cyrilzakka/clinical-trials huggingface dataset:
Effects of Wearable Devices Initiates Behavioral Change Intervention on Body Composition, Physical Activity, Sleep Quality and Stress of Nurses in Hospital Working Place

Background: Physically inactive and poor sleep quality are at increased risk for non-communicable diseases. Nurses were the most vulnerable inactive healthcare personnel who may not meet global physical activity recommendations because of complicated rotation shifts and heavy working loading. Wearable devices initiate behavior intervention combined with smartphone applications could offer new opportunities for social connection by a convenient way for nurses to improve physical activity and sleep quality.

Objectives: To evaluate the effects of wearable devices initiate behavioral intervention on body composition, physical activity, sleep quality and stress of nurses in hospital working place.

Method: This is a randomized controlled trial that will recruit 120 nurses and randomly assign them into two groups from a hospital working place. The nurses in the intervention group will receive 12-week wearable devices to initiate behavioral intervention. The nurses in the comparison group will only receive 12-week wearable devices monitoring. Data will be collected at baseline and 12-week and 24-week follow-up. The body composition will be measured by bioelectrical impedance analysis (BIA). The physical activity and sleep quality will be monitored by the Fitbit wearable device and application. The mediator parameter of the stress will be measured by salivary amylase activity (SAA). We will control the internal validity to assure the quality of training, treatment fidelity, identify barriers and facilitators of implementation, and assess participants' satisfaction. General estimating equations (GEE) will be applied to examine the effects of time and group interaction.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who give informed consent for this study and are 20 years old or older.
* Those who own a smartphone and are willing to join the study's LINE group.
* Individuals whose mobile application (APP) can synchronize with the Fitbit Charge 6 wearable device.
* Nurses who hold a nursing license and are working in a clinical setting.

Exclusion Criteria:

* Individuals unable to provide informed consent for this study and are younger than 20 years old.
* Those who do not own a smartphone.
* Individuals who do not have a nursing license or are not employed in a clinical setting as a nurse.
* Participants who are already involved in other health promotion or exercise training studies.
* Nurses who are currently pregnant.
Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients

Frailty is defined as a geriatric syndrome of impaired resiliency to stressors (such as cardiac surgery) that has been delineated recently in the cardiovascular literature. One of the most controversial areas of cardiac surgery has been whether off-pump coronary artery bypass grafting (OPCAB) surgery is superior to conventional on-pump coronary artery bypass grafting (CABG) surgery. There is an ongoing debate about the benefits and disadvantages of OPCAB surgery and we believe that this remains an important technique for the improvement of coronary surgery. The benefits of CABG surgery in frail patients are still undetermined. The aim of this study is to clarify the potential benefit of OPCAB surgery in pre-frail and frail patients by comparing off-pump versus on-pump CABG in these patients.

The FRAGILE protocol is a national multicenter randomized controlled trial (RCT), conducted in 6 Brazilian institutions. The study is already approved by a certified ethics committee. Funding is provided by a grant from São Paulo Research Foundation (FAPESP), which otherwise will not have any role in the conduct of the study nor in the analysis nor in the reporting of data. A confidentiality agreement regarding data use and the data safety will be monitored by an independent monitoring board. All the authors will provide revisions and comments and be testifying for the accuracy and completeness of the report, as well as for the fidelity of the report to the study protocol.

Eligibility Criteria:
Inclusion criteria:

- Participants aged ≥60 years with the indication of myocardial revascularization with ≥2 criteria of frailty by Fried Frailty Criteria, and suitable to undergo either Off-pump or On-pump CABG.

Exclusion criteria:

- Patients with the indication of angioplasty or another procedure in addition to CABG; patients who underwent an emergency operation (within 24 hours after hospital admission); patients who underwent previous cardiac surgery, even with other approaches than median sternotomy; patients who do not have free, prior and informed consent to participate in this study.
Kaiser Permanente Evaluation of Medically Tailored Meals in Adults With Medical Conditions at High Readmission Risk

This study is a virtual, remote, decentralized pragmatic clinical trial comparing the efficacy of medically tailored meals alone or medically tailored meals with remote nutritional counseling compared with usual standard of care in adults with a targeted, nutrition-sensitive chronic medical condition (heart failure, diabetes mellitus, chronic kidney disease).

