cyrilzakka/clinical-trials huggingface dataset:
Phase I Study of Episcleral Celecoxib for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole

This phase I trial will assess primarily the safety and secondarily the anti-inflammatory and anti-neovascular effect of Episcleral Celecoxib in patients suffering from macular edema and other inflammatory disorders of the retina, choroid and vitreous.

This phase I trial will assess primarily the safety and secondarily anti-inflammatory/neovascular effect of Episcleral Celecoxib in patients suffering from macular edema \& inflammatory disorders of the eye posterior pole Including sclera, choroid, retina, or vitreous. Celecoxib is a specific cyclooxygenase-2 inhibitor that possesses anti-angiogenic, anti-inflammatory, and anti-fibrotic properties. Non-clinical studies have documented the activity of Celecoxib in reducing leakage of the blood-retina barrier as well as inhibiting vascular endothelial growth factor (VEGF) and prostaglandin E2 (PGE2) expression in the retina of diabetic rats. The underlying mechanisms for its anti-inflammatory and anti-angiogenic properties have been extensively characterized. The investigators hypothesize that Episcleral Celecoxib is safe, tolerable and that its anti-inflammatory/anti-neovascular activity will reduce macular edema and improve vision in patients with macular edema. Objective: to primarily assess the safety, tolerability and pharmacokinetics of Episcleral Celecoxib in patients with macular edema and other inflammatory disorders of the posterior pole including retina, choroid and vitreous to secondarily assess efficacy in reducing macular edema and improving visual function. Methods: The main outcome of the study is safety assessment. Secondary outcomes are assessment of visual acuity and anatomical changes in the macula as measured via optical coherence tomography (OCT).

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years;
* Visual acuity letter score in study eye \< 70 and ≥ 25 letters (approximate Snellen equivalent 20/32 to 20/320);
* Ophthalmoscopic evidence of center-involved macular edema, within the central subfield (CSF); • Inflammatory disorders of the sclera, choroid, retina or vitreous

Exclusion Criteria:

* Inability to understand informed consent, cooperate with testing or return to follow up visits;
* Pregnant or lactating women;
* Co-existent ocular disorder of the cornea, lens or media that will interfere with assessment of safety or efficacy.
SOFT- Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases

The SOFT study will evaluate the feasibility and safety of MR-guided stereotactic ablative radiotherapy (SABR) for infra-diaphragmatic soft tissue metastases.

The investigators wish to evaluate the safety and feasibility of MR-guided stereotactic radiation to patients with infra-diaphragmatic oligometastatic disease including quality of life assessments and patient-reported outcome measures. Further, the investigators assess clinical response among patients with oligometastatic disease (OMD), defined as up to five metastases in up to three different organs.

Eligibility Criteria:
Inclusion Criteria:

* Histology or cytology proven non-haematological cancer.
* At least one metastasis should be localized in the infra-diaphragmatic soft tissue.
* Eastern Cooperative Oncology Group (ECOG) scale of performance status ≤ 2.
* ≥ 18 years old.
* Life expectancy \> 6 months.
* Target diameter (GTV) ≤ 5 cm.
* Metastatic lesions must be visible, imaging defined targets and suitable for treatment with SABR.
* In case of de novo OMD and oligometastatic recurrence a maximum of 5 targets (including the primary tumour) in a maximum of 3 organ sites are allowed.
* In case of oligoprogressive disease (OPD) \* and induced OMD \*\* only 3 metastases (including the primary tumour) are allowed.
* All metastatic sites are treated or planned for ablative therapy (including surgery). For OPD, only the sites in progression is required to fulfil this criterion.
* A baseline scan within 28 days of inclusion (PET-CT or CT and MR scanning).
* No curative intended treatment option available.
* An ablative strategy should be deemed clinically relevant and it is at the discretion of the treating physician to decide.
* Ability to understand and the willingness to sign a written informed consent document.
* If the target is in the liver, a Child-Pugh Score A is required.

