cyrilzakka/clinical-trials huggingface dataset:
Lay Health Worker Expanded Intervention in Community Oncology Practices

Undertreated patient symptoms and resulting acute care use require approaches that improve symptom-burden. Previously a lay health worker (LHW)-led symptom screening intervention was developed for patients with cancer. In pilot work, the intervention was associated with improvements in patient symptom burden and reductions in healthcare use and costs of care at the end of life. This intervention will be expanded across several clinics to evaluate the impact of the LHW intervention on with cancer and the LHW will be trained to refer patients to palliative care. This randomized intervention will evaluate the effect on healthcare use, total costs, palliative care and hospice referral.

All patients with newly diagnosed cancer, over the age of 75 will be randomized into the CareMore Pilot 2 Program with 200 randomized to the intervention grou and 200 randomized to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed or relapsed cancer diagnosis.
* 75 years or older
* Diagnosis of relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
* Must have capacity to verbally consent

Exclusion Criteria:

* Inability to consent to the study due to lack of capacity as documented by the referring physician.
Effect of Educational Intervention in Patients With Low-Risk Chronic Obstructive Pulmonary Disease

The purpose of this study is to determine if educational intervention is effective in reducing exacerbations of chronic obstructive pulmonary disease in patients with low-risk disease.

There is growing evidence about the effectiveness of case management in preventing adverse events in patients with high-risk chronic obstructive pulmonary disease(COPD). But the majority of COPD patients belong to the low-risk category. We propose that a less intense educational intervention will have a similar beneficial effect in reducing hospital admissions and emergency department (ED) visits in this larger group of low-risk COPD patients.

Eligibility Criteria:
Inclusion Criteria: Spirometrically confirmed COPD in VISN23 registry. FEV1/FVC \<70%.

Exclusion Criteria:Hospital admissions or ED visits in the VISN23 disease registry for COPD within last one year

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Advanced Cognitive Stimulation Therapy Hong Kong (ACST-HK)

This study is a feasibility randomized controlled trial (RCT) for an evidence-based intervention for people with moderate to severe dementia in Hong Kong. The psychosocial intervention is adapted from Cognitive Stimulation Therapy (CST), translated and adapted for the Hong Kong Chinese population, and developed within the Medical Research Council (MRC) framework.

The World Health Organization calls for an increase of psychosocial interventions for dementia-a global epidemic. Cognitive Stimulation Therapy (CST) is the only non-pharmacological therapy recommended by the National Institute for Health and Care Excellence for improving cognition for mild to moderate dementia. However, there is little guidance on how to maximise cognition for severe dementia. Advanced Cognitive Stimulation Therapy (ACST) will be the first evidence-based complex intervention for moderate to severe dementia developed within the Medical Research Framework and building upon CST's key principles. This feasibility randomised controlled trial (RCT) aims to 1) translate and adapt ACST for the Chinese population; 3) evaluate the feasibility of Advanced Cognitive Stimulation Therapy - Hong Kong (ACST-HK). A sample of 32 participants will be recruited, where 16 will be randomly allocated to ACST, and 16 to treatment as usual (TAU). Data will be collected pre and post the 7-week intervention period. Improving the cognition and QoL for people with moderate to severe dementia is vital because dementia's prevalence is projected to reach 152 million by 2050, resulting in excessive excess disability. Developing an intervention targeting Chinese-the largest aging population-is also novel and allows ACST-HK to impact internationally from its infancy.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. Diagnosis of dementia, according to the DSM-V
3. CMMSE ≤ 12
4. Ability to communicate in English
5. Ability to complete outcome measures
6. Not having major physical illness or disability that affects participation
7. Consultee willing and able to provide written informed consent, if participant is not able to provide consent.
8. Ability to remain in a group for around an hour (e.g. no challenging behaviour)

Exclusion Criteria:

1. Illness and disability that affects participation (as deemed by researcher or attending
2. care home staff)
3. CMMSE \< 5
4. Participation in other psychosocial intervention studies
Evaluation of a Tele-Rehabilitation Service Program

Is a unique tele-rehabilitation service directed at treating upper limb weakness due to stroke feasible to provide at Mayo Clinic and are the individuals with stroke and the clinicians providing the care satisfied with the process?