For the KP NOURISH Study, eligible members hospitalized within participating Kaiser Permanente Northern California medical centers will be identified and screened electronically and pre-randomized to 1 of 3 arms (medically tailored meals alone vs. medically tailored meals with remotely delivered enhanced nutritional counseling sessions vs. usual care). Patients enrolled in the medically tailored meals arm will receive 1 medically-tailored meal per day for 10 weeks after hospital discharge. Patients enrolled in the medically tailored meals with enhanced nutritional counseling arm will receive 1 medically-tailored meal per day for 10 weeks after discharge with up to 3 remotely delivered nutritional counseling sessions with a registered dietician nutritionist during the same time period. Patients enrolled in the usual care arm will continue to receive their typical standard of care management. All enrolled patients will complete a questionnaire for patient-reported outcomes (i.e., self-efficacy, social isolation, patient satisfaction, and caring science domains) at baseline and at 10 weeks after discharge and followed electronically for total resource utilization and 30-, 60-, and 90-day outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized at Kaiser Permanente Santa Rosa, Santa Clara, San Francisco, Oakland, or San Rafael Medical Centers
* Kaiser Permanente member at admission
* Has a prior history of at least one of the following:

  1. Heart failure
  2. Diabetes mellitus
  3. Chronic kidney disease

Exclusion Criteria:

* Receiving primary care at Kaiser Permanente facilities outside of Kaiser Permanente Santa Rosa, Santa Clara, San Francisco, Oakland, or San Rafael Medical Centers
* Language interpreter needed
* Admitted from skilled nursing facility or nursing home
* Homeless at admission
* Residence outside the geographic area covered by the medically tailored meals vendors
* Prior history of organ transplant
Return to Work After Potential Severe Injury

In Norway an estimated 10 % of the population is injured annually. Of these 36.000 sustain permanent functional impairment, 1.200 receive disability pension, and approximately 2.500 die because of their injuries. Mortality is the most common variable measuring trauma outcome. However, measuring only trauma mortality may be looking merely at the tip of the iceberg. For every trauma death, there are ten-folds suffering long term functional impairment. Mortality is therefore a too crude variable to describe the impact of injuries - both for the individual trauma patient and for society as a whole. There is a need for variables describing long-term outcomes on a functional level. The aim of this study is to use the rate of return to work and education as an alternative outcome measure. The ability of returning to work after injury is a central indicator of individual functional outcome, combining both physical and mental skills in performing complex and compound tasks. Previous studies on return to work after injury are limited by a combination of short follow-up times, the use of patient reported outcomes and having mainly been focusing on only severely injured patients (ISS \> 15). This a population-based study including all patients in working age (16 - 65 years) received by a trauma team in any of the eight hospitals within the region of Central Norway in the time period from June 1st,2007 to May 30th, 2010. Already collected trauma registry data will be linked with national register data on sickness and disability benefits, employment and education.


Eligibility Criteria:
Inclusion Criteria:

* exposed to traumatic injuries
* received by trauma team attendance
* received by trauma team activation protocol
Combination Study of Urelumab and Cetuximab in Patients With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Head and Neck Cancer

The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Cetuximab in patients with Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck.


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

Inclusion Criteria:

* Subjects with advanced/metastatic Colorectal Cancer(CRC) who have failed or been intolerant to both irinotecan- and oxaliplatin- based regimens
* Subjects with advanced/metastatic Squamous cell carcinoma of the head and neck (SCCHN) who are without options for curative treatment
* Subjects must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
* Men and women 18 and older
* Women of childbearing potential (WOCBP) and men must use highly effective methods of contraception
* Eastern Cooperative Oncology Group (ECOG) of 0 or 1
* Subjects must have a life expectancy of at least 3 months

Exclusion Criteria:

* Active or progressing brain metastases
* Other concomitant malignancies (with some exceptions per protocol)
* Nasopharyngeal carcinoma
* Active or history of autoimmune disease
* Positive test for Human Immunodeficiency Virus (HIV) 1\&2 or known AIDS
* History of any hepatitis (A,B or C)
* Known current drug or alcohol abuse
* Active Tuberculosis (TB)
* Use of anti-cancer treatments within 28 days
* Prior therapy with anti-CD137 antibody

Other protocol defined inclusion/exclusion criteria could apply
Irofulven in Treating Patients With Stage IVB or Recurrent Cervical Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have stage IVB or recurrent cervical cancer.

OBJECTIVES: I. Evaluate the efficacy of 6-hydroxymethylacylfulvene in patients with stage IVB or recurrent cervical carcinoma. II. Determine the safety of this drug in this patient population.

OUTLINE: Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes daily for 5 consecutive days. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed primary metastatic (stage IVB) or recurrent cervical carcinoma not amenable to curative therapy Squamous Adenocarcinoma Adenosquamous Bidimensionally measurable disease No active brain metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal ALT/AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN (1.95 mg/dL at MSKCC) OR Creatinine clearance at least 50 mL/min Cardiovascular: No New York Heart Association class III or IV congestive heart failure No ECG evidence of acute ischemia No significant conduction abnormality (e.g., bifascicular block, 2nd or 3rd degree AV blocks) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years and deemed low risk for recurrence No other concurrent clinical circumstances that would compromise safety or integrity of trial

PRIOR CONCURRENT THERAPY: Prior multimodality therapy at diagnosis allowed (i.e., concurrent chemotherapy and radiotherapy, neoadjuvant chemotherapy followed by surgery and/or radiotherapy, adjuvant chemotherapy and/or radiotherapy following surgery, or adjuvant chemotherapy following radiotherapy) Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic or recurrent disease Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgery
Effectiveness of Mulligan Mobilization Technique

The aim of this study was to investigate the effects of the Mulligan mobilization technique (MMT) on pain intensity, joint position sense (JPS), kinesiophobia, and disability level in individuals with nonspecific neck pain. A total of 34 female individuals with nonspecific neck pain were included in the study. Pain intensity, JPS, kinesiophobia, and disability levels of all participants were evaluated before and after the 3-week intervention. Participants were randomly divided into two groups. In the first group, the participants received MMT by the physiotherapist twice a week for 3 weeks, and self-mobilization techniques as a home exercise program. The second group was trained only self-mobilization techniques.

A total of 34 female individuals with nonspecific neck pain that persisted for at least 3 months were included in the study. Individuals who had a surgical indication for the cervical region and/or had undergone surgery, who had received physiotherapy or other treatment in the last year due to neck pain, who had a history of trauma to the cervical and thoracic region, and who additionally had a musculoskeletal system disease were excluded. All participants were evaluated for pain intensity, JPS, kinesiophobia, and disability levels before and after the 3-week intervention. Participants were randomly divided into two groups using the coin toss method. In the first group, the participants received MMT by the physiotherapist twice a week for 3 weeks, and self-mobilization techniques as a home exercise program. The second group was trained only self-mobilization technique.

Eligibility Criteria:
Inclusion Criteria:

* Nonspecific neck pain

Exclusion Criteria:

* History of trauma to the cervical and thoracic region
Individual Workload Perception Scale - Revised (IWPS-R)

The purpose of this study is to validate the psychometrics of the Individual Workload Perception Scale (IWPS).

The purpose of this study is to validate the psychometrics of the Individual Workload Perception Scale (IWPS) designed to measure the perception of individual workloads of inpatient registered nurses.

Eligibility Criteria:
Inclusion Criteria:

* Nurses
Evaluating a Pharmacogenetic Testing Panel in Patients Suspected to be at Increased Risk for Pharmacogenetics-related AEs While Receiving Fluoropyrimidine or Irinotecan Therapy

This study will be evaluating patients suspected to carry DPYD or UGT1A1 variants based off of Michigan Genomics Initiative (MGI) results. Standard of care treatment will be initiated with either Fluoropyrimidine or Irinotecan therapy. Retrospective collection of treatment related AEs and SAEs, dose delays, dose reductions, and treatment discontinuations will be completed.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Prospectively enrolled cases:

A. Suspected to carry an actionable DPYD phenotype per MGI and initiating treatment with systemic FP OR suspected to carry an actionable UGT1A1 phenotype per MGI and initiating treatment with irinotecan for cancer

B. The ability to understand and the willingness to sign a written informed consent.

* Retrospective cases:

A. Confirmed actionable DPYD phenotype before treatment with systemic FP OR confirmed actionable UGT1A1 phenotype before treatment with irinotecan

B. Clinician initiated dose reduction of the fluoropyrimidine or irinotecan therapy based upon genotype result

* Retrospective controls:

A. Suspected actionable DPYD phenotype per MGI and treatment with systemic FP OR suspected actionable UGT1A1 phenotype per MGI and treatment with irinotecan

Exclusion Criteria:

* For prospective cases, prior treatment with systemic FP if suspected to carry an actionable DPYD phenotype
* For prospective cases, prior treatment with irinotecan if suspected to carry an actionable UGT1A1 phenotype
* For prospective cases, inability to understand consent or make health-related decisions
* History of allogeneic bone marrow transplant prior to genotype testing
* History of liver transplant
Varicocelectomy To Treat Pain, Predictors Of Success

there are many studies studying the effectiveness of surgical treatment in patients treated for infertility, but only a few reporting the results of varicocelectomy done for pain. This study attempted to examine the success rate of varicocele ligation when performed for the treatment of pain and to evaluate all the predictor factors that may affect the pain resolve

varicocelectomy for patients complaining of pain and studying the effectiveness and all predictors that can affect the degree of response

Eligibility Criteria:
Inclusion Criteria:

* painful varicocele after failure of medical therapy

Exclusion Criteria:

* responders to medical therapy
Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy

The purpose of this study is to determine the safety and clinical effectiveness of umbilical cord mesenchymal cells transplanted by intravenous infusion in patients with heart failure.

Phase I-II Clinical Trial - Safety and efficacy of umbilical cord derived mesenchymal stem cells (ucMSC) in patients with heart failure Randomized, double blind, controlled prospective study in patients with compensated heart failure in dilated phase.

