cyrilzakka/clinical-trials huggingface dataset:
Mindfulness-Based Meditation to Treat Stress in Unemployed Community Adults

The purpose of this study is to determine the effects of a three-day mindfulness meditation retreat (vs. a three-day relaxation retreat) in stressed, unemployed, community adults on brain function, brain structure, and overall health and immunity.

Chronic stress has been shown to be a significant risk factor for increased morbidity and mortality. Eight-week Mindfulness-Based Meditation programs (MBSR) have been shown to improve participants' health and well-being, including reducing inflammation and slowing the progression of chronic diseases such as HIV. The purpose of this study is to evaluate the potential benefits of a three-day mindfulness-based meditation retreat program (vs. an active rest and relaxation retreat control condition) on a highly stressed, unemployed, community adult population.

Participants are recruited from the Pittsburgh area and are randomly assigned to either the mindfulness-based retreat program or the rest and relaxation retreat program. All participants complete a psychosocial survey, blood work, and a baseline fMRI before completing the intervention. Participants complete a second fMRI immediately following the intervention and then additional blood work and psychosocial surveys at a four month follow-up timepoint. At each fMRI appointment, participants will complete neuroimaging tasks (where they will be presented with words, picture, and sounds) that will assess neuroreactivity, regulation responses, and brain volume before and after mindfulness meditation training.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking adults between the ages of 24 and 52 years at time of entry
* non-pregnant women only
* currently unemployed
* high levels of self-reported stress
* geographically accessible and willing to travel to and attend all study sessions

Exclusion Criteria:

* not able to attend scheduled three-day retreat
* have regularly (\>1 time per week) practiced a mind-body therapy anytime in the last six months (e.g., meditation, yoga, tai chi)
* indicate any major physical health problems in the last six months
* have more than 15 alcoholic drinks in the average week
* have been diagnosed with a chronic disease (e.g. HIV, diabetes, arthritis)
* use medications affecting cardiovascular or endocrine function
* are left-handed
* have metal in their bodies (including pacemakers and permanent piercings (e.g., bellyrings, but not dental fillings))
* indicate regular use of psychotropic medication or psychotherapy in the last six months
* cognitive impairment as indicated by a score lower than 23 on the Mini-Mental State examination
* demonstrate low levels of stress due to unemployment
* smokers
* indicate use of recreational drugs in the past month
* indicate feeling claustrophobic in confined spaces, such as an fMRI scanner
* weigh over 350 lbs
* have any neurological disorders
* indicate any use of doctor prescribed cholesterol lowering medications (e.g., statins)
* currently employed
* not currently looking for a job
An Attention-Restorative Therapy (ART)-Based Virtual Reality Intervention to Address Cancer-Related Cognitive Impairments Among Breast Cancer Survivors

This study is to assess the feasibility of using a Virtual Reality (VR) headset to provide nature-based Attention-Restorative Therapy (ART) as treatment for cognitive impairment in post-treatment cancer survivors. At ART's foundation is the belief that exposure to nature can improve attention by fully engaging a person in a safe and relaxing experience. This intervention uses a VR headset to expose the participant to nature while overcoming some potential barriers of nature-based interventions like access, physical ability, and bad weather. The goal of this study is to understand if people are willing to use the VR headsets to experience nature virtually, if they find it helpful with cancer-related cognitive impairments (CRCI) symptoms and if they are satisfied with using it. Participants will be asked to use self-management materials (weekly home practice logs, Oculus Go™ and online questionnaires) for 6 weeks. Investigators hope to use information from this small feasibility study to study the effectiveness of the intervention in a larger group of cancer survivors and ultimately to help cancer survivors struggling with cognitive impairments.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age ≥18
* Stage I-III breast cancer
* Reports a negative change in cognitive function since their cancer diagnosis and rate their cognitive fatigue using a single item questions as a ≥4 on a numeric rating scale of 0-10 for 1 month or more.
* Completed primary treatment (chemotherapy, radiation and/or surgery) ≥ 3 months but no more than 10 years prior to registration.
* May use concurrent adjuvant endocrine therapy and/or HER2-targeted therapy while on study.
* Ability to provide informed written consent.
* Ability to read and write English.
* Ability to be independent in decision making. Must respond No to "Do you have a guardian or blanket power of attorney for legal transactions?"

