cyrilzakka/clinical-trials huggingface dataset:
COVID-19 and the Brain

The main objective of this project is:

1. To assess the impact of COVID-19 on the brain and executive functioning.

Twenty adult subjects of UZ Brussels (volunteers), who needed intensive care due to COVID-19 (n=10) or exhibited mild symptoms due to COVID-19 (n=10), will be recruited after hospital discharge. After signing an informed consent the subjects will undergo brain scans (T1, DTI, SWI, DWI, FLAIR MRI and rsfMRI), an emotion regulation task and a neurocognitive test battery. The latter test battery will be performed using an iPad and will test different neurocognitive functions such as memory, abstract thinking, spatial orientation and attention. The duration of the test battery is 18min. The total duration of one trial is estimated at one hour and a half. All tests are planned at the department of Radiology-Magnetic Resonance (UZ Brussel). After three months patients will visit the department of Radiology-Magnetic Resonance a second time for the same experimental trial. Additionally, a matched control group (n = 20; non covid or ICU patients) will be included and undergo the same tests in order to compare the results of the brain scans, emotional regulation task and neurocognitive test battery with results of both Covid-groups. Next to objective data, questionnaires will be filled out, i.e. visual analogue scales of mental and physical fatigue, Profile of Mood States and some additional return to work questions.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of UZ Brussels, who left the hospital and needed intensive care
* Adult patients of UZ Brussels, who left the hospital and exhibited mild symptoms
* Healthy volunteers (who never had COVID-19)
* Ability to give informed consent
* Dutch or French speaking

Exclusion Criteria:

* History of neurological diseases
Post-marketing Safety Study in Participants of All Pathologies Who Receive Gadolinium-Based Contrast Agents (GBCAs) for Contrast-Enhanced Magnetic Resonance Imaging (MR) Examination

The purpose of this study is to prospectively collect data on the pattern of use for gadolinium-based contrast agents (GBCAs) in real-life setting with special reference to Clariscan after its commercial launch in Europe and in addition quality of images, diagnostic confidence and customer satisfaction will be assessed on a Likert scale by the local radiologist/technician and spontaneously reported immediate and delayed adverse events (AEs) to assess the effectiveness and safety profile of GBCAs in clinical practice respectively.


Eligibility Criteria:
Inclusion Criteria: Participants may be included in the study if they meet all of the following criteria:

* Participants of all ages and both male/females
* Participants of all pathologies who require contrast-enhanced magnetic resonance (CE-MR) imaging as part of their diagnostic work up and the radiologist/physician has made the decision to use extracellular gadolinium-based contrast agents (GBCAs) as part of routine clinical practice
* Participants Who Provide informed consent to participate in study

Exclusion Criteria:

* Use of liver-specific GBCAs (Primovist and MultiHance when used for liver excretion properties)
A SU011248 Expanded Access Protocol for Systemic Therapy of Patients With Metastatic Renal Cell Carcinoma Who Are Ineligible for Participation in Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248

A SU011248 expanded access protocol for systemic therapy of patients with metastatic Renal Cell Carcinoma who are ineligible for participation in other SU011248 protocols but may derive benefit from treatment with SU011248


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic Renal Cell Carcinoma who are ineligible for participation in other SU011248 protocols but may derive benefit from treatment with SU011248
Timeliness of Immunization and Compliance Assessment Study

Although coverage for primary childhood immunizations has improved, a significant proportion of young children and pregnant women living in low-resource settings remain inadequately immunized. While young children receive some primary vaccines, many are never fully vaccinated. Progressive decline in immunizations are in large part attributable to poor follow-up and compliance. Major challenges include maintaining immunization records linked to positive identification of the individual child, incentivizing follow-up and return immunizations and efficiently identifying and targeting non-compliant subjects. Mobile-phone costs have decreased dramatically in the developing world with rapid proliferation of web and mobile-phone connectivity. Novel approaches that integrate these modern technologies with existing resources in low and middle income countries can cost-effectively address these challenges. In this proposal, investigators will evaluate a novel software platform, utilizing biometric identification and of subjects, paired with intelligent and subject-aware, mobile-phone reminders and compliance-linked incentives to improve uptake and coverage of primary vaccinations in young children.

A cloud-based, biometric-linked vaccination record, mobile-phone reminder and compliance-linked incentive software platform to provide robust and universal access of vaccinations. The investigators will implement this platform in a low-resource settings with the following features: a) Cloud-based for robust and universal access. b) Biometric-linked for positive identification. c) Digital storage and reporting for transparent view of program operations. d) Global Positioning System (GPS)-linked, allowing rapid assessment of vaccination status of communities. e) Increasing vaccination uptake and coverage by intelligent and subject-aware automated reminders and compliance-linked incentives.

