cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial to Evaluate the Effect and Safety of MSV in Xerostomy

Phase II not controlled, open-label, prospective, single center clinical trial

* Determine changes in the xerostomia characteristics and discomfort degree by means of questionnaires addressed to the physician and subject of study.
* Determine the volume of submaxilar saliva without stimulation and with stimulation by sialometry (SL).
* Detect changes in volume, vascularization and fibrosis of submaxillary glands based on magnetic resonance imaging (MRI) with contrast.
* Detect changes of submaxillary gland functionalism based on Gammagraphy (GF).

Eligibility Criteria:
Inclusion Criteria:

1. Patients from 18 to 75 years old of both sexes.
2. Biochemical analysis without significant alterations which could contraindicate the treatment.
3. Bilateral radiotherapy of the previous neck due to neoplasia in states T1-T2 and N0, N1 and N2a.
4. 2 years of follow-up without recurrence.
5. Reduction of salivation and hyposalivation, evaluated by an examination, flow rate or whole unstimulated saliva in the range of 0.05- 0.20 ml / min.
6. Grade 1-3 xerostomy as assessed by the grading scale.
7. The patient is able to understand the nature of the study.
8. Written informed consent of the patient

Exclusion Criteria:

1. Participation in another clinical trial in the 3 months prior to his/her inclusion.
2. Present infection (no infectious sign should be evidenced with repercussion on the evolution of the treated lesion).
3. Patients with positive serologies for HIV, lues and hepatitis with positive viral load.
4. History of cancer in the last 2 years. History of teratoma, adenocarcinoma derived from one of the salivary glands, lymphoma of the tonsils or some other lymphatic tissue or melanoma of pigmented cells of the oral mucosa.
5. Xerogenic medication in progress.
6. Other diseases of the salivary glands, for example, Sjögren's syndrome, sialolithiasis, etc.
7. Local infection.
8. Pregnancy or pregnancy planned within the next 2 years.
9. Breastfeeding.
10. Treatment with anticoagulants (not interruptible in MO or application).
11. Any other illness or condition that is grounds for exclusion for the investigator.
Effects Of Lymphatic Drainage on Axillary Web Syndrome

Axillary web syndrome (AWS) is a common condition related to cording in axilla as a result of axillary lymph nodes dissection surgery in breast cancer patients. This condition comprises of 86% population who underwent breast cancer surgery, but this condition is usually under diagnosed. Usually characterized by pain full cording of soft tissue and contractures at axillary region. This study aims to see the effects of manual lymphatic drainage with or without soft tissue mobilization on patients with axillary web syndrome.

It will be a randomized control trial which will be conducted in cancer centers in government sector hospitals. 30 participants will be enrolled by non probability sampling technique through lottery method into two groups, 15 participants in each group. One group will receive manual lymphatic drainage, while other group will receive manual lymphatic drainage in addition to soft tissue mobilization (3-5 treatment sessions per week for 4 weeks). Base line treatment regimen include stretching, range of motion and strengthening exercises. For outcome measures treatment will be assessed on questionnaires including Disabilities of Arm Shoulder and Hand questionnaire (DASH), Numeric Pain Rating scale (NRS), Breast cancer specific QOL questionnaires (EORTC QLQ-C30, EORTC QLQ BR-23), Patient specific Functional Scale (PSFS), Goniometer and Dynamometer.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients with pain over \&gt;3 points, 4 weeks after surgery using
* Numeric Pain Rating scale on upper limb.
* With visible and palpable cords in axilla, arm and breast after surgery.

