cyrilzakka/clinical-trials huggingface dataset:
Enhanced Pharmacist-Managed Anticoagulation Service in a University-based Family Medicine Clinic

Introduction:

The ambulatory care pharmacist service is a vision that is supported by several national pharmacy associations and expected by many clinical environments. However, pharmacists practicing in such settings often lack the data to demonstrate their value for the services they provide. Consequently, clinical services provided by pharmacists are not viewed as a billable expense and reimbursements are bundled with drug dispensing. Thus, if a pharmacy service is to sustain for the long-term, it is imperative to develop a value model to support monetary compensation for the cognitive services provided.

Background and Significance:

Anticoagulation with warfarin is a high risk therapy involving complex dosing, monitoring, and ensuring adherence to outpatient therapy. Monitoring anticoagulation intensity utilizing the prothrombin time (PT) and the international normalized ratio (INR) is used to determine the effectiveness of anticoagulation therapy. The proportion of time the INR is within the therapeutic range (TTR) is considered a surrogate measure of anticoagulation control and is associated with lower rates of major bleeds and thromboembolism.

Pharmacist managed anticoagulation clinics eliminate the waiting period between lab work from an external facility and decisions from physicians. Pharmacists practicing in anticoagulation clinics with point-of-care INR testing usually practice under a collaborative agreement, which allows them to adjust and reverse warfarin dosing based on established protocols. This reduces the wait time and is expected to increase patient satisfaction. Despite the wide acceptance of pharmacist-managed anticoagulation clinics, there is inconsistent evidence to support prevention of major bleeding.

Methods:

This is an IRB-approved prospective, unblinded randomized controlled trial of the clinical impact of home anticoagulation monitoring. The study will enroll all patients (who meet eligibility criteria) who require long-term anticoagulation therapy from a pharmacist-managed anticoagulation clinic.

Expected Outcomes:

The purpose of this study is to evaluate if self- monitoring in addition to pharmacist review will increase the TTR. This will allow university- based pharmacists to provide care for more patients effectively in addition to their academic duties.


Eligibility Criteria:
Inclusion Criteria:

* Established patients within the USF Morsani Center Family Medicine department
* Adults over the age of 18 years
* Long-term (\> 12 months) warfarin therapy
* Taking warfarin for at least 90 days prior to enrollment
* Willing and able to perform home INR monitoring with correct technique (or caregiver)

Exclusion Criteria:

* Failure by either the patient or caregiver to demonstrate successful INR monitoring technique
* Issues with mental and/or physical dexterity as evaluated and determined by the pharmacist
* Unwillingness to take full financial responsibility for costs not covered (by patient's insurance and/or grant money) incurred with home INR monitoring
MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma

This phase III trial aims to compare the efficacy and safety of MIL62 combined lenalidomide and lenalidomide alone to treat patient diagnosed with Follicular Lymphoma (FL) and refractory to rituximab. The study randomized patients with a 1:1 ratio to receive either MIL62 plus lenalidomide or lenalidomide.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients, \>=18 years of age;
2. Patients with either histologically documented CD20-positive FL, WHO grade 1, 2 or 3a
3. Evidence of refractory to rituximab
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
5. At least one bi-dimensionally measurable nodal or tumor lesion defined by CT scan as: greatest transverse diameter \> 1.5 cm and a short axis ≥ 10mm
6. Adequate hematologic function
7. Life expectancy \>5 years
8. Able and willing to provide written informed consent and to comply with the study protocol

Exclusion Criteria:

1. Evidence of refractory to lenalinomide
2. Central nervous system lymphoma
3. Patients with progressive multifocalleukoencephalopathy (PML)
4. Prior use of any antibody therapy(except for Rituximab ) within 3 months of study start
5. Prior use of any anti-cancer vaccine
6. Prior administration of radiotherapy 42 days prior to study entry
7. Prior administration of chemotherapy 28 days prior to study entry
8. History of prior malignancy within the last 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
9. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
10. Known hypersensitivity to thalidomide or lenalidomide
11. Regular treatment with corticosteroids prior to the start of cycle 1, unless administered for indications other than NHL at a dose equivalent to \< 20 mg/day prednisone
12. Any serious active disease or co-morbid medical condition (such as New York Heart Association Class II or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision)
13. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
14. Pregnant or lactating females
Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics

The purpose of this study is to understand, with the use of functional magnetic resonance imaging, the neural correlates involved in appetite control and the mechanism of weight gain in patients with schizophrenia treated with atypical antipsychotics. We hypothesize that a difference in cerebral activations between weight gaining and non-weight gaining patients will be detected after four months of treatment with olanzapine.

