cyrilzakka/clinical-trials huggingface dataset:
A Study of MSI-1256F (Squalamine Lactate) To Treat "Wet" Age-Related Macular Degeneration

Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. AMD presents in two different types - "dry" and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will test the safety and efficacy of Squalamine in the treatment of AMD.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects ≥ 50 years of age.
* minimally classic or active occult choroidal neovascularization associated with age-related macular degeneration in one or both eyes.
* baseline best corrected visual acuity score between 35 to 65 letters according to the Early Treatment of Diabetic Retinopathy Study protocol.
* central retinal thickness by optical coherence tomography of \> 250 microns.
* lesions \> 9 disc areas.
* \> 25% fibrosis in the lesion.

Exclusion Criteria:

* Previous history of triamcinolone, bevacizumab, ranibizumab, or pegaptanib sodium injection therapy in the study eye.
* retinal or optic nerve disease.
* uncontrolled diabetes.
* ongoing malignancy.
Assessment of Non-invasive Tools for Detecting Active Inflammatory Bowel Disease

Part of the success of the treatment of people living with inflammatory bowel diseases (IBD) depends on the information that the doctor can obtain from the different clinical tests. Some of these tests are invasive such as the colonoscopy but other such the fecal calprotectin test, which measures intestinal inflammation, are non-invasive and useful to evaluate the success of the treatments. Unfortunately, the results from the non-invasive tests are not always clear and need to be complete with invasive tests for the right diagnosis.

The aim of this research is to test new stool markers for assisting the gastroenterologist to diagnose inflammatory bowel conditions including Crohn's disease (CD) and ulcerative colitis (UC) and to carefully monitoring the effects of medications on remission. We are using applications based on the use of mass spectrometry for identifying the proteins that are released by the host in the stools. We have identified more than 400 proteins in total. Based on informatics, we have been able to produce lists of unique stool proteins that can rapidly inform the doctor if the person has an IBD, whether it is a CD or an UC and, more importantly for the treatment, if the IBD is active or in remission.

The purpose of this study is to validate these protein markers in a blind test, where the real diagnosis will only be revealed after the analysis of the samples.

This study will bring a new power tool to assist the gastroenterologist in the treatment of people living with IBD.


Eligibility Criteria:
Inclusion Criteria:

* Be affected with one of the two main inflammatory bowel diseases (Crohn's disease of ulcerative colitis).
* Be invited to participate on the base of a routine follow up by their gastroenterologist.
* Be scheduled for a calprotectin test and a colonoscopy.
* Accept to participate and provide an extra stool sample for analysis.

Exclusion Criteria:

* Having no history of inflammatory bowel disease.
* Be affected with an history of gastrointestinal disease other than Crohn disease or ulcerative colitis.
An Investigation of Performance and Safety of the Wound Dressing FibDex in Patients With Superficial Dermal Burns

This is a prospective, randomised, open-label, within-patient controlled, non-inferiority clinical investigation of the nanofibrillar cellulose (NFC) wound dressing FibDex® for treatment of superficial dermal burns in paediatric and adult patients. The clinical performance and safety of FibDex® will be compared to Epicitehydro (QRSKIN GmbH, Würzburg, Germany) and Epiprotect® (S2Medical AB, Linköping, Sweden). Epicitehydro is considered to be the primary comparator. The investigation will be conducted at 2 clinical research sites in Sweden.


Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent (by the patient and/or the patient's parent\[s\]/legal guardian\[s\] as applicable).
2. Patient with superficial dermal burn wound(s) (class II/A) ≤36h as assessed by the Investigator.
3. Patient at least 1 year old.
4. Patient who has at least 3 superficial dermal burn wounds on anatomically equivalent areas or a superficial dermal burn large enough to allow a lateral comparison.
5. Wound area at least 50 cm2 (per wound, if 3 separate wounds) or at least 150 cm2 (if single wound) as judged by the Investigator.

Exclusion Criteria:

1. Patient hyper-sensitive or allergic to, or have had a hypersensitivity/allergic reaction to, any of the dressing components.
2. Pregnant or breast-feeding female.
3. Patient with chemically or electrically induced burns.
4. Other non-burn wound in target wound area.
5. Not suitable for inclusion according to the Investigator.
6. Cognitive dysfunction or psychiatric history (Investigator's discretion).
7. Chronic or presently active skin condition that is judged as interfering with normal wound healing process (Investigator's discretion)
8. Target burns on sensitive skin areas, such as the facial or genital area.
9. Inability or unwillingness of participant or parent(s)/legal guardian(s) to give written informed consent.
Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors

To evaluate the safety and tolerability of oral SKI-606 (bosutinib) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population.


