cyrilzakka/clinical-trials huggingface dataset:
Omega-3 Supplementation on Serum Fetuin-A Levels

Background and aims: One of the investigated possible modulators of serum fetuin-A, associated with the risk of developing coronary artery disease (CAD), is omega-3 fatty acids (FAs). This study aims to evaluate the effects of omega-3 FA supplementation on serum fetuin-A concentration in patients with CAD.

Methods: The study was carried out on 34 male volunteer patients aged 35-75 years, newly diagnosed with CAD by conventional coronary angiography. Patients with CAD were divided into the "Omega-3 Group (n:16)" and "Control Group (n:18)". Low-fat diet principles were explained to both groups at baseline. While 1.560 mg/day omega-3 FA supplementation was given to the patients in the omega-3 group for eight weeks, but not in the control group. Food intake was recorded using six-day food records.

The study was carried out on 34 male volunteer patients aged 35-75 years, newly diagnosed with coronary artery disease (CAD) by conventional coronary angiography. The study did not include the individuals who have dieted in the last six months, been taking an omega-3 FA and/or vitamin/mineral supplements or statin group drugs, been BMI \<18.5 and ≥40 kg/m2, been fasting blood glucose ≥ 126 mg/dL, had a systemic disease such as Type 1 and Type 2 diabetes, kidney diseases, liver diseases, cancer and neurological diseases, active athletes, regular exercisers. Gazi University Faculty of Medicine Clinical Research Ethics Committee approved the study on 26 November 2020 with approval number 810. In addition, the necessary approval was obtained from the Turkish Medicines and Medical Devices Agency with the decision numbered 66175679-514.11.01-E.290378. All participants gave signed informed consent and the study was conducted in accordance with Helsinki Declaration.

Patients with CAD were divided into the "Omega-3 Group (n:16)" and "Control Group (n:18)" to evaluate the effects of omega-3 FA supplementation on biochemical parameters, especially serum fetuin-A, anthropometric measurements, and nutritional status. 1.560 mg/day omega-3 FA supplementation was applied for 8 weeks to 16 participants with CAD included in the omega-3 group, and the principles of a low-fat diet were explained. The principles of the low-fat diet without omega-3 FA supplementation were explained to 18 participants with CAD in the control group. The data of the participants were collected at the beginning, every 15 days and at the end of the 8th week.

Eligibility Criteria:
Inclusion Criteria:

* Male volunteer patients aged 35-75 years
* Patients with newly diagnosed with coronary artery disease by conventional coronary angiography

Exclusion Criteria:

* Individuals who have dieted in the last six months
* Use of omega-3 fatty acid and/or vitamin/mineral supplements or statin group drugs
* BMI \<18.5 and ≥40 kg/m2
* Fasting blood glucose ≥ 126 mg/dL
* Presence of systemic diseases such as Type 1 and Type 2 diabetes, kidney diseases, liver diseases, cancer or neurological diseases
* Active athletes and/or those who exercise regularly
Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas

This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132 mutations.


Eligibility Criteria:
Inclusion Criteria:

1. Has histologically confirmed glioma with an IDH1-R132 mutation
2. Has disease that has recurred or progressed following standard treatment including radiotherapy
3. Has measurable lesion(s) as per RANO criteria
4. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Exclusion Criteria:

1. Has significant symptoms of increased intracranial pressure
2. Has another active neoplasm
3. Has active infection requiring systemic treatment
4. Has a history of severe cardiac disease
5. Has had prior treatment with any inhibitor targeting mutant IDH1
6. Has had investigational drug treatment within 4 weeks prior to the first dose of study treatment
7. Is a pregnant or lactating female
Ultrasound Elastography of Breast Lesions

Our hypothesis is that the addition of ShearWave Elastography (SWE) to a conventional breast ultrasound examination provides useful information for the radiologist when imaging lesions in the breast, as compared to conventional grayscale ultrasound alone.


Eligibility Criteria:
Inclusion Criteria:

* patients who have been referred to a breast ultrasound because of a positive physical palpation and/or positive mammograms and/or positive ultrasound and/or positive MRI.
* female
* age 21 or older
* provide informed consent

Exclusion Criteria:

* Women who are unwilling or unable to provide informed consent
* Women with breast implants
* Women with superficial lesions or lesions on skin (with the most superficial surface of the lesion within 5 mm of the skin surface)
* Women who are pregnant or breastfeeding
* Women who are undergoing chemotherapy or radiotherapy for any cancer
* Women with previous breast conserving surgery on the breast of interest Note: Previous excision of a benign lesion 4 cm or more away from the suspected lesion does not constitute an exclusion criterion.
The Effect of a Perinatal Health Promotion Program on the Different Levels of Gestational Hyperglycemic Women

Taiwan National Health Insurance system was launched in 1995 and the diagnosis and treatment for gestational diabetes mellitus were reimbursed. However, controversy regarding treatment and prevention programs for the other different levels of gestational hyperglycemia continues. Moreover, long-term follow-up studies for the impact of different levels of gestational hyperglycemia on women's perinatal consequences were not found. Thus, the purpose of the study, is to explore the effect of a perinatal health promotion program on three different levels of gestational hyperglycemic women's bio-psycho-social features and their offspring's development.

