cyrilzakka/clinical-trials huggingface dataset:
Designing an Implementation Strategy for Lung Screening and Smoking Cessation Treatment in Community Health Centers

Tobacco use is the leading preventable cause of death in the US and a major driver of health disparities. Among our tools for reducing the harms of tobacco is lung cancer screening (LCS). This study will combine a review of existing qualitative and quantitative data on barriers to lung cancer screening and smoking cessation in underserved populations, a quantitative analysis of predictors of lung cancer screening and smoking cessation treatment use among Massachusetts Federally Qualified Health Centers (FQHC)s, and a stakeholder advisory group to synthesize these data and select implementation strategies that reflects the critical determinants and the strengths and resource constraints of the Federally Qualified Health Centers (FQHC) context.

Aim 1) To design an implementation strategy that targets critical components in the delivery of SCT or LCS services for patients who smoke.

Aim 2) To assess the acceptability, appropriateness and feasibility of the implementation strategy among community health center staff.

Eligibility Criteria:
Inclusion Criteria:

FQHC implementation team including staff in the intervention FQHCs and their lung screening partners

Exclusion Criteria:

FQHC staff or partners who leave the organization before end of study
Breathing Relaxation Exercise Heart Failure

The aim of the study is to determine the effect of breathing and relaxation exercises on dyspnea, fatigue and self-care level in heart failure patients.

The Effect of Breathing and Relaxation Exercise on Dyspnea, Fatigue and Self-Care Level in Patients with Heart Failure: A Randomized Controlled Study It was planned according to CONSORT rules as a randomized controlled study to determine its effect on self-care level.

The hypotheses of the research are as follows:

a: Breathing exercise applied to HF patients has an effect on the mean dyspnea score. b: Breathing exercise applied to HF patients has an effect on the mean fatigue score. c: Breathing exercise applied to HF patients has an effect on self-care mean scores. d: Relaxation exercise applied to HF patients has an effect on the mean dyspnea score. e: Relaxation exercise applied to HF patients has an effect on the mean fatigue score.

f: Relaxation exercise applied to HF patients has an effect on self-care mean scores.

Eligibility Criteria:
Inclusion Criteria:

(a) 18 years of age or older; (b) Patients with HF stage NYHA II-III; (c) hospitalized for two weeks; (d) Not pregnant; (e) Not applying any integrated treatment; (f) Patients who have been taking the same heart failure medication for at least three months.

Exclusion Criteria:

The exclusion criteria of patients are as follows: (a) Not expected to participate in a breathing or progressive relaxation exercise study in expert opinion; (b) Patients with COPD, (d) Patients with severe mental disorders.

Individuals' eligibility for inclusion and exclusion criteria will be evaluated through patient file records and interviews with the physician.
The Effect of Emotional Freedom Technique on Premenstrual Syndrome

Introduction: Premenstrual Syndrome (PMS) is a condition that occurs in the luteal phase of the menstrual cycle and affects women's lives physically, psychologically and behaviorally, starting approximately five days before menstruation and decreasing spontaneously a few days later.

Purpose: This research is planned to examine the effect of the Emotional Freedom Technique on the experience of premenstrual syndrome and menstrual symptoms and the quality of life of nursing students with premenstrual syndrome.

Method: The research will be conducted with first, second, third and fourth year female students studying at Dokuz Eylül University Faculty of Nursing. Diagnostic information form, premenstrual syndrome scale, menstruation symptom scale, SF-12 quality of life scale and subjective danger units will be collected via Google form. SUD Scale will be applied. The research is designed with experimental and control groups, and it is found that a total of 70 female students are needed, 35 in the experimental group and 35 in the control group. PMSS analysis will be performed and students who score over 132 points and meet the inclusion criteria will be numbered in the order of filling out the survey, and randomization will be done using the "Random Sequence Generator" through www.random.org, which provides computer-assisted randomization, and experimental and control groups will be created. Simple randomization will be applied to keep the control and experimental groups equal. To ensure blinding in the study, randomization will be carried out by someone other than the researchers. A total of 8 sessions of Emotional Freedom Technique (EFT) will be applied to the experimental group, once a week. No application other than the scales will planned for the control group.


Eligibility Criteria:
Inclusion Criteria:

* Scoring over 132 on the premenstrual syndrome scale
* Over 18 years old
* Having had a regular menstrual cycle for the last three months (21-35)
* Owner of a smartphone and internet
* Agreeing to participate in the research

Exclusion Criteria:

* Psychiatric treatment and antidepressant medication in the last three months who have started,
* Who are pregnant,
* Who have given birth,
* Who use oral contraceptives,
* Who have difficulty accessing the internet
* Who did not participate in the post-test will be excluded.
Study to Assess the Efficacy and Safety of GF-001001-00 Cream in Secondarily-Infected Traumatic Lesions

This is a double-blind, randomized, placebo-controlled, parallel-group, dose-finding study.