Participants will be identified from Mayo Clinic Division of Brain Rehabilitation's existing clinical practice and recruited either in person or by using a phone script.

Eligible participants will have 2 in-person clinical assessments, one before the intervention and one concluding the protocol. The first clinical assessment will involve introducing and familiarizing the participant with the study procedure, demonstrating and practicing with the system, and obtaining baseline clinical measures. During this first session the participant's technical skills and home equipment capabilities will be assessed and any assistance needed for establishing the technology in their home will be determined and provided. The second clinical assessment will include acquiring post-intervention clinical and outcome measures. Intervention duration will be 3 months. During the study period, each participant will receive online treatment for up to 45 minutes (in order to have net 30 min clinical time) twice per week. During these sessions, the clinician will teach system interaction including integrating feedback, instruct in system intervention activities and assure participant competence in system use, and adjust the level of difficulty in each activity according to the participant's abilities and needs. After the first month of intervention, the participant may be given permission by the therapist to train with the system for no more than 40 minutes per day. Such self-training opportunities are in addition to the twice weekly online sessions with the therapist.

Eligibility Criteria:
Inclusion

* \>12 months after stroke
* Age 21-80 years
* A minimum of 45 degrees of flexion in the affected shoulder
* Active extension of the affected elbow to 150 degrees
* Independent sitting balance
* Able to understand simple instructions
* Lives within a 100 mile radius and able to attend two clinical assessments at Mayo Clinic
* Able to install the tele-rehabilitation software with minimal remote technical support
* Available caregiver as needed who has basic technical understanding of computer operation
* i3 processor based PC; 26" monitor; Windows 7 or 8 operating system; Internet connection of at least 10Mbps.

Exclusion

* Medical conditions that may limit physical activity at the level of low intensity cardio-vascular exercise
* Any contraindication related to the integrity of the musculoskeletal system
* Active malignancy
* Uncontrolled epilepsy
* Global aphasia
* Severe apraxia
* Severe ataxia
* Unilateral spatial neglect
* Chronic pain
* Pregnancy
* Adults lacking capacity
Pain Relief After PrimaryTKA

While a majority of people who undergo TKA have significant long-term improvement in functional ability, many patients may experience significant pain in the early postoperative period, which may adversely impact postoperative rehabilitation and recovery. Traditionally, opioid medications have been used to control postoperative pain. However, there are many risks with using opioid medications, including addiction and overdose, which kills over 48,000 people yearly. In an effort to overcome this, opioid-sparing multimodal analgesia (MMA) regimens have been developed, commonly using nonsteroid anti-inflammatory drugs (NSAIDs), acetaminophen, regional nerve blocks, and local anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older
* Patients undergoing primary unilateral TKA
* Patients receiving spinal anesthesia during primary TKA
* Patients with adequate cognitive function to participate and complete questionnaires for the study

Exclusion Criteria:

* Patients undergoing bilateral simultaneous TKA
* Patients undergoing conversion TKA
* Patients undergoing unicompartmental knee arthroplasty
* Patients undergoing patellofemoral arthroplasty
* Patients with an allergy to NSAIDs or bupivacaine
* Patients who have a contraindication to the use of NSAIDs
* Patients who are using chronic anticoagulation, precluding them from using NSAIDs
* Patients with a history or diagnosis of chronic pain syndrome or complex regional pain syndrome
* Patients who are determined to be in severe pain from other concomitant conditions
* Patients with chronic opioid use disorder, defined as patients who are taking more than 20 mg/day morphine milligram equivalents for 30 days consecutively in the 3 months prior to surgery.
Anti-CXCR4 (BMS-936564) Alone and in Combination With Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma

The purpose of this study is to determine 1) the safety and tolerability of multiple intravenous doses of anti-CXCR4 (BMS-936564) as monotherapy and as combination, and 2) the maximum tolerated dose (MTD) of BMS-936564 in combination with Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in subjects with relapsed or refractory multiple myeloma.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Subjects must have confirmed diagnosis of multiple myeloma with measurable disease Excluded are subjects with only plasmacytomas, plasma cell leukemia, or non-secretory myeloma.
* Disease must be assessed within 28 days prior to treatment initiation.
* Subjects must have evidence of relapsed or relapsed/refractory disease.
* Subjects must have received at least 2 prior regimens for multiple myeloma.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2.
* Subjects must have received last treatment (ie, chemotherapy, radiotherapy, biological, immunotherapy or investigational agent \[therapeutic or diagnostic\]) at least 14 days prior to treatment initiation. The last treatment of systemically absorbed steroids must be at least 2 weeks or 5 half lives (whichever is shorter) before the first dose of BMS-936564.

Exclusion Criteria:

* A serious uncontrolled medical disorder or active infection.
* Current or recent (within 3 months) gastrointestinal disease or condition that could impact the absorption of orally-administered drug.
* Inability to swallow oral medication.
* Uncontrolled or significant heart disease.
* Any other malignancy, excluding basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, localized prostate cancer, or superficial bladder cancer stage 0, from which the subject has not been disease-free for at least 3 years.
Study Of SU011248 In Combination With Paclitaxel In Patients With Metastatic Breast Cancer

This study is to evaluate the safety of SU011248 in combination with paclitaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer with evidence of unresectable, locally recurrent or metastatic disease.
* Candidate for treatment with paclitaxel.

Exclusion Criteria:

* Prior chemotherapy in the advanced disease setting.
* HER2 positive disease unless previously treated with trastuzumab.
Kinesthetic Ability Trainer for Peripheral Neuropathic Pain

Objective: To determine the effectiveness of balance training with Kinesthetic Ability Trainer 2000 (KAT 2000) in patients with peripheral neuropathic pain related balance disorder.

Methods: A total of 60 patients who developed peripheral neuropathic pain-related balance impairment in the chronic phase due to lumber disc herniation, lumber spondylosis and gonarthrosis were included into this randomized controlled prospective study and randomized into either balance exercises groups or KAT 2000 exercises groups. Balance exercises were given all patients in Group 1 (n=30). In addition to balance exercises, KAT 2000 balance exercises were given all patients in group 2 (n=30). All patients received 45-min individualized training session for three times a week for 4 weeks. Patients were evaluated according to pain, static and dynamic balance and quality of life (QoL).

Neuropathic pain was determined by the Douleur Neuropathique 4 (DN4) questionnaire. Pain severity was assessed by using a visual analogue scale (VAS). KAT 2000 was used to evaluate static and dynamic balance. Dynamic balance and mobility also was assessed using the Berg Balance Scale (BBS) and Time Up and Go (TUG) test. QoL was assessed by using Nottingham Health Profile (NHP). Patients were evaluated at baseline and the end of the 4-week exercise program.

Eligibility Criteria:
Inclusion Criteria:

* DN4 scores ≥4 and moderately impaired balance with a score of 21-40 points on the Berg Balance Scale.

Exclusion Criteria:

* Who had history of previous cerebrovascular events; other neurological, musculoskeletal, inner ear or eye disease that may lead to impaired vision or standing balance.
Effect of 2-Week Continuous Glucose Monitoring on Glycemic Management in Patients New-to-Insulin on Hospital Discharge