Eligibility Criteria:
Inclusion Criteria:

* Mother (or caregiver) with one or more children ≤24 months in their family will be enrolled
* There will be no exclusion criteria based on race, ethnicity or gender.

Exclusion Criteria:

- Participants unable or unwilling to comply with the protocol or with any other condition that would impede compliance or hinder completion of the study (e.g. no mobile-phone in the family), or failure to give informed consent would be the only exclusion criteria.
Effect of Multisensory Stimulation on Upper Extremity Motor Recovery in Stroke Patient: a Preliminary Testing

Despite the advances in stroke rehabilitation, post-stroke upper extremity impairment is still a major challenge. Increasing evidence can be found supporting stimulation of the afferent receptor enhances neuroplasticity in the brain. Studies have suggested multisensory stimulation could promote motor learning by re-establishing the disrupted sensorimotor loop due to stroke and enhance neuroplasticity.

The objective of the study was to examine the effect of multisensory stimulation on upper-extremity motor recovery and self-care function in stroke patients.

Stroke patients referred to occupational therapy division of geriatric day hospital will be recruited and randomly assigned to a multisensory therapy group or a conventional training group. The Multisensory therapy group received 12 weeks (two sessions/ week; 90 minutes/session) training. Each session began with 15 minutes of sensory stimulation (cold and vibration), 45 minutes of motor training and 30 minutes of self-care training. The conventional training group included 12 weeks (two sessions/ week; 90 minutes/session) training. Each session included 60 minutes of upper extremity motor practice and 30 minutes of self-care training.

Outcome measures included: Brunnstrom's stage, Fugl-Meyer Assessment Scale and Functional Test for the Hemiplegic Upper Extremity were used for upper limb motor control and function; and Manual muscle testing was used for muscle strength. The modified Barthel Index was used for self-care performance

Eligibility Criteria:
Inclusion criteria:

* First-time ischemic or hemorrhagic stroke;
* Stroke onset \> 4 weeks and \< 6 months
* Single lesion
* Upper extremity motor deficit
* No severe cognitive impairment and able to follow verbal instructions.

Exclusion Criteria:

* Skin conditions/ injuries over the stimulation application areas
* Contraindication for cold or vibration application
* Speech disorder or global aphasia
* Musculoskeletal or cardiac disorders
* Other neurological conditions
* History of diabetes or sensory impairment attributable to peripheral vascular disease or neuropathy
Correlation of the Clinical Behaviour of Renal Cell Carcinoma (RCC) After Debulking Nephrectomy With Tumor Gene Expression in Nephrectomy Specimens

The objective of the study is to determine whether a specific immune microenvironment in the primary tumor is associated with a favorable clinical course after nephrectomy and in the absence of adjuvant treatment.

Renal cell carcinoma (RCC) is a tumor with clinically apparent immunologic phenomena, such as response to immunotherapies (interferon, interleukin-2, immune cellular therapy etc), spontaneous regression, and sometimes indolent behaviour. Nephrectomy itself influences the prognosis of advanced RCC patients as shown in 2 randomised trials, and could have an immune basis. We previously reported on the variability of clinical behaviour in advanced RCC patients who had not received systemic treatment after debulking nephrectomy (Debulking Nephrectomy Followed By A "Watch And Wait" Approach In Metastatic Renal Cell Carcinoma .Wong A, et al. Urol Oncol, in press). The clinical significance of this includes the avoidance of toxic systemic therapies after nephrectomy, or the possibility of using non-toxic vaccine approaches in metastatic patients after cytoreductive nephrectomy. In this research proposal we would like to analyse the immune related gene expression profile on nephrectomy tumor samples and correlate them with the clinical course of the patient after the nephrectomy. This will be an exploratory and retrospective study of 15 patients in whom debulking nephrectomy for advanced RCC had been done, who did not receive any adjuvant treatment, and in whom the clinical course had been monitored after the nephrectomy.

We will first carry out a feasibility study during which we will isolate RNA from 3 FFPE (formalin-fixed,paraffin-embedded) samples using commercially available RNA isolation kit and we will determine if their quality is compatible with quantitative polymerase chain reaction (qPCR) or microarray studies. Upon successful feasibility study, the analysis will be extended to 15 patients. RNA will be isolated from FFPE samples and the gene expression profiles will be evaluated by qPCR and/or microarray. Emphasis will be placed on the expression profile of immune-related genes. Finally, transcriptome analysis results will be extended at the protein and cell level using immunohistochemistry assays.

