cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Vein of Marshall Ethanol Infusion During Left Atrial Linear Ablation in Patients With Persistent Atrial Fibrillation

In this prospective, randomized, controlled, unblinded, mono-center study, we aim to evaluate the efficacy of vein of Marshall ethanol infusion during left atrial linear ablation in patients with atrial fibrillation compared to the ALINE protocol.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 85 years
* Diagnosed with symptomatic AF without previous mitral isthmus line ablation

Exclusion Criteria:

* Previous MI line ablation
* Left atrial thrombus. LAA thrombus can be determined by preprocedural imaging: CT, TEE or MRI.
* LA diameter greater than 55 mm on long axis parasternal view, or left atrial volume more than 200 cc.
* Left ventricular ejection fraction \<35%.
* Cardiac surgery within the previous 90 days.
* Expecting cardiac transplantation or other cardiac surgery within 180 days.
* Coronary PTCA/stenting within the previous 90 days or myocardial infarction within the previous 60 days.
* Documented history of a thromboembolic event within the previous 90 days.
* Diagnosed atrial myxoma.
* Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
* Women who are pregnant or who plan to become pregnant during the study.
* Acute illness or active infection at time of index procedure
* Renal insufficiency
* Unstable angina.
* History of blood clotting or bleeding abnormalities.
* Contraindication to anticoagulation.
* Life expectancy less than 1 year.
* Uncontrolled heart failure.
* Presence of a condition that precludes vascular access.
* INR greater than 3.5 within 24 hours of procedure - for patients taking warfarin.
* Patient cannot be removed from antiarrhythmic drugs for reasons other than AF.
* Unwilling or unable to provide informed consent.
Study of CM310 Injection in Subjects With Moderate-to-Severe Atopic Dermatitis

This study is a multi-center, randomized, double-blind, parallel controlled phase 2 study, aimed at evaluating the efficacy and safety of CM310 in the treatment of patients with moderate-to-severe atopic dermatitis, and observing Pharmacokinetics characteristics, Pharmacodynamics effects and immunogenicity.

This study includes screening, treatment and follow-up periods. 160 subjects will be enrolled to receive CM310.

Eligibility Criteria:
Inclusion Criteria:

* Have the ability to understand the study and voluntarily sign a written ICF.
* Age ≥ 18 and ≤ 75 years old, male or female.
* The fertile subjects agreed to take effective contraceptive measures throughout the study period.
* The subjects can communicate well with the investigators and complete the follow-up according to the protocol.

Exclusion Criteria:

* Live vaccine or attenuated live vaccine has been vaccinated or planned to be vaccinated within 12 weeks before randomization.
* He received allergen-specific immunotherapy (desensitization therapy) within 6 months before randomization.
* Major surgery is planned during the study period.
* Previous history of atopic keratoconjunctivitis and corneal involvement.
* Other combined skin diseases that may affect the evaluation of the study.
* Confronting IL-4R α Monoclonal antibody or CM310/placebo drug or ingredient allergy.
Efficacy of a Behavioral Based Education Intervention to Decrease Medication History Errors Among Professional Nurses.

The purpose of the study is to determine if a behavioral knowledge based education intervention will decrease medication transcription errors among professional nurses when admitting elder patients to a hospital. The hypothesis is those professional nurses who receive the behavioral-cognitive eduction medication taking intervention will have fewer medication errors than those professional nurses who do not.


Eligibility Criteria:
Inclusion Criteria:

* Nurses working 20 hours a week or more

Exclusion Criteria:

* Nurses working less than 20 hours a week
* Nurse working as a float or pool nurse
The Purpose of the Study is to Examine Whether Iron Deficiency Anemia is Associated With Increased Production of Thrombin and Whether Correction of Anemia by Providing Iron Intravenously Causes a Significant Reduction in Production of Thrombin.

