cyrilzakka/clinical-trials huggingface dataset:
PET/MRI in the Diagnosis of Chronic Pain

Several studies have implicated involvement of sigma-1 receptors (SR1s) in the generation of chronic pain, while others are investigating anti SR1 drugs for treatment of chronic pain. Using \[18F\]-FTC-146 and positron emission tomography/magnetic resonance imaging (PET/MRI), the investigators hope to identify the source of pain generation in patients with chronic pain. The purpose of this study is to compare the uptake of \[18F\]FTC-146 in healthy volunteers to that of individuals suffering from chronic pain.

Chronic pain is a significant, widespread problem affecting every fifth person worldwide. Reported in 2011 by the Institute of Medicine, chronic pain affects 116 million American adults - more than the total number of individuals affected by heart disease, cancer, and diabetes combined. An estimated $635 billion each year is spent in the medical management of chronic pain and lost productivity. Better clinical methods to diagnose and localize pain are needed.

The investigators have developed a S1R-specific radiotracer, \[18F\]FTC-146. Using imaging approaches to assess the location of S1R in pain may provide a tool to diagnose pain generators, monitor treatment response, and aid in the selection of patients for treatment.

The goal is to use \[18F\]FTC-146 to image S1R expression in healthy volunteers and to compare the images to those individuals suffering from pain conditions in the following categories: (1) nociceptive pain (pain that results from tissue injury or inflammation), (2) neuropathic pain (pain that results from direct injury, disruption, impingement/compression or malfunction of the peripheral and/or central nervous system), and (3) mixed pain (pain that appears to have both nociceptive and neuropathic).

Eligibility Criteria:
Inclusion Criteria:

Healthy Volunteers:

1. At least 18 years old.
2. Covid Vaccination status: Vaccinated or unvaccinated subjects who received a negative test result from the Covid test within 72 hours of the scan.

Pain Patients:

1. At least 18 years old.
2. Chronic pain (nociceptive, neuropathic or mixed pain) lasting greater than 2 months.
3. Pain level of at least 4/10 on a 0-10 Comparative Pain Scale.
4. Covid Vaccination status: Vaccinated or unvaccinated subjects who received a negative test result from the Covid test within 72 hours of the scan.

Exclusion Criteria:

Healthy Volunteers:

1. Pain
2. Pain Medication
3. MRI incompatible
4. Pregnant or nursing
5. Non-English speaker
6. Claustrophobic

Pain Patients:

1. MRI incompatible
2. Pregnant or nursing
3. Non-English speaker
4. Claustrophobic
Effect of Auditory Stimulation by Family Voices in Preventing Delirium: A Randomized Controlled Trial

Delirium is an acute cerebral dysfunction syndrome characterized by acute fluctuating changes in consciousness, cognitive dysfunction, and disorientation. It's especially common in critically ill patients of emergency intensive care units and seriously threatens the survival and prognosis of patients and causes heavy economic burdens to the family, society, and medical service system. Impaired verbal communication, unfamiliar medical personnel, physical restraint, spatial-temporal disorientation, mechanical ventilation and sedation medication use can lead to a lack of adequate sensory stimulation and a high risk of delirium. Acoustic stimulation as a non-invasive non-pharmacological intervention can provide some sensory stimulation as a surrogate for critically ill patients. This research designs the content scripts from the needs of ICU patients and families for sound stimulation. The goal of this randomized controlled study is to test the effect of auditory stimulation by family voices in preventing delirium among sedative patients in emergency Intensive care units.

Patients are separated from their families and society under the closed management of the intensive care unit, the use of sedative drugs, mechanical ventilation, impaired verbal communication, physical restraint, environmental noise, and prolonged light exposure, which lead to a lack of adequate sensory stimulation, causing sensory deprivation in patients to some extent. In turn, sensory deprivation may cause multisensory perceptual confusion and hallucinations, affecting patients' orientation and thinking and triggering delirium, so providing appropriate sensory stimulation to critically ill patients may help to improve patients' orientation and attention, correct patients' thinking confusion and prevent delirium, and in clinical practice, sensory stimulation is considered as an important part of multicomponent delirium prevention programs.

Eligibility Criteria:
Inclusion Criteria:

* transferred to the EICU from emergency admission
* no other history of emergency, surgery, or ICU admission history within 30 days
* no delirium in the first screening of Emergency Intensive Care Unit(EICU) admission
* with an expected length of stay in EICU longer than 24h and use of sedation medication

Exclusion Criteria

* Presence of hearing impairment, severe dementia, psychiatric disorder, or other severe brain dysfunction that hinders delirium assessment
* persistent coma or deep sedation (RASS score of -4 to -5)
* patients without a family member who can cooperate with the recording
* external ear disease or surgery that hinders earphone wearing
A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer

The purpose of this study is to compare the efficacy and toxicities of hypofractionation radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated with mastectomy.It is hypothesized that the efficacy and toxicities are similar between the two groups.

Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:conventional fractionation radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and hypofractionation radiotherapy of 43.5Gy in 15 fractions within 3 weeks to the same region.

During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Ipsilateral histologically confirmed invasive breast cancer
* Undergone total mastectomy and axillary dissection
* T3-4,or \>=4 positive axillary lymph nodes
* Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation
* Written,informed consent
* cT3-4,or cN2, or pathological positive axillary lymph nodes during mastectomy for patients who had received neoadjuvant chemotherapy or hormone therapy
* no supraclavicular or internal mammary nodes metastases
* no distant metastases
* enrollment date no more than 8 months after surgery or no more than 2 months after chemotherapy for patients who didn't receive neoadjuvant systemic therapy.
* enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and didn't need adjuvant chemotherapy.

Exclusion Criteria:

* Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region
* Previous or concurrent malignant other than non-melanomatous skin cancer
* Unable or unwilling to give informed consent
* bilateral breast cancer
* immediate or delayed ipsilateral breast cancer reconstruction
Effect of Intravenous Fentanyl on the Occurrence of Postoperative Nausea and Vomiting According to Time of Administration Around the End of Tonsillectomy With or Without Adenoidectomy

Fentanyl is a commonly used drug for the prevention of emergence agitation and reduction in postoperative pain in children receiving tonsillectomy. However, fentanyl can cause postoperative nausea and vomiting (PONV), which is a main target side effect that medical staff strives to prevent. However, recent meta-analysis showed that the incidence of PONV may be different depending on the time of administration of fentanyl. However, the research design of patients enrolled in each study, such as the age, the name of the operation, and the method of anesthesia, is not identical. The aim of this study was to evaluate the efficacy and safety of fentanyl in patients undergoing tonsillectomy with a prospective randomized controlled trial. Secondary outcomes include incidence and severity of emergence agitation and anesthesia recovery time, postanesthesia care unit (PACU) time, side effects.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged 3 to 7 years with ASA 1-II scheduled for tonsillectomy (or adenoidal tonsillectomy)

Exclusion Criteria:

* 1. History of developmental disorder, cognitive impairment, cerebral palsy
* 2. History of seizures(not simple febrile convulsions)
* 3. Upper respiratory infections
* 4. Structural airway disease predicting difficult airway
* 5. History of an adverse reaction, including allergic reactions to fentanyl
Different Insufflation Flows and Effects on Cerebral Oxygenation in Laparoscopic Cholecystectomy

Previous studies conducted on the hemodynamic effects of pneumoperitoneum pressures created by different insufflation flows are very limited in the literature. In a current literature review, there was no study found comparing the effects of hemodynamic changes created by low and high insufflation flows and pneumoperitoneum pressure on cerebral oxygenation. The purpose of the study was to contribute to the literature by investigating the effects of pneumoperitoneum pressures created by different flows on brain oxygenation.

After the approval of the Ethics Committee, a total of 69 (sixty-nine) patients who would undergo elective laparoscopic cholecystectomy were planned as ASA I-III, 18-65 years old, 34 (thirty-four) patients low insufflation flow (10 lt/min) and 35 (thirty-five) patients and high insufflation flow (40 lt/min) with pneumoperitoneum pressure.

The study will be conducted as a single-center observational study in Trabzon KTU Faculty of Medicine General Surgery Operating Room. Anesthesia always be performed by the same anesthesia team, and no intervention will be made regarding the choice of the method. The data obtained will be recorded by the anesthetists other than the team who constitute the study group, and the data obtained at the end of the surgery will be interpreted by the study team. The decision for laparoscopic cholecystectomy of the patients who will be included in the study will be made by the General Surgery doctor, and the patients who are scheduled to be operated on electively will be included in the study.

