cyrilzakka/clinical-trials huggingface dataset:
Study on the Impact of Ocular Anesthetic Procedures in Ocular Blood Flow

Anaesthetic procedures in ophthalmology surgery have been a subject rapidly evolving in the past decades. When deciding for a retrobulbar block, the local injection of varying mixtures and volumes of fast-acting anesthetics (such as lidocaine) - with or without a vasoconstrictive agent (such as adrenaline) - coupled with Hyaluronidase have been the standard care to provide painless surgery while minimizing the possible risks such as increased intraocular pressure (IOP), brainstem anesthesia, toxic reaction and ocular blood flow changes. These iatrogenic-induced vascular dysfunctions have been also suggested to play a role in intra-operatory vision loss (a "wipe-out" phenomenon) in patients with advanced glaucoma.

The rationale for the use of epinephrine in retrobulbar anesthesia is to slow absorption of the anesthetic in general circulation and thus to achieve a longer effect in the orbit. However, studies on ocular blood flow after adrenaline-containing compounds have consistently showed a decrease in ocular blood flow, thus raising the issue of whether it should be used in patients with known vascular dysfunction, namely glaucoma patients. Nevertheless, there has been no study to verify this claim concerning the safety of non-adrenaline containing anesthetics.

Injecting a pre-determined volume of anesthetic compound behind the globe, regardless of its formulation has also been debated. The orbital pressure increase can lead to a number of adverse reactions, not only increasing IOP but also potentially decreasing vascular input by local compression. In glaucoma for instance, there has been suggested optic nerve sheaths to be less elastic than in healthy individuals, potentially making this structure less compliant to outside compression. These more rigid orbital tissues could also impair the orbit's ability to deal with the iatrogenic increased volume.

As seen, the current concepts on the impact of ocular anesthesiology in the orbit and the vascular supply to the eye are limited to a small number of non-homogeneous studies. We aim to study this impact through a non-invasive, widely established ultrasound based method of ocular blood flow research (color Doppler Imaging). Potentially, our study could help determine a taylor-made choice of the anesthesiology procedure to apply to a specific patient, thereby advancing the current standard of care in ophthalmology.

1. Ultrasound B-mode scans will be performed before and after the anesthetic procedure
2. Doppler scan will be added to the B-mode ultrasound to register the blood flow pattern of the ophthalmic and central retinal arteries
3. Blood pressure and heart rate will be monitored

Eligibility Criteria:
Inclusion Criteria:

* individuals over 18 years old
* willing to sign an informed consent and able to comply with the requirements of the study

Exclusion Criteria:

* history of ocular trauma
* previous extraocular surgery
* ocular disease other than the one motivating surgery
* systemic diseases with ocular involvement like diabetes or Graves Ophthalmopathy
Pilot Study of Etoposide-based Therapy and Hematopoietic Cell Transplantation for Hemophagocytic Lymphohistiocytosis

The investigators would like to propose a pilot study evaluating the efficacy of etoposide combined with immunosuppressive agents for adult secondary hemophagocytic lymphohistiocytosis (HLH), in order to prove out whether the modification of previous HLH-94 or HLH-2004 protocol for childhood patients can improve the outcome and decrease the toxicities. The results of this pilot study will be a base of a more-improved phase-2 protocol.

The treatment of HLH in adult patients has not been determined yet. Actually, we adopted the treatment protocol HLH2004, which was developed for pediatric HLH patients. The HLH2004 protocol, which is a potent and successful treatment for HLH, has shown some limitations in the treatment of adult HLH. First, the dose of etoposide is somewhat high for adult patients to tolerate. Second, the high incidence of opportunistic infection such as fungal, bacterial, and viral has threatened the patients. Third, more aggressive and intensive approach to adopt allogeneic hematopoietic cell transplantation will be needed earlier in adult patients. Based on these rationales, we developed a modified protocol based on HLH2004 to pit the treatment of adult HLH patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose clinical findings satisfy 5 or more criteria out of the following 8 ones

  1. Fever ≥ 38.5 ℃ for ≥ 7 days
  2. Splenomegaly ≥ 3 FB below left subcostal margin
  3. Cytopenias affecting ≥ 2 of 3 lineages in PB Hb \< 9 g/L Platelet \< 100 x 109 /L ANC \< 1.0 x 109 /L
  4. Hypertriglyceridemia and/or hypofibrinogenemia (fasting triglycerides ≥ 265 mg/dL, fibrinogen ≤ 1.5 g/L)
  5. Hemophagocytosis in BM or spleen or LN
  6. Low or absent NK-cell activity ( according to local laboratory reference)
  7. Serum-ferritin ≥ 500 mcg/L
  8. Soluble CD25(sIL-2 receptor) ≥ 2,400 U/ml
* 18 years of age and over.
* All patients (or his/her family when the patient cannot sign the consent form because of his/her general conditions) give written informed consent according to guidelines at institution's committee on human research.

Exclusion Criteria:

* HLH from malignancy (such as lymphoma, myeloma, leukemia, and other solid tumor)
* HLH from rheumatic disorder (such as SLE, AOSD, antiphospholipid antibody syndrome)
* Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
* Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
* Male patient who reject the methods of avoiding pregnancy via methods such as abstinence, barrier method (condom etc).
* Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
Immunogenicity and Reactogenicity of a Meningococcal B Outer Membrane Vesicle Vaccine Given in a 0,6,12 Month Schedule to Health UK Adults

To measure the serum bactericidal antibody levels and cell mediated immune responses before and six weeks after each dose of meningococcal outer membrane vesicle vaccine given at 0,6 and 12 weeks to healthy UK adults.


Eligibility Criteria:
Inclusion Criteria:

* Informed written consent given for three immunizations with MenBVac and five blood tests
* Between the ages of 18 and 55 years inclusive at recruitment

Exclusion Criteria:

* Previous history of bacteriologically confirmed meningococcal disease
* History of clinically significant allergic sensitivity to any vaccine received in the past
* Immunodeficiency
* Any other acute or chronic systemic illness or dependence or abuse of drugs or alcohol
* Language difficulties sufficient to preclude adequate comprehension of the study information
* Possibility of pregnancy
* Receipt of any other vaccine in the previous 4 weeks
* Receipt of any group B vaccine in the past
* Current participation in any other clinical trial
* Generalized acute systemic illness and/or temp \>38C on day of vaccination deferral
Negative Oral Contrast Agents Utilization in PET/CT Studies

To compare the performance of different negative oral contrast agents in bowel distension in patient referred for PET/CT studies for various causes aiming for identification of ideal oral contrast agent(OCA).

Evaluation of gastrointestinal pathology depends on adequate bowel distention, which optimizes resolution of the bowel wall and contents. Traditionally, high-attenuation oral Contrast material in the form of iodine solutions or barium suspensions has been used to obtain bowel distension in MDCT examinations

Traditional high-contrast oral agents like iodine solutions, and barium suspensions which due to overcorrection problems in PET-CT interpretation lowers the accuracy of diagnosis. Negative oral contrast agents like water, air, fat containing agents used with 12.5% corn oil and polyethylene glycol has been used in radiological studies. Milk with 4% fat content has also been tested out in radiological studies and found to be effective. As it is more easily available, palatable, and acceptable especially, by children it needed to be tested in the visualization of the GIT in the PET-CT studies compared to other negative contrast agents.

Eligibility Criteria:
Inclusion Criteria:

* all patients referred to our unit for PET/CT study for various causes

Exclusion Criteria:

* Patients with GIT disease.
* Pregnancy and lactation.
* Severely ill patients.
The Effect Of Reflexology On Pain, Anxiety And Comfort Level

This study was performed as a randomized controlled a study with a pre test-post test design, aimed to determine affect of reflexology masagge to the pain, anxiety and comfort level on the patients that are percutaneous coronary intervention.

A total of 74 patients, 37 in the experimental group and 37 in the placebo group, who met the criteria for inclusion in the study, constituted the sample of the study. Research data were collected with "Structured Patient Information Form", "Vital Signs Form", "State Anxiety Scale", "Visual Comparison Scale", "McGill Pain Scale Short Form" and "General Comfort Scale Short Form". Appropriate statistical methods were used in the analysis of the data.

Reflexology massage is a well tolerated, inexpensive, applicable and safe non-pharmacological method. The fact that nurses are educated and experienced about reflexology massage is of great importance for integrating reflexology massage into clinical settings.

If the results of this study are significant, it will be concluded that reflexology massage is effective in the management of pain and anxiety and increasing the comfort level in patients undergoing PCI. It will be recommended that reflexology massage be used in clinics to reduce pain, anxiety and increase comfort level in individuals undergoing PCI, and to include it in patient education. No study has been found in the national literature evaluating the effectiveness of reflexology massage in the management of PCI-related pain, anxiety and comfort. It is thought that this study will fill an important gap in the literature. The aim of this study, carried out in this context, is to reveal the effect of reflexology massage on pain, anxiety and comfort level in patients undergoing PCI.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old,
* Literate, Diagnosed with PCI-related pain,
* Pain score of 4 out of 10 according to Visual Comparison Scale (VAS) after PCI.

Exclusion Criteria:

* Presence of a pacemaker,
* Having a diagnosis of diabetic foot,
* Presence of vision, hearing, cognitive ability impairment or psychosis,
* Being pregnant,
* Presence of disc herniation,
* Any contagious skin disease (shingles, fungus, etc.), open lesion/wound on the lower extremities, scar tissue, fracture, dislocation, amputation, edema, hematoma, thrombophlebitis, inflammatory and degenerative joint disease,
* Having applied reflexology massage in the last month
Femoral Arterial Cannulation

Many children undergoing surgery for congenital heart disease have had prior operations. Re-operative sternotomy carries with it the risk of cardiac injury and the need for emergent peripheral cannulation.

Our first aim is to demonstrate that peripheral arterial cannulation may be lifesaving in cases of complicated sternal re-entry in children and that angio-catheters can be utilized when vessels are too small for standard cannulas.

Our secondary aim is to present a case report of successful femoral cannulation in a 5 kg child.

In children, many of the standard operative sites are either occluded, stenosed, or too small for the smallest manufactured cannulas. In these instances, it may be feasible to utilize angio-catheters for arterial access until central cannulation can be achieved safely. In an in vitro model, we have simulated a cardiopulmonary bypass circuit and arterial cannulation with angio-catheters.

It appears that angio-catheters may be used with acceptable flow hemodynamics for blood vessels too small for standard cannulas.

We have performed this successfully in a 5 kg child.

We have completed the cardiopulmonary bypass model and are ready to submit the hemodynamic data. We would like to submit to a national meeting and hopefully for publication thereafter.

Eligibility Criteria:
Inclusion Criteria:

* case report of successful angio-catheter use on 5 kg child

Exclusion Criteria:

* that which does not meet inclusion criteria
Passive Stretching Versus Electrical Stimulation on Glucose Level, in Elderly With Type II Diabetes

Sixty elderly diabetics (type II) their age ranged from 60-75 years had been divided into two equal groups; group (A) treated by 40-minute passive stretching exercises, while the group (B) treated by 30 minutes electrical stimulation three times per week for 12 weeks. Blood glucose level,Time up and go test (TUG) and Fatigue severity scale were done before and after 12 weeks of the study.Conclusion: Both electrical stimulation and passive stretching are effective to lowering blood glucose level and can be proposed for those people restricted to perform exercise.

Background: Physical exercise is one of the bases for controlling and treatment type 2 diabetes mellitus. But not all diabetic elderly is able to perform physical exercise because of their physical limitation condition. The approach for those people in this study is electrical stimulation and passive stretching. Purpose: The aim of this study is to compare the effect of passive stretching and electrical stimulation on blood glucose level, functional mobility and Perceived-Fatigue in diabetic elderly. Methods: Sixty elderly diabetics (type II) their age ranged from 60-75 years had been divided into two equal groups; group (A) treated by 40-minute passive stretching exercises, while the group (B) treated by 30 minutes electrical stimulation three times per week for 12 weeks. Blood glucose level,Time up and go test (TUG) and Fatigue severity scale were done before and after 12 weeks of the study.

Eligibility Criteria:
Inclusion Criteria:

* HbA1c value between 6.5% -8.5%,
* age ranged from 60-75 years patients have
* body mass index (BMI) from 25 to 29.9 kg/m2,
* duration of diabetes ranged from 5-7 years. They were
* on oral hypoglycemic medications at the same dose.
* All patients were clinically and medically stable when attending the study.

Exclusion Criteria:

* unstable cardiovascular,
* chest problems
* other types of diabetes
* on insulin therapy
* chronic renal failure and
* iron deficient anemia and
* musculoskeletal disorders which may affect their physical ability to do the exercises.
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum

This prospective observational study will evaluate the safety and efficacy of first-line Avastin (bevacizumab) in combination with standard chemotherapy in routine clinical practice in patients with metastatic cancer of the colon and/or rectum. Patients will be followed for the duration of their treatment and a 30-day follow-up after the last dose of study drug.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of metastases
* At least one measurable metastatic lesion (as per RECIST criteria)
* Life expectancy of \> 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate hematological, renal and liver function

Exclusion Criteria:

* Prior chemotherapy for metastatic disease
* Clinically significant cardiovascular disease
* Ongoing treatment with aspirin (325 mg/day) or other medications known to predispose for gastrointestinal ulceration
* Participation in an investigational trial in the previous 3 months
* Pregnant or lactating women
* History of thrombotic or haemorrhagic disorders
* Evidence of bleeding diathesis or coagulopathy
* Uncontrolled hypertension
* Known hypersensitivity to Avastin and any of its excipients, or any of the chemotherapies
* Evidence of any disease or disorder that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
Phase IIa Safety and Efficacy Study of SRD174 Cream in Patients With AD-associated Pruritus

Pruritus is an essential feature for the diagnosis of atopic dermatitis and may play an important part in disease progression. Itching has a significant impact on the quality of life of AD sufferers, in particular night-time itching leading to sleep disturbance and subsequent poor daytime performance.

The objective of this study is to determine whether SRD174 Cream is a safe and effective therapy for moderate to severe pruritus associated with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 years and over moderate to severe AD pruritus
* Written signed and dated informed consent
* Satisfactory medical assessment with no clinically relevant abnormalities

Exclusion Criteria:

* Subject with active and pruritic AD covering a body surface area (BSA) \> 20%
* Subject with severe AD defined as an IGA score of 4
* Subject with current or recurrent skin disease (except AD) that could affect the site of application of action, absorption or disposition of the investigational product, or clinical, laboratory assessments.
* Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
* Subject with known or suspected intolerance or hypersensitivity to the Investigational products or any of the stated ingredients.
* Subject who has a medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with interpretation of trial results and, in the judgment if the investigator, would make the subject inappropriate for entry into this trial.
Glycemic Response to Road Cycling in Type 1 Diabetes

The purpose of this study is to assess the glycemic response to cycling road races (using continuous glucose monitoring ) in elite athletes with type 1 diabetes and non-diabetic controls. The investigators will also assess the relationship between power/work during cycling (using a power meter) and the subject's glucose profile.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* A1C ≤8.0% if diagnosed with type 1 DM

Exclusion Criteria:

* If diagnosed with type 1 diabetes, has had recurrent severe hypoglycemia (greater than 2 episodes in previous 6 months requiring assistance by a third party)
* Has any medical condition or medical history that may affect successful completion of the study and/or personal well-being (as assessed by the PI)
Multi-modality Evaluation of Flow Rate, Pressure and Size of Spine Epidural Venous Plexus

Vertebra is one of the most common site of metastatic disease, which may cause severe pain or neurological deficit. Debulking surgery usually has better local control and survival benefit as compared with decompression or radiotherapy. However, debulking surgery often accompany with massive blood loss, which may cause hemorrhagic shock or death. The major bleeding point during operation including tumor parenchyma, arteries that are difficult to ligate, and epidural venous plexus. Vascularity of tumor parenchyma had been associated with increased intraoperative blood loss, on the other hand, there is a lack in the literature regarding to evaluation of the size, flow and pressure of epidural venous plexus, and their changes after embolization.


Eligibility Criteria:
Inclusion Criteria:

1. Patient who receive pre-operative angiography and possible embolization before debulking surgery or en bloc resection of the spinal tumor.
2. The tumor has to be located in thoracic or lumbar spine.

Exclusion Criteria:

1. Confirmed non-tumor diagnosis.
2. Patient who cannot tolerate the procedure due to severe pain.
3. Patients who cannot receive angiography or embolization due to contraindications, including poor renal function (Serum creatinine \>2.0 deciliter/mg or estimated glomerular filtration rate(eGFR)) \< 30ml/min) , severe allergy to contrast medium, uncorrectable coagulopathy and bleeding diathesis.
4. Patient who has severe neurological deficit that should receive emergent decompression.
5. Poor image quality.
6. Expected life expectancy \< 6 months.
Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease

Moderate exercise with a low fat and/or a moderate fat with low processed carbohydrate diet will have a greater effect on slowing disease progression and reversing hepatic steatosis and/or necro-inflammation in the liver of adult patients with NAFLD and NASH when compared to a regular healthy diet alone.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 yrs
* DEERS eligible (DoD beneficiary)
* All participants must plan to be in the area for at least nine months
* Liver biopsy confirmed NAFLD/NASH (NAS Score evaluating steatosis, lobular inflammation and hepatocyte ballooning) within the past 6 months

Exclusion Criteria:

* Alcohol consumption \> 20 g/d or history of alcohol abuse
* Hepatitis A, B, C
* Chronic liver disease of any other etiology
* Fatty acid oxidation disorder (Inborn errors of metabolism)
* Insulin therapy regime for treatment of diabetes
* Pregnancy
Clinical Value and Efficacy Index of Lymphadenectomy for Thoracic Escc

The goal of this observational study is to to clarify the focus of lymph node dissection during esophagectomy.. The main question\[s\] it aims to answer is:

* provide a basis for accurate staging and the relationship between OS and lymph node dissection


Eligibility Criteria:
Inclusion Criteria:

1. Pathologic findings proved ESCC (8th AJCC/UICC stage T1b-4aN0-3M0)
2. Underwent esophagecomy (two-field or three-field LN dissection)
3. The primary tumor was thoracic ESCC

Exclusion Criteria:

1. Located outside the thoracic
2. Patients underwent salvage or R1/R2 esophagecomy
3. The number of resected lymph nodes (RLNs) less than 15
4. With neoadjuvant therapy(NT) or salvage chemoradiotherapy(SCRT)