Exclusion Criteria:

* Patient cannot tolerate physical set up required for SABR.
* Active bowel obstruction.
* Uncontrolled intercurrent illness.
* Medical contraindication to undergoing MR-imaging.
* Pregnancy.
* Patients with uncontrolled brain metastases.
* Uncontrolled disease in respect to malignant pleural effusion, ascites, lymphangitic carcinomatosis, pleural carcinomatosis or peritoneal carcinomatosis.
* If the patient has received previous radiotherapy, the combined dose at the radiation site must not exceed the dose constraints.
The Association Between CBT-I Dose and Innate Immunity in Insomnia and Fatigue in Prostate Cancer Patients

The objective of this project is to test the association between Cognitive Behavioral Therapy for Insomnia dose (number of sessions), severity of cancer related fatigue, and levels of innate immunity biomarkers. Ultimately, this research will help to develop a better understanding of the underlying mechanisms of cancer related fatigue.

Cancer-related fatigue (CRF) and insomnia are prevalent among cancer patients and have been linked to decreases in quality of life and poorer overall survivorship. Currently, the mechanisms underlying CRF are not well understood, which has led to treatments that are only moderately effective. In addition, when compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) in the general population, the treatment outcomes in CBT-I with cancer patients are subpar and, as such, this study will evaluate whether dose of CBT-I is effective in ameliorating CRF.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of organ-confined breast cancer or prostate cancer
* Received radiation treatment
* Willing and able to provide informed consent
* Endorse problem with both insomnia and cancer-related fatigue, as measured by the insomnia severity index, Multidimensional Fatigue Symptom Inventory (short form) and the Brief Fatigue Inventory

Exclusion Criteria:

* History of obstructive Sleep Apnea
* History of narcolepsy
* Night shift work
* Distant metastatic disease at presentation
* Active drug/alcohol dependence
Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis)

Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big challenge. The aim of the study was to compare the long-term results of antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical therapy in patients with aggressive periodontitis. Clinical parameters of probing depth, clinical attachment level and bleeding on probing (BOP) were assessed at baseline, 3, 6, 9 and 12 months after treatment.

Background: Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big challenge. The aim of the study was to compare the long-term results of antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical therapy in patients with aggressive periodontitis. Materials and methods: Twenty subjects with untreated aggressive periodontitis (stage III, grade C periodontitis) were divided into two groups: the test group (TG) received non-surgical therapy and two sessions of aPDT using a laser (HELBO TheraLite laser) with a wavelength of 670nm associated with HELBO Blue photosensitizer, and the control group (CG) received non-surgical therapy and antibiotics (amoxicillin 500mg and metronidazole 400mg, 7 days). Clinical parameters of probing depth, clinical attachment level and bleeding on probing (BOP) were assessed at baseline, 3, 6, 9 and 12 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* aggressive periodontitis (stage III, grade C periodontitis)
* nonsmokers
* at least 20 teeth in oral cavity
* systemically healthy

Exclusion Criteria:

* any previous periodontal treatment
* smoking
* pregnancy
* ingestion of systemic antibiotics within three months before therapy
Obesity, Oral Contraception, and Ovarian Suppression

This study proposes a double blind randomized clinical trial to include normal weight and obese women who have normal ovulatory function at baseline; the investigators will randomize women to 2 widely used OCs and evaluate ovarian follicle development and circulating progesterone to assess ovarian suppression during OC use.

There is a large gap between lowest expected failure rates of about 1.5% and typical use failure rates of about 7% per year. This gap may be due to incorrect use or to decreased oral contraceptive (OC) effectiveness in population subgroups. Recent reports suggest greater OC failure among heavier women, particularly those using the lowest doses. The prevalence of obesity in the US population has recently increased to about 23% in women aged 20-29, peak years for OC use. OC physiology and effectiveness have not been evaluated in obese women.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-35
* Body Mass Index (BMI) 19-24.9 or 30-39.9 kg/m\^2
* Willing to take birth control pills for 3-4 months
* Recent spontaneous pregnancy or cyclic menses

Exclusion Criteria:

* Contraindications to hormonal contraceptives
* Oophorectomy/Polycystic ovary syndrome (PCOS)
* Taken oral contraceptives to regulate menses recently
* Weight reduction surgery
* Used Depo-Provera within the last 12 months
* Pregnant or currently breastfeeding
* Desiring pregnancy within the next 4 months
* Unable to make study visit commitment
* Previous participation in this study
Text-message Reminders to Increase Rates of Postpartum Diabetes Screening in Women With Gestational Diabetes

Purpose: The purpose of this study is to see whether a text-message reminder system will increase the number of women who complete their diabetes screening after delivery.

Study Design: Prospective randomized control trial

Hypothesis: Gestational diabetics will be significantly more likely to follow up with their postpartum screening for diabetes if they receive text-message reminders to set up their lab appointment compared to those who receive usual care.

Eligible participants will be recruited after delivery while on the postpartum ward. Recruitment will be conducted by the PI or a member of the study team. After informed consent is obtained, the patients will be randomized into one of two study groups: the intervention group or the control group. Women in the intervention group will receive a test text-message reminder at the time of enrollment. They will then receive a text-reminder to schedule their oral glucose tolerance test at 6 weeks postpartum, with further reminders at 3 months and 6 months if they have not completed their testing. Women in the control group will only receive the test text-message reminder. The PI or member of the study team obtaining the informed consent will verify the participant has received the text-message prior to completing enrollment. A computer-generated randomization list will be generated according to intervention vs. control group. Simple randomization will be used for the purposes of this study. 316 participants will be recruited based on the sample size calculations already performed. One group of 316 randomized opaque envelopes will be prepared. These sealed envelopes will be stored in a secured designated area at Tampa General Hospital. Once a patient has agreed to participate and is consented an envelope will be selected from the next sequentially numbered envelope and the number on the envelope will be recorded on their study sheet. Enrollment will continue until 316 participants have been recruited.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with gestational diabetes (GDM) based on a 100-g, 3-hour glucose tolerance test with 2 or more abnormal values according to the Carpenter-Coustan criteria OR Women with a 50-g, 1-hour loading test \>200mg/dl.
* Diagnosed with GDM at least at 24 weeks gestation or later
* Access to a personal mobile phone with text-messaging capabilities.
* Age 18 or greater
* Able to provide written and informed consent in English or Spanish language

Exclusion Criteria:

* Women that were ever diagnosed with diabetes outside of pregnancy.
Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum

The purpose of this study is to explore the efficacy and safety of anti-Interleukin-(IL)17 therapy (secukinumab, administered weekly for 4 weeks followed by four-weekly administration until week 16) for the treatment of pyoderma gangrenosum.


Eligibility Criteria:
* Key Inclusion Criteria:

  * Confirmed diagnosis of Pyoderma gangrenosum
  * Biopsy-proven, non-healing ulcer with primarily neutrophil infiltration, regardless of size and location
  * Characterization of target lesion (size, PGA, duration)
  * 18-75 years of age
  * Body weight ≥ 40 kg and ≤ 160 kg
  * Signed informed consent
* Key Exclusion Criteria:

  * Permanent severe diseases, especially those affecting the immune system
  * Pregnancy or breast feeding
  * History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
  * Myocardial infarction or cardiac arrhythmia which requires drug therapy
  * Evidence of severe renal dysfunction or significant hepatic disease
  * History of irritable bowel disease
  * History of lymphoproliferative disorders
  * Evidence for active infection including but not limited to active tuberculosis, HIV or hepatitis B/C that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
  * History of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
HPV Self-sampling to Improve Access to Cervical Cancer Screening for Persons With HIV and/or Underserved Individuals

The objective of this study is to evaluate self-collection of vaginal samples for HPV testing as an alternative cervical cancer screening strategy for persons with HIV and/or limited access to care. Self-collection kits will be offered to persons who refuse a Pap smear or are overdue (\>=6 months) for cervical cancer screening, with screening uptake recorded as a primary outcome. Kits will be offered in-clinic to individuals who refuse a Pap smear, and individuals overdue for screening will have the option to receive and return kits in the mail. The investigators will additionally administer a phone-based survey to evaluate knowledge about HPV and cervical cancer, barriers and facilitators to screening, and attitudes towards screening. Data from medical records will be abstracted to describe the clinical characteristics of the sample and measure receipt of follow-up procedures. Focus groups will be conducted with clinic administrators, staff, and HIV and women's health experts to evaluate clinic and provider barriers and facilitators to cervical cancer screening. The investigators hypothesize that HPV self-sampling will result in favorable patient-centered outcomes and could reduce disparities in access to screening.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=25 and \<65 (individuals without diagnosed HIV) or \>=30 years (individuals with diagnosed HIV)
* Female sex at birth
* Proficient in English or Spanish
* Refused a Pap smear or are \>=6 months overdue for cervical cancer screening

Exclusion Criteria:

* Current pregnancy
* Complete hysterectomy
* History of cervical cancer
* Unable to provide informed consent
Comparison of Diagnostic Sensitivity Between ctDNA Methylation and CEA in Colorectal Cancer

This is a prospective diagnostic study. This study is to compare the performance between circulating tumor DNA (ctDNA) methylation and carcinoembryonic antigen (CEA) in detecting colorectal tumor. Firstly, based on the identification of differential ctDNA methylation biomarkers, the diagnostic model is established and the diagnostic performance was compared with that of CEA. Secondly, the stage stratification model was established preliminarily based on differential ctDNA methylation biomarkers and the performance was also compared with that of CEA.

Colorectal cancer (CRC) is the third most common cancer worldwide, the second deadliest cancer. It is reported that patients prefer non-invasive methods rather than invasive methods for the detection of CRC. Carcinoembryonic antigen (CEA) is commonly employed in clinical practice for early detection of CRC, but it is limited for its low sensitivity, which is around 30%-40%. DNA methylation is a commonly used biomarker for non-invasive tumor detection in plasma. We aim to develop and validate a ctDNA methylation-based blood test for CRC diagnosis based on genome-wide methylation detection. There are two steps in the study. Firstly, this prospective study aims to identify colorectal tumor differential circulating tumor DNA (ctDNA) methylation biomarkers, establish the diagnostic model. Secondly, we performed a preliminary study to stratify early-stage and advanced-stage disease based on the differential biomarkers.

Eligibility Criteria:
Inclusion Criteria:

Case group

* Patients must have histologically confirmed colorectal cancer or advanced adenoma.
* Patients need to receive surgical resection or endoscopic resection.
* Patients have a performance status of ≤1 on the ECOG Performance Scale.
* Written informed consent must be obtained.

Control group

* Written informed consent must be obtained.
* Individuals must receive colonoscopy.

Exclusion Criteria:

* Patients received tumor treatment prior to the drawn of blood sample, including surgical resection, neoadjuvant chemoradiotherapy and targeted therapy.
* Patients received antibiotics regularly.
* Patients received blood transfusion two weeks before the drawn of blood sample.
* Patients with indications of emergency surgery, including bleeding, obstruction and perforation.
* Patients who are positive for Human Immunodeficiency Virus (HIV).
* Patients with abnormal liver and kidney function.
* Patients with the history of other malignancies, inflammatory bowel disease and Lynch syndrome.
* Patients who are pregnant or breastfeeding.
* Alcoholic or drug abusers.
Anisakis Blastocystis Cryptosporidium Fish Prevalence

Anisakidae frequently infect fish species that are commonly eaten by humans. Some of them are recognized as zoonotic agents, and have a high impact on human health.

Infestation results from the ingestion of living larvae from contaminated fishes. It can be asymptomatic or symptomatic, resulting in acute gastric, acute intestinal or chronic forms. Allergic manifestations are frequently encountered in gastric forms, but isolated allergic symptoms can occur after ingestion of Anisakidae antigens in raw or cooked fish. Cutaneous contact or Anisakis allergen inhalation have also been reported to induce allergy/anaphylactic reactions or sensitization in the occupational setting in Spain, Italy, Sicilia or South Africa. But no data is available in France.

In this context, the investigators propose to determine and compare the frequency and characteristics of fish allergy in fish workers (fishermen and fish-processing factory workers) and a control population of workers without occupational exposure to fish, in Boulogne-sur-Mer, which is an important fishing port in France, and the first European center for fish processing.

162 fishermen, 162 fish-processing factory workers, and 162 control subjects will be consecutively recruited by their occupational doctor during a routine consultation. A standardized questionnaire will be used to collect epidemiological and clinical data on potential allergic manifestation resulting from digestive, cutaneous, or respiratory contact with fish. Domestic and occupational risk factors for fish and Anisakis exposure will also be collected for both allergic and non-allergic patients.

Eligibility Criteria:
Inclusion Criteria:

* Fisherman followed by the "Service de Santé des Gens de Mer" of Boulogne-sur-Mer, fish-processing factory worker followed by the "Service de Santé au Travail" of Boulogne-sur-Mer, or worker followed by the "Service de Santé au Travail" of Boulogne-sur-Mer, but not working in a fish-processing factory.

Exclusion Criteria:

* Pregnant or breast-feeding female
* Patient with no social insurance
* Patient unwilling to comply with the protocol
* Patient unable to understand the study and its objectives
* Patient under guardianship
Retrospective Registry Providing Baseline Data on the Outcome of Left Atrial (LA) or LA Appendage (LAA) Thrombus in Patients With Nonvalvular Atrial Fibrillation (AF) or Atrial Flutter After Standard of Care (SoC) Anticoagulant Therapy

Thrombus outcome data will be collected retrospectively during 2011-2012 as a historical baseline of SoC with oral VKA (Vitamin K Antagonist(s) for the treatment of patients with nonvalvular AF or atrial flutter documented with LA/ LAA thrombi on transesophag-eal echocardiography (TEE).

The study is a company-sponsored, global, multi-center, retrospective, non-interventional study. Patients who suffered from hemodynamically stable nonvalvular AF or atrial flutter and had a diagnosed LA/ LAA thrombus between January 1st, 2011 and December 31st, 2012 will be identified through screening and review of medical records and included in the registry. Retrospective patient data will be collected from May 2nd, 2013 to May 2nd, 2014. The observation of each patient will cover the period from the diagnosis of an LA/ LAA thrombus until the end-of-treatment TEE following the 3-12 week SoC anticoagulation (AC) therapy. If no end-of-treatment TEE has been performed during 3-12 weeks of AC therapy, the observational period will end at 12 weeks after diagnosis at the latest. If more than one TEE was performed during treatment, the thrombus outcome will be collected from the last TEE performed within 12 weeks of treatment start.


Eligibility Criteria:
Inclusion Criteria:

* Men or women age ≥ 18 years at data recording
* Hemodynamically stable nonvalvular AF or atrial flutter
* Documented LA/ LA thrombus on TEE

Exclusion Criteria:

* Valvular AF ( ESC 2012 definition)
* History of cardiac thrombus confirmed on TEE
* Intracardiac tumors, e.g. atrial myxoma
* Active endocarditis
Diphenhydramine in Catheter Related Bladder Discomfort

Diphenhydramine has H1-antihistamine action, it also possesses anti-muscarinic properties. Thus, diphenhydramine might be able to reduce the problem of catheter related bladder discomfort by inhibiting smooth muscle spasm of the urinary bladder via its anti-muscarinic action .


Eligibility Criteria:
Inclusion Criteria:

male patients aged more than18-80 years ASA I and II , upper ureteric stone removal under general anesthesia r

Exclusion Criteria:

overactive bladder cognitive impairment a neuropsychological disorder, bladder outflow obstruction urinary tract infection, , neurogenic bladder, operative time \> 6 h