Eligibility Criteria:
Inclusion Criteria:

* Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
* Measurable disease as outlined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* Other inclusion applies.

Exclusion Criteria:

* Use of any systemic antitumor agents or any investigational agent within 28 days before the first dose of test article is administered.
* Prior exposure to SKI-606 or any other Src-kinase inhibitor, major surgery or radiotherapy within 14 days before the first dose of test article (recovery from previous surgery should be complete before day 1).
* Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth (Treated CNS metastases must be stable for \>= 2 weeks before day 1).
* Other exclusion applies.
INTENT Pilot Study - Enhancing Adherence Intentions to Endocrine Therapy

This research is being done to pilot an intervention which aims to improve participants' experiences on Endocrine Therapy.

The name of the intervention used in this research study is:

Endocrine Therapy Education Program (a brief, video-based intervention)

This research study is a randomized pilot study to determine whether a brief-video based intervention program can improve experiences of Endocrine Therapy (ET). Participants will be randomized into one of two groups: Group A: Endocrine Therapy Education Intervention vs. Group B Wait-list Control Group. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, in-clinic visits, and survey questionnaires.

Participation in this research study is expected to last 3 months.

It is expected that about 60 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Biologically female
* About to begin or just started (within four weeks of starting) an oral form of ET (either tamoxifen or AI)
* 18 years of age or older
* English fluency for reading and writing.
* Computer literacy (ability to watch videos and fill out questionnaires online)

Exclusion Criteria:

* Adults unable to consent
* Individuals with metastatic cancer
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Using Digestive Microbial Information to Enhance the Early Detection of Pancreatic Cancer

Pancreatic cancer (PCA) is a leading death-related cancer. There is an urgent need for accurate, noninvasive diagnostic options in the early detection of pancreatic cancer (PCA), since delayed diagnosis increases the risk of metastasis and recurrence. In this study, by analyzing gut and fecal microbial data among the pancreatic versus healthy populations, we aim to establish an early detection tool to improve PCA detection, and to explore potential diagnostic biomarkers.


Eligibility Criteria:
Inclusion Criteria:

PCA Newly diagnosed pancreatic cancer patients; No symptoms of jaundice; Did not yet receive any treatment

NC Individuals who were undergoing routine screenings or physical examination

Exclusion Criteria:
GSH Supplementation on Cold/Flu Symptoms in Older Healthy Adults

A randomized, double blind placebo-controlled parallel intervention in adults over the age of 50 will be performed. Participants will receive a supplement capsule containing placebo (Crystalline Cellulose) or 500mg of Setria® Glutathione to eat for 120 days. Glutathione is hypothesized to replenish the body's reserves that may be depleted through natural aging process, poor diet, or due to the detoxification process for drugs. The primary end point is the number of healthy days experienced during cold and flu season. Secondary endpoints include cellular and biochemical measures from blood samples taken before and after the study.

The long term goal of this investigation is to understand how food components improve immune function, both in its ability to respond to pathogens and its ability to turn off when the response is no longer needed. The goal of this application is to examine mechanisms by which glutathione improves immune cells after consumption. The central hypothesis is that glutathione improves redox status within the cell, thereby improving cell function and increasing the number of healthy days experienced by the participants.

After obtaining informed consent, human participants will receive 500 mg/day of Setria® Glutathione or placebo for 120 days. Peripheral blood mononuclear cells (PBMC), neutrophils and serum will be obtained from blood draws before and after the 120 days. A daily diary of illness will be kept by each participant and will record any incidence of illness, the number of symptoms per incidence, and the number of days in which symptoms are present. This study is powered on the basis that over 120 days, the glutathione-supplemented group would experience 3% more healthy days compared to the placebo group. The analysis indicated 60 people per group. Timeline should be between mid-January to May because the Center for Disease Control and Prevention indicates that this is the cold and flu season (http://www.cdc.gov/flu/weekly/fluactivity.htm) in the southwest part of the country.

