cyrilzakka/clinical-trials huggingface dataset:
The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors

This study evaluates the possible benefits of a tasteless and sugar free chewing gum as a salivary stimulant for head and neck cancer patients treated with curative intended radiotherapy.

Radiation-induced xerostomia and hyposalivation are frequent side effects after completed treatment for oral and oropharyngeal cancers. This may induce eating and swallowing difficulties, compromised oral hygiene, pain in the mouth, or speech deficiencies. As a consequence, quality of life is often impaired for this group of patients even after completing treatment.

This study hypothesize that chewing gum can stimulate salivary flow from the residual functional salivary glands and thereby improving the patient's oral well-being.

Primary endpoint:

- To assess whether the difference between the unstimulated and stimulated salivary flow after a one-month period of using chewing gum will result in improved oral well-being.

Secondary endpoint:

* To assess if unstimulated and stimulated salivary flow differs between the two groups of patients
* To evaluate changes in quality of life with EORTC QLQ H\&N-35 for patients using chewing gum
* To evaluate differences in quality of life with EORTC QLQ H\&N-35 between the two groups of patients.

All patients who have received curative intended treatment for oral or oropharyngeal carcinomas at the Department of Oncology, Odense University Hospital, will be invited to participate in the study. If the eligibility criteria are met the patient will be randomized 2:1 to either the intervention arm with chewing gum or the control arm with standard oral care. The study intends to include 210 patients in total. Of these, 140 patients in the intervention arm and 70 in the control arm. Recruitment to the study was initiated in September 2016 and is expected to be completed in July 2018.

The duration of the study is one month from inclusion and randomization to final follow up. For all included patients, saliva samples are collected (unstimulated and stimulated sialometry) and the EORTC QLQ H\&N-35 questionnaire and a xerostomia specific questionnaire are completed. The patients in the control arm are only introduced to chewing gum at the last follow up visit. In the intervention arm, all patients are instructed to use the chewing gum on a daily basis (preferably 5 times a day) and to make notes in a patient diary to document compliance.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Diagnosed with oral or oropharyngeal carcinoma
* Received curative intended radiation therapy (primary or postoperative), 60-66Gy including concurrent chemotherapy
* Within 6 to 60 months after radiation therapy
* Complains of xerostomia level 1 (according to Danish Head and Neck Cancer group)
* Written informed consent

Exclusion Criteria:

* Poor teeth condition or full set of dentures
* Recurrence of cancer or palliative treatment
Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Cerebral Palsy.

The aim of the study is to evaluate a short term influence of the Spinal Manipulation (SM) on the wrist muscles spasticity and manual dexterity in children with spastic Cerebral Palsy.

Effect of SM and imitation of the SM has to be compared in the double-blinded randomized clinical trial.

Muscle spasticity is an important clinical syndrome of Cerebral Palsy (CP) resulting from upper motor neuron lesion, and its reduction is a significant therapeutic target for optimizing motor performance.

Investigator's recent study describes decrease in spasticity after SM in a group of children with CP. But that case series has no control group and the sample size was small so it does not prove the influence of the SM on the muscle spasticity.

The purpose of the present study is to evaluate influence of the SM on muscle spasticity and on manual dexterity of the child with CP in a double-blind randomized clinical trial with two arms: SM (experimental group) and imitation of SM (control group).

Children admitted to the International Clinic of Rehabilitation are selected according to inclusion-exclusion criteria and invited to participate. After getting the permission the baseline assessment is performed.

Patients are allocated to the experimental or control group using stratified randomization. Medical doctor certified in Manual Therapy performs the intervention (SM in the experimental group and imitation in the control group) and in 15 minutes the second assessment is performed. Investigators, children and parents are blinded to group allocation.

