cyrilzakka/clinical-trials huggingface dataset:
Using Spices and Herbs to Increase Vegetable Intake Among Urban High School Students

A two-phase, school-based intervention will be conducted at a high school in Baltimore to evaluate whether the addition of spices and herbs to vegetable dishes in the National School Lunch Program (NSLP) can increase vegetable intake among students in an urban and predominantly African-American high school.

The proposed research will be conducted at Cristo Rey Jesuit High School in Baltimore, Maryland. In this two-phase intervention, the research team will work in Phase I with stakeholders throughout the high school community to identify the barriers to vegetable intake in the NSLP in this student population and to determine how spices and herbs might help overcome these barriers. The stakeholders with whom we will collaborate will include students, school administration, and cafeteria staff.

Phase II will focus on the direct measurement of vegetable intake among students both before and after spices and herbs are added to the vegetables in the NSLP. The spiced vegetable recipes that received the most favorable student rankings in the taste tests of Phase I will be offered.

The vegetable recipes flavored with spices and herbs will meet all NSLP requirements for fat, sugar, total calories, and all other guidelines.

Student vegetable intake will be assessed through two outcomes: 1.) plate waste, and 2.) production waste.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled student at Cristo Rey High School
* Able to read and write English (exclusive to Phase 1 participants)

Exclusion Criteria:

* Does not eat lunch in the Cristo Rey High School cafeteria
* Not willing to complete questionnaires (exclusive to Phase 1 participants)
Prevalence of Non-alcoholic Fatty Liver Disease in Patients With Chronic Kidney Disease in Assiut

The goal of this observational study is to detect the prevalence of NAFLD in CKD patients

The main question\[s\] it aims to answer are:

* \[question 1\] prevalence of NAFLD in CKD patients.
* \[question 2\] the relationship between NAFLD and CKD.

The goal of this observational study is to detect the prevalence of NAFLD in CKD patients

The main question\[s\] it aims to answer are:

* \[question 1\] prevalence of NAFLD in CKD patients.
* \[question 2\] the relationship between NAFLD and CKD.

Eligibility Criteria:
Inclusion Criteria:

* CKD patients

Exclusion Criteria:

* HCV and HBV Positive patients
* Alcoholics
* patient on Hemodialysis
* patients with wilson disease
* patients with alpha one antitrypsin deficiency
Efficacy and Safety of FS VH S/D 4 S-apr for Flap Adherence in Rhytidectomy

The purpose of the study is to compare the safety and efficacy of FS VH S/D 4 s-apr versus standard of care in adhering tissue and improving wound healing in subjects undergoing facelift.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject is 18 to 75 years of age at the time of screening
* Subject is planned for facial rhytidectomy
* Subject has read, understood and signed the written informed consent
* Subject is healthy, as determined by the investigator using standard pre-operative assessments to include laboratory tests and electrocardiograms
* Subject is of childbearing potential, presents with a negative serum pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
* Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

* Subject is indicated for an abbreviated or modified face-lift procedure such as deep plane procedures, minimal undermining procedures, thread lifts, and minimal access cranial suspension
* Subject is indicated for concurrent facial surgeries during the operation (eg forehead plasty,blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.)
* Subject is indicated for additional procedures to the body during the same operation (eg liposuction, mastoplasty etc.)
* Subject has undergone a prior rhytidectomy surgery
* Subject is an active smoker, as assessed by the investigator
* Subject has a known (documented) bleeding or coagulation disorder
* Subject is being treated with anti-coagulants or with Aspirin (that was not discontinued 7 days prior to surgery)
* Subject has a vascular disorder, cardiovascular disease, and/or uncontrolled hypertension
* Subject has diabetes mellitus with glycosylated hemoglobin (HbA1c) \> 7
* Subject is receiving active treatment for a malignancy
* Subject has a connective tissue disorder
* Subject has an active or chronic skin disorder
* Subject has history of Bell's palsy
* Subject has a documented history of pathologically or pharmacologically induced immune deficiency
* Subject has received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery
* Subject has a known sensitivity to components of FS VH S/D 4 s-apr
* Subject has a known psychiatric disorder (eg, obsessive compulsive disorder, anxiety, eating disorders, etc.)
* Subject has documented healing complications following previous surgeries (eg, hypertrophic scarring)
* Subject is pregnant or lactating at the time of enrollment
* Subject has participated in another clinical study involving an investigational product/device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product/device during the course of this study
Automatic Diagnosis of Early Esophageal Squamous Neoplasia Using pCLE With AI