In total 50 subjects with iron deficiency anemia treated with intravenous iron are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant before iron treatment. The investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). patient will go face to face interview and will be asked to answer structured questionnaire which will include information on demographics, clinical data ( fever, allergies , etc.) and comorbidities

Two weeks after completing intravenous iron administration additional blood samples will be taken: thrombin generation will be measured


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* Iron deficiency anemia that did not response to oral iron treatment and is planned to receive iron supplement intravenously.
* Signing the informed consent

exclusion criteria:

* chronic inflammatory disease
* renal failure
* Malignancy
* Infectious disease
* Other reason for anemia except iron deficiency anemia.
* Pregnant women
* Use of anti aggregating agents or anticoagulants
Palliative Care in Pulmonary Fibrosis

The investigators will examine the effect of introducing palliative in patients with end-stage idiopathic pulmonary fibrosis, refractory to the pharmacological treatment or not deemed to be treated, on patient-reported outcomes and end-of-life care. The investigators will randomly assign patients who receive either early palliative care integrated with standard respiratory care or standard respiratory care alone.

Quality of life and symptoms will assessed at baseline and at 12 weeks The primary outcome will be the change in the quality of life and symptoms at 12 months.

Advanced fibrosing interstitial lung disease (ILD) is a group of often progressive and incurable conditions.

The most common form of ILD, idiopathic pulmonary fibrosis (IPF), is associated with poor survival, and high symptom burden and poor quality of life as the disease progresses.

ILD represents an increasing proportion of patients with chronic hypoxemic respiratory failure.

Despite this poor prognosis, palliative care remains underused in patients with ILD. This may be due to under-recognition of the palliative care needs and symptom burden, or unfamiliarity and discomfort with palliative therapies.

Though oncology has largely embraced earlier integration of palliative care, which has translated into improvements in end-of-life (EOL) care for patients with lung cancer,palliative and EOL care for non-malignant diseases are now gaining increased attention.

In pulmonary disease, this research has mainly focused on COPD and demonstrated a significant burden of unmet palliative care needs and lower quality of EOL care compared with patients with cancer. Similar attention is only beginning to be paid to ILD, but symptom burden and quality of EOL care in patients with ILD have yet to be quantified, and furthermore none has so far investigated the possible role of palliative care in these patients.

The investigators will examine with the present study the effect of introducing palliative in patients with end-stage idiopathic pulmonary fibrosis, refractory to the pharmacological treatment or not deemed to be treated, on patient-reported outcomes and end-of-life care. The investigators will randomly assign patients who receive either early palliative care integrated with standard respiratory care or standard respiratory care alone.

Quality of life and symptoms will assessed at baseline and at 12 weeks The primary outcome will be the change in the quality of life and symptoms at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of idiophatic pulmonary fibrosis
* resting partial arterial oxygen pressure (PaO2) \< 60 mmHg
* Decline in Forced Vital Capacity (FVC) \> 10% in the last 6 months
* stage 3 according to the GAP index

Exclusion Criteria:

* active treatment with antifibrotic drug
* concomitant cancer
Prospective Trial of Oral Vancomycin Therapy vs. Placebo for Prevention of CDI

The purpose of this research study is to determine in patients receiving intravenous (IV) antibiotic(s), if giving oral vancomycin therapy will prevent C. difficile-associated infection (commonly called CDI). Oral vancomycin is an antibiotic that is commonly used to treat CDI. The investigators want to study if using this drug can prevent the development of CDI while you are in the hospital receiving IV antibiotics. The key risk factors for developing CDI are age and IV antibiotic therapy. CDI is an infection in your colon caused by an organism called Clostridium difficile (or C. diff for short) that causes diarrhea. Up to 12% of hospital-acquired infections have been reported to be CDI. It can lead to longer hospital stays and more costs associated with the hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* 1. Older patients (\> 65 years of age), hospitalized for \> 48 hours and treated with parenteral antimicrobial therapy for \> 48 hours at CHI Creighton University Medical Center-Bergan Mercy will be eligible for enrollment.