200 eligible patients will be included in the double-blind phase (50 in each group, randomised 1:1:1:1 to GF-001001-00 at a concentration of 0.25%, 1% or 2% or placebo).

Randomised patients will apply the study medication as follows depending on their assigned treatment group.

* GF-001001-00 2%, 2 times daily, for 7 days
* GF-001001-00 1%, 2 times daily, for 7 days
* GF-001001-00 0.25%, 2 times daily, for 7 days
* Placebo, 2 times daily, for 7 days

The first application will be done after randomisation at Visit 1 under the guidance of the investigator. Patients will return for control visits: Visit 2 (Day 5) and Visit 3 (Day 7), after randomisation. Patients will return for the Final Visit (Visit 4, Day 14 after initiation of treatment).

Primary objective:

To determine the most effective dose of GF-001001-00 cream for treatment of adult patients with secondarily infected traumatic lesions.

Primary efficacy endpoint:

Clinical response (success or failure) at the Final Visit (Day 14) in the ITTC population.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years of age.
* Presence of small laceration, sutured wound, abrasion or burn, which has a secondary bacterial infection.

Exclusion Criteria:

* None.
Effects of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors

To explore the effect of different doses of vitamin D drugs on gastrointestinal cancer cancer-related cognitive impairment, so as to provide reference and basis for the clinical use of our cognitive function surgery nursing plan for patients with gastrointestinal cancer.

To determine the incidence of postoperative cognitive dysfunction in patients with gastrointestinal tumors to determine the influencing factors of postoperative cognitive dysfunction in patients with gastrointestinal tumors. The characteristics of perioperative cancer-related cognitive impairment in patients with gastrointestinal tumors were analyzed by monitoring preoperative and postoperative FACT-COG cognitive scale connection test (Hua-Shan-version auditory word learning test) DSST digit symbol test gaffes detection task and hematology indexes, such as observation and analysis of the interference pattern of supplement vitamin D preparation postoperative hospital stay in patients with gastrointestinal tumor short-term cognitive impairment related to cancer, in order to reduce the incidence of complications and hospitalization days, improve cognitive function in patients with gastrointestinal tumor surgery, and improve the quality of nursing.

Eligibility Criteria:
Inclusion Criteria:

* Patients with gastrointestinal tumors diagnosed by gastroscopy and histology and their family members
* Elective surgery
* Education level in primary school or above
* Be able to fill in the questionnaire alone or under the guidance of the researcher
* Informed consent and voluntary participation in this study

Exclusion Criteria:

* Patients with cognitive impairment (illiteracy less than 17 points, primary school less than 20 points, secondary school or above less than 24 points) or previous history of cognitive impairment, dementia and delirium confirmed by MMSE examination before surgery
* Patients with life-threatening acute and chronic diseases
* Patients with eye or ear diseases leading to rapid loss of hearing or vision without AIDS
* Patients who have taken drugs related to improving cognitive function or drugs for psychiatric disorders
* Patients who cannot take care of themselves or are physically disabled and unable to perform neurological function tests
* Intraoperative hypoxemia (blood oxygen saturation \< 94％) more than 10 minutes
* Patients who quit or died due to non-cooperation or emergency
Generalized Seizure Detection And Alerting In The EMU With The Empatica Embrace Watch And Smartphone-Based Alert System

To demonstrate safety and effectiveness of the Embrace device in identifying convulsive seizures (CS) and notifying a caregiver during patient hospitalization at an epilepsy monitoring unit (EMU).

To demonstrate safety and effectiveness of the Embrace device in identifying convulsive seizures (CS) and notifying a caregiver during patient hospitalization at an epilepsy monitoring unit (EMU).

Subjects will be fit with an Embrace device upon admittance into the EMU. The Embrace system will be used in conjunction with the EMU standard care practices to monitor the subject during the subject's stay. EMU standard care practices will not be impacted by the Embrace system, but rather the Embrace will be used to supplement the EMU monitoring. The events detected by Embrace will later be compared to the gold standard results of the video EEG.

A convulsive seizure (CS) is defined for the purpose of this study as any seizure with non-facial motor activity involving one or both upper and/or lower extremities that has repetitive motor activity (rhythmic motor movements).

