cyrilzakka/clinical-trials huggingface dataset:
Storytelling Video Intervention for Depressed Primary Care Patients - Open Trial

The overall aim of this program of research is to develop a collaborative narrative intervention for patients with depression being treated in primary care.

The purpose of the proposed project is to establish the feasibility, acceptability, and preliminary effects of our newly developed narrative intervention on depression.

To achieve the specific aims, the investigators will conduct an open trial to further develop and refine the intervention (n = 10).

The public health impact of existing treatments for major depression is limited by our ability to disseminate those treatments. There is a particular need to find innovative ways to disseminate key principles of empirically supported psychotherapy in primary care settings. Narrative communication is an alternative way to disseminate psychotherapy behavior change principles. Narrative communication refers to "storytelling" -real people talking about their struggles and successful ways of coping. An advantage of narrative communication is that it can be easily distributed (by video) and may reach people who do not have access to other technologies or who experience barriers to traditional psychotherapy. We propose that key principles of a type of cognitive-behavioral therapy (Acceptance and Commitment Therapy, or ACT) can be readily disseminated through a video storytelling intervention. ACT is an empirically supported therapy for depression. Together with a video production firm with a record of working in healthcare and developing documentary-style videos, we will produce a storytelling video intervention (sTVi).

Our aim is to conduct a small open trial (n = 10) of antidepressant medication treatment as usual + sTVi. Assessments will occur at baseline and 4 weeks (post-treatment). We will examine the feasibility and acceptability of sTVi (e.g., uptake and completion of sTVi, engagement with videos, and understanding of key ACT principles) and of this research design. We will examine treatment effects (within relevant confidence intervals) on outcomes (e.g., depression severity). We will examine change in potential mechanisms, i.e., ACT-consistent coping strategies derived from key ACT principles.

Eligibility Criteria:
Inclusion Criteria:

1. Meets DSM-5 criteria for current or lifetime major depressive disorder.
2. No Lifetime diagnosis of bipolar disorder, schizophrenia, or chronic psychotic condition.
3. No current hazardous illicit drug or alcohol use.
4. No suicidal ideation or behavior requiring immediate attention.
5. Depression symptom severity: a Quick Inventory of Depressive Symptoms (QIDS) score \>11.
6. Taking an antidepressant medication for at least 6 weeks; prescribed by their primary care provider.
7. Not in psychotherapy during the study period.
8. Have a PCP at our enrollment site.
9. If pregnant, less than 24 weeks gestation.
10. English speaking.
11. Aged 18 or older.
Body Cooling in Hyperthermic Males and Females

Exertional heat stroke (EHS) is an emergency medical condition that is prevalent in military soldiers, athletes, and laborers. It is diagnosed when the rectal temperature is above 40°C with the presence of central nervous dysfunction (altered mental status). The gold standard method of care for EHS is immediate onsite whole body cooling using cold-water immersion (cooling rates \>0.15°C•min-1), which is reported to have the highest cooling rate. In the treatment of EHS, selecting a cooling modality with a high cooling rate becomes crucial to minimize the time above the critical threshold of body temperature at 40°C to less than 30 minutes for the best chance of survival and to minimize the severity of prognosis. However, in situations where cold water immersion is not feasible (in certain military, firefighter, or other remote settings), other cooling modalities must be available that have a cooling capacity similar to that of cold-water immersion. In this proposed study, we aim to compare the cooling rates of the Polar Breeze® (developed by Polar Breeze ®, Clearwater, FL), cold-water immersion (the current gold standard for EHS treatment), and passive cooling in individuals with exercise-induced hyperthermia


Eligibility Criteria:
Inclusion Criteria:

* males and females between the ages of 18-35.
* recreationally active (regularly exercise at a minimum of 4-5 times per week for greater than 30 minutes per session)

Exclusion Criteria:

* chronic health problems
* fever or current illness at the time of testing
* history of cardiovascular, metabolic, or respiratory disease
* current musculoskeletal injury that limits physical activity
* history of exertional heat illness in the past three years
Modufolin (Arfolitixorin) in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer

The purpose is to characterise the tolerability of Modufolin (arfolitixorin) in combination with 5-FU alone, in combination with 5-FU and Oxaliplatin, in combination with 5-FU and Irinotecan and in combination with 5-FU, Oxaliplatin and Bevacizumab.

