cyrilzakka/clinical-trials huggingface dataset:
The Effect of a Healthy Diet Containing Flaxseed and Olive Oil on Cardiovascular Disease Risk Markers

Flaxseed and olive oil consumption have beneficial effects on cardiovascular risk factors. Nonetheless the effects of their simultaneous consumption have not yet been studied.The purpose of this study is to investigate the effects of a healthy diet containing flaxseed and olive oil compared with healthy dietary advice on cardiovascular disease risk markers in patients with coronary artery disease (CAD), in improving flow-mediated dilation, plasma lipid profile and fatty acids composition of red blood cells.

A randomized controlled clinical trial will be conducted in Rajaie Cardiovascular Center in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. The participants are 50 eligible coronary artery disease patients, aged 30-75 years. Intervention group will be received a heart-healthy diet with a specified number of food servings from different food groups (including vegetables, fruits, grains, dairy products, meats) + daily consumption of 30 grams of flaxseed + 25 mL/day of refined olive oil (equivalent to 4 tablespoons; 2 tablespoons for lunch and 2 tablespoons for dinner); and control group will be received recommendations for a heart-healthy diet, such as those of the American Heart Association for 3 months. These include eating at least 5 servings of vegetables and fruits daily, reduction in the consumption of sources of saturated and trans fats by avoiding the consumption of high-fat red meats and replacing them with low-fat meat or with poultry and fish, replacing low-fat dairy sources with regular or high-fat ones; consumption of regular vegetable oils such as canola and sunflower; reduction in salt consumption; and reduction in the consumption of simple sugars, for 3 months. Flow mediated dilatation (FMD) in brachial artery via ultrasonography, plasma levels of lipids and lipoproteins via enzymatic method, and fatty acids composition of red blood cells via gas chromatography method were measured.

Eligibility Criteria:
Inclusion Criteria:

1. Established coronary artery disease as verified by coronary angiography
2. Body ass index \<30 kg/m2
3. men and postmenopausal women
4. Willing to participate in the study

Exclusion Criteria:

1. Unwilling to follow the protocol and/or give informed consent
2. Chronic Kidney Disease stage 4 or 5 or a reported history cancer
3. Regular consumption of flaxseed or omega-3 supplements during previous month
4. Any changes in the disease treatment plan including type or dose of lipid-lowering medications or coronary artery bypass graft during the study period
Iatrogenic Effects of Treatment for Childhood Cancer Constitution of a Biological Samples Bank

The constitution of a biological samples bank, attached to epidemiological studies Cohort F-CCSS on iatrogenic effects of treatment of childhood cancer, will identify genetic variants that can modulate the iatrogenic risks of these treatments. The main objective is to provide a biological samples bank to consider, besides the carcinogenic risks, the risk of other iatrogenic diseases in these children, in particular cardiac, cerebrovascular, lung, bone and kidney. These conditions can be very incapacitating and in some cases, fatal. Their impact, however, is poorly estimated as occurring in adulthood, they are rarely made in relation to the treatment received in childhood. The overall project is expected to eventually better define the iatrogenic effects prevention strategies for cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated for a first cancer in childhood
* Adult patients
* Signed informed consent
* Patient insured or enjoying a social security scheme

Exclusion Criteria:

* Minor patients
* Under legal protection measure patients
* Refusal of consent
Needs Assessment After Cancer in Patients Treated for Breast Cancer

observational monocentric study

observational monocentric study

Primary objective :

Describe post-cancer supportive care needs, assessed by questionnaire in patients treated for breast cancer after completion of treatment and 2 years later.

Secondary objective :

* Correlation between needs after cancer and the fear of recidivism assessed by the scale of the inventory of fear.
* Compare the need for supportive care between the end of treatment and 2 years after.
* Assess needs after cancer according to the stage of the disease
* Evaluate the needs after cancer according to the treatments received: surgery-radiotherapy versus surgery-chemotherapy-radiotherapy.
* Assess needs after cancer according to age and socio-professional category.

Schedule :

The selected patients then received a letter including an information and non-objection note, the post-cancer needs questionnaire, the Fear Inventory severity subscale questionnaire, and the QLQ-C30 questionnaire. A delay of 1 month was chosen to return the questionnaire with a phone call after 15 days for an analysis of responses in February 2019.

Eligibility Criteria:
Inclusion Criteria:

Women who have been treated for breast cancer and whose treatment ended in 2017 (cohort A) and in 2015 (cohort B), aged between 18 and 80 years, and who declared their non-opposition free and enlightened.

Exclusion Criteria:

Patients who have been treated for recurrence or 2nd cancer, metastases from the outset, male, refusal to participate.
Safety, Tolerability, and Efficacy of ISIS-PTP1BRx in Type 2 Diabetes

The purpose of this study is to evaluate the safety, tolerability, and efficacy of ISIS-PTP1BRx + oral antidiabetic drug/s (metformin and/or sulfonylurea) versus placebo + oral antidiabetic drug/s.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \>/= 27 kg/m2
* HbA1c between 7.5% and 10.5% (inclusive)
* C-Peptide (fasting) greater than or equal to 500 pmol/L
* On stable dose of metformin alone or in combination with a stable dose of sulfonylurea for \>/= 3 months prior to screening, and remain on stable dose throughout the study
* Agree to conduct home-based (fasted) blood glucose testing as directed

Exclusion Criteria:

* Clinically significant abnormalities in medical history or physical exam
* Serum creatinine \> ULN at Screening
* Clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT or AST \> 1.5x ULN at Screening
* History of renal transplantation or renal dialysis
* GFR \< 60 mL/min at Screening
* History of diabetic ketoacidosis
* History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
* Allergy to sulfur containing drugs
* Treatment with other drugs or medications not allowed per study specific Disallowed Concomitant Medicines
* Any other significant illness or condition that may interfere with the patient participating or completing the study
* Inability or unwillingness to comply with protocol or study procedures
Malnutrition's Role in Fall Risk

Falls and falls related injuries are considered one of the most adverse events that a patient can experience. Several assessment instruments to assess and mitigate risks for falls have been developed. However, these instruments have not addressed nutritional risk factors.

Weight loss and low hemoglobin levels are key components of Malnutrition. Malnutrition in the hospital setting is a significant concern and may play a role as a fall risk factor.

The World Health Organization (WHO) maintains a global anemia database. WHO has identified iron deficiency anemia, based on hemoglobin value alone as the most common, wide-spread nutritional deficiency worldwide. Anemia is present in 30% of the worlds population including industrialized nations.

The consensus statement of the Academy of Nutrition and Dietetics / American Society of Parenteral and Enteral Nutrition simply defines adult under-nutrition as a continuum of inadequate intake along with a multitude of other factors. Weight loss occurs at multiple points along this continuum.

this multiphase retrospective descriptive analysis hypothesizes that degree of weight loss and degree of Hgb decline may be fall risk factors.

Eat Well, Fall Less is a multiphase retrospective descriptive analysis of single event fallers and repeat fallers. Data source: Documented falls occurring between October 1, 2010 and October 31, 2012.

Chart Review data on weight loss and decline in Hemoglobin levels were collected 12 months, 6 months and 3months and 1 month prior to the first fall along as the most recent value prior to the event. Additional data on vitamin D levels and C-reactive Protein values will be collected at the 12 month, 6month, and 1 month prior to the first fall

Statistical Analysis using SAS version 9.1. a two tailed t-test was performed to evaluate differences in HGB characteristics between single and frequent fallers. One way ANOVA evaluated changes in Hgb, c-Reactive Protein, vitamin D values and weight over time are being collected.

Two constellations of fallers emerged. Those with and those without dementia. The two groups appeared to have different nutrition risk factors. All statistical analysis was done using JMP Pro (version 10.0.0, SAS Institute, Inc, Cary, NC). Statistical significance was set at p \< 0.05

Eligibility Criteria:
Inclusion Criteria:

* Veteran experienced a fall during a hospitalization between October 1, 2010 and October 31, 2012
* Veteran must have at least one documented weight a minimum of 24 months prior to admission

Exclusion Criteria:

* Adults who suffer from neurological disease or stroke
* Adults with documented orthopedic fracture in the past 12 months
* Documented amputation of a lower limb in the past 24 months
* Blindness
* History of volume overload, renal, cardiovascular or other in nature
* current alcoholic
* It is felt that a co-morbidity exists which makes the individuals weight history inaccurate, such as a recent prosthetic device alteration.
The Comparison of Pulse Oximetry, End-tidal Capnometry, and Integrated Pulmonary Index (IPI)

To compare two ways to test breathing after surgery in acute care setting. One method tests oxygen level of the blood, and one method will test oxygen and the carbon dioxide that is breathed out.

A simple comparison design will be used to compare pulse SpO2 monitoring of respiratory status to a combination of pulse SpO2 monitoring and EtCO2 nasal cannula monitoring with Integrated Pulmonary Index (IPI). Using combination monitor, each subject will serve as their own control with repeated measurements of respiratory rate, SpO2, EtCO2 and IPI at 5 second intervals. Patients will be monitored for a minimum of 8 hours after admission to the acute care unit and through the first night.

Subjects for this study will be a convenience sample post-operative in-patients admitted to 2 East after surgery at Allenmore Hospital/Multicare Health System a 75 bed community facility.

Eligibility Criteria:
Inclusion criteria:

* Age greater than 18
* Increased Body Mass Index (BMI) \> 31
* History of chronic obstructive pulmonary disease (COPD)
* History of Sleep Apnea

Exclusion criteria:

* Respiratory failure
* Isolation requirements
* Surgical patients admitted to 2 West or ICU
Elastic Stable Intramedullary Nailing of Dislocated Clavicle Fractures in Children

Most Clavicular Fractures in Children can be Treated Conservatively. Our Own Study showed a Benefit towards Much Lower Pain and Better Cosmesis in Adolescents when Treated with Elastic Stable Intramedullary Nailing.

The First 20 Patients Treated with this Method will be examined for Functional (CONSTANT and MURLEY-Score) and Cosmetic Results as well as Ultrasound-Morphology of both clavicles and Patients'satisfaction (CSS-8). Further on, all complications and problems will be documented.


Eligibility Criteria:
Inclusion Criteria:

* Only Dislocated Shaft Fractures or Pseudarthrosis after Conservative Treatment of Dislocated CSF in Children and Adolescents Treated with Elastic Stable Intramedullary Nailing

Exclusion Criteria:

* Age \> 17 years
* Pathologic fractures
* Lateral or Medial Fractures of the Clavicle
Evaluation of Formin Gene Status and Expression in Myeloproliferative and Myelodysplastic Disorders

Aim of the study is to analyze the expression of genes and sequences encoding the human mammalian diaphanous (mDia) related formin proteins to test the hypothesis that defects in the mDia expression or function might drive the pathophysiology of myelodysplastic syndrome, acute myeloid leukemia and other myeloproliferative diseases.

Leukocytes and myeloid lineage cells from these specimens will be assayed for expression of DRF genes using standard molecular biological approaches to measure mRNA levels. Extracted DNA will be analyzed for mutations that affect expressions or function using direct sequencing techniques.

Alternatively, expression of DRF gene products (mDia proteins) will be assessed using specific antibodies and flow cytometry. Molecular findings resulting from these assays will be correlated with clinical information recorded in specimen logbook.

Eligibility Criteria:
Inclusion Criteria:

* 18 and over
* Male
* Female
* Diagnosed with MDS, MPD and AML

Exclusion Criteria:

* Under the age of 18
* Received bone marrow transplant

Control Group Criteria:

inclusion:

* healthy men and women
* ≥ 55 years of age

exclusion:

* history of hematological condition
* history of cancer
The Construction of a Chinese Picture Naming Test and Its Preliminary Normative Data

We will construct a Chinese Picture Naming test which include 60 items with various word frequency and familiarity and is arranged by their familiarity in daily life.

Then we will collect the normative data for this test using normal subjects of various age and educational level.

In this study, we will first construct a Chinese Picture Naming Testing following the format of Boston Naming test. We will use the original 60 items from BNT and also choose another 100 items of objects with various frequency using the word frequency data from the Linguistic Corpus of the Academia Sinica. Colored pictures will be constructed accordingly. University students will be recruited to name the pictures and to judge the familiarity and image agreement for these pictures. Then, we will choose 60 pictures of according to the principles of 1. high image agreement 2. high naming agreement 3. including items of various familiarity and word frequency 4. double or triple phoneme words 5. including the original BNT items as possible. The 60 pictures will be arranged by their familiarity to construct the Chinese Picture Naming Test.

Then, we will recruit normal subjects of various age group and educational level to to the Naming test and to construct the preliminary norm.

Eligibility Criteria:
Inclusion Criteria:

* living in Taiwan for more than 5 years fluent in Chinese

Exclusion Criteria:

* previous neurological, psychiatric or speech language disorders
Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC

The purpose of this study is to determine whether 100mg erlotinib had similar effect compared with 150mg erlotinib in NSCLC patients with EGFR mutation in China.

In China it was confirmed that 150mg Erlotinib was effective in NSCLC patients wtih EGFR mutation, but reducing dose occurring in some patients because of the drug related side-effects. Thus, we sought to investigate that in Chinese patients with EGFR mutation whether low dose (100mg) Erlotinib had similar efficacy but lower toxcities compared with standad dose (150mg) Erlotinib.

Eligibility Criteria:
Inclusion Criteria:

1. Histological diagnosis of NSCLC with phase IIIB or IV disease;
2. Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection methods:ARMS-PCR, sequence method)
3. Never received anti-tumor therapies for the advanced stage;
4. Never used EGFR inhibitors;
5. Measurable disease by RECIST criteria;
6. Male or female patients \>=18 years of age;
7. ECOG karnofsky performance 0\~3, life expectancy is greater than 12 weeks;
8. Patients must be accessible for treatment and follow-up;

Exclusion Criteria:

1. Previously used EGFR inhibitors
2. Mix ingredients in patients with squamous cell carcinoma, small cell lung cancer;
3. Allergic to erlotinib;
4. Non-measurable lesions
5. Pregnant or lactating women;
6. Patients having other factors that preventing researchers from enrollment them.
The Effect of Reiki on Hopelessness Level

This quasi-experimental study aims to examine the effect of Reiki on the level of hopelessness in oncology patients.

The study was conducted at İzmir Tepecik Training and Research Hospital with 32 patients in both experimental and control groups. Patients performed Reiki daily for a week following each chemotherapy session for 4 cycles. Data were collected using the "Individual Information Form" and the "Beck Hopelessness Scale" through face-to-face and telephone interviews. Ethical approval was obtained, and data were analyzed using SPSS.

Reiki is considered a complementary and alternative therapy method that can be effective in coping with such emotional challenges and enhancing psychological well-being. It is thought that Reiki practices, by regulating the flow of energy and providing deep relaxation, can reduce individuals' levels of hopelessness and improve overall quality of life. This study will investigate the effect of Reiki practices on the levels of hopelessness in oncology patients.

Eligibility Criteria:
inclusion criteria: Receiving treatment at the Outpatient Chemotherapy Unit of İzmir Tepecik Training and Research Hospital University of Health Sciences, Diagnosed with cancer, Aged 18 and over, Willing to participate in the research

exclusion criteria: Not willing to participate in the research, Having communication problems
Clinical Utility of a Non Endoscopic Device EsoCheck and Biomarker EsoGuard as Alternative to Endoscopy for Screening for Barrett's Esophagus in At Risk Population

This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral.

The participants will complete two rounds of questions concerning the assessed risk for BE and decision for endoscopy referral of 6 patient cases (clinical vignettes).

After the first round has been completed, an EsoCheck/EsoGuard educational information package and the second round of 6 clinical vignettes including EsoGuard results will be sent.

This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral.

Around 200 US physicians will be asked to participate in this study and at least 100 will be enrolled. Physicians eligible for participation are those whose scope of practice includes preventative care and disease screening - namely screening of BE, such as primary care physicians, family medicine physicians, and general practitioners; physicians whose scope of practice include diagnosis and management of esophageal disease may also participate.

The participants will complete two rounds of questions concerning the assessed risk for BE and decision for endoscopy referral of 6 patient cases (clinical vignettes). Per round, there will be 3 different questionnaires consisting of 6 clinical vignettes (A/B/C). Participants will be randomized to questionnaire A, B or C according to the randomization scheme. After the first round has been completed, an EsoCheck/EsoGuard educational information package and the second round of 6 clinical vignettes including EsoGuard results will be sent.

Eligibility Criteria:
Inclusion Criteria:

1. Board-certified physicians whose scope of practice includes preventative care and disease screening, and/or those whose scope of practice include diagnosis and management of esophageal disease (examples include but are not limited to primary care physicians/ general practitioners, family medicine physicians, gastroenterologists, and foregut surgeons);
2. Have between 1 to 40 years of post-residency clinical experience within their field of practice;
3. Have an active panel (whether as part of a group practice, or individually) of over 1000 patients with an adult patient load of more than 50%.

Exclusion Criteria:

* None
Endotracheal Intubation Using Bonfils Fibrescope Without Neuromuscular Blockade

We studied intubating conditions and hemodynamic changes during endotracheal intubation employing either Bonfils intubating fiberscope or the conventional Macintosh laryngoscopy in 80 healthy patients candidates for elective surgery requiring endotracheal intubation. We omitted neuromuscular blocking drugs from the induction regimen.

BACKGROUND:

Neuromuscular blocking drugs (NMBDs) are believed to be the dominating antigens causing bronchospasm and anaphylaxis during anaesthesia. Avoidance of these drugs, however, renders compromised intubating conditions and higher morbidity with conventional Macintosh laryngoscopy. Thus, we compared Macintosh laryngoscopy with Bonfils intubation fibrescope without administering NMBDs.

METHODS:

Eighty male and female patients scheduled for elective surgery, aged 15 to 60 years, ASA class II or I, non-obese, with lower risk for difficult intubation were enrolled in this study. They were randomly allocated into the Bonfils group or the Macintosh group (40 each). Following adequate hydration and preoxygenation, midazolam 0.05 mg kg-1 was administered, followed by alfentanil 20 µg kg-1, lidocaine 1.5 mg kg-1, and propofol 2 mg kg-1 intravenously. Tracheal intubation was then carried out using Bonfils intubation fibrescope (Bonfils group) or employing conventional Macintosh laryngoscopy (Macintosh group). The primary outcome measure was the intubating condition, with mean arterial blood pressure and heart rate as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) physical status was class I or II
* body mass index (BMI) \< 30
* ability to assume the 'sniffing' position

Exclusion Criteria:

* smokers
* drug users
* pregnant
* expected to present difficult intubation
* history of oesophageal reflux
* any systemic or airway disease
* known allergy to the protocol medications
Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR)

The main aim of the study is to explore HFs in SRV, comparing their magnitude and direction with that of subpulmonary RV and systemic LV. As a secondary aim, possible association or correlation will be investigated between SRV energetics and: i) patient functional parameters, e.g., the results from cardiopulmonary exercise test (CPET), ii) patient clinical status, including the occurrence of adverse outcome (a composite of death, hospitalization for heart failure, cardiovascular arrest, sustained arrhythmias).


Eligibility Criteria:
Inclusion Criteria:Case group:

The study will include patients aged ≥ 18 years with the diagnosis of L-TGA and D-TGA, who:

* are admitted to UNICCA, the Adult Congenital Heart Unit or
* are scheduled for a Cardiovascular Magnetic Resonance examination in this Institution

Control group:

The study will include subjects aged ≥ 18 years who will invited for a Cardiovascular Magnetic Resonance examination in our Institution. This group of control will include n=15 of adult healthy subjects. A further inclusion criteria for the control subjects are age and male proportion comparable to those of the TGA group.

Exclusion Criteria:

* (case and control group)

  * Subjects with intrabody ferromagnetic material precluding subject's safety
  * Subjects with non CMR-conditional devices
  * Subjects with claustrophobia or breath-holding precluding an adequate CMR and 4D Flow images quality
  * Pregnant women