Exclusion Criteria:

* Other therapies intended to treat CRCI (allowed if person has been on them for 30 days prior to registration, and dose or treatment is not expected to change, and CRCI remains sufficiently uncontrolled per criteria of 4 or more on a 0 to 10 scale).
* Antidepressants (allowed if person has been on them for 30 days prior to registration, and dose or treatment is not expected to change, and CRCI remains sufficiently uncontrolled per inclusion criteria).
* Chronic oral or intravenous systemic steroid use (defined as being used on a regular basis or who have a problem that has required ongoing use of steroids in the last 180 days for greater than 7 days).
* Psychiatric disorder such as severe depression, bipolar disorder, obsessive compulsive disorder or schizophrenia. (Defined per medical history and/or patient self-report.)
* Pain requiring opioid pain medication.
* Electronic implanted medical device (e.g. pacemaker).
* History of motion sickness within 5 years prior to enrollment will require a tolerability test at baseline.
Comparative Evaluation of Continuous and Pulse Mode of Ultrasound Therapy in Myalgia of Maxillofacial Region

Pain and trismus caused by Myalgia in masticatory muscles are one of the prime concerns for the patients. Various studies have been performed using US therapy for myofascial pain syndrome of head \& neck region. US is a non-invasive frequently used physical agent which increase blood flow in tissues and collagen fibers ability to grow, \& reduce muscle spasm with its thermal effect. It is difficult to imply the results of studies performed in muscles of other regions of body to the maxillofacial region because of the superficial placement of these muscles.US is being frequently used for myofascial pain, but there is an absence of a consensus regarding the frequency and mode of administration available in literature for administration of this therapy in maxillofacial region. Therefore, the present study has been designed to compare the therapeutic effect of two modes of US i.e., continuous and pulsed at 3 MHz frequency

Pain and trismus caused by Myalgia in masticatory muscles are one of the prime concerns for the patients. There are limited number of studies in the literature that have evaluated therapeutic ultrasound for the management of Myalgia of maxillofacial region. Various studies have been performed, evaluating the treatment of myofascial pain with trigger point in other parts of body including neck region using ultrasound, but not all patient of myalgia present with trigger point. The most frequently used ultrasound frequencies are 1 and 3MHz. 1 MHz has more penetrating power as compared to 3MHz. Masticatory muscles being superficial in location need less penetrating waves as compared to other muscles. The ultrasound can be applied in a continuous or pulsed manner. There are studies supporting the fact that Continuous ultrasound therapy is more efficient in reducing myofascial pain syndrome of trapezius muscle at rest because it produces a heating effect in the muscles, that help in breaking the spasm. On the other hand, the pulsed mode, produces more of penetrating effect and acts on the gas bubbles of the soft tissues, thereby decreasing the inflammation. However, the two methods have not yet been compared in maxillofacial muscles. Therefore, this study aims to compare the outcome of therapeutic Ultrasound administered at 3MHz frequency in continuous \& pulse modes in myalgia of maxillofacial region

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with myalgia within orofacial muscle as per DC/TMD (Ia and Ib)
2. Patient's consent for participation in this study.

Exclusion Criteria:

1. Patients with epilepsy/seizures
2. Patients with radiographic changes suggestive of pathological conditions of temporomandibular joint (TMJ).
3. Patients with undiagnosed orofacial pain
4. Any sort of skin lesion at the site where electrode is to be placed.
5. Therapeutic ultrasound must not be applied over areas of impaired circulation, ischemic areas, or areas having sensory deficit.
6. Sites of active infection
7. Patients with metal prosthesis
8. Patients with Becks depression score \>25 will be excluded.
Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform

BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.

This platform is purely exploratory, without hierarchical order of the objectives and associated outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Provision of a signed, written and dated informed consent or non-opposition (where applicable)

Exclusion Criteria

* Device(s) used in multiple procedures (two, or more, pathologies treated during the same procedure)
* Contra-indications of each device as described in the instructions for use.
Diffuse Large B Cell Lymphoma of the Adult: Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14-Rituximab

The aim of the protocol is to compare the outcome of patients with DLBCL stage II bulky, III or IV with 1 to 3 adverse prognostic factors according to the International prognostic index. Patients with eligibility criteria and who gave informed consent will be randomised between CHOP-14- Rituximab x 8 courses and High dose chemotherapy with rituximab including autologous stem cell support. The aim of the study is to compare the Event free survival between the two arms and to gain insight into the prognostic significance of several biological markers gathered at the time of diagnosis/randomisation ( i.e. Fcgamma R III A genotyping, DNA profile and BCL é expression).

