cyrilzakka/clinical-trials huggingface dataset:
Facet Versus Trigger Point Injections for Chronic Neck Pain

A) Background Chronic neck pain is a significant and common issue which is difficult to treat. Tight bands of muscle (trigger points) can be a source of chronic neck pain and they are sometimes injected to manage chronic neck pain. However, these injections seldom lead to significant, long-lasting relief. In some cases, these trigger points may originate from injury or damage to a specific joint in the neck (the facet joint). Treatment of this joint with cortisone injection may lead to improved pain relief and function.

B) Hypothesis By injecting the facet joint with cortisone, the pain associated with tight bands of muscle in the neck and shoulders will be relieved to a greater extent than that attained through trigger point injection.

C) Methods Patients with neck pain will have a test to determine if any pain originates from the facet joint. Among those who have significant pain from these joints, a comparison between the effect of cortisone injection into these joints versus injection into the trigger points will be evaluated.

D) Expected Results and Significance

It is expected that injection with cortisone into the facet joints will lead to improved pain and function when compared to that attained from trigger point injection. In addition, the number of trigger points, and the pain and headache that originate from these trigger points, are expected to decrease with cortisone injection into the facets to a statistically and clinically significant extent. Results from this pilot study will then influence the design of future trials into chronic neck pain treatment, leading to better clinical recommendations. A peer-reviewed publication and conference presentations will facilitate dissemination.


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 65 years of age and able to speak and understand conversational English
* Primary diagnosis of chronic (\>6 months) mechanical / myofascial neck pain

Exclusion Criteria:

* Those with significant cognitive decline or cognitive interference (as identified by the physician) will be excluded, as will those who have received radiofrequency ablation of any cervical nerve within the past year, intra-articular cortisone facet injection within the past 4 months, trigger point injection into the cervical/shoulder girdle muscles within the past 4 months, or the presence of any known contraindication to injection (Attachments).
* Women who are or may be pregnant (based on last menstruation) will be excluded.
* Finally, for the purposes of this pilot study, those currently involved in active litigation regarding the neck pain will be excluded. Those with active worker's compensation claims or currently receiving salary indemnity benefits through motor vehicle insurance providers will be included, as they represent a significant proportion of this population.
Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions

The purpose of this study is to evaluate a mindfulness-based meditation app provided to outpatients (or community participants) who are waitlisted for standard psychological care for mental health or substance use concerns.

This project aims to provide a previously validated mindfulness meditation app to up to 200 adults waitlisted for psychological services in a psychiatric hospital setting or in the broader community. Outpatients (or community participants) who have been referred to and waitlisted for treatment for their mood, anxiety, alcohol, and/or substance use concerns, will be offered access to the digital intervention for 1 year. We will follow participants for 3 months to evaluate usability and psychological symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years of age
2. Fluency in English
3. Understanding and willingness to comply with study requirements
4. Waitlisted for outpatient psychosocial programming at CAMH (or psychosocial programming in the community)
5. Smartphone or tablet capable of downloading and running the mindfulness app.

Exclusion Criteria:

1. Any known practical factor that would preclude participation (e.g., extended absences)
2. Acute psychiatric (e.g., acute suicidality, psychosis) or serious medical condition that precludes participation in this study.
3. Participation in another treatment/intervention study
The Evaluation of the Summer EBT for Children Demonstration

The Summer Electronic Benefit for Children (SEBTC) demonstration provided food assistance to households with school-aged children during the summer through electronic benefit transfer (EBT) procedures used by the Supplemental Nutrition Assistance Program (SNAP) and Special Supplemental Nutrition Program for Women, Infants and Children (WIC) programs. The evaluation design included two components: an impact study and an implementation study. The evaluation assessed the impact of SEBTC on children's food security and nutritional status, household food expenditures and purchasing behaviors, parental perceptions, and participation in nutrition assistance programs. The implementation study analyzed SEBTC use patterns using administrative data, and described demonstration implementation and costs.

