cyrilzakka/clinical-trials huggingface dataset:
NIRS Directed Optimal Cerebral Perfusion Pressure on the Outcome of Aneurysmal Subarachnoid Hemorrhage Patients

Objectives: To investigate the impact of NIRS directed optimal cerebral perfusion pressure on the outcome of aSAH patients.

Study design: A multicenter, single-blinded, randomized controlled trial. Setting: Departments of critical care medicine of tertiary hospitals in China. Patients: 150 aSAH patients (≥ 18 years old) who admitted to ICU (predicted ICU duration time ≥ 24 hours)

Intervention:

Patients with aSAH will be randomly divided into the control group and the intervention group. The control group will follow the SAH guidelines. The intervention group will be given continuous NIRS and invasive blood pressure monitoring at same time. The correlation curve between the brain oxygenation index or the brain hemoglobin index (ORI/THx) and the blood pressure will be obtained through continuous monitoring. According to the correlation curve, the optimal blood pressure will be determined which provides the optimal CPP. Then the goal of blood pressure (within 5 mmHg of CPPopt) will be maintained as the target of blood pressure management for the intervention group during ICU stay.

Primary outcome: Neurological prognosis (GCS score，GOS score, and NIHSS score when discharge from ICU; GOS score at 6 months), etc.

Predicted duration of the study: 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Admitted to ICU because of aSAH.
* Predicted to stay in ICU ≥ 24 hours
* Provide written informed consent.

Exclusion Criteria:

* Unable to perform NIRS monitoring because of anatomic factors;
* Patients with severe organ failure;
* In addition to aneurysmal subarachnoid hemorrhage, there are other serious intracranial diseases (intracranial infection, cerebral hemorrhage, cerebral infarction, brain trauma, other patients after intracranial surgery);
* Patients with carotid plaque or thrombus;
* Patients with severe intracranial pneumatosis after craniotomy.
The Pilot Study of High-throughput Sequencing in Neonatal Birth Defects

In China, birth defects can reach as high as 5.6%, about 900,000 new cases of birth defects are added each year, making it the second cause of death for infants, with a total death rate of 19.1%. At present, China implements the three-level prevention and control system for birth defects, which is performed before marriage, before birth, and during the neonatal period. Newborn screening is the last line of defense against birth defects. Early screening diagnosis and timely intervention are extremely important, especially for diseases which can be preventive and treatable. This study aims to evaluate the clinical application of high-throughput targeting sequencing in newborns, and investigate whether this new technology can significantly shorten the time of examination, improve the diagnosis rate, guide the intervention treatments and promote prognosis for these disease.


Eligibility Criteria:
Inclusion Criteria:

1. Neonates in one of the study hospitals
2. Abnormal laboratory testing or abnormal response to standard therapy suggestive of a genetic disease

Exclusion Criteria:

1. Any infant whose genome has been shown to have large chromosomal aberration (Trisomy 13, 18, 21 or other)
2. Any infant in which clinical considerations preclude drawing 1.0 ml of peripheral blood
3. Parents refuse consent
Efficacy of Coconut Oil With Peppermint Essential for Oral Hygiene Routine

This randomized clinical trial will be conducted to investigate the efficacy of an innovative tooth cleaning agent extra virgin coconut oil with peppermint essential oil by oil pulling and toothbrushing with oil on reducing salivary Streptococcus mutans levels, tooth decay and plaque buildup versus on the counter toothpaste in high caries risk patients.