Exclusion Criteria:

* Acute Thrombosis, Musculoskeletal Disorders,Skin
* Problems: Infections, Osteoarthritis, Rheumatoid Arthritis, Rotator Cuff Syndrome, Adhesive Capsulitis,
* Any other Injury, Trauma and
* Any other Surgery.
Assessing Antibody Responsiveness to Hepatitis B Vaccine in Aged Lymphoma Patients Undergoing Treatment With Rituximab

Background:

The ability of the immune system to function declines with aging. This is reflected by a marked decrease in the responsiveness to vaccinations and to infectious agents. Consequentially, there is a profound reduction in the quality of live and an increased dependency on the health systems. Studies have shown that the production of B lymphocytes in the bone marrow declines with aging and long-lived B cells accumulate in the periphery. Thus, instead of a juvenile repertoire of B cells that is capable to recognize any new pathogen, the repertoire of the elderly becomes more restricted and fails to respond to new antigens.

Working hypothesis and aims: We hypothesize that the dramatic change in the cellular composition in aging reflects homeostasis pressures that are set by long-lived peripheral B cells. Here, the investigators hypothesize that altering the homeostasis, by active depletion of the peripheral B cells, will revive B lymphopoiesis in the BM and rejuvenate the peripheral repertoire of B cells in aging. Consequentially, this will significantly improve immune responsiveness of aged individuals to new antigenic challenges.

Methods:

The investigators propose a parallel study in human and mouse. For our clinical study we will use old lymphoma patients that were treated with the B cell depleting therapy, RITUXIMAB, for transient B cell depletion and established full B cell reconstitution. We will test the responsiveness of these patients to hepatitis B vaccine and compare it to aged-matched control group. The investigators will also use old human CD20 transgenic mice where B cell depletion is imposed by anti human CD20 antibodies. In these experiments we will study physiological and immunological changes to understand aging mechanisms in the B lineage.

Expected results: We expect that old patients treated for B cell depletion will have an increased responsiveness to the hepatitis B vaccine relative to the control group.

Importance:

The investigators propose an efficient approach to improve immune response in the elderly population. This will increase efficacy of vaccination, reduce morbidity and improve quality of life. It will also reduce the cost of medical treatment. In addition, this study will show that senescence in the B lineage can be reversed, which is in contrast to the general concepts of aging.

Probable implications to the welfare and health of the aged population Medicine:

Improving the immune competence will increase efficacy of vaccination, reduce morbidity, and reduce dependency on health systems. This will significantly improve the quality of life.


Eligibility Criteria:
Inclusion Criteria:

* 55 years and older
* lymphoma
* rituximab

Exclusion Criteria:

* disease remission
Identifying Effective Treatment for Veterans Unwilling to Quit Smoking

This project will generate knowledge about the effectiveness of Enhanced Chronic Care, an intervention designed to enhance treatment use and smoking abstinence in Veterans who are initially unwilling to quit. Enhanced Chronic Care provides ongoing motivational interventions and interpersonal support designed to promote readiness to quit smoking. Enhanced Chronic Care will be compared with Standard Care (brief advice to quit once per year) on criteria that are of great clinical and public health importance: use of cessation treatment and smoking abstinence. It is expected that Enhanced Chronic Care will increase treatment use and smoking abstinence relative to Standard Care.

This project will generate knowledge about the effectiveness of Enhanced Chronic Care, an intervention designed to enhance treatment use and smoking abstinence in Veterans who are initially unwilling to quit. Enhanced Chronic Care provides ongoing motivational interventions and interpersonal support designed to promote readiness to quit smoking. Enhanced Chronic Care will be compared with Standard Care (brief advice to quit once per year) on criteria that are of great clinical and public health importance: smoking treatment reach (use of cessation treatment) and abstinence. It is expected that Enhanced Chronic Care will increase treatment use and smoking abstinence relative to Standard Care.