Diffuse Large B Cell Lymphoma not previously treated

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 et ≤ 60 and male and female
* Diffuse large B cell lymphoma according to WHO classification phénotype B CD 20 +
* Stage I et II tumor bulk \> 7 cm and stage III et IV Ann Arbor.
* Non previously treated
* HIV négative
* Signed informed consent

Exclusion Criteria:

* Age \< 18 and/or \> 60 ans
* NHL not DLBCL
* Lymphoblastic Lymphoma
* Burkitt's Lymphoma
* Low grade Lymphoma transformed
* Primary CNS Lymphomal
* Post- transplantation Lymphoma
* CD20 negative
* Ann Arbor stage I or II without tumor bulk \> 7 cm
* Previous treatment
* HIV positive
* Contre-indication to Rituximab use according to SmPC
* Contre-indication to high dose chemotherapy due to organ failure not related to the lymphoma
* Cancer or history of cancer with the exception of in situ cancer of the cervix or non-invasive skin epithelioma
* Patient not able to understand the proposed treatments
* Refusal to sign the informed consent
Team-based Technology-enabled Integrated Patient/Caregiver-focused Dementia Study

Dementia patients experience memory and other cognitive function deterioration leading to loss of independent function. Care required for dementia is multifactorial, spanning cognitive, behavioral, emotional, and physical symptoms, and complicates aspects of daily living. This places tremendous strain on caregivers who, in turn, experience their own increased physical and mental health needs. The current care model focuses primarily on patient pharmacological management but misses the mark on caregiver focus and collaboration. Building on systematic reviews and existing evidence gaps in information and support for patient/caregiver dyads, dealing with behavioral symptoms, referrals to available community resources, and multidisciplinary team care with improved coordination and communication17, the study investigators propose a patient- and caregiver-targeted Integrated Dementia Practice Unit (IDPU) model of care. IDPU integrates disconnected care under a centralized specialty team, providing monitoring, education, individualized support, and proactive, ongoing collaboration and coaching using technology and home/virtual visits for maximal impact. Days alive at home (DAAH) best captures quality of life (QOL) for the index dementia patient, from the perspective of both the healthcare system and the caregiver, and degree of support for the caregiver and is often an outcome in assessing health delivery. The study investigators hypothesize IDPU will increase DAAH and improve patient-level (behavioral; depressive symptoms; chronic disease management) and caregiver-level (strain, depressive symptoms, social support) outcomes relative to an Educational+ model, merging a standard care design with additional education support for patients/caregivers and their Primary Care Providers (PCP). This study seeks to (a) improve and establish IDPU feasibility of the in the feasibility phase, (b) determine if IDPU is more effective than Education+ in increasing DAAH and patient- and caregiver-level outcomes, and (c) determine if benefits of IDPU are more or less pronounced in vulnerable subgroups in the full-scale study.


Eligibility Criteria:
Inclusion Criteria include:

* Alzheimer's Disease or Vascular Dementia diagnosis provided by a study investigator
* 2 or 3 on the Clinical Dementia Rating Scale at time of enrollment
* Mini Mental Status Examination score of \>10 or \<25 administered at the time of enrollment
* Willingness and ability to provide patient or surrogate consent, and since caregiver cooperation will be an integral part of this study, an ability to provide caregiver consent to participate

Exclusion criteria include:

* Individuals with Mild Cognitive Impairment
* Institutionalized individuals (extended care facility, nursing home, group home, or similar institutional setting)
* Individuals who in the opinion of the investigator cannot be enrolled or followed due to geographic or other constraints
Trial of Transcranial Direct Current Stimulation (tDCS) for Depression

Among antidepressant treatments, ECT stands as the most effective in treating acute depression. However, patient concerns with the cognitive side effects of ECT have encouraged the development of new and more focal forms of brain stimulation such as transcranial Direct Current Stimulation (tDCS). However, not all patients may respond to this treatment in the way that it is currently administered and this has raised interest in finding alternative, possibly more optimal ways of administering tDCS. This study will investigate whether tDCS stimulation using an alternative electrode montage has antidepressant effects.


Eligibility Criteria:
Inclusion Criteria:

1. Subject meets criteria for a DSM-IV Major Depressive Episode.
2. Total MADRS score ≥20.
3. Subject has not responded to tDCS given with a standard montage OR subject is unable to receive tDCS with standard montage - for example, due to skin rash etc at site of electrode placement for standard montage.