Eligibility Criteria:
Inclusion Criteria:

* Advanced RCC who had a cytoreductive nephrectomy done.
* Patients did not receive specific anti-cancer systemic therapy after the nephrectomy, except after clinical disease progression.
* Tumor samples available.
Ten Years Results of a Score System to Address Adjuvant Therapies After Breast Conserving Surgery for Ductal Carcinoma in Situ of the Breast

By this non-randomized prospective study, it's evaluated the outcome of patients underwent BCS for DCIS at whom an established score system to address adjuvant therapies have been prospectively applied, according to the wideness of free margins.

Between March 2000 and April 2006, 224 patients were enrolled and followed within the study.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years;
* female candidate to breast conservative surgery

Exclusion Criteria:

* female with previous omolateral or controlateral breast cancer;
* female with previous radiotherapy (RT).
COVID-19 Fourth Dose Study in Australia

This clinical trial will be a blinded, randomised study to determine the safety, reactogenicity, and immunogenicity of a second booster dose of SARS-CoV-2 vaccines in adults enrolled over two consecutive stages. Stage 1 will commence at the time of study approval and transition to stage 2 once bivalent vaccines are approved and available in Australia.

Participants will be adults aged 18 years or older who have been previously primed with two doses of either Pfizer-BioNTech (BNT162b2, or Comirnaty®) or AstraZeneca (ChAdOx1-S, or Vaxzevria®) and boosted at least 3 months earlier with Pfizer BioNTech vaccine (30µg). There will be no upper age limit. Participants will be recruited from the Murdoch Children's Research Institute, the Royal Children's Hospital (RCH), the Peter Doherty Research Institute, and, if necessary, the greater Melbourne area. Ideally, 100 participants will be recruited per group unless bivalent Omicron-specific vaccines are introduced before this target is reached for monovalent ancestral vaccines. There will be 800 participants in total. Procedures will be implemented to ensure participants of all ages (aged 18 and above) are included and that there is an even age distribution in each group (\<50 and ≥50 years).

Eligibility Criteria:
Inclusion Criteria:

1. Have completed a primary schedule of two doses of Pfizer-BioNTech or AstraZeneca vaccines and received a booster of Pfizer-BioNTech vaccine (30µg) at least 3 months earlier.
2. No confirmed SARS-CoV-2 infection on PCR or RAT within the last 3 months.
3. Willing and able to give written informed consent.
4. Aged 18 years or above.
5. Willing to complete the follow-up requirements of the study.

Exclusion Criteria:

1. Currently receiving immunosuppressive medication or anti-cancer chemotherapy.
2. Known HIV infection.
3. Congenital immune deficiency syndrome.
4. Received immunoglobulin or other blood products in the three months prior to potential study booster vaccination.
5. Study staff and their relatives.
6. Have a history of a severe allergic reaction to any COVID-19 vaccines or have a medical exemption to receiving further COVID-19 vaccines.
7. Cannot read or understand English.
Caffeine Disposition After Inhalation

The purpose of this study is to determine how fast caffeine gets into your body with a product called Aeroshot™. Aeroshot™ is a lipstick sized device that you slide open and then put your mouth over the opening and inhale. A fine powder containing 100 mg of caffeine is deposited on your tongue and the inside of your mouth. Caffeine will be absorbed through the membranes in your mouth or swallowed and then absorbed in your stomach. We will compare the absorption of caffeine after using the Aeroshot™ with the absorption after drinking an energy drink by taking 15 blood samples over 8 hours and measuring the caffeine levels in your blood. You will also be asked to fill out some scales to measure the effects you feel after the caffeine dose. We hypothesize that caffeine absorption after inhalation will be faster than after an energy drink.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer
* non-smoker

Exclusion Criteria:

* Take chronic medication
* Co-existing diseases
* Platelet count less than 100,000/uL (per microliter)
* Acute or chronic psychiatric condition
* Consume more than 300 mg of caffeine per day
* Participated in another study within last 30 days or donated blood in last 6 weeks
To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of Glabellar Lines

To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 65
* Patients attaining grade 2 or 3 in the investigator's rating of glabellar lines severity at maximum frown
* Patients who voluntarily sign the informed consent
* Patients who can comply with the study procedures and visit schedule

Exclusion Criteria:

