cyrilzakka/clinical-trials huggingface dataset:
Anti-OX40 Antibody (MEDI6469) in Patients With Metastatic Colorectal Cancer

This study will test the ability of an immune modulator, anti-OX40 (MEDI6469) to alter the immune cell environment within colorectal cancer metastases. The drug will be administered to patients before surgical treatment.

There will be three distinct cohorts of patients which will vary the timing of the MEDI6469 dose, starting three weeks before surgery and decreasing the interval before surgery by one week with each cohort, as long as no dose-limiting toxicity attributable to the anti-OX40 are observed.

Immunohistochemistry will be used to measure the immune cells within primary and metastatic tumors when resected tissue is available, and surgically ablated tumors, giving each specimen an "immune score". The primary endpoint of the study will be the difference in immune scores of patients treated with anti-OX40 compared to historical controls (immune scores of untreated patients). Secondary endpoints will include both clinical (survival) and immunological data (specific measurements of immune cell populations based on flow cytometry and immunohistochemistry).

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo staged liver resections are included in this study. In these cases, preoperative MEDI6469 will be given prior to the initial procedure.
* Patients with small \<3 cm tumors located \>2 cm away from central bile ducts will be considered for either radiofrequency ablation or resection, the choice of which will be determined at the time of surgery.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Laboratory values during preoperative assessment within the protocol specified range
* Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand the investigational nature of the study and the risks associated with the therapy.
* No active gastrointestinal bleeding.
* No clinical or laboratory coagulopathy
* Anticipated lifespan greater than 12 weeks

Exclusion Criteria:

* Metastatic disease outside of the liver that is not considered surgically resectable or curable.
* Active infection.
* Active autoimmune disease including patients with Inflammatory Bowel Disease as determined by an autoimmune questionnaire.
* Previous treatment with mouse monoclonal antibodies.
* Need for chronic maintenance oral steroids.
* Any medical or psychiatric condition that in the opinion of the PI would preclude compliance with study procedures.
* Enrollment in a clinical trial in which a different investigational agent is administered within 4 weeks prior to the first dose of MEDI6469.
PROGENI (Parkinson's Research: The Organized Genetics Initiative) Family Study of LRRK2 (Leucine-rich Repeat Kinase 2)

The PROGENI Family Study is part of a larger consortium that is studying a gene shown to be important in Parkinson's disease, called LRRK2. People who have a defect in the LRRK2 gene will often develop Parkinson's disease. Eligible participants will be asked to complete a single Study Visit at an affiliated research facility closest to their home.

Participants will be asked to complete a family history questionnaire, which will gather information about their family history of Parkinson's disease and related disorders. They will be asked to complete a single Study Visit, during which they will be asked to do some or all of the following:

1. Complete questionnaires regarding Parkinson's disease symptoms, medical history, mood, sleep, mental status, and activity level.
2. Be given a brief standard neurological examination.
3. Be given a scratch and sniff smell identification test.
4. Be asked to give a sample of approximately 2 tablespoons of blood.
5. Be asked to give a urine sample of approximately 1 tablespoon of urine.

Eligibility Criteria:
Inclusion Criteria:

Positive for a LRRK2 mutation
Silver Diamine Fluoride/ Potassium Iodide in Indirect Pulp Capping of Young Permanent Molars

The aim of this study is to evaluate and compare the clinical effectiveness of 38% silver diamine fluoride with and without potassium iodide with that of resin modified glass ionomer cement in indirect pulp capping of young permanent molars.

A sample of children with an age range of 6-9 years, having a first permanent molar erupted with deep occlusal carious lesion, will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. All selected 108 first permanent molars will be randomly equally allocated into three groups according to capping material used. Group I (n=36) SDF/ KI and Group II (n=36) SDF and Group III (n=36) Glass ionomer cement. Indirect pulp capping treatment procedure will be performed with identical protocols except for the capping material to be used and its application will be according to manufacturer's instructions. Glass ionomer cement will be used as a base and resin-based composite restoration will be used in the three groups.

Eligibility Criteria:
Inclusion Criteria:

For children:

1. Children who are generally healthy.
2. Children having a deep dentin carious lesion in a permanent first molar (upper or lower).
3. Parents signed informed consent.

For first permanent molars:

1. Cavitated class I carious lesions with opaque or discolored enamel exposing the dentin beneath corresponding to ICDAS II score 5 and 6 (visible dentin). (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007)
2. Teeth having lesions that are considered active according to ICDAS II activity criteria for primary coronal caries. (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007; Dikmen B. 2015)
3. Immature with open apex as revealed by periapical X-ray.