The proposed study will be a randomized, prospective, non-blinded study of 120 participants with type 1 or type 2 diabetes that are new-to-insulin on hospital discharge. On hospital discharge, participants will be assigned to either the intervention of wearing a continuous glucose monitor (CGM) for 2 weeks or blood glucose monitoring (BGM) for 2 weeks. They will have a 2-week follow up visit, during which insulin doses will be adjusted as needed, and a 3-month follow-up visit, at which point HbA1c will be measured.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18-100 years
2. Known history of type 1 or type 2 diabetes
3. Admitted to NYU Langone Hospital - Long Island between September 1st, 2022 and August 31st, 2023
4. New initiation of insulin therapy, including basal insulin regimen, basal-bolus insulin regimen, or mixed insulin regimen at the time of hospital discharge

Exclusion Criteria:

1. Prior to admission use of home insulin therapy
2. Current use of systemic corticosteroids
3. Active pregnancy; as pregnancy requires different blood glucose targets, subjects known to be pregnant will be excluded from this study. Subjects will not be tested for pregnancy outside of testing performed in routine medical care; pregnancy will be determined by patient self-reporting. Females of childbearing potential will not be instructed to avoid pregnancy, however if they became pregnant during the study (detected by self-reporting), they will be withdrawn from the study.
Reducing Veterans Hospitalizations From Community Living Centers

The goal of the project was to implement and evaluate the intervention, Interventions to Reduce Acute Care Transfers (INTERACT) in VHA CLCs, which is designed to improve the care of Veterans using CLCs who experience acute changes in their condition and at the same time reduce their rate of hospitalization.

The project was designed to show that engagement by frontline CLC staff, in using the INTERACT (VA version of INTERACT) program will identify Veterans' clinical problems earlier, help evaluate and safely initiate management of acute changes in conditions in the CLC, communicate more effectively with physicians about Veterans' conditions, thereby avoiding unnecessary hospitalizations, and provide more emergent hospitalizations when necessary.

The project planned to implement the INTERACT quality improvement program as the intervention in up to 15 randomly selected, pair matched CLCs for a 6 month intensive training period and an additional 12-18 month ongoing follow-up monitoring period.

Additionally, a quantitative and qualitative evaluation of the implementation of the INTERACT intervention was done to characterize the fidelity with which CLCs in the intervention pairs participated in training, engaged in regular conference calls, undertook root cause analyses identifying why hospitalizations occurred and used the tools in which they were trained.

The program's effect is based on three core strategies: 1) enabling front-line NH staff to identify acute conditions early in their course, thereby helping to prevent them from becoming severe enough to require acute hospitalization; 2) providing communication and decision support tools that assist with the safe and effective management of certain conditions in the Community Living Center (CLC) without transfer to the acute hospital; and 3) educating CLC staff in advance care planning and discussions about end-of-life and comfort care plans, and thus increasing the use of advance directives, comfort care measures, and palliative and hospice care as an alternative to hospitalization when appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Veterans in experimental and control CLCs during 18 months during which the INTERAC intervention was implemented.

Exclusion Criteria:

* Veterans not in participating CLCs
Effect of 3g Versus 2 g MMF in Combination With Tacrolimus on Progression of Renal Allograft Interstitial Fibrosis

Development of chronic changes (scarring) in transplanted kidney tissue is a major cause of long-term kidney function deterioration and ultimately graft loss. It results from both immunologic and non-immunologic mechanisms. Mycophenolate mofetil (MMF) is immunosuppressive drug used for prevention of rejection after kidney transplant, usually in combination with a calcineurin inhibitor (tacrolimus or cyclosporine), with or without corticosteroids. Besides immunosuppression, MMF may also have direct antifibrotic properties. Tacrolimus has potent immunosuppressive effects and is the cornerstone of contemporary posttransplant immunosuppressive therapy in kidney recipients. However, it is also nephrotoxic. The hypothesis of the present study is that in the setting of similar net immunosuppression, higher dose of MMF (3 g daily) will result in slower progression of kidney fibrosis during first year posttransplant as compared to MMF 2 g daily. To test this hypothesis, the present study will randomly assign low immunological risk kidney transplant recipients to either 2g or 3 g MMF daily, in combination with tacrolimus, with, or without maintenance steroids. All patients will have kidney biopsy at implantation and at 12 months after transplantation. Main outcome will be 1-year change in chronic kidney histology (interstitial fibrosis) assessed by protocol biopsy.


