cyrilzakka/clinical-trials huggingface dataset:
Improving Night Shift Nurses' Health and Reducing Burnout

Healthy and happy nurses are essential to ensuring optimal patient outcomes and organizational success. The evidence on the negative impacts of night shift on nurses' health and cognitive function, and their implications on patient outcomes and organizational costs, reflect the need for interventions to mitigate these detrimental outcomes.

This pilot, feasibility, clinical trial will examine the feasibility of two fatigue countermeasure interventions (access to napping/relaxation room and use of blue/green light blocking glass during night shift) and explore the interventions effects on nurses' health, missed care, and burnout.

Aim 1 (Primary): Examine the feasibility of a larger study and hospital-wide implementation of two fatigue countermeasure interventions (access to napping/relaxation rooms and use of blue/green light blocking glass during night shift).

Aim 2 (Exploratory): Explore the effects of the interventions on melatonin levels, overall health, sleep, fatigue, cognitive function, missed care, nurse burnout, and salivary melatonin levels.

Eligibility Criteria:
Inclusion Criteria:

* Being a registered nurse at UPMC Shadyside (Pittsburgh, PA)
* Working full-time night or rotating shifts
* Willing to wear a Fitbit around-the-clock during the study
* Willing to use nap/relaxation room and glasses only when assigned to that condition
* Willing to provide saliva samples

Exclusion Criteria:

* Having a diagnosed sleep disorder (e.g., obstructive sleep apnea, insomnia, restless leg syndrome, or shift work disorder)
* Currently being treated for a serious mental illness
* Needing to use eye glasses to complete work related activities (note: contact lenses are acceptable)
* Use of prescription or over-the-counter sleep aides including melatonin
Screening to Prophylax Against Clostridium Difficile Infection -

The goal of this study is to evaluate whether using vancomycin orally can prevent CDI in patients who are colonized with C. difficile who are admitted to the hospital and need antibiotics for another infection.

Screening to Prophylax against CDI (SToP CDI) is a prospective, single-center, double-blinded, randomized, placebo-controlled study of the effectiveness of vancomycin vs. placebo for preventing CDI in patients colonized with toxigenic C. difficile and receiving high-risk antibiotics. The investigators plan to screen 2500 patients to randomize 200.

Consented patients will have a stool sample collected and tested for presence of toxigenic C. difficile by polymerase chain reaction (PCR) test. Patients who test negative will simply be followed for development, severity and outcome of CDI. Patients who test positive (are colonized with C. difficile) will be randomized to one of two arms:

Arm 1: Patients receive 125 mg vancomycin by mouth (PO) every 6 hours as prophylaxis against C. difficile for the duration of their antibiotic treatment +3 days.

Arm 2: Patients receive placebo by mouth (PO) every 6 hours for the duration of their antibiotic treatment +3 days.

Eligibility Criteria:
Inclusion Criteria:

1. Expected duration of admission sufficient to complete screening and enrollment
2. Age ≥18
3. Able to give informed consent
4. Initiated on one of the following antibiotics within the prior 72 hours with an expected duration of at least 72 hours from enrollment: clindamycin, ampicillin, ampicillin/sulbactam, amoxicillin, amoxicillin/clavulanate, moxifloxacin, levofloxacin, piperacillin/tazobactam, or any cephalosporin
5. Maximum expected duration of antibiotics 8 weeks
6. Able to take oral study medications
7. Able to provide a stool sample during hospitalization or within 3 days of discharge
8. Reasonably expected to be able to complete follow up

Exclusion Criteria:

1. Chron's disease, ulcerative colitis, celiac disease, or other chronic diarrheal illness
2. CDI within prior 90 days
3. Currently on metronidazole, oral vancomycin, rifaximin, fidaxomicin, or any other antibiotic active against C. difficile
4. Current diarrhea
5. Current ileostomy, colostomy or other form of surgically disconnected gut such that oral therapy would not be expected to reach the entire lumen of the gut
6. Pregnancy or breast feeding (determined prior to randomization)
7. Travel to an area of endemic diarrheal illness within the last 30 days
8. Life expectancy of less than 60 days
9. Known allergy to vancomycin
10. Participation with other research trials that could impact the results of this trial within the last 30 days
11. Previously enrolled in this study
Effect of Vitamin E Supplementation in Methylation and microRNAs Profile