Another purpose is to investigate 4 doses of Modufolin to identify the best dose for further assessment.

The study will investigate the tolerability of Modufolin at four (4) different dose levels (30 to 240 mg/m2) in therapy combinations with the chemotherapeutic agents 5-FU, Oxaliplatin +/- bevcizumab, and Irinotecan.

When the selected phase 2 dose is determined, 40 additional patients, will be included in the study in order to acquire more data on the safety and tolerability of Modufolin at this dose level. Twenty (20) of these additional patients will be treated in with Oxaliplatin, 20 with Irinotecan.

Eligibility Criteria:
Inclusion Criteria:

Advanced metastatic colorectal (Stage IV) cancer verified by biopsy
Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Non-Squamous Non-Small Cell Lung Cancer

The purpose of this trial is to determine whether Ipilimumab will prolong survival when compared to Pemetrexed in subjects with nonsquamous, non-small cell lung cancer.


Eligibility Criteria:
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

* Non-Squamous, Non-Small Cell Lung Cancer
* Recurrent/Stage IV Non-small cell lung cancer (NSCLC)
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Not progressing after 4 cycles of a platinum-based first line chemotherapy

Exclusion Criteria:

* Brain Metastases (unless stable)
* Autoimmune Diseases
PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease

Patients with rheumatoid arthritis have a significantly higher risk to develop heart attacks and other complications of their blood vessels. New therapies are needed to prevent this complication. The purpose of this study is to establish the role of the medication pioglitazone in improving the function of the blood vessels and heart and decreasing the risk of future atherosclerosis development in individuals with rheumatoid arthritis. As a secondary aim-point, we will evaluate the efficacy of pioglitazone in improving rheumatoid arthritis disease activity and markers of inflammation.

This study will establish the role of pioglitazone in improvement of endothelial function, arterial compliance and disease activity in patients with rheumatoid arthritis. This will be a placebo-controlled, double blind, cross-over trial.

Two of the measures which were initially listed as separate outcome measures: (Decrease in inflammation) and Efficacy of pioglitazone in improving rheumatoid arthritis disease activity and markers of inflammation are now shown as a combined score (DAS-28-CRP). The Risks or Side Effects as an outcome measure would be duplicative of the tables in the adverse event section and therefore were deleted as an outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Women on adequate contraception if they are of child-bearing age.
* Meet revised ACR criteria for RA.
* Stable doses of DMARDS,biologic agents and or corticosteroids for at least 3 months.

Exclusion Criteria:

* Pregnant or lactating women.
* Current smokers or individuals who smoked in the last 6 months.
* Diagnosis of Diabetes, heart failure, or infection.
* Current diagnosis of malignant disease except for basal cell or squamous cell carcinoma of the skin.
* No active liver disease.
* No cholesterol-lowering medications or oral hypoglycemic agents.
Noninvasive Spinal Stimulation to Restore Hand Function in Children with Spinal Cord Injury

The main goal of this pilot study is to find the best ways to use transcutaneous spinal cord stimulation (scTS) to improve hand function in children with spinal cord injuries (SCI). The investigators will start by exploring the best places and strengths for applying scTS on the neck, the added benefits of applying scTS on the lower back (T11-T12), and comparing the effects of using activity based upper extremity training (a control treatment) alone versus combining it with scTS to help children with chronic SCI regain hand function.

