cyrilzakka/clinical-trials huggingface dataset:
Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension (0507A-152)(COMPLETED)

To evaluate if preservative free cosopt is well tolerated in patients with Open angle glaucoma (OAG) or Ocular hypertension (OH) with dry eyes.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient with newly diagnosed and untreated for open-angle glaucoma or ocular hypertension with an Intra-ocular Pressure (IOP) of \> 27 mm Hg (in at least one eye) and a baseline GSS SYMP-6 total score of 75 or less
* Patient is male or a female who is highly unlikely to conceive
* Patient has been recently diagnosed and is presently untreated for open-angle glaucoma or ocular hypertension with an IOP of at least 27 mm Hg in at least one eye (patient's worse eye)
* Patient already diagnosed with open-angle glaucoma or ocular hypertension and untreated for at least 30 days are eligible for the study if they have an IOP of 27 mm Hg or more in at least one eye

Exclusion Criteria:

* A history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk by administering preservative free dorzolamide-timolol (preservative-free Cosopt®)
* The presence of any fundus pathology likely to change during the study or to influence IOP (background of diabetic retinopathy is permitted)
* Any contraindication to the use of preservative-free Cosopt® including:
* bronchospasm, including bronchial asthma or a history of bronchial asthma or chronic obstructive pulmonary disease, sinus bradycardia, second or third degree AV block, cardiac failure (grade III and IV), cardiogenic shock, severe renal impairment (serum creatinine \> 150 umol/L or creatinine clearance \< 30 ml/min)
* Patient on:
* carbonic anhydrase inhibitor, concomitant systemic or dermatological medication known to affect the IOP, e.g. clonidine, corticosteroids, oral beta-blocking agents. patient on a non-glaucoma medication that contains a preservative agent, i.e. benzalkonium chloride, benzododecinium bromide or stabilized oxychloro complex
* Patient with hypersensitivity to any component of preservative free dorzolamide-timolol (preservative-free Cosopt®)
Using Circulating Tumor DNA to Personalize Duration of Consolidation Durvalumab

This research aims to incorporate ctDNA analysis into clinical practice to individualize therapy in patients with stage III NSCLC by moving to a treatment-by-marker based approach (as opposed to treatment based on clinical or radiographic evidence of disease).

There is a critical need to identify MRD to determine which patients benefit from checkpoint inhibitor therapy and to optimize and personalize the duration of consolidation Durvalumab. The long-term goal is to incorporate ctDNA analysis into clinical practice to individualize therapy in patients with stage III NSCLC by moving to a treatment-by-marker based approach (as opposed to treatment based on clinical or radiographic evidence of disease). This approach may spare a subset of patients from treatment with unnecessarily excessive cycles of consolidation immunotherapy if they are already cured with CRT alone and individualize the duration of consolidation immunotherapy in patients not cured with CRT. The study team also seek to identify early in the treatment course, patients who are destined not to be cured with consolidation immunotherapy so that alternative strategies can be tested when tumor burden is low.

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years

Ability to provide written informed consent and HIPAA authorization

Patients with inoperable or unresectable stage III NSCLC who are planning to receive concurrent CRT followed by consolidation Durvalumab OR Patients with inoperable or unresectable stage III NSCLC who have previously received concurrent CRT and are planning or currently receiving C1-4 consolidation durvalumab

Must have viable tissue for ctDNA profiling, (fresh or archived tissue)

Exclusion Criteria:

Patient unwilling to provide tissue and blood samples for ctDNA testing.

Patient has contraindications to treatment with concurrent CRT and/or consolidation Durvalumab.

Patients with any other active cancer; excluding squamous cell or basal cell cancer.
Prediction of Clinical Outcome in Lumbar ESPB

The primary endpoint of this study was to identify that Perfusion index (PI) has any predictive value for the treatment outcome of cervical radiculopathy

The erector spinae plane block (ESPB) is a less invasive, safer, and technically easy alternative procedure to conventional neuraxial anesthetic techniques. In contrast to common neuraxial techniques such as paravertebral and epidural injections, the ESPB targets an interfascial plane which is far from the spinal cord, root, and pleura. First applied to thoracic neuropathic pain, currently ESPB is being applied to postoperative pain control and includes variable clinical situations. In the abdomen and thoracic wall, thoracic ESPB can be applied for pain control after cardiac surgery, video-assisted thoracic surgery, laparoscopic cholecystectomy, and thoracotomy. Recently, favorable postoperative pain control after lumbar spinal or lower limb surgeries has been reported with lumbar ESPB. In addition, ESPB has also been used for chronic pain conditions in the upper and lower extremities. The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. Although the special probe for PI measurement is relatively more expensive compared with ordinary pulse oximetery probes, its benefit as a marker of peripheral perfusion and as an idex for sympathetic stimulation have increased its use progressively. PI has been used widely for the prediction of success of brachial plexus block or axillary block. Changes of PI ratio value showed an excellent predictive value for the success of block.

There have been no studies demonstrating predictive value of PI in lumbar ESPB ESPB for the relief of low back pain or leg pain due to lumbar disc herniation or stenosis.

Eligibility Criteria:
Inclusion Criteria:

* Lumbar foraminal stenosis
* Lumbar central stenosis
* Lumbar disc herniation
* Lumbar spondylolisthesis

Exclusion Criteria:

* Infection
* Pregnancy
* allergy to local anesthetic agnets
* Previous lumbar spine surgery
D-Ribose for Fatigue in Subjects With Fibromyalgia

To evaluate the safety and to determine the efficacy of D-ribose for the amelioration of fatigue in subjects with fibromyalgia. This is a phase IIa, randomized, double-blind, placebo-controlled, multi-center, multiple dose study of D-ribose versus placebo administered at doses of 5 g three times a day (TID) over a 12-week period to subjects who are experiencing fatigue associated with a diagnosis of fibromyalgia.


Eligibility Criteria:
Major Inclusion Criteria:

* must have a diagnosis of primary fibromyalgia, as defined by the 1990 American College of Rheumatology (ACR) Criteria for the Classification of Fibromyalgia made at least 6 weeks prior to the Pretreatment Screening Visit;
* must have a score of ≥5 on the Subject's Assessment of Fatigue 11-point numerical rating scale (NRS) at the Pretreatment Screening and Baseline Visits;
* if taking acetaminophen or other non-opioid analgesics, NSAIDs, fibromyalgia medications, medications to induce sleep, or prednisone ≤ 10 mg (or equivalent dose of other glucocorticoids), must be on stable dose(s) for at least 4 weeks prior to the baseline visit;
* must have discontinued any ribose-containing products (including foods, drinks, and supplements) at least 4 weeks prior to the Pretreatment Baseline Visit.

Major Exclusion Criteria:

* current major depressive episode (MDE);
* has been diagnosed with any autoimmune disease;
* has been diagnosed with type I or type II diabetes;
* has a history of cancer, other than basal cell carcinoma, stage 1 squamous cell carcinoma or cervical carcinoma in situ, that has not been in remission for at least five years prior to the Pretreatment Screening Visit;
* has been diagnosed with chronic fatigue syndrome.
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Port wine stains are red birthmarks that without treatment persist for a lifetime. They are frequently found on the face and can be conspicuous and disfiguring, negatively impacting social interactions for these patients. Treating Port wine stains is difficult. The standard of care is to use laser treatment, but over 80% of patients fail to completely clear despite multiple treatments. The growth of additional blood vessels (angiogenesis) following the Laser treatment is likely an important factor in why these lesions persist despite therapy.

Imiquimod is a topical cream that affects the immune response and has been noted to inhibit blood vessel formation. It has been used to successfully treat other vascular growths such as hemangiomas. The research can use imiquimod cream 5% cream apply to port wine stains after laser therapy to improve lightening of port wine stains. The imiquimod 5% cream cream apply to Port wine stains everyday for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Port Wine Stain birthmark
* Male and female subjects of any age who are in good health.
* Fitzpatrick skin type I-VI

Exclusion Criteria:

* Pregnant or lactating
* History of cutaneous photosensitivity
* History of hypersensitivity to imiquimod 5% cream or any of its components
* History of photodermatoses
Validity Of Ultrasound As Regards Correlation To Cormack-Lehane Grading In Obese Patients

Since the introduction of real-time ultrasound (US) capabilities, ultrasound technology has been adopted and incorporated into daily practice by many medical and surgical specialties. Using US to help assess the difficult airway constitutes just yet another valuable application of this versatile technology . Since many anesthesia providers had already acquired proficiency in US techniques in US guided vascular access and regional nerve blocks, using US to evaluate the airway could be learned and mastered without too much difficulty. Ultrasound of the upper airway may prove to become a useful adjunct to conventional clinical assessment tools, as it has been successful in visualizing the relevant anatomy and critical structures of the airway..

The study is cross sectional observational study in which obese patients will be assessed using conventional clinical methods of airway assessment and by using US for the same patient before induction of anesthesia then correlated to the Cormack-Lehane finding after induction of anesthesia..

Eligibility Criteria:
Inclusion Criteria:

* Age of the patient : (21-60) years old.
* Sex : male \& female.
* Physical Status : The American Society of Anesthesiologists (ASA) II-III patients.
* Body mass index : 30 to more than 30 kg / m² .
* Operations: Laparoscopic surgeries,bariatric surgeries and any operation that requires general anesthesia with endotracheal tube placement .

Exclusion Criteria:

Patient refusal.

* Deformity of the airway anatomy \[by masses or tumors\].
* Patients with thyroid swellings 'Goitre'.
* Pathology of the airway \[edema,burn and arthritis\].
Preoperative Image-based Education Effect on Postoperative Satisfaction of Patients Undergoing First-time Dermatologic Surgery

This research study aims to understand whether visual and written education on wound appearance can improve patients' experience and understanding of what their wound will look like following dermatologic surgery.

Undergoing surgery is a stressful process for many patients. By its nature, dermatologic surgery carries additional stressors given that it is performed on the skin, a very cosmetically sensitive area. In our dermatologic surgery practice, we have found that patients are often surprised by the length of their surgical wound immediately post-surgery; many have expressed confusion about the length of the wound relative to the much smaller targeted lesion.

Our research study will utilize image-based education prior to patients' first dermatologic surgery to determine whether this intervention helps patients feel more satisfied with their wound appearance immediately post-surgery. Our primary hypothesis is that patients who are undergoing dermatologic surgery for the first time will benefit from image-based education about the surgical wound closure process. We hypothesize that a greater proportion of such patients would feel more satisfied and less distressed with the cosmetic outcomes immediately after their surgery relative to patients who did not receive image-based education.

If this hypothesis is found to be true, we will conclude that there is a need for better patient education prior to their dermatologic surgery procedure. We hope that this study will create a framework for sharing educational resources with patients so that they may set expectations as to surgical outcomes. These findings may also be relevant to other surgical procedures where patient satisfaction would be improved by the implementation of pre-operative education.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria: Adult patients (ages 18-100) who will be undergoing dermatology surgery at Johns Hopkins. We will include only patients who are undergoing their first dermatology surgery. Only patients whose incisions are closed with primary closure will be eligible.

Exclusion Criteria:

* Patients who have already undergone dermatology surgery.
* Patients whose incisions are not closed with primary closure
Automated Detection of Metastatic Bone Disease on Bone Scintigraphy Scans

Bone scintigraphy scans are two dimensional medical images that are used heavily in nuclear medicine. The scans detect changes in bone metabolism with high sensitivity, yet it lacks the specificity to underlying causes. Therefore, further imaging would be required to confirm the underlying cause. The aim of this study is to investigate whether deep learning can improve clinical decision based on bone scintigraphy scans.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a bone scintigraphy scan that is available with the radiologic report between 2010-2018

Exclusion Criteria:

* The lack of a bone scan, or corresponding radiologic report
Digestive Endoscopy Suite Radiation Controlling Protective Strategies

ERCP is associated with radiation exposure to the endoscopist and staff, which may be significant at high volume programs despite the use of lead aprons. We hypothesize that draping of the fluoroscopy image intensifier may significantly reduce staff radiation exposure and help achieve implementation of the ALARA (As Low As Reasonably Achievable) principle.

A total of 100 consecutive ERCP procedures were randomly assigned to the radiation-attenuating or sham drape in a 1:1 ratio. There were 2 subjects, the endoscopists performing ERCP and the nurse assisting in the procedure.

Eligibility Criteria:
Inclusion Criteria:

* All the ERCP procedures done by the same endoscopist and nurse are enrolled
* Patients age \>19

Exclusion Criteria:

* Fluoroscopic procedures other than ERCP were excluded.
Novel Screening Tools For the Evaluation and Management of Malnourished Children in the Developing World

The purpose of this study is to evaluate the accuracy of a new device that may be used for the evaluation and management of malnourished infants and children. The device will measure the levels of two hormones made by fat tissue: leptin and adiponectin.

The purpose of this study is to validate novel screening tools for the evaluation and management of malnourished infants and children in the developing world. The study will validate 2-D diffusion point of care testing (POCT) for the rapid analysis of leptin and adiponectin, as these cytokines have been shown to predict mortality in malnourished infants and children. The study will enroll 20 participants, 10 overweight or obese adolescents presenting to the Duke Division of Pediatric Endocrinology outpatient clinics, in whom leptin is expected to be high and adiponectin low, and 10 premature or small for gestational age infants hospitalized in the Duke Transitional Care Nursery, in whom leptin is expected to be low and adiponectin high. Informed consent will be obtained and 0-1 mL of blood will be collected and analyzed using the 2-D POCT and commercial ELISA assays. To reduce potential risks associated with venipuncture and/or finger or heelstick, blood draws for the purposes of this study will take place only when blood sampling is performed at the request of the primary provider, and an attempt will be made to utilize scavenge samples from infants where applicable. The POCT will be validated against the commercial ELISA assays. The investigators will analyze the results of each assay in addition to the means and standard deviations of the POCT and ELISAs and will consider the POCT valid if their variation from ELISA is \<20%. The long-term goal of this project is to utilize this novel technology to identify and treat high-risk malnourished infants and children before they have reached the stage of critical, life-threatening illness.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or Obese: Inclusion criteria for these subjects will include:

  1. Age 8-17 years;
  2. male or female; and
  3. BMI \>85% for age.
* Premature or Small for Gestational Age: Inclusion criteria for these subjects will include:

  1. Age \<1 year,
  2. male or female,
  3. small for gestational age or intra-uterine growth restriction (IUGR) defined by the 9th revision of the International Classification for Diseases OR
  4. prematurity as defined by the 9th revision of the International Classification for Diseases.

Exclusion Criteria:

* Exclusion criteria include refusal or inability to provide samples of blood.
Quantifying Nitrous Oxide Effect on Depth of Anaesthesia Using Theoretically Based Time Series Modelling

Our hypothesis is that a new method of depth of anaesthesia monitoring, using theoretically based time series modelling will result in improved ability to determine nitrous oxide anaesthetic effect

We randomised patients to 0% 33% or 66% nitrous oxide during sevoflurane induction and measured anesthetic endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Presenting for surgery under general anaesthesia

Exclusion Criteria:

* Poor English language comprehension
* Risk of reflux
* Epilepsy or other EEG abnormality
Improved Analysis Methods for Infusion Tests

Objective: Patients with Idiopathic Normal Pressure Hydrocephalus are improved with shunt surgery. To increase the accuracy of the diagnosis, supplementary tests that characterize the cerebrospinal fluid (CSF) dynamics are used. The infusion test is one of these, used for shunt surgery selection and postoperative evaluation of shunt function. Forty-eight patients that had a preoperative investigation because of communicating hydrocephalus at the university hospitals in Umeå and Uppsala, Sweden, participated in the study. The purpose of this study was to evaluate a new method, with a new infusion protocol and new analysis methods, and compare it to the current method.


Eligibility Criteria:
Inclusion Criteria:

* preoperative investigation because of communicating hydrocephalus
* ventriculomegaly (Evans ratio \> 0.3)
* no obstruction to CSF flow at visual inspection

Exclusion Criteria:

* postoperative infusion test investigations
* patients that were unable to understand instructions
Clinical Study of SU 11248 (Sutent) Combined With Standard Chemotherapy in Patients With FLT3 Mutated AML Over 60 Years

In this study safety and tolerability of two dose levels of SU 11248 (sutent) with standard chemotherapy in patients with FLT3 mutated AML over 60 years will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary or secondary acute myeloid leukemia (any FAB type, except M3).
* No prior systemic chemotherapy for AML except hydroxyurea. Cytoreductive therapy with hydroxyurea is recommended if WBC is \> 50.000/µl, but should cease at least one day prior to starting study medication
* Patient age equal or of greater than 60 years
* Patients must have FLT3 mutated AML, either ITD or kinase domain mutations
* ECOG Performance score 3 or less (Karnofsky Performance Score \>40%).
* Life expectancy more than four weeks.
* Adequate hepatic and renal function, as defined by serum transaminases \<2.5x ULN, bilirubin \<1.5x ULN. Creatinine \<1.5x ULN.
* Patients must provide written informed consent to participate in the trial.
* Normal heart function on cardiac ultrasound
* Prothrombin time (PT) and partial thromboplastin time (PTT) \<=1.5 x ULN
* Serum albumin \>=3.0 g/dl
* Serum amylase and lipase \<=1.0 x ULN
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

The presence of any of the following will exclude a subject from study enrollment:

* Treatment with any investigational agent within four weeks.
* Known HIV infection
* Presence of any medical or psychiatric condition which may limit full compliance with the study, including but not limited to:
* Presence of CNS leukaemia
* Unresolved toxicity from previous anti-cancer therapy or incomplete recovery from surgery.
* Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
* Current treatment with therapeutic doses of anticoagulant (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
* Hypertension that cannot be controlled by medications (\>150/100 mmHg despite optimal medical therapy).
* Pre existing thyroid abnormality of thyroid function that cannot be maintained in the normal range with medication.
* Ongoing cardiac dysrhythmias of NCI CTCAE Grade \>=2, atrial fibrillation of any Grade, or prolongation of the QTc interval to \>450 msec for males or \>470 msec for females.
* Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.