It is a study of clinical and interventional character, in which individuals who participate in the intervention will be selected for convenience of the project database entitled "Second Cycle Diagnosis and Intervention Food Situation, Nutrition and Noncommunicable Disease More Prevalent Population of the city of João Pessoa / PB ". They will be invited to participate in the intervention female subjects, overweight or obese, aged 20 and 59 years. The selected individuals will be distributed randomly into four groups: receive daily supplementation of 01 capsules containing 400 mg of vitamin E synthetic source (Group 1); receive daily supplementation of 01 capsules containing 400 mg of natural source vitamin E (Group 2); receive daily supplementation of 01 placebo capsule (control group); and non-intervention group. Individuals of intervention groups will receive dietary plan respecting individual needs, in order to control weight during the 08 weeks period. The subjects of the group without intervention, did not follow a diet plan, nor did they take vitamin E or placebo capsules, and were asked to continue their current eating habits over the 8-week period This project aims to evaluate whether vitamin E supplementation may modify the methylation and microRNAs profile.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects;
* Persons aged between 20 and 59 years;
* Overweight or obese;

Exclusion Criteria:

* Individuals consumed alcohol and / or chronic smokers;
* Individuals who do not have preserved cognitive status;
* Individuals users of multivitamins and mineral supplements, appetite suppressants and steroids;
* Pregnant women.
Stony Brook Medicine Anti-Inflammatory Trial

This is an experimental study designed to measure the effect of celecoxib or minocycline on depressive symptoms in unipolar and bipolar depression. Participants will be equally randomized to either celecoxib or minocycline. All participants will complete a battery of clinical and psychological assessments prior to treatment assignment, and again after treatment completion, to assess any changes or improvements in depression.


Eligibility Criteria:
Inclusion Criteria:

* Current consent form signed
* Capacity to give informed consent
* Age range 18-65 (inclusive)
* Diagnosis of MDD or bipolar depression and currently in a major depressive episode
* Score of at least 29 on the MADRS (at least moderate depression)

Exclusion Criteria:

* Hypersensitivity to celecoxib, minocycline, tetracyclines, sulfonamides, aspirin, other NSAIDs, or any component of the formulation; previous asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
* History of myocardial infarction or current cardiac condition
* Heptic impairment, heart failure, severe renal impairment, recent GI bleed, history of peptic ulcer disease, anemia or any other contraindication for celecoxib or minocycline
* Poor CYP2C9 metabolizer
* Currently taking medications that interact with celecoxib (digoxin, antihypertensives, diuretics, anticoagulant or anti-platelet treatment, including aspirin), or minocycline (isotretinoin, ergot alkaloids) without providing physicians approval
* Use of herbs, drugs, or medications with anti-inflammatory or immunomodulatory properties (within 5 half-lives of starting celecoxib or minocycline treatment)
* Unlikely to tolerate medication washout or the medication-free period following washout.
* Participant considered at significant risk for suicide.
* Electroconvulsive therapy (ECT) within 1 month
* High potential for excessive drug/alcohol use during the treatment period (excluding nicotine or cannabis)
* Significant active physical illness or neurological deficit that may affect brain functioning.
* If participant is currently pregnant, breastfeeding, or planning to conceive during the course of study participation.
* Need for medications that control mania.
Group-based Cardiac Telerehabilitation and Its Effectiveness

Cardiovascular diseases (CVD) and coronary artery diseases (CAD) are the most common cause of death worldwide. After an acute cardiac event, prevention of new cardiac events is essential and reduces suffering. Group-based cardiac telerehabilitation (CTR) refers to the use of information and communication technologies for rehabilitation purposes in promoting CAD patients´ health.

This study aims to assess the group-based cardiac telerehabilitation model and its effectiveness. The data is collected from two University hospitals in Finland. Patients with coronary heart disease two months after percutaneous coronary intervention (N=198) are invited to the study. All the participants are being treated in a healthcare unit that uses digital care pathways for coronary patients. Patients can choose the usual care or group-based cardiac telerehabilitation as follow-up care. All the patients are invited to the study after the chosen follow-up care (telerehabilitation or usual care). Patients will be allocated into two groups: The telerehabilitation group is the intervention group and the usual care group is the control group. Quality of life, adherence to treatment, and lifestyle changes are measured at the baseline and 3, 6, and 12 after the intervention baseline.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have patients with coronary heart disease two months after percutaneous coronary intervention.
* Participants must have ≥18 years of age, and ≤100 years of age
* Participants are being treated in a healthcare unit that uses digital care pathways for coronary patients.

Exclusion Criteria:

* Participants must not have coronary artery disease diagnosed.
* Participants have been in other operations than percutaneous coronary intervention.
Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of anti-CD5 CART cells in patients with relapsed and/or refractory T cell lymphoma or leukemia.

Anti- CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD5 antigen. CD5+ T cell lymphomas or leukemia are a subset of leukemias and lymphomas that are positive for the surface protein CD5. The purpose of this study is to evaluate the efficacy and safety of anti-CD5 CAR T cells.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent; Patients volunteer to participate in the research
2. Diagnosis is mainly based on the World Health Organization (WHO) 2008
3. Patients have exhausted standard therapeutic options
4. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
5. Female must be not pregnant during the study

Exclusion Criteria:

1. Patients declining to consent for treatment
2. Prior solid organ transplantation
3. Potentially curative therapy including chemotherapy or hematopoietic cell transplant
4. Any drug used for GVHD must be stopped \>1 week
Cardiovascular Manifestation of Inflamatory Bowel Disease Patient ( Tissue Doppler Echocardiography and Cardiac MRI )

1. Evaluation of cardiovascular changes using Doppler echocardiography and cardiac MRI in IBD patients
2. To detect the frequency of myocardial injury in IBD patients
3. To detect the sensitivity and specificity of echocardiography for the detection of cardiac injury in comparison to cardiac MRI in IBD patients

The burden of extra-intestinal disease is high in patients with IBD, some of whom respond to or are prevented by treating the bowel inflammation, whereas others require specific treatment because they are independent of the underlying bowel inflammation .

Cardiovascular diseases are the major causes of mortality and morbidity worldwide. They may arise for various reasons such as obesity, type 2 diabetes, genetic, environmental, dietary, and lifestyle factors. Besides all these, there is much evidence suggesting that inflammation is an important player in the pathogenesis of heart disease, as well as atherogenesis and atherosclerosis . A most common systemic inflammatory disease is inflammatory bowel disease (IBD), which is a collection of ulcerative colitis and Crohn's disease, a chronic intestinal disease that may arise due to different factors, and is precipitated by environmental and genetic susceptibility Tissue Doppler imaging (TDI) is a useful echocardiographic technique to evaluate global and regional myocardial systolic as well as diastolic function. It can also be used to quantify right ventricular and left atrial function.

To date, cardiac magnetic resonance imaging (cMRI) is mostly used to detect significantly decreased EFs and abnormalities in wall motion. Contrast enhancement (CE) CMR is a more sensitive technique of cMRI and can detect areas of myocardial damage in patients with acute myocarditis .

Eligibility Criteria:
Inclusion Criteria:

* IBD patients presented with disease flare, which is grouped by the 3 domains of disease severity:

  * Measurable inflammatory burden (C-reactive protein, mucosal lesions, upper gastrointestinal involvement, and disease extent.
  * Disease course (including structural damage, history/extension of intestinal resection, perianal disease, number of flares, and extraintestinal manifestations)

Exclusion Criteria:

* Patients with poor echocardiographic window, previously diagnosed as IHD, complete heart block, mitral stenosis, prosthetic mitral valve, congenital heart disease with a left to right shunt, and CKD patients will be excluded from the study.
RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas

The urgent need for new effective therapy for T-cell lymphoma patients and promising results observed so far in trials with RAD001(everolimus, mTOR inhibitor) strongly warrants the investigation of RAD001 combined with CHOP as a first-line treatment in peripheral T-cell lymphoma patients.

Thus, we designed a phase I/II study with the combination of RAD001 with CHOP chemotherapy for newly diagnosed peripheral T-cell lymphoma patients.

Phase I

1. Primary objective

   : To define the maximum tolerable dose
2. Secondary objective

   * To evaluate the dose-limiting toxicity
   * To evaluate the pharmacokinetics of RAD001
   * Pharmacogenomic profiling

Phase II

1. Primary objective

   : To evaluate the overall response rate
2. Secondary objective

   * To estimate the time to progression
   * To estimate overall survival
   * Pharmacogenomic profiling

Phase I Level 1: RAD001 2.5 mg PO daily D1-14 + CHOP Level 2: RAD001 5 mg PO daily D1-14 + CHOP Level 3: RAD001 7.5 mg PO daily D1-14 + CHOP Level 4: RAD001 10 mg PO daily D1-14 + CHOP CHOP every 3 weeks D1 Cytoxan 750mg/m2 + D5W 100ml MIV over 1hr D1 Doxorubicin 50mg/m2 + D5W 100ml MIV over 30mins D1 Vincristine 1.4mg/m2 (max.2mg) IV push D1-D5 Prednisolone 100mg/d PO (40-30-30) Phase II Determined dosage of RAD001 + CHOP every 3 weeks Treatment will be continued until planned 6 cycles or disease progression

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven peripheral T-cell lymphoma, unspecified, (PTCL), ALK-negative anaplastic large cell T-cell lymphoma (ALCL), Angioimmunoblastic T cell lymphoma (AITL), Cutaneous T-cell lymphoma
2. Adequate organ function as defined by the following criteria:

   A.Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy B.Total serum bilirubin ≤1.5 x ULN C.Absolute neutrophil count (ANC) ≥1500/µL D.Platelets ≥100,000/µL E.Hemoglobin ≥9.0 g/dL (may be transfused or erythropoietin treated) F.Serum calcium ≤12.0 mg/dL G.Serum creatinine ≤1.5 x ULN
3. At least one measurable lesion
4. ECOG PS 0-2
5. Informed consent
6. Age 20 to 70 years old

Exclusion Criteria:

1. Prior radiation therapy or surgery within 4 weeks prior to study entry
2. History of central nervous system (CNS) metastases
3. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.
4. Pregnancy or breastfeeding.
5. Hepatitis B virus surface antigen positive
6. Extranodal NK/T cell lymphoma
7. Mycosis fungoides
8. ALK-positive Anaplastic large cell lymphoma
Efficacy of Laser Versus Cryotherapy in the Treatment of Warts

The purpose of this study is to test the efficacy of laser versus cryotherapy on the treatment of warts

Cutaneous warts were a common skin diseases caused by human papilloma virus (HPV) infection. Although warts may spontaneously resolve, many patients seek for treatment for various reasons. There are many kinds of treatments for cutaneous warts, including salicylic acid, cryotherapy, laser, etc. A recent high quality RCT confirmed that the cure rate of topical salicylic acid and frozen has no difference at six months, but the efficacy of laser versus cryotherapy on the treatment of warts remains unclear. Therefore, we designed a randomized controlled trial to test the efficacy of laser versus cryotherapy on the treatment of warts.

Eligibility Criteria:
Inclusion Criteria:

* Patients have cutaneous warts, including common warts(d≥1cm or n≥5 ), plantar warts, periungual warts, mosaic warts, which are suitable for cryotherapy and laser treatment .
* patients aged eighting years and over, who have junior school degree or above

Exclusion Criteria:

* Patients who have more than 20 warts
* Patients who are currently participating in another trial for the treatment of their warts
* Patients who took immunosuppressant drugs such as oral corticosteroids within the past three months.
* Patients who are pregnant or ready for pregnancies or breast-feeding.
* Patients who have impaired healing eg due to diabetes, vascular disease, vitamin A deficiency, hyperthyroidism and hypothyroidism.
* Patients who have autoimmune diseases, eg SLE, dermatomyositis, scleroderma and other diseases .
* Patients who have cold intolerance, eg cold urticaria, cryoglobulinaemia, cold agglutinin syndrome, Raynaud's syndrome.
* Patients who have local injections intolerance.
* Patients who have local hypoesthesia .
* Patients who can not tolerate cryotherapy or laser treatment for their own reasons.
A Communication-Priming Intervention to Improve Shared Decision-Making Between Older Adults With Advanced CKD and Clinicians

To achieve the goal of reaching consensus about the preferred treatment option that best aligns with the goals and values of patients, the investigators developed a 'CKD Jumpstart- Tips" priming tool tailored for older adults with advanced CKD that is based on communication principles from VitalTalk and Elwyn's goal-based SDM model.

The investigators hypothesize that compared with patients in the usual care group, patients in the 'CKD Jumpstart- Tips' intervention group will have:

1. increased level of shared decision-making (observer-based and patient-reported),
2. improved quality of communication,
3. increased patient involvement in decision-making,
4. lower decisional conflict,
5. lower decision regret,
6. decreased time to decision,
7. improved adherence to treatment choice, and
8. improved health-related quality-of-life.

To enhance the communication on shared decision-making between older adults with advanced kidney disease and clinicians, the investigator's research team developed the "CKD Jumpstart- Tips" communication-priming intervention.

This study aims to conduct a cluster-randomized controlled trial to assess the effects of the 'CKD Jumpstart- Tips' communication-priming intervention on shared decision-making between older adults with advanced kidney disease and their clinicians.

The primary objective of the study is to evaluate the effects of the intervention on observer-based shared decision-making in the target consultation.

The secondary objective is to evaluate the effects of intervention on patient-reported shared decision-making, quality of communication, patient involvement in decision-making, decisional conflict, decision regret, timing of and adherence to treatment choice, and health-related quality of life. Consultation length will also be captured as a process measure.

Eligibility Criteria:
Inclusion criteria for the two groups of participants (i.e. Clinicians and Patients):

1. Clinicians

   - Nephrology specialists or higher physician trainees who provide specialty care to older adults with advanced chronic kidney disease
2. Patients

   * Diagnosis of advanced CKD Stage 4 or 5 (eGRF \<30 ml/min)
   * Chinese- or English-speaking
   * Identified as patient with whom their clinician plans to discuss advanced kidney disease treatment options in the upcoming clinic visit
   * Able to provide written informed consent and complete questionnaires
   * Can be contacted by phone

Exclusion criteria for patients:

* Patients will be excluded if they are eligible for kidney transplant, currently on dialysis, or lack decision-making capacity
The Use of Manual Muscle Relaxation Techniques in the Treatment of Temporomandibular Joint Disorders

The aim of the study was to compare the degree of relaxation of the anterior part of the temporal muscles and the masseter muscles achieved with the use of post-isometric relaxation and myofascial release methods in patients requiring prosthetic treatment due to temporomandibular joint disorders (TMD) with a dominant muscular component.

The study included 60 patients, both sexes, aged between 19 and 40. The patients who met the inclusion criteria were alternately assigned to one of the two study groups: I group consisted of the patients received post-isometric relaxation treatment (PIR), II group - patients received myofascial release treatment (MFR). Each group consisted of 30 subjects. The series of ten treatments were performed in both groups. The comparative assessment was carried out based on the data obtained from the physical examination, physiotherapeutic examination of the masticatory system, surface electromyography (sEMG) of anterior temporal and masseter muscles and the data on the intensity of spontaneous masticatory muscle pain assessed using the Visual Analogue Scale (VAS).


Eligibility Criteria:
Inclusion Criteria:

* diagnosed functional disorders of the masticatory system with the accompanying excessive tension of the masseter muscles,
* no clinical signs of displacement of the disc with a blockage in the temporomandibular joint,
* spontaneous pain in the masticatory muscles, lasting at least one month before treatment,
* good general health of the patient,
* full dental arches
* written consent to participate in the study

Exclusion Criteria:

* occurrence of a face or head injury during participation in the research project,
* open wounds in the area where the therapy was carried out,
* sudden illness of the patient preventing participation in the study,
* the will to terminate participation in the study