Exclusion Criteria:

For children:

1. Any allergy reported by the parents. (Crystal YO, Marghalani AA, Ureles SD, Wright JT, Sulyanto R, Divaris K, et al. 2017)
2. Children unable to return for recall visits.

For first permanent molars:

1. Any clinical signs of irreversible pulpitis (spontaneous pain, pain on percussion, abscess, sinus.
2. Any radiographic sign of irreversible pulp pathologies or necrosis periapical radiolucency, internal or external root resorption).
3. Teeth with inactive lesions. (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007; Dikmen B. 2015)
The Listening Project: Tuning Into Change

A research project funded by the Australian Childhood Foundation (ACF) will be conducted in Australian facilities of the ACF to evaluate the effectiveness of the Listening Project Protocol (LPP) in children with a trauma history. The LPP is designed as a "neural exercise" to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. The LPP uses acoustic stimulation to exercise the neural regulation of the middle ear structures to rehabilitate and to normalize the acoustic transfer function of the middle ear structures. The current study is being conducted to evaluate efficacy and feasibility of the LPP and will use objective measures to evaluate changes in acoustic transfer function of the middle ears structures, auditory processing skills, physiological state regulation, and sensory symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Children must be between ages 7-14 years
* Children and parent providing permission must be able to read/speak in English
* Children must be receiving services from the Child Trauma Service unit of the Australian Childhood Foundation

Exclusion Criteria:

* Children who wear a hearing-device
* Children with a history of heart disease
* Children who are currently being treated for seizure disorder
New Techniques to Reduce Intra-operative Bleeding During Complex Liver Resection

This observational study introduced an new advanced bleeding control strategy during complex liver resection.This newly described "stepwise vascular control" technique was efficacious and feasible to control intra-operative bleeding in complex hepatectomy involving second hepatic hilum and retro-hepatic inferior vena cava.


Eligibility Criteria:
Inclusion Criteria:

* tumor size is more than 5cm in diameter;
* these tumor were close to or were compressing main hepatic veins and RIVC directly;
* Pugh-Child Grade is A or Indocyanine green retention rate at 15min (ICG15%) is less than 10% .
AI Detection of Incidental Coronary Artery Calcium to Enhance Cardiovascular Disease Prevention

AI INFORM is a multicenter randomized trial that will test the hypothesis that providing clinicians information on the presence and amount of coronary artery calcifications (CAC), will result in initiation or intensification of preventive therapies. The study will use a cloud-based artificial intelligence (AI) platform (Nanox.AI) that can analyze non contrast chest CT and estimate the amount of CAC.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 40-75 with prior chest CT within last 3 years

Exclusion Criteria:

* Prior coronary artery disease
* Prior cancer
* Other life-limiting condition
Advanced Multimodal Anesthesia Care for Patients Undergoing Oro-maxillofacial Surgery

The purpose of this research is to develop from enhanced multimodal anesthesia care to verify and optimize ERAS strategies for orthognathic surgery. If the elements of anesthesia care can be accurately controlled, the harmful pressure factors caused by surgery can be minimized and the patients undergoing facial surgery can be improved.

Orthognathic surgery (Orthognathic surgery) is currently one of the most commonly performed surgical items in oral and maxillofacial surgery because it corrects facial deformities, improves teeth chewing and face glowing. In general, the kind of operations are performed under nasotracheal intubating general anesthesia.

Due to the patients were required for motionless, low pressure, controlled ventilation, and adequate analgesia during anesthesia undergoing orthognathic surgery, advanced multimodal anesthesia care developing to the Enhanced Recovery After surgery (ERAS) should be conducted under patient safety. The ERAS concept emphasizes the importance of clinical multidisciplinary teamwork cooperation including of oro-surgeon, anesthesiologist, operating and post-anesthesia care nurses. The core elements of ERAS lies in the management of the entire peri-operative period of anesthesia. In clinical practice, focus on entire anesthesia care during the operation includes of precise anesthesia depth, adequate muscle relaxation, multiple modes of pain controlled and adequate analgesia, stable body temperature maintenance, use of goal-oriented infusion therapy, early extubation, and prevention of postoperative nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

* America society anesthesiologist classification class I to III patients undergoing oro-maxillo-facial surgery
* unlimited mouth opening
* nasotracheal intubation general anesthesia for at least 120 minutes.