Detection and differentiation of esophageal squamous neoplasia (ESN) are of value in improving patient outcomes. Probe-based confocal laser endomicroscopy (pCLE) can diagnose ESN accurately.However this requires much experience, which limits the application of pCLE. The investigators designed a computer-aided diagnosis program using deep neural network to make diagnosis automatically in pCLE examination and contrast its performance with endoscopists.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 80;
* agree to give written informed consent；

Exclusion Criteria:

* advanced esophageal squamous cell carcinoma or esophageal stenosis;
* having no suspicious lesion of ESN found by WLE and IEE
* known allergy to fluorescein sodium;
* having coagulopathy or impaired renal function;
* being pregnant or breastfeeding.
The Two-Way Communication Checklist (2-COM) in First Episode Psychosis Patients in Hong Kong

The Two-Way Communication Checklist (2-COM) is a communication tool developed by van Os et al. (2002). It aims to provide an opportunity for patients to voice their needs and problem to minimize the discrepancy and miscommunication between patient and professional carer. In this randomized controlled trial, the investigators aim to examine whether using 2-COM checklist would lead to improvement in first episode psychosis patient's overall satisfaction, change in treatment option in clinicians and consultation time.

Communication is at the heart of psychiatric practice. Good communication has positive impact on treatment, treatment satisfaction and treatment adherence. However, different characteristics of psychosis barricade the communication between clinicians and patients. Consequently, the divergent views of needs of care between patients and clinicians may be established due to miscommunication. Such divergence may barricade the planning and the outcome of treatment.

In Hong Kong, the core psychiatric services as well as early intervention for first episode psychosis patients are provided by psychiatric outpatient clinics. Mental health services in Hong Kong are overwhelmed by large demands of the services and inadequate mental health care workforce such as low psychiatrists-to-population ratio and psychiatric nurse-to-population ratio. The large demands of services and inadequate mental health care workforce restrained the services' quality. In some busy psychiatric outpatient clinic, a clinician needs to consult 30 patients in a 3-hour session. Hui et al. (2008) study showed that the mean consultation time in one of the general psychiatric outpatient clinic in Hong Kong is 5.8 minutes.

To sum up, a cost-effectiveness instrument is in need for the early intervention psychiatric outpatient clinic in Hong Kong. The instrument has to reduce the needs' divergence, communication between clinicians and patients, and enhance the patients' involvement of clinical decision-making in the rushed psychiatric consultation. The Two-Way Communication Checklist (2-COM) may satisfy the demand.

Eligibility Criteria:
Inclusion Criteria:

Patients will be included if they meet the following criteria:

1. attended the EASY service;
2. were diagnosed with schizophrenia ,schizoaffective disorder or schizophreniform disorder according to ICD-10;
3. were age between 15-64;
4. were able to complete the informed consent.

Exclusion Criteria:

Patients will be excluded if they meet the following criteria:

1. had history of substance misuse;
2. had history of intellectual disability;
3. were non- Chinese speaking patients
4. had violent risk
5. had suicidal risk
Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers

This is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening;
* Negative tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody;
* Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome);
* Use of medically effective contraception with a failure rate of \< 1% per year when used consistently and correctly from screening until 6 months following last dose or be post-menopausal or be surgically sterile or have a partner who is sterile.

Exclusion Criteria:

* Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 1 month following last dose;
* Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0;
* Previous receipt of an investigational vaccine product for prevention of Lassa Fever;
* Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles;
* Audiometry testing that demonstrates a hearing level threshold of 30 dB or greater for any frequency tested between 250 Hz - 8000 Hz;
* Recent (within 6 months) or planned travel to Lassa-endemic region;
* Current or anticipated concomitant immunosuppressive therapy.
Reliability and Validity of the Traumatic Injuries Distress Scale to Turkish

The Traumatic Injuries distress Scale is a patient-reported measure that assesses suffering following non-catastrophic musculoskeletal injuries. The original English version demonstrated acceptable accuracy in predicting recovery trajectories up to 12 months later. This study aimed to determine the cultural adaptation, validity and reliability of the Turkish version of TIDS-TR in young and physically active patients with hip pain.