The SEBTC evaluation took place in the summers of 2011 through 2014. Ten grantees implemented the demonstration in a total of 16 sites; the number of participating sites and/or the evaluation components differed by year. In 2011, 5 grantees with five sites participated and the evaluation included implementation and cost analysis, EBT analysis, and an impact study. In 2012, 10 grantees implemented SEBTC in 14 sites and the evaluation included the same study components. In 2013, four grantees with six sites participated and the study components included EBT analysis and an impact study (no implementation or cost data collection). Finally, in 2014, three grantees participated in three sites and only implementation data were collected. Information on human subjects was collected for the evaluation's impact evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Households with children who were certified to receive the National School Lunch program or the School Breakfast Program in the prior school year in participating sites, Summers 2011-2013
The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery

Hand edema following hand surgery is a common yet devastating side effect that can lead to early stiffness, prolonged rehabilitation and diminished function. These factors can reduce a patient's quality of life; mounting to an overall delay in recovery, return to work and daily activities. Conventional edema therapy includes cryotherapy, external compression, active and passive exercises and various types of massage. However, there is little evidence to suggest these modalities are effective. Tranexamic acid (TXA) is an antifibrinolytic that has been used in surgical disciplines for decades to aid in reducing intraoperative blood loss and consequent transfusions. Recently, the use of TXA for curbing post-operative edema and ecchymosis has shown promising results, however, its use in hand surgery has not been studied.


Eligibility Criteria:
Inclusion Criteria:

* All patients \>18 years old undergoing distal radius fracture open reduction and internal fixation through a volar approach at St. Joseph's hospital in London, Ontario
* All patients \>18 years old undergoing open fasciectomy for Dupuytren's disease at St. Joseph's hospital in London, Ontario

Exclusion Criteria:

* Revision surgery
* Distal radius fractures treated with additive or alternative approaches and fixation to the volar approach
* Known history of lymphedema or lymph node dissection on either upper extremity
* Known allergic reaction to TXA
* Cardiovascular problems (history of myocardial infraction, angina, and atrial fibrillation)
* Cerebrovascular conditions (history of previous stroke)
* Thromboembolic disorders (history of deep vein thrombosis \[DVT\] or pulmonary embolism \[PE\]), clotting disorders)
* Known seizure disorder
* Currently on dialysis
* Current pregnancy or breastfeeding
* Current use of hormone contraception
* Unable to read consent and patient surveys related to the study in English
WALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment Examination

The purpose of this study is to evaluate the safety, tolerability, and effects of investigational drug AL-39324 for the treatment of wet AMD.

Following a single administration, patients will be followed for 6 months postinjection.

Eligibility Criteria:
Inclusion Criteria:

* Willing to give written informed consent, make the required study visits and follow instructions;
* The study eye:

  * must have a primary diagnosis of choroidal neovascularization (CNV) secondary to AMD;
  * lesion must be no larger than 30 mm2;
  * must have edema measuring greater than 340 μm;
  * must have a visual score between 73 and 34 letters, inclusive;
  * must be able to have clear picture taken of the back of the eye;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* The study eye must not have been treated for exudative AMD previously;
* The study eye must not have any other ocular disease, condition, infection, or recent surgery that would interfere with vision or examination of the back of the eye;
* The study eye must not have uncontrolled glaucoma;
* The study eye must not be missing a lens;
* Must not be taking any medication that is toxic to the lens;
* Must not be taking oral or ocular corticosteroids;
* Must not have an unstable or progressive condition that would interfere with study visits;
* Must not have allergies to any component of the test article or sensitivity to fluorescein dye;
* If female, must not be pregnant or nursing and must agree to adequate birth control;
* Must not be participating in another drug or device study within 30 days of screening for this study;
* Other protocol-defined exclusion criteria may apply.
Apathy in Schizophrenia

Apathy, defined as a quantitative reduction of voluntary, goal-directed behaviours (GDB), is a core component of negative symptoms. It has been suggested that the physiopathology of apathy is not a single entity but may be multiple, depending on which specific process or macrofunction is disrupted during completion of GDB. In line with this notion, Levy and Dubois proposed dividing apathic syndromes into three subtypes of disrupted processing: 'a-motivation', 'cognitive inertia', and 'uncoupling'. In schizophrenia, apathy has been associated with executive dysfunction, functional impairment and poor outcome. However, the neurobiological underpinnings of apathy in schizophrenia are poorly understood.

Primary objective: confirm that chronic schizophrenic patients are apathic compared to healthy volunteers

Secondary objectives:

* investigate if apathy is related to a particular aspect of the disease (i.e. negative, positive symptomatology and/or deficit form)
* investigate if apathy correlates with executive dysfunction
* investigate if apathy is associated with a specific mechanism using an experimental task specially designed to investigate the different mechanism (i.e. 'a-motivation', 'cognitive inertia', and 'uncoupling')
* investigate if there is a volumetric abnormality affecting the executive system in apathic schizophrenic patients
* link these eventual volumetric abnormalities to prefrontal cortex-basal ganglia circuits according to a specific subtype of apathy in the apathic schizophrenic group


Eligibility Criteria:
Inclusion Criteria (healthy volunteers):

* Male or Female aged 20 to 55 years old included
* Under French public assurance system

Exclusion Criteria (healthy volunteers):

* Personal history of neurological disorders
* Personal history of head injury
* Alcohol or substance abuse
* Under psychotropic drug
* Contraindication for MRI

Inclusion Criteria (schizophrenic patients):

* Male or Female aged 20 to 55 years old included
* Under French public assurance system
* diagnosis of schizophrenia according to the DSM-IV R criteria
* Duration of illness \> 5 years
* clinical stability during the past 2 months (defined as no treatment modification or hospitalisation 2 months prior evaluation)

Exclusion Criteria (schizophrenic patients):

* Schizo-affective disorder
* Personal history of neurological disorders
* Personal history of head injury
* Alcohol or substance abuse
* Contraindication for MRI
The Patients' Experience After Stem Cell Transplant

This study will examine how adults ≥ 60 years old thinking and memory abilities are affected by stem cell transplant; whether these changes affect day-to-day activities and quality of life and how thinking and memory abilities are affected by genetics, depression, anxiety and physical function. Genetics and other factors may affect the brain's chemicals or structure, and may increase risk for negative effects on thinking and memory.

In this study, the investigators are looking to understand: 1) how adults ≥ 60 years old thinking and memory abilities are affected by stem cell transplant; 2) whether these changes affect day-to-day activities and quality of life; and 3) how thinking and memory abilities are affected by genetics, depression, anxiety and physical function. Genetics and other factors may affect the brain's chemicals or structure, and may increase risk for negative effects on thinking and memory. Participants will undergo neurocognitive testing along with the collection of a saliva sample and completing a battery of questionnaires and assessments.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 60-85
* Diagnosed with a hematological malignancy
* Is considering an autologous or allogeneic stem cell transplant OR has undergone stem cell transplant in the past 12 months and seen by the PI for pre-transplant evaluation.
* Is able to read, write, speak, and understand English

Exclusion Criteria:

* As per self report or medical record, history of central nervous system involvement and/or history of cranial irradiation or intrathecal chemotherapy except for patients with history of prophylactic intrathecal chemotherapy.
* As per self report or medical record, history of stroke, head injury, neurosurgery, seizure disorder, or demyelinating disorder.
* As per self report or medical record, history of substance use disorder.
* As per self report or in the judgement of the consenting professional, uncorrected vision loss.
* As per self report or medical record, primary psychiatric disorder necessitating inpatient treatment in the last 12 months.
* As per self report or medical record, history of allogeneic and or autologous stem cell transplant.
A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment

This study will assess the pharmacokinetics and tolerability of a single dose of GW406381 in subjects with moderate hepatic impairment in comparison to matched healthy volunteers. The hepatically impaired and healthy groups will be given a single 20 mg oral dose of GW406381. Blood samples for PK analysis will be collected pre-dose and over the 72 hours post dosing. Subjects will be housed from the evening before dosing until 24 hours after dosing. A follow-up visit will be conducted between 7 to 10 days from the last dose of study drug.


Eligibility Criteria:
Inclusion criteria:

* Healthy subjects or subjects with moderate hepatic impairment as defined by a Child-Pugh score of 7-9
* Body weight less = 100 kg
* Body mass index (BMI) within range of 19 - 32 32kg/m2

Exclusion criteria:

* Presence of any other significant disease
* Use of any medication within the 2 weeks prior to dosing, unless approved by both the investigator and GSK personnel
COIN: A Pilot Study of Cash Transfers to Improve Outcomes in Low-Income Preterm Neonates and Their Families

The investigators are conducting a pilot randomized controlled trial of unconditional cash transfers among Medicaid-eligible birthing parents of preterm infants in a single neonatal intensive care unit (NICU) in Pennsylvania.

The investigators will measure the feasibility and acceptability of the intervention, birthing parents' lived experiences of having a preterm infant and the impacts of cash transfers, and conduct a preliminary assessment of efficacy on birthing parent psychological stress and ability to invest in their infant's care.

Poverty is an important social determinant of health and contributes to child heath disparities. Among preterm infants, low-income is associated with worse long-term health outcomes. Given the connection between poverty and poor health outcomes, an urgent need exists to move beyond describing health disparities for low-income infants and towards interventions that interrupt these pathways in early childhood to improve outcomes.

A growing body of literature suggests that monthly unconditional cash transfers (UCTs) - no strings attached monthly cash payments - to low-income families may be an effective intervention to reduce poverty and financial stress, improve psychological health, and improve child health outcomes. However, current studies on UCTs focus primarily on term infants or heterogenous samples of children, with only a single pilot delivering direct financial assistance to low-income preterm infants. Thus, despite well-documented disparities in outcomes for low-income preterm infants, the impact of UCTs among low-income preterm infants and their families remains unknown.

Toward that end, the investigators are conducting a pilot randomized controlled trial of unconditional cash transfers among Medicaid-eligible birthing parents of preterm infants in a single NICU in Pennsylvania. The investigators have three specific aims:

Aim 1: To determine the feasibility and acceptability of randomizing high-value ($325/month) and low-value ($25/month) UCTs to low-income birthing parents of preterm infants beginning in the first month of life.

Aim 2: To examine birthing parents' lived experiences managing the financial impact of having a preterm infant and the perceived impact.

Exploratory Aim 3: To conduct a preliminary assessment of the efficacy of monthly UCTs on birthing parent psychological stress and ability to invest in their infant's care, recognizing the pilot is not designed to be powered for statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* Medicaid-insured or uninsured by meets income requirements for Medicaid-eligibility, Over 18 years old, Speaks English or Spanish fluently, Lives in Philadelphia county, Has an infant born \>=22 and \<36 weeks gestational age

Exclusion Criteria:

* Reports being "highly likely" to move to a different state in the next 12 months, Reports planning to place the infant up for adoption at the time of enrollment
Comparison of Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq) in Cancer Breakthrough Pain (FT-019-IM)

Primary:

• To compare the efficacy of nasal fentanyl (NF) to oral transmucosal fentanyl (Actiq®) (hereafter Actiq) in the management of breakthrough pain in cancer patients.

Secondary:

* To compare patients' general impression and preference of NF and Actiq
* To explore the relationship between NF doses and dose of current opioid for breakthrough pain (BTP) and the relationship between dose of NF and of background opioid
* To assess safety and tolerability of NF


Eligibility Criteria:
Inclusion Criteria:

* Adult in- or out patient with cancer and breakthrough pain; using a stable, chronic opioid treatment for background pain.
* Minimum three BTP episodes per week and maximum four per day. Life expectancy of at least three months.
* Chemotherapy and palliative radiotherapy (except facial radiotherapy) are allowed.
* Randomisation in previous studies with NF, i.e. FT-016-IM, FT-017-IM or FT-018-IM, is not allowed.
* Previous use of Actiq is accepted.
Physical Activity Following the Containment Period Imposed by the COVID-19 Pandemic in Patients

In the context of the containment imposed by the COVID-19 pandemic and taking into account the numerous restrictions imposed, the practice of physical and sports activities (PSA) could be reduced by general population and sports population. While the practice of regular physical activity (PA) is prescribed and widely recognized as effective for the management of many chronic conditions and that regular participation in sports (SA) reduces the risk of injury and cardiac accidents- vascular disease in sports subjects, the reduction in regular physical activity levels in the wake of the period of confinement is likely to induce a medical risk in connection with the resumption of PSA.

The study is non-interventional. The data that will be collected are data that can be integrated into a care procedure in accordance with the recommendations to accompany the patients with chronic pathology and athletes for the resumption of PSA after hypothetical deconditioning. Support will be implemented in accordance with the recommendations of the HCSP and the Ministry of Sports. The objective of this study is to evaluate the data of this recommended medical follow-up.

The questionnaires used for the subjects' self-evaluation are all validated in French language, used in the context of medical monitoring, and used in clinical research: assessment of physical activity levels by the questionnaire of RICCI and GAGNON (RG), evaluation of the level of Anxiety and Depression by the Hospital and Anxiety Scale Depression (AHH), assessment of sleep quality by the score of LEEDS.

Medical questionnaires to assess the evolutionary stage of chronic pathologies (MS, Parkinson's disease and Fibromyalgia) will be informed by the investigating physician during the interview telephone with the patient.

Eligibility Criteria:
Inclusion Criteria:

* non-working or tele-working subjects, subjects who have returned to work, subjects who have taken up a part-time professional activity, subjects who have resumed an activity full-time professional
* subjects who have given their consent
* for the sports topics group: amateur level (no sportsmen and women professionals), including sports subjects in the disabled category, with no chronic pathology, already followed by the investigating medical units.
* for the group of patients with chronic diseases: subjects carrying a chronic pathology (rheumatic pathologies, etc) and fibromyalgia, Parkinson's disease and multiple sclerosis, cancer of the breast, metabolic diseases without cardiovascular failure) usually accompanied by the medical units for the implementation of a programme of physic adapted and medically prescribed (Sport-Santé approach)
* social security affiliation

Exclusion Criteria:

* Patient under the protection of adults (guardianship, curators), safeguard of justice),
* Pregnant and/or breastfeeding woman.