cyrilzakka/clinical-trials huggingface dataset:
Confocal Microscopy in Barrett's Esophagus

This data review will be done to evaluate the use of confocal microscopy imaging in patients who were seen for clinically indicated endoscopic surveillance and biopsies of Barretts Esophagus

This retrospective chart review will be done to evaluate the use of confocal microscopy imaging in patients who were seen at Mayo Clinic for clinically indicated endoscopic surveillance and biopsies of BE.

Endoscopy reports and pathology results will be reviewed from 100 patients who have undergone endoscopy. These results will be correlated with images obtained with confocal microscopy at the time of the endoscopy. There will be no patient contact.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone confocal microscopy at the time of surveillance endoscopy for Barrett's Esophagus
Horse Chestnut Seed Extract for Lymphedema

To help Treat Lymphedema of the Arm in Breast Cancer Survivors with Horse chestnut Seed Extract

The objectives of this study are to evaluate the effectiveness of escin (as horse chestnut seed extract) for arm lymphedema in women following treatment for breast cancer, to evaluate the accuracy and sensitivity of bioelectric impedance as a measurement of lymphedema of the arm, and to validate the proposed arm lymphedema quality-of-life questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patient demonstrates unilateral (ipsilateral to breast cancer resection side) lymphedema of the upper extremity. An extravascular water ratio of ³1.1/1 between the affected vs normal arm using multiple-frequency bioelectric impedance will be used as a criterion for lymphedema. There is not upper limit to the extent of arm volume (lymphedema)
* Patient is greater than 6 months from last surgical and/or radiation treatment to the affected axilla.

Exclusion Criteria:

* Patients may not be receiving or be scheduled to receive cytotoxic or radiation chemotherapy treatment while on this lymphedema study (Last chemotherapy \> 4 weeks prior). Women who are being treated adjuvantly with tamoxifen, raloxifene, or an aromatase inhibitor remain eligible
* Patients with a history of recurrent (more than 1 episode) arm cellulitis, prior or existing venous clot, or considered to have "woody" fibrosis of the affected arm are not eligible. Antibiotics used to treat any prior episode of cellulitis must have be completed no more recently than 3 months prior to initial screening.
Quality of Anticoagulation With Warfarin in Patient With Atrial Fibrillation for Secondary Stroke Prevention in Korea

The current study aims to assess the quality of anticoagulation with warfarin in real world practice of secondary stroke prevention in Korean patients with Atrial fibrillation (AF) and to explore predictors for poor International Normalized Range (INR) control.

* To assess the quality of anticoagulation with warfarin in real world practice of Korea for secondary stroke prevention in patients with AF-related Cardioembolic (CE) stroke 1) who initiated warfarin therapy and treatment at least for more than 7 days of warfarin adjustment period (warfarin-initiated cohort), and 2) who initiated and maintained warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period (long-term warfarin-treated cohort).
* To explore predictors for poor INR control.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for the warfarin-initiated cohort

1. Admission due to AF-related ischemic stroke
2. Initiation of warfarin therapy and treatment at least for more than 7 days of warfarin adjustment period
3. For TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment

Inclusion criteria for the long-term warfarin-treated cohort

1. Admission due to AF-related ischemic stroke
2. Long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period
3. For TTR calculation, available consecutive INR values ≥3 after the 7 days of warfarin adjustment
4. TTR evaluable days ≥ 90 days

Exclusion Criteria:

1. AF with mechanical valve
2. Enrollment in anticoagulation randomized clinical trial
3. Enrollment in studies affecting the target INR range.
Efficacy and Safety of XEN63 Gel Implant

The study is prospective, observational, multicenter and has the aim of evaluating the efficacy and safety of the XEN63 implant in patients with primary or secondary glaucoma who require surgery in association or not with cataract surgery, for IOP not controlled by medical therapy, disease progression or intolerance to topical therapy, comparing IOP values before and 24 months after implantation.

The study is prospective, observational, multicenter and has the aim of evaluating the efficacy and safety of the XEN63 implant in patients with primary or secondary glaucoma who require surgery in association or not with cataract surgery, for IOP not controlled by medical therapy, disease progression or intolerance to topical therapy, comparing IOP values before and 24 months after implantation. Every patients will be followed for 24 months.

Secondary aims of the study are:

* Evaluating the hypotensive efficacy of the XEN63 12 months after implantation.
* Assessing the safety of the XEN63 device after 12 and 24 months after implantation.
* Comparing the hypotensive efficacy of the XEN63 in glaucomatous patients undergoing the solo procedure and in those undergoing the combo procedure
* Evaluating the quality of life of patients undergoing XEN63 implantation 12 and 24 months after implantation.
* Evaluating the association between factors related to the patient, the surgical technique or post-operative management and the hypotensive efficacy of the device during follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Diagnosis of primary or secondary open-angle glaucoma according to the diagnostic criteria of 4th edition of the European Glaucoma Society Guidelines.
3. Need for XEN63 implantation for IOP not controlled by medical therapy, progression of disease or intolerance to topical therapy, in association or not with cataract surgery.
4. Informed consent freely given and obtained before the start of the study.
5. The participant has the ability to understand and the willingness to follow the study instructions and is likely to complete all required visits and procedures.

Exclusion Criteria:

1. Closed-angle glaucoma
2. Previous trabeculectomy or valve or tube placement.
3. Presence of conjunctival scarring, previous conjunctival surgery or other conjunctival pathologies (e.g. pterygium) in the target quadrant.
4. Signs of active inflammation (e.g. blepharitis, conjunctivitis, keratitis, uveitis)
5. Active iris neovascularization or presence of iris new vessels within 6 months of the date of surgery
6. Anterior chamber lenses
7. Presence of intraocular silicone oil
8. Vitreous in anterior chamber
9. Altered episcleral venous drainage (e.g. Sturge Webwer syndrome, nanophthalmos)
10. Known or suspected allergy or sensitization to medications required for the surgical procedure or some component of the device (e.g. glutaraldehyde or porcine derivatives)
11. History of predisposition to the formation of keloids.
12. Pregnancy or breastfeeding.
Advanced Cognitive Stimulation Therapy (ACST)

This study is a feasibility randomised controlled trial (RCT) for an evidence-based intervention for people with moderate to severe dementia. The psychosocial intervention is adapted from Cognitive Stimulation Therapy (CST) and developed within the Medical Research Council (MRC) framework.

The World Health Organization calls for an increase of psychosocial interventions for dementia-a global epidemic. Cognitive Stimulation Therapy (CST) is the only non-pharmacological therapy recommended by the National Institute for Health and Care Excellence for improving cognition for mild to moderate dementia. However, there is little guidance on how to maximise cognition for severe dementia. Advanced Cognitive Stimulation Therapy (ACST) will be the first evidence-based complex intervention for moderate to severe dementia developed within the Medical Research Council (MRC) framework and building upon CST's key principles. This feasibility randomised controlled trial (RCT) aims to 1) evaluate the feasibility of ACST 2) explore if ACST can improve the cognitive function, and QoL, as well as other outcomes including behaviour, engagement, and communication, for people with moderate to severe dementia. A sample of 32 participants will be recruited, where 16 will be randomly allocated to ACST, and 16 to treatment as usual (TAU). Data will be collected pre and post the 7-week intervention period. Improving cognition and QoL for people with moderate to severe dementia is vital because dementia's prevalence is projected to reach 152 million by 2050, resulting in excessive excess disability.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. Diagnosis of dementia, according to the DSM-IV
3. SMMSE ≤ 12
4. Ability to communicate in English
5. Ability to complete outcome measures
6. Not having major physical illness or disability that affects participation
7. Consultee is willing and able to provide written informed consent if the participant is not able to provide consent.
8. Ability to remain in a group for around an hour (e.g. no challenging behaviour)

Exclusion Criteria:

1. Illness and disability that affects participation (as deemed by the researcher or attending care home staff)
2. SMMSE \< 5
3. Participation in other psychosocial intervention studies
Serum Exosomal Long Noncoding RNAs as Potential Biomarkers for Lung Cancer Diagnosis

The study is to investigate the sensitivity and specificity of serum exosome noncoding RNA as a biomarker for the diagnosis of lung cancer

Conventional tumor markers for non-invasive diagnosis of Lung cancer (LC) exhibit insufficient sensitivity and specificity to facilitate detection of early lung cancer (ELC). The investigators aimed to identify ELC-specific exosomal lncRNA biomarkers that are highly sensitive and stable for the non-invasive diagnosis of ELC.Hence, in the present study, exosomes from the plasma of five healthy individuals and 30 LC patients and from culture media of four human bronchial epithelial cells and four cancer cells were isolated. Exosomal RNA profiling was performed using RNA sequencing to identify LC specific exosomal lncRNAs.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are willing to sign the informed consent form;
* Normal subjects have no evidence of any disease;
* Lung cancer patients are 18 to 75 years old, diagnosed as lung cancer by histopathology or cytopathology

Exclusion Criteria:

* People are unwilling to sign the informed consent form;
* Patients with heart disease, rheumatic disease, allergic disease, COPD, pulmonary fibrosis, diabetes, thyroid disease, liver, kidney, brain disease and hematopoietic system disease;
* Pregnant or lactating women;
* Patients did not cooperate or participate in other clinical trials
Effect of Oatmeal Varieties on Glycemic and Insulinemic Responses in Healthy Individuals

The objectives of this study are to compare the glycemic and insulinemic responses over 3 hours elicited by 3 oatmeal varieties compared to each other and to controls of ready to eat and hot cereals.

