cyrilzakka/clinical-trials huggingface dataset:
IMRT Tomotherapy for Esophagus Cancer

Concurrent chemotherapy and radiation therapy are the standard of care for inoperable patients with esophagus cancer. Unfortunately, the 5-year survival of 20% for this population is quite low. Methods to intensify radiation therapy delivery without increasing local toxicities are needed. Intensity modulated radiation therapy (IMRT) is an advanced method of delivering external beam radiation that may minimize the volume of normal tissue irradiated to high dose and thus decrease the risk of normal tissue toxicity. The proposed study will prospectively test whether IMRT is tolerable for delivering IMRT doses of 60 Gy for patients with esophagus cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18
* Karnofsky Performance Status of \>= 60
* TNM Stages T1-4, N0-3, M0
* Pathologic confirmation of esophagus cancer
* Evaluation by medical oncologist determines that the patient is medically fit for concurrent chemotherapy
* Evaluation by surgeon determines that patient is unresectable

Exclusion Criteria:

* Age \< 18
* Karnofsky Performance Status \< 60
* Radiographic or pathologic evidence of distant metastatic disease (classified as M1b in AJCC staging manual)
* Prior radiation therapy to the thorax or upper abdomen, preventing definitive radiation therapy.
* Pregnant or lactating, if female.
The Possible Association Between Pseudoexfoliation Syndrome And Corneal Endothelial Cell Changes

The study aims to compare the endothelial cell count in patients with pseudoexfoliation syndrome to the the endothelial cell count in normal patients above the age of 50.

Pseudoexfoliation syndrome is a systemic, age related condition, characterized by the deposition of a basement membrane like material within the anterior segment of the eye, most notably on the anterior lens capsule, the iris, the anterior chamber angle, and the anterior vitreous. Both genetic and environmental factors may play a role in its pathogenesis . This condition may present unilaterally or bilaterally and is known to be a major risk factor for secondary open angle glaucoma. Pseudoexfoliation glaucoma is seen in up to 50% of eyes with pseudoexfoliation. In contrast to primary open angel glaucoma, this disease runs a more aggressive clinical course with high intraocular pressure at onset, fast rate of progression, poor the response to medical therapy is, as well as increased need for surgical intervention.

The prevalence of pseudoexfoliation syndrome demonstrates considerable geographic, ethnic and racial variation, ranging from low rates (\< 6% in patients older than 70 years) to higher rates (more than 15%) in other regions. In Egypt, the reported incidence of pseudo-exfoliation syndrome in the population older than 40 years of age is 4.14%.

Several studies have shown the influence of pseudoexfoliation syndrome on the corneal endothelium cell density (ECD). Multiple studies showed decreased ECDs of patients with pseudoexfoliation syndrome compared to control patients. However, since the pseudoexfoliation syndrome varies greatly between different populations, in terms of prevalence and progression, it is valuable to study the potential corneal endothelial cell changes in an Egyptian population.

Factors that can change corneal density include Age, race, history of intraocular surgery, use of contact lenses and endothelial dystrophies. That's why in this study, history of intraocular surgery, corneal endothelial dystrophies and contact lens use are among exclusion criteria and includes patients 50 years in age or older.A low endothelial cell count may be a risk in cataract surgery if needed.

Eligibility Criteria:
Inclusion Criteria:

- Pesudoexfoliation Egyptian patients and controls groups must be at least 50 years old and matched from age.

Controls will be selected from the same outpatient clinic.

Exclusion Criteria:

* Patients with history of previous intraocular surgeries, wearing contact lens and endothelial dystrophies.
A Study to Evaluate Lower Extremity Sleeve and Pump Device to Treat Hemiparesis

The primary purpose of this study is to establish that application of a Sequential Compression Device (SCD) and lower extremity (LE) sleeve applied to a hemi-paretic upper extremity is safe.