The investigators will recruit 120 women with three different levels of gestational hyperglycemia and assign them to either experimental group (a total of 60 women of gestational hyperglycemia) or control group (a total of 60 women of gestational hyperglycemia). Data will be collected at the women's six-month gestation, hospitalization for childbirth, and six weeks, six months, and one year postpartum. The three-year study findings can demonstrate the consequences and risk factors for women with three different levels of gestational hyperglycemia to suffer from type 2 diabetes mellitus. In addition, the results can be taken as an evidence-based intervention for the perinatal health promotion program in preventing the gestational hyperglycemic women to suffer from type 2 diabetes mellitus and in decreasing the impact of gestational hyperglycemia on the development of the gestational hyperglycemic women's offspring.

Eligibility Criteria:
Inclusion Criteria:The woman who

* Is 20 years old or above.
* Has a positive test for gestational diabetes mellifluous with the 75% oral glucose tolerance test during 24\~28 gestation.
* Has junior high or above educational level.
* Can speak Mandarin Chinese.
* Is Taiwanese residence.
* Plans to give a childbirth at the medical center.

Exclusion Criteria:The woman who

-Is immigrant.
Point-of-Care Follow-Up With Primary Care After Emergency Department Discharge

The purpose of this trial is to determine whether setting up a follow-up appointment for patients who received treatment and were discharged from the emergency department increases their compliance with the follow-up appointment. We are enrolling patients who need a follow-up visit, have health insurance but report do not have a primary care doctor. Patients are randomized to one of three treatment groups: (1) assistance setting up a follow-up appointment by a research assistant using ZocDoc; (2) ZocDoc information given to the subject to set up follow-up appointment by him/herself; or (3) usual discharge instructions by ED staff. Subjects are phoned approximately 2 weeks after the ED visit and asked whether they completed a follow-up visit, satisfaction with their ED visit, satisfaction with their follow-up visit, and additional ED treatment and recovery.

This is a randomized controlled trial involving adult emergency department (ED) patients who need a follow-up visit as defined by the ED provider (importance of follow-up rated as 5 or greater on a 0 to 10 scale). There is software available called ZocDoc that provides a user the ability to identify primary care providers who have open appointments and will take the person's health insurance (in network and outside of network) and list the doctors based on their proximity to the person in need. We are testing whether booking appointments for ED patients using ZocDoc vs. giving patients the information to use ZocDoc themselves vs. standard discharge instructions given by ED staff (i.e. you should follow-up with a primary care doctor) affects compliance with self-reported follow-up visits. We are enrolling patients while they are in the ED, completed a short baseline interview and then another interview with them over the telephone approximately two weeks after the index ED visit. The follow-up interview asks subjects whether they have completed a follow-up visit, satisfaction with the ED visit and the primary care visit, any other additional ED treatment and extent of recovery from the problem that brought them to the ED the first time.

Eligibility Criteria:
Inclusion Criteria: Patients with health insurance but report not having a primary care provider and are rated by the ED provider as needing a follow-up visit with a primary care provider (rated as moderate to high need by ED provider).

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Exclusion Criteria: Patients doesn't want a primary care provider or patient doesn't want a follow-up visit. Patient is unable to understand consent, is a prisoner, or does not have access to email (because ZocDoc sends appointment information to email).

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Presbyopia Compensation: Looking for Electrophysiological Predictors

The main purpose of this study was to identify electrophysiological predictive markers of post-correction visual comfort for presbyopic patients.

For each participant, presbyopia was compensated with contact lenses by monovision during three weeks and multifocality (three weeks again). A break of two weeks without any presbyopia compensation came in between the two phases of the test that were randomized.

All subjects were tested three times: before any compensation, after three weeks with monovsion and after three weeks with multifocality.

Each testing session was strictly the same including visual examinations and VEPs (visual evoked potentials).

Eligibility Criteria:
Inclusion Criteria:

* normal acuity

Exclusion Criteria:

* stereoacuity disorder
* neurological disorders
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System

The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751. In addition, questions regarding device satisfaction, sound satisfaction, usability and health care utilisation will be asked.


Eligibility Criteria:
Inclusion Criteria:

* Subject has performed Hearing assessment at 3 and/or 6 months in the clinical investigation CBAS5751
* Willing and able to provide written informed consent

Exclusion Criteria:

* Unable to follow investigational procedures, e.g. to complete quality of life scales, or unwilling to comply with the requirements of the clinical investigation as determined by the investigator
* Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
Effect of Therapeutic Touch on Sleep Quality and Anxiety in Individuals With Chronic Obstructive Pulmonary Disease

Purpose: The purpose is to determine the effect of therapeutic touch on the sleep quality and anxiety of individuals with chronic obstructive pulmonary disease.

Material and methods: This study was conducted between March 2018 and March 2019 as a randomized controlled experimental study conducted with pre-test post-test model. In addition to the routine nursing care, therapeutic touch (TT) and study scales were applied to the experimental group for a total of three sessions, once a day and 10 minutes each, for three consecutive days and only study scales were applied to the control group. The data was collected using Personal Information Form, Richard-Campbell Sleep Questionnaire and State Anxiety Inventory.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Literate
* Oriented, open to communication and cooperation
* Those who are hospitalized in the clinic for at least four days
* Patients who volunteered to participate in the study were included.

Exclusion Criteria:

* Have any diagnosed psychiatric disorder
* Using antidepressants, antihistamines, benzodiazepines, hypnotic and narcotic drugs
* Persons using any other complementary and alternative treatment method during the therapeutic touch application were not included in the study.
Mediterranean Diet as an add-on Therapy for Induction of Remission in Patients With Active Crohn's Disease

This clinical study is designed to evaluate the effect of Mediterranean diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters.

The Mediterranean diet has been associated with anti-inflammatory properties and with decreased risk for several chronic diseases. However, the effect of Mediterranean diet has not been evaluated in patients with inflammatory bowel diseases.

The purpose of this study is to determine whether Mediterranean diet is superior to a low residue diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters.

Seventy eligible patients will be randomly assigned to one of two dietary interventions: Mediterranean diet or low residue diet, as an add-on therapy for induction of remission of active Crohn's disease. The effect of the dietary regimens on clinical, inflammatory and microbial parameters will be assessed at 8 and 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age: 18-75
* Diagnosis of Crohn's Disease
* Montreal classification- B1
* CDAI: 150-450 + CRP\>0.5 or fecal calprotectin \>200
* Induction therapy with corticosteroids, 5-ASA, AZA, 6-MP, MTX or biologic therapy
* Capacity to give informed consent

Exclusion Criteria:

* Ileostomy or colostomy
* Exclusive enteral nutrition/ partial enteral nutrition
* History of or current severe systemic diseases
* History of admission due to bowel obstruction
* Positive Clostridium difficile toxin
* Positive Salmonella, Shigella, Campylobacter, stool culture
* Pregnancy or lactation
* Use of antibiotics or steroids one month prior to inclusion
Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions

This study aims to identify the accuracy of DNA integrity index in differentiating between oral premalignant lesions and oral cancer.

As stated by the U.S. Preventive Services Task Force and the National Institute of Dental and Craniofacial Research, the main screening test for oral cancer remains conventional oral examination of the oral cavity. Most cases of oral cancer are preceded by a clinically visible lesion. These lesions are called oral potentially malignant disorders. These are leukoplakia, erythroplakia, oral submucous fibrosis, oral lichen planus and discoid lupus erythematosis. Leukoplakia has a reported annual transformation rate of 2-3%, while OLP has a rate of 0.5% .

Full thickness tissue biopsy is the "gold standard" for diagnosing suspicious lesions should they be encountered during COE. However, oral biopsy is an invasive technique that can be challenging in sites as the floor of the mouth or the soft palate . The invasive nature of a biopsy also makes it unsuitable for cancer screening in high-risk populations.

Thus there is a need for a diagnostic aid that can help primary care providers determine which patients need to be biopsied or referred to a specialist.

Nucleic acids can be released actively or passively into the circulation by both living and dead cells, where the latter is considered the predominant source. Programmed cell death gives neatly digested DNA fragments of approximately 180 bp in length. In case of solid tumors, cell-free DNA is released through necrosis which generates longer DNA fragments due to haphazard and incomplete digestion of DNA. Thus, the integrity of the DNA fragment can determine its origin making DNA integrity a potential marker for oral cancer.

The DNA integrity index (DII) is the ratio between the longer DNA fragments to the shorter ones. A higher index has been reported in breast, prostate, liver and cervical cancer. Jiang et al. 2006 found that the DNA integrity index was significantly higher in oral cancer patients than in normal ones and reported a sensitivity and specificity values of 84.5% 83% respectively . The next step for such a marker would be early quantification of performance in clinical settings to determine if it is possible to extrapolate cut off values.

Eligibility Criteria:
Patients in this study will be divided into three groups:

Group I: Patients diagnosed histopathologically with oral cancer recruited from the National Cancer Institute, who have yet to receive treatment.