Eligibility Criteria:
Inclusion Criteria:

* Spastic uni-, bilateral Cerebral Palsy
* Manual Ability classification level (MACS) - I-III level
* Modified Ashworth scale (MAS) grade 1-3 in wrist or fingers flexors

Exclusion Criteria:

* Dyskinetic or ataxic syndrome
* Less than 40 degrees of passive wrist extension with fingers extended
* Botox injections in hand muscles during last year or recent antispastic drugs
* Fracture in hand or forearm less than 6 month prior to examination
* Uncooperative behavior, inability to understand and comply with instructions
* Severe pain preventing the child from being able to complete examinations
Socially Assistive Robots for Interaction With Older Adults With Dementia

A 12-month pilot study will be comprised of two groups of people diagnosed with mild Alzheimer's disease and related dementia for a total of 80 senior subjects. Subjects will be randomly assigned to two groups: Group 1 users will play games with and administered by Ryan, 2-3 times a week and 30-minutes per day. Group 2 (Active Control Group) will play solitary games and activities but will have to interaction with Ryan. The team will measure the changes and improvement in the social/emotional well-being of these two groups and eventual changes in the cognitive/memory functions of elderly people living in the similar environment.


Eligibility Criteria:
Inclusion Criteria

* Age ≥ 65 years
* Early Alzheimer's disease and related dementia diagnosed by a qualified provider
* Saint Louis University Mental Status (SLUMS) score between 10 and 25
* Resident of assisted living facility for at least one month prior and for the duration of the study
* Deemed conditioned enough to participate in physical activities after a wellness check
* Verbal skill to interact
* Participant or Legal decision

Exclusion Criteria:

Aggressive behavior

* Diagnosed with severe dementia or memory loss
* Acute physical illness that impairs ability to participate
* Patients with serious comorbidity, tumors and other diseases casually related to cognitive impairment
* History of alcohol or drug abuse, head trauma, psychoactive substance use and other causes of memory impairment
* Significant sensory impairment
Kinetic Study of CD8+ CMV-specific Cellular Immunity in Renal Transplant Patients After Receiving Thymoglobulin

Renal transplant candidates who have CMV-specific, CD8+ T-cells, are CMV-seropositive and carry HLA-A1 and/ or HLA- A2 alleles have a high probability to maintain this type of immunity during the three first months after the transplant, despite induction immunosuppressive therapy (thymoglobulin).


Eligibility Criteria:
Inclusion Criteria:

1. Renal transplant recipients with CMV-positive serology.
2. Patients with pre-transplant, CMV-specific CD8+ T cell-mediated immunity, i.e. IFNγ levels ≥0.2 UI/mL (QF-CMV Reactive).
3. Adults over 18 years of age.
4. Patients receiving induction therapy with thymoglobulin (at least a cumulative dosage of 1mg/kg).
5. Patients receiving prophylaxis with valganciclovir (900 mg/day, adjusted to kidney function) until day 90 after transplant.
6. Patients who signed an informed consent

Exclusion Criteria:

1. Multivisceral transplantation, including pancreas-kidney transplantation.
2. HIV infected patients.
3. Patients who cannot comply with the monitoring protocol.
Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0)

Prospective, open labelled, monocentric trial to evaluation of the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up

The ct DNA R0 study is a prospective, open labelled, monocentric trial. The aim is to evaluate the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up.

The patient will have a blood sample before and after the surgery and during the post-surgery follow-up. The patient will have a maximum of 10 blood samples during the 2 years of his follow-up of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years old or more
2. Patient with hepatic injury of metastatic uveal melanoma eligible for curative surgery (R0).
3. No other distant metastasis (CT thoracic -abdomino -pelvic, bone scan).Measurable metastatic disease (echography, CT and/or MRI, FDG-PET, (fluoro- D-glucose integrated with computed tomography)).
4. Patient able to stand a blood collection.
5. Patient explanation given and consent information signed or by legal representative.

   Exclusion Criteria:
6. Patient without social protection / insurance..
7. Patient with hepatic metastasis unresectable by surgery
8. Patient with extra-hepatic metastasis.
9. Person deprived of liberty or under guardianship
10. Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.
18F-FDG PET Metabolic Phenotype in Evaluating Therapeutic Response for Breast Cancer Patients With Bone Metastases.

This study is to evaluate the effectiveness of 18F-FDG PET in following up of metastastic bone lesions and in predicting outcome for breast cancer patients after therapy.

Primary outcome: Using 18F-FDG uptake to evaluate the metastatic bone status after treatment. The PET results will be compared with the results in Tc-99m MDP bone scintigraphy.

Secondary outcome: Evaluate the relationship between the 18F-FDG uptake of the metastatic bone lesions and (1) breast cancer related tumor marker, (2) patients' survival.

Background: Although 99mTc MDP bone scintigraphy is a sensitive tool for screening metastatic bone status, it is not a satisfactory imaging modality in evaluating residual disease after therapy. 18F-FDG PET has been an effective imaging tool for many malignancies including breast cancer, not only in diagnosis and staging, but also in monitoring response and following up disease status after therapy.

Purpose: This study is to evaluate the effectiveness of 18F-FDG PET in following up of metastastic bone lesions and in predicting outcome for breast cancer patients after therapy.

Method: Breast cancer patients with bone metastases, age 20-90 year-old, will be included in this study.

Primary outcome: Using 18F-FDG uptake to evaluate the metastatic bone status after treatment. The PET results will be compared with the results in Tc-99m MDP bone scintigraphy.

Secondary outcome: Evaluate the relationship between the 18F-FDG uptake of the metastatic bone lesions and (1) breast cancer related tumor marker, (2) patients' survival.

Eligibility Criteria:
Inclusion Criteria:

1. Age：20-90 years old
2. Histological proven breast cancer, with known metastatic bone lesion(s)
3. written informed consent signed

Exclusion Criteria:

1. pregnant or intend to be pregnant
2. other malignancies known
Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ Lymphoscintigraphy

This study evaluates the ability of a prototype intraoperative handheld gamma camera (pIHGC) to image (detect) sentinel lymph nodes (SLNs) in melanoma and breast cancer during surgical excision, as compared to standard of care intraoperative gamma probes (GP). The unit of study in this trial was SNLs rather individual participants. Each device was assessed for relative node detection sensitivity (S) of those SLNs.

Lymphoscintigraphy is an accepted and commonly-performed procedure used for staging of certain cancers, especially melanoma and breast cancer. It involves injecting a small amount of radioactivity under the skin in order to identify lymph nodes which should be biopsied (ie, the "sentinel lymph node, SLN") to determine if cancer has spread. The study objective was to evaluate the potential benefit of a new, camera-based technology (prototype device) which allows actual images to be obtained intra-operatively in the identification of sentinel nodes.

Each device was assessed for relative node detection sensitivity (S), defined as the proportion of sentinel lymph nodes (SLNs) that were identified with each instrument, with the proportion determined as the number of true positives (TP) divided by the total evaluated (N).

Eligibility Criteria:
INCLUSION CRITERIA

* Malignancy for which sentinel node biopsy with lymphoscintigraphy are indicated as part of the standard of care for tumor staging
* Age 18 or greater.
* Healthy enough for surgery
* Able to understand and willing to sign a written informed consent document.

EXCLUSION CRITERIA

* No exclusion requirements due to co-morbid disease or intercurrent illness.
* Documented allergy to colloid.
* Lymphoscintigraphy presents excessive high risk, eg, a consideration if pregnant or lactating
Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy

1. Primary objectives

   a. To evaluate the Effects of intravitreal Bevacizumab on polypoidal choroidal vasculopathy(PCV)
2. Secondary objectives

   1. To assess the changes in visual acuity
   2. To assess the change in lesion characteristics of PCV

      * size of PCV
      * fluorescein leakage
      * foveal thickness
   3. To investigate the safety of intravitreal Bevacizumab in patients with PCV
   4. To assess the effect of intravitreal Bevacizumab on the recurrence rate and the the incidence of submacular hemorrhage in patients with PCV


Eligibility Criteria:
Inclusion Criteria:

* Male or female, CNV secondary to PCV
* BCVA of 20/40 to 20/320 (Snellen equivalent)
* Evidence of presumed recent disease progression (blood, growth by FA, or recent VA loss)

Exclusion Criteria:

* Uncontrolled glaucoma or any other ocular condition that would prevent an improvement in visual acuity
* Media opacity in the study eye that precludes clinical and photographic evaluation
* Intraocular surgery \< 1 month before day 0
* Use of heparin/warfarin within 1 month prior to injection
* Known allergy or hypersensitivity to fluorescein, indocyanine green or povidone iodine
* Contraindication to pupil dilation in either eye
* Any condition which precludes patients' ability to comply with study requirements including completion of the study
A Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults

The purpose of this study is to see how many people respond to a smallpox vaccine when a sore forms where the shot was given.

The world was declared free of smallpox in 1980. General routine vaccinations for smallpox were stopped in the U.S. in 1971. In 1976, the recommendation for routine vaccination of healthcare workers was also discontinued. The only people who presently receive this vaccine are people who work with vaccinia virus or monkeypox virus. Because the world was considered free of smallpox infections, this vaccine was no longer produced; there is a limited supply available in the United States.

Because of the limited amount of Dryvax vaccine (vaccinia virus) against smallpox, this study will look at the ability to dilute the vaccine making more doses available in the event of a smallpox outbreak. The study seeks to characterize a strategy of vaccination against smallpox with various doses of Dryvax, followed by revaccination with the same dose, if required, in volunteers 18-32 years of age with a negative history of smallpox vaccination.


Eligibility Criteria:
Inclusion Criteria:

Patients may be eligible for this study if they:

* Are between 18 and 32 years of age.
* Give written informed consent.
* Are available for follow-up for 2.5 months.
* Have an acceptable medical history by screening evaluation and brief clinical assessment.
* Are HIV-negative.
* Agree to use acceptable contraception and to not get pregnant during the study.

Exclusion Criteria:

Patients may not be eligible for this study if they:

* Have a suppressed immune system.
* Have participated in an HIV vaccine trial.
* Have liver disease, diabetes, or kidney problems.
* Have malignant skin cancer.
* Have autoimmune disease.
* Have used medication that suppresses the immune system.
* Have had psychiatric or medical problems or have job responsibilites that will keep them from participating in the study.
* Use illegal intravenous drugs.
* Have received any live vaccines within 60 days of study start.
* Have used experimental therapies within 30 days before study start.
* Have been vaccinated with certain experimental vaccines.
* Have a vaccination scar but have no record of having a vaccine.
* Have received a smallpox vaccine.
* Have taken blood products or immunoglobulin in the past 6 months.
* Have a fever on the day of vaccination.
* Have certain skin disorders, including eczema, exfoliative skin, lacerations that require stitches or burns larger than 2 x 2 cm.
* Live with, have sexual contact with, or work with anyone who is pregnant, less than a year old, has eczema, has certain skin disorders, has a disease or takes medication that suppresses the immune system.
* Have a condition that, in the opinion of the investigator, might interfere with the study.
* Are allergic to any parts of the vaccine.
* Are allergic to thimerosal, immunoglobulins, cidofovir, or probenecid.
* Are pregnant or breast feeding.
Waveform Capnography Compared to Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults

This study will compare the sensitivity and specificity of waveform capnography versus colorimetric carbon dioxide detection to identify tracheal placement of the endotracheal tube during intubation of critically ill adults.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is located in a participating unit (ED or ICU)
2. Patient is undergoing tracheal intubation.
3. The clinician intends to use an exhaled CO2 detection device to confirm tracheal placement of the tube.

Exclusion Criteria:

1. Patient is known to be a prisoner
2. Patient is known to be \< 18 years old
3. A responsible clinician has determined that sole use of either waveform capnography or colorimetric testing is required for optimal care of the patient.
Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis

The study is a 'pilot study' to assess the effect of a mindfulness-based stress reduction (MBSR) intervention on patients with autoimmune liver disease specifically autoimmune hepatitis type I. MBSR is a standardized intervention that has shown benefit in addiction disorders and other psychiatric disorders. There has been no study evaluating or showing the benefit of the use of MBSR in autoimmune liver disease. With published data showing the evidence of an association of stress and relapse in autoimmune hepatitis, it is hypothesized that such an intervention such as MBSR may have therapeutic effect in patients with autoimmune liver disease.

With the understanding that autoimmune hepatitis has a relationship with psychological stress, the use of a strategy such as mindfulness stress based reduction (MBSR) may similarly have a substantial impact as seen in other disease conditions. The proposed hypothesis is that undergoing MBSR has potential to benefit patients with autoimmune hepatitis in relation to decreased relapse rate and ultimately improved quality of life.

The focus of this study is surrounding the possibility of psychosocial stress for relapse in AIH. The investigators, however, would like to also understand the role of serological testing at the time of these relapses and during states of psychosocial stress to demonstrate if the association can be found. During active disease activity or relapses of autoimmune hepatitis, there is an expected rise in alanine aminotransferase (ALT) and immunoglobulin G (IgG) levels. Demonstrating the correlation of ALT and IgG with disease status and possible improvement with stress modifications is also key for this proposed study.

Eligibility Criteria:
Inclusion Criteria:

* Between ages 18-80 years
* Diagnosis of Autoimmune Hepatitis Type I

Exclusion Criteria:

Medical

* Hospitalization in the last 30 days
* New immunosuppression agent started \<6 weeks prior to study
* Patients with concurrent viral hepatitis and/or alcoholic liver disease
* Patients with decompensated cirrhosis (defined as ascites, encephalopathy, variceal hemorrhage)
* Patients with hepatocellular carcinoma
* Patients post-liver transplantation Psychological
* Any psychotic disorder or current psychiatric symptoms

Attitudinal

* Inability to commit to program schedule and attendance of classes

Physical

* Inability to physically attend classes; disability or physical impairment not included as an exclusion criteria Other
* Inadequate English proficiency
* Inability to read and/or write
Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness

Previous studies showed that anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal (DLPF) cortex transiently improves performance of memory and attention. Investigator assessed the effects of left DLPF-tDCS on Coma Recovery Scale-Revised (CRS-R) scores in severely brain damaged patients with disorders of consciousness in a double-blind sham-controlled experimental design.

Following severe brain damage and coma, some patients may remain in a vegetative state (VS) or minimally conscious state (MCS). At present, there are no evidence-based guidelines regarding the treatment of patients with disorders of consciousness (DOC).

Investigator aim to assess the effect of single session anodal (i.e., excitatory) transcranial direct current stimulation (tDCS) of the left dorsolateral prefrontal cortex (DLPF) on the level of consciousness in DOC patients in a double blind randomized sham controlled study.

tDCS is a form of safe non-invasive cortical stimulation, modulating cortical excitability at stimulation sites via weak polarizing currents, previously reported to transiently improve working memory and attention by stimulating the left DLPF in healthy subjects and patients with stroke, Parkinson's or Alzheimer's disease.

Eligibility Criteria:
Inclusion Criteria:

* post-comatose patients
* patients in vegetative/unresponsive or minimally conscious state
* patients with stable cardiorespiratory parameters
* patients free of sedative drugs and Na+ or Ca++ channel blockers (e.g., carbamazepine) or NMDA receptor antagonists (e.g., dextromethorphan)

Exclusion Criteria:

* premorbit neurology antecedent
* patients in coma or \<1week after the acute brain insult
* patients with a metallic cerebral implant or a pacemaker (in line with the safety criteria for tDCS in humans)