cyrilzakka/clinical-trials huggingface dataset:
Estimate the Safety and Effectiveness of Adjuvanted Influenza Vaccine Among Asian Elderly People When Compared to Non-adjuvanted Vaccines

To compare the immunogenicity, cellular immune response, and safety between adjuvanted (aIIV4) and non-adjuvanted (IIV4) seasonal influenza vaccines in the Taiwanese elderly population with chronic medical conditions.

Annual influenza vaccination is the most important and cost-effective intervention in reducing the impact of influenza, and a key component of the WHO response and preparedness efforts for influenza of pandemic potential. Reduced effectiveness of conventional egg-based vaccination was observed among risk group, such as elderly and people on with chronic medical conditions, which may result from their impaired immunogenicity. WHO, as well as ACIP of the USA, Europe, and Australia suggested adjuvanted influenza vaccines as one of alternatives for those people, which could decrease the disease burden significantly in several analyses. An adjuvanted commercial vaccine has been approved in Taiwan recently, but the local data of safety and effectiveness analysis is limited. This 1-year randomized control trial is designed to estimate the safety and effectiveness of adjuvanted influenza vaccine among Asian elderly people when compared to non-adjuvanted vaccines.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 65 years or above
* Presence of at least 1 chronic medical condition associated with increased risk of complicated influenza, including hypertension, chronic obstructive pulmonary disease (group A, B, E), asthma, congestive heart failure (ACC/AHA stage A, B, C, D), coronary arterial disease, diabetes mellitus, chronic liver disease (Child-Pugh score A, B, C) or chronic kidney disease (stage 1\~4), neuromuscular disorders, hematological or solid organ malignancies, recipient of hematopoietic stem cell transplantation or solid organ transplantation.

Exclusion Criteria:

* Contraindications to influenza vaccination including history of severe adverse event after vaccination, such as anaphylaxis or Guillain-Barré Syndrome, or a severe bleeding tendency
* Prior receipt of influenza vaccination during the current flu season.
* Determination by the Principal Investigator (PI) that the participant is ineligible for enrollment based on clinical assessment.
Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions

This prospective, observational study is designed to investigate clinical outcomes and collect patient feedback on the use of Wellinks, an integrated virtual chronic obstructive pulmonary disease (COPD) management solution, for patients recently discharged from the hospital due to an acute exacerbation of their COPD.

Wellinks, an integrated virtual COPD management solution consists of a combination of health coaching, Bluetooth-connected devices, collection of patient-reported symptoms and medication use, and virtual pulmonary rehabilitation, all centralized by the use of a mobile-phone application (mobile app) downloaded onto a study participant's iOS (iPhone) or Android device. The clinical objectives of this study are to determine whether utilization of Wellinks can reduce the rate of hospital readmissions due to a COPD exacerbation for patients recently discharged from the hospital. The nonclinical objectives of this study are to describe the experience of study participants using Wellinks through the assessment of engagement with the components of Wellinks, as well as by participant-reported satisfaction and perceived value (e.g., willingness to pay). Qualitative feedback on the features and functionality of Wellinks will be solicited.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (≥18 years of age with no upper age limit) 2. Any sex, race and ethnicity 3. COPD diagnosis 4. Current hospital admission or observation status resulting from exacerbation of COPD or generally including respiratory signs/symptoms indicative of difficulty breathing (e.g., need for oxygen or nebulized therapy, increased use of rescue medication) 4. Telephone (landline or mobile) and internet access 5. Access to a smartphone: iPhone 6S or later model, running iOS 14.0 or later; Android 6 or later model 6. Proficient in English language due to the availability of all study materials in the English language only 7. Living/staying in the United States throughout the study duration 8. Eligible to participate in asynchronous virtual pulmonary rehabilitation in the opinion of the investigator (e.g., patients determined to be ineligible to participate may include those with acute coronary syndrome for whom an exercise regimen is not advisable at present time) 9. Willing and able to comply with study requirements 10. Able to provide written informed consent

Exclusion Criteria:

1. Diagnosis of acute decompensated heart failure
2. Currently pregnant or planning to become pregnant during the study period
3. Life expectancy \<17 weeks
4. Current participation in other interventional clinical trials
5. Current participation in a pulmonary rehabilitation program

7. Enrollment in an existing Wellinks program 8. Unable or unwilling to cooperate with remote assessments and engagement with Coaches 9. Unable to comply with the study procedures in the opinion of the investigator (e.g., unlikely to be compliant, unlikely to comprehend instructions or education provided)
Text Message Intervention to Improve Cardiac Rehab Participation

Cardiac rehabilitation (CR) is strongly recommended for patients with coronary heart disease. However, patient enrollment and completion of cardiac rehabilitation is low. This study will examine if a mobile phone intervention that uses a text messaging program can successfully promote participation in cardiac rehabilitation.