Group II: Healthy Controls

Inclusion Criteria:

* No visible oral lesions as detected by conventional oral examination
* Good oral hygiene, with healthy gingival tissues
* Non-smokers
* No systemic disease Group III: Patients diagnosed with oral lichen planus according to the modified WHO (van der Meij and van der Waal, 2003)diagnostic criteria not receiving treatment at least 8 weeks prior to enrollment.
Clinical Utility of an Age, Sex, and Gene Expression Score (ASGES or Corus CAD) in African American Patients.

This is a retrospective study, designed to be conducted at a single-center in the US. The study will conduct a one-time data abstraction from approximately 500 patient medical charts who received Age/Sex/Gene Expression score (ASGES) also knows as Corus CAD testing, by order of the Principal Investigator. Limited demographic data and patient data pertaining to cardiology referral or advanced diagnostic testing will be collected. All data will be collected anonymously.

Though the diagnostic properties of Age/Sex/Gene Expression Score (ASGES) or Corus CAD have been evaluated in previous observational studies, there are limited data regarding how primary care clinicians are using the results of the test in the care and management of patients with symptoms suggestive of angina in the African-America patient population. This retrospective study is designed to examine the relationship between the Corus CAD (ASGES) score and patterns of care regarding cardiology referral or further cardiac diagnostic testing in an African-American patient population single-center site.

This is a retrospective study, designed to be conducted at a single-center in the US. The study will conduct a one-time data abstraction from approximately 500 patient medical charts who received Corus CAD (ASGES) testing, by order of the Principal Investigator. Limited demographic data and patient data pertaining to cardiology referral or advanced diagnostic testing will be collected. All data will be collected anonymously. IRB approval will be requested with a waiver of informed consent, as no identifying information will be collected.

This retrospective study is designed to understand the patterns of care, including referrals for cardiac care and testing (including referrals to a cardiologist, exercise stress testing, cardiac computerized tomography angiography (CCTA), invasive cardiac angiography (ICA)) within an African-American patient population.

Eligibility Criteria:
Inclusion Criteria:

* All patients receiving Corus CAD (ASGES) from 2008-2012.

Exclusion Criteria:

* If any of the following co-moribidities, medical conditions, or current medical statuses are noted in the patient medical chart, s/he will be excluded from the analysis dataset:

  1. History of diabetes;
  2. Revascularization or myocardial infarction;
  3. Systemic infection or inflammatory condition; or
  4. Use of steroids, immunosuppressive agents, or chemotherapeutic agents.
Essential Fatty Acids in Adult ADHD

The aim of this project is to investigate the effect of a dietary supplementation with essential fatty acids in adults on cognitive functions related to attention and impulse control in the general population and in individuals with a diagnosis of attention deficit hyperactivity disorder (ADHD).


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV ADHD

Exclusion Criteria:

* any acute psychiatric disorder
Multisession Radiosurgery in Large Meningiomas

This is a prospective observational trial consisting of robotic multisession radiosurgery (CyberKnife ®) for large and medium size and/or located at critical site benign intracranial meningiomas.

To date, the treatment of choice for intracranial meningiomas is surgical removal.

Radiotherapy, especially the radiosurgery (SRS), in exclusive, adjuvant or salvage setting represents an alternative or complementary viable treatment to the neurosurgery. Despite being a well-established treatment for intracranial meningiomas, SRS might be associated with significant morbidity when large volumes or critical sites are treated. Hypofractionated stereotactic radiotherapy has the potential to deliver sharply focused high doses per fraction without increasing the risk of toxicity.

The aims of our study are toxicity and symptom control evaluation of radiosurgery treatment delivered in multisession, for large or medium size intracranial meningiomas and/or for intracranial meningioma located at the critical sites (perichiasmatic area, perioptic area, PCA). We will evaluate also the efficacy of the treatment by volumetric analysis of treated meningiomas carrying out a volumetric comparison between pre- and post-radiosurgery treatment (every 6 month after treatment).

The neurological and clinical assessment before and after s-SRS will be based on CTCAE v4.0 and BPN BSN House-Brackman and sensorineural internation scale assessment.

Eligibility Criteria:
Inclusion Criteria:

* either histologically confirmed or imaging-defined benign meningioma diagnosis;
* large or medium lesion size and/or in critical area (e.i. perichiasmatic area);
* signed specific informed consent;
* age ≥ 18 years;
* for female patients, execution of pregnancy blood test;
* Karnofsky Performance Status (KPS) ≥ 70.

Exclusion Criteria:

* histologically confirmed diagnosis of atypical or malignant meningiomas;
* patients who had received prior radiotherapy in the same site;
* pregnancy;
* allergy for contrast medium;
* neurofibromatosis diagnosis.