Studies has shown that passively stimulating the arm with vibration can improve sensory and motor recovery and movement. Researchers want to expand on this with a more advanced stimulation but in a device that is already routinely used. The SCD is normally used to prevent blood clots. It uses pressure to keep blood moving in the leg. It is routinely used in hospitals across the country. While it does this it warms and even vibrates the leg giving many types of stimulation to the limb and to the brain. This stimulation may help improve recovery further, at marginal cost, while possibly reducing the chances of blood clots in an immobile limb.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to Mayo Clinic/Jacksonville, post-stroke with a hemiparetic upper extremity.
* Able to provide consent of participation by self-agreement.
* Patients with a hemiparetic upper extremity will be determined using the NIH Motor Arm subsection from the NIH scale and score a 1-4.
* Patients who have received thrombolytic therapeutic medicine \> 13 hours (per site specific policy) will not be excluded from inclusion in this study.
* Patients who score \> 13 on the BIMS to ensure intact cognition.

Exclusion Criteria:

* Inability to provide consent of participation.
* Subjects with aphasia or the inability to effectively communicate their pain consistently.
* Questionable reliability scoring \< 13 on the BIMS, has an existing invasive line (PICC line, IV, AV fistula or AV graft); recent surgery or vein ligation in the involved extremity.
* Recent skin graft in the involved extremity.
* Confirmed DVT in the affected.
* Upper extremity including axillary or subclavian veins; open or active wounds or infection in the involved extremity.
* Upper extremity ischemia, gangrene, cellulitis or severe arteriosclerosis in the affected upper extremity.
* Status-post axillary lymph node dissection on the involved side; congestive heart failure (CHF) acute exacerbation; acute edema of unknown etiology in the involved upper extremity.
* Subjects with extreme deformity of the affected upper extremity.
* Subjects with an acute kidney injury.
* Subjects who are hemodynamically unstable 1,7,17.
* Patients who have received thrombolytic therapeutic medicine administered \< 13 hours (per site specific policy) prior to application of SCD sleeve.
Choroidal Thickness Vitrectomy

The purpose of this study is to assess the influence of vitrectomy on changes in central choroidea and comparing the results in imaging of the choroidea with two different OCT devices.

This is a prospective, open, non-randomized, observational, MPG study This study will be performed at the Department of Ophthalmology, Medical University of Vienna.

40 Patients who undergo vitrectomy will be included into this study. The investigation will help to gain new information about the effects of vitrectomy on the choroid.

Since the development of new OCT modalities, like enhanced depth or swept-source OCT imaging, a better visualization and evaluation of retinal structures and the choroidea became possible. 23G Vitrectomy and membrane peeling seem to have an influence on posterior segment structures of the eye but data show no clear evidence evaluating those changes after surgery. Only little information is currently available on the influence or the changes resulting from vitreous surgery on the central choroidea. Hence, the aim of this study is to evaluate those influences resulting on choroidea using two different OCT devices.

To assess the influence of vitrectomy on changes in central choroidea and comparing the results in imaging of the choroidea with two different OCT devices.

This is a prospective, open, non-randomized, observational, MPG study This study will be performed at the Department of Ophthalmology, Medical University of Vienna.

40 Patients who undergo vitrectomy will be included into this study. The investigation will help to gain new information about the effects of vitrectomy on the choroid.

The measuring procedures used in this study are well tolerated and used in routine clinical practice and are non-invasive.

Eligibility Criteria:
Inclusion Criteria:

* Patients with epiretinal membrane scheduled to undergo vitrectomy without endotamponade
* Male or female, at least 18 years of age
* Written informed consent has been obtained
* Visual acuity ≥0.4

Exclusion Criteria:

* Any abnormalities preventing reliable measurements as judged by the investigator
* Participation in a clinical trial in the 3 weeks preceding the study
Mesenchymal Stem Cell in Patients With Acute Severe Respiratory Failure

Although the advent of advanced medical support for respiratory failure, the mortality rate of acute severe respiratory failure is still high and the life quality is frequently compromised from pulmonary fibrosis.

The investigators hypothesize that the treatment using mesenchymal stem cell can be beneficial in patients with respiratory failure. The present study is a pilot study evaluating the efficacy and safety of mesenchymal stem cell treatment in patients with respiratory failure.