The Traumatic Injuries distress Scale (TIDS) is commonly used to measure methods of coping with various forms of Traumatic Injuries. TIDS is a self-report questionnaire developed by David M. Walton et al. in 2016 to assess the magnitude of stress experienced as a result of recent musculoskeletal trauma. It is administered between 2 days and 4 weeks after injury and is used to estimate the likelihood of recovery within 6 to 12 months. Each item in the TIDS questionnaire, which consists of 12 items, is scored as 0, 1, or 2, and the total score is at least 0 and at most 24. The total TIDS score is interpreted as low risk (≤ 3), medium or unknown risk (4 to 10), and high risk (≥ 11) according to the score obtained. TIDS consists of three subscales: 1) uncontrolled pain (4 items), 2) negative affect (6 items), and 3) intrusion/hyperarousal (2 items). Each of the subscales has guiding features for clinicians to determine treatment priorities such as pain management, cognitive or psychological intervention, and stress management techniques. It is recommended that when the uncontrolled pain subscale score is 3 and above, the applications should be aimed at symptom control, when the negative affect score is 3 and above, the applications should be aimed at correcting negative mood, and when the intrusion/hyperarousal score is 1 and above, the applications should be aimed at treating anxiety and post-traumatic stress disorder.

The questionnaires validity and reliability were examined, and good findings were found, leading to the tools widespread use. The purpose of this study was to translate and culturally adapt the original English version of the TIDS into Turkish, as well as to evaluate the instruments validity and reliability in patients with traumatic musculoskeletal injury.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old,
* Having good reading and writing skills in Turkish,
* Having suffered a traumatic musculoskeletal injury that does not require surgery or inpatient treatment
* At least 2 and at most 4 weeks have passed since the injury

Exclusion Criteria:

* Those with organ disease
* Those with blood clotting disorders
* Those with neuromuscular disorders
* Those with rheumatoid diseases
* Those with cancer
* Those with systemic diseases such as uncontrollable psychopathology
BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer

This is an international, randomized phase II trial. The aim is to assess the efficacy and the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum resistant/refractory ovarian cancer.

100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50 patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be continued until disease progression or unacceptable toxicity. Primary endpoint: disease control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version 1.1.

Secondary endpoints: efficacy (progression free survival, overall survival, biological tumour response, biological progression free survival assessed by serum CA 125 according to Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms questionnaires, pharmacokinetics of BI 6727.

Others endpoints: biomarkers and pharmacogenetics analysis (optional)


Eligibility Criteria:
Inclusion criteria:

1. Confirmed recurrent epithelial ovarian carcinoma, peritoneal carcinoma or fallopian tube carcinoma.
2. Platinum resistant or platinum refractory disease.
3. Eastern Collaborative Oncology Group performance status \< = 2.
4. Life expectancy \> = 3 months.
5. At least one measurable lesion (Response Evaluation Criteria In Solid Tumours version 1.1).
6. Adequate hepatic, renal and bone marrow functions.
7. signed written informed consent prior to admission to the study.

Exclusion criteria:

1. Contre-indications for cytotoxic treatment according to the Summary of Product Characteristics (Arm B).
2. Clinical evidence of active brain metastasis or leptomeningeal involvement.
3. Other malignancy currently requiring active therapy.
4. QTc prolongation according to Fridericia formula deemed clinically relevant by the investigator (e.g., congenital long QT syndrome, QTc according to Fridericia formula \> 470 ms).
5. Hypersensitivity to one of the trial drugs or the excipients.
6. Serious illness or concomitant non- oncological disease.
7. Systemic anticancer therapy within 4 weeks before the start of the study.
8. Evidence of ileus sor sub ileus.
Evaluation of an Education Program to Increase Knowledge and Participation in Clinical Trials Among Racial/Ethnic and Rural Populations

This clinical trial evaluates a culturally tailored educational outreach intervention for increasing clinical trial knowledge, referral, and participation among racial/ethnic minority and rural populations. Clinical trials are research studies that involve people. Through clinical trials, researchers are able to determine whether new treatments are safe and effective and work better than current treatments. Clinical trials can also help find new ways to prevent and detect cancer and improve the quality of life for people during and after treatment. Recruitment and retention of underrepresented groups in clinical trials remains a challenge. Racial and ethnic minority groups bear a disproportionate burden of cancer compared with other groups yet these populations continue to be underrepresented in clinical trials. This clinical trial uses community health educators (CHEs) to facilitate individual and group education sessions to improve knowledge of what constitutes a clinical trial, the value of participating in clinical trials, and why it is important for racial/ethnic minorities to participate in clinical trials.

PRIMARY OBJECTIVE:

I. To implement culturally tailored educational outreach activities with the goal of increasing clinical trial (CT) knowledge, referral and participation among racial/ethnic and rural populations.

OUTLINE:

Participants attend an educational session with CHEs and receive educational materials on study.

Eligibility Criteria:
Inclusion Criteria:

* Adult males and females 18 years of age and older from Ohio
* Will not let anyone who is not cognitively able to give voluntary informed consent take part in the education sessions
Postoperative Pain in Orbital Disease and Ocular Tumor

The purpose of this study is to evaluate the postoperative pain after general anesthesia of orbital diseases and ocular tumor patients.