The investigators will evaluate these interventions using a 2-arm randomized controlled trial. Veterans who smoke daily, but who are not willing to enter smoking cessation treatment, will be eligible to participate, with no obligation to quit smoking. Participants (N=500) will be randomized to one of the following treatments: 1) Enhanced Chronic Care (n=250) or 2) Standard Care (n=250). These intervention conditions will last 2 years to permit analysis of their cumulative impact on abstinence and treatment use

Eligibility Criteria:
Inclusion Criteria:

* Not willing to set a quit date in the next 30 days
* Report smoking an average of 4 or more cigarettes daily for at least six months
* Read, write, and speak English
* Be medically eligible to use nicotine replacement therapy
* If female, use an approved method of birth control if they use nicotine replacement therapy
* Agree to participate in the study
* Be at least 18 years old
* Be a Veteran

Exclusion Criteria:

* Unable to give informed, voluntary consent to participate
* Current use of any pharmacotherapy for smoking cessation not provided by the researchers during tobacco treatment
* Use of non-cigarette tobacco products as a primary form of tobacco use
* Incarceration
Periodontally Accelerated Orthodontics - A Novel Technique For a Shortened Orthodontic Treatment With a Stable Result. A Clinical and Computerized Tomography Analysis

Periodontally accelerated orthodontics, also known as PAO, is a novel technique combining alveolar corticotomy and bone grafting prior to commencing orthodontic treatment. Using this technique orthodontic de-crowding and space closing, can be completed in 60-70% less active orthodontic treatment time. The addition of particulated bone graft following decortication allows for the widening of the bucco-lingual alveolar bony dimension, thus creating space for the movement of teeth, without the creation of dehiscences, usually a negative sequel of the standard orthodontic treatment.

Aim: To evaluate the use of the PAO technique for the treatment of 20 adult patients 1 year post orthodontic treatment.

Methods: 20 periodontally healthy adult patients requiring orthodontic treatment were admitted in the departments of Periodontics and Orthodontics in Hadassah Medical Center. All patients underwent full orthodontic and periodontal examination upon admission including a pretreatment CBCT scan. Decortication followed by grafting was made after the orthodontic appliances have been placed. The orthodontic appliances were activated immediately after surgery and every 2 weeks. During the 1 year follow up a periodontal and orthodontic clinical evaluation were made, as well as a CBCT scan.

20 patients were periodontally and orthodontically examined. including: full chart:ppd, free gin line, bleeding on probing, plaque score, teeth mobility. cephalometric analysis, clinical photographes, full periapical x rays.

perio=ortho treatment plan was scheduled, a periodontal surgery for the decortication of buccal bone and bone grafting was preformed.

at the same day orthodontic appliances were activated. in the follow up exam a full periodontal exam will be made (as at the beginning).

the patient will be referred to CBCT scan. all dicom files will be uploaded to simplant software, and measurements will be made: buccal bone width from crest to apex. distance from CEJ to crest. presence of root dehiscence and fenestrations. root resorption.

clinical measurements:

* recessions
* vas

Eligibility Criteria:
Inclusion Criteria:

* orthodontic treatment with periodontal surgery

Exclusion Criteria:

* smoking alcohol consumption pregnancy
Efficacy and Safety of an Ethanol/Sodium Citrate Locking Solution: A Pilot Study

Currently in Canada, either 4% sodium citrate or heparin 1,000-10,000 U/ml solutions are "locked" into hemodialysis catheters between dialysis sessions to prevent thrombosis. The use of an ethanol/sodium citrate locking solution may have advantages over either of these agents alone. The investigators hypothesize that the 30 % ethanol/4% sodium citrate catheter locking solution is safe and effective in the prevention of catheter-related infections and thrombosis.

The pilot study will utilize a prospective, randomized design. After meeting the inclusion/exclusion criteria and providing written informed consent, patients will be randomly assigned to a 30 % ethanol/ 4% sodium citrate locking solution or heparin 1000 U/ml. Patients will be enrolled from the Health Sciences Centre and the Sherbrook Dialysis Units in Winnipeg, Manitoba, Canada.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Stage V chronic kidney disease preparing to start hemodialysis
* Exchange of an existing catheter to a cuffed, tunneled catheter OR planned vascular access with a cuffed, tunneled catheter
* CVC used for hemodialysis made of alcohol-resistant polymers ie. carbothane

Exclusion Criteria:

* Patients receiving catheters not made of alcohol resistant polymers
* Critically ill patients in ICU setting
* Patients with acute renal failure, who will likely not require prolonged vascular access ( ie. \> months)
* Patients with maturing fistulas/graft creation within 2 months
* Patients with planned antibiotic treatment courses lasting longer than 4 weeks from the date of new catheter insertion
* Patients receiving a new cuffed, tunneled catheter over a guide wire, if a fibrin sheath angioplasty was not performed after removing the previous dysfunctional catheter
VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.

Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.


Eligibility Criteria:
Inclusion Criteria:

* In overall general good health.
* HSV-2 (Herpes Simplex Virus-2) seropositive at screening.

Exclusion criteria:

* have active lesions consistent with genital herpes.
* previous history of symptomatic genital herpes.
* history of recurrent, undiagnosed symptoms consistent with genital herpes.
Impact of a Mental Health Curriculum for High School Students on Knowledge and Stigma

This study examines the effectiveness of a school based mental health literacy intervention for high school students, on improving mental health knowledge and reducing stigma. Twenty-four high schools in the regional area of Ottawa, Canada were randomly assigned to either the curriculum or control condition at a two to one ratio. The educational curriculum was integrated within grade 11 and 12 Provincial "Healthy Living" courses, delivered by teachers, and replaced existing educational content on mental health.

There is limited evidence and consensus on the effectiveness of school-based mental health educational programs, and no standardization for mental health education being taught in schools. This study examines the effectiveness of a school-based mental health literacy intervention for adolescents, on knowledge and stigma. A secondary objective was to determine the generalizability and applicability of an educational resource for mental health in high schools.

Eligibility Criteria:
Inclusion Criteria:

* Students enrolled in the Healthy Living course of participating Ottawa area community high schools.

Exclusion Criteria:

* Students not enrolled in the Healthy Living course of participating Ottawa area community high schools.
* Students with an English reading and comprehension level lower than the sixth grade
Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty

The purpose of this study is to determine whether the use of fibrin glue during nasal surgery leads to a shorter recovery period with less bruising and/or swelling.

Septorhinoplasty is a well established technique to correct nasal deformity. Drawbacks of this procedure include a significant recovery following surgery which may often require nasal taping and casting. Swelling and bruising in and around the surgical site may persist for months after the operation. At present, there is no standard regarding the length of time nasal tape and cast should be used following septorhinoplasty. It has never been proven that taping or casting is required - in surgeries that require minimal amounts of tissue handling, we may not use any tape or cast following the procedure. Homologous fibrin glue has been used for various cosmetic facial plastic procedures since the early 1980's. It has been shown to decrease bruising and swelling following surgery. This study is being undertaken to evaluate these benefits of using fibrin glue in nasal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Any patient over 18 years of age undergoing septorhinoplasty.

Exclusion Criteria:

* Any patient having more than one procedure performed during one anesthetic.(i.e.brow lift, face lift, blepharoplasty)
Ganglionated Plexus Ablation For Treatment of Atrial Fibrillation

This study evaluates the effect of catheter ablation of ganglionated plexi (GP) for the treatment of adult patients with atrial fibrillation heart arrhythmias. The location of GP will be demonstrated by a novel nuclear imaging cardiac camera. 3D images from the cardiac camera will guide the GP ablation procedure.

Catheter ablation procedures are nowadays routine procedures in patients with drug-refractory atrial fibrillation (AF). However, ablation success for patients even in the early stages of AF is currently only around 70% and may require multiple procedures.

The intrinsic cardiac autonomic nervous system (ANS), which forms a neural network, has been shown to be a critical element responsible for the initiation and maintenance of AF. Autonomic inputs to the heart converge at several locations; these convergence points are typically embedded in the epicardial fat pads and form ganglionated plexi (GP) that contain autonomic ganglia and nerves. In human hearts, there are at least 7 GP and the 4 major left atrial GP are located around the antrum of the pulmonary veins (PVs). High-frequency stimulation (HFS; 20 Hz, 10-150 V and pulse width 1-10 ms) can localize GP during an invasive electrophysiology (EP) study.