Mobile phone interventions, such as text messaging programs, have been shown to promote healthy behaviors in patients with coronary heart disease, but it is unknown whether text messaging can successfully promote participation in cardiac rehabilitation.

This study will have the following aims:

Aim 1: Adapt a theory- and evidence-based text messaging intervention to promote participation in cardiac rehabilitation.

Aim 2: Determine whether text messaging improves participation in cardiac rehabilitation among eligible patients.

This study will have two parts. In part 1, the investigators will enroll patients with heart disease to rate the acceptability of text messages. In part 2, the investigators will enroll patients to participate in a randomized controlled trial. Participants will be randomized to receive text messages or no text messages for 6 months. Those who have been assigned to receive the text messaging intervention will be sent several text messages per week throughout the study period. The content of these text messages is designed promote healthy behaviors and participation in cardiac rehabilitation. Those who have not been assigned to receive the text messaging intervention will receive usual care. Outcome measures will be assessed at a baseline visit and at a 6-month follow-up visit at the end of the intervention. Additionally, some participants in the text messaging intervention group will be interviewed about their overall satisfaction and engagement with the text messages upon completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Part 1: Diagnosis eligible for cardiac rehabilitation within 90 days (myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, heart valve repair/replacement, heart transplant, left ventricular assist device, chronic stable angina, chronic stable heart failure)
* Part 2: Hospitalized for diagnosis eligible for cardiac rehabilitation (myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, heart valve repair/replacement, heart transplant, left ventricular assist device)
* Eligible for cardiac rehabilitation
* Owns a smartphone capable of receiving and sending SMS text messages

Exclusion Criteria:

* Unable to communicate in English
Quality of Life of Patients With Bone Tumor of the Lower Limbs Treated With Salvage Surgery

The aim of the study is to describe, through a minimum follow-up of 18 months, the quality of life of patients undergoing salvage surgery of lower limb for musculoskeletal tumors and to identify possible prognostic factor correlated.

Quality of life will be evaluated with Bt-DUX (Bt=bone tumor)

Musculoskeletal cancers are extremely rare, accounting for approximately 0.2% of all cancers, 14% are bone sarcomas, which occur more frequently in children and adolescents. The most frequent location is at the metaphyseal level of the femur (42%) and tibia (19%).

Surgery and chemotherapy treatments have significantly increased survival rates for patients with bone tumor. Early rehabilitation of these patients after surgery is to promote recovery as early as possible with maximum autonomy. In literature, data about the association between the early functional recovery and quality of life are few. Long-term studies about the quality of life of these patients are so necessary. The quality of life is measured with several scale that included a set of non-specific domains for bone tumor patients. For this reason, a specific assessment scale was introduced and validated in 2013 to measure the quality of life of patients with bone cancer of the lower limbs, the Bt-DUX scale.

In 2019 the Bt-DUX scale was validated in Italian.

Considering the rarity of the disease, and verified that the number of patients treated in 2019 and 2020, is 30 and 32, respectively, the investigators estimate to enroll from January 2019 to June 2023 a number of patients equal to 100, considering a rejection rate of 10%.

Patient characteristics and scale values will be summarized using descriptive statistics (absolute frequencies and percentages for categorical variables, mean and standard deviation or median and interquartile range for continuous variables).

The variables collected will be: age, sex, diagnosis, type of surgery, site of tumour, complication (infection, relapses, metastasis), TESS (Toronto Extremity Salvage Score) (at 3 and 6 months), knee or hip flexion (at 3 and 6 months), quadriceps or hip abductor strength (at 3 and 6 months) and time up and go (at 3 and 6 months).

The relationship of patient characteristics with functional outcomes and quality of life will be investigated using multiple regression models, while the correlation between measures of functional recovery will be analyzed using Pearson's or Spearman's correlation coefficient, depending on the distribution of the variables considered.

The aim of the study is to describe the quality of life of patients undergoing salvage surgery of the lower limb for musculoskeletal tumors with a long follow-up and to investigate the association with early functional recovery.

Eligibility Criteria:
Inclusion Criteria:

* Patients 12 years of age or older with musculoskeletal cancer undergoing lower extremity salvage surgery

Exclusion Criteria:

* patients undergoing amputation
* patients with difficulties in understanding the Italian language
Transcranial Magnetic Stimulation on Dorsomedial Prefrontal Cortex in Borderline Personality Disorder

This study evaluates the effect of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) on Dorsomedial Prefrontal Cortex on Borderline Personality Disorder (BPD).