The purpose of this study is to evaluate patients diagnosed of orbital diseases or ocular tumor over 16 years old of the postoperative pain after general anesthesia , and to analyze the related factors of pain after operation.

Eligibility Criteria:
Inclusion Criteria:

* over 16 years old
* diagnosed as orbital disease or ocular tumor
* surgery under general anesthesia

Exclusion Criteria:

* any uncontrolled clinical problems
The Effect Of 4-7-8 Breathıng Exercıs After Laparoscopıc Surgery

The study was a single-centre, parallel randomised controlled experimental study conducted with block randomisation method.

In determining the sample of the research, power analysis was performed and it was planned to have a total of 62 participants, with 31 participants in each group.Women undergoing gynaecological operations will be recruited in the order of hospitalisation according to the block randomisation method. The letters A and B in the blocks will be determined as experimental or control according to the coin flip method. One of the researchers will evaluate the participants according to the inclusion criteria and randomly assign them according to the block order after obtaining their informed consent. One of the researchers in this study will carry out the application. The other researchers will be blinded. The data obtained will be analysed by an independent statistician. Participant blinding will not be performed since the participants were informed about the study in informed consent. Descriptive Information Form, Mcgill Pain Scale Short Form (Biçici, 2010) and Vital Signs Assessment Form to evaluate vital signs and mobilisation will be used for data collection.Women who applied to the hospital due to benign gynaecological disorders and underwent laparoscopic surgery will first be evaluated whether they are eligible for the study according to the inclusion criteria evaluation form. Afterwards, women who are eligible to participate in the study will be randomly assigned by an independent researcher to determine whether they are in the experimental or control group.

Eligibility Criteria:
Inclusion Criteria:

Being literate, Having benign gynaecological disease, Not having any other disease affecting pain/living findings (neuropathy, migraine, Cardiovascular diseases, oncological disease, ...), Not using painkillers regularly, Not having substance addiction, Not having communication barrier.

Exclusion Criteria:

It was determined that women did not perform 4-7-8 breathing exercises regularly, Women wanted to leave the study, Complications related to surgery occurred at any stage of the study, Women did not complete the data collection tools.
Transfer of Cardioprotection During RIPC

Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion provides peri-operative myocardial protection, is safe and improves prognosis in patients undergoing elective CABG surgery.

The signal transfer from limb to heart is unknown. Thus, the aim of this study is to identify the pathways which transfer the cardioprotective signal from the ischemic/reperfused extremity to the heart in humans undergoing surgical coronary revascularization.

The investigators will obtain arterial blood samples before skin incision and 1-72 h after the remote ischemic preconditioning protocol and analyze them biochemically. The investigators focus on those ligands that have been previously implicated in conditioning protocols at any organ. In addition, the investigators will use a bioassay system, consisting of a Langendorff-perfused isolated heart with coronary occlusion/reperfusion and infarct size by TTC staining as endpoint, and then expose this bioassay system to arterial plasma obtained after the remote ischemic preconditioning stimulus or placebo. This approach will allow us to further characterize any potential transfer signal candidate with a pharmacological antagonist approach.

The investigators will also obtain human atrial appendages after the remote ischemic preconditioning protocol or placebo and before patients were connected to the extracorporeal circulation. Contractile function of isolated trabeculae and vasomotor function of isolated arterial vessels will be analyzed in a bioassay system.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients \> 18 years after written informed consent
* elective, isolated CABG surgery with and without valvuloplastic surgery
* two-stage cannulation, cardiopulmonary bypass
* antegrade Bretschneider cardioplegia
* mild hypothermia (32°C)
* preoperative standard medication (statins, betablocker, aspirin)
* standard anesthesia (see above)
* intraoperative standard protocol (full heparinization with ACT, aprotinin, protamin)
* postoperative standard protocol (500 mg aspirin after 2 h, low-dose heparin after 4 h)

Exclusion Criteria:

preoperative

* prior percutaneous coronary intervention (PCI) within 6 weeks
* any preoperative troponin T elevation
* renal insufficiency (creatinine \>200 µmol/l)
* reoperation
* emergency surgery
* acute coronary syndrome (unstable angina, STEMI, NSTEMI) within 4 weeks
* dual anti-platelet therapy (clopidogrel+aspirin)

intraoperative

* harvesting of a. radialis
* coronary thrombendarterectomy
* complications (bypass-low flow/ -occlusion)
* antithrombotic therapy (intraoperative clopidogrel + aspirin)
* retrograde cardioplegia