Exclusion Criteria:

1. Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.
2. History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
3. Inadequate response to ECT in the current episode of depression.
4. Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
5. Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
6. Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.
7. Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
8. Female subject who is pregnant.
9. Participants who are not fluent in English will not be included in the trial for safety reasons: a) It is usually not possible to have an interpreter reliably available every weekday for up to 4 weeks and it is not safe to give tDCS to a subject who cannot tell us immediately of any side effects; b) As this is a novel treatment, the study involves detailed neuropsychological testing for safety reasons. This testing cannot be effectively or validly completed by someone who is not fluent in English. Note that translation of the proposed tests into English has not been validated and that we cannot be confident that neuropsychological impairment would be detected using this method.
Evaluation of Peripheral Itch Mechanisms Following Injection of Morphine

The aim of this study is to the effect of opioid (morphine) intradermal application on histaminergic and non-histaminergic itch. In particular, we would like to demonstrate that also peripheral administration of morphine may affect mast cell release of histamine.

Opioids (i.e. substances extracted from opium poppies, e.g. morphine) are used for treatment of both acute and chronic pain conditions as well as in surgical procedures. Opioids render effective pain relief, however, they may cause bothersome itch as a side effect. With this series of experiments, we wish to clarify how an injection with morphine in the skin layer called dermis (located right below the upper skin) will affect itch.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Participants with any clinically significant abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other addictive drugs
* Lack of ability to cooperate
* Current use of medications that may affect the trial such as antihistamines, antipsychotics and pain killers as well as systemic or topical steroids.
* Participants with known allergy/discomfort to the opioid morphine and antihistamine.
* Skin diseases
* Moles, scars or tattoos in the area to be treated or tested.
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
Prophylaxis Vaccine Antibodies Ebola

* Three measures are currently being implemented to control Ebola outbreaks:

  * Monitoring of contacts
  * Isolation and treatment of sick people
  * Vaccination of the population in high-risk areas.
* In contacts with high viral exposure and therefore a high risk of incubation and rapid expression of infection, the r-VSV-ZEBOV vaccine does not provide adequate protection because vaccine antibody production is effective 6 to 10 days after administration.
* Specific monoclonal antibodies (Mab) from the Regeneron and mAb114 research specialties have been shown to be effective in reducing mortality in patients with Ebola virus disease (EVD).
* Their use in a single parenteral administration and good tolerability make them candidates for use in post-exposure prophylaxis (PEP) in individuals at high risk of viral exposure.
* A comprehensive strategy for the protection of high-risk contacts must therefore be implemented, including the vaccine and the Mabs, to ensure both immediate and prolonged protection. Indeed, the efficacy of the vaccine is likely to be diminished when co-administered with Mabs, as both strategies share the same viral target (the GP envelope glycoprotein) and the vaccine is replicative (and therefore may be inhibited by Mabs).

PROVAE aim to evaluate the effectiveness of a comprehensive strategy to prevent transmission of MVE in contacts at high risk of infection, including (i) post-exposure prophylaxis with Mabs and (ii) vaccination with r-VSV-ZEBOV.


Eligibility Criteria:
The inclusion criteria for the efficacy trial are:

* Have had, within the previous 72 hours, a high-risk contact with an Ebola patient confirmed by RT-PCR;
* Be 18 years of age or older at the time of inclusion;
* Have no symptoms of EVD;
* Give consent to participate in the efficacy trial;
* Agree not to participate in any other therapeutic or vaccine study until the end of the trial follow-up.

The criteria for non-inclusion in the efficacy trial are:

* Have a history of EVD (self-report);
* Have been vaccinated with ERVEBO prior to the start of the study;
* Have participated in another therapeutic or vaccine study within 15 days prior to inclusion.

Inclusion criteria for the immunology ancillary study are:

High Risk Arm:

* Be included in the efficacy trial;
* Be available for extended follow-up as specified in the protocol;
* Specifically consent to the immunology ancillary study.

Control arm:

* Be 18 years of age or older at the time of inclusion;
* Have no symptoms of EVD;
* Eligible for ERVEBO vaccination according to national program criteria;
* Be available for extended follow-up as specified in the protocol;
* Consent specifically for the ancillary immunology study.

The criteria for non-inclusion in the immunologic ancillary study are:

* All efficacy trial non-inclusion criteria;
* HIV positive;
* Pregnant women.