The patients will be taken to the operating room after their written consents are obtained and preoperative evaluations are made, and routine premedication will be applied to the patients who arrive at the operating room. The patients who will be included in the study will be monitored routinely in the general surgery room (i.e. electrocardiography (ECG), non-invasive blood pressure measurement, peripheral oxygen saturation, Bispectral Index (BIS), and additionally NIRS monitoring. No interference will be made regarding the groups in which patients who will undergo general anesthesia will be in the pneumoperitoneum group formed with low insufflation flow or high insufflation flow, only non-invasive cerebral oxygenation measurements will be made with NIRS monitor (INVOS™ 5100C Cerebral/Somatic Oximeter, SOMANETICS, COVIDIEN, Mansfield/ USA)

Eligibility Criteria:
Inclusion Criteria:

* elective laparoscopic cholecystectomy were planned,
* ASA I-III,
* 18-65 years old

Exclusion Criteria:

* Cerebrovascular diseases and/or intracranial pathologies and/or related neurological events,
* Uncontrolled diabetes
* Uncontrolled hypertension
* Coagulopathy,
* Cirrhosis and/or peritonitis,
* Asthma and/or respiratory diseases e.g. COPD,
* Morbid obesity,
* Patients with severe organ failure,
* Emergency cases,
* Cases converted to laparotomic cholecystectomy.
Role of Oral Chlorhexidine Gel in Prevention of Ventilator Associated Pneumonia

The purpose of this study is to determine if oral mucosal application of chlorhexidine gel will prevent the development of ventilator associated pneumonia in children.

Ventilator associated pneumonia as the name suggests refers to pneumonia occurring in the setting of mechanical ventilation. It accounts of 86% of nosocomial pneumonia and in contrast to other more common nosocomial infections is accompanied by a mortality rate of upto 76% in certain settings. A number of preventive methods have been studied to reduce the rate of VAP but a consensus is lacking with regards to appropriate preventive strategies. Studies in adults have shown a beneficial effect of oral mucosal application of chlorhexidine but similar studies in pediatric population are not available. This research project aims at addressing the gap.

Eligibility Criteria:
Inclusion criteria:

1. Patients in PICU requiring mechanical ventilation
2. Above the age of 3 months
3. Oro or nasotracheal intubation

Exclusion criteria:

1. Known hypersensitivity to chlorhexidine
2. Inability to access the oral cavity for any reason
3. Patients with tracheostomy
4. Mechanical ventilation for more than 24 hours prior to PICU admission.
5. Death or extubation within 24 hours of ICU admission.
Application of Psychiatric Knowledge in the Rehabilitation Process in Return to Work.

The hypothesis was that education of rehabilitation officers who were responsible for rehabilitation back to work for sick-listed individuals in screening for mental disorders and psychiatric topics would increase the rate of return to work and reduce the number of sicklisted days


Eligibility Criteria:
Inclusion Criteria:

* sick-listed and belonging to the case-load of rehabilitation officers who participated in the intervention

Exclusion Criteria:

* no
Wake Therapy in the Treatment of Depression

This pilot study seeks to replicate previous findings that sleep deprivation results in marked improvement in depression symptoms, as well as to test whether concurrent treatment with Light Therapy and Lithium are successful in locking in and maintaining therapeutic effects in both bipolar and unipolar depressed subjects.

Both refractory depression and bipolar depression are difficult to treat. A night of complete sleep deprivation has been shown to result in marked improvement in 60% of depressed patients, although maintenance of therapeutic effects have not been sustained with wake therapy alone. This pilot study will assess the effectiveness of wake therapy in treating both bipolar depression (5 participants)and major depression (5 participants), as well as the effectiveness of concomitant light therapy and lithium in maintaining the therapeutic effects. Participants will undergo direct observation in the hospital for one week during initial treatment with alternating nights of sleep deprivation, light therapy and lithium treatment, and then will be seen weekly as outpatients for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. current major depressive episode (MDD, BP-I or BP-II)
2. if not BP-I or BP-II, treatment refractory to ≥ 2 adequately used antidepressants having different mechanisms
3. If BP-I or BP-II, treatment refractory to ≥ 1 standard treatment, such as lithium or valproate
4. physically healthy
5. age 18-75
6. not taking current antidepressants(antidepressants deemed effective will not be discontinued

Exclusion Criteria:

1. medically unstable condition
2. past intolerance of lithium (bipolar only)
3. history of (or current) psychosis or epilepsy
4. current (past six months) drug or alcohol abuse/dependence
5. pregnancy
6. contraindication to lithium (bipolar only)
7. significant retinal pathology (e.g., retinitis pigmentosa, macular degeneration)
8. currently taking effective antidepressant
9. cognitive dysfunction
10. Parkinson's Disease
11. Thyroid Stimulating Hormone \> 5 milli International Units/Liter
12. left ventricular hypertrophy
13. symptomatic mitral valve prolapse
14. abnormal creatinine
Study of AMV564 in Subjects With Advanced Solid Tumors

This Phase 1 study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of AMV564 alone and in combination with Pembrolizumab in patients with advanced solid tumors.

AMV564-301 is a Phase 1, open-label, multicenter dose-escalation with expansion trial in patients with locally advanced or metastatic solid tumors. In the dose-escalation portion of the study, cohorts of patients will receive AMV564 alone or in combination with Pembrolizumab at increasing dose levels to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion. In the expansion portion of the study, one or more cohorts of patients will receive AMV564 at the MTD or recommended dose to further evaluate safety, tolerability, and clinical activity.

Eligibility Criteria:
Key Inclusion Criteria:

* 18 years of age or older
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Histologically or cytologically documented, incurable or metastatic solid tumor that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard therapy exists
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or per other criteria best suited for the specific tumor type being evaluated
* Willing to complete all scheduled visits and assessments at the institution administering therapy

Key Exclusion Criteria:

* Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 3 weeks prior to first dose of AMV564
* Major trauma or major surgery within 4 weeks prior to first dose of AMV564
* Prior treatment with chimeric antigen receptor (CAR) T-cell therapy or T-cell engager therapy
* Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to first dose of AMV564
* Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia
* Known, central nervous system (CNS) disease involvement, or prior history of National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Grade ≥ 3 drug-related CNS toxicity
Antagonization of Heparin with Protamine Sulfate After TAVI

Transcatheter aortic valve replacement (TAVR) is now the first therapeutic option offered to high and intermediate risk patients with symptomatic aortic stenosis but even to low-risk, when the aortic valve is tricuspid and the transfemoral approach is suitable. Vascular and bleeding complications are the most frequent procedure-related unwanted events associated with increased short-term morbidity and mortality. Selection of the appropriate vascular access site and pre-closing devices as well as stent implantation mitigate these complications.

ACT-guided heparin reaching a target of 300 seconds or more is recommended prior to the placement of the guiding sheath in the common femoral artery. Protamine sulfate is the heparin antidote, which antagonizes 100% of its anti-IIa activity and 60% of its anti-Xa activity. Reversal of heparin using protamine sulfate is recommended for transapical and complicated transfemoral aortic valve placement.However, there is a great heterogeneity of protamine use in daily practice and supportive evidence for the prevention of bleeding complications as well as its safety is lacking. In addition, the radial approach for the second vascular access is more commonly used as well as the use of echo-guided femoral puncture further questioning reversal of heparin when the procedure has been successfully completed without overt bleeding complications.

Our study aims to demonstrate the superiority of a strategy of systematic ACT-guided heparin administration followed by systematic antagonization with protamine sulfate over usual of care to reduce in-hospital mortality, vascular/bleeding complications, stroke and transcient ischemic attack, myocardial infarction or red blood cell transfusion, from randomization to hospital discharge


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥18 years of age
* Any patient eligible for transfemoral TAVI, irrespective of the chronic antithrombotic treatment
* Written informed consent
* Registered at the French social healthcare

Exclusion Criteria:

* Any major protamine sulfate exposure contraindications defined as a history of severe pulmonary hypertension, acute pulmonary edema or history of bronchospasm related to protamine sulfate administration
* Known allergy to protamine sulfate
* Hypersensitivity to protamine sulfate including protamine contained as an excipient in NPH \[Neutral Protamine Hagedorn\] insulin, known protamine or protamine-heparine complex antibodies
* Non-femoral approach for the TAVI procedure
* Protamine sulfate exposure within 24h of randomization
* Fish allergy
* Mechanical valves
* For men: Sterile or Vasectomy
* Women of childbearing potential
* Pregnancy and breast feeding women
* Contemporaneous enrolment in an interventional clinical trial
* Patient under guardianship or curatorship
Efficacy and Safety of Aripiprazole in Patients With Schizophrenia or Bipolar Disorder

This is a multicenter,open-label,prospective study of Aripiprazole use in patients with schizophrenia and bipolar disorder.

This is a multicenter,open-label,prospective study of Aripiprazole use in patients with schizophrenia and bipolar disorder.

Qualified schizophrenia patients will be enrolled to an 12-week treatment phase of Aripiprazole by physician's assessment.

Qualified bipolar disorder patients will be enrolled to an 8-week treatment phase of Aripiprazole by physician's assessment.

This study will be continued for 6 years. The final report of Aripiprazole PMS will be submitted to KFDA on December 28, 2009.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a schizophrenia or schizoaffective disorder or bipolar disorder according to DSM-IV criteria
* Age: more than 18 years of age

Exclusion Criteria:

* Unqualified patients judged by study investigator(s)