Eligibility Criteria:
Inclusion Criteria:

* generally healthy
* must have had at least one cold during the previous year
* age 50-75
* must discontinue other dietary supplement use

Exclusion Criteria:

* on arthritis medication
* on hypertension medication
* severe allergies
* compromised immune system
* high cholesterol, heart failure, angina, etc.
* diagnoses of diabetes or metabolic syndrome
Cardiac Arrest and Intra Osseous Infusion

the international recommendations don't explain the place of the intraosseous infusion in the reanimation of adult cardiac arrest; the goal of this preliminary study is to inform the delay for obtaining a vascular access by evaluation of a current strategy (using intraosseous infusion after one peripheral venous access failure) and to determine the potential failure risk factors of venous access.

In 2010, the European Resuscitation Council and the International Liaison Commitee on Resuscitation have made new recommendations about management of cardiac arrest. The intraosseous infusion was described as an alternative to the peripheral venous access, before the intra tracheal way for adrenaline administration. But this work doesn't specify the delay and the circumstance for this use: time to obtain a vascular access, number of failure, difficulty to obtain a venous access. Furthermore the recent improvements in intraosseous devices may make it relevant to compare intra osseous infusion and venous access in first intention in adult's cardiac arrest in view of the significant number of venous failures and of the subsequent delay of adrenaline administration.

The goal of this preliminary study is to inform the delay to obtain a vascular access by evaluation of a current care (using intravenous infusion after one peripheral venous access failure) and to determine the potential failure's risk factors of venous access.

Main objective: estimate the delay to obtain an effective vascular access (peripheral venous access, intra osseous infusion, central venous access) in resuscitation of adult's cardiac arrest by out of hospital care unit according to the international recommendations.

Study design: monocentric prospective cohort of consecutive patients presenting with out-of-hospital cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or over
* patients insured by social security
* cardiac arrest (all causes) with mobilisation of a intensive mobile care unit in primary intervention
* medical resuscitation indicated

Exclusion Criteria:

* pregnancy
* contraindication osseous infusion
Existential Issues in Elderly People With Cancer

The purpose is to describe, interpret and provide a detailed understanding of what it means to be elderly people with cancer who receive treatment in specialized health care. Focus is especially put on the content and expression of existential issues and the importance of spirituality for the patient´s life story and medical story.

Existential and spiritual issues in elderly people with cancer are scarcely investigated with respect to the content and importance of these aspects to this patient group in terms of living with their disease and benefit from specialist health treatment and care. The present study is an independent doctoral study that also has an initial function for an intended multidisciplinary research project with the working title "Aged people with cancer".

Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer from the age 70 and older receiving palliative treatment in specialized health care

Exclusion Criteria:

* Terminal patients
* Patients considered as too sick for the interview session
* Patients with lack of consent
Development of Dysphagia Protocol in Ankara City Hospital Stroke Patients

Stroke, also called cerebrovascular disease, is a sudden-onset neurological disorder that causes a regional or general dysfunction in the brain due to vascular causes. Dysphagia, one of the common complications of stroke, is associated with increased morbidity and mortality.The aim of this study is to evaluate the clinical evaluation of swallowing in stroke patients and to determine the factors affecting the severity and prognosis of dysphagia in patients with dysphagia.Fifty-five patients with acute stroke and dysphagia who were admitted to Ankara City Hospital Neurology Clinic and diagnosed with stroke by neurology and who did not meet the exclusion criteria will be included in this study. When the patients are admitted to the neurology clinic and will be discharged, they will be evaluated three times, in the first month after discharge.

Stroke, also called cerebrovascular disease, is a sudden-onset neurological disorder that causes a regional or general dysfunction in the brain due to vascular causes. Dysphagia, one of the common complications of stroke, is associated with increased morbidity and mortality.The aim of this study is to evaluate the clinical evaluation of swallowing in stroke patients and to determine the factors affecting the severity and prognosis of dysphagia in patients with dysphagia.Fifty-five patients with acute stroke and dysphagia who were admitted to Ankara City Hospital Neurology Clinic and diagnosed with stroke by neurology and who did not meet the exclusion criteria will be included in this study. When the patients are admitted to the neurology clinic and will be discharged, they will be evaluated three times, in the first month after discharge. Clinical evaluations will be made by the responsible investigator in the examination room. Patients will be evaluated with a bedside swallowing screening test. Patients will be divided into 3 groups as mild, moderate and severe dysphagia according to the test. The patients will be evaluated while they are in the neurology clinic and 1 month after the treatment is given.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with acute stroke by neurology
* Having trouble swallowing
* 18-85 years old, volunteers

Exclusion Criteria:

* Unconscious
* Uncooperative
* Those with oropharyngeal structural damage
* Patients with malignancies involving the head and neck region
Gastroesophageal Reflux Disease Prospective Registry

The purpose of this registry is to evaluate information to determine which operations and treatments for gastroesophageal reflux disease or similar diseases of the stomach, esophagus or digestive tract are providing the most benefit including the long-term effects of treatment (or no treatment) and the progression of the disease over time.