After learning about the study and potential risks, parents/legal guardians and their eligible children with SCI will sign consent and assent forms, respectively. For the first two aims of the study, the investigators will recruit and enroll 10 participants. In the first week, participants will undergo clinical assessments from day 1 to day 4 to categorize the severity and level of their injuries and assess their current arm and hand function. On day 5, eligible participants will have experimental assessments to measure hand grip and control, both with and without spinal cord stimulation (scTS) at one or two neck sites optimized to improve hand grip. On day 6, participants will have similar assessments, this time adding stimulation to the trunk area to help with upright sitting and study its impact on hand grip and control.

For the third aim, 4 participants who showed improved hand grip and control with stimulation in aims 1 and 2 will be selected on a first-come, first-served basis. They will undergo 20 sessions of activity-based upper extremity training, followed by 20 more sessions with the optimal stimulation sites identified from aims 1 and 2. After completing the training, participants will be asked to follow up and repeat experimental and clinical assessments to determine how long the improvements last.

Eligibility Criteria:
Inclusion Criteria:

For aim 1 and 2, 10 participants with SCI:

1. age 7-12 years;
2. chronic (\>6 months), acquired upper motor neuron SCI;
3. cervical SCI at or above C8 neurological level with motor score of 1-3 for finger flexors
4. Pediatric Neurorecovery scale score of ≥2B and ≤ 4C for impaired grip

For Aim 3, 4 participants with SCI who:

1. complete aim 1 and 2;
2. consent/assent for aim 3
3. demonstrate a minimum of 10% increase in HG force with scTS (aim1-2)
4. confirmed volitional activation in hand muscles during hang grip assessment without scTS

Exclusion Criteria:

For all 3 aims will include:

1. Botox use within past 3 months (for upper or lower extremity);
2. current oral baclofen (or pump);
3. musculoskeletal impairment limiting range of motion;
4. unhealed fracture or other medical condition limiting participation in AB-UET;
5. etiology of spina bifida;
6. total ventilator dependence.
Chronic Pain in Rheumatoid Arthritis

The objective is to identify modifiable clinical factors and neurobiological pathways that lead to the development of chronic pain in patients with early rheumatoid arthritis. Participants will undergo quantitative sensory testing, a type of testing that involves assessing response to well-defined, quantifiable painful stimuli, at 0, 3, and 12 months. A subset of participants will also undergo magnetic resonance imaging at 0 and 12 months to assess neuroimaging markers that have previously been shown to be involved in chronic pain.


Eligibility Criteria:
Inclusion Criteria for QST:

1. Age ≥18 years
2. Meet either the 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for RA
3. Persistent joint symptoms ≤ 2 years
4. Active inflammatory disease
5. If taking opioids on an as needed (prn) basis, must be able to hold opioid for 12 hours before study procedures
6. If taking NSAIDs, must be able to hold NSAIDS for 24 hours before study procedures
7. If taking a central-acting pain medication, must be on a stable dose and able to stay on a stable dose throughout study

Exclusion Criteria for QST:

1. Routine, scheduled opioid use
2. Routine, scheduled prednisone dose \>10 mg or its equivalent
3. Peripheral neuropathy
4. Peripheral vascular disease
5. Raynaud's phenomenon requiring treatment, manifested by claudication or ischemic rest pain
6. Uncontrolled blood pressure

Additional Inclusion Criteria for neuroimaging:

1. Age ≤ 80 years old
2. Right-handed or ambidextrous
3. Ability to lie on their back for the duration of the MRI scans

Additional Exclusion Criteria for neuroimaging:

1. Severe claustrophobia precluding MRI
2. Unable to fit comfortably in the MRI scanner (usually only occurs if body mass index \>40 kg/m2)
3. Pregnant
4. Contraindications to MRI
Non-invasive Cardiac Output Monitoring in Obstetric Patients

The investigators hypothesize that continuously measuring stroke volume (SV) and cardiac output (CO) will 1) reveal hemodynamic instability in a timely manner and alert the physician promptly, 2) provide information for the physician to make the differential diagnosis as to whether the hemodynamic instability was due to vasodilatation or reduction of venous blood return, and 3) lead to appropriate and prompt treatment to improve patient outcome.

