cyrilzakka/clinical-trials huggingface dataset:
Multicenter Neonatal Eye Disease Screening in China

These exams are vital to protect healthy neonates from blindness. The purpose of this study is to better screen ocular disease in otherwise healthy neonates using wide-field digital imaging system (RetCam III) in a multi-center network in China leaded by Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. The multi-center network will be built with the collaboration of eight hospitals from different parts of China.

Studies reveal that ocular anomalies may also be found in healthy full-term babies. These abnormal ocular findings included subconjunctival haemorrhage, congenital microphthalmos, congenital corneal leukoma, posterior synechia, persistent pupillary membrane, congenital cataract, enlarged C/D ratio, retinal hamartoma versus retinoblastoma, optic nerve defects, macular pigment disorder and non-specific peripheral retinopathy. The highest proportion of these abnormal findings is retinal haemorrhages, accounting for 92% of abnormalities. Most retinal hemorrhages are benign and will finally self-resolve. However, sometimes it takes a long time for the hemorrhage to resolve. Some slow-resolving hemorrhages could obstruct the visual axis and may do great harm to visual development in critical period. Some neonatal eye diseases are time sensitive, such as retinoblastoma, and if found late, the best opportunity for effective treatment is missed, leading to irreversible visual impairment. Newborns are unable to express their discomforts or visual disorders as adults do and only through an examination, the neonatal eye diseases can be detected. Therefore, this screening protocol is designed to screen the otherwise healthy neonates in a multi-center network on neonatal ophthalmopathy and to achieve early diagnosis and timely treatment. All the neonates will undergo eye examination by using RetCam III. The external eye, pupillary light reflex, red reflex, opacity of refractive media, anterior chamber and posterior segments will be examined. The outcomes will be analyzed by a blinded specialist in order to discover serious congenital, hereditary and acquired diseases in the neonatal period of healthy newborns and to improve epidemiological information of neonatal ophthalmopathy. Neonatal ocular examination may play a positive role in promoting paediatric eye health to paediatricians and parents.

Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy neonates ( ≥37weeks' gestational age, weighing ≥2500 g, no evidence of systemic disease and an Apgar score of 7 or more.)

Exclusion Criteria:

* Preterm /Neonates with systemic diseases
* Neonates unable to undergo the examination
Depo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception

To evaluate and compare Bone Mineral Density (BMD) in adolescent Depo-Provera Contraceptive Injection (DP150CI) users during depo medroxyprogesterone acetate (DMPA) therapy and following discontinuation of DMPA. Another group electing non-hormonal contraception or abstinence will be recruited as a reference population, across all study sites. The primary variable is BMD, measured by Dual Energy X-ray Absorptiometry (DXA). Secondary variables are: Total Body Composition\& Total Body Calcium (TBC), measured by Dual Energy X-ray Absorptiometry (DXA), and surrogate biologic BMD markers. Safety will be evaluated by adverse event reporting, laboratory evaluations, pregnancies, weight and vital signs.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent females who have had any menses in the 6 months prior to enrollment
* Must have a negative pregnancy test

Exclusion Criteria:

* Concomitant medication exclusion use of bone modifying agents, glucocorticoids, heparin, and anticonvulsants
* Screening Spinal BMD with z score not greater than -2 of matched young normals
Outcomes of Severe Sepsis Patients in Surgical Intensive Care Units

Retrospective review of the outcomes of severe sepsis patients in Surgical Intensive Care Unit of National Taiwan University Hospital from January 1, 2009 to December 31, 2011.

Patients suffered from severe sepsis or septic shock have a mortality of 20\~54%. It is major healthcare problems, affecting millions of individuals around the world each year. An international group of experts in the diagnosis and management of infection and sepsis, representing 11 organizations, published the first internationally accepted guidelines that the bedside clinician could use to improve outcomes in severe sepsis and septic shock in 2004, and further outcome was reported in 2008. Lots of medical centers have joined the Surviving Sepsis Campaign and follow the latest guideline. Many reports have shown that Surviving Sepsis Campaign Guideline can reduce patient mortality.

