cyrilzakka/clinical-trials huggingface dataset:
The Prophylactic Use of Topical Cyclosporine A 0.05% to Prevent Graft Versus Host Disease Related Dry Eye

The purpose of this study is to determine whether Restasis is an effective treatment for preventing the occurrence and progression of dry eye syndrome in patients who have recently received a bone marrow transplant and are at risk to graft-versus-host disease.

The purpose of this research study is to determine if early treatment using Restasis eye drops can prevent the development or delay the progression of dry eye syndrome in allogeneic bone marrow transplant (BMT) recipients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* At least 18 years of age
* Approved candidate for allogeneic HSCT
* Ability to understand and provide informed consent to participate in this study
* Willingness to follow study instructions and likely to complete all required visits

Exclusion Criteria:

* History of ocular or eyelid surgery
* History of glaucoma or ocular hypertension
* History of herpetic eye disease
* Patient with acne rosacea, blepharitis, or meibomitis, in the opinion of the investigator
* Any ocular disorder or condition (including ocular infection, trauma, and disease) that could possibly interfere with the interpretation of the study results
* Recent (3-month) history of wearing contact lens
* Anticipated contact lens wear during any portion of the study
* Recent (3-month) history of current use of topical steroids or antiglaucoma agents
* Any punctal occlusion within 2 months of the screening visit
* Significant sign or symptoms of dry eye (the definition of "dry eye" used for exclusion criteria is compatible with the recommendations of the NEI/Industry Workshop on Clinical Trials in Dry Eyes (Lemp, 1995) (see Appendix 1and 2))
* History of connective tissue disease or diabetes
* Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study
DAAOI-1 Treatment for Treatment-resistant Schizophrenia

Pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia (particularly clozapine-resistant) is still a difficult clinical issue at present. According to the N-methyl-D-aspartate (NMDA) hypothesis, adjuvant NMDA-enhancing agents may have therapeutic benefit. DAAOI-1, a D-amino acid oxidase (DAAO) inhibitor, is a NMDA-enhancing agents.

The aim of this project is to examine the effectiveness and safety of DAAOI-1 adjuvant treatment for clozapine-resistant refractory schizophrenia patients in a randomized, double-blind, placebo - controlled trial.

Pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia (particularly clozapine-resistant) is still a difficult clinical issue at present. Among schizophrenia patients, around 20-25%are treatment-resistant. According to the N-methyl-D-aspartate (NMDA) hypothesis, many clinical trials on NMDA-enhancing agents were studied. Adjuvant NMDA-enhancing agents, including glycine, D-amino acids (D-serine, D-alanine), and sarcosine (a glycine transporter I inhibitor), revealed beneficial but limited efficacy for positive and negative symptoms. The investigators recently started to study the potential of DAAOI-1, a D-amino acid oxidase (DAAO) inhibitor which can elevate synaptic concentration of D-amino acids.

The aims of this project is to examine the effectiveness and safety of DAAOI-1 adjuvant treatment for clozapine-resistant refractory schizophrenia patients in a randomized, double-blind, placebo - controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Fulfilled the DSM-IV criteria of schizophrenia
* Poor responder of clozapine: a 12-week treatment without satisfactory response: a minimal total score of 70 on the Positive and Negative Syndrome Scale (PANSS) (Kay 1987), and a minimal total score of 40 on the Scale for the Assessment of Negative Symptoms (SANS) (Andreasen 1983).
* Agree to participate in the study and provide informed consent

Exclusion Criteria:

* Meet DSM-IV criteria of other AXIS I disorder, current substance dependence or mental retardation
* Serious medical or neurological illness
* Pregnancy or lactation
* Use of depot antipsychotic in the past 6 months
* Inability to follow protocol.
Caring for Family Caregivers:a Research-action Study

The purpose of this study is to evaluate the effectiveness of the Problem Solving Technique (PST) in reducing symptoms of anxiety and depression among primary caregivers of chronically ill patients.

And also to describe and evaluate the process carried out by nurses when implementing the PST as a useful tool for care for family caregivers.

Background: In Spain, home care for the chronically ill and their family caregivers should be a priority in health and social policies due to the aging of the population and the progressive increase in dependent individuals. In our case, 88% of healthcare within dependency care is provided by the family and only 12% by health professionals. The family requires comprehensive and multidisciplinary ongoing care, in which the primary healthcare nurse plays a leading role. One of the areas involved is home-based nursing and counselling for family caregivers, in order to improve the quality of the care provided and to prevent issues arising that may adversely affect the caregiver's life.