-determine the SV and CO and their kinetic change using ICON® to establish a hemodynamic profile of the patient under spinal anesthesia for cesarean section. To determine if using instantaneous measurements of SV and CO to guide patient management improves hemodynamic stability.


Eligibility Criteria:
Inclusion Criteria:

* age 18-45;
* receiving spinal anesthesia or combined spinal and epidural anesthesia to undergo cesarean section

Exclusion Criteria:

* Patients who have major cardiovascular disease,preexisting of hypertension or gestational hypertension, preeclampsia and body mass index greater than 35kg/m2;
* Patients who have skin lesion at the place where the electrode is supposed to be applied;
* Emergency cesarean section patients.
Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamic Effect of Different Concentrations of a New Anti-inflammatory Substance in Subjects With Chronic Plaque Psoriasis

To assess safety and tolerability after treatment with LEO 134310 cutaneous solution.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18-64 years (inclusive) with plaque psoriasis in a chronic stable phase.
* Men or women of non-child bearing potential.

Exclusion Criteria:

* Acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, pustular, exfoliative or inverse psoriasis.
* According to defined washout periods: topical antipsoriatic drugs (except salicylic acid in petroleum jelly); systemic antipsoriatics and biologics; ultraviolet (UV) therapy.
Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis

This study is designed to evaluate the safety and beneficial effects of elagolix (NBI-56418) compared to placebo and leuprorelin (an approved endometriosis therapy) over a three month period followed by an additional three months of treatment on elagolix.

The study followed a parallel-group design in which participants were randomized (1:1:1:1) to one of the following treatment groups for the first 12 weeks of dosing: 150 mg elagolix once daily (q.d.); 250 mg elagolix q.d.; placebo; or leuprorelin acetate depot injection 3.75 mg (monthly). Blinding was achieved using a double-dummy design. Following 12 weeks of dosing, participants continued in the study for an additional 12 weeks; participants randomized to elagolix continued to receive their assigned dose and participants randomized to placebo or leuprorelin acetate were re-randomized to receive one of the two doses of elagolix (150 mg q.d. or 250 mg q.d.) for 12 weeks in a double-blind fashion. Six weeks after the last dose of the study drug at the end of Week 24, a follow-up visit was performed (end of Week 30).

There was no pre-specified primary efficacy end point as there was no single key efficacy outcome measure in this exploratory Phase 2 study. For purposes of results reported here, Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain is designated as the primary outcome measure.

Eligibility Criteria:
Inclusion Criteria

* Female, aged 18 to 45 years, inclusive
* Have moderate to severe pelvic pain due to endometriosis
* Have been surgically (laparoscopy) diagnosed with endometriosis within the last 5 years and have recurrent or persistent endometriosis symptoms
* Have regular menstrual cycle (23-33 day)
* Agree to use two forms of non-hormonal contraception during the study

Exclusion Criteria:

* Received a Gonadotropin-releasing hormone (GnRH) agonist, GnRH antagonist, danazol, or have received any of these agents within 6 months of the start of screening.
* Received subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular (i.m.) medroxyprogesterone acetate (DMPA-IM), or have received either of these agents within 3 months of the start of screening.
* Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month
* Have had surgery for endometriosis within the last month
* Are using systemic steroids on a chronic or regular basis within 3 months
* Have uterine fibroids or other pelvic lesions ≥ 3 cm in diameter
* Have had a hysterectomy or oophorectomy
* Have pelvic pain that is not caused by endometriosis
* Have unstable medical condition or chronic disease
* Have been pregnant within the last 6 months and is currently breast feeding
Investigation on the Value of Bilateral Index (BIS) Monitoring for Magnetic Seizure Versus Electroconvulsive Therapy

Electroconvulsive therapy (ECT) has been shown to be an effective treatment for patients suffering from depression, who do not respond to medical treatment. However it is often dismissed by patients, who feel uncomfortably about the application of electric shocks to their heads. In 2000, magnetic seizure therapy (MST) has been introduced which uses magnetism instead of electricity to evoke convulsions. MST seems to be as effective as ECT in terms of its antidepressant potency but may be associated with less severe cognitive side effects.