Although the advent of advanced medical support for respiratory failure, the mortality rate of acute severe respiratory failure is still reported to be more than 40%. The respiratory distress syndrome may develop in all ages resulting in progressive pulmonary fibrosis. A number of survivors from respiratory failure suffer from the sequelas of pulmonary fibrosis.

However, the treatments of respiratory failure are limited to the correction of baseline disease, cardiopulmonary support, and conservative management to minimize the lung injury. There has not been any effective and specific treatment for respirator distress nor medicine to reduce mortality.

There have been reports of mesenchymal stem cell experimental animals with chronic obstructive pulmonary disease, interstitial lung disease, and sepsis. In addition, the mesenchymal stem cell treatment showed beneficial effect in bleomycin endotoxin induced lung injury.

Authors hypothesize that the mesenchymal stem cell treatment in patients with respiratory failure will show efficacy. We would conduct the present pilot study to evaluate the efficacy and safety in patients with respiratory failure and intend to suggest an additional alternative treatment option for those without additional treatment option.

Eligibility Criteria:
Inclusion Criteria:

* Ventilator care from respiratory failure
* Ventilator care for 7 or more days
* at least one of the followings

  1. PaO2/FiO2 = 200 or less when PEEP 5 cmH2O or more.
  2. PaCO2 = 50 mmHg or more when plateau pressure of 30 cmH2O or more.
  3. pH = 7.25 or less when plateau pressure of 30 cmH2O or more.
  4. No other treatment option except for lung transplantation and not candidate for recipient (organ failure, comorbid infection, economy,...)
  5. Ventilatory care with weaning failure 3 times or more
  6. Ventilator care requiring 7 days or more from the first self respiration to weaning of ventilator.

     * PEEP, positive endexpiratory pressure

Exclusion Criteria:

* Severe aplastic anemia
* Malignant hematologic disorder or history of stem cell treatment.
* Currently uncontrolled malignancy or history of solid cancer within 2 years
* HIV Infection
* Expected life \< 3 months from other cause than the respiratory failure
* Pregnancy or breast feeding
* Expected hypersensitivity for study drug
Effects of Diacutaneous Fibrolysis Over Neuromuscular Response

The study consists in evaluating the neuromuscular response of the gastrocnemious muscles before and after a diacutaneous fibrolysis over the gastrocnemious muscles.


Eligibility Criteria:
Exclusion Criteria:

* Muscle injury in the last two months
* To not understand the study orders
* Suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol
COVID-19 Epidemic and Patients With Myeloproliferative Neoplasias

The classic myeloproliferative neoplasias (MNP), including polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF) or secondary to PV or ET, are among the most frequent of malignant hemopathies, with overall prevalence estimated at around 10,000 patients followed in France. Due to the median age of patients around 65, the frequency of cardiovascular complications of these thrombogenic diseases and the impact of cytoreductive treatments on immune cells, these patients are considered to be at risk of developing forms severe of COVID-19. This study will assess the impact of MNPs on the risk of developing a severe form of COVID-19, identify new risk factors linked to the disease as well as the impact of treatments for MNPs according to their pharmacological class.

It is a descriptive, prospective epidemiological study using retrospective patient data, multicenter, non-interventional, carried out in FIM (French Intergroup of Myeloproliferative syndromes) / FILO (French Innovative Leukemia Organization) centers.

This is an exploratory descriptive study in order to put in place as soon as possible a possible strategy for the protection of patients most at risk.

The study will include all consecutive patients with MNP according to the WHO (World Health Organization) classification seen in consultation or teleconsultation over the duration of the study, whether or not they have had a COVID-19 infection.

The collection of clinical data, treatment regimens and survival and death data will be carried out by the investigator or a member of his medical team, after delivering an information note to the patient informing him of the computerized processing of his data, subject to the patient's non-objection.

The diagnosis of asymptomatic COVID 19 will be made on the presence of a positive serology and on the absence of clinical signs on questioning.

The presence of a symptomatic COVID 19 infection will be posed on the presence of clinical signs +/- CT as identified by the practitioner who treated the patient and confirmed or not by a positive PCR and / or a positive serology.

Data collected:

* Socio-demographic data (gender, date of birth)
* Description of hemopathy and its treatment
* Description of COVID-19 infection and its management
* Biological data: blood count, specific COVID-19 test results if available (PCR, serology).
* History, comorbidities
* Evolution of COVID-19 infection and possible specific treatment

Eligibility Criteria:
Inclusion Criteria:

* Patient with PV, ET, PMF or MF secondary to PV or ET diagnosed before the COVID-19 pandemic
* Seen in consultation or teleconsultation from May 2020 or deceased if the investigator became aware of this death during the study period

Exclusion Criteria:

* Refusal to participate in the study
Effect of Folic Acid, Vitamin B6 and Vitamin B12 in Diabetic Retinopathy

Homocysteine, a well-known inducer of vascular endothelial cell damage has been associated with extracellular matrix changes. Many studies demonstrated that high levels of this aminoacid in diabetic patients increases significantly the risk of the development of this pathology. This study has been undertaken to investigate the role of homocysteine and its cofactors (folic acid, vitamin B6 and B12) during the progression of the diabetic retinopathy.


Eligibility Criteria:
Inclusion Criteria:

* diabetic patients with proliferative and non proliferative retinopathy

Exclusion Criteria:

* Patients with chronic liver disease Patients with kidney disease.
Use of High-Frequency Jet Ventilation During Percutaneous Tracheostomy

Percutaneous tracheostomy is the mouth opening of the tracheal ostium to the skin by creating an opening in the anterior wall of the trachea using Seldinger methods. This procedure is done using an endotracheal tube (ETT) or a laryngeal mask (LMA). High-frequency jet ventilation (HFJV) commonly used in oropharyngeal surgeries and creates an extra passage for the procedure. The investigators aimed to demonstrate the effective use of HFJV in percutaneous tracheostomy.

Seventy five patients between 18-80 years of age who were hospitalized in intensive care unit were included in the study. The number of patients will be finalized by power analysis. whose written consent cannot be obtained and who undergo surgical tracheostomy for any reason will be excluded from the study. In addition, patients with active infection in the area of the procedure, bleeding diathesis and pathologies that interfere with the procedure in the ultrasonographic evaluation (thyroid diseases, etc.) will be excluded from the study. Patients will be divided into three groups as those using classical ventilation (group 1), HFJV (group 2) and classical laryngeal mask (group 3). Age, gender, height, BMI, ASA scores, presence and type of additional diseases, tracheostomy day, pre- and post-procedure blood gas analysis, duration of procedure, duration of anesthesia, complications during the procedure (bleeding , desaturation, accidental extubation, malposition, bradycardia, hypotension, etc.) will be recorded. Patients will be observed for mortality in the first 30 days after the procedure. Mortality results will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* percutaneous tracheostomy procedure

Exclusion Criteria:

* whose written consent cannot be obtained
* who undergo surgical tracheostomy for any reason
* patients with active infection in the area of the procedure,
* bleeding diathesis
* pathologies that interfere with the procedure in the ultrasonographic evaluation (thyroid diseases, etc.)
Use of the BrainPort® Balance Device to Improve Balance in Adults With Balance Deficits Due to Stroke

The purpose of this study is to evaluate the safety and efficacy of the BrainPort balance device in improving balance in people with balance deficits due to stroke.

Following baseline assessments, subjects participate in 5 consecutive days (10 hours) of clinic training with the BrainPort balance device with a Physical Therapist. Assessments are repeated at the end of clinic training. Following clinic training, subjects take the device home to use for two (2) 20 minute training sessions each day. Subjects return to the clinic for one (1) day of testing after using the device at home for 7 weeks.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old.
* Diagnosis of stroke for at least 6 months.
* Reached a plateau and been discharged from physical therapy.
* Able to ambulate with or without assistance.
* Ongoing balance problem.
* Able to read and understand the informed consent form, and willing to sign the informed consent form.

Exclusion Criteria:

* Current oral health problems as determined by health questionnaire and an examination of the oral cavity.
* Any medical condition that would interfere with performance on the assessments.
* History of seizures.
* Pregnancy.
* Cognitive deficits (Mini-Mental 25 or below), joint replacements, cervical vertigo, or major neurologic disease, major depression or disabling psychiatric disorder.
* Known neuropathies of tongue or skin tactile system.
* Prior exposure to BrainPort® balance device.
* Subjects who are unwilling or unable to adhere to all study requirements, including completion of the training period, evaluation tests, and return to clinic for a follow-up visit.
* Subjects who have undergone middle ear or other surgery with sacrifice or damage to the chorda tympani nerve, lingual nerve, or hypoglossal nerve.
Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs

This study is to assess the value of incorporating a malaria RDT based strategy in HMM. The primary activity of the study wil be a two armed cluster randomised trial in two study sites in Uganda, one in Ghana and one in Burkina Faso. One of the Uganda sites is highly endemic and the other meso-endemic for malaria. In one arm the children will be treated presumptively for malaria with ACT (control arm) and the other arm the children will receive ACT only when they have a positive RDT result (implementation arm). The children in the implementation arm will also receive antibiotics if they have a raised respiratory rate. The primary outcome will be the recovery rate in the intervention arm compared to that of the control arm on Day 3. In addition, an acceptability assessment of RDTs in the community will be undertaken both before and after the intervention trial and a cost-effectiveness analysis of the RDT strategy will also be completed. For a sub-sample, microscopy slides will also be taken on Day 0 to demonstrate comparable levels of endemicity in control and intervention groups. These activities will be carried out over a two year period.

This is an open, cluster randomised multicentre two arm trial in the three countries of Burkina Faso, Ghana and Uganda. Clusters are villages (catchment populations) of individual community health workers (CHWs). Within the study areas, clusters that are more than 5 km from a designate health facility where CHWs referred cases for special care will be excluded. A cluster randomized design was chosen over an individually randomized design to reduce contamination, facilitate supervision, reduce costs, and to ensure that the CHWs maintained the correct treatments based on the tests in the Intervention arm and the presumptive treatment in the Control arm.

Eligibility Criteria:
Inclusion Criteria:

* Children between 4-59 months of age with a history of fever in the last 24 hours presenting to the community medicine distributor

Exclusion Criteria:

* Children classified as having severe illness according to IMCI guidelines. Children suffering from Chronic disease(s), those with reported anti malarial or antibiotic treatment (intervention) arm in previous two weeks and those whose caregivers refuse to consent to participate
The Use of Transcranial Ultrasound Treatment of Obsessive-Compulsive Disorder

The primary objective of this study is to determine the safety and efficacy of ultrasound as a treatment for Obsessive Compulsive disorder.

The present study is being undertaken as an open-label study to evaluate the safety and feasibility of focused ultrasound as an intervention for patients with obsessive compulsive disorder (OCD). Participants in this study will undergo 8 consecutive weekly sessions of transcranial low-intensity focused ultrasound (LIFUP) targeting the caudate of the basal ganglia. The safety of this protocol will be closely monitored and data will be used to determine whether any significant safety issues exist when using focused ultrasound for this neurological application. Treatment response will be measured using the Beck Depression \& Anxiety Inventories, the Yale-Brown Obsessive-Compulsive Scale, and the Global Rating of Change Scale.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Obsessive Compulsive Disorder
* Score greater than 15 on the Yale-Brown Obsessive Compulsive Scale (Y- BOCS)
* Failure to remit with 3 SSRIs, antidepressants and/or anxiolytics
* Must be willing to comply with the study protocol
* English Proficiency
* At least 18 years of age

Exclusion Criteria:

* Subjects not English proficient
* Subjects unable to give informed con-sent
* Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
* Pregnancy, women who may become pregnant or are breastfeeding
* Advanced terminal illness
* Any active cancer or chemotherapy
* Any other neoplastic illness or illness characterized by neovascularity
* Macular degeneration
* Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
* Advanced kidney, pulmonary, cardiac or liver failure