Atypical antipsychotics (AAP) have revolutionize treatment of schizophrenia. They are considered to be more effective in reducing positive and negative symptoms and in improving cognitive deficits. They cause less extrapyramidal symptoms and tardive dyskinesia than typical antipsychotics. They still have a lot of important side effects like sedation, metabolic syndrome and weight gain. These effects could lead to obesity, type II diabetes and cardiovascular diseases, particularly for schizophrenia patients because they are already at an increased risk for these complications. Moreover, an increase in weight gain has been demonstrate to exacerbate negative symptoms and can lead to non compliance with a consequent risk of relapse. It also can create an additional social disadvantage for schizophrenia patients and decrease their quality of life. The weight gain will result, in part from an increased food intake (and probably an increased appetite) and from a decreased energy expenditure.

The purpose of this study is to understand the cerebral mechanisms of appetite in patients with schizophrenia treated with atypical antipsychotics to prevent or treat their weight gain.

Eligibility Criteria:
Inclusion Criteria:

* Patients with schizophrenia (DMS-IV)
* 18 to 60 years old
* Right handed
* Begin a treatment with olanzapine and had not received it for at leat 6 months
* Other medication accepted (except antipsychotic)

Exclusion Criteria:

* concomitant axis-I or axis-II disorders
* unstable medical condition
* Concomitant antipsychotic medications
The Effect of Patient Education and Rehabilitation on Quality of Life in Patients With Permanent Stomas

The purpose of the experiment is to study the effect it has on patients' quality of life if they go through a structured process marked by intensified and specialized effort by ostomy nurse. This includes close monitoring during hospitalization, telephone contact and guidance following discharge and participation in a group based patient school up to 4 months after discharge .

At the same time the study also examines what the economic effect of following the intervention will have.

Construction of an ostomy is a radical treatment with permanent physical signs of body alteration. It leads to loss of a central and very personal bodily function (excretion of faeces through the rectum) and there is a significant change in personal hygiene.

Having a colostomy is not a uniform state but is characterized by many different factors: Several types of ostomy, several underlying causes that lead to stoma creation such as cancer, several individual psychosocial profile, which naturally affect individuals differently. Patients are forced to living with a changed body image, a change in daily routines, and for some there will also be changes in lifestyle, social standing and their sexuality will be affected. At the same time patients experience a break when they are discharged from the hospital, and they may lack the practical and emotional support.

The training and education of patients is increasingly being carried out by stoma nurses both in Denmark and internationally. The primary role is to inform and prepare patients before surgery and to keep the contact with patients after surgery to ensure the fulfillment of the patient´s independent and meaningful life after ostomy construction. It is assumed that ostomy nurse's intervention and involvement are important for the patient's quality of life, but there are no studies that uniquely identifies the type of education that has the greatest effect, which applies both to content and methods.

Quality of life measurement in health care is a merging method to ensure the patient´s perspective on health treatments.It is greatly needed to test the efficacy of nursing interventions on patients' quality of life. Pressure on health services increase which makes it imperative also to include analysis and calculation of economic effect of the intervention.

Eligibility Criteria:
Inclusion criteria:

* All patients with permanent or temporary stomas regardless of cause that are expected to be able to cooperate in filling out questionnaires and who will participate in the planned interventions.

Exclusion criteria:

* Patients that post-operatively are not able to cooperate and participate in the planned interventions.
County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial

The goal of this cluster randomized trial is to evaluate the effectiveness of the RISIMA model based on an integrated county healthcare consortium implemented by multi-level family health teams (FHTs)on patients with diabetes and/or hypertension, including CVD risk assessment, treatment, and management.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 40 and 70 years old;
2. Patients with hypertension or diabetes;
3. Permanent residents of the county where the research is conducted;
4. Already signed up with the family doctor team in the township where the research is located.