Control of anaesthesia during seizure therapy is demanding since light anesthesia might be associated with awareness, whereas deep anesthesia impedes the antidepressant effect of the convulsion. Therefore, Bispectral index (BIS) monitoring is frequently used to tailor anaesthesia for ECT, however little is known about BIS following MST.

The investigators hypothesize that in comparing MST with ECT, (a) patients show a faster increase in BIS and that (b)less left-right differences occur in BIS.


Eligibility Criteria:
Inclusion Criteria:

* depression

Exclusion Criteria:

* age \< 18 years old
* pregnancy
Integrated Approaches to Health and Safety in a Dynamic Construction Work Environment

"All the Right Moves for Subcontractors" aims to improve safety, health and well-being, through the development of a communication infrastructure with supplemental tools where construction workers and company mangers (project, operations and safety) work together to collaboratively identify problems and strategies to improve their conditions of work. The intervention is grounded in the key characteristics of integrated organizational interventions to improve workers' health safety and well-being detailed in Harvard Center for Work, Health and Well-being's Implementation Guidelines (McLellan et al, 2016).

The intervention involves a cyclical approach through which the research team facilitate a participatory process to identify workers' health concerns, prioritize these concerns, use an action planning process to identify and operationalize solutions, and develop a company-specific evaluation plan to measure change. We will evaluate this program by measuring safety climate, health climate, pain and injury and health behaviors.


Eligibility Criteria:
Inclusion Criteria:

* All workers employed by the recruited contractors at the eligible worksites

Exclusion Criteria:

* Companies with less than 5 workers
SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor

The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors.

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the participant breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse oximetry sensors will meet a specification of +/-3% or better in non-motion conditions for the range of 70 - 100% SaO2 (typically, saturation is determined once with air breathing and then at one of 3 levels, e.g. 95%, 85%, and 75% saturation for about 30-60 seconds at each level), thereby demonstrating an acceptable SpO2 accuracy performance specification.

Eligibility Criteria:
Inclusion Criteria:

* Good general health with no evidence of pre-existing medical problems
* Fluent in both written and spoken English
* Must be able to review informed consent and is willing to comply with study procedures

Exclusion Criteria:

* Obesity (BMI \>30)
* Known history of heart disease, lung disease, kidney or liver disease
* Prior diagnosis of asthma, sleep apnea, or use of CPAP
* Diabetes
* Clotting disorder
* Hemoglobinopathy or history of anemia that in the opinion of the investigators would make them unsuitable for study participation
* Any serious systemic illness
* Current smoker
* Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigator would interfere with the sensors working correctly
* History of fainting or vasovagal response
* History of sensitivity to local anesthesia
* Prior diagnosis of Raynaud's disease
* Unacceptable collateral circulation based on exam by investigators (Allen's test)
* Pregnant, lactating, or trying to get pregnant
* Unable or unwilling to provide informed consent, or unable or unwilling to comply with study procedures
* Any other condition which in the opinion of the investigators would make them unsuitable for the study
Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease

The purpose of this research study is to compare two different ways to give opioid pain medicine to treat sickle cell disease pain that is bad enough to go to the emergency department for treatment. One way uses your weight to decide how much pain medicine to give you while in the emergency department. This is called weight based treatment. The other way uses how much pain medicine you take at home and how much medicine you needed during past emergency department visits to decide how much medicine to give you. This is called patient specific treatment.


Eligibility Criteria:
Inclusion Criteria:

* All adult (18 years or older);
* Sickle Cell Disease patients with the following genotypes: Hgb SS (sickle cell anemia), SC(Sickle hemoglobin-c) , and SB+(sickle Beta-Plus thalassemia) and SB-(sickle Beta zero thalassemia)

Exclusion Criteria:

* determined to not benefit from opioids and therefore won't receive opioids in any future Emergency Department visit.