cyrilzakka/clinical-trials huggingface dataset:
Nutritional Habits Among People with and Without Diabetes in Upper Egypt

Type2 Diabetes is a serious chronic disease associated with numerous complications. It is pandemic disease due to worsening of diatery habits and westernization of diet. These complications contribute to nearly half (46.1%) of deaths occurring in adults under 60, the working-age population. With this alarming increase, and in order to decrease complications and diabetes-related mortality, this health problem requires a comprehensive management plan where patients should be educated to make informed decisions about diet, exercise, weight, and medications, as recommended by the American Diabetes Association (ADA).

the aim of the study is -to detect nutritional habits in our locality among diabetic patients comparing to non diabetics.

Recent analysis has reported that for the management of diabetes, only pharmacologic approaches are not sufficient. The management of diabetes is a multifactorial process involving life style and dietery factors that influence the treatment outcomes. There are also patient-related factors, such as self-care behaviors, that have a strong influence on glycemic intolerance.

Diabetes management necessitates both medication and lifestyle adjustments, which are associated with a decreased risk of death. people with T2DM find dietary advice confusing, contradictory, and report that understanding and making healthy eating choices are the most challenging parts of living with the condition. Therefore, national guidelines recommend that all patients with T2DM should receive individualized, ongoing dietary advice from a health professional with expertise in nutrition. The role standing of diet in controlling of diabetes is considered imperative; still, diabetes patients are unaware of how they should approach this issue to ensure good glycaemiccontrol .in Egypt no sufficient screening about diatery habits .hypothesis:there is difference in diatery habits between patients with and without diabetes

Eligibility Criteria:
Inclusion Criteria:

* adults participant whose age \> 18or older .
* type 2 DM

Exclusion Criteria:

* Patients who have stroke patients who have dementia. CKD patients (as it affects appetite and diet)
Cognitive Therapy in Patients Failing ART

Highly active antiretroviral therapy (HAART) has been the greatest achievement to control the HIV/AIDS epidemic in the world. HAART has been shown to reduce virus replication to undetectable levels and to favor the recovery of immune function, avoiding the occurrence of opportunistic diseases. Although existing treatments have been shown to lower AIDS-related morbimortality and to increase patients' quality of life, the success of HAART requires high levels of adherence to the prescribed treatment regimen.

Adherence to HAART has become the major challenge for global public policy managers and healthcare teams involved in the care of HIV/AIDS patients. Mental healthcare professionals should use structured and effective intervention as strategies to facilitate a better approach, increase patients' autonomy and achieve optimal adherence.

Trial-Based Cognitive Therapy (TBCT) is a new, structured, and short-term version of cognitive behavior therapy developed by de Oliveira (2011). TBCT is an active approach that aims to change negative cognitions, especially dysfunctional core beliefs, that negatively influence patient's life in different domains. TBCT helps patients recognize situationally based thoughts, unhelpful beliefs and maladaptive behaviors that exacerbate emotional distress.

This study aims to assess the efficacy of TBCT in helping the patients to identify thoughts, emotions, assumptions and behaviors associated with non-adherence to antiretroviral therapy, and to improve adherence to treatment.


Eligibility Criteria:
Inclusion Criteria:

* The last two detectable CV \> 500 copies
* At least one year of antiretroviral treatment
* Age between 18 and 65 years
* Literate person.

Exclusion Criteria:

* Difficulty to read and to write
* Being currently in psychotherapy
* Clinical diagnoses of neurocognitive or psychotic disorders
Study Concerning Relationship Between Mixed Venous Saturation (SvO2) and Balance

It is the purpose of the investigators to investigate the possible relationship between fall in the amount of Oxygen in the blood and disturbances of balance-function before and after surgery.

It has been shown that the mixed venous saturation (SvO2) is usable as a parameter of fluid status. It has also been suggested that there is a connection between SvO2 and blood flow in tissue , and that a SvO2 of less than 40% is a sign of tissue hypoxia.

Recently it has been shown that patients going through heart surgery experience a drop in SvO2 during early mobilization.This drop lasts throughout the mobilisation process.

We want to investigate whether the same mechanism applies to patients going through other types of surgery, and whether there is a connection between a drop in SvO2 and orthostatic function.

This will be done by making 3 tests. One pre-operatively,one six hours post-operatively and one 18-24 hours after surgery.

The tests will consist of:

1. 10 min of rest.
2. 3 min of sitting upright on the side of the bed. C. 3 min of standing on the floor. D. 10 min of rest.

Between each position a venous blood sample will be taken. Also 1 blood sample will be taken at the end of surgery.

Continuous measurements by the Finapres system wil be made throughout the test-sequence to investigate changes in BP, SV, TPR and HR.

At the same time the patient will be pain-scored when taking a new position.

Eligibility Criteria:
Inclusion Criteria:

* Patients going through Radical Prostatectomy, where CVC is standard.

Exclusion Criteria:

* Non informed consent
* ASA \> II
* Age less than 18, or more than 80 years
* Diabetes Mellitus
* Epidural analgetics
* Alcohol abuse (investigators assessment)
* Unable to understand written or spoken information
* Using beta-blockers
Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease

The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.

On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

Eligibility Criteria:
Inclusion Criteria:

* Stable but active Crohn's disease at the time of screening
* Must be able to self-inject or have another person who can help with the injection

Exclusion Criteria:

* Not have a colostomy or ileostomy
* Not be taking prohibited medications as defined in the protocol
* Not have had GI surgery or a bowel obstruction in the last 6 months or planned surgery for the next months
* Not have ever taken this drug or drugs of similar type in the past
Bleeding Prediction in Patients Following Cardiac Surgery Using Whole Blood Aggregometry and Thromboelastometry

Use of whole blood impedance aggregometry and rotational thromboelastometry can reveal useful data about platelet function and viscoelastic properties of blood clot in patients undergoing cardiac surgery.

The purpose of this study is to clarify whether it is possible to predict patients on excessive risk of perioperative bleeding using whole blood impedance aggregometry and rotational thromoelastometry.

Antiplatelet therapy is the cornerstone in treatment of patients with coronary artery disease. Another research goal is to determine the degree of response to antiplatelet therapy before and after surgery and to investigate whether patients by level of response to antiplatelet therapy before surgery have a higher risk of perioperative bleeding.


Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years old
2. Elective cardiac surgery patients
3. Coronary artery disease
4. Aortic valve disease
5. Mitral valve disease
6. Ascendent aorta aneurysm
7. Combine coronary and valve disease
8. Cardiac surgery procedures using cardiopulmonary bypass

Exclusion Criteria:

1. Missing consent
2. Patients with emergent cardiac surgical procedures
3. Patients on antiplatelet therapy other than aspirin or clopidogrel
4. Patients with inaccurate antiplatelet therapy administration documentation
5. Missing data
6. Off-pump procedures
7. Patients younger than 18 years old
8. Patients with severe mental disorders
9. Intrinsic coagulopathy
Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients.

PROMs questionnaires seem to be an effective tool to obtain a greater knowledge of the physical and emotional state of patients. Despite this, few studies have been performed using patient reported outcomes in Head \& Neck (H\&N) cancer patients during and after treatment. The use of a novel topical mucosa composition (Saliactive®) is studied along the use of questionnaires.

This study analyses the severity of oral mucositis of H\&N cancer patients along the first 6 weeks of radiotherapy with or without chemotherapy (Phase 1).

Phase 2 evaluates Quality of Life in a pool of H\&N cancer patients 6 months after cancer treatment is completed. Quality of life of patients is analysed before (baseline) and after 1 month period of use of the tested composition (Saliactive®) begining 6 months after oncological treatment completion.

During cancer treatment (Phase 1), mucositis may affect the course of therapy and long-term survival, while after treatment (Phase 2) chronic pain, xerostomia, dysphagia and speech limitations between others are behind anxiety and poor quality of life.

The WHO oral mucositis scale together with a structured qualitative questionnaire to recover patient reported symptoms are used during phase 1.

A validated Quality of Life questionnaire described by the University of Washington, is chosen for Phase 2 evaluation.

Oral mucosa management is homogenized both during acute and chronic phase with the use of a composition (Saliactive®) which comprises olive oil, betaine and xylitol delivered in the form of a topical non-rinsing gel.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnose of Head \& Neck cancer that are going to receive cancer therapy (radio and/or chemotherapy).

Exclusion Criteria:

* Patients taking drugs for xerostomia.
Evaluation of Diagnostic Yield of EUS-Guided Tissue Sampling

All patients will receive standard medical care and no experimental interventions will be performed. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a well-established procedure commonly used for the investigation of lesions within or adjacent to the gastrointestinal (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions). EUS-guided tissue sampling has been commonly performed with different size and types of aspiration and core biopsy needles.

Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a well-established procedure commonly used for the investigation of lesions within or adjacent to the gastrointestinal (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions). EUS-guided tissue sampling has been commonly performed with different size and types of aspiration and core biopsy needles. More recently, a novel through-the-needle microforceps has been introduced. The MorayTM microforceps fits through a 19-gauge FNA needle and allows targeted tissue sampling under EUS visualization.

Aim - To prospectively evaluate the safety and diagnostic yield of the through-the-needle microforceps for pancreatic and non-pancreatic solid, cystic and mixed solid/cystic lesions.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years old
2. Patients referred for EUS-guided tissue sampling for lesions (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions).
3. Target lesion should be ≥ 15 mm in size (long axis).

Exclusion Criteria:

1. Any contraindication to performing endoscopy
2. Unable to provide informed consent
Safety of Gebauer's Pain Ease and Gebauer's Ethyl Chloride

This study aims to determine if Gebauer's Pain Ease or Gebauer's Ethyl Chloride topical anesthetic sprays are safe for use as numbing agents prior to placing epidurals and arterial lines, based on whether they introduce increased microbial growth after application to skin. Due to the recent national shortage of lidocaine, we hope to find a suitable alternative to lidocaine for topical analgesia when placing arterial lines and epidurals. Our hypothesis is that the sprays will not affect the sterility of the area. We will compare microbial growth from three subsequent swabs taken from a single area of skin on the wrist and lower back: one with no treatment, the second after treatment with ChloraPrep, and the third after applying one of the numbing sprays. If there is significantly higher growth in the swabs containing the topical anesthetic spray versus the ChloraPrep alone, this will indicate that the sprays introduce microbes to the sites of skin.

The purpose of this study is to determine whether Gebauer's Pain Ease and Ethyl Chloride topical anesthetic sprays are safe for application on the areas of skin where epidurals (lower back) and arterial lines (wrist) are placed, based on whether they introduce microbial growth to these areas. The investigators will compare microbial growth by swabbing both of these skin sites following: 1) no treatment 2) ChloraPrep treatment and 3) ChloraPrep plus numbing spray (Ethyl Chloride or Pain Ease) treatment. The cultures will then be incubated to test for anaerobic bacteria, aerobic bacteria, and mold growth. The microbial growth will be compared between the three treatment groups based on the number of colony forming units present.

Funding for the project will be from the manufacturer of the numbing sprays, Gebauer Company.

Based on power analysis, for each of the numbing sprays, a total of 72 subjects must be enrolled, with 6 swabs taken per subject (untreated, ChloraPrep, and topical anesthetic spray samples will be taken from both the wrist and lower back of each subject). A sample size of 72 pairs achieves 80 % power to detect an odds ratio of 24 using a two-sided McNemar test with a significance level of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Henry Ford employees

Exclusion Criteria:

* People with infections at the site of prep
* People with history of hypersensitivity to numbing sprays or chloraprep
Assessment of Changes in Renal Cortical and Medullary Blood Flow by Contrast Ultrasound

The purpose of this study is to determine if contrast enhanced ultrasound (CEU) using microbubbles, is useful in assessing changes in kidney blood flow.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Males and females
* Ages 18-65 years old

Exclusion Criteria:

* Pregnancy or lactation
* H/o kidney disease
* H/o congestive heart failure, ischemic heart disease, severe pulmonary disease or allergy to the drug
* H/o any cardiovascular disease
* Abnormal liver function (liver function tests out of specified ranges)
* Screening urinalysis which indicates infection or inflammation
* Taking regular medications (except for over-the-counter vitamins or hormonal contraceptives.)
* Taking supplements, like protein shakes
* Unwilling or unable to eat chicken (used as protein meal)
Norwegian COgnitive Impairment After STroke (NorCOAST) Study

A prospective observational multicenter study aiming to describe incidence, and identify predictors for development of poststroke dementia (PSD) and mild cognitive impairment (MCI) after stroke

About 15000 Norwegians suffer a stroke every year and 2/3 will be more or less disabled. In addition to motor impairments and comorbidities, disability after stroke is often related to post stroke dementia (PSD) or mild neurocognitive disorder (NCD). However, these problems are hardly addressed in stroke or dementia research and frequently ignored in clinical practise. In the Nor-COAST study an interdisciplinary research group will collaborate to establish a research platform across all Norwegian Health Authorities. The overall aim of the study is to improve competence on PSD and NCD in order to improve individual health outcomes following a stroke. The specific objectives are to determine the incidence of PSD and NCD and the consequences on function and use of health care services and to enhance the early detection of PSD and NCD by identifying a set of risk factors, ranging from genetics to physical activity. The incidence and impact of PSD and NCD on function and use of health care services, medication and life-style changes are important when planning future health care services. Tools identifying patients at risk might improve diagnostic work up and together with knowledge on pathogenic aspects it will contribute to future treatment and prevention of PSD and NCD.

Eligibility Criteria:
Inclusion Criteria:

* Stroke diagnosis according to the WHO criteria

Exclusion Criteria:

* Not scandinavian speaking
Study of NTBC for Tyrosinemia I

OBJECTIVES: I. Assess the safety and efficacy of NTBC in children with tyrosinemia I.

II. Evaluate the effects of NTBC on survival, rate of neurologic crises, improvement in renal tubular damage, reduction in the need for liver transplantation, and reduction in the development of hepatocarcinoma in these patients.

PROTOCOL OUTLINE: Patients are stratified according to age at onset of symptoms (0-2 months vs 2-6 months vs greater than 6 months).

Patients receive oral NTBC twice a day. Treatment continues in the absence of unacceptable toxicity.

Patients are followed once a month for 6 months, then every 3 months thereafter.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
* Confirmed diagnosis of tyrosinemia Detected through newborn screening before the onset of symptoms OR Diagnosed on the basis of symptoms (liver disease, neurological crises, growth failure) and succinylacetone in urine or blood and/or fumarylacetoacetate dehydratase deficiency in cultured fibroblasts or liver biopsy
Bronchiectasis and Long Term Azithromycin Treatment

1. SUMMARY

Rationale: Patients with bronchiectasis often experience lower respiratory tract infections with progression of symptoms and decline in quality of life. Macrolides, as has been shown in panbronchiolitis and cystic fibrosis, may break or weaken the link between infection and inflammation resulting in an improvement of symptoms. Also the number of exacerbations may lowered.

Objective: A reduction in number of infective exacerbations and improvement in lung function by AZT treatment are the primary objectives. Secondary objectives that will be evaluated are: symptoms score, quality of life, inflammatory parameters, bacterial colonisation, and adverse events.

Study design: Randomised double blind multicenter study in the Netherlands. Patients will be stratified for colonisation with P.aeruginosa.

Study population: Patients with bronchiectasis demonstrated by high-resolution computed tomography (HR-CT) scan or bronchography.

Intervention: Patients receive Azithromycin 250mg(p.o.) once daily or placebo.

Main study parameters/endpoints: Reduction in number exacerbations, defined as increase symptoms such as dyspnoea, coughing, and sputum production for which a course of prednisolone and/or antibiotic is needed. Change in lung function parameters (forced expiratory volume in 1 second \[FEV1\], forced vital capacity \[FVC\]) measured by spirometry is the other primary endpoint.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk of participating in this study is low. Laboratory, radiographic examinations, and pulmonary function tests are commonly used as diagnostic procedures during outpatients visits and during exacerbations. Adverse effects in maintenance treatment with AZT are usually mild and mainly gastrointestinal. Sometimes rash and abnormal liver function tests are observed. A better quality of life will probably be the beneficial effect of long term treatment with AZT. This will be achieved by a reduction in respiratory and non-respiratory symptoms and number of exacerbations.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 ≥ years
* Bronchiectasis diagnosed by plain bronchography or high resolution computer tomography.
* Minimal 3 lower respiratory tract infections (LRTI) treated with oral/intravenous (IV) antibiotics in the year preceding the study inclusion.
* The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum.
* At least one positive sputum culture in the preceding year.
* Informed consent

Exclusion Criteria:

* Previous ( ≥ 4 weeks) prolonged macrolide therapy.
* Pregnant or lactating women.
* Allergy to macrolides.
* Intolerance to macrolides.
* Liver disease (alanine transaminase and/or aspartate transaminase levels 2 or more times the upper limit of normal).
* Use of antibiotics within 14 days of screening.
* Use of oral or IV corticosteroids (≥ 30 mg prednisolone/daily) within 30 days of screening.
* Other research medication started 2 months prior to inclusion.
Feasibility of Middle Ear OCT Imaging

Feasibility of structural and functional imaging of the middle ear and its constituents by optical coherence tomography.

Rationale: Various middle ear diseases can affect anatomical structures of the middle ear in different ways. Unfortunately, current methods for assessing the structure and function of the constituents of the middle ear are limited and often fail to provide all clinically relevant data. Optical coherence tomography (OCT) is a technology that can provide valuable, additional information with a newly developed prototype OCT-device for structural and functional imaging of the middle ear.

Objective: To assess the feasibility and the clinical potential of structural and functional OCT imaging with a newly developed OCT-device in patients with various middle ear problems.

Study design: Observational study Study population: Adult patients presenting with various middle ear complaints at the Ear Nose Throat department of the Department of Otorhinolaryngology and Head and Neck Surgery, Erasmus Medical Center, Rotterdam, the Netherlands.

Main study parameters/endpoints: Percentage of patients in which structural OCT imaging was feasible (i.e., the OCT images showed a discernible tympanic membrane (TM) and at least one of the ossicles).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden is minimal: patient examination with Aurisvue is similar to the conventional examination with a standard otoscope and will take approximately 5 to 10 minutes. The risks are negligible: imaging is done with light levels well below the maximum permissible exposure level and sound levels to induce movement of the TM and the ossicular chain are well below the hazardous threshold.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* competent, willing and able to cooperate

Exclusion Criteria:

* any acute or chronic condition that would limit the ability of the patient to participate in the study, per attending physician's indication
* refusal to give informed consent
* pregnancy or breastfeeding