* Subjects who had facial plastic surgery (tissue augmentation, brow lift, and dermal resurfacing)treatment within 6 months. Those who had peeling or laser therapy
* Subjects with skin disorders, scar or infection around glabellar region
* Subjects who are taking Aspirin, NSAIDS or anti-coagulant
* Subjects with facial palsy or eyelid ptosis
* Subjects who diagnosed as neuromuscular junction disorder (e.g., myasthenia gravis, Lambert-Eaton Syndrome)
* Subjects with history of drug intoxication, alcohol abuse and/or depressive disorder
* Subjects with severe internal diseases (cardiovascular, respiratory, renal disease, liver disorder)
* Subjects who have previously been treated with botulinum toxin within 3 months (Botulinum toxin type A: 3months, type B: 4 months)
* Subject who have administered following drugs within the previous 4 months: Spectinomycin Hydrochloride, Aminoglycoside antibiotics, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics, muscle relaxants, anti-cholinergic agents, benzodiazepine and similar drugs, benzamide drugs, Tubocurarine-type muscle relaxants
* Subjects who have possibility to take the drugs listed above
* Subjects who have a plan to receive facial cosmetic procedures including dermal filler, chemical peeling and dermabrasion during study period
* Subjects who have glabellar lines that are unable to be improved with any physical method
* Subjects who have history of hypersensitivity to Botulinum toxin and other agents
* Subjects who are pregnant or breast-feeding
* Subjects who have a plan to be pregnant in 3months, or who are not doing contraceptive
* Subjects who participated in other studies within 30 days or were not passed over 5 times of half life for investigational product
* Subjects who are having trouble with acute disease
* Subjects who have taken any treatment that can affect to glabellar lines and/or any lines around forehead within the previous 6 months
* Subjects who are unable to communicate or follow the instructions
* Subjects who are not eligible for this study based on investigator's judgement
AI-guided Prognostication and Cranial Radiotherapy Optimization in EGFR-TKI-treated Non-small Cell Lung Cancer Patients With Baseline Brain Metastases

The goal of this observational study is to extract the imaging features of brain lesions and primary lung lesions in NSCLC patients with brain metastases by deep learning, as well as common clinicopathological parameters, which are used to construct a multimode model that can accurately predict the treatment efficacy and survival of the third-generation EGFR-TKI treatment, and to use the model to assist in screening high-risk populations suitable for upfront cranial radiotherapy.

Participants receiving third-generation EGFR-TKI treatment will be enrolled in our study and we will collect their regular contrast-enhanced chest CT and contrast-enhanced brain MRI for model construction.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed non-small cell lung cancer;
* clinical stage IV (AJCC, 8th edition, 2017);
* EGFR sensitive mutations: EGFR L858R, EGFR exon 19 deletion;
* age≥18 years old;
* KPS score≥70;
* brain metastases at diagnosis;
* complete systemic imaging (including brain MRI) before third-generation EGFR-TKI treatment;
* received standard third-generation EGFR-TKI therapy (monotherapy or combined with brain radiotherapy);
* willing to cooperate with the follow-up after third-generation EGFR-TKI treatment;
* informed consent of the patient.

Exclusion Criteria:

* Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);
* Pregnant or lactating women who, as judged by the investigator, were not candidates for brain MRI;
* EGFR sensitive mutations were negative or EGFR mutation status was not detected.
* Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.
Enhancing Adaptations to Exercise

Researchers are trying to understand how chronic inflammation affects muscle function and responses to exercise.They are also trying to determine if suppressing chronic inflammation using omega-3 fatty acids (n3-PUFA) restores skeletal muscle function and exercise responsiveness in older adults.

Participants will be divided into two groups. Men and women between the ages of 20-35 years and 65-85 years. Participants in the older age group will be randomly assigned to receive groups (n3-PUFA or placebo (soybean oil)) in a double-blind manner. Before and after the intervention, all participants will complete an outpatient study day (body composition, blood draw, treadmill test, strength test) and an inpatient study day (muscle biopsies, fat biopsies, indirect calorimetry, exercise test, mixed meal test). During the intervention phase of the study, participants will be instructed to swallow 2 softgels twice per day with meals (morning and evening) for a total of 4 softgels per day. Every 4 weeks, participants will report to the Clinical Research and Trials Unit (CRTU) to pick up a new prescription and return any remaining capsules from the previous prescription. On the day they pick up prescription refills, participants will report to the CRTU for a fasting blood sample. The duration of the intervention will be 6 months.

Eligibility Criteria:
Inclusion criteria:

* Men and women between the ages of 20-35 years
* Men and women between the ages of 65-85 years

Exclusion criteria:

* Regular use of omega-3 nutritional supplements
* Diabetes or fasting plasma glucose \> or equal to 126 mg/dL
* Anemia (female subjects hemoglobin of \<11 g/dl and male subjects hemoglobin \<12 g/dl)
* Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment)
* Renal failure (serum creatinine \> 1.5mg/dl)
* Chronic active liver disease (AST\>144 IU/L or ALT\>165 IU/L)
* Oral warfarin group medications or history of blood clotting disorders.
* international normalized ratio (INR) \>2.01.5
* Smoking
* Pregnancy or breastfeeding
* Alcohol consumption greater than 2 glasses/day or other substance abuse
* Untreated or uncontrolled hypothyroidism
* Debilitating chronic disease (at the discretion of the investigators)
* Fish or shellfish allergy