Borderline Personality Disorder (BPD) is a mental illness with a high worldwide prevalence and economic costs, and is characterized with impulsiveness, both interpersonal relationships and emotional disturbance. Symptoms are related to hypofunction of frontal areas like Dorsomedial Prefrontal Cortex (DMPFC). Psychotherapy is the base treatment in this disease, but economic costs and long-time therapy have made difficult the attachment. Repetitive Transcranial Magnetic Stimulation(rTMS), authorized by Food and Drug Administration (FDA) on Major Depressive Disorder (MDD) treatment has proven good results in previous works in BPD clinical characteristics on both dorsolateral prefrontal cortex (DLPFC) and enhancement in depressive symptoms stimulating DMPFC in high frequency. However, there are no current research that have addressed the use of low-frequency on this anatomical area.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years old.
* Meet DSM 5 (Diagnostic and Statistical Manual, 5th edition) diagnostic criteria for Borderline Personality Disorder.
* Score of \>7 in the Diagnostic Interview for Borderline (Revised version, DIB-R)
* All patients must have follow-up psychotherapy of at least one month.
* No changes on pharmacological treatment within the last month.
* Patients must provide their oral and written informed consent.

Exclusion Criteria:

* Subjects with history of traumatic brain injury with loss of consciousness.
* Subjects with intracranial metallic objects or metal plates in the skull.
* Subjects diagnosed with uncontrolled chronic (for example: hypertension, diabetes) or neurological diseases.
* Comorbidity with other mental illness. (Except Depressive symptoms and Anxiety Disorders).
* Presence of psychotic symptoms.
* Alterations in the electroencephalogram (epileptiform activity).
* Self injury or suicidal attempts in less than 2 weeks (depends on the severity and deepness).
Furosemide Inhalation in Dyspnea of Mustard Gas Exposed Patients

to assess the efficacy of inhaled furosemide in mustard gas exposed patients with acute respiratory failure


Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of exposure to sulfur mustard with a complaint of dyspnea

Exclusion Criteria:

* A contraindication for furosemide use;
* An accompanying disease in which other drugs effective for dyspnea were used
Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Non-small Cell Lung Cancer (PEARL)

To improve the clinical outcomes of patients with non-small cell lung cancer treated with radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed non-small cell lung cancer (squamous cell, adenocarcinoma, poorly differentiated non-small cell carcinoma, or some combination of these); and
* Symptomatic patients (defined at discretion of investigator) for whom palliative thoracic radiation is planned (3000cGy/10 fractions); and
* At least 18 years of age.

Exclusion Criteria:

* Previous erlotinib therapy; or
* Planned concurrent chemotherapy; or
* Expected survival of less than 3 months; or
* ECOG Performance Status of 3 or 4; or
* Multiple CNS metastasis or a single CNS lesion that has not demonstrated radiologic stability (screening CT/MRI or head not required); or
* Granulocyte count \<1,500/mm3, platelet count \<100,000/mm3, or haemoglobin \<9.0g/dl; or
* SGOT (AST) or SGPT (ALT) \> 2.5 times (x) upper limit of normal (ULN) in the absence of known liver metastases or \> 5 x ULN in case of known liver metastases; or
* Alkaline phosphatase (ALP) \> 2.5 x ULN; or
* Serum bilirubin \> 1.5 ULN; or
* Serum creatinine \> 1.5 ULN or creatinine clearance \< 60 ml/min; or
* Serum calcium beyond ULN; or
* Patients requiring systemic anti-fungal therapy, clarithromycin, phenytoin, or oral anticoagulation therapy (see Appendix VI for complete list of medications); or
* A history of interstitial lung disease; or
* Known sensitivity to erlotinib; or
* Pregnancy, lactation, or parturition within the previous 30 days; or
* Unwillingness or inability to complete the required assessments of the trial; or
* Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful informed consent; or
* History of recurrent conjunctivitis or keratitis or other inflammatory changes of the surface of the eye.
* Geographically inaccessible for treatment or follow-up evaluations; or
* Involved in an ongoing therapeutic trial.
The Role of Gastroesophageal Reflux in Scleroderma Pulmonary Fibrosis

Scarring of the lungs is common in patients with scleroderma and is one of the main causes of death. Patients with scleroderma very frequently have problems with their gullet (esophagus), the food pipe that leads into the stomach.

Normally, a small circular muscle at the base of the esophagus opens to allow food to pass into the stomach and closes to keep the digestive fluids from flowing back up into the gullet. In patients with scleroderma, the muscle may become weak and no longer close properly. Gastroesophageal reflux (GER) is the medical term for reflux of stomach contents into the esophagus.