Eligibility Criteria:
Inclusion Criteria:

1. first kidney or kidney-pancreas transplantation
2. CDC PRA \<=20%

Exclusion Criteria:

1. dual kidney transplantation
2. AB0 incompatible transplantation
3. 0 biopsy ci, ct, cv, or ah score \>=2
Assessment of Fatty Acids in Infants' Blood Cells When Consuming Infant Formula Containing Long-Chain Polyunsaturated Fatty Acids

To compare amounts of DHA, ARA, and other fatty acids in the blood cells of infants consuming infant formulas containing differing levels of fatty acids


Eligibility Criteria:
Inclusion Criteria:

* Singleton birth
* 12-25 days of age
* Gestational age of 37-42 weeks
* Solely formula fed for at least 24 hours prior to randomization
* Birth weight 2500 g - 4000 g

Exclusion Criteria:

* Serious concurrent illness or congenital malformation
* Systemic or congenital infection
* Immunocompromised
* History of intolerance or allergy to cow milk
* Maternal autoimmune disorder
* Participation in another clinical study
BIOMARKER and IMAGING CHARACTERISATION of INFLAMMATORY ATHEROMA in PATIENTS RECEIVING IMMUNOTHERAPY and ANGIOGENESIS INHIBITORS

The advent of immunotherapy (immune checkpoint inhibitors \[ICI\]) has been an extremely important advancement for cancer treatment in recent decades. The anti-cancer effects of these agents is profound and can lead to radiological \&#39;disappearance\&#39; of the primary cancer and metastatic deposits. ICI are now commonly used in the treatment of multiple cancers including melanoma, kidney cancer, liver cancer and lung cancer. ICI can be used on their own or in combination with other agents such as vascular endothelial growth factor inhibitors (VEGFi) which is first line treatment for many patients. However, it has become clear that these drugs have cardiovascular side effects including high blood pressure and a reduction in the heart muscle pumping function. It is also increasingly recognised that ICIs may have a toxic effect on blood vessels resulting in an increased risk of heart attack or stroke. These side effects can have a significant impact on patients\&#39; health and can lead to withdrawal of important cancer treatment. The mechanisms by which these side effects occur are unclear and have not been well described to date.

The aim of this study is to examine the effect of ICI and VEGFi, both alone and in combination, on blood vessels and to understand their effects on blood markers and heart function. This study is observational and will not require any modification of cancer therapy.

This study will aim to recruit patients diagnosed with cancer who are already planned to receive ICI or VEGFi alone or in combination at the Beatson West of Scotland Oncology Centre. Patients will undergo a vascular PET-CT scan before and 6 months after starting treatment. In addition patients will undergo echocardiography and tests of the function of the small blood vessels in the fingertips with a special machine (EndoPat). Blood and urine samples will also be collected.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with cancer who are planned for treatment with ICI or VEGFI, including combination therapy
2. ≥6 months predicted survival
3. Age ≥18 years

Exclusion Criteria:

1. Patients who are unable or unwilling to provide valid consent for the study
2. Patients with diabetes who are on oral anti-diabetic treatment or insulin at baseline
3. patients who have exposure to either immune checkpoint inhibitor or VEGF inhibitor in the 12 months before enrolment
A Study to Evaluate Efficacy and Safety of GC3110B in Healthy Adults

The purpose of this study is to evaluate immunological efficacy and safety of GC3110B versus GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age.

Adults 18 to 60 years of age will be randomly assigned in a 1:1 ratio to receive either GC3110B or GCFLU Quadrivalent Inj.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18 to 60 years
* Informed consent form has been signed and dated
* Able to comply with the requirements of the study

Exclusion Criteria:

* Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components
* Personal history of Guillain-Barré syndrome
* Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
* Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
* Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy