cyrilzakka/clinical-trials huggingface dataset:
Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye

This study will evaluate the safety, tolerability and pharmacokinetics of two formulations of cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). The parallel-group phase will be followed by a paired-eye phase which will evaluate the safety and tolerability of two formulations of cyclosporine ophthalmic emulsion compared with cyclosporine ophthalmic emulsion (RESTASIS®) in patients with dry eye.


Eligibility Criteria:
Inclusion Criteria:

Parallel-Group Phase:

* Weigh at least 110 lbs
* 18 to 45 years old

Paired-Eye Phase:

* Dry eye disease in both eyes

Exclusion Criteria:

Parallel-Group Phase:

* Use of nicotine products, any medications, supplements or herbal products or consumption of grapefruit juice within 14 days or anticipated use during the study
* Has donated blood within 90 days
* Significant weight change (over 10 lbs) within 60 days
* Previous use of RESTASIS®

Parallel-Group and Paired-Eye Phases:

* Anticipated wearing of contact lenses during the study or wearing of contact lenses within 14 days
* Consumption of alcohol products within 72 hours

Paired-Eye Phase:

* Previous ocular surgery
* Use of RESTASIS® within 30 days
A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

The purpose of this study is to compare the efficacy and safety of intravenous iron therapy with oral iron therapy in patients with cancer and chemotherapy induced anaemia.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged more than 18 years.
2. Subjects diagnosed with cancer (non-myeloid malignancies) receiving chemotherapy at least 1 day prior to screening and who are going to receive at least two more chemotherapy cycles.
3. Hb \< 12 g/dL (7.4 mmol/L).
4. TfS \<50%.
5. Serum Ferritin \<800 ng/ml.
6. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
7. Willingness to participate after informed consent (including HIPAA, if applicable).

Exclusion Criteria:

1. Anemia caused primarily by other factors than CIA.
2. IV or oral iron treatment within 4 weeks prior to screening visit.
3. Erythropoietin treatment within 4 weeks prior to screening visit.
4. Blood transfusion within 4 weeks prior to screening visit.
5. Imminent expectation of blood transfusion on part of treating physician.
6. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
7. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulfate).
8. Known hypersensitivity to any excipients in the investigational drug products.
9. Subjects with a history of multiple allergies.
10. Decompensated liver cirrhosis or active hepatitis (alanine aminotransferase (ALAT) \> 3 times upper normal limit).
11. Active acute or chronic infections (assessed by clinical judgement and if deemed necessary by investigator supplied with white blood cells (WBC) and C-reactive protein (CRP)).
12. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
13. Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
14. Planned elective surgery during the study.
15. Participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening.
16. Known intolerance to oral iron treatment.
17. Untreated B12 or folate deficiency.
18. Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
Effect of Lower Leg Heating and Transcutaneous Electrical Nerve Stimulation on Exercise Capacity in Patients With PAD

Peripheral arterial disease (PAD) is characterized by poor circulation in the lower extremities that often provokes claudication (leg pain, numbness, and heaviness) with physical exertion. The aim of this research protocol is to determine the effect of two non-invasive treatment modalities on leg blood flow and exercise capacity in those with PAD. Specifically, we are measuring popliteal artery blood flow (Doppler ultrasound), toe oxygen saturation, ankle-brachial index (ABI), and 6-minute walking distance (6MWD) in men and women who have intermittent claudication (Fontaine Stage II; Rutherford Category 1-2) in response to 15 or 45 minutes of lower limb heating and transcutaneous electrical nerve stimulation (TENS).


Eligibility Criteria:
Inclusion Criteria:

* Intermittent claudication (Fontaine Stage II)
* Resting ankle-brachial index (ABI) \< 0.90
* Ability to walk \> 60 meters in six minutes

Exclusion Criteria:

* Body mass index (BMI) \> 35 kg/m2
* Severe exercise limitations (more than PAD) due to co-morbidity
* Taking illegal/recreational drugs
* Uncontrolled hypertension (\>180/100 mmHg)
* Severe peripheral neuropathy
* Foot ulcers
* Gangrene
* Pregnant or breast feeding
Unified Airway Model

Chronic rhinosinusitis (CRS) impacts approximately 5% of Canadians. CRS patients suffer from a combination of symptoms that include facial pain, nasal obstruction, hyposmia and mucopurulence discharge. Asthma may additionally worsen quality of life and many patients suffer from both conditions. The unified airway model illustrates a link between both conditions as tissue from the middle ear to the sinus cavity to the lungs function as one unit. Despite evidence for the unified airway model in the setting of CRS and asthma, there are no studies to our knowledge that have evaluated the microbiome (the resident microbes and their genetic expressions that affect disease) of the upper and lower airways in this patient population. Determining the microbiome of the upper and lower airways in patients suffering from CRS and asthma will further support the unified airway model but more importantly, will help contribute to understanding the pathophysiology of this inflammatory process and may help guide future management.


Eligibility Criteria:
Inclusion Criteria:

* 19 years or older
* Able to speak and understand English
* Diagnosed with chronic rhinosinusitis with or without asthma and COPD or with a sinonasal tumor
* Undergoing sinus surgery in St Paul's Hospital

Exclusion Criteria:

* Oral antibiotics in the past month prior to surgery;
* Immunocompromised;
* Prior lung transplants;
* Known sinonasal or bronchial tumors, current or previous;
* Smoking;
* Known bleeding disorders:
* Deemed unfit by the rhinologists/respirologist for bronchoscopy.
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Obsessive-Compulsive Disorder

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to infection with Obsessive-Compulsive Disorder.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages
3. OCI greater than or equal to 21

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
This Three-year Observational Study Involves Patients of All Ages Undergoing Endovascular Treatment for Various Cerebral or Spinal Vascular Conditions. It Aims to Assess Pre- and Post-operative Clinical Conditions, Report Complications, and Identify Preoperative Indicators of Treatment Outcomes. Pat

This three-year observational study involves patients of all ages undergoing endovascular treatment for various cerebral or spinal vascular conditions. It aims to assess pre- and post-operative clinical conditions, report complications, and identify preoperative indicators of treatment outcomes. Patients will also receive psychological support and Neuropsychological assessment. Clinical, medical, and demographic data will be recorded in a database during hospitalization and follow-up visits.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes and any age, who are referred to the Department of Neurosurgery and Clinical Neurosciences and are candidates for interventional endovascular procedures for any cerebral or spinal pathology, will be included in the study.

Exclusion Criteria:

* /
Comparison of Virtual Reality and Passive Distraction on Burn Wound Care Pain in Adolescents

Relief of severe burn wound care pain may require both medications to relieve pain and non-medication interventions,such as distraction. Little is known about distraction's effectiveness. Virtual reality may be an effective distraction. The aims of this study are 1)to evaluate the effect of virtual reality (VR), a newer interactive kind of distraction, compared to passive distraction (PD) by watching a movie, and usual care (SC) that is provided by the nurses, on pain experienced by adolescents during burn wound care and 2)to determine the relationship among anxiety, desire for distraction, and engagement with distraction on the pain.


Eligibility Criteria:
Inclusion Criteria:

* undergoing burn wound care in the Arkansas Children's Hospital (ACH) outpatient burn clinic;
* first time visit to the ACH outpatient burn clinic or first clinic visit without conscious sedation;
* adolescents ages 10 to 17 years;
* English speaking;
* absence of a history of motion sickness (motion sickness has been reported in some VR users);
* absence of a seizure disorder (because prolonged immersion in VR may lead to seizures and vertigo in individuals with seizure disorders, these individuals will be excluded from the study);
* absence of a cognitive developmental disability determined on prescreening by presence of a Section 504 accommodation plan or Title VIII individualized educational plan (IEP) in school. If the parent identifies the nature of the IEP or 504 plan as unrelated to a cognitive delay, then the child or adolescent will be included in the study.

Exclusion Criteria:

* Burns that would interfere with study procedures
* Incarcerated minors
* Children in foster care
Investigate the Diagnostic Value and Possibilities of OCT in Non-Melanoma Skin Cancer.

We will do systematic and functional assessment of non-melanoma skin cancer including precancerous lesions by OCT imaging and other diagnostic methods. The systematic assessment will be comparison of clinical diagnosis, histopathology, OCT images, spectrophotometry and high frequency ultrasound of non-melanoma skin cancer Functional exploration of non-melanoma skin cancer is done with Doppler-OCT and polarization-sensitive-OCT.

Optimal management of skin malignancies relies on early and accurate diagnosis. The reference standard in skin cancer is biopsy and histopathological assessment from a clinical suspicious skin lesion. The clinical diagnosis of skin cancer has sensitivity ranging from 50% to 90 % and specificity around 70% to 80% depending on the population studied and the experience of the clinician.

A rapid, non-invasive technique that could be used for characterization of skin lesions prior to biopsy would be valuable. In some patients with multiple, recurrent skin tumours the need for numerous biopsies in the same area is problematic, both cosmetically and diagnostically, as the cancer can be hidden under scar tissue.

The biopsy has several weaknesses: The biopsy must be done exactly in the tumour, and it does not delineate the tumour borders. Biopsy from skin is in general easy, but there are problematic places such as the T-zone in the face, the eyelids and the ears. Notably these places are areas where most types of skin cancer exhibit aggressive, invasive growth and have a high recurrence rate.

OCT is a novel, non-invasive optical imaging technology. It can provide cross-sectional tomographic images of tissue pathology in situ and in real time, without the need for excision and processing of specimens, as in conventional histopathology. OCT uses harmless, infrared light to create high-resolution images of tissue. OCT provides cross-sectional images of structures below the tissue surface in analogy to histopathology. Hence OCT can function as an "optical biopsy" providing images of tissue structure on the micron scale. For example, OCT could be used where standard excisional biopsy is hazardous or impossible, and OCT could reduce sampling errors associated with excisional biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Patients above the age of 18 years with primary non-melanoma skin cancer NMSC or precancerous lesions from the Dermatology Department, and the Plastic Surgery Department at Roskilde Hospital, and from office based dermatologist in Roskilde County. Patients will only be recruited after informed consent.

Exclusion Criteria:

* Pregnancy.
* To avoid the potential bias of scar tissue in the OCT images we will not include OCT images from recurrent NMSC in this study.
* Patients will be excluded from the study if they are not able to give an informed consent. Staff from the Dermatology, Internal Medicine and Plastic Surgery Departments at RAS cannot be included in the phase I/phase 2 study.
* Gender: both
* Age limits: 18- no max
Using MRI Scans to Evaluate Spinal Manipulation

Lumbar spinal manipulation, or chiropractic adjusting, is thought to separate the surfaces of the spinal joints and thereby relieve lower back pain. This study will use MRI scans to evaluate the spinal joints before and after spinal manipulation.

Zygapophysial joints, better known as facet or "Z" joints, are located on the back (posterior) of the spine on each side of the vertebrae where it overlaps the neighboring vertebrae. Z joints provide stability and allow the spine to bend and twist. Adhesions in the Z joints may develop following hypomobility of vertebrae. These adhesions may be alleviated by separation (gapping) of the Z joints.

Side posture adjusting (spinal manipulation) is thought by many to gap the Z joints, yet no measurable differences of the Z joints before and after spinal manipulation have ever been published. This study will evaluate gapping of the L3/L4, L4/L5, and L5/S1 Z joints by taking measurements directly from MRI scans of the Z joints before and during positioning for a side posture adjustment, and before and after side posture adjusting.

Health volunteers will be randomly assigned to one of four groups: 1) neutral position followed by side posture positioning (trunk rotated to the volunteer's right); 2) neutral position followed by side posture spinal adjusting followed by neutral positioning; 3) neutral position followed by side posture spinal adjusting, followed by side posture positioning; and 4) neutral position followed by neutral position (control group). MRI scans will be taken with the volunteers in the original neutral position and in the final position (either second neutral position or side posture positioning).

Eligibility Criteria:
Inclusion Criteria:

* Student at the National University of Health Sciences
* 185 pounds or less for males and 145 pounds or less for females
* No previous history of lower back pain lasting more than 2 weeks, or no more than three episodes of back pain of brief duration (1 to 2 weeks) in any given year

Exclusion Criteria:

* History of lower back pain
* Presence of disc degeneration, significant osteoarthritis, scoliosis of greater than 20 degrees (Cobb's angle), or other significant pathology seen on x-rays
* Positive findings on orthopedic or neurologic test
* Pregnancy
* Inability of the examining chiropractor to obtain articular releases (audible pop) during lumbar side posture adjustment given at the conclusion of the examination
Evaluating the Effect of a Supplement on Symptoms of Hormonal Imbalance.

This is a virtual single-group trial lasting 12 weeks to evaluate the effects of Perelel Health's hormonal balance support on symptoms of hormonal imbalance and overall menstrual health.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported symptoms of hormonal imbalance (e.g., mood swings, irregular menstrual cycles)
* Generally healthy without uncontrolled chronic diseases
* Willing to avoid new hormonal balance treatments during the study
* Consistent use of current hormonal balance treatments for at least 3 months prior to the study

Exclusion Criteria:

* Chronic conditions preventing adherence to the protocol Diabetes
* Planned hormonal balance-related procedures during the study
* Started any new medications or supplements that target hormonal balance in the past 3 months
* Anyone with diabetes
* Severe allergies requiring EpiPen
* Pregnant, breastfeeding, or trying to conceive
* Recent surgeries or planned surgeries during the study
* Unwilling to follow the study protocol
Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey

The objective of this survey is to establish the clinical course of vision loss and recovery in patients with a genetically confirmed diagnosis of Leber Hereditary Optic Neuropathy (LHON).

Visual acuity changes over time from onset of symptoms and from visual acuity nadir will be the main endpoint analysed.

The survey will collect historically documented visual acuity data for all patients at participating sites with a genetically confirmed diagnosis of LHON. No exclusion criteria apply. Patients are not required to attend the clinic for the survey.

Data will be collected in a completely anonymous manner. Ethical approvals and data release agreements will be obtained as required by local regulations.


Eligibility Criteria:
Inclusion Criteria:

* patients with genetically confirmed diagnosis of LHON
AngioJET Thrombectomy and STENTing for Treatment of Acute Myocardial Infarction

The purpose of this study is to determine whether prompt removal of thrombus (blood clot) from a blocked coronary artery using the AngioJet rheolytic thrombectomy device will result in improved blood flow within the heart and a smaller final infarct size (reduced injury to the heart muscle).

Occlusive thrombosis triggered by a disrupted or eroded atherosclerotic plaque is the anatomic substrate of most acute myocardial infarctions (AMI). Macro- and microembolization of thrombus during percutaneous coronary intervention (PCI) in AMI is frequent and may result in obstruction of the microvessel network, and decreased efficacy of reperfusion and myocardial salvage. Direct stenting without predilation or postdilation is the most simplistic approach to the problem of embolization, and may decrease embolization and the incidence of the no-reflow phenomenon. Other approaches to the problem of microvessel embolization include percutaneous rheolytic thrombectomy (RT) with the AngioJet catheter before stent implantation. The objectives of the study are: to assess whether RT before direct infarct artery stenting results in improved reperfusion success in patients with acute ST-segment elevation myocardial infarction (STEMI) and angiographically evident thrombus; and to validate a technique for use of the AngioJet RT catheter in the treatment of STEMI.

Comparisons: Treatment with AngioJet RT immediately before direct infarct artery stenting versus direct stenting alone, in patients with STEMI and angiographically visible thrombus presenting within 6 hours of symptom onset for primary PCI.

Eligibility Criteria:
Inclusion Criteria:

* Patient age \> 18 years
* ST-segment elevation myocardial infarction
* Angiographically visible thrombus
* Presentation within 6 hours of symptom onset for primary percutaneous coronary intervention
* Patient, or relative or legal guardian,provides written informed consent
* Patient has no childbearing potential or is not pregnant

Exclusion Criteria:

* Prior administration of thrombolysis for current MI
* Participation in another Study
* Major surgery within past 6 weeks
* History of stroke within 30 days, or any history of hemorrhagic stroke
* Severe hypertension (systolic BP \> 200 mm Hg or diastolic BP \> 110 mm Hg) not controlled on antihypertensive therapy
* Known neutropenia ( \<1000 neutrophils per mm3) or known severe thrombocytopenia (\< 50,000 platelets per mm3)
* Known prior history of renal insufficiency
* Co-morbidities with expected survival \< 1 year
* Patient unwilling to receive blood products
Radiofrequency Ablation of Atrial Fibrillation Under Apnea

This study seeks to assess the effect of apnea (breath hold) during atrial fibrillation (AF) ablation by having all ablations performed under apnea. By prospectively studying the effects of apnea on AF ablation, the investigators wish to demonstrate its feasibility, safety and impact on patient outcomes. This is a prospective study that includes both an apnea arm and a control arm. The subjects who consent to the apnea arm will undergo an atrial fibrillation ablation with periods of apnea. The subjects who consent to the control arm will agree to have their data from their standard of care atrial fibrillation be collected for comparison.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 80 years old.
* Symptomatic paroxysmal atrial fibrillation.

Exclusion Criteria:

* Patients with persistent or permanent atrial fibrillation or prior atrial fibrillation ablation.
* Significant chronic obstructive pulmonary disease (such as those requiring home oxygen).
* Severe pulmonary hypertension.
* Other intrinsic lung pathology such as interstitial lung disease.
* Severe systolic dysfunction defined as left ventricular ejection fraction \< 30%.