Exclusion criteria:

* patients with arthritis with limited mouth opening
* diabetes with insulin treatment
* essential hypertension without controlled
* past history of malignant hyperthermia or personal or family history
* persistent liver dysfunction
* chronic renal insufficiency
* body mass index ≧35 kg/m2.
Clinical Validation of the Rating Scale for Psychotic Depression (RAS-PD)

The aim of this study is to develop a scale to measure the severity of depression with psychotic symptoms (psychotic depression). Furthermore, we hope to detect potential biomarkers (substances in the blood) which can aid in the detection of psychotic depression.

Main hypothesis: A clinically valid rating scale measuring the severity of psychotic depression can be developed.


Eligibility Criteria:
Inclusion Criteria:

* Fulfilling ICD-10 criteria DF32.3 or DF33.3
* At least 18 years old
* Legally competent
* Informed consent (oral \& written)

Exclusion Criteria:

* Insufficient Danish Language skills
* Moderate to severe dementia
* Abuse of psychoactive substances
Clinical Development of Deep Learning for the OtoSight

The objective of this study is to clinically develop and evaluate a machine learning approach to improve the performance and data interpretation of the PhotoniCare OtoSight Middle Ear Scope in pediatric patients presenting at the primary care office for suspected ear infections. In this observational study, results of OtoSight imaging will not affect patient standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients presenting for an office visit with ear-related complaints

Exclusion Criteria:

* Otoscopy contra-indicated or not possible per attending clinician's decision, Down's syndrome (due to abnormalities in ear canal anatomy)
Cryoablation for the Promotion of Local Tumor Infiltration in Patients With Mesothelioma

This trial evaluates if cryoablation will stimulate a local immune response by cluster of differentiation 8 positive (CD8+) cells which are not present in ablation naive regions of the tumors in patients with mesothelioma. Cryoablation uses extreme cold to damage or destroy tumor lesions. Mesothelioma is a rare cancer that grows and spreads quickly, and has low survival rates. The information learned from this study may provide evidence as to whether there is a measurable, local immune response from cryoablation. Studying samples of mesothelioma tissue in the laboratory from patients who have undergone biopsy may help doctors learn more about the effects of cryoablation on cells. It may also help doctors understand how well patients respond to treatment.

PRIMARY OBJECTIVES:

I. To evaluate the simple hypothesis that cryoablation of mesothelioma will promote local tumor infiltration by cytotoxic cluster of differentiation 8 positive (CD8+) cells that will not be present in ablation naive regions of the tumors.

II. To determine whether there is a preponderance of T cells in ablated tumor tissue in comparison to non-cryoablated tissue.

OUTLINE:

At the time of standard of care pleural biopsy, patients undergo cryoablation over 30 minutes, then a sample of tissue from the ablated region and a non-ablated (tumor negative control) region are collected.

Eligibility Criteria:
Inclusion Criteria:

* Adults that have been identified at tumor board with high suspicion for mesothelioma and are anticipated to be surgical candidates, as determined/discussed at Mesothelioma Tumor Board

Exclusion Criteria:

* Patients that have a questionable diagnosis of mesothelioma (i.e. there are other potentially more likely considerations in the differential diagnosis) or in patients that would not be expected to be good surgical candidates
Role of Nitric Oxide in Diabetic Patients With Erectile Dysfunction

Erectile dysfunction (ED) is defined as penile erection that is insufficient and unsustainable for a satisfactory sexual performance.

The etiology of ED is multifactorial including chronic diseases such as hypertension, diabetes mellitus and coronary artery disease However, the main underlying cause is degenerative changes that result in endothelial dysfunction

Diabetes leads to endothelial dysfunction and a pro-inflammatory state, which reduces the usability and activity of nitric oxide (NO). NO is a powerful force for sustaining penile blood flow.

Diabetes is an estab¬lished risk factor for sexual dysfunction in men; a three-fold increased risk of erectile dysfunction (ED) was documented in diabetics compared with non-diabetic men.

In smooth muscles, NO activates guanyl cyclase and increases cyclic guanosine monophosphate (cGMP) concentration. cGMP activates certain intracellular protein kinases that phosphorylate receptor proteins. Activated protein kinases open the potassium channels and increase the influx of potassium and block the influx of calcium by inhibiting calcium channels. This leads to hyperpolarization and relaxation of smooth muscle. Reduced arteriolar resistance leads to sinusoidal spaces filled with blood. These enlarged sinusoids further increase the intracavernosal pressure by blocking the venous return and producing a rigid erection. cGMP is converted to GMP by phosphodiesterase, which is inhibited by phosphodiesterase 5 (PDE-5) inhibitors.

(NO) has vasodilatory properties and balances RhoA/Rho