In surgical intensive care units of National Taiwan University Hospital (NTUH), the Surviving Sepsis Campaign Guideline was conducted since 2009. Our purpose is to investigate the characteristics and outcomes of severe sepsis patient in surgical intensive care units of NTUH by retrospective review of medical chart.

Eligibility Criteria:
Inclusion Criteria:

* Patients were diagnosed as severe sepsis in Surgical Intensive Care units of National Taiwan University Hospital

Exclusion Criteria:

* \< 20 years old
Dexmedetomidine or Hyalase : Which of Them Can Augment Lumbar Epidural Steroid Injection in Failed Back Surgery Patients. A Randomized Clinical Trial

hyalase and dexmedtemodine are well known adjuvants given epidurally to alleviate chronic back pain. Use in failed back surgery is an up to date field to hasten analgesia and py off recurrence .


Eligibility Criteria:
Inclusion Criteria:

* Age group. 25-75ys old
* Both sex.
* persistent (at least 6 month) pain and or disability following laminectomy with or without sensory-motor neurological deficits or any form of urinary or bowel incontinence
* Patients suffering from persistent (\> 6 months) back pain following laminectomy for spinal canal stenosis and/or discectomy for herniated nucleus pulposus documented by magnetic resonance imaging (MRI) were included for screening and enrollment.

Exclusion Criteria:

* Diabetic patients.
* Refusal to participate
* MRI with disc sequestration, concurrent sacro-ilitis, facet arthropathy .
* Coagulopathic patients
* Surgical induced discitis.
Adipose Derived Mesenchymal Stem Cell Characteristics in Anal Fistulas

This study investigated the cellular and molecular characteristics of AT-MSCs obtained from autologous AT therapy in patients with high transphincteric perianal fistulas of crytoglandular origin. Adipose tissue was injected into anal fistulas. Characteristics of adipose tissue mesenchymal stemcells (AT-MSC) was investigated and compared in patients with fistula that healed after the treatment (responders) to patients who failed to heal (non-responders)

Injection with allogene or autologous stem cells has been reported to be efficient treatment of perianal fistulas. An alternative to this treatment could be injection with freshly collected autologous adipose tissue. In this study 27 patients with cryptoglandular anal fistulas were treated with freshly collected autologous adipose tissue.A clinical assessment of the patient prior to inclusion was undertaken and a loose seton placed for at least 6 weeks prior to fat injection. An MRI of the pelvis was performed before inclusion. Fistulas with secondary tracts and/or cavities were excluded. The operation was performed in one procedure including liposuction and injection of adipose tissue. A sample of adipose tissue from all 27 patients was analyzed. AT-MSCs were isolated and characterized using cellular and molecular analyses. Clinical and MRI-scanning evaluation of fistula healing and evaluation of ano-rectal function was performed after 6 months. AT-MSCs phenotype was compared between responders and non-responders with respect to fistula healing. The evaluation of the AT-MSCs was performed in a blinded manner.

Eligibility Criteria:
Inclusion Criteria:

* high trans-sphincteric fistulas
* fistula confirmed and classified by an MRI.
* seton (\> 6 weeks) prior to fat injection
* informed, written consent.

Exclusion Criteria:

Anovaginal fistula

* Active sepsis
* IBD, immunodeficiency, prior pelvic irradiation and malignancy
* Insulin dependent diabetes
* More than 4 prior attempts of fistula closure
* Tobacco smoking or nicotine substitution 8 weeks prior to fat injection.
* Pregnancy
* Psychiatric disorders
* BMI ≥ 35 or BMI\<20
* Active tuberculosis
* Patient less than 18 years
* Unable to undergo MRI
Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy

This is a single site, randomized, open-label comparison pilot study to assess the feasibility and effectiveness of KeraStat Cream compared with routine skin care (RSC) in managing radiotherapy-induced early adverse skin reaction (EASR) in patients undergoing radiotherapy to the head and/or neck.

Hypothesis: The use of KeraStat Cream in patients receiving radiotherapy for head and neck is feasible, tolerable, and reduces the severity of early adverse skin reaction in the treated region of interest.

Primary Objective(s)

• To determine the feasibility of the use of KeraStat Cream in patients receiving radiotherapy for head and neck cancer.

Secondary Objective(s)

* To determine the tolerability of KeraStat Cream in patients receiving radiotherapy for head and neck cancer compared to routine skin care.
* To assess the effectiveness of KeraStat Cream in reducing the severity of EASR in patients receiving radiotherapy for head and neck cancer, compared to routine skin care. This will be performed by evaluating:
* Objective evaluation of EASR using the CTCAE Version 5.0 scale of radiation dermatitis,
* Patient-reported outcomes of radiation dermatitis using the PRO-CTCAE version 1.0, and
* Dermatologic-specific quality of life assessment
* To estimate the amount of KeraStat Cream used per patient and coverage on the skin.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of head and neck cancer planned to receive conventionally-fractionated definitive radiotherapy to the head and neck to a total prescribed dose of at least 60 Gy
* Able and willing to sign protocol consent form
* Able and willing to complete tolerability and quality of life assessments
* Able and willing to have photographs of the affected area taken regularly

Exclusion Criteria:

* Women who are pregnant, lactating/nursing or plan to become pregnant
* Previous radiation therapy to the area to be treated with radiation therapy
* Active, medically necessary use of topical corticosteroids in the irradiation area
* Active scleroderma or lupus requiring systemic medication
* Treatment with anti-EGFR antibodies for head and neck cancer (previously or planned)
A Sustainable Diet for Hadassah Employees Workers

The aim of this protocol is to use a multidisciplinary approach to convey nutrition and activity messages to randomly selected Hadassah Medical Center employees. The intervention will be for one academic year and include frontal talks, email and internet focus group interactions, public demonstrations and a focused intervention within the hospital kitchen.

The outcomes are specific parameters of dietary modifications, degree of physical activity and health related perspectives. Outcomes will be recorded at baseline and by the end of the intervention ( one year).

The participants will be selected randomly from the campus employees. They will be exposed to multiple levels of health promotion at the work place as well as via multiple media tools. Analysis will be performed at baseline by using multiple nutrition and health perception questionnaires. A second group from the employees will be selected for assessment of the same outcomes at the end of the year.

Eligibility Criteria:
Inclusion Criteria:

Hadassah medical center employees Age 21-67

-

Exclusion Criteria:

- Refusal to participate
Comparison 1 Plane-2 Injection and 2 Plane-2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block

The supraclavicular block can provide effective surgical anesthesia of the forearm and hand. There have been many different approaches to ultrasound-guided supraclavicular brachial plexus block (US-SCBPB) according to the needle injection site (e.g. corner pocket approach, cluster approach) or number of needling (single or double injection). Numerous studies demonstrates good results (e.g. faster onset time) when using double injections rather than single injection. But double injection does not guarantee complete sensory block because ulnar nerve tends to be spared by its anatomical location.

The investigators hypothesized that double injection in different plane (we call this new approach as a 2 plane-2 injection approach;2P2I) would overcome the weakness of the existing double injection in same plane (we call this approach as a 1 plane-2 injection approach;1P2I) like "ulnar nerve sparing effect", and could have a good results (e.g. shortening the onset time or increasing rate of all four nerves block). Because 2P2I can achieve an effect of a "tridimensionally administered LA", rather 1P2I only achieve an effect of a " two-dimensionally administered LA".

Eligibility Criteria:
Inclusion Criteria:

* all patients anticipating surgery of the wrist or hand
* age: 18 to 80 years
* American Society of Anesthesiologists physical status (ASA): I or II

Exclusion Criteria:

* neuropathy in the operated limb
* ASA greater than III
* coagulation disorders
* known allergy to local anesthetics
* local infection at the puncture site
* chronic obstructive pulmonary disease or respiratory failure
* pregnancy or breast-feeding
* prior surgery in the supraclavicular region
* BMI ≥ 35 kg/㎡
* uncooperative patients
* patients' refusal
Hepatitis C Antiviral Resistance in African-Americans

This study is designed to test the hypothesis that African-Americans respond less well to combination pegylated interferon and ribavirin therapy than Caucasian-Americans who have chronic hepatitis C genotype 1 and who were not previously treated with either interferon or ribavirin. Reasons for differences in response, regardless of race, will be studied.


Eligibility Criteria:
Inclusion:

* Age between 18 and 70 years at screening
* Black/African American or White/Caucasian
* Born in the United States
* Quantifiable Serum HCV RNA
* Hepatitis C genotype 1
* Liver biopsy consistent with chronic hepatitis C
* Negative urine pregnancy test
* Males and Females must be using two reliable forms of effective contraception while on drug and during follow-up.

Exclusion:

* Previous treatment with interferon or ribavirin
* Positive test at screening for anti-HIV
* Positive test for HBsAg
* Alcohol consumption of more than two drinks/day
* History of other chronic liver disease
* Pregnant or breast-feeding women
* Male partners of women who are pregnant or contemplating pregnancy
* Neutrophil count \<1000 cells/mm3
* Hgb \<11 g/dl in women or 12 g/dl in men
* Platelet count \<75,000 cells/mm3.
* Thalassemia, spherocytosis, history of GI bleeding or those at increased risk of anemia
* Serum creatinine level \>1.5 times the upper limit of normal at screening or CrCl \< 75cc/min
* Current dialysis
* Alcohol or drug abuse within 6 months
* Current (\<6 months)severe psychiatric disorder
* History of immunologically mediated disease
* Decompensated liver disease
* High risk cardiovascular/coronary artery disease
* Severe seizure disorder or anticonvulsant use
* Solid organ or bone marrow transplantation
* Thyroid disease poorly controlled on prescribed medications
* History or other evidence of retinopathy
* Chronic use of oral steroids
* Inability or unwillingness to provide informed consent or abide by the study protocol
An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

The purpose of this study is to confirm the clinical and economic benefits of IRay treatment with respect to the number of anti-VEGF injections and frequency of visits during the first year after treatment for patients with wet Age-related Macular Degeneration (AMD).

The objective of this study is to confirm the clinical and economic benefits of low voltage external beam radiotherapy with the IRay with respect to number of anti-VEGF injections and frequency of ophthalmic assessments during the one year interval following treatment in subjects with neovascular AMD.

Eligibility Criteria:
Inclusion Criteria:

* Must have neovascular AMD and have received an anti-VEGF injections within 1 month prior to entering the study, and have the need for further treatment with anti-VEGF therapy.
* Must have a total lesion size of \<12 disc areas and a CNV lesion with the greatest linear dimension of \<6 mm, but not greater than 3 mm from the center of the fovea to the furthest point on lesion perimeter.
* Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.
* Must be willing and able to return for scheduled treatment and follow-up examinations for the 3-year duration of the study.
* Must be at least 50 years of age.
* Women must be post-menopausal ≥1 year or surgically sterilized.
* Must have best corrected visual acuity of greater than or equal to 24 letters in the study eye and at least 20 letters in the fellow eye (if both eyes meet all the study criteria, then the eye with the worst vision should be selected as the study eye).

Exclusion Criteria:

* Present with any implanted device, where the device labeling specifically contraindicates subjects undergoing x-rays.
* An axial length of \<20 mm (because of limitations of the IRay device) or \>26 mm (to exclude subjects with pathologic myopia).
* Evidence of diabetes or retinal findings consistent with diabetic retinopathy, or retinopathy for any cause.
* Prior or concurrent therapies in the study eye for age related macular degeneration (other than intravitreal anti-VEGF), including submacular surgery, subfoveal thermal laser photocoagulation (with or without photographic evidence), transpupillary thermotherapy (TTT) and ocular photodynamic therapy.
Long-term Follow-up of Interleukin-1B and H+,K+-ATPase mRNA Expression After Helicobacter Pylori Eradication

We will evaluate the long-term changes of gastric H+, K+-adenosine triphosphatase (H+, K+-ATPase) and Interleukin-1B mRNA expression according to Helicobacter pylori (H.pylori) infection and intestinal metaplasia and investigate the long-term effect of H. pylori eradication

H. pylori suppresses gastric acid secretion by repressing gastric acid pump, H+, K+-ATPase, and stimulating Interleukin-1B. In this study, we will evaluate the expression of H+, K+-ATPase and Interleukin-1B mRNA according to H. pylori infection and intestinal metaplasia in controls and patients with gastric cancer. In addition, we observe the changes of H+, K+-ATPase and Interleukin-1B mRNA expression over 5 years after H. pylori eradication.

Eligibility Criteria:
Inclusion Criteria:

* Controls who did not have any evidence of gastric cancer, gastric dysplasia, esophageal tumor, peptic ulcer and lymphoma on esophagogastroduodenoscopy
* Patients with gastric dysplasia or gastric cancer who diagnosed with gastric dysplasia or early gastric cancer in the final pathological report

Exclusion Criteria:

* Subjects with previous eradication treatment for H. pylori
* Subjects with previous gastrectomy
Photodynamic Therapy in Treatment of Verrucae

To assess the efficacy (clinically and dermoscopically) and safety of photodynamic therapy using intralesional injection of 4% methylene blue solution as a photosensitizer with IPL versus IPL only in treatment of warts.

This study will be conducted on:

Eighty patients suffering of verruca (male and female) divided randomly into three groups: group A, B\&C :

Group A: 30 patients will undergo photodynamic therapy using intralesional 4%methylene blue solution and IPL.

Group B: 30 patients will undergo IPL only. Group C (control group):20 patients will undergo intralesional saline.

Eligibility Criteria:
Inclusion Criteria:

1. Age:Above 16 years old.
2. Sex:Both males and female patients.
3. Clinically and dermoscopically documented verruca.
4. No verruca treatment in the last 2 weeks.

Exclusion Criteria:

1. History of photosensitivity disorder.
2. Pregnant and lactating females.
3. Diseases with risk of koebnerization e.g. Psoriasis and Lichen planus.
4. Anogenital warts.
5. Warts on head and neck.
Phase II Trial of EP4 Receptor Antagonist, AAT-007 (RQ-07; CJ-023,423) in Advanced Solid Tumors

This is a phase II trial of (RQ-07) in advanced solid tumors in prostate, breast or non-small cell lung cancer.

This is a phase II trial of (RQ-07) in advanced solid tumors in advanced prostate, breast or lung cancer. The purpose of this trial is to determine whether the administration of the study drug RQ-07 can decrease circulating tumor cells in advanced prostate, breast or lung cancer. Additionally, the study will evaluate whether the study drug may improve outcome in advanced prostate, breast or lungs cancer either by itself or when combined with gemcitabine, a standard chemotherapy drug. The combination of with gemcitabine will only be investigated after disease has worsened with the study drug RQ-07 by itself and only in patients with prostate or lung cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed breast, prostate or non-small cell lung cancer or other A tissue block, 10 unstained slides or fresh tissue biopsy is required.
2. At least 2 weeks should have elapsed since the last treatment and patients should have recovered from previous significant toxicity (i.e. to grade 1 or less).
3. ECOG Performance Status \<2.
4. Patient at least 18 years of age or older.
5. Adequate hematological function as defined by the protocol, section 4.1.5.
6. Patients must have a serum creatinine within normal limits, or an estimated or measured creatinine clearance \> 35 mg/ml/min.
7. Normal serum electrolytes (no \>grade 2 abnormalities), magnesium and phosphorus on the day of therapy. Correction of abnormalities is permitted.

   Adequate hepatic function per institutional standards (see exclusion).
8. All patients must be informed of the investigational nature of this study and must sign and give written informed consent.
9. Serum calcium, magnesium and potassium must be within normal limits. Supplementation to achieve normal values is permitted.
10. Patients who are potentially fertile and sexually active must be willing to utilize effective birth control.
11. Patients with CNS metastases which are/were symptomatic must have completed therapy (surgery, gamma knife, XRT) and be neurologically stable.
12. Patients must have \> or = 4 circulating tumor cells

Exclusion Criteria:

1. Patients must not have serious infection or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment.
2. Current uncontrolled cardiac disease
3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 4 weeks of registration.
5. Patients with acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition or patients known to be HIV positive
6. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception