cyrilzakka/clinical-trials huggingface dataset:
Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Solid Organ Transplant Recipients

Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia and contribute to the development of rejection. Although the annual influenza vaccine is recommended for transplant patients, studies have shown that a single intramuscular dose has poor immunogenicity. There are no studies that define the effect of intradermal doses in this population. We plan to study the immunogenicity of two different administration routes of the influenza vaccine in 200 solid organ transplant patients during the 2010-2011 season. Patients will be randomized to receive influenza vaccine either intradermally or intramuscularly. We hypothesize that the patients who receive the intradermal influenza vaccine will significantly reach a higher response to the vaccine. This study advances research on the prevention of serious viral infections in transplant recipients. Results from this study have the potential to directly improve patient care. If the use of the intradermal influenza vaccine is successful, this strategy may lead to a significant reduction in burden of disease, hospitalizations, and long-term morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 59,
* Greater than 3 months post-transplant,
* Any solid organ transplant (kidney, liver, heart, lung, pancreas, intestinal or combinations of the aforementioned organs)

Exclusion Criteria:

* Has already received influenza vaccination for 2010-2011 season;
* Egg allergy,
* Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome),
* Ongoing therapy for rejection,
* Febrile illness in the past two weeks,
* Unable to provide informed consent,
* Unable to comply with study protocol
Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome

Empty Nose Syndrome patients suffer from disabling physical symptoms and considerable distress. To date there is no definitive cure for these symptoms. Established treatment modalities include saline irrigation, surgical implantation of materials or simply use of cotton wads/ silicon cones to simulate the resistive action to airflow of the resected turbinates.

This study will research the effectiveness of a new treatment modality in the treatment of Empty Nose Syndrome. This novel treatment method involves the use of botulinum toxin type A (Botox).

Background:

Empty Nose Syndrome (ENS) is the term used to describe the condition resulting from over resection of nasal turbinate. Symptoms include depression, dysosmia, bleeding, discharge, crusting, dryness, dysosmia, and pain.

Treatment modalities include adjunctive comfort measures (primarily irrigation), mechanical measures (Silicon cones, cotton wads) and surgical treatment (alloderm implants, plastipore cartilage grafts etc.) We will investigate a new method of treatment for ENS. This will involve injection of botulinum toxin type A into the dilator nasalis muscle thus collapsing the internal nasal valve to provide added resistance to air flow.

Objective:

To evaluate effectiveness of botulinum toxin type A in improving overall quality of life in ENS patients.

Methods:

ENS patients in this study will receive botulinum toxin type A along with adjunctive treatment which will include several measures. First of all, patients will be given a nasal rinse bottle and will be instructed to irrigate their noses twice a day as follows:

* Irrigate the nose 250cc (about 125cc each side) to clear the mucus.
* Stop and gently clear the nose.
* Irrigate the nose 250cc (about 125cc each side) once again.
* Sit quietly for 10 minutes. No blowing.
* Do not blow the nose for 2 hours.

Patients will be asked to use sesame oil once a day to prevent drying of the nasal mucosa with further administration as needed. In addition they will advised to make certain lifestyle modifications that will include sleeping with a cool mist humidifier, drinking plenty of fluids and engaging in regular physical activity.

Before and after treatment data will be obtained in the form of a breathing test and patient questionnaires that will measure changes in physical and mental health.

Eligibility Criteria:
Inclusion Criteria:

* Any patient aged 18-65 years of age presenting with a known diagnosis of ENS who has no known allergies to Botox.

Exclusion Criteria:

* Patients younger than 18 years or older than 65 years of age.
* Patients with neuromuscular disorders or neuropathic diseases.
* Patients with infection and or swelling at the site where Botox is to be injected.
* Patients with known hypersensitivity to any ingredient in the drug formulation (botulinum toxin, human albumin)
* Patients who are or plan to become pregnant within the time period in which the study will be conducted.
* Patients who are nursing
Perceptual Learning Treatment for Amblyopia

Objectives. To develop a new treatment for amblyopia using a perceptual learning approach.

Hypothesis to be tested. Our proposed experiments are designed to investigate whether practicing a grating detection task can improve vision in patients with amblyopia.

Design and subjects. A total of 36 patients with amblyopia will be randomized allocated into two intervention groups: Group 1, perceptual learning therapy. Group 2, occlusion therapy. A control group comprising of 18 subjects with normal vision will be recruited for comparison. A battery of tests will be used to assess a range of visual functions before and after the treatment intervention.

Study instruments. Grating acuity testing system

Interventions. We have established a clinical protocol for acuity training. On each trial, a properly oriented stimulus will be presented randomly at one of the four locations on a flat monitor screen. The visual task is to indicate the location of the stimulus. Participants will be required to undertake 20 one-hour sessions of training.

Main outcome measures. Resolution acuity, visual acuity, contrast sensitivity function


Eligibility Criteria:
Inclusion Criteria:

* Visual acuity in the amblyopic eye: 20/25 or worse

Exclusion Criteria:

* Manifest eye disease \& nystagmus
Effect of Enteral Nutrition Support for Critically Ill Patients

To determine whether specialized enteral nutrition support can improve oxygenation status in critically ill patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) comparing to a standard enteral nutritional formula.


Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant female.
2. ALI or ARDS
3. PaO2/FiO2 \> 100 and ≤ 300 torr.
4. Evidence of bilateral pulmonary infiltrates/opacity on chest radiograph.
5. Enteral access
6. Systemic inflammatory response syndrome (SIRS) - two or more of the following must be present:

   1. Body temperature less than 36°C or greater than 38°C
   2. Heart rate \> 90 beats per minute
   3. Tachypnea with \> 20 breaths per minute; or an arterial partial pressure of carbon dioxide \< 4.3 kPa (32 mmHg)
   4. White blood cell count \< 4000 cells/mm³ or \> 12,000 cells/mm³; or the presence of \> 10% immature neutrophils.

Exclusion Criteria:

1. Dialysis for renal failure
2. Unable to initiate Enteral feeding within 48 hours since all inclusion criteria met.
3. Anticipated life expectancy less than 24 hours.
4. Patient with severe chronic liver disease
5. Neuromuscular disease that impairs ability to ventilate without assistance
6. Head trauma and/or drowning with a Glasgow coma score of 5
7. Receiving intravenous lipid emulsions from parenteral nutrition within 12 hours of baseline.
8. Receiving propofol
9. Airway reconstructive surgery.
10. Malignancy or irreversible disease for which 6-month mortality is greater than 50%.
11. Burns greater than 25% total body surface area.
12. Unwillingness or inability to utilize the ARDS network ventilation protocol.
13. HIV positive.
14. Chronic mechanical ventilation.
15. Severe, acute pancreatitis.
16. Refractory shock
17. Congestive heart failure with pulmonary edema as the primary cause of hypoxemia.
18. Acute myocardial infarction or cardiac surgery within 7 days.
19. Solid organ transplant.
20. INR \> 5.0 or platelet count \< 30,000/mm3 or history of bleeding disorder.
21. Intracranial hemorrhage within the past 30 days.
Computerized Screening, Brief Intervention, and Referral to Treatment in Primary Care

This is a randomized, controlled clinical trial to evaluate the effect of a computerized screening, assessment, and brief intervention on substance use in patients recruited from a primary care clinic. Study participants will be assigned to one of the following 4 study groups: computerized health screening alone (standard care) (SC); computerized assessment-only intervention (CA); computerized assessment followed by a computer-directed motivational intervention (CACI); or computerized assessment followed by a therapist-delivered motivational intervention (CATI). Data regarding substance use, medical and psychosocial functioning, and economic outcomes will be collected.

The investigators hypothesize that patients randomized to CACI and CATI will be more likely to report drug abstinence at the 3-month follow-up visit and will show greater reductions in drug use at 1, 3 and 6 months follow-up than patients assigned to CA or SC. Similarly, patients in the CACI and CATI groups will report greater reductions in HIV risk behaviors, lower rates of medical and psychosocial problems, and increased economic gains at the 6-month follow-up. In addition, patients in the assessment only intervention (CA) will have outcomes superior to those found for SC patients. A cost-effectiveness analysis will also be done comparing economic costs associated with CA, CACI and CATI and their relationship to substance use reductions and related improvements in medical and psychosocial outcomes at the 6 month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 65 years
* Primary care clinic patient

Exclusion Criteria:

* Pregnant
Evaluation of the Screening Effect of Artificial Intelligence Hand Activity Evaluation System for Cervical Spondylosis

The purpose of this study:

1. Build an artificial intelligence screening tool for cervical spondylosis based on hand function analysis;
2. Verify the accuracy of cervical spondylosis screening tools.

Cervical spondylotic myelopathy (CSM) has a high incidence in the middle-aged and elderly people. According to clinical research, the surgeon can makes a preliminary assessment of the severity of CSM based on a 10-second grip and release (G\&R) test. The statistics of G\&R test mainly rely on the surgeon's manual counting. When a patient's hand motion speed is too fast, the surgeon's manual counting is prone to error, leading to potential misdiagnosis. We construct and verify the intelligent video analysis system for Grip-\&-release. The system has a high accuracy and inference speed that ensure the proposed model can be used as a screening examination tool for CSM and a medical assistance tool to help decision making during CSM treatment planning.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-80 years old;
2. Patients who have received cervical CT or MR examination within the last month and have been clearly diagnosed or excluded from cervical spondylosis (i.e., those who have been clearly diagnosed before participating in the study);
3. People who are willing to participate in the study with CT/MR examination (i.e., those who have not been diagnosed before joining the study).

Exclusion Criteria:

1. Subjects with cervical spondylosis who have been examined but still cannot be definitively diagnosed or ruled out;
2. Subjects with definite presence of hand trauma;
3. People who do not have access to CT or MR;
4. Subjects who did not comply with the examination, were unable to perform neurological assessment, or were unable to fill out questionnaires.
Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation

This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to receive study drug for 48 weeks or take part in an untreated observational arm for the first 24 weeks followed by study drug for another 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Chronic infection with Hepatitis C with HCV RNA \> 1000 IU/mL
* Individuals with cirrhosis with Child-Pugh score \< 10
* Esophageal or gastric varices on endoscopy within 6 months prior to or at screening
* Hepatic Venous Pressure Gradient (HVPG) \> 6 mmHg
* Body mass index (BMI) ≥ 18 kg/m\^2
* Naïve to all nucleotides/nucleoside treatments for chronic HCV infection

Exclusion Criteria:

* Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
* HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive)
* Alpha-fetoprotein (AFP) \> 50 unless negative imaging for hepatic masses within the last 6 months or during screening
* Refractory ascites as defined by requiring paracentesis \> twice within 1 month prior to screening
* Active variceal bleeding within 6 months of screening
* Expected survival of \< 1 year
* History of hepatorenal, or hepatopulmonary syndrome.
* Evidence of renal impairment (CrCl \< 50 mL/min)
* History of major organ transplantation, including liver transplant.
Is the Degree of Perceived Effort During Resistance Exercise Important for Improvements in Blood Glucose

The goal of this clinical trial is to compare the degree of effort during a resistance exercise session on blood glucose levels in individuals with prediabetes or type 2 diabetes mellitus. The main questions it aims to answer are:

* Do individuals with prediabetes or type 2 diabetes mellitus need to perform resistance exercise with a high degree of effort for their blood glucose to improve?
* How do they feel (their enjoyment, discomfort) after the sessions with different degrees of effort?

Participants will perform 3 situations separated by at least 4 days, after being familiarized with all exercises and procedures:

* One control day, when they will not exercise;
* A high-effort resistance exercise session;
* A low-effort resistance exercise session Researchers will measure blood glucose levels and psychological responses after these situations to see if the effort was important for the improvement of their blood glucose and how effort affected the way they felt after each situation.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 75 years;
* presence of prediabetes (fasting glycemia between 100 and 125 mg/dL or glycated hemoglobin \[A1c\] between 5.7 and 6.4%) or T2DM (fasting glycemia 126 mg/dL or above or A1c 6.5% or above).

Exclusion Criteria:

* renal failure,
* liver disease,
* uncontrolled hypertension (equal or greater than 160 mmHg systolic and/or equal or greater than 100 mmHg diastolic),
* history of severe cardiovascular problems,
* in case of oral hypoglycemic drugs usage, being on them for less than 6 months,
* inability to perform resistance exercise,
* being pregnant or trying to become pregnant during the course of the study,
* use of oral contraceptives,
* prisoners,
* persons requiring a legally authorized representative,
* non-English speakers.
Analysis of the Immune Parameters of COVID-19 Infection in Patients With Multiple Myeloma

Among all MM patients included in the cohort at the time of diagnosis of SARS-CoV-2 infection, blood samples will be collected at inclusion, at time of the infection acute phase in the most severe cases (when admitted in intensive care units), and at recovery. The following immune function tests will be evaluated, gammaglobulin measurements, lymphocytes counts, B, T, and NK cells analyses by cytometry, including exhaustion analyses. In addition, T cell repertoire sequencing looking for SARS-CoV-2- specific T cells, and serologies, will be evaluated at recovery and 6 months after MM treatment re-initiation.

MM is a hematological malignancy, supposed mainly not curable, except for some exceptional patients, despite the availability of numerous new drugs. The patients are highly susceptible to infections, both bacterial and viral, due to a defect immune status, both at the antibody level (hypogammaglobulinemia) and the cellular level. This immunosuppression is further worsened by the treatments, and especially high dose glucocorticoids used at each phase of the disease. Consequently, MM patients are highly susceptible to contract COVID19, and to develop a severe form. This has been confirmed in a first study in Spring, showing a mortality rate of 37%. Among all MM patients included in the cohort at the time of diagnosis of SARS-CoV-2 infection, blood samples will be collected at inclusion, at time of the infection acute phase in the most severe cases (when admitted in intensive care units), and at recovery. The following immune function tests will be evaluated, gammaglobulin measurements, lymphocytes counts, B, T, and NK cells analyses by cytometry, including exhaustion analyses. In addition, T cell repertoire sequencing looking for SARS-CoV-2- specific T cells, and serologies, will be evaluated at recovery and 6 months after MM treatment re-initiation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a multiple myeloma and a documented COVID19 (by RT-PCR, thoracic TDM, and/or antigenix test).
* Patients having received the information to participate in the research and having expressed their non-opposition
* Patients with social security insurance or equivalent

Exclusion Criteria:

* Patients without multiple myeloma
* Patients without COVID19
* Patients under juridical protection guardianship, or tutelage measure
MRI Analysis of Glycosaminoglycan Modifications Inside the Intervertebral Disk After Distraction and Posterior Fusion

Degenerative disc disease (DDD) is the primary cause of low back pain. The most important factor in the development of DDD is the vertical load force on the disc, increasing the hydrostatic pressure and facilitating discs degenerations. One of the most common conditions accompanying DDD is segmental instability of the spine. The pathogenesis evolves in three phases characterized by a progressive disc dehydration and loss of the disc height.

This phenomenon can be observed in magnetic resonance imaging (T2 weighted MRI) as a decrease of the water signal inside the intervertebral disc. It is considered as an indirect sign of the alteration of the composition (including glycosaminoglycans) and the structure of the intervertebral disk with, as consequence, a modification of the spine biomechanics. Animal studies showed that disc regeneration could be enhanced by a decrease of the hydrostatic pressure. This could be observed as a signal increase on T2 weighted MRI.

Recent quantitative MRI sequences now allow the quantification of glycosaminoglycans (GAG) concentration inside the cartilage and in the intervertebral disc.

The actual surgical trends are in favor of an anterior (intersomatic) vertebrak fusion, associated or not with a posterior fusion. These technics sacrifice the intervertebral disc and change the spine biomechanics.

Based on a pilot study, the investigators believe that the conservation and even a regeneration of the intervertebral disc is possible and allows the preservation of the spine biomechanics.

