cyrilzakka/clinical-trials huggingface dataset:
The Effect of the Emotional Freedom Technique on Students

Introduction: The interruption of education within the scope of quarantine and isolation methods during the pandemic process has caused nursing students studying in clinical practice areas to be away from the clinic for a long time. This situation not only affected the anxiety levels of nursing students, but also caused them to feel inadequate and to experience stress.

Purpose: The aim of this study is to investigate the effect of emotional freedom technique on nursing students' styles of coping with anxiety and stress.

Method:In this experimentally designed study with pretest-posttest control group, freedom of emotion technique will be applied to the experimental group for 4 sessions. In the pre-implementation phase and after the emotional freedom technique session, the state anxiety scale, coping styles scale, and subjective discomfort level scale will be applied.

Emotional Freedom Technique (EFT), a type of energy that has been applied recently, is a technique applied by touching meridian points to provide anxiety, depression, burnout, stress management, and desensitization to fear. The basic principle of EFT is to send activation and deactivation signals to the brain by stimulating points on the skin with different electrical properties, usually by touching them. The findings obtained from the studies show that this technique, which is a psychotherapeutic technique and provides cognitive restructuring, has statistically significant improvements at the rate of 98% in the management of psychological problems. Studies show that this approach is positive in coping with stress when considered in a wide range. Church et al. revealed that self-administered EFT provides significant improvements in anxiety, depression, pain and craving scores. A large therapeutic effect for EFT was reported in a meta-analysis of 14 randomized controlled trials using the EFT technique for anxiety disorders. In the studies, it was aimed to apply this application, which has proven positive results, to apply the emotional freedom technique in order to reduce the anxiety experienced by the students due to the reasons such as distance education and clinical education during the COVID-19 pandemic process and to enable them to cope with stress.

research questions

This study aims to address the following research questions:

What are the anxiety levels of the students who applied the emotional freedom technique (EFT)? What are the stress coping styles of the students who applied emotional freedom technique (EFT)?

Eligibility Criteria:
Inclusion criteria:

* Not receiving any psychiatric diagnosis,
* Not receiving any therapy for coping with anxiety and stress,
* Not applying emotional freedom technique before,
* Not being in the COVID-19 diagnosis, treatment care process, and
* Participating in the study determined to be voluntary.

Exclusion Criteria:

-Not participating in any of the EFT sessions and being diagnosed with COVID-19.
Biomarkers in Predicting Response in Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy

This research trial studies prognostic and predictive markers in patients with early stage non-small cell lung cancer receiving chemotherapy. Prognostic markers are patient or tumor factors that predict patient survival independent of treatment. Predictive markers are factors that may influence and predict the outcome of treatment in terms of either response or survival benefit. Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about cancer and identify biomarkers related to cancer.

PRIMARY OBJECTIVES:

I. Evaluate potential prognostic and predictive markers in patients receiving adjuvant chemotherapy for early stage non-small cell lung cancer (NSCLC).

II. To perform cross-validation analyses for the predictive value of cyclin-dependent kinase inhibitor 1B (p27), excision repair cross-complementation group 1 (ERCC1), beta-tubulin and B-cell lymphoma 2 (BCL2)-associated X protein (BAX).

III. To perform cross-validation analyses for the prognostic value of mucin and breast cancer (BRCA)1 expression.

IV. To perform a pooled analysis for the prognostic impact of p53 protein expression by immunohistochemistry (IHC), tumor protein p53 (p53) mutation, ras mutation and epidermal growth factor receptor (EGFR) mutation, and Fas cell surface death receptor (Fas)/Fas ligand (FasL) expression by IHC.

V. Validation of the 15-gene prognostic and predictive messenger ribonucleic acid (mRNA) signature on Lung Adjuvant Cisplatin Evaluation (LACE)-Bio formalin-fixed paraffin-embedded (FFPE) tumor samples.

VI. Exploratory evaluation of the prognostic and predictive values of known potential oncogenic mutations using LACE-Bio FFPE.

VII. Exploratory evaluation of the prognostic and predictive values of gene copy variation using LACE-Bio FFPE tumor samples.

VIII. Exploratory identification and evaluation of prognostic and predictive value of novel genomic aberrations discovered by Next Generation Sequencing on LACE-Bio tumor samples.

OUTLINE:

Previously collected tissue samples are analyzed by IHC.

Eligibility Criteria:
Inclusion Criteria:

* Registration to CALGB9633 for this study
* Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required
* Informed consent:

  * The subject population to be studied in this protocol includes patients selected from CALGB 9633 for whom an available specimen is present at the Alliance Ohio State University (OSU); all such patients have signed a written informed consent document meeting all federal, state, and institutional guidelines as part of entry into that trial
  * Only cases with adequate tumor formalin FFPE material without depleting the available clinical block(s) are eligible
Assess Increased Mortality Risk With Each Year of Delayed Tobramycin Solution (TIS) Initiation, and Effect of TIS on Mortality Across Study Centers

Using CFF registry data, this analysis will: describe patterns of time to TIS initiation from first year of TIS eligibility, estimate the increased risk of death attributable to each year of delayed TIS initiation, and investigate TIS effects across study centers.


Eligibility Criteria:
Inclusion Criteria:

* ≥6 years of age with a documented Cystic fibrosis (CF) diagnosis,
* moderate-to-severe lung disease,
* Pseudomonas aeruginosa (PA) airway infection.

Exclusion Criteria:

Other protocol-defined inclusion/exclusion criteria may apply.
Evaluation Of The Efficacy Of HalfLYTELY For Bowel Cleansing Before Virtual Colonoscopy and Conventional Colonoscopy.

To evaluate the efficacy of standard HalfLYTELY® as a bowel cleansing preparation for adult patients undergoing virtual colonoscopy (VC).


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients who are undergoing colonoscopy for routinely accepted indications, Evaluation of BE results, GI bleeding, Anemia of unknown etiology, Neoplastic disease surveillance, Endosonography, Inflammatory bowel disease (except as noted below), Unknown diarrhea etiology, Prior Polypectomy, Laser therapy, Foreign body removal and decompression (except as noted below).
* 18 years of age or older.
* Otherwise in good health, as determined by physical exam and medical history.
* If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, or vasectomized spouse)
* Subject has read and signed the written informed consent document prior to study participation

Exclusion Criteria:

* Subjects with known or suspected bowel perforation or obstruction, inflammatory bowel disease, ileus, acute alimentary tract surgery, significant gastroparesis or gastric outlet obstruction, appendicitis, gastric retention, toxic colitis, toxic megacolon or rectal bleeding.
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
* Subjects with uncontrolled cardiovascular disease
* Subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
* Subjects who have participated in an investigational clinical surgical, drug or device study within the past 30 days.
* Subjects who are pregnant or lactating.
* Subjects who are allergic to Polyethyleneglycol.
* Subjects receiving non-study laxatives, antacids and prokinetic agents during the study.
Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination: Feasibility Trial

HPV vaccine coverage among adolescents in the US is suboptimal. This is particularly true among traditionally underserved adolescents. Few parent-targeted interventions have focused on the parental decision-making process. Self-persuasion, generating one's own arguments for engaging in a behavior, may be an effective means to influence parents' motivation to vaccinate their children. In a three-phase study, investigators are using quantitative and qualitative research methods to develop and refine a tablet-based self-persuasion intervention for parents who are undecided about the HPV vaccine. This clinical trial submission focuses on the third phase of the study (the second stage is also registered in clinical trials).

Despite the fact that HPV vaccination is recommended for male and female adolescents, HPV vaccine coverage among adolescents age 13-17 is poor (60% for girls, 41.7% for boys). HPV-related cancers are a significant burden on the US healthcare system and could be prevented through adolescent vaccination. Rates of vaccination are suboptimal among underserved populations (uninsured, low-income, racial and ethnic minorities) often seen in safety-net clinics. Few interventions have been designed that target decision-making among parents of unvaccinated adolescents. Self-persuasion, generating of one's own arguments for a health behavior, may be an effective means of influencing HPV vaccination behaviors among undecided or ambivalent parents. Through three stages, investigators will identify and develop a self-persuasion intervention strategy to promote adolescent HPV vaccination in safety-net clinics. In Stage 3, reported here, investigators will conduct a two-arm pilot randomized control trial in the safety-net clinics to assess feasibility of testing the self-persuasion intervention condition against standard of care (control group). Parent-adolescent child dyads will be enrolled. Parents will be exposed to the intervention and the primary outcome (HPV vaccination) will be assessed on the adolescent child via the electronic health record. Investigators will also examine the impact of the intervention on parent-provider discussions about HPV vaccination.

Eligibility Criteria:
Inclusion Criteria for the Parent-Adolescent Dyad:

* Parents: Undecided about the HPV vaccine
* Adolescent child: 11-17 years old and has not begun the HPV vaccine series.

Exclusion Criteria:

* Parents: Having impairing hearing or speech
* Adolescents: pregnant at the time of the clinic visit
* Dyad: participated in Phase 1 and 2 of the study
Study Comparing Short Infusion Vs. Fixed Dose of Cisplatin + Gemcitabine in Non Small Cell Lung Cancer.

The purposes of this study are to determine:

How standard gemcitabine plus cisplatin compares to fixed dose rate of gemcitabine plus cisplatin in the treatment of non-small cell lung cancer.

The safety of standard gemcitabine plus cisplatin and any side effects that might be associated with it as compared to a fixed dose rate of gemcitabine plus cisplatin.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Histologically or cytologically confirmed diagnosis of NSCLC
* Have provided written informed consent
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Adequate organ function

Exclusion Criteria:

* Prior chemotherapy or biologic therapy (approved or experimental) for NSCLC
* Presence of uncontrolled central nervous system (CNS) metastases
* Inability to comply with protocol or study procedures
* Pregnancy
* Breast feeding
STRENGTH Expansion

Patients seen in the EGMDC (Esophageal and Gastric Multidisciplinary Clinic) for treatment planning who are recommended to receive neoadjuvant treatment followed by surgery at UCCC Metro will be offered enrollment into the study. Patients will complete the self-assessments outlined below on provided tablet computers during UCCC visits. If unable to complete assessments in person they will be e-mailed via REDCap Survey to the patient to complete individually.

Patients with esophageal (EC) and gastroesophageal junction (GEJC) cancers who are seen in the Esophageal and Gastric Multidisciplinary Clinic (EGMDC) for treatment planning and are recommended to receive neoadjuvant therapy and plan to receive treatment at UCCC Metro will be offered enrollment into the study. Patients will complete the patient reported assessments focused on QOL and physical activity on provided tablet computers during UCCC visits at specified time points. If unable to complete assessments in person they will be e-mailed to the patient via REDCap to complete. Additional data regarding dosing of chemotherapy, radiation, nutrition and surgical outcomes will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Provision to sign and date the consent form
2. Age ≥ 18 years
3. Receiving treatment according to the STRENGTH pathway
4. Diagnosed with esophageal(EC)/gastroesophageal junction cancer(GEJC) stage IB-IIIB
5. Planning to receive neoadjuvant treatment followed by surgery at University of Colorado Cancer Center (UCCC) Metro
6. Ability to complete surveys online via an emailed REDCap survey link if unable to complete in person

Exclusion Criteria:

1. Inability to read English and complete questionnaires independently
2. Per the investigator, unable to comply with study criteria or assessments
3. Inability to receive and complete REDCap survey online
A Multi-Reader Multi-Case Pivotal Trial

The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm FFDM plus DBT versus FFDM alone in the detection of breast cancer.

The safety and effectiveness of FFDM + DBT are both linked to the ability of radiologists interpreting FFDM + DBT images to accurately diagnose breast cancer. Each study endpoint therefore addresses both safety and effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects under protocol FMSU2013-004A, defined as female subjects with known true clinical status and with complete FFDM and DBT examinations, in which there is sufficient anatomical coverage, sufficient contrast, and no significant motion or other artifacts, as determined by the image-acquisition sites.
* Meet none of the exclusion criteria under protocol FMSU2013-004A.

Exclusion Criteria:

* Subjects who are in violation of protocol FMSU2013-004A.
* Subjects who meet exclusion criteria under protocol FMSU2013-004A.
* Subjects with unknown clinical status.
* Any subject whose positive mammogram was not read during the truthing process (see section 8) will not be considered for the pivotal MRMC reader study.
Comparative Efficacy of Cemiplimab to Historical Standard of Care in France

Primary Objective:

-Assess the effectiveness of cemiplimab versus other available systemic therapies in patients up to 2018 or say historical system organ class (SOC) with metastatic or locally advanced cutaneous Squamous Cell Carcinoma (CSCC) who are not candidates for curative surgery or curative radiation, on overall survival (OS).

Secondary Objectives:

* Assess Progression Free Survival (PFS)
* To assess Duration of Response (DOR)
* To assess Objective Response Rate (ORR)
* To describe adverse events leading to treatment interruptions and deaths

Study duration is approximately 9 months. For the Standard of Care Arm, data of the subjects evaluated between 01 Aug 2013 and 01 Aug 2018 was observed. For the Cemiplimab arm, data of the subjects evaluated between Aug 2018 and October 2019 was observed.

