cyrilzakka/clinical-trials huggingface dataset:
Home Monitoring of Diabetic Macular Edema

Diabetic macular edema (DME) is part of diabetic retinopathy (DR) and a leading cause of central visual loss in people with diabetes . Most patients require pharmacological inhibition using anti-vascular endothelial growth factor (VEGF) agents with multiple monitoring visits that include optical coherence tomography (OCT), visual acuity test, and multiple injections.The substantial visit frequency puts pressure on ophthalmic clinics, and can impose a tremendous burden on both patients and their caregivers. Therefore, self-service examination instruments that can be portable and fast-moving become the key for realizing tele-medicine. Recently, the investigators have developed a portable, self-administrated home OCT machine, which is designed for home-based OCT scanning and monitoring for patients with retinal diseases including DME, age related macular degeneration (AMD) and choroidal neovascularization (CNV) that require multiple anti-VEGF injections. The investigators have confirmed its image quality and validated the retinal thickness measurements obtained from this device by comparing with hospital OCT (staff-administrated and clinic-based).In this study, the investigators will conduct a randomized clinical trial (RCT) to compare the efficacy and cost-effectiveness of a home OCT monitoring model versus standard hospital care model for patients with diabetic macular edema who need anti-VEGF injections.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years;
2. Diagnosis of diabetic macular edema:

   * Type 1 or type 2 diabetes mellitus;
   * Center-involved macular edema;
3. Willing to receive anti-VEGF treatment;
4. Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCT examination;
5. Able to operate self-administratedhome OCT by themselves or with the help of family;
6. Travel time from home to hospital: within 2 hours driving.
7. Able and willing to provide informed consent.

Exclusion Criteria:

1. History of systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization. (These drugs should not be used during the study);
2. History of corticosteroid treatment (intravitreal or peribulbar) at any time in the past 4 months;
3. History of macular laser photocoagulation in the past 4 months;
4. Macular edema due to reasons other than diabetes;
5. Coexisting ocular diseases that might alter visual acuity during the course of the study, such as retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.);
6. Hypertension (systolic blood pressure (BP) above 180 or diastolic BP above 110);
7. History of myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization;
8. Pregnant or lactating;
9. Currently participating in other clinical trials;
Diagnosis and Management of Enhanced Myometrial Vascularity Associated With Retained Products of Conception

Background:

Hypervascularized products of conception remain a topic debated in terms of definitions (ultrasound criteria, need complement by angio MRI) and management. The different uterine vascular lesions are often confused. This is a recurrent problem and care are heterogeneous. The aim of the study is to evaluate the management of these entities in CHU of Montpellier and determine more homogeneous care. The investigators further aimed to evaluate clinical presentation, ultrasound criteria, complications and the gynaecological and obstetrical outcomes of patients •Methods: This study will be conducted in compliance of ethic comitee. The investigators will collect data from 64 individuals, aged 18 to 50, suffering from uterine vascular lesions associated or not with products of conception between 2013 and 2019. Caracterisitics of the population, ultrasound and angio MRI data will be collected. Management wll be described as expectative, surgery or embolization of uterine arteries and the success or not will be noted. The investigators will question patients on their gynaecologic and obstetrical outcomes by telephone.

•Discussion: The investigators aim to define and characterize the different lesions, establish ultrasound criteria that would guide treatments. Describe the current treatments and compare them in terms of efficiency and safety in order to establish a homogeneous treatment protocol in our center

* data are collected by computer software and patient phone calls
* ultrasounds criteria are reviewed by two clinicians
* statistical analysis is realized by a independent clinician
* the consent and agreement of the ethics committee has been sought

Eligibility Criteria:
Inclusion criteria:

* Women
* Aged between 18 and 50 years
* Managed in CHU Montpellier
* Diagnosis of hypervascularized products of conception
* Available ultrasound pictures

Exclusion criteria:

* Subject unable to understand the study
* Subject with another diagnosis of bleeding
* Subject who have retained products of conception with no vascularity or immediate curettage with uterine vacuity
* Subject who have no available ultrasound pictures
Comparisons of Inhaled LAMA or LAMA+LABA or ICS+LABA for COPD With Bronchiectasis

The purpose of this study is to determine which treatment is more effective and safer for the patients in COPD C group with bronchiectasis.The research results will help guide physicians to select appropriate individualized treatment and hopefully provide some evidence-based medicine proofs for revising guide.

The diagnosis and treatment of COPD and bronchiectasis together seems to be more complicated than the diagnosis and treatment of either condition alone. According to the GOLD，there are three treatments for patients with COPD in group C: ICS combined with LABA or LAMA alone or LABA combined with LAMA. However, it has not yet been demonstrated about which method is more effective for the patients with COPD in group C and bronchiectasis.

This study is designed as a prospective, randomized, case-control trial. Patients are divided into three groups, one group inhaled with ICS and LABA (Symbicort), the second group inhaled with LAMA (Tiotropium Bromide) and the third group inhaled with LAMA(Tiotropium Bromide) and (Symbicort).The course of treatment is 12 months.

The investigators will also assess other relevant outcomes, including the quality of life (QOL) score, pulmonary function test and the incidence of adverse event.

Eligibility Criteria:
Inclusion Criteria:

* Patients are suitable for inclusion in the study when they are 18 years or older diagnosed with COPD C group and bronchiectasis.

Exclusion Criteria:

* active tuberculosis
* severe respiratory disease (such as Lung cancer, ARDS, pulmonary encephalopathy, respiratory failure)
* uncontrollable diabetes
* hypersensitivity to any components of ICS/LABA or LAMA.
Safety and Performance of the Steroid-Releasing S8 Sinus Implant

The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.

The S8 PK study was a single-center, open label study treating 5 adult (18 years or older) patients diagnosed with chronic sinusitis, who had undergone prior bilateral total ethmoidectomy and later presented with recurrent nasal obstruction/congestion symptoms and bilateral ethmoid polyposis. The S8 PK study assessed the safety, implant delivery to the ethmoid sinus, and systemic exposure to mometasone furoate (MF) by measuring plasma MF and cortisol concentrations through 30 days post-procedure.

Eligibility Criteria:
Key Inclusion Criteria:

* 18 years of age or older
* Diagnosis of chronic sinusitis
* Prior bilateral total ethmoidectomy
* Recurrent sinus obstruction due to polyps grade 2 or higher

Key Exclusion Criteria:

* Required use of mometasone furoate within 2 weeks prior to implant procedure
* Significant scarring or adhesions of the sinus
Dynamic Changes of Gut Microbiota in UC After FMT

A prospective study to investigate the dynamic changes of gut microbiota through colonic transendoscopic enteral tubing in patients with ulcerative colitis after fecal microbiota transplantation.

Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment. This tube also can serve as a medium for collecting gut microbiota. Fecal Microbiota Transplantation (FMT) was identified to be promising for ulcerative colitis (UC). This study aims to investigate the dynamic changes of gut microbiota in patients with UC after FMT.

Eligibility Criteria:
Inclusion Criteria:

* Patients were diagnosed with mild or moderate ulcerative colitis.
* Patients need colonic TET and FMT
* Must be able to colonic TET and no contraindication by endoscopic examination, consent colon TET implantation and not associated with severe intestinal lesions such as fistula, stenosis, complex perianal lesions, severe ileocecal or ascending colon lesions resulting in no proper site for titanium clip fixation.
* Age \> 7 years old and \< 65 years old

Exclusion Criteria:

* gut microbiota was not collected successfully
Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy: A Study in Germany

The aim of this prospective randomized study is to investigate the efficacy and safety of trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open angle glaucoma.

ologen® Collagen Matrix (CM) is an artificial extracellular matrix (ECM) specifically configured to support repair in connective and epithelial ocular tissue. The device is constructed so as to minimize random growth of fibroblasts and instead to allow them to grow through the pores in the matrix. ologen® CM is a biodegradable scaffold matrix, inducing a regenerative non-scarring wound healing process without using anti-fibrotic agents. For application in glaucoma filtration surgery, ologen® CM is designed to prevent scar formation (subconjunctival and scleral flap scarring is the major risk factor for failure of trabeculectomy). After implanting the ologen® CM on top of the scleral flap in the subconjunctival space, a functional bleb can be created.

The aim of the present study is to determine the effectiveness of the ologen® CM and reduce wound scarring, thereby increasing success of trabeculectomy without side effects of MMC. A means of producing better success rate and reduced complications is the purpose of ologen® Collagen Matrix for the aid of glaucoma surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or over
* Uncontrolled open-angle glaucoma
* Subject is willing to sign informed consent
* Subject is able and willing to complete post-operative follow-up requirements

Exclusion Criteria:

* Inflammatory eye diseases
* Angle-closure glaucoma
* Secondary glaucoma with anatomical malformations of the eye
* Subjects having single functional eye
* Previous conjunctival surgery
* Known allergic reactions to ingredients of ologen Collagen Matrix
* Excessive myopia (axial length (AL)\> 27 mm or more than -10 diopters)
* Previous vitrectomy eye surgery
* Subjects do not consent to participate
Study of the Response to Irradiation on Prostatic Explants ex Vivo, as a Predictive Factor of the Clinical Response to Irradiation of Prostate Cancers

Of the 50,000 prostate cancers that occur each year in France, more than half will benefit from curative radiotherapy, alone or in combination with hormone therapy from 6 months to 3 years depending on the stage of the disease. At present, there are few ways to predict the response to this irradiation.

Evaluating the early response of tumor tissue to irradiation could predict the final response to treatment. It is difficult to offer biopsies during treatment for reasons of patient comfort. This is why this study consists in analysing transcriptomic and protein responses (immunohistochemistry) to irradiation on ex vivo prostate explants. These explants will be irradiated after culture and the transcriptional and immunohistochemical changes analysed before and after irradiation to determine an early tumor tissue response profile to irradiation.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old
2. Patient with non-operated prostate adenocarcinoma for whom radiotherapy treatment is scheduled
3. Signed Informed Consent
4. No contraindications to biopsy performance:

   * No anticoagulant treatment in progress
   * Absence of infection during diagnostic biopsies
   * Absence of pain requiring level 2 analgesics during diagnostic biopsies
   * Absence of bleeding complications during diagnostic biopsies
   * Absence of anal stenosis
5. Normal coagulation examination :

   * Prothrombin Ratio between 80 and 100%.
   * Active Cephalin Time from 24 to 41 seconds, \> 1.5 times that of the indicator
   * Platelets \> 150,000 G/L
   * International Normalised Ratio(INR) = 1 after stopping the anticoagulant
6. No contraindication to MRI:

   * Ocular metallic foreign body
   * Pacemaker
   * Old mechanical heart valve
   * Ancient vascular clips on cranial aneurysms

Exclusion Criteria:

1. History of radical prostatectomy. A history of transurethral prostate resection is not a contraindication
2. History of prostate infection
3. Hemorrhagic complications in diagnostic biopsies
4. Pain requiring level 2 analgesics in diagnostic biopsies
5. Anticoagulant treatment in progress (aspirin will be stopped 1 week before biopsies are performed)
6. Abnormal coagulation assessment
7. Anal stenosis
8. Contraindications to radiotherapy: chronic inflammatory bowel disease, scleroderma
9. Protected or tutored patient
10. Patient whose follow-up at two years is not possible
LFR-260 vs Traditional Phoropter in Visual Acuity Testing

The purpose of this study is to establish if LFR-260 (investigational device) is not inferior in effectiveness to a traditional phoropter (control device) when applied in visual acuity test in subjects undergoing a full routine eye examination. LFR-260 proposes to provide information of the visual capabilities of the patient. The test will be provided and supervised by a qualified eye care provider. The informed consent, screening, randomization (into the order of visual test device used), (visual) device testing (to include precision testing, remote and offsite testing) will all occur at a single visit.


Eligibility Criteria:
Inclusion Criteria:

1. The participant or legal guardian is willing and able to understand, sign and date the Ethics committee approved study specific Informed Consent Form.
2. The participant is a male or female between the ages of 12 and 65 (inclusive).
3. The participant has no more than mild to moderate far-sightedness, near-sightedness, astigmatism or anisometropia.
4. The participant is free of ocular and systemic abnormalities that might affect visual functions.

Exclusion Criteria:

1. The participant has diabetes mellitus (Type 1 or 2).
2. The participant has an autoimmune condition.
3. The participant is pregnant (self-reported).
4. The participant has an active corneal or conjunctival infection.
5. The participant has an active corneal, conjunctival, or intraocular inflammation (i.e. - uveitis).
6. The participant has diabetic retinopathy.
7. The participant has glaucoma or ocular hypertension.
8. The participant has macular degeneration.
9. The participant has had a previous ocular surgery.
10. The participant has ocular and systemic diseases or abnormalities that might affect visual functions.
11. The participant has a history of amblyopia, strabismus, or any other binocular vision abnormality.
12. The participant has a history of AMD (age macular degeneration).
13. The participant is a prisoner, a transient or has been treated for alcohol and/or drug abuse in an inpatient substance abuse program within 6 months prior to proposed study enrolment.
14. The participant will not be able to complete questionnaires.
15. The participant is currently in an investigational study for a similar purpose.
16. The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures.
The Efficacy of N-acetyl-cysteine in the Treatment of Burning Mouth Syndrome

The purpose of this study was to examine the efficacy of N-acetyl cysteine in the treatment of burning mouth syndrome. A control group of patients with burning mouth syndrome will receive a placebo. The effect of the therapy will be monitored with the help of the visual-analogue scale (VAS) and the oral health-related quality of life questionnaire (OHIP-14).

The research will include patients who come to the Department of Oral Medicine at the Faculty of Dentistry in Zagreb, and who have been diagnosed with burning mouth syndrome. It is planned to gather a total of 60 patients, 30 patients in the treatment group and 30 in the placebo group.

The purpose and protocol of the research will be explained to the patients. If they are willing to participate, they will sign an informed consent previously approved by the Ethics Committee of the Faculty of Dentistry. They will fill in the OHIP-14 questionnaire and the VAS scale, grading from 0-10, where 0 indicates a condition without symptoms, and 10 the strongest possible intensity of symptoms. They will be randomly assigned to a therapeutic or placebo group and will receive the medicine in an unmarked box. The drug will be taken for two months at a dose of 1200 mg per day. After that, they will come for a check-up and re-complete OHIP-14 and record the intensity of symptoms according to the VAS scale.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of burning mouth syndrome

Exclusion Criteria:

* pregnancy, breastfeeding or pregnancy planning
* anamnestic data about active gastric or duodenal ulcer
* decreased levels of serum iron or B vitamins
Safety and Feasibility Study of Autologous Bone Marrow Cell Transplantation in Patients With Peripheral Arterial Occlusive Disease (PAOD)

Patients with peripheral artery disease, stage III or IV who are not candidates for interventional or operative therapy should be treated with intraarterial progenitor cell therapy (autologous bone marrow cells) in a randomized, placebo controlled trial.

Main goal:

Improvement of limb perfusion (Ankle brachial index).

Secondary aims:

Reduction of pain Reduction of Ulcer size Walking distance Improvement in tissue oxygenation (TCO2) Minor or major amputation

Eligibility Criteria:
Inclusion Criteria:

* Patients with PAOD (Stage III or IV)
* Distal arterial occlusions
* Patients with Buergers Disease
* Signed informed consent

Exclusion Criteria:

* Successful bypass operation or intervention within the last 3 months
* Active infection, feber, chronic inflammatory disease
* HIV, Hepatitis
* Tumor within the last 5 years, complete remission required
* Stroke or myocardial infarction within last 3 months
* Renal insufficiency (creatinine \> 2 mg/dl)
* Liver disease (GOT \> 2x upper limit oder spontaneous INR \> 1,5).
* Anemia (hemoglobin \< \<10 mg/dl)
* Thrombocytopenia \< 100.000/µl
* Allergies to Aspirin, Clopidogrel, Heparin
* Bleeding disorder
* Gastrointestinal bleeding within last 3 months
* Surgery or trauma within the last 2 months
* Pregnancy
* Mental retardation
* Inclusion in other clinical study within last 30 days
Prophylactic Mesh Implantation in Patients With Peritonitis for the Prevention of Incisional Hernia

In patients undergoing laparotomy, the incidence of abdominal wall related complications such as incisional hernia is very high. In particular in patients with peritonitis undergoing laparotomy the incidence of incisional hernia is up to 54.3%. Furthermore, these patients are at great risk for development of postoperative fascial dehiscence.

The gold standard of abdominal wall closure is a running slowly absorbable suture irrespective of the presence of peritonitis. Implantation of an intraperitoneal mesh potentially reduces the incidence of incisional hernia.

In a series of high risk patients in which we implanted non-absorbable intraperitoneal mesh prophylactically we reduced the incidence of incisional hernia down to 3.2%.

Background

Incisional hernia is a common complication in visceral surgery and varies between 11 and 26% in the general surgical population \[1,2\]. An incisional hernia is defined as any abdominal wall gap with or without a bulge in the area of postoperative scar perceptible or palpable by clinical examination or imaging \[3\]. Overall incidence of incisional hernia at our institution with a follow-up of five years was 14%, whereas in patients undergoing liver transplantation we found an incidence of incisional hernia of 25% in a prospective study \[2\]. However, patients with peritonitis are at very high risk for the development of incisional hernia. Moussavian et al demonstrated an incidence of incisional hernia of 54.3% after a median follow-up of 6 years in patients undergoing emergency surgery for secondary peritonitis \[4\]. In patients undergoing surgical therapy for secondary peritonitis, redo surgery because of complications associated with the abdominal wall, such as fascial dehiscence and surgical site infection are frequent. Impaired wound healing in response to the systemic inflammatory response and the high incidence of surgical site infection might render the abdominal wall even more susceptible for incisional hernia, compared with the general surgical population \[5,6\]. Furthermore, patients with peritonitis undergoing emergency laparotomy develop fascial dehiscence in up to 24.1% \[7\]. Fascial dehiscence requires reoperation and is associated with a mortality rate up to 44% \[8\].

Objective

To compare prophylactic mesh implantation to conventional abdominal wall closure in patients undergoing emergency laparotomy for peritonitis.

Methods

Implantation of a non-resorbable intraperitoneal mesh in patients with peritonitis undergoing emergency laparotomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical signs of peritonitis
* Emergency laparotomy or laparoscopy with conversion to laparotomy
* Patients \> 18 years
* Written informed consent

Exclusion Criteria

* Previous implanted mesh
* Incisional hernia present
* Small bowel obstruction without bowel resection
* Surgery for cholecystitis
* Inflammatory bowel disease (Crohn's disease, Ulcerative colitis)
* Polytrauma patients
* Pregnant women
* Women younger than 45 years