Participant eligibility will be screened at visit 1. The study will be a randomized, cross-over design. Participants will come to the study site on 5 separate occasions separated by a 2-day to 2-week washout period. Participants will arrive to the lab in a fasted state. 2 fasting blood samples will be collected, and further blood sampled will be taken over a 3-hour period post study product consumption.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant females, 18-75 years of age, inclusive
* Body mass index (BMI) ≥ 20.0 and \< 35 kg/m² at screening (visit 1).
* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and to refrain from smoking for 12hr prior to each visit.
* Willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit.
* Normal fasting serum glucose (\<7.0mmol/L capillary corresponding to whole blood glucose \<6.3mmol/L).
* Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits.
* Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
* Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.

Exclusion Criteria:

* Failure to meet any one of the inclusion criteria
* Known history of AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders.
* Use of medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or with any condition which might, in the opinion of Dr. Wolever, the president of GI Testing, either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
* Major trauma or surgical event within 3 months of screening.
* Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
* Known intolerance, sensitivity or allergy to any ingredients in the study products.
* Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc).
CHO(E)P-14 Followed by Alemtuzumab Consolidation in Peripheral T Cell Lymphoma

Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation

Peripheral T cell lymphoma patients of all subtypes according to WHO are treated with an induction of 6 cycles of CHOP-etoposide-14 (if below 60 years of age) oder CHOP-14. If at least a PR is reached, consolidation with alemtuzumab, total dose 133 mg, is given i.v.

Eligibility Criteria:
Inclusion Criteria:

* all risk groups in international prognostic index
* diagnosis of aggressive T-cell-lymphoma, confirmed by an excisional biopsy of a lymph node or by sufficiently extensive biopsy of an extranodal involvment, if there is no lymph node involvment.
* these lymphomas comprise: peripheral T-cell lymphoma PTCL-NOS Lennert´s lymphoma T-zone lymphoma angioimmunoblastic T-cell-lymphoma
* Performance status: ECOG (Eastern Cooperative Oncology Group Score) 0-3(Karnofsky index 40-100%)
* written consent of the patient
* Declaration of center participation

Exclusion Criteria:

* Already initiated lymphoma therapy(exept for the prephase treatment specified for this study)
* Serious accompanying disorder or impaired organ function
* bone marrow involvement\>25%
* Known hypersensitivity to medications to be used
* Know HIV-positivity
* Active hepatitis infection, active CMV infection, prior florid tuberculosis
* floride systemic infections
* suspicion that patient compliance will be poor
* Simultaneous participation in any the study protocol
* prior chemo-or radiotherapy for malignancy
* other concomitant malignant disease
* Pregnancy or lactation period
Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy

To evaluate the efficacy of combination therapy with ranibizumab (RBZ) and panretinal photocoagulation (PRP) versus PRP alone in patients with treatment-naive bilateral proliferative diabetic retinopathy (PDR) as measured by mean change in visual acuity (VA), mean change in central retinal thickness (CRT) as measured by time-domain optic coherence tomography (TD-OCT) and incidence of vitreous hemorrhage (VH).

Comparative efficacy of combined treatment including intravitreal injection of 0.5 mg of Lucentis (ranibizumab) and laser photocoagulation for patients with Proliferative Diabetic Retinopathy (PDR).

Objectives:

Primary objective:

The primary objective will be to evaluate the efficacy of combined treatment with ranibizumab and laser photocoagulation versus laser photocoagulation alone in patients with severe PDR by the mean change in BCVA at V7/M6 compared to baseline. The Best Visual Acuity (BCVA) measured by the Early Treatment Diabetic Retinopathy Study (EDTRS).

Secondary objectives:

To evaluate differences in Optic Coherence Tomography (OCT) retinal thickness and total macular volume of combined treatment regiment including intravitreal injection of 0,5 mg of Lucentis (ranibizumab) and laser photocoagulation for patients with PDR at visit 7 compared to the baseline assessments.

To evaluate the percentage of patients that present with vitreous hemorrhage after the beginning of the laser treatment at visit 7 compared to the baseline assessments.