Exclusion Criteria:

1. Unable to independently carry out the interventions required for the study;
2. Residing far from the village or township health center where the research is located, making it difficult to cooperate with visits;
3. Patients who refuse to participate;
4. Patients with comorbidities such as cancer that may interfere with the study visits or intervention effects;
5. Pregnant or lactating women
The Power of 24-hour: Co-designing Intervention Components

Most of the existing lifestyle interventions in adults with overweight or obesity focus on one movement behavior in isolation (i.e. moderate to vigorous physical activity (MVPA)). However, recent research suggests to incorporate all movement behaviors performed in one day to explore the possible synergistic health effects of targeting more than one behavior. Moreover, more optimal 24-hour movement behavior compositions are related with better cardiometabolic health. Literature shows that adults with obesity have less optimal 24-hour compositions (8-9). Therefore it would be of interest to discover the needs related to an optimal 24-hour movement behavior intervention for a group of adults with overweight and obesity using co-design to develop an intervention.

This study will conduct a concept mapping protocol to explore the needs to of people with overweight and obesity to change their sedentary behavior into more physical activity as well to include the opinion of health care providers (HCP are physiotherapists) on the needs of their patients.


Eligibility Criteria:
Group Health Care providers

Inclusion Criteria:

* The HCP will consist of physiotherapists and movement on referral coaches (https://www.gezondleven.be/projecten/bewegen-op-verwijzing). HCP are included when working on a healthy lifestyle as well as working with clients struggling with overweight or obesity.

Group Adults with overweight and obesity

Inclusion Criteria:

* Adults aged 25-64 years
* Active on the job market for at least 50 percent
* BMI ≥25kg/m²

Exclusion Criteria:

* - Retirement and early retirement
* Unemployment
* Working for less than 50 percent
* Working in night shifts
* Physical (e.g. amputations, paralysis, recovering from stroke, osteoarthritis), cognitive (e.g. dementia, psychological disorders) and major medical (e.g. Chronic respiratory diseases, heart failure, cardiovascular diseases, cancer) conditions that obstruct daily functioning
* Diabetes diagnosed by a general practitioner
* Pregnancy
* Pregnancy \<1 year ago
* Currently involved in study specific weight loss interventions
* Post-surgery weight loss interventions
* Waitlist for weight loss surgery
* Hospitalized
Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke

The main purpose of this trial is to analyse the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke by Metabonomics, proteomics and clinical parameters.

Xingnaojing is widely used in China, but there is lack of sufficient and reasonable explanation of its intervention effects for acute ischemic stroke currently. The primary hypothesis of this trial is that , Compared with the blank control group, Xingnaojing will produce serial changes in plasma and urine metabolites and biomarkers at baseline (pre-dose), 8 days and 11days . The serial changes may be the potential support to explain the intervention effect of Xingnaojing. All participants will have a National Institutes of Health Stroke Scale(NIHSS)entry score of 4-25. Participants who have planned or already received the intravenous thrombolysis or endovascular treatment will be excluded. The primary outcome will be determined at 11 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Acute ischemic stroke；
* Symptom onset within 24 hours；
* 35 ≤ Age ≤ 80 years；
* 4 ≤ NIHSS ≤ 25；
* Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

* Expected length of hospital stay is less than 10 days;
* Planned or already receiving intravenous thrombolysis or endovascular treatment;
* Use of drugs with unknown composition within 1 week before enrollment;
* Patients with acute infectious diseases (e.g. acute pneumonia) or taking related drugs within 1 month before treatment in the group;
* Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases;
* Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score ≥ 2) ;
* Other conditions that cause cardiogenic embolism (e.g., atrial fibrillation, rheumatic heart disease, valvular heart disease);
* Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis);
* Significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal);
* Life expectancy of 3 months or less due to other life-threatening illness (e.g.,advanced cancer)
* Other conditions that render outcomes or follow-up unlikely to be assessed;
* Known to be pregnant or breastfeeding;
* Currently receiving an investigational drug.
High Flow vs Conventional Oxygen in Head and Neck Surgery

Patients undergoing major head and neck surgery are at risk for postoperative pulmonary complications. The goal of this randomized clinical trial is to evaluate the effectiveness of high flow heated humidified oxygen at preventing postoperative pulmonary complications after major head and neck surgery, when compared to conventional oxygen therapy (aerosol cool mist).