All patients in this registry will have a diagnosis of gastroesophageal reflux disease or a similar disease of the stomach, esophagus or digestive tract. Each patient undergoing anti-reflux surgery will be asked to participate in the registry to gather preoperative, intraoperative and postoperative outcomes. The data collected from the registry will be used to assess the outcome of various treatments, both standard and new: some specific areas of interest include the long-term effects of treatment (or no treatment), the progression of the disease over time, and the overall length of survival of the patient.

Eligibility Criteria:
Inclusion Criteria:

- Any patient undergoing anti-reflux surgery

Exclusion Criteria:

- None
Studies of Sulfur Metabolism in Humans

The study test whether the NSAID allosteric site of human sulfotransferase 1A1 (SULT1A1) is operative in humans. The study will test the effects of mefenamic acid (MEF) on the sulfonation of acetaminophen (APAP, a SULT1A1 specific substrate) and dehydroepiandrosterone (DHEA, a SULT2A1 substrate). If the allosteric site is active in vivo, MEF is predicted to result in a decrease in sulfonation of APAP (MEF inhibits SULT with high affinity (Ki = 23 nM), and to have no effect on sulfonation of the DHEA (MEF has little or no effect on SULT2A1 activity).

No patient registries associated with this study.

A single, therapeutic dose of acetaminophen (APAP, 1.0 g)) or dehydroepiandrosterone (DHEA, 75 mg) is taken orally (with 375 ml of water) either alone or simultaneously with a single, oral, therapeutic dose of mefenamic acid (MEF, 0.75 g). In total, 5 experiments will be performed: 1, APAP alone; 2, DHEA alone; 3, MEF alone; 4, APAP + MEF; and 5, DHEA + MEF. Each experiment will be performed in duplicate. Compounds will be taken prior to eating breakfast. One hour later, the patient has a light breakfast (Cheerios and milk, and a cup of coffee) and eats normally thereafter. Urine samples are collected at 15', 30', 1 h, 2h, 3h, 4h, 5 h, 6h, 7h, 8h, 9h, 10h, 11h, and 12h intervals following dosing. The study subject will attempt to completely empty their bladder at each urine-collection time point. The samples are weighed. A 10 ml aliquot is taken from each time point and the aliquots are stored at -20 °C. Samples (0.5 ml) are then transferred to nuclear magnetic resonance (NMR) tubes and NMR spectra are taken to assess drug metabolites in urine. Proton NMR will be performed using the 600 MHz instrument in the Einstein facility.

Eligibility Criteria:
Inclusion criteria:

* Gender - one male
* Age - 61 y.o.
* Healthy
* Agreed to sign the consent form

Exclusion criteria:

● None
Prevention of Radiodermatitis in Breast and Head and Neck Cancer Patients in Cyprus

The treatment of cancer as a multidimensional disease has improved in recent years with the development of new chemotherapies, targeted biological therapies or radiation therapy protocols and have led to an overall improvement in the survival of oncology patients. These treatments often cause adverse effects on the skin, which can be accompanied by physical and mental suffering and have a significant impact on patients' quality of life. Improving the quality of life of patients is today a therapeutic challenge. The objective of this clinical study is to assess the tolerability of an innovative skin cosmetic product that will be developed specifically for use during curative anticancer treatments, as well as to study the impact on quality of life of skin side effects caused by the treatments.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age,
* understand and be able to provide signed consent for the purpose of the research,
* be diagnosed with breast or head and neck cancer,
* undergo subfractionated radiotherapy of the breast in 15 sessions of a total dose of 40-42Gy, with or without the administration of a booster dose (boost),
* to know the Greek or English language well
* any wound should have healed after radiotherapy. The criteria will be evaluated by the medical staff of the hospital.

Exclusion Criteria:

* those who do not meet the aforementioned inclusion criteria as well as:
* those who suffer from inflammatory cancer,
* those who have untreated wounds and/or other serious dermatological problems
* those with severe/extensive burns
* those who suffer from serious mental disorders (dementia, drug addiction, etc.) that require intensive treatment or monitoring,
* those who have a sensitivity/allergy to any of the product's ingredients. The criteria will be evaluated by the medical staff of the hospital.