Thirty patients will be selected, who will undergo a strict 3-month followup of ventricular function before being sequentially randomized into two groups: the first group of 15 patients will receive a sole injection of ucMSC and the remaining 15 patients will comprise the control group.

Every patient will maintain their standard treatment of heart failure, with maximum tolerated dosage without side effects.

The day of infusion will be considered day zero. From that moment, followup will be divided into 0-3, 3-6, and 6-12 months.

Clinical results will be analyzed after completion of 12 months of followup.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic heart failure patients in dilated stages
* Etiologies: dilated cardiomyopathy, chronic hypertensive cardiopathy in dilated stage, chronic coronary cardiopathy in dilated stage
* Ejection fraction ≤ 40%.
* Patients who are stable under optimal medical treatment for a period of at least 3 months prior to randomization

Exclusion Criteria:

* Severe or persistent heart failure
* Recurrent myocardial ischemia
* Uncontrolled ventricular tachycardia
* Malignant disease (life expectancy of less than one year)
* Manifest ventricular asynchrony
* Hematologic disease
* Recent cerebrovascular disease
* Recent acute coronary syndrome
* Serum creatinine \>2.26 mg/dL (200 umol/L)
* Atrial fibrillation without heart rate control in the last 3 months
NMES for Rehab After Surgery

A randomised pilot study assessing the acceptability and feasibility of utilising neuromuscular stimulation devices to enhance post-operative rehabilitation and recovery after general, vascular and urological surgery procedures.

Patients undergoing inpatient rehabilitation after general, vascular or urological surgery will be invited to take part in a randomised study utilising either sham or active neuromuscular stimulation devices to enhance post-operative rehabilitation and physiotherapy.

Eligibility Criteria:
Inclusion Criteria

* Medically stable after index surgery
* Willing and able to participate in study protocol
* All ethnic groups, male or female above the age of 18 years
* Baseline Rockwood Frailty Score of 3 or greater

Exclusion Criteria

* Inability or unwillingness to participate in trial
* Implanted electrical device such as Pacemaker or defibrillator.
* Pregnant
* Acute deep vein thrombosis
* Previous use of NMES device
Novel Brominated and Organophosphate Flame Retardants and Type 2 Diabetes

As alternative flame retardants (FRs), novel brominated flame retardants (NBFRs) and organophosphate flame retardants (OPFRs) are ubiquitous in environment and may cause endocrine disruption effects. The associations between traditional endocrine-disrupting chemicals (EDCs) and type 2 diabetes have been extensively reported in epidemiological studies. To date, however, human-based evidence on the effects of NBFRs and OPFRs is lacking. The investigators conducted a case-control study of 344 participants aged 25-80 years from Shandong Province, East China, to assess potential associations between serum NBFR and OPFR concentrations and etiology of type 2 diabetes for the first time.

In this study, the investigators conducted a case-control study in Shandong Province, East China, to evaluate the associations between serum NBFR and OPFR and risk of type 2 diabetes. The aims of the present study were to (1) evaluate the associations between alternative FRs in human serum and the risk of type 2 diabetes, (2) assess the relationships between alternative FR concentrations and fasting plasma glucose (FPG), (3) investigate the correlations between alternative FRs and concentrations of lipid fractions, including TG, TC, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C), and (4) clarify the joint effects of NBFR and OPFR mixtures on the risk of type 2 diabetes

Eligibility Criteria:
Inclusion Criteria:

Group of Type 2 diabetes patients:

1. age 18 \~ 75 years old;
2. type 2 diabetes patients diagnosed in the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) , HBA1C ≥7.0% and \<10.5% ;
3. patients signed informed consent.

Control Group:

1. age 18 \~ 75 years old;
2. healthy population recruited from the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) ;
3. living in the monitoring area for more than 6 months within 12 months;
4. normal thyroid function and no history of thyroid cancer were needed in the control group;
5. Fasting Blood Glucose level of 0.7 mmol/l was needed in the Control Group of Type 2 diabetes Mellitus Without History of diabetes;
6. patients with informed consent.

Exclusion Criteria:

* Group of Type 2 diabetes:

  1. pregnant, lactating women, patients with acute cardiac cerebrovascular disease;
  2. patients with severe liver and Renal Impairment (related laboratory tests more than 2 times the normal) ;
  3. patients with Type 1 diabetes;
  4. participants in other clinical trials within 3 months;
  5. patients with malignant tumors.
  6. has the disease and so on serious anemia, is not suitable to carry on the patient which the blood draws the test.

Control Group:

1. patients with serious heart, liver or kidney disease;
2. patients with iodine or Thyroid hormone;
3. patients with confirmed malignant tumor;
4. pregnant women or those who have recently taken contraception or estrogen.