Participants enrolled in this study are randomly assigned to receive either conventional oxygen therapy (aerosol cool mist) or heated humidified high flow oxygen via the trach after head and neck surgery. The study team then collects information regarding clinical outcomes to explore if there are differences between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing major head and neck surgery that includes any neck dissection
* Major head and neck surgery is defined as having a mean length of stay of three or more days, based on the diagnosis \[14\]
* Surgery requires an elective tracheostomy for airway protection or laryngectomy tube in the case of total laryngectomy

Exclusion Criteria:

* \<18 years of age
Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer

The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) in patients with metastatic breast cancer helps to decrease or stop tumor growth.

This study has previously been registered by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of this study.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic breast cancer (meaning the cancer has spread beyond its original location)
* At least one measurable lesion by CT or MRI
* Progression of disease following previous therapy for breast cancer
* Have received previous treatment with anthracyclines (e.g. doxorubicin\[Adriamycin or Doxil\] or epirubicin \[Ellence\]), taxanes (paclitaxel \[Taxol or Abraxane\] or docetaxel \[taxotere\]) for your breast cancer
* Not be pregnant
* Additional criteria to be determined at screening visit.

Exclusion Criteria:

* More than 3 previous chemotherapy regimens
* More than one treatment with non cytotoxic agents for breast cancer therapy (e.g. herceptin \[trastuzumab\] or Avastin \[bevacizumab)
* Prior treatment with epothilones (e.g. Ixabepilone)
* Symptomatic brain metastases
* Additional criteria to be determined at screening visit
Phase II Study of RR110 in Patients With Active Crohn's Disease

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics profile of 1 and 4 mg/kg/day RR110 administrated orally for 8 weeks in patients with active Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CDAI score ranging from 220 to 450
* Patients with CRP \> 1 mg/dL
* Patients who can be hospitalized at least 2 weeks after first administration

Exclusion Criteria:

* Patients who have previously used anti-TNF antibody, cyclosporine, methotrexate or tacrolimus within 12 weeks of screening
* Patients who have had surgical bowel resections within 4 weeks of screening
* Patients who have previously used total parental nutrition or more than 900 kcal/day of enteral nutrition within 4 weeks of screening
Prospective Study on Monitoring Parotid Gland Injury After Radiotherapy for Head and Neck Tumors Using Multimodal Radiomics

Exploring a non-invasive and objective method for ultra early quantitative assessment of radiation-induced parotid gland injury. To provide a new and early method for evaluating changes in parotid gland function in clinical practice, and to guide the timing of interventions to protect the parotid gland.

Exploring the application value of magnetic resonance fingerprinting (MRF) and intravoxel incoherent motion (IVIM) techniques in dynamically monitoring parotid gland injury and predicting the risk of dry mouth after radiotherapy for head and neck tumors. The study evaluated the changes in parotid gland cell density and microcirculation function by quantifying MRF (T1/T2 relaxation time, proton density) and IVIM parameters (D value, D \* value, f value), combined with parotid gland volume reduction rate, to establish an early risk model for predicting dry mouth syndrome and optimize parotid gland protection strategies.

Eligibility Criteria:
Exclusion Criteria:

1. Contraindications to MRI, such as metallic implants or claustrophobia.
2. Severe comorbid conditions, including significant renal or hepatic dysfunction.
3. Concurrent participation in another interventional clinical trial.
4. Pregnant or breastfeeding.
5. Any condition that may impair compliance with study procedures.

Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of nasopharyngeal carcinoma.
2. Scheduled to undergo radiotherapy as part of standard treatment.
3. Aged 18 years or older.
4. No contraindications to MRI scans (e.g., no implanted metallic devices).
5. Written informed consent has been provided.
Association of Carotid Arterial Circumferential Strain With Left Ventricular Function and Hemodynamic Compromise During Off-pump Coronary Artery Bypass Surgery

This study is aimed to evaluate the association of common carotid artery circumferential strain with the echocardiographic parameters of left ventricular function and the degree of actual hemodynamic deterioration in patients undergoing multi-vessel off-pump coronary artery bypass with preserved left ventricular ejection fraction.


Eligibility Criteria:
Inclusion Criteria:

1. three vessel coronary artery disease
2. sinus rhythm

Exclusion Criteria:

1. New York Heart Association functional class ≥3
2. known pulmonary hypertension
3. known valvular heart disease
4. serum creatinine ≥2.0 mg/dL
5. myocardial infarction within 1 week before the surgery
6. history of cerebral or peripheral arterial occlusive disease