Method: This is a research-action study with a mixed analysis methodology. Quantitative analysis was used to evaluate the effectiveness of the Problem Solving Technique in reducing symptoms of anxiety and depression among family caregivers. The clinical trial involved a control and experimental group and pre-post intervention measurements, using the Goldberg scale of anxiety and depression. The sample consisted of 122 caregivers who presented one of these positive subscales. The technique's application process was evaluated for the qualitative analysis, with a content analysis of the records of 10 nurses performing the experimental intervention.

Eligibility Criteria:
Inclusion Criteria:

Caregivers of chronically ill patients included in the ATDOM programme, who at the time of the intervention had a positive score on the Goldberg scale for anxiety and/or depression.

Exclusion Criteria:

Professional caregivers
Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution

This is a research study of a novel, "breast-dedicated" positron emission tomography (PET) camera with 1 millimeter spatial resolution. The main goal of the study is for the personnel to understand practical and logistical issues with using the camera in the clinic

Primary Objective To obtain initial experience using the novel, breast-dedicated PET camera design in the breast imaging clinic.

Secondary Objectives To understand, given the 10-fold higher sensitivity of this novel camera, how low we can go with administered tracer dose, and, given the \>100-fold better volumetric spatial resolution, understand the achievable image quality.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-confirmed breast cancer measuring ≥ 5 mm on mammogram or ultrasound.
* Prior diagnostic imaging test(s) with another modality such as MRI, CT, or x-ray mammography (or other applicable imaging modalities) within 60 days prior to the study date.
* Documented written informed consent document.

Exclusion Criteria:

* 1. Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.
* Known allergies to FDG
* Pregnant or nursing.
bTAE-HAIC Combined With System Therapy for Intermediate-advanced Huge HCC

This study intends to evaluate the efficacy and safety of blank- microsphere transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (bTAE-HAIC) plus Lenvatinib and Camrelizumab for patients with intermediate-advanced huge hepatocellular carcinoma.

Blank-microsphere transcatheter arterial embolization (bTAE) and hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin are effective and safe for hepatocellular carcinoma. Lenvatinib is non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. Camrelizumab, a programmed cell death protein-1 (PD-1) inhibitor, is effective and tolerable in patients with unresectable hepatocellular carcinoma. No study has evaluated bTAE-HAIC plus Lenvatinib and Camrelizumab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of HCC.
2. Age between 18 and 75 years;
3. The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm;
4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I or type II or limited metastases (≤5).
5. Child-Pugh class A or B;
6. Eastern Cooperative Group performance status (ECOG) score of 0-2;
7. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
8. Prothrombin time ≤18s or international normalized ratio \< 1.7.
9. Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria:

1. Diffuse HCC;
2. Extrahepatic metastasis \>5;
3. Obstructive PVTT involving the main portal vein.
4. Serious medical comorbidities.
5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
6. Known history of HIV
7. History of organ allograft
8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
10. Evidence of bleeding diathesis.
11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance

Neoplasia in Barrett's esophagus could be missed during routine random biopsies. We propose a study using chromoendoscopy with Acetic Acid to increase the yield of biopsies in detecting neoplasia.

Neoplasia in Barrett's esophagus is often focal and can be missed by nontargeted biopsies alone. In recent years, various advanced endoscopic techniques have been utilized, but with varying success rates. Narrow-band imaging, trimodal imaging, spectral imaging and i-scan are technologies that are manufacturer dependent with limited varying success rates and have financial implications. At our institution, narrow band imaging is routinely utilized as a diagnostic tool for detecting Barrett's esophagus. Acetic acid is a commonly available dye that has been used in the detection of neoplasia in Barrett's esophagus.

This study is aimed to prove the effectiveness of acetic acid chromoendoscopy in our Barrett's esophagus surveillance population. The goal is to compare the neoplasia yield of acetic acid chromoendoscopy with that of standardized random biopsy protocol. The sensitivity and specificity for neoplasia detection by these two methods will also be analyzed.

Investigators plan to conduct this prospective randomized study for a period of one and a half years (beginning August 1, 2015, ending February 29, 2016). Based on data from 2014, we anticipate to enroll approximately 185 patients. All gastroenterologists (with privileges at Doctors Hospital at Renaissance) will participate in this study. Patients will be randomized to either acetic acid chromoendoscopy or current standard of care (standardized random biopsy protocol utilizing narrow band imaging). Random biopsies from both protocols and targeted biopsies (if identified) will be obtained and submitted to pathology department. These will be reviewed independently by two pathologists. Any discordant results will be reviewed by an outside expert pathologist. Statistical data analysis will be performed utilizing Datadesk XL software.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and older
* Previous diagnosis of Barrett's esophagus, confirmed by pathology.