Eligibility Criteria:
Inclusion Criteria:

All patients:

* Adult 18 years of age or older
* With an unresectable locally advanced CSCC (who are not candidates for curative surgery or curative radiation therapy) or metastatic CSCC (nodal or distant)
* Subject alive at start data collection who has received information note and has not opposed to data collection OR

  * Subject who died before study initiation and who has not opposed to data collection for research purpose when he/she was alive

Treatment Group:

* Patient treated by cemiplimab in monotherapy through the cATU or patient included in the nATU that evolved into the cATU.
* With an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 at the time of cemiplimab initiation

Control Group:

* Patient treated by any systemic treatment initiated until August 1st , 2018 included
* With an ECOG score of 0 or 1 at the time of treatment initiation for at least one line of systemic therapy initiated from August 1st 2013 to August 1st 2018. The related treatment line must be among the 3 first systemic treatment lines for patients having initiated more than 3 lines.

Exclusion Criteria:

All patients:

- Patient treated by another anti- Programmed Cell Death Receptor-1 (PD1)

Control group:

-Patient subsequently treated with cemiplimab

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Buprenorphine Detoxification With Two Types of Treatment. BBD IV - 13

The purpose of this study is to evaluate buprenorphine and behavioral treatment with and without contingent payment on compliance with pro-social activities. In addition, we will examine whether blind naltrexone dosing is effective in indicating naltrexone consumption.


Eligibility Criteria:
Please contact site for information.
Dual Mobility Acetabular Cups in Revision TJA

The aim of this study is to the compare clinical outcomes of patients undergoing a revision total hip arthroplasty (THA) with the use of a dual mobility bearing versus a single bearing design with the use of a large femoral head (36mm or 40mm). We hypothesize the use of dual-mobility components in revision THA will be associated with a lower dislocation rate in the first year following surgery.

The aim of this study is to the compare clinical outcomes of patients undergoing a revision total hip arthroplasty (THA) with the use of a dual mobility bearing versus a single bearing design with the use of a large femoral head (36mm or 40mm). We hypothesize the use of dual-mobility components in revision THA will be associated with a lower dislocation rate in the first year following surgery.

Eligibility Criteria:
Inclusion Criteria:

* Any patient older than 18 years of age scheduled for a revision THA, including revision of both components, conversion of a hip resurfacing to THA, conversion of a hemiarthroplasty to THA, and revision of single components which allow implantation of dual-mobility bearings. In addition, patients undergoing reimplantation of a total hip arthroplasty following a two-stage revision for periprosthetic infection will also be included. Only patients with an acetabular shell diameter capable of accommodating at least a 36mm femoral head will be included.

Exclusion Criteria:

* Less than 18 years of age, primary THA,
* conversion of non-arthroplasty femoral neck fracture fixation to THA,
* patients unwilling to participate.
* patients where the surgeon makes the intraoperative decision to use a constrained liner will be excluded.
Multiple-portal VATS Versus Uniportal VATS Lobectomy for Non-small Cell Lung Cancer

This study evaluate multiple-portal VATS and uniportal VATS lobectomy for NSCLC, half of participants will receive multiple VATS, while the other half will receive uniportal VATS lobectomy.

Conventional VATS and uniportal VATS lobectomy can be performed each for NSCLC. Conventional VATS lobectomy employ 3 or 4 ports for completing the operation. Usually the camera port is performed at the seventh or eighth intercostals space within the trocar, so it's easy to cause the intercostals nerve and vessel injure, and still create obvious pain.

However, the lobectomy for lung cancer can be accomplished with a single incision. According to the initial results, Uniportal VATS (UVATS) lobectomy procedure has been wide adopted by less acess trauma, relieve postoperative pain. But these were retrospective and descriptive, not randomized study. Further randomized control studies will be required to demonstrate that there are more benefits in UVATS techniques compared with conventional VATS for lobectomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnosis of primary lung cancer with the age between 35 and 75 years old;
* Patients with Tumor size ≤5cm，clinically staged T1-2N0-1M0，prepared for lobectomy and mediastinal lymph node dissection;
* Patients with an American Society of Anesthesiology score of 0-1.

Exclusion Criteria:

* Patients with N2 or N3 positive or distant metastasis.
* Patients who had undergone Neoadjuvant chemotherapy.
* Patients with tumor invasion to the peripheral structures.
* Patients with previous history of thoracic operations.
* Patients with serious thoracic adhesion.
* Patients who will undergo Pneumonectomy, sleeve lobectomy, segmentectomy, wedge resection.
* Patients with preexisting chronic obstructive pulmonarydisease, asthma, or interstitial lung disease;
* Patients with cardiac, hepatic, or renal dysfunction;