Strategic goal:

The main goal of this study is to evaluate if the use of intravitreal ranibizumab in eyes submitted to Pan-Retinal Photocoagulation (PRP) due to PDR induces less macular edema and less vitreous hemorrhage and therefore leads to a better visual outcome

Eligibility Criteria:
Inclusion Criteria:

* Naive Proliferative diabetic retinopathy eyes.
* Best Corrected-Visual Acuity at baseline \> 20/320 in the study eye
* Patients with and without diabetic macular edema
* Type II diabetic subjects as defined by the World Health Organization aged ≥ 18 years.
* Women must be using effective contraception
* Ability to provide written informed consent.
* Indication of panretinal photocoagulation in both eyes

Exclusion Criteria:

* Vitreous hemorrhage or pre-retinal hemorrhage
* Eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months
* Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
* Cataract
* Any intraocular surgery within 6 months before trial enrollment
* Previous vitrectomy.
* Any of the following underlying systemic diseases:
* History or evidence of severe cardiac disease or previous thrombus-embolic event
Natural History and Risk Factors of TAO

The aim of this study is to complete the identification of genetic factors predisposing to thyroid associated ophthalmopathy (TAO) by constituting a cohort of 400 Grave's patients with or without ocular signs.

Graves' disease (GD) is a common autoimmune condition, and its ocular condition is known as thyroid-associated ophthalmopathy (TAO). There is considerable evidence that both genetic and environmental factors are involved in the development of TAO. We conduct a study of 400 Grave's patients, with or without TAO, and obtain the following data: genetic tests, ocular imaging and life style information. Genetic tests are obtained by collection of blood samples for DNA extraction, whole-genome sequencing, and identification of cellular biomarkers, using transcriptomics and mass cytometry. Ocular imaging data are collected from Orbit MRI examination. Life style data are collected using a standardized questionnaire.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of Grave's disease with the history of more than 1 years
2. Informed consent signed by a patient or legal guardian, or having the ability to comply with study assessments for the full duration of the study

Exclusion Criteria:

1. Pregnancy (positive test) or lactation
2. Participating in another simultaneous medical investigation or clinical trial within 3 months
3. Having received cellular therapy
4. With a history of psychotropic drugs abuse
5. With a history of mental disorder
6. With a history of malignant tumor
7. Any medical or social condition that in the judgment of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent
Percutaneous Cochlear Implantation: Implementation of Technique

The investigators are studying a new way of doing cochlear implant surgery called "Percutaneous Cochlear Implantation". In this surgery, instead of doing a mastoidectomy where about 30ml of bone is removed, the investigators use image-guided technology (similar to GPS systems used to guide automobile travel) to drill directly from the surface of the skull to the cochlea, removing less than 2ml of bone. To use this technique, three markers (or anchor screws) are screwed into the bone around the ear. Next, an x-ray of the head (called a CT scan) is taken. Using this CT scan, a path to the inner ear (cochlea) is planned and a drill guide (Microtable) is made that mounts on the anchor screws. A drill will be attached to the guide and used to drill a path from the surface of the skull to the inner ear (cochlea). The implant electrode will be threaded through this path. All of these procedures take place under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 year old patients undergoing cochlear implantation who are able to participate in the informed consent process.
* Pre-operative CT scan of head performed as standard of care for cochlear implant work-up.

Exclusion Criteria:

* Patients with co-morbidities so severe that the potential additional operating room time is deemed to be too significant of an operative risk. This assessment is made by the local institutions pre-operative work-up.
* History of allergic reaction/intolerance of local anesthesia and/or epinephrine.
* History of allergic reaction to titanium.
* Patients with severe anatomical abnormality of the temporal bone.
* Patients with severe chronic ear disease for whom traditional mastoidectomy might offer benefit.
* Females who are pregnant.
Raltegravir Intensification in HIV-infected Patients

The purpose of this study is to determine whether treatment with Raltegravir further decreases HIV viral replication in HAART-suppressed, HIV-infected patients, potentially improving immune response to antiretroviral therapy.


Eligibility Criteria:
Inclusion Criteria:

* Stable antiretroviral therapy for at least 12 months
* Screening CD4+ T cell count \< 350 cells/mm3
* All available CD4+ T cell counts in the last year and at screening \< 350 cells/mm3
* Screening plasma HIV RNA levels below level of detection (\< 50 copies RNA/mL using Roche Amplicor or \< 75 copies/mL using Bayer bDNA or \< 40 copies/mL using Abbott RT-PCR), and all available determinations in past 12 months also below level of detection (isolated single values \> 75 but \< 1000 copies/mL will be allowed if they were preceded and followed by undetectable viral load determinations).
* \>90% adherence to therapy within the preceding 30 days, as determined by self-report
* Both male and female adult (at least 18 years old) subjects are eligible. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.

Exclusion Criteria:

* Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason
* Serious illness requiring hospitalization or parental antibiotics within preceding 3 months
* \*\*Any vaccination 2 weeks prior to baseline (day 0) visit and throughout the study period
* Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in past 16 weeks
* Concurrent treatment with phenobarbital, phenytoin, or rifampin.
* Screening absolute neutrophil count \<1,000 cells/mm3, platelet count \<70,000 cells/mm3, hemoglobin \< 8 mg/dL, estimated creatinine clearance \<40 mL/minute
* Pregnant or breastfeeding women