Exclusion Criteria:

1. Patients diagnosed with CDI within the first 72 hours of hospitalization and/or diagnosed with CDI within the past 3 months
2. Patients diagnosed with gastrointestinal infection other than CDI
3. Patients who have received a solid-organ transplant in the past 12 months
4. Females who are pregnant or immediately post-partum
5. Patients admitted to the hospital with an opportunistic infection secondary to HIV-1 and CD4 cell count of \< 200 cell/mm3
6. Patients receiving cancer chemotherapy or immune modulator drugs (i.e. Checkpoint inhibitors; PD-1/PD-L1 inhibitors; biologic DMARDs) as examples
7. Patients being treated with ≥ 28 days of intravenous (IV) antimicrobials (complex S. aureus bacteremia, osteomyelitis, endocarditis)
Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study)

It is important to confirm health benefits experienced by breast cancer survivors after participation in a physical activity behavior change intervention. One such potential benefit is a reduction in harmful inflammation that might lead to increased symptoms or cancer risk. Because little is known about how physical activity behavior change interventions influence inflammation in breast cancer survivors, the investigators study will measure inflammation with blood markers known as cytokines among breast cancer survivors before and after a physical activity intervention. Such information has the potential to lead to improved physical functioning, reduction in bothersome symptoms (e.g., fatigue), and reduced cancer risk in breast cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* Female breast cancer patients between the ages of 18 and 70 years of age with a diagnosis of Stage I, II, or IIIA breast cancer who are not currently receiving (and do not plan to receive during the study duration) chemotherapy or radiation therapy. The participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc.
* If the patient has undergone a surgical procedure, must be at least 8 weeks post-procedure.
* English speaking.
* Medical clearance for participation provided by primary care physician or oncologist.

Exclusion Criteria:

* Diagnosis of dementia or organic brain syndrome.
* Medical, psychological, or social characteristic that would interfere with ability to fully participate in program activities and assessments (e.g., psychosis, schizophrenia, etc.).
* Contraindication to participation in a regular physical activity program.
* Metastatic or recurrent disease
* Inability to ambulate
* Engaged in ≥ 60 minutes of vigorous physical activity or ≥ 150 minutes of moderate plus vigorous activity per week during the past month.
* Anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery).
* Participant does not live or work within 50 miles of the study site.
Effects of EMG-driven Robot-assisted Therapy for the Distal Upper Limb Motor Function in the Chronic Stroke Patients With Botox Injections

Over fifty percent of stroke patients experience chronic arm hand performance problems, compromising independence in daily life activities and quality of life. Traditionally, the effectiveness of rehabilitation in improving functioning for stroke patients more than 6 months has not been proven. However, spontaneous neurological recovery reaches the plateau at 3\~6 months later.

Hand of Hope is a virtual reality (VR)-based, electromyography (EMG)-driven, and task-oriented hand robot. Otherwise, it needs patients to have active participation during the intervention which is critical for motor recovery after stroke. Robotic rehabilitation devices have the potential to deliver high-intensity, reproducible therapy. Robot-assisted task-oriented training had been proposed by several researchers, but the evidence of clinical effectiveness in highly functional chronic stroke patients is still lack.

Spasticity is a common disorder which occurs following stroke. The prevalence of post-stroke spasticity can be as high as 46% in the chronic phase (over 3 months). Spasticity impacted activities of daily living, quality of life, pain, and functional impairments. Long-term spasticity may lead to tendon contracture and limb deformities. Botulinum toxin injection, which mostly used in chronic phase (over 6 months), had been proved to be a safe agent representing the gold standard treatment for focal spasticity, while avoiding systemic effects. But the effects of botulism toxin on functional ability are still unclear. Moreover, there is insufficient evidence on adjunctive therapies following botulism toxin.

The purpose of the present study is to examine the effects of botulinum toxin injection combined with Hand of Hope and standard occupational therapy on upper extremity function, and compares the findings to those of amount-matched chronic stroke survivors who received only Botulinum toxin injection and standard occupational therapy.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 20-85 year-old
* The onset of stroke must be at least 6 month previously
* The stroke must be the first event
* The stroke must be unilateral brain lesion
* Spasticity measured as Modified Ashworth scale during 1+ to 3
* Score at least 1 point in the wrist subtest of Fugl-Meyer Assessment
* Brunnstrom stage of proximal upper limb at least 3, distal upper limb between 2 to 5
* No impairment in visual tracking ability
* No impairment in proprioception

Exclusion Criteria:

* Severe joints pain of hand or finger at affected limb
* Fracture of affected limb in three months
* Brunnstrom stage of proximal upper limb not more than 2, distal upper limb more than 5
AGE/sRAGE Ratio in Diabetic Periodontitis

The goal of this observational study is to learn about some molecules in the disease mechanism of type 2 diabetes and periodontitis. There are end products inside the body called AGEs and their receptors binding to them especially (sRAGE, RAGE) in people with diabetes in hyperglycemic state.These molecules are important also in periodontitis (the disease of teeth that may end with exfoliation of the tooth). Diabetes and periodontitis enhance each other's disease-causing effects. Both is chronic inflammatory diseases and IL-17 is another molecule having role in this process.

Totally 64 men and women aged between 27-60 included in the study. Study groups were : 1.participants with healthy teeth and no diabetes, 2. participants with periodontitis without diabetes, 3.participants with periodontitis and controlled diabetes, 4.participants with periodontitis and uncontrolled diabetes (6.5% and fasting blood sugar levels \<200 mg/dl). Researchers got saliva and gingival crevicular fluid (GCF) samples from diseased teeth and examined AGE, sRAGE, IL-17 levels. GCF is a fluid around the crevice of the theeth with different characteristics from saliva.

As a result AGE/sRAGE ratio and IL-17 levels of diseased groups were higher than healthy group, while sRAGE levels were significantly lower in GCF samples. Researchers concluded that GCF and saliva AGE/sRAGE ratio may represent as a biomarker in periodontitis patients with uncontrolled diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Having interdental attachment loss in at least two non-adjacent teeth, or with \>3 mm of attachment loss in the buccal or palatal/lingual region with \>3 mm probing depth in at least two teeth for periodontitis groups.
* Having minimum 5mm or more pocket depth in at least 6 periodontal pockets.
* HbA1c value ≤ 6.5% and fasting blood sugar levels \<200 mg/dl for the controlled diabetes group.
* HbA1c value \> 6.5% and fasting blood sugar levels \> 200 mg/dl for uncontrolled diabetes group.

Exclusion Criteria:

* having periodontal treatment in the last six months;
* participants with smoking habit or history; and
* usage of medicine that may affect study results (mouthwash, antibiotics, corticosteroid, statins etc.) three months before collecting dental plaque and GCF samples.
* Lactating or pregnant patients
* Patients with systemic diseases other than type 2 diabetes.
Microbiome Therapy in Covid-19 Primary Care Support

This double-blind, randomized, placebo-controlled study aims to investigate whether a throat spray containing probiotic bacteria (i.e. microbiome spray) can reduce the symptoms and complaints of the SARS-CoV-2 virus in patients with mild to moderate symptoms. In addition, the aim is to investigate whether the microbiome spray can prevent transmission of the SARS-CoV-2 virus to household members.


Eligibility Criteria:
Inclusion Criteria:

* Patients in primary care with a positive SARS-CoV-2 test based on PCR
* Instructed during screening and agreed not to use other probiotic nutritional supplements outside of the study during the study period
* Sign the consent form

Exclusion Criteria:

* Antibiotic use at baseline and during the study
* Vaccinated against SARS-CoV-2 at start of the study (both for index patients and household members that participate)
* Pregnant women
* History of use of probiotic supplements in the past two weeks
* Current diagnosis of cancer or immunosuppressive therapy within the past 6 months
* Acute and chronic infectious and inflammatory upper airway diseases (eg acute / chronic rhinosinusitis)
* Clinically significant bleeding disorder
* Any other medical condition that, in the principal investigator's opinion, warrants exclusion from the trial
De Novo Everolimus Versus Tacrolimus in Combination With Mofetil Mycophenolate and Low Dose Corticosteroids to Reduce Tacrolimus Induced Nephrotoxicity in Liver Transplantation: a Prospective, Multicentric, Randomised Study

Tacrolimus is a calcineurin inhibitor. This is the immunosuppression of reference for patients undergoing a first liver transplant. This treatment can prevent graft rejection, but can cause side effects including kidney failure (in 25% after the first year).

Everolimus is an immunosuppressive that effectively prevents acute rejection in heart and kidney transplant recipients. It preserves renal function when it is started soon after the transplant, i.e. before a severe dysfunction is installed.

In the liver transplant, early interruption of calcineurin inhibitors with a quick relay everolimus monotherapy preserves renal function and is associated with a lower acute rejection rate.

We wish to assess whether the introduction of a de novo immunosuppression everolimus under protection of basiliximab induction, mycophenolate mofetil and then low doses of corticosteroids, reduces the nephrotoxicity of immunosuppressive therapy in liver transplant patients, compared to a standard protocol with tacrolimus associated with mycophenolate mofetil and low dose corticosteroids.

Eligibility Criteria:
Pre-transplantation Inclusion Criteria:

* Adults (≥18 years), male or female,
* Patients due to receive a first liver transplant with a full or reduced graft taken from a donor brain-dead beating heart or a related living donor,
* Patients having given a free and informed written consent .

Post-transplantation Inclusion criteria: Patients meeting the following criteria will be included:

* Receiving basiliximab (Simulect)
* Whose immunosuppression regimen from day 5 could immediately consist of either tacrolimus or everolimus, in combination with mycophenolate mofetil and low dose corticosteroids
* With hepatic artery permeable to echo Doppler 4 days after transplant.

Exclusion Criteria:

* History of immunosuppressive therapy,
* Known hypersensitivity to the treatments or macrolides,
* HIV infection
* Autoimmune hepatitis,
* Primary sclerosing cholangitis,
* Programming or realization of a combined transplant,
* Pregnancy or lack of effective contraception,
* Breastfeeding.
* Incompatibility with the donor,
* Thrombosis of the hepatic artery between D0 and D4,
* Non-primary graft function leading to a re-registration on the waiting list.
Reducing Range of Motion Deficits Post Radial Fracture

This a randomized controlled study to test the hypothesis that patients who perform in-cast exercises will have superior range of motion immediately post-cast removal, without a concomitant increase in complication rate when compared with a control group who receives standard post cast care which does not include the intervention exercises.


Eligibility Criteria:
Inclusion Criteria:

* patient experienced distal radial fracture
* patient is over 18 years of age
* patient can follow instructions and comply with protocol
* fracture is managed non-operatively

Exclusion Criteria:

* bilateral wrist fractures
* previous fracture to the affected wrist
* previous range of motion limitations to the affected wrist
* involvement of other upper extremity structures (i.e. shoulder)
Booster as an Adjunct to Internet-based Cognitive Behavior Therapy (CBT)

In this trial, we test if adding an Internet-based booster program to regular Internet-based cognitive behavior therapy (ICBT) is effective for patients with obsessive-compulsive disorder (OCD).

Written consent form. Completing ICBT in our previous study: Please see NCT01347099 for more details.

Eligibility Criteria:
Inclusion Criteria:

* Signed consent
* Previously enrolled in our randomized controlled trial testing ICBT for OCD: NCT01347099

Exclusion Criteria:

* Suicidal ideation that could jeopardize participation