Exclusion Criteria:

* Patients diagnosed with any level of dysplasia on previous esophageal biopsies.
* Patients who had esophageal therapy with Halo radiofrequency ablation in the past, or esophagectomy.
* History of allergy to Acetic Acid
* History of esophageal dysplasia or cancer
* Esophageal ulcerations
* Esophageal Candida
* Esophageal Varices
* Patients with active esophagitis
* Patients who cannot provide a valid consent
* Patients who are currently pregnant
TACE-HAIC vs. HAIC for Potentially Resectable HCC

Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world. Hepatic resection or liver transplantation is the radical method to cure the disease. However, due to large tumors, surgical treatment is suitable for early-stage and well-reserved liver function patients. Therefore, in clinical practice, transarterial chemoembolization (TACE) is a preferential and standard treatment of potentially resectable HCC.

EACH trial opened the door to FOLFOX-based system chemotherapy for advanced HCC patients. Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for HCC patients. Several clinical studies showed that HAIC bring better tumor response rate that the conditional TACE. The combination of TACE with HAIC (TACE-HAIC), theoretically can significantly increase the local doses of chemotherapeutic agents in the liver, reduce the viability of HCC cells and increase the hepatectomy rate. However, this hasn't been verified in clinical application. To identify a more effective and safety way for treating potentially resectable HCC patients, this study is designed to compare the safety and efficacy between HAIC and TACE-HAIC for those patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Diagnosed as potentially resectable with consensus by the panel of liver surgeons
* stage BCLC A/B, without extra-hepatic involvement
* No previous anti-HCC treatment
* Eastern Co-operative Group performance status 2 or less
* Liver function: Child's A or B (score \< 7)

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* underlying serve cardiac or renal diseases
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Patients ineligible for hepatic artery embolization
Measuring Cell-Free DNA (cfDNA) Levels in People With Follicular Lymphoma

The researchers are doing this study to measure and test cell-free DNA (cfDNA) in the blood before, during, and after first-line treatment for follicular lymphoma. They will look at whether cfDNA levels are related to a person's response to the usual first-line treatment for follicular lymphoma. Researchers also want to understand how different genetic changes in follicular lymphoma relate to a person's response to the usual first-line treatment.

This is a non-therapeutic protocol aimed to assess the ability of the s cfDNA assay to detect clinical response in FL when compared to conventional approaches for assessing response, such as PET-CT scans.

Study assessments will include: 1) identification of the mutations present in the primary tumor, 2) identification of these mutations in the peripheral blood samples collected before initiation of standard therapy, after 2 cycles of therapy, at the completion of 6-8 cycles of induction therapy, and then every 6 months for a total of 2 years from the initiation of therapy using a cfDNA assay. For patients who receive RT, peripheral blood samples will be collected before initiation of RT, and then 3 months, 6 months, 12 months, 18 months and 24 months post RT using a s cfDNA assay.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age at time of signing informed consent. Consent is permitted from either the participant or from a Legally Authorized Representative (LAR) on their behalf.
* Histology-confirmed follicular lymphoma grade 1-3a, verified by the enrolling institution
* Ability to adhere to the study visit schedule and all the protocol requirements
* Measurable FDG-avid disease
* Not applicable for retrospective patients in CR

Exclusion Criteria:

* Patients receiving second or greater line of therapy (except in retrospective cohort of long-term survivors of FL \[i.e. \>10 years out from frontline treatment\])
Soy Protein in Early Diabetic Nephropathy

Diabetic nephropathy is a frequent cause of end-stage renal disease. Reduction of dietary protein has been used to slow down renal disease progression, but patients are often unwilling to make these dietary changes. Other research suggests that changing the quality of dietary protein may be as effective as reducing the total amount of ingested protein. This study hopes to show that soy protein, a plant protein relatively high in essential amino acids and with high nutritional value, maye be beneficial to Type I diabetic patients with incipient renal disease.


Eligibility Criteria:
Inclusion criteria:

* Age 18-40;
* Diabetic nephropathy;
* Type I diabetes mellitus.
Computed Tomography Enterography (CTE) Versus Capsule Endoscopy for Overt, Obscure Gastrointestinal (GI) Bleeding

Up to 5% of patients with recurrent gastrointestinal (GI) bleeding remain undiagnosed by upper endoscopy and colonoscopy, the presumed source of bleeding in these patients being the small intestine. These patients fall under the category of "obscure gastrointestinal bleeding," and frequently require an extensive diagnostic work-up.

Obscure gastrointestinal bleeding (OGIB) refers to bleeding undiagnosed by upper endoscopy and colonoscopy. In 40-70% of cases of OGIB, a bleeding lesion is localizable to the small bowel. In OGIB, capsule endoscopy (CE) has a diagnostic yield of 40-80%, and has demonstrated diagnostic superiority to push enteroscopy, barium studies, angiography, CT angiography, and routine abdominal CT scan. When CE is non-diagnostic, however, the subsequent diagnostic algorithm is not well-defined. There is currently no established role for cross-sectional imaging for this indication. CT enterography (CTE) combines the spatial and temporal resolution of CT with an orally administered neutral enteric contrast material that permits detailed visualization of the small bowel. Unlike other imaging modalities such as nuclear medicine techniques and catheter angiography, CT is less labor-intensive, more readily available, and provides precise anatomic localization. A novel OGIB-protocol available at Brigham and Women's Hospital for CTE utilizes a dual-phase, dual energy technique that obtains images at two time points to better identify active bleeding in the mesentery. We, the investigators, plan to prospectively study an algorithm that employs CTE and compare to capsule endoscopy to investigate the effectiveness of both modalities and to evaluate the potential role of CTE in OGIB.

The goal of our study is to determine observationally the contribution of both CE and the new protocol for CTE to the evaluation and management of overt obscure GI bleeding and accordingly revise the clinical algorithm.

We hypothesize that CTE will be as or more effective than CE at identifying culprit lesions in overt, obscure gastrointestinal bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with signs and symptoms of "overt, obscure GI bleeding" including hematemesis, melena, and hematochezia within the past 14 days with negative endoscopic evaluation (including upper endoscopy for hematemesis, and both upper and lower endoscopy for hematochezia) despite clinical evidence of GI bleeding.

Exclusion Criteria:

* Known renal insufficiency (or blood Creat \>1.5 or estimated glomerular filtration rate \[eGFR\]\<60)
* Allergy to iodinated intravenous (IV) contrast media
* Swallowing difficulties
* Known small bowel strictures
* Suspected bowel obstruction
* Under the age of 18
* Unable to give consent
* Currently pregnant
Short vs Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization

The primary objective of the trial is to evaluate short versus long duration dual antiplatelet therapy in patients undergoing lower extremity endovascular revascularization.


Eligibility Criteria:
Inclusion Criteria:

1. Provide signed informed consent before initiation of any study related procedures
2. Be at least 18 years of age
3. Successful percutaneous lower extremity (iliac and infrainguinal) endovascular revascularization (percutaneous transluminal angioplasty, and /or stent).
4. At least 1 vessel run-off in segment distal to the intervention
5. Rutherford Classification 2-5 that is unresponsive to medical therapy

Exclusion Criteria:

1. Acute limb ischemia
2. Procedure includes device deployment that has specific FDA regulations for anticoagulation/anti-platelet medication regimen.
3. Patient undergoing atherectomy procedure
4. Intervention includes deployment of drug eluted stent
5. Critical limb ischemia (Rutherford Classification 6)
6. Thrombocytopenia: Platelet count \<50k
7. Liver disease (Childs-Pugh B or C)
8. Existing need for on going clopidogrel therapy
9. Proton Pump Inhibitor Use (If unable to be switched)
10. Need for therapeutic anticoagulation
11. Known hypercoagulable disorder
12. Allergy or contraindication to aspirin or clopidogrel
13. Pregnancy
14. Patients enrolled in another investigational drug or device study within the past 30 days
EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications

The EASYX™ Liquid Embolic is a new injectable, precipitating polymeric agent for the obliteration of vascular spaces through direct puncture or catheter access performed under X-ray guidance. The embolic liquid is an iodinized Polyvinyl Alcohol (PVA) Polymer ether. Iodine groups are covalently grafted to the PVA polymer backbone, whereby a stable nondegradable polymer with the desired features is created. The resulting polymer is dissolved in Dimethyl Sulfoxide (DMSO). EASYX™ is CE-marked since December 2016 and has been used in humans a few time for type II endoleaks, portal vein and varicocele (\<10 cases at the date of submission). The purpose of this study is to evaluate the safety and efficacy of EASYX™ embolization liquid for the percutaneous treatment of vascular lesions, i.e. embolization of varicocele, type II endoleaks, portal vein before surgery, active peripheral bleeding or angiomyolipoma (AML).


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting with indication of varicocele, type II endoleaks, portal vein, AML or active embolization with a liquid agent
* Aged ≥ 18 years
* Affiliated to a French health insurance system

Exclusion Criteria:

* Hypersensitivity to Polyvinyl Alcohol (PVA) Polymer
* Hypersensitivity to DMSO solvent
* Patient unable or unwilling to provide a written informed consent
* Patient participating in another interventional study
* Pregnant or breastfeeding woman
* Prisoners