Everyday use of dental health care products has increased. Therefore, there is a legitimately increased interest of healthcare clinicians and consumers in substances added to the toothpaste with the intention to improve their performance and potential benefits and risks that may arise from it. As there are harmful products in the toothpaste for instance: (Fluoride, Sodium Lauryl Sulphate (SLS), Sodium Saccharin and Triclosan which is assumed that it because local reaction includes oral mucosa irritation and desquamation (stomatitis, glossitis, gingivitis, buccal mucositis), while systemic ones are allergic and acute or chronic toxic reactions. Rational Harmful products in the toothpaste for instance: (Fluoride, Sodium Lauryl Sulphate (SLS), Sodium Saccharin and Triclosan which is assumed that it because local reaction includes oral mucosa irritation and desquamation (stomatitis, glossitis, gingivitis, buccal mucositis), while systemic ones are allergic and acute or chronic toxic reactions.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be recruited in this study, will be medically free.
* Age range 20-50 years
* Patients with high caries risk assessment (0- 30% high caries risk) according to Cariogram - a multifactorial risk assessment model for dental caries.
* Non-Smoking patients
* Not under antibiotic therapy either at the time of the study or up to the last month before the start of the study.
* Male or Female patients
* Patients have brushing habits
* No Fixed orthodontic treatment
* No active or untreated caries
* Patients on non-cariogenic diet

Exclusion Criteria:

* Patients with a compromised medical history.
* Patients with low caries risk assessment according to Cariogram - a multifactorial risk assessment model for dental caries.
* Patients with severe or active periodontal disease.
* Patients with a history of allergy to any of the drugs or chemicals will be used in the study.
* Patients on any antibiotics during the past month.
* Smoking patient
* Patients with very low saliva secretion xerostomia less than 0.5ml stimulated saliva /min score 3 according to Cariogram
* Pregnant female patient
* No brushing habits
* Fixed orthodontic treatment
* Active or untreated caries
* Patients on cariogenic diet
Demographic Data and Clinical Presentation of Pediatric Uveitis

To describe and analyze the demographics, Clinical characteristics, etiology, and visual outcomes of pediatric uveitis cases attending the outpatient clinic of Ophthalmology department, Assiut University Hospital.

Uveitis is a form of eye inflammation that affects the middle layer of tissue in the eye wall (uvea).

It is the third leading cause of blindness worldwide .Uveitis is more common in adults; however, children comprise 2.2% to 21.6% of patients in various studies.Despite a lower incidence of uveitis in children, the rate of visual loss may be worse than that of adults . The onset of uveitis in children is often insidious and is only discovered during routine screening.The lack of significant symptoms and delayed presentation to an ophthalmologist leads to morbidity and a decrease in visual acuity . The length of time between the diagnosis of uveitis and the referral to a tertiary eye center is strongly correlated with the complications rate and degree of visual impairment.

Uveitis is classified according to the International Uveitis Study Group criteria based on the anatomical location of the inflammation and is categorized as anterior, intermediate, Posterior or panuveitis. It is also described based on clinical onset, duration and course.

Some uveitis syndromes are unique to children, such as juvenile idiopathic arthritis (JIA), Kawasaki syndrome, Familial Juvenile Systemic Granulomatosis and Tubulointerstitial Nephritis-Uveitis syndrome. Other conditions are more prevalent in the pediatric population due to environmental factors such as trematode induced uveitis.

Due to the lack of epidemiological studies on the demographic and Clinical Characteristics of pediatric uveitis in Upper Egypt. This study aims to improve diagnosis, management, and treatment strategies tailored to the population.

Eligibility Criteria:
Inclusion Criteria:

* Uveitis patients \<18 years old
* must be able to participate in the study.

Exclusion Criteria:

* Age over 18 years.
* Patients with post pentrating ocular trauma.
* Patients whose legal guardians are unwilling to participate in the study.
The Use of Eye Patches and Earplugs in Intensive Care in Cases of Craniotomy.

This study aims to evaluate the effects of using eye patch and earplugs on anxiety, patient comfort, and sleep quality after craniotomy. The study will be carried out in a hospital located in the Northwest of Turkey. A total of 60 patients meeting the research criteria will be randomized to intervention and control groups. An eye patch and earplug will be applied to the intervention group in the intensive care unit on the day of craniotomy and on the post-operative 1st day between 22:00 and 06:00. Standard care procedure will be applied to the control group. Richard-Campbell Sleep Questionnaire, Aktiwatch, Hospital Anxiety and Depression Scale and General Comfort Questionnaire will be used to collect study data.

This study was designed as a non-drug clinical study with 2 randomly selected groups to evaluate the effect of eye patch and earplug use on sleep quality, anxiety and comfort level in patients hospitalized in the intensive care unit after craniotomy. The study will be carried out in a hospital located in the Northwest of Turkey. A total of 60 patients meeting the research criteria will be randomized to intervention and control groups. An eye patch and earplug will be applied to the intervention group in the intensive care unit on the day of craniotomy and on the post-operative 1st day between 22:00 and 06:00. Standard care procedure will be applied to the control group. Richard-Campbell Sleep Questionnaire, Aktiwatch, Hospital Anxiety and Depression Scale and General Comfort Questionnaire will be used to collect study data.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective craniotomy and intensive care for at least 48 hours
* Glasgow Coma Scale score = 15
* Turkish literate

Exclusion Criteria:

* Diagnosis of sleep disorder
* Hearing and/or vision loss
* Hearing aid use
* Pregnant women
* Communication and/or cooperation problem
* Chronic pain medication
Changes of the Neuronal Activity in the Subthalamic Nucleus Under Remifentanil Sedation During Stereotactic Electrode Implantation

Deep brain stimulation is commonly used for the treatment of movement disorders. Electrode positioning is usually performed under local anesthesia in fully awake patients. The procedure is uncomfortable to the patients who has to remain motionless during the whole surgery. Previous reports of electrode positioning under general anesthesia was found to be less accurate. This result was probably due to the effect of the anesthetics on the electrical activity of the basal ganglia.

The purpose of this study is to detect possible changes in the electrical activity of the basal ganglia related to remifentanil sedation. electrical activity of single neurons will be recorded before, during and after sedation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with movement disorder, who are candidates for implantation of deep brain stimulation electrode.

Exclusion Criteria:

* Suspected difficult intubation
* history of sleep apnea
* known allergy for remifentanil
Joint Outcome Study Continuation for Children With Severe Factor VIII Deficiency

The original Joint Outcome Study (JOS) enrolled 65 boys with hemophilia from 16 sites nationally. The subjects were randomized to one of two arms (prophylaxis or an enhanced episode-based treatment)and were followed prospectively until the age of six. At the age of six, the proportion of children on each treatment arm who developed bone or cartilage damage as determined by X-Ray or MRI was assessed. In addition, the function and structure of the index joints (defined as knees, ankles, and elbows)were evaluated using a physical assessment scale specially designed for preschool children.

The specific aim of the Joint Outcome Study Continuation (JOSC) is to extend observations of the children participating in the original JOS until the subjects reach the age of 18 years in order to determine the natural history of joint development in hemophilia and the impact of primary or secondary prophylaxis on the prevention, limitation, or reversal of hemophilic arthropathy. In addition, plasma and DNA will be collected and banked yearly for current and future studies of biomarkers and predictors of hemophilia outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the original JOS study, "A Randomized Prospective Study for the Prevention of Joint Disease in Children with Factor VIII Deficiency"
* Written, informed consent of parent or guardian for the proposed study
* The local hemophilia treatment center staff must evaluate the family's participation in the original treatment protocol and determine that the family is capable of complying with the continuation protocol

Exclusion Criteria:

* Unable or unwilling to record the study information
Evaluation of Joint Position Sense in Healthy Individuals

It was aimed to measure the elbow joint position sense in healthy individuals in the case of a closed kinetic chain and to compare it with the measurement made in the case of an open kinetic chain.

The study was designed as a non-invasive, cross-sectional study. The population of this research will consist of healthy individuals. Joint position sense will be measured in open kinetic chain and closed kinetic chain via universal goniometer . Each angle position will be repeated 3 times with the elbow in 45, 60, 75 degree flexion angle positions and the average will be calculated. Measurements will be evaluated simultaneously but independently with the 2 different evaluators. Measurements will be repeated after 3 days.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-25
* Being healthy
* Agreeing to participate in the study

Exclusion Criteria:

* Those who have had upper extremity surgery within the last year
* Those with neurological, orthopedic, rheumatic or cardiovascular problems affecting the neck, shoulder, elbow, hand and wrist
* Those with central and peripheral nervous system involvement Having pain anywhere in the body
Over-the-Counter Antihistamines & Heat Stress

Allergic rhinitis (AR) currently affects \~25% of Canadians, and due to factors of climate change, this number is expected to increase over the coming decade. AR symptoms can significantly impact individuals' quality of life by compromising sleep, productivity, and social interactions. To alleviate AR symptoms, North Americans tend to rely on H1 antihistamine medications available over-the-counter (OTC) at most pharmacies. However, public health authorities currently suggest restraining all antihistamines during heat waves due to beliefs that M3 muscarinic receptor and H1 receptor antagonism, independent pharmacological mechanisms of H1 antihistamines, might suppress thermoregulatory responses to heat stress and increase individuals' susceptibility to heat-related illness/injury. To date, studies using supramaximal doses of antihistamines have demonstrated reductions in sweating, however these doses and administration routes are not the typical use case. Additional studies utilizing fexofenadine, a second-generation H1 antihistamine, have linked H1 receptor antagonism to reductions in skin blood flow, potentially impacting thermoregulation by reducing peripheral blood redistribution. Empirical evidence supporting OTC H1 antihistamines impacting thermoregulatory control at recommended doses is scarce. Thus, this study aims to systematically assess whether three common OTC H1 antihistamines, taken as prescribed, alter thermoregulatory responses during thermal stress.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female between ages 19 and 39 years
* Fully vaccinated against COVID-19
* Able to provide informed consent
* Body-mass index under 30

Exclusion Criteria:

* Body-mass index over 30
* Currently taking sedative or autonomic nervous system depressant medication
* Hypersensitivity to diphenhydramine, loratadine, or desloratadine
* History of cardiovascular disease, cancer, type 1 or 2 diabetes, chronic obstructive pulmonary disorder, or cystic fibrosis
* Have smoked tobacco products less than 12 months prior to participation
* Pregnant/Breastfeeding
Zirconium-89-girentuximab PET/CT Imaging in Renal Cell Carcinoma

Girentuximab is an antibody against Carbonic Anhydrase IX (CAIX), an antigen that is expressed on the cell surface of 95% of clear cell RCC (ccRCC). Zr-89-girentuximab PET/CT (Positron Emission Tomography) may be a valuable imaging technique in the diagnosis of patients with RCC. The aim of the present study is to show the impact of the Zr-89-girentuximab PET/CT on the clinical management of ccRCC patients.

More advanced imaging methods are needed to reliably distinguish benign small renal masses (SRM) from renal cell carcinoma (RCC) to prevent invasive biopsies or unnecessary surgery. Similarly, improved imaging methods are needed for unambiguous detection of lesions suspect for metastatic and relapse RCC during follow-up. Girentuximab is an antibody against Carbonic Anhydrase IX (CAIX), an antigen that is expressed on the cell surface of 95% of clear cell RCC (ccRCC). Zr-89-girentuximab PET/CT may be a valuable imaging technique in the diagnosis of patients with RCC. The aim of the present study is to show the impact of the Zr-89-girentuximab PET/CT on the clinical management of ccRCC patients. Thirty patients will be included in whom conventional diagnostics are inconclusive. During a multidisciplinary team (MDT) the hypothetical next step in the clinical process will be noted (e.g. further diagnostics, treatment or active surveillance). Subsequently, in these patients a Zirconium-89-girentuximab PET/CT will be performed. Patients will receive a single intravenous dose of 5 mg Zirconium-89-girentuximab (37 MBq). A PET/CT scan will be acquired 4 or 5 days after injection. The Zirconium-89-girentuximab PET/CT will be read by a clinician with extensive experience in radiolabeled girentuximab imaging. The results of the PET/CT will be discussed during the MDT and will be used to decide what the next step in the clinical process will be. This step will be compared with the hypothetical next step from the MDT before the scan.

Eligibility Criteria:
Inclusion Criteria:

In order to participate in this study, a subject must meet all of the following criteria:

1. His or her clinician should face a diagnostic dilemma; e.g.

   * patients with a renal mass of unknown origin, or
   * patients with a primary renal mass in whom it is unclear whether there is metastatic disease, or
   * patients with a history of clear cell RCC with a suspicion of relapse or metastatic disease.
2. Minimum age 18 years
3. Signed informed consent

Exclusion Criteria:

* History of a CAIX-negative or non clear cell RCC.
* Administration of tyrosine kinase inhibiters within 1 month prior to inclusion.
* Any medical condition present that in the opinion of the investigator will affect patients' clinical status. - Administration of a radioisotope within 10 physical half lives prior to study enrollment
* Pregnancy or lactation.
* Known hypersensitivity or HACA (human anti chimeric antibodies) against Girentuximab.
Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery

Patients undergoing 1-3 level Anterior Cervical Discectomy and Fusion (ACDF) at the levels between C2 and T1 will be enrolled into this randomized prospective study. All patients enrolled in this study will undergo a trial of non-surgical treatment prior to the recommendation for surgery. After enrollment, patients will be randomized utilizing a block randomization strategy to one of two treatment groups - a standard opioid-containing postoperative pain regimen versus a non-opioid postoperative pain regimen. Postoperative outcomes will be assessed.

Patients will be followed for 12 months and the following Specific Aims will be assessed:

Aim 1: Evaluate whether utilization of a non-opioid postoperative pain regimen after ACDF leads to lower rates of new chronic opioid use when compared with postoperative pain regimens utilizing opioids.

Aim 2: Evaluate whether utilization of a non-opioid postoperative pain regimen after ACDF results in equivalent postoperative pain scores in the early postoperative period.

Aim 3: Evaluate whether utilization of a non-opioid postoperative pain regimen after ACDF leads to equivalent clinical outcomes when compared with postoperative pain regimens utilizing opioids at 3 months and 12 months.

Aim 4: Evaluate whether utilization of a non-opioid postoperative pain regimen after ACDF leads to fewer postoperative complications when compared with postoperative pain regimens utilizing opioids.

Eligibility Criteria:
Inclusion Criteria:

* Radiographic evidence of degenerative cervical spine disease
* Failure of conservative therapy
* Age ≥18 years
* Skeletal maturity.

Exclusion Criteria:

* Preoperative chronic opioid use as determined by self report (\>45 out of past 90 days)
* History of chronic kidney disease
* Revision cervical spine surgery
* Concurrent posterior cervical fusion
* Does the patient have an intolerance to NSAIDs (non-steroidal anti-inflammatory drugs)?
* Does the patient have any preexisting health condition the study physician believes will be exacerbated by participating in this study?
GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma

A Phase I Clinical Trial for Evaluating the Safety, Tolerance and Efficacy of GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma

This is an open-label, dose escalation/expansion study to assess the safety, tolerability, and efficacy of CART cell in patients ≥ 18 years of age with relapsed or refractory advanced hepatocellular carcinoma. Patients who meet the eligibility criteria will receive cell infusion. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment and follow up

Eligibility Criteria:
Inclusion Criteria:

1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent;
2. Age 18-75 years;
3. Patients diagnosed as advanced hepatocellular carcinoma (HCC) histopathologically or cytologically; Progression or intolerance after previous standard systemic therapy;
4. GPC3 is detected positive by immunohistochemistry (IHC);
5. Child-Pugh score ≤ 7;
6. At least one assessable tumor lesion;
7. ECOG score: 0-1;
8. Expected survival ≥ 3 months;
9. Clinical laboratory values meet screening visit criteria

Exclusion Criteria:

1. Previous CAR-T cell, TCR-T cell or other cell therapies or therapeutic tumor vaccination directed at any target;
2. Any previous GPC3 targeted therapy;
3. Prior antitumor therapy with insufficient washout period;
4. Brain metastases with central nervous system symptoms;
5. Pregnant or lactating women
6. HCV-Ab or/and HIV-Ab positive; active syphilis;
7. Severe underlying diseases
8. Any condition that, in the opinion of the investigator, will make the subject unsuitable for participation in this study.