cyrilzakka/clinical-trials huggingface dataset:
Individualized Exercise Program for Treatment of Fatigue in Patients After Hematologic Stem Cell Transplant (HSCT)

The purpose of this study is to investigate the impact of fatigue in severely affected transplant patients.

Investigates impact of a monitored program in kinesiology lab at the University of Calgary on fatigue in severely affected transplant patients.

Eligibility Criteria:
Inclusion Criteria:

* Severe fatigue post transplant

Exclusion Criteria:

* Other conditions contributing to fatigue (graft versus host disease)
Correlation of High Resolution Esophageal Manometry With Symptoms

High Resolution Manometry is a new technology that utilizes 36 solid state sensors on a thin catheter spaced at 1-cm intervals. One can more effectively measure the pressure of the esophagus. It includes a sophisticated software to display the pressures data as color topography plot using time, length of the esophagus and pressure within the entire esophagus. It is unclear if this technology improvement actually correlates with patient's symptoms.

In a 2007 retrospective study performed using this technology, 400 subjects referred to the motility lab underwent high resolution manometry (HRM) for complaints of dysphasia, gastroesophageal reflux disease, chest pain and miscellaneous complaints. HRM offered greater detail of individual contracting segments of the esophagus, including the duration of contraction and propagation of individual contractions.

For example, a new subclass of achalasia was defined by HRM. In this classification, achalasia is divided into types 1, 2 and 3. Type 1 corresponds to classic achalasia (complete esophageal motor failure), type 2 is a compression achalasia (simultaneous panesophageal pressurization with aperistalsis), and type 3 is spastic achalasia with aperistalsis (100% spasm). However, it is unclear if this categorization represents a spectrum of disease among patients with achalasia, or it represents distinct subgroups of patients with different symptom presentation and etiology.

This study will attempt to correlate the data from HRM to patient's chief compliants, symptom severity, and clinical presentation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are referred to the motility lab to undergoing esophageal HRM for various clinical indications.

Exclusion Criteria:

* Pregnancy
* Unable to give consent
* Less than 18 years old
* Prisoner
Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients

This is a randomized, open-label, multi-center, phase 2 study of RCHOP with or without VELCADE in adult patients with previously untreated non-(Germinal B-Cell-like) GCB Diffuse Large B-cell Lymphoma (DLBCL). The study will determine whether the addition of VELCADE to RCHOP improves progression-free survival (PFS) in patients with non-GCB DLBCL.

The drug tested in this study is called bortezomib (VELCADE®). VELCADE® was tested in people who have Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma. This study looked at the efficacy of RCHOP \[rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone\] with or without VELCADE®.

The study enrolled 206 patients. Participants were enrolled in one of the two open label treatment groups:

* RCHOP
* Vc-RCHOP \[bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone\]

Participants received treatment for up to six, 21-day cycles.

This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 48 months. Participants made multiple visits to the clinic, and were followed for progression free survival and overall survival until patient withdrawal, death, or 2 years after the last participant was enrolled.

Eligibility Criteria:
Each patient must meet all of the following inclusion criteria to be enrolled in the study:

Inclusion Criteria:

* Patients with previously untreated DLBCL that has been sub classified as the non-GCB subtype.
* At least 1 measurable tumor mass.
* Availability of paraffin block with sufficient tumor tissue.
* No evidence of central nervous system lymphoma.
* Eastern Cooperative Oncology Group (ECOG) performance status of \< or equal to 2.
* Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.
* Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse.

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

Exclusion Criteria:

* Diagnosed or treated for a malignancy other than DLBCL within 2 years of first dose or evidence of active malignancy other than DLBCL.
* Peripheral neuropathy of Grade 2 or greater.
* Known history of human immunodeficiency virus (HIV) infection, unless receiving highly active antiretroviral therapy (HAART).
* Active infection requiring systemic therapy.
* Major surgery within 2 weeks before first dose.
* Patients with a left ventricular ejection fraction (LVEF) or less than 45%.
* Myocardial infarction with 6 months of enrollment or evidence of current uncontrolled cardiovascular conditions as described in the protocol.
* History of allergic reaction/ hypersensitivity attributable to boron, mannitol, polysorbate 80 or sodium citrate dehydrate, or anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab.
Small Incision Technique Versus Upper Blepharoplasty in Upper Eyelid Medial Pad Fat Removal

Medial upper eyelid pad of fat bulge is a common problem. Small incision surgery could be a time-efficient, minimally invasive and scar formation procedure .

Traditional upper eyelid blepharoplasty: an entire length upper eyelid crease followed by proper dissection are applied . identification and removal of medial pad of fat.

Small Incision technique: 4 mm medial upper eyelid small incision followed by proper dissection to gain direct access to the medial fat pad removal

Eligibility Criteria:
Inclusion Criteria:

* upper eyelid medial pad of fat bulge

Exclusion Criteria:

Other eyelid diseases and previous eyelid surgery
Validating the MATADOC Against Best Practice Standard External Reference Standard

The purpose of this project is to further develop a standardized music-based measure used in music therapy with adults who have emerged from coma following profound brain injury, but are not able to demonstrate responsiveness to their environment due to complex clinical needs. Building on previous work, the project aims to strengthen the psychometric properties (e.g. concurrent validity, responsiveness) of the measure for its use with adults with profound brain damage.

Adult patients with prolonged disorders of consciousness (PDOC), but who have not been diagnosed as Minimally Conscious or Vegetative State, will be recruited. All participants will be assessed using the Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC) standardized protocol. Assessment intervention will take place in four individual clinical contacts, over a 16 day period. Data will be collected using the MATADOC rating form and scored according to the MATADOC manual. Participants will concurrently be assessed with Coma Recovery Scale-Revised (CRS-R).

The MATADOC is implemented by Music Therapists who have been trained in its use and who are experienced in working with adults with PDOC. CRS-R data will be collected by members of the treatment team who are experienced or trained in its use. MATADOC and CRS-R assessors will remain blinded to the data collected.

Analysis will compare diagnostic outcomes of the two measures as well as explore the function of comparable items of each measure across similar domains (e.g. auditory, visual).

Eligibility Criteria:
Inclusion Criteria:

* Medically stable patients (i.e. not currently suspected of or under investigation for infection)who have a prolonged disorder of consciousness i.e. has persisted for longer than 4 weeks
* Between the ages of 18 and 70 years of age
* A diagnosis of awareness (i.e., VS, MCS or emergent) is not confirmed or is under investigation
* Fluent in English language comprehension as reported by the family

Exclusion Criteria:

* Known pre-morbid hearing impairments
* The patient has a previous diagnosis of musicogenic epilepsy
* The patient had previously refused music therapy intervention
* Patients with a suspected diagnosis of locked-in syndrome
* Non-fluent in English comprehension as reported by family.
Calibr-Ì: Comparative Evaluation of Phantomless Calibration Methods to Quantify Bone Mineral Density for Opportunistic Analysis of CT Scans

Osteoporosis is a systemic disease characterized by a reduction in bone mineral density (BMD) and qualitative alteration of the skeleton, resulting in increased bone fragility and fracture risk. The epidemiological impact of osteoporosis is extremely high. Proper diagnosis and clinical management of osteoporosis are critical to reducing the incidence of fragility fractures and preventing their complications. The diagnosis is generally confirmed by instrumental analysis of bone mineral density. The standard method is X-ray bone densitometry (DXA), which allows diagnosis based on criteria defined by the World Health Organization (WHO) by virtue of the T-score. DXA is a relatively quick and inexpensive examination with low exposure to ionizing radiation. However, this method has limitations in detecting fracture risk, and in addition, not all patients are properly referred for DXA services, which, among other things, require specific criteria to be reimbursed by the National Health System. Currently, computed tomography (CT) scanning is the most widely used three-dimensional diagnostic modality in clinical practice, and the number of investigations performed in high-income countries is continuously growing. Quantitative assessment of bone mineral density by CT is possible by proper calibration of the machine for the purpose of converting the CT numbers (or Hounsfield units) measured by the scanner into BMD units.


Eligibility Criteria:
Inclusion Criteria:

* Both sexes.
* All ethnicities.
* Age equal or above 18 years.
* Any clinical indication (no specific pathology is required) for a CT scan of the lumbosacral spine or abdomen in which the entire lumbar spine (L1 to L5), paravertebral muscles, abdominal aorta, and subcutaneous adipose tissue are visible.
* Ability to give informed consent.

Exclusion Criteria:

* General contraindications to CT examination, including pregnancy or body weight/size exceeding scanner limits.
* Severe degenerative manifestations of the lumbosacral spine.
* Severe scoliosis of the lumbosacral spine.
* Surgical hardware that prevents adequate CT scanning.
* Oncologic pathology in progress or in recent history.
* Any other situation deemed incompatible with the study by the designated physician or investigator.
Simvastatin to Prevent SCI-Induced Bone Loss

This is a double blind, randomized, placebo -controlled clinical trial with the primary goal of determining the osteogenic benefits of simvastatin in acute SCI.

Investigators will test if a 1- year course of simvastatin (40 mg daily) will prevent bone loss compared to placebo in the first year following SCI.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years of age
* acute SCI (AIS A-C) who are enrolled at our center in an ongoing surveillance study.
* use a wheelchair as their primary mobility mode
* reside in the greater Denver metropolitan area
* within 3 months of injury
* medically stable
* able to follow directions
* provide informed consent.

Exclusion Criteria:

- have any simvastatin contraindications including:

* drug allergy,
* active liver disease,
* renal dysfunction,
* concurrent use of drugs that cause myopathy or increase the risk of myopathy with simvastatin therapy (gemfibrozil, niacin, cyclosporine, danazol, amiodarone, dronedarone, ranolazine, calcium channel blockers, colchicine), strong CYP34A inhibitors (itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, cobicistat-containing products), low plasma cholesterol levels,
* uncontrolled or poorly controlled diabetes,
* unstable anti-coagulation treatment,
* taking a statin in the preceding 12 months,
* metabolic bone disease, thyroid disorder,
* history of bilateral oophorectomy,
* current use of medications potentially affecting bone health including bisphosphonates, androgenic steroids, estrogenic steroids, anti-epileptics, lithium glucocorticoid use for more than 3 months,
* have received inhaled glucocorticoids in the past 12 months,
* pregnant or lactating women,
* women of childbearing potential who are unwilling or unable to use a reliable form of contraception.
Lido Workset Study

This is a single-site, pilot study. In this study, we hope to learn if the Lido Workset is a sensitive measure of limb spasticity in patients with Multiple Sclerosis (MS). The Lido Workset is a FDA approved, non-invasive device which has been used to assess motor function and spasticity. The testing will take approximately 25 minutes. Subjects will lie down on a table and have a leg attached to the Lido Workset device arm. The Lido Workset will move the leg back and forth many times at different speeds. The Lido Workset will also analyze resistance to passive (while subject is not moving or resisting movement) movement of the wrist and knee.

The information gathered from testing individuals with spasticity due to multiple sclerosis with the Lido Workset has been important in making adjustments to the Lido Workset to show a greater degree of sensitivity in assessing varying degrees of spasticity.

Healthy control subjects will be used to compare the spasticity data of multiple sclerosis subjects with subjects with normal muscle tone to determine the sensitivity of the Lido measurements.

The testing will be performed one time for each patient and will take approximately 25 minutes. The servo-controlled torque motor system will analyze resistance to passive movement of the knee. This testing may be repeated for a group of randomly selected subjects from both the MS subjects and control subjects. The testing for this subset of subjects will be done as follows: first session, second session one week after the first session, third session three weeks after the first session. The total length of time for participation in this study may be up to three weeks. This additional testing will be done in order to compare the results with the Lido data obtained at similar timepoints from the subjects enrolled in the Cannabis for Spasticity in MS study. Each subject will be given the option to participate in the extended testing or to decline.

Eligibility Criteria:
Inclusion Criteria:

* Must have a diagnosis of multiple sclerosis and
* Must have some degree of spasticity or
* Must be a healthy control subject
* Ability to give informed consent

Exclusion Criteria:

* Patients with any life-threatening or unstable clinically significant disease
* Patients with other causes of reduced range of motion of the knee or wrist
Evaluation of Proper Radiofrequency Catheter Ablation Strategy for the Patients Who Were Changed to Paroxysmal Atrial Fibrillation From Persistent Atrial Fibrillation

1. Purpose of the study

1) To compare clinical outcome, procedure time, complication rate of patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation between ablation with conventional pulmonary vein isolation and ablation with conventional pulmonary vein isolation with conventional linear ablation.

2. Scientific evidence of the study

1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality.
2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed.
3. catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy.
4. However, there are no consensus for proper ablation strategy in patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation .
5. additional ablation make extent of myocardial injury and paradoxically increase recurrence rate, thus still controversial.
6. Therefore, we will compare conventional pulmonary vein isolation with additional conventional linear ablation.

3. Methods

1. Treatment of All patients with atrial fibrillation is performed according to the standard treatment guideline of atrial fibrillation.
2. there is no additional blood sampling, imaging study, or any other invasive procedure according to the inclusion of the study.

4. study contents

1) to evaluate superior ablation strategy in patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation

* compare conventional pulmonary vein isolation with additional liner ablation, both strategies are conventional ablation strategies being performed world-wide.


Eligibility Criteria:
Inclusion Criteria:

1) patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation

Exclusion Criteria:

1. patients who do not agree with study inclusion
2. permanent AF refractory to electrical cardioversion
3. AF with valvular disease ≥ grade 2
4. Patients with left atrial diameter greater than 60mm
5. patients with age less than 19
Conventional Fluid Management vs Plethysmographic Variability Index -Based Goal Directed Fluid Management

Plethysmographic variability index is a dynamic method for evaluation of volume status which depends on estimation of respiratory variations in pulse oximeter waveform amplitude. The PVI has been studied in various patient populations and clinical settings, and has been shown to reliably predict fluid responsiveness and guide fluid resuscitation.

conventional fluid management. Fluid replacement is managed according to clinical assessment, heart rate, arterial blood pressure and central venous pressure monitoring. However, clinical studies indicate that changes in ABP cannot be used for the monitoring of stroke volume and cardiac output. Another method is the goal-directed fluid management and it is based on individualized fluid management using static and dynamic parameters.

This study aims to compare the conventional fluid managment and Plethysmographic Variability index based during elective spine surgeries in prone position.

the study hypothesize is: plethysmographic variability index (PVI) based fluid management is more accurate than conventional method in preventing hypovolemia ana hypotension associated with prone position.

The patients will be randomly assigned into two equal groups using computer-generated random numbers with closed envelop, each of which will include 33 patients.

Group conventional: (n=33) patients are in the conventional fluid management group.

Group PVI: (n=33) patients are in the PVI-based goal-directed fluid management group.

Eligibility Criteria:
Inclusion Criteria:

* • Adult patients (18-65 years)

  * ASA I-II
  * Patients scheduled for elective lumbar spine surgeries (e.g.: Lumbar fixation and simple discectomy) under general anaesthesia in prone position.

Exclusion Criteria:

* • Operations which will last for less than 15 minutes. (e.g.: plate and screw adjustment or incomplete terminated surgery)

  * Patients with cardiac morbidities e.g. history of unstable angina, impaired contractility with ejection fraction \< 40%, wall motional abnormalities or tight valvular lesions detected by echocardiography, previous cardiac operations or cardiac catherization with stent.
  * Patients with heart block and arrhythmia (atrial fibrillation and frequent ventricular or supraventricular premature beat).
  * Patient with decompensated respiratory disease (poor functional capacity, generalized wheezes, peripheral O2 saturation \< 90% on room air).
  * Patients with peripheral vascular disease or long-standing DM affecting PVI readings.
  * Complicated surgeries (huge spine tumors, intraoperative vascular or neurological complications and prolonged durations more than 5 hours) or surgeries with massive blood loss (4 units of packed RBCs in 1 hour or replacement of 50% of total blood volume within 3 hours )
  * Pregnancy.
Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

To determinate feasibility, safety and outcome with convalescent plasma in patients with severe COVID-19 penumonia

COVID-19 convalescent plasma will be infused to patients with severe COVID-19 pneumonia to determine feasibility, safety and clinical outcome efficacy by survival at-28 days. Data will be compared with match control arm patients without plasma infusion

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥18, and non-pregnant women
* Severe or critical COVID-19 disease define by one or more of the following: blood oxygen saturation ≤ 94% on supplemental oxygen by nasal cannula at least 3 L/min, non-rebreathing mask (NRO2-mask) or on noninvasive ventilation; and pulmonary infiltrates with \>50% increase within 24 to 48 hours in chest-X-ray or chest CT. Life-threatening disease was defined as one or more of the following: respiratory failure on mechanical ventilation with PaO2 / FiO2 less than 300 mm Hg, septic shock, and/or multiple organ dysfunction.

  * 10 days from the onset of symptoms or ≤ 7 days on mechanical ventilation. -

Exclusion Criteria:

* More than 10 days from symptoms onset or more than 7 days on mechanical ventilation
* Pregnancy
* Contraindication for plasma infusion because anaphylaxis history
* Patients with high risk of circulatory overload
* Limitation of therapeutic efforts
* Refractory shock define by norepinephrine dose more than 1 ug/k/min
* SOFA score more than 15 points at the moment of the protocol inclusion i Coagulopathy with requirements of plasma infusion
Evaluation of Drug Utilization Patterns for Extended Release/Long Acting Opioids and Comparator Products

A drug utilization study will be performed to describe trends in the number of prescriptions and patients for class REMS ER/LA opioids and comparator products.

A drug utilization study will be performed to describe trends in the number of prescriptions and patients for class REMS ER/LA opioids and comparator products.

The specific objectives of the Drug Utilization Study are:

1. To estimate trends by month in the number of prescriptions for a one-year period before, and each month after, the implementation of the REMS
2. To compare average number of prescriptions per 3 month (quarter) period in the 2 years before as compared to the same measure during Implementation and the Active Period
3. To evaluate change by patient characteristics (age group, gender, pay type, prescriber specialty)
4. To compare the trends in prescribing, both number of prescriptions and patients, by prescriber specialty

   These trends and changes over time will be estimated for the following groups of opioids:
   * ER/LA opioids included in the class REMS
   * Comparator products/classes

     * Immediate release (IR) opioids
     * Celecoxib
     * Benzodiazepines
5. To show switches (absolute and rates of switching) from ER/LA opioids to comparator analgesics (IR opioids or celecoxib) with introduction of REMS

Eligibility Criteria:
Inclusion Criteria:

* Subjects filling a prescription for a product of interest during the specified time period will be included.

Exclusion Criteria:

* None