion Criteria:

* younger than 40 years of age
* at least four or more months of amenorrhea, two or more instances in which the serum FSH level is \> 40 U/L (i.e., two inspections at intervals of 1 month or more), with an oestradiol level of \<20pg/ml

Exclusion Criteria:

-
An Attempt at Translating Novelty-enhanced Extinction of Context Conditioning From Rodents to Humans

In rodents, novel exploration has been used to strengthen the consolidation of a variety of hippocampal-dependent learning tasks. To our knowledge, no attempt have been made to translate the effect of strengthening the memory of an extinction of a context conditioning memory. This study uses virtual reality for both context conditioning and novel exploration in an attempt at translating these findings from rodents to humans, thus, using novel exploration to strengthen an extinction memory. Threat responses are measured with skin conductance and startle responses. If this effect could be shown experimentally in humans, that experimental setup could become an important tool in understanding important memory processes of fear, such as reconsolidation and behavioral tagging.

The study employs healthy participants and includes three experimental sessions, roughly 24 h apart. During the first session, participants undergo context conditioning in virtual reality where the CS+ and CS- are two different rooms. During the second session, half of the participants perform an exploration of a novel virtual environment, and the other half performs a visual attention task. About 60 min later, participants undergo extinction to the context conditioning performed in session 1, again in virtual reality. In session 3, remaining threat responses are measured through a reinstatement procedure, again in virtual reality.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent and complete study procedures

Exclusion Criteria:

* Current psychiatric disorder.
* Current use of psychotropic medication
* Current use of neurological conditions
Axillary Vein Cannulation: 'Hockey' Probe Versus Linear Probe

Central venous catheterization, specifically through the axillary vein, is a procedure of critical importance in various clinical contexts. Site selection is dependent on clinical assessment, experience and the physician preference. This study aims to evaluate the potential advantages of using the "hockey stick" ultrasonography probe for axillary vein cannulation and determine whether this probe enhances axillary vein imaging, accelerates the central vein cannulation procedure and reduces the rate of complications compared to the linear probe. Methods: 100 participants were recruited and allocated into two groups: the linear probe group and the hockey stick probe group. All procedures were performed by two senior anesthesia and intensive care residents, each with experience of over 100 central vascular access procedures. Follow-up chest X-rays were taken two hours post-procedure to verify the correct position of the catheter and to rule out complications such as pneumothorax, hemothorax, cardiac tamponade, and incorrect line placement.


Eligibility Criteria:
Inclusion Criteria:

* age above 18 years old
* scheduled for elective central venous catheter in the axillary vein

Exclusion Criteria:

* medical contraindication for axillary vein cannulation (coagulation abnormalities, local skin infection or chest wall deformation)
* patient consent decline
Clipped Versus Handsewn Arteriovenous Fistula Anastomosis

The purpose of this study is to determine whether handsewn anastomosis versus clipped technique is associated with more complications, fistula failures, surgical cost and surgical time.

End stage renal disease requiring hemodialysis has become more prevalent in recent years. Achieving vascular access is an important step in receiving hemodialysis. Recent national goals have established that approximately 65% of all dialysis access points should be arteriovenous fistulas due to higher patency rates and decreased rates of further surgeries. Multiple studies have been done to assess optimal suture technique for arteriovenous anastomoses. The use of clips versus a handsewn technique has been evaluated in retrospective studies with some reports indicating a higher primary patency rate with a clip technique. Further study is needed to definitively determine the technique that results in the highest patency rates and lowest rate of re-operation. The purpose of this study is to determine whether hand-sewn anastomosis versus a clipped technique is associated with more complications, failures, surgical cost and surgical time by randomizing patients to either a clipped anastomosis group or a handsewn anastomosis group.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Need for AVF creation for vascular access for planned hemodialysis (within 1 year).
* The planned AVF site must be naïve of prior AVF creations.
* Vein mapping studies completed
* 2.5 - 3mm minimum vein diameter on mapping

Exclusion Criteria:

* Less than 18 years of age.
* Inability to provide consent.
* Previous failed AVFs in both arms.
* Contraindications to AVF creation:

  * ipsilateral proximal venous and arterial occlusion or stenosis
  * systemic or local infection
  * too ill to operate
* Anticipated inability to keep 30-day postoperative follow-up appointment.
Low Back Pain and Osteopathy in Italian Young People

This is a behavioral observational study aimed at evaluating the presence of low back pain in young people and the intention to undertake osteopathic treatments. It consists of a short self-administered questionnaire which will be given to adolescents with gnathological/orthodontics disorders to complete. Relationships between low back pain of young individuals' answers with the intention to undertake osteopathic treatments will be evaluated.

This is a behavioral observational study aimed at evaluating the presence of low back pain in young people and the intention to undertake osteopathic treatments.

Literature found out that low back pain is a common occurrence in young people. Adolescents develop frequently gnathological/orthodontics disorders. In Italy, young individuals with low back pain and gnathological/orthodontics disorders are frequently referred to osteopaths.

In Literature there are not studies which correlate low back pain, osteopathic cures and gnathological/orthodontics disorders as for young persons.

The study consists of a short self-administered questionnaire which will be given to young people to complete. In more details, the survey is made of 8 questions collecting information on presence/intensity of low back pain, intention to have osteopathic treatments, and (in that case) the satisfaction after the cures. Further, participants will have to complete a self-administered pain intensity numerical rating scale.

Descriptive statistics will be presented by taking into account the socio-demographic characteristics of the sample being investigated. Statistical correlations between adolescents' answers and the pain intensity numerical rating scale will be also evaluated.

This study investigates the relationships among low back pain, gnathological/orthodontics disorders, and osteopathic cures.

Eligibility Criteria:
Inclusion Criteria:

* common low back pain
* ability to read and understand the Italian language

Exclusion Criteria:

* any diagnosable cause of low back pain
* previous spinal surgery
* cognitive impairment
* refusal to adhere
TCA Cycle in the Dentate in Friedreich's Ataxia

OBJECTIVE: To measure the tricarboxylic acid (TCA) cycle rate in the dentate nucleus in a group of control subjects and subjects with Friedreich's Ataxia (FRDA).

HYPOTHESIS: The TCA cycle rate will be lower in FRDA subjects than in controls APPROACH: The investigators will infuse carbon-13 (13C) labeled glucose and measure the rate of 13C label incorporation from glucose to glutamate in the brain using in vivo magnetic resonance spectroscopy.

The investigators will measure the TCA cycle rate in the dentate nucleus in a group of FRDA patients and in a group of age-matched healthy controls using 13C MRS in vivo together with systemic i.v. infusion of 13C-labeled glucose.

The investigators aim to obtain adequate data in 16 subjects grouped as follows:

* n=4 pilot subjects (healthy subjects) for testing and optimization of the experimental setup.
* n=6 healthy controls
* n=6 FRDA patients

In other to reach this goal, the investigators plan to recruit up to 20 subjects, in case some subjects withdraw before completion of the MR scan, or in case the measured data are not adequate (e.g. technical problem with the scanner).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* able to consent for themselves
* considered healthy (controls) OR be diagnosed with FRDA.

Exclusion Criteria:

* All subjects:
* Participants who cannot have an MRI, as determined by the CMRR safety screening form (e.g. metal implant)
* Pregnancy
* Clautrophobia
* Diabetes
* Clinically significant cardiac disease

Control subjects:

- Neurological disease
A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension

This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ocular hypertension or glaucoma
* Requires intraocular pressure (IOP)-lowering therapy

Exclusion Criteria:

* Cataract surgery in one eye
* Ocular laser or intraocular surgery within 6 months
* Refractive surgery in either eye
* Anticipated use of contact lenses during the study
* Expected use of artificial tears during the study
Zinc for the Treatment of Herpes Simplex Labialis (HSL)

Evaluate the effectiveness of a topical preparation of zinc to treat cold sores.

Zinc salts irreversibly inhibit herpes virus replication in vitro and are effective in treating herpes infections in vivo and have been shown in a clinical trial to be a effective topical treatment for HSL. Zinc salt solutions applied to herpetic lesions decrease viral load and markedly improve healing rates, relieving the symptoms of herpes as healing occurs. Zinc swabs contain 33 mmol/l of ionic Zinc in an emulsification of Benzalkonium chloride, glycerin, hydroxyethylcellulose, sodium chloride, and sodium hydroxide (ph 7.2). Zinc gluconate is monographed in the Homeopathic Pharmacopoeia of the United States (HPUS) and one of OTC indications for Zinc and its salts is for the treatment of cold sores.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a history of HSL with at least 2 episodes/year for the past two years that have proceeded beyond the prodromal (initial) stage
* Male or female subjects between 18 and 65 years of age
* Symptoms or signs of HSL for less than one day (max. 36 hours from onset of symptoms to first visit)
* Confirmation of HSL by a clinician at the study site
* Willing to comply with study instructions and sign an informed consent

Exclusion Criteria:

* HSL symptoms or signs for more than one day
* Cold sore outbreak within the past 2 weeks
* Previous participation in this clinical trial
* Topical or oral antiviral drug use in the past 1 week
* Immune deficiency (HIV positive), chronic steroid therapy, present anti-neoplastic or radiation therapy, Hodgkin's disease, splenectomy, leukemia, myeloma, lymphoma, or another condition/drug per judgment of attending health care professional) or currently taking immune suppressive drugs. Previous organ or bone marrow transplant.
* Pregnancy or lactation
* Unable to travel to the clinic area for the required visits
* Apparent inability to understand or follow the instructions associated with the clinical study
* History of adverse events to the study material or facial cosmetics
Postpartum Depression Prevention Trial

The primary objective of this study is to evaluate the effect of peer (mother-to-mother) support on the prevention of postpartum depression among mothers identified as high-risk.

Many new mothers from diverse cultures experience postpartum depression (PPD), a serious form of maternal morbidity with well documented health consequences for the mother, child, and family. While the cause of PPD remains unclear, research consistently demonstrates the importance of psychosocial variables. The purpose of this randomized controlled trial is to evaluate the effect of peer (mother-to-mother) support on the prevention of PPD among mothers identified as high-risk. Public health nurses using the Edinburgh Postnatal Depression Scale (EPDS) screened mothers who were less than 2 weeks postpartum in the regions of Toronto, Peel, Halton, York, Windsor, Sudbury, and Ottawa. Eligible and consenting mothers were randomized to either a control group (usual postpartum care) or experimental group (usual postpartum care plus telephone-based support from an experienced mother who has participated in a 4-hour training session). Diverse study outcomes, including depressive symptomatology and health service utilization, were assessed at 12 and 24 weeks postpartum. The results from this trial will make substantive contributions in six areas: (1) develop the body of knowledge concerning the effectiveness of peer support in the prevention of PPD among at-risk mothers; (2) advance our understanding of the advantages and disadvantages of using peer volunteers as a complementary form of health care; (3) provide an economic evaluation of a peer support intervention; (4) offer a detailed analysis of peer support interactions including supportive functions provided, types of relationships developed, and health benefits perceived; (5) investigate the utility of screening at-risk mothers using the EPDS in general public health nursing practice; and (6) present valuable information regarding PPD among a multicultural Canadian population.

Eligibility Criteria:
Inclusion Criteria:

* live birth
* discharged from hospital
* \<2 weeks postpartum
* scored \>9 on the EPDS
* availability of a peer volunteer who speaks the potential participant's language

Exclusion Criteria:

* infant not discharged home with mother
* current use of anti-depressant or anti-psychotic medication
* prior self-reported mental illness, including prior PPD, will NOT be an exclusion criterion
A Study of Allogeneic Mesenchymal Bone Marrow Cells in Subjects With Ischemic Stroke

The purpose of this study is to assess the safety and tolerability of allogeneic adult mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke.

Stroke remains a major global healthcare problem. Recent data compiled by the American Heart Association (AHA) for 2008 show that the annual incidence of new or recurrent stroke in the United States is about 780,000, with approximately 600,000 of these strokes being first attacks. Among adults age 20 and older, the estimated prevalence of stroke in 2005 was 5.8 million in the United States, resulting in \>150,000 deaths annually, with 4.8 million stroke survivors alive today. Stroke ranks as the country's third leading cause of death, behind only cancer and heart disease. The only approved treatments of acute ischemic stroke involve restoring blood flow to the affected region by using thrombolytics or mechanical devices that physically remove clots. However, the use of thrombolytics is limited due to the therapeutic window of \< 3-6 hours post onset of stroke symptoms such that only a small fraction of stroke patients receive this therapy. Following the completion of a stroke, there is little therapy to offer patients to promote recovery other than physical, occupational, and speech therapy.

Allogeneic mesenchymal stem cells have been used in a number of clinical trials for different indications demonstrated the safety of allogeneic mesenchymal stem cell treatment. In addition to their ability to differentiate into multiple different cell types that would be contributory to the recovery and repair of the brain by replacing destroyed cells, mesenchymal stem cells also secrete angiogenins, cytokines and trophic factors that can support and stimulate multiple other cell types. The cascade of cellular events following the release of these cytokines and trophic factors would also potentially lead to beneficial effects by restoring blood supply, by rescuing cells at risk, and by stimulating the remaining cell populations to repair and propagate new cells and synaptic connections.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ischemic stroke for longer than 6 months
* Brain CT/MRI scan at initial diagnosis and at enrollment consistent with ischemic stroke
* No substantial improvement in neurologic or functional deficits for the 2 months prior to enrollment
* NIHSS score between 6-20
* Life expectancy greater than 12 months
* Prior to treatment patient received standard medical care for the secondary prevention of ischemic stroke
* Adequate organ function as defined by the following criteria:

Exclusion Criteria:

* History of uncontrolled seizure disorder
* History of cancer within the past 5 years.
* History of cerebral neoplasm
* Positive for hepatitis B, C or HIV
* Myocardial infarction withing six months of study entry
* Findings on baseline CT suggestive of subarachnoid or intracerebral hemorrhage within past 12 months.
* Allergies to Bovine or Porcine products
Memantine in Bipolar Patients With Alcoholism

Since memantine may not only inhibit overactivity of microglial cell, but also repair the damaged neurons and neurogenesis through activation of astroglial cell and release of neurotrophic factors, the investigators propose that the neurotrophic effect of memantine may benefit neurodegenerative diseases including bipolar disorders (BP) and alcohol dependence. In the current study, the investigator will investigate whether add-on memantine at a dose of 5 mg/day has a beneficial effect on BP comorbid with alcohol dependence.

Each individual enter into this project will receive regulate treatment adding-on memantine medication. During each visit, patients will receive evaluation for their symptoms and plasma Brain-Derived Neurotropic Factor (BDNF), cytokines (e.g.., Interleukin-6(IL-6), IL-8) and neuropsychological performance.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient aged ≧18 and ≦65 years.
2. Signed informed consent by patient or legal representative.
3. The Chinese version of the modified Structural Interview of Affective Disorder and Schizophrenia-L(SADS-L), a semi-structured interview aimed at formulating the main bipolar II diagnoses based upon DSM-IV-TR criteria
4. A 2-day minimum for hypomania to diagnose BP.
5. Patient or a reliable caregiver was expected to ensure acceptable compliance and visit attendance for the duration of the study.

Exclusion Criteria:

1. Females who are pregnant or nursing.
2. Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for duration of study.
3. Patient has received memantine, other anti-inflammatory medication within 1 week prior to first dose of double-blind medication, such as cyclo-oxygenase 2 (Cox-2) inhibitors.
4. Clinically significant medical condition e.g., cardiac, hepatic and renal disease with current evidence of poor controlled.
5. Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to the first dose of double-blind medication.
6. Increase in total SGOT, SGPT, BUN and creatinine by more than 3X upper limit of normal.