Our hypothesis is that small amounts of GER can move back up into the esophagus and get inhaled into the lungs, and may be one of the triggers for lung scarring. We propose to look for certain substances normally only found in the stomach in the "exhaled breath condensate" which is collected by breathing comfortably into a cooled cylinder, allowing the breath to condensate. In a smaller group of patients, we also plan to perform a bronchoalveolar lavage, a more widely studied test in which a small amount of fluid is introduced into a small part of the lungs through a fine tube, and then removed for examination, to evaluate whether the two tests provide similar measurements. We will also evaluate the correlation between these molecules and other tests, including lung function, and markers of lung scarring activity, and tests to look at how the esophagus is working so that we can get a clearer picture of how this affects patients' daily lives. Finally, we will be following up patients over time with lung function to see whether evidence of GER into the lungs is linked with a greater likelihood of worsening of lung scarring in the future.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 18 years
* Diagnosis of SSc (American College of Rheumatology criteria)
* Interstitial lung disease (\>5% extent of ILD on HRCT)
* Only for bronchoscopy: presence of troublesome cough and/or GER symptoms and/or recurrent chest infections and/or asymmetry of ILD changes on CT

Exclusion Criteria:

* Significant communication difficulties
* Unable to perform reliable lung function tests
* Current smokers
* Only for bronchoscopy: FEV1 less than 1L or DLCO less than 30% of the predicted
Temporalis Myofascial Flap Effectiveness

This research is conducted as trial to improve lifestyle of patients with cranio-maxillofacial defects following major insults like trauma or tumor resection in form of speech problems or dysphagia by usage temporalis myofascial flap and assessment of it's effectiveness


Eligibility Criteria:
Inclusion Criteria:

* patients with:

  * TMJ ankylosis

    * Osteomyelitis following mucormycosis
    * Following tumor resection like maxillectomy or temporal bone resection
    * Following orbital exentration due to tumors or infections
    * Following massive trauma
    * Facial reanimation

Exclusion Criteria:

* • History of head \& neck embolization as it may compromise blood supply of the flap

  * Extensive tumors involving maxillary artery
  * History of head \& neck radiation or chemotherapy
  * Temporalis muscle wasting due to any reason
  * Bad general condition
Effect of Immersive Virtual Reality on Pain in Different Dental Procedures in Children

the current study aims to assess virtual reality as an effective pain management technique for children undergoing different dental procedures.

The iWear is the immersive virtual reality device was used for this study from (Vuzix®, Rochester, New York, USA). The iWear consists of a lightweight high-end pair of video headphones that contain pair of VR goggles

The peadiatric dentist examined children to assess their needs. At the screening, a full mouth oral examination was performed. Different dental procedures needed were determined based on the outcome of the clinical examination performed. Some of these dental procedures did not require administration of local anesthesia (LA), such as fissure sealant, space maintainer, fluoride therapy, impression taking for space maintainers, and scaling. Other dental procedures require the administration of LA , such as stainless-steel crown, pulp therapy, restorations, and extraction (Figure 2). The peadiatric dentist divided the children into two groups (Group A \& B) according to the need for usage of LA. The children with dental procedures not requiring administration of LA were assigned to Group A, and the children with dental procedures requiring administration of LA were assigned to Group B. A computer-generated random number was used to randomly divide the children in Group A into two sub-groups(Group A1 \& A2) according to the usage of VR. Patients included in Group A1 randomly assigned to receive no VR. On the other hand, patients included in Group A2 randomly assigned to receive VR. Also, children in Group B were randomly assigned into two sub-groups (Group B1 \& B2) to receive no VR or VR respectively.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5-12 years
* Good general health,
* Taking no medications,
* Willingness to participate in the study

Exclusion Criteria:

* Subjects with a convulsive disorder,
* Subjects with a history of serious vestibular abnormalities,
* Subjects with musculoskeletal disorders, or developmental delay taking psychotropic drugs
Safety, Tolerability, and the Body's Ability to Develop Resistance to an Investigational Vaccine for Shingles (V211-007)

The purpose of this study is to determine the immunity (the body's protection) against shingles after receiving two doses of an investigational vaccine or placebo (a look alike vaccine with no active ingredients).

The duration of treatment is 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who are at least 60 years of age with a history of varicella (shingles)
* Females must have been postmenopausal.

Exclusion Criteria:

* Subjects who did not previously participate in the main study of this protocol.
* Subject had shingles since their 6 month follow-up visit in main phase of study.
89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111

This is an open-label, single center, pilot study to assess the feasibility of baseline 89Zr-trastuzumab PET/CT to predict response to treatment with monotherapy MT-5111


Eligibility Criteria:
Inclusion Criteria:

* Must meet eligibility criteria and be registered to receive treatment under Protocol MT-5111_001 (WU HRPO # 201907092).
* Must have at least one measurable lesion by RECIST 1.1 during the dose expansion phase of MT-5111_001. Osteosarcoma subjects with evaluable (e.g., bone-only) disease may be included.
* Must have standard of care 18F-FDG-PET/CT within 90 days before administration of 89Zr-trastuzumab OR be willing to undergo 18F-FDG PET/CT scan for research purposes.
* Able to undergo PET/CT imaging
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Hepatic only disease
* Pregnant or breastfeeding.