The purpose of the study is to analyze the relations between specific MRI signals, the GAGs concentration, and the functional outcome before and after the surgical treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient with segmental instability of the lumbar spine
* Patient with planned surgery

Exclusion Criteria:

* clinical and iconographic signs of neurological compression
* intervertebral disc completely degenerated
* infection
* spondylolisthesis (superior to grade I)
* fracture
* neoplasia.
Lung Perfusion With Oxygenated Blood During Aortic Clamping

Pulmonary dysfunction presumably linked to an inflammatory response is frequent after cardiac operations using cardiopulmonary bypass (CPB) and pulmonary hypoperfusion.

Aim of the study: To evaluate the protective effect of continuous pulmonary perfusion with oxygenated blood during aortic crossclamping on the inflammatory response.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 ys
* Cardiopulmonary bypass procedure
* FEV1 \<80%
* COPD \>II

Exclusion Criteria:

* Emergency cases
Efficacy of Purslane in Treatment of Oral Lichen Planus

Oral lichen planus (OLP) is a chronic inflammatory disease whose prevalence in the general population is 0.5 -2.2%.Oral lesions in OLP are chronic, rarely undergo spontaneous remission. Patients with OLP had significantly increased risk of oral squamous cell carcinoma, irrespective of the clinical type of OLP and therapy. there is currently no cure for OLP. Previous study demonstrated a decreased antioxidant defence and increased oxidative damage to lipids.DNA and proteins in lichen planus. This oxidative modifications point to pathophysiological alterations mainly within the basal cell layers of epidermis and at the dermoepidermal junction. Purslane is an excellent source of vitamin A,C and E and essential amino acids, has been described as a power food of the future because of its high nutritive and antioxidant properties. The purpose of the study was to determined the efficacy of Purslane in the treatment of oral lichen planus.

Oral lichen planus is a chronic common inflammatory disorder affecting stratified squamous epithelia. The majority problem of OLP is development of oral squamous cell carcinoma , irrespective of the clinical type of OLP and therapy. Previous study demonstrated a decreased antioxidant defence and increased oxidative damage to lipids, DNA and proteins in lichen planus .This oxidative modifications point to pathophysiological alterations mainly within the basal cell layers of epidermis and at the dermoepidermal junction. So oxidative stress could be effective in pathogenesis of OLP. Purslane is an excellent source of vitamin A,C and E and essential amino acids, has been described as a power food of the future because of its high nutritive and antioxidant properties. Purslane also decreased the level of TNF-α and IL6, that are responsible for up-regulated adhesion molecules (in OLP lymphocyte T (T cell) recruited and retained in sub mucosa through receptors to endothelial adhesion molecule. and basal keratinocytes undergo apoptosis). The purpose of the study was to determined the efficacy of Purslane in the treatment of oral lichen planus.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy confirmed symptomatic oral lichen planus: WHO histological criteria in combination with clinical appearance will be used for diagnosis
* Patients who had symptoms such as burning sensation, pain
* Patients not on any immunosuppressive or immunomodulatory treatment. In case they were,then such treatment should be stopped and a washout period of 1 month was given.
* Patients of both sexes between 30 to 70 year's old
* Patients who gave written informed consent
* Patients who were willing for evaluation in second week after therapy and every 1 month up to 6 months

Exclusion Criteria:

* The presence of histological signs of dysplasia
* Patients suffering from any localized or systemic disease
* Renal disease patients
* Pregnant patients
* Patients who can not continue the study for private or social reasons
* Patients who used lichenoid reaction including drugs
A Phase II Study of Anecortave Acetate for the Treatment of Exudative Age-Related Macular Degeneration

The purpose of the study is to determine the concentration of anecortave acetate (15 or 30 mg versus placebo) that is safe and effective for the inhibition of the growth of blood vessels in the retina in patients with wet AMD.


Eligibility Criteria:
Inclusion Criteria:

* Ages 50 years and over
* Other protocol-defined inclusion and exclusion criteria may apply.