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with a history of convulsive seizure (as defined above) who are admitted to a hospital for routine vEEG monitoring related to seizures. Patients who are expected to have a convulsive seizure during their monitoring based on interpretation of clinical history.

Exclusion Criteria:

* Patients who are not expected to have their typical convulsive seizure during the course of their hospital admission (i.e. expected reduction due to anti-epileptic drugs during hospital admission).
* Women who are pregnant.
* Patients who are known or suspected to have a history of PNES only.
* Patients with known allergic reactions to nickel or stainless steel
* Infants who were born pre-term and may not have fully developed skin
Epicutaneous 1-Chloro-2, 4-Dinitrobenzene (DNCB) Patch in HIV Infection.

To evaluate the efficacy of dinitrochlorobenzene (DNCB) in patients with early HIV infection by monitoring immunologic parameters and serum HIV RNA. To facilitate the understanding of possible alterations in the immunological status of the HIV+ patient cohort.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* EITHER HIV negative or documented HIV+ by both the ELISA and Western blot tests.

For HIV+ patients:

* Patients must fail to meet the AIDS-defining criteria.
* CD4 lymphocyte count between 200 - 500 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Excluded:

Patients with obvious ultra violet(UV)-irradiated skin damage in the treatment sites.

Concurrent Medication:

Excluded:

* Patients who are likely to commence antiretrovirals within the 6-month study period.
* Patients using other immunomodulator therapies or other alternative therapies.
* Patients likely to require chemotherapy during the course of the study.

Concurrent Treatment:

Excluded:

* Patients who are likely to require significant UV light exposure during the study period.
* Patients who are likely to require radiation therapy during the course of the study.

Prior Medication:

Excluded:

* Prior exposure to DNCB.
* Patients who have used antiretroviral medications within the previous 3 months.
Vaccination With COMIRNATY in Subjects With a VAXZEVRIA First Dose

CombiVacS is a phase 2 randomized, adaptive trial developed to evaluate the immunogenicity of a dose of COMIRNATY after a previous single dose of VAXZEVRIA. A stratification will be made based on the following factors: study site, sex and age. This protocol allows to test the immunogenicity and safety of a heterologous vaccination strategy after a previous single dose of VAXZEVRIA.

This is a randomized, non-blinded, controlled, adaptive, multicenter, Phase II study in subjects aged ≥18 years and in good health or stable clinical situation that have received a previous single dose of VAXZEVRIA. Subjects will be randomized to immediately receive or not a dose of COMIRNATY in a ratio of 2:1. If primary analysis at day 14th confirms the starting hypothesis, subjects randomized to no vaccination will be considered for administration of one dose of COMINARTY at day 28th according to Public Health Department of the Ministry of Health recommendations on heterologous vaccination. In case the primary analysis does not confirm the starting hypothesis, subjects will be followed at the time points defined in the flow-chart without administration of COMIRNATY.

Other heterologous vaccination strategies could be incorporated if deemed necessary for public health reasons. This could include the use of different vaccination strategies including those already marketed vaccines for comparative assessment of their safety and efficacy on SARS-CoV-2 and its variants.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (18 years old) having received a prime VAXZEVRIA vaccination between 8 and 12 weeks before the screening visit
* Participants must provide consent indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study.
* Subjects in good health or stable clinical situation.
* Participant is willing and able to adhere to the procedures specified in this protocol.

Exclusion Criteria:

* Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC within 24 hours prior to the planned dose of study vaccine.
* Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to COMIRNATY excipients.
* Subjects with any contraindication to the administration of COMIRNATY, included pregnancy.
* Subjects with prior documented COVID19 since VAXZEVRIA vaccination.
* Subjects have symptoms or signs compatible with COVID19.
* Subjects participating in a clinical trial in the last three months.
* Any condition or situation precluding or interfering the compliance with the protocol.
Preeclampsia Subtypes and Surrogate Markers of CVD Risk

In order to assess surrogate markers of cardiovascular risk in subtypes of preeclampsia, we will conduct a 10-year follow-up study comparing 40 women with a history of early onset preeclampsia; 40 women with a history of late onset preeclampsia and 40 women with a history of normotensive pregnancies.

Eligible participants delivered at the Department of Obstetrics at Randers Regional Hospital 1998-2008.

Early-onset preeclampsia is defined as preeclampsia that develops before 34 weeks of gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.


Eligibility Criteria:
Inclusion Criteria:

* Women who delievered at the Department of Obstetrics at Randers Regional Hospital 1998-2008

Exclusion Criteria:

* Current pregnancy or breastfeeding
PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin

The primary objective of this study is to determine the efficacy of once-daily rosuvastatin in reducing LDL-C in children and adolescents aged 10-17 years with HeFH from baseline (Day 0) to the end of the 12-week double-blind treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (at least 1 year post-menarche) children and adolescents (aged 10 -17 years) with heterozygous familial hypercholesterolemia (HeFH)

Exclusion Criteria:

* Certain medical conditions and lab test results
* History of a reaction to rosuvastatin or other statin drugs
* Use of specified disallowed medications
CD-19 CAR-T Cell for Pediatric ALL or Lymphoma

This study seeks to examine the efficacy and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor (CAR) targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoma. The overall goal of this study is to validate the safety profile of administration CD19-CAR T cells and describe the response rate in children with relapsed/refractory ALL or lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have relapsed or refractory ALL or lymphoma treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve partial or complete remission with the last regimen.
* The patient's disease must be CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available.
* Age 1-17 years.
* Performance status: Subjects \> 10 years of age: Karnofsky ≥ 50%; Subjects ≤ 10 years of age: Lansky scale ≥ 50%.
* Normal organ function.

  * Total bilirubin ≤ 3 times upper limit of normal
  * AST (SGOT) ≤ 5 times upper limit of normal
  * ALT (SGPT) ≤ 5 times upper limit of normal
  * Serum Creatinine ≤ 2 times upper limit of normal
  * Subjects must have the following hematologic function parameters: Hemoglobin (Hb) level \> 8 g/dL; Absolute Lymphocyte Count \> 0.1x10\^9/L; Platelet \> 50x10\^9/L
* Prior therapy wash-out. At least 2 weeks or 5 half lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis.
* Subjects' parent or legal guardian must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Autologous transplant within 6 weeks of planned CAR T cell infusion.
* Recipient of CAR-T cell therapy outside of this protocol.
* Active central nervous system (CNS) or meningeal involvement by tumor.
* History of additional active malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast).
* Active human immunodeficiency virus (HIV) infection.
* Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant or breastfeeding women.
* Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.
* Serologic status reflecting active hepatitis B or C infection.
Point-of-care Tests for Bacterial Vaginosis and Candidosis

Vaginal infection in early pregnancy is associated with an increased risk of spontaneous preterm delivery and late miscarriage. Most studies presume that vaginal infections are responsible for up to 40% of preterm birth. Although the causative microorganisms of vaginal infections are manifold, the three pathogens most commonly associated with vaginal infections are Gardnerella vaginalis, Candida albicans and Trichomonas vaginalis. The aim of this prospective study is the validation of the point-of-care tests OSOM BVBLUE for bacterial vaginosis and SavvyCheck Vaginal Yeast Test for candidosis in comparison to Gram stain.

In the present study, it should be examined whether the OSOM BVBLUE for bacterial vaginosis and the SavvyCheck Vaginal Yeast Test for vaginal candidosis are superior, equal/comparable or inferior to diagnosis on Gram stained smears. The point-of-care-tests are potential tools for the adequate diagnosis of bacterial vaginosis and vaginal candidosis in early pregnancy, since the prevention of these infections, as well as the infection screening per se, have the potential to prevent preterm birth and reduce the rate of late abortion. Point-of-care-tests are easy to perform, relatively cheap, and widely available. Routine implementation of the tests would be an effective contribution to the reduction of preterm labor and late-onset mortality.

Eligibility Criteria:
Inclusion criteria:

* Legal age (Participants must be 18 years or over)
* Singleton pregnancy
* No recent therapy with antibiotics within the last two weeks
* No application of the following in the previous 72 hours before testing: vaginal ointments/crèmes, douches, spermicides, vaginal lubricants or feminine sprays

Exclusion criteria:

* Age below 18 years
* Multiple pregnancy
* Recent treatment with antibiotics
* Application of the following in the previous 72 hours: vaginal ointments/crèmes, douches, spermicides, vaginal lubricants or feminine sprays
Measuring Auto-fluorescence of White Corpuscles for the Early Diagnosis and the Monitoring of Pneumonia in ICU

The diagnosis of pneumonia is challenging in Intensive Care Unit. The auto-fluorescence of white corpuscles is altered during pneumonia. In presence of bacterial growth on lung samples, the measure of autofluorescence of white corpuscles could help the clinicians to discriminate bacterial colonization from acute infection.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalization in intensive care units
* Mechanical ventilation
* Age \> 18 years
* Collection of a lung sample for bacteriological analysis for the suspicion of a first episode of lung infection.

Exclusion Criteria:

* Refuse to participate