A novel dedicated cardiac nuclear imaging camera with solid-state detectors (D-SPECT, Spectrum Dynamics) has demonstrated significantly improved sensitivity and image resolution and can provide novel imaging information on previously 'invisible' structures like the GP. Using this 3D image information to guide GP ablation could significantly facilitate AF ablation and result in improved ablation outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal or early persistent atrial fibrillation with ongoing AF for less than 1 week
* Able to give written informed consent
* Age \>18 years old and ≤ 80 years
* Fulfil established clinical criteria for catheter ablation of atrial fibrillation
* Normal left ventricular (LV) ejection fraction and no evidence of significant structural heart disease

Exclusion Criteria:

* Reversible cause of atrial fibrillation
* Recent cardiovascular event including transient ischaemic attack (TIA)
* Intolerance or unwillingness to oral anticoagulation with Warfarin
* Bleeding disorder
* Contraindication to computed tomography (CT) scan
* Presence of intracardiac thrombus
* Vascular disorder preventing access to femoral veins
* Cardiac congenital abnormality
* Severe, life threatening non cardiac disease
* Active malignant disease or recent (\<5 years) malignant disease
* Presence of atrial septal defect (ASD) or patent foramen ovale (PFO) closure device
* Unable or unwilling to comply with follow-up requirements
* Patients on amiodarone until less than 3 months prior to the screening visit
* Left atrium size \> 5.5 cm on parasternal diameter in transthoracic echocardiography (TTE)
* Renal impairment
* Pregnancy
IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia

The purpose of this research study is to determine if the two common ways of administering additional opioids (morphine like substance, narcotic) with an epidural, either mixed in the epidural solution or given separately through the intravenous, are equally effective in controlling post-operative pain

Open label, observer and patient blinded randomized control study of patients age 18 to 85 who are booked to have an open upper abdominal surgical incision where an epidural would normally be offered and expected to be used for an average of 4 to 5 days.

Study will be done at University of Iowa Hospitals and Clinics main operating room and post-operative surgical wards.

Eligible patients who choose to consent to participate in the study will be randomized to either have the opioid administered intravenously using patient controlled administration (PCA) device along with a local anesthetic only continuous epidural infusion ,the control group, or to the treatment group of the opioid combined with the local anesthetic in the epidural with a continuous infusion combined with patient controlled epidural administered (PCEA) bolus. The epidural pump along with the PCA machine will be placed in such away that they can be obscured by a removable cover. The patient will be seen daily to obtain pain and satisfaction scores using the Quality of Recovery (QoR) 15. Secondary data will also be collected including presence of side effects, ability to mobilize, signs of return of bowel function, need for supplemental oxygen and total amount of opioid required. Patients will be assigned a study number, which all data will be kept under.

Eligibility Criteria:
Inclusion Criteria:

1. Age including and between 18 to 85 years old
2. Planned open abdominal procedure with an incision that is or includes above the umbilicus, where epidural would normally be offered and epidural would be maintained for an average of 4 to 5 days
3. Patient has consented for an epidural
4. Patient is able to converse in English
5. Patient is able to use a patient controlled pump

Exclusion Criteria:

1. Has a known contraindication for an epidural
2. Known mental or cognitive disability
3. History of chronic opioid use or substance abuse disorder
4. Pre-operative use of opioids
5. History of chronic pain
6. Routine use of marijuana
7. Incarcerated
8. Unable to converse in English
9. Planned to remain intubated post-operatively
10. Need for post-operative use of anticoagulant regiment that would be contraindicated with an indwelling epidural catheter
11. End stage renal disease or dialysis
12. Hepatic disease that affects metabolism of drugs
13. Known contraindication to any of the study drugs
14. Known pregnancy or positive pre-operative pregnancy test
15. Known neurological condition that may affect motor or sensory systems