cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants

The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of JNJ61803534 in healthy participants after administration of single ascending oral doses of JNJ-61803534 (Part 1) and multiple ascending oral doses of JNJ-61803534, administered for 14 consecutive days (Part 2) as well as the potential of JNJ-61803534 to interact with other drugs (Part 3).


Eligibility Criteria:
Inclusion Criteria:

* Participant must have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2) (BMI = weight/height\^2), and a body weight of not less than 50 kilogram (kg)
* Participant must be healthy on the basis of their medical history, a physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed during screening
* Participant must be healthy on the basis of clinical laboratory tests performed during screening and at Day -1
* A woman must have a negative urine pregnancy test at screening and a negative highly sensitive serum pregnancy test on Day -1

Exclusion Criteria:

* Participant has a history of liver or renal insufficiency or significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, dermatologic, rheumatologic, psychiatric, or metabolic disturbances
* Participant has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
* Participant has an active acute or chronic infection (including chronic recurrent or invasive candidiasis) or diagnosed latent infection
* Participant has received an investigational treatment (including investigational vaccines) within 2 months or 5 half-lives (whichever is longer) or used an invasive investigational medical device within 3 months before the planned first dose of study treatment or is currently enrolled in an investigational study
* Participant had major surgery, (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study or within 4 weeks after the last dose of study treatment administration
GI Tolerance and Acceptability of a New Thickener

The current study is designed to evaluate the gastrointestinal tolerance and acceptability of a new thickener for dysphagia patients.


Eligibility Criteria:
Inclusion Criteria:

* Subject has voluntarily signed and dated an ICF approved by an IRB/IEC, and provided applicable privacy authorization prior to any participation in the study.
* Subject is diagnosed with dysphagia.
* Subject is under the care of a Speech and Language Therapist and is currently using a thickener.
* Subject currently has normal GI function.
* Subject is interested in participating in the study, willing to comply with the study protocol and product.
* Subject who is able to consent and is able to evaluate the product.

Exclusion Criteria:

* Subject has a normal swallow.
* Subject at high risk of aspiration with oral fluids requiring nil by mouth and enteral tube feeding.
* Subject has impaired renal function.
* Subject has liver failure, decompensated chronic liver disease, active hepatitis B or C receiving treatment, or hepatic encephalopathy.
* Subject has severe dementia or unable to communicate or consent or delirium, eating disorder, history of significant neurological or psychiatric disorder affecting abilities to answer questions, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures.
* Participant is known to be allergic or intolerant to any ingredient found in the study product.
* Participation in another study that has not been approved as a concomitant study.
* Subject has a clinical condition that is contraindicated with this product such as hepatic and renal disease.
* Subject has a clinical condition which may interfere with gastrointestinal tolerance.
* Subject is pregnant.
Extracellular Vesicles as Potential Biomarkers and Therapeutic Target in Gaucher Disease

This is an observational study intended to generate preliminary data to understand how lysosomal dysfunction can affect the biogenesis of extracellular vesicles, its content and function. The primary objective of the proposed project is to decipher how extracellular vesicle (EV) biogenesis and its role in intercellular communication can be impaired as a consequence of defects in lysosomal function. Collectively these defects in EV biogenesis and function can contribute to the neuroinflammation observed in lysosomal storage diseases. Since EVs can cross the blood-brain barrier, their characterization may be valuable in identifying novel biomarkers. In the presence of a GBA1 mutation, the decrease in GCase activity will lower overall lysosome function and increase the secretion of EVs. Further, there will be differences in EV size, its cargo including lipids, RNA and proteins and their aggregates. In comparison to healthy controls, EVs isolated from patients with Gaucher disease (GD) and GBA1 carriers is hypothesized to show significant differences in terms of its characteristics and content, which can contribute to our understanding of the link between lysosomes and neurological disease.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-80yrs
* Restricted to participants who are untreated, obligate carriers and healthy controls.
* Participants with GD should have confirmed GD diagnosis, mutation confirmed for carriers and healthy controls confirmed to have no GBA1 mutation by gene sequencing.

Exclusion Criteria:

* Exclude participants who have any hematological malignancy or other uncontrolled comorbid conditions.
* Exclude participants who are currently on therapy for their GD
* Exclude participants who have any hematological malignancy or other uncontrolled comorbid conditions.
Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM005 in Patients

68Ga-NYM005 is a CAIX-targeting small-molecular radiotracer for PET/CT imaging of clear cell renal cell carcinoma


Eligibility Criteria:
Inclusion Criteria:

1. Patients with pathologically confirmed metastatic renal clear cell carcinoma;
2. Age range from 18 to 75 years old (including 18 and 75 years old);
3. ECOG score of 0 or 1;
4. Expected life \> 6 months;
5. GFR\> 60 ml/min;
6. Women of childbearing age need to have a negative pregnancy test, and the subjects(including male subjects)agree to take effective contraceptive measures during the study period and for at least three months after the drug administration;
7. The subjects are able to maintain good communication with the researchers；understand and follow the requirements of this study and sign an informed consent form before the start of relevant research operations.

Exclusion Criteria:

1. Pregnant or lactating women, or women who plan to conceive during the study period or within three months after drug administration;
2. Known or suspected to be allergic to the investigational drug or any of its components,acetazolamide or other sulfonamides:
3. Accepting other investigational drugs upon enrollment, or within 5 biological half-lives of the drug at enrollment, or within 30 days after its last administration, whichever is longer;
4. Those who have used any radioactive therapy medication within 90 days before investigational drug administration, or have received any radioactive diagnostic medication within 3 days before investigational drug administration;
5. On VEGF TKI treatment less than 7 days before 68Ga-NYM005 PET/CT, such as sunitinib,sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NYM005 PET/CT is required;
6. Planned (for the period between injection of 68Ga-NYM005 and imaging) antineoplastic therapies;
7. Plan to arrange surgery and other invasive interventions within 2 days after the injection of the investigational drug;
8. Ongoing toxicity \>grade l from previous standard or investigational therapies；
9. Patients with active infections during screening;
10. Those who have no guarantee of being able to lie down quietly in the examination cabin during a PET examination, or those who suffer from claustrophobia and cannot cooperate in a PET examination:
11. Other situations where the researchers believe that the subject is not suitable for inclusion in this study.
Postoperative Prognosis Management Service Based mHealth for Colon Cancer Patients

Recently, the use of mobile health is increasing for the purpose of managing prognosis such as recurrence, survival and quality of life by using a wearable smart band and a smartphone application. In the era of the 4th revolution, mobile health for the purpose of comprehensive prognosis for cancer patients is becoming a very good tool.

It is possible to confirm the clinical significance of short-term and temporary health care through a mobile application and a smart band during the treatment process for cancer patients, but the study is insufficient to generalize the number of subjects.

Therefore, for colon cancer patients who need prognosis management after surgery, we will investigate the effect of a mobile application using a smart band which has a modular structure reflecting the treatment method and treatment process after surgery.

This study targets patients who underwent prostate cancer surgery. An intervention group (App+IoT device) uses a smart care application for 12 months. This application was tailored for prostate cancer patients and created by reflecting the treatment process after surgery. And they also uses a wearable smart band for 12 months. Control group is provided general education through the hospital brochure. Evaluation will be conducted 2-3days after surgery (before discharge), and at 1, 3, 6, and 12 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Those who have been diagnosed with colorectal cancer and have undergone surgery (not related to chemotherapy treatment)
* Patients aged 19 to 75 years old
* Those who can use prognosis management applications and can perform regular follow-up inspections outpatients
* Patients carrying Android or iOS smartphones
* Patients who voluntarily decide to participate and give written consent after hearing detailed explanations about this study

Exclusion Criteria:

* Those who are judged to be difficult to perform smartphone exercise and dietary management for colorectal cancer in general due to uncontrolled severe or underlying diseases, neuromuscular and musculoskeletal diseases
* Serious complications of Clavein dindo classification grade 3 or higher after surgery
* Patients who were not discharged within 2 weeks after surgery
Impact of Early Goal-Directed Therapy to Perfusion and Metabolism of Brain

Early goal directed therapy (EGDT) is an effective treatment for patients with septic shock, which is widely used in clinic. Fluid resuscitation can significantly reduce the mortality of patients with septic shock and improve the prognosis of patients with EGDT. However, in recent years, the standard of EGDT to determine the existence of the target of septic shock. Some studies have shown that there may be a manifestation of the deficiency of kidney and liver and other organs such as kidney, liver and other organs in the recovery of EGDT. Therefore, this experiment is to explore the brain perfusion and metabolism of the EGDT when the target is reached.The aim of this study was to investigate the effects of EGDT as a guide to the cerebral perfusion and metabolism in order to provide clinical evidence for the treatment of fluid resuscitation in patients with septic shock.

1. patients enrollment this project: Met the inclusion criteria without exclusion criteria were entered test, and record the general information, including name, hospital number, gender, age, height, weight, admission, and in time, ICU admission and in ICU diagnosis, previous underlying diseases, into the group of APACHE II score and SOFA score
2. implement septic shock bundle: measurement the value of lactic acid of patients after administrating of ICU, take blood culture before antibiotic using, give wide-spectrum antibiotic treatment and began liquid resuscitation
3. preparation： A. basic state records B. using CAM-ICU delirium assessment for patients, and record the assessment results C. cerebral oxygen saturation monitor D. via the jugular vein placed central venous catheter and femoral artery placed PiCCO catheter
4. monitoring of hemodynamics and cerebral perfusion and metabolic indicators

Eligibility Criteria:
Inclusion Criteria:

* New infectious shock in accordance with the diagnostic criteria of the 2012 SSC guidelines；
* Liquid recovery is not fully achieved EGDT standards, at least meet the following criteria:

  * mean arterial pressure \< 65mmHg
  * central venous pressure \< 8mmHg
  * per hour urine volume was less than 0.5ml/kg
  * central venous oxygen saturation \<70%
  * arterial blood lactic acid value \> 2.5mmol/L
* Signed informed consent

Exclusion Criteria:

* Subjects/subjects client reject the invasive hemodynamic monitoring
* have contraindications to place hemodynamic monitoring
* unconsciousness state before septic shock and GCS\<12
* cannot put the electrodes on the eyebrow
* pregnant or lactating women
* end stage of illness or death rate is more than 80%
Influenza Vaccine in Lung Transplant Patients

This 5-year study was designed to investigate how antibody and T cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation, and healthy individuals.

\[Note: there are 6 ClinicalTrials.gov records associated with this study, each representing a different sub-study of the population over the 5-year period, please see NCT04533061, NCT04533139, NCT04531787, NCT04530786, and NCT04531657 for related data\]

Although pre-transplant immunization is routinely recommended, this recommendation is based on little data. The primary objective of this study is to compare antibody responses in lung transplant patients who receive influenza vaccine before transplant, within the first six months of transplant, between 13 and 60 months post-transplant, and 110 months or beyond transplant.

This prospective cohort study is to include immunization events performed over five years to measure H1N1, H3N2, and B antibody responses to the influenza vaccine in pre- and post-lung transplant patients. The pre-transplant patients will move to the post-transplant group as the study progressed. Similarly, participants are allowed to move to the next time-since-transplant group as time elapsed.

Serum was collected from participants prior to and two-four weeks following trivalent inactivated influenza immunization for each season.

Geometric mean titers, seroprotection (antibody titer at least 1:40), seroconversion (fourfold increase between pre and post), and mean fold increases will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Receiving care pre- or post-lung transplant at University of Wisconsin Hospital
* Healthy adult

Exclusion Criteria:

* Allergy to eggs
* Moderate to severe febrile illness
* Active treatment for acute rejection
* Received season's influenza vaccine prior to enrollment
Awareness of COVID-19 in Turkey

Because COVID-19 is a new virus, it is believed that awareness assessment will inform and guide what steps should be taken and which groups should be targeted in terms of controlling the pandemic. According to our hypothesis, COVID-19 awareness of individuals in different age groups in the Turkish population also varies. There are controlling pratices based on scientific studies made during the outbreak, but there is no certainty as to how much these measures are known by our society. Based on these, the aim of our study was to investigate and compare the awareness of new Coronavirus (COVID-19) in different age groups across Turkey.

Statistical Analysis: In the statistical analysis of the data obtained at the end of the study, SPSS (Statistical Package for Social Sciences / SPSS 21.0) was analyzed using the statistical program. In the study, arithmetic averages are presented with tables and graphs as mean ± SD (standard deviation) and values indicated by counting in numbers (percent). Demographic information of the participants and their responses to the questionnaire questions were evaluated using descriptive statistical analysis method. In the study, Independent Sample t Test was used in parametric data and ANOVA was used in normal non-parametric data. In all analyzes, p \<0,05 was considered statistically significant.

Sampling: Sample size was calculated based on the number of questions asked. Accordingly, the number of questions multiplied by the formula of 60 is the lower limit (42\*60=2520). Considering the 20% probability of a drop-out and the fact that participants did not want to volunteer, it was decided to take 3150 people to the study. Consent will be obtained from the participants through a voluntary information form.

Eligibility Criteria:
Inclusion Criteria:

* Having at least primary education
* Being literate in Turkish
* There is a level of cooperation to understand the evaluations
* Agree to participate in the study

Exclusion Criteria:

* Those with audio and visual problems that prevent communication
Effectiveness of Mobile Applications During the Administration of Local Anesthesia in Pediatric Dentistry

To evaluate the mobile games' effect on patient acceptance of local anesthesia and decreasing dental pain and anxiety levels in pediatric patients.

a randomized clinical trial with parallel-group and allocation ratio (1:1). intervention group: mobile application (little lovely dentist) control group: Tell-Show-Do technique. in children aged 4-6 years who need local anesthesia for dental treatment during their first dental visit.

For both groups:

Verbal assent from participating patients and written consent from their legal guardians will be taken.

1. Taking personal data, medical and dental history.
2. Diagnosis and determination of the required treatment.
3. Measuring preoperative anxiety using a pulse oximeter.
4. Evaluate preoperative anxiety using RMS-pictorial scale.
5. Using the behavior guidance technique:

   Intervention group: Allow the child to play the module simulating the required procedure. Control group: tell-show-do technique is used to explain the procedure to the child
6. Administration of local anesthesia and evaluation of child behaviour during the administration of local anaesthesia using Venham's behaviour rating scale and Frankl behaviour rating scale .
7. Measuring postoperative anxiety using the pulse oximeter.
8. Evaluate postoperative anxiety using RMS-pictorial scale.
9. Evaluate postoperative pain using the visual analog scale.

in second visit (after 1 week)

1) Evaluation of child behavior during the second dental visit using Venham's behavior rating scale and Frankl behavior rating scale. outcome:

1. ry: Pre and postoperative anxiety using Pulse oximeter and RMS-pictorial scale.
2. ry: Postoperative pain using Visual analog scale, evaluation of attitude during the administration of local anaesthesia at first and second dental visits using -Venham's behavior rating scale-Frankl behavior rating scale. the study will be held in 2 visits.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 4-6 years.
* Children without any systemic or mental disorders.
* Children without any prior experience with the dental environment or treatment procedures (first dental visit).
* Children whose behavior could be rated as positive or negative based on the Frankl behavior rating scale.

Exclusion Criteria:

* Children seeking dental treatment that does not necessitate local anesthesia.
* Children suffering from any systemic or mental disorders.
* Children who are not willing to participate in the study
Improving Motor Stroke Recovery Using Patient-tailored Non-invasive Brain Stimulation

Many individuals are often left with problems moving their arm and hand, months to even years after a stroke. Recent progress in research suggests the application of non-invasive brain stimulation, such as transcranial direct current stimulation (TDCS), in conjunction with rehabilitation exercises can further improve a person's ability to move after stroke. However, the problem is that this doesn't work for everyone, and researchers do not know why. One reason may be that TDCS is currently applied using a one-size-fits-all approach. Researchers apply the same type of TDCS to everyone, assuming the stroke affects everyone in the same way. But, researchers know this is not the case. For example, each person will likely have different amounts of damage to brain regions that control movements. A better understanding of how the stroke uniquely affects a person's brain will help us to know which is the correct type of TDCS to apply for that person. Therefore, the objective of this research is to determine whether the amount of damage to brain regions that control movements can predict which type of TDCS will be more effective to help a person improve their ability to move. Participants will undergo 1 session of magnetic resonance imaging, and three sessions of TDCS.


Eligibility Criteria:
Inclusion Criteria:

* unilateral first time stroke in middle cerebral artery territory
* greater 3 months post-stroke
* able to raise arm onto a table from a seated position

Exclusion Criteria:

* severe cognitive or comprehension deficits that may compromise informed consent or understanding of instructions
* severe apraxia and neglect
* neurodegenerative or psychiatric disease
* contraindications to MRI and TDCS (e.g. metal in head, pacemaker, claustrophobia)
Study of Metabolic Changes in the Transformation Malignant Precancerous Skin Lesions

Skin carcinomas are the most frequent cancers in the world, including basal cell carcinomas and cutaneous squamous cell carcinoma (cSCCs), with more than 60.000 new annual cases in France. Their incidence increases mainly due to ultraviolet (UV) exposure and population ageing. Then from 1994 to 2006, the incidence of cSCC has increased by 300%. CSCCs typically manifests as a spectrum from a precursor actinic keratosis (AK) - possible spontaneous regression at this stage- to in situ cSCC invasive cSCC and finally metastatic cSCC.

Although growing evidence indicates that bioenergetic metabolism plays an important role in the progression of tumorigenesis, little information is available on the contribution of reprogramming of energy metabolism in cancer initiation and how it influences further the bioenergetic behavior of tumors.

By applying a quantitative proteomic approach, the consortium has recently found that specific metabolic modifications precede cSCC.

This study will investigate the role of energy metabolism in malignant transformation of premalignant skin lesions into cSCC, and in cSCC progression, with correlation with clinical characteristics and metastatic outcomes. Using several cutting-edge technologies in human samples, the team will evaluate whether targeting energy metabolism has the potential to be used as curative treatments for cSCC and whether pre-determined metabolic alterations could be exploited as new preventive strategies. These modifications in energy metabolism could be used as prognostic and diagnostic biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Every patient with suspected lesion :

  * AK,
  * in situ cSCC,
  * infiltrative cSSC
  * cSCC with recurrent disease
  * cSCC with cutaneous metastases.
* Patients 18 years of age or older,
* Patients with suspected AK or BCC lesions (in situ, infiltrating or metastatic),
* Patient able to sign a consent form,
* Patient affiliated with a Social Security system.

Exclusion Criteria:

* Prior systemic treatment such as checkpoint inhibitors or chemotherapy.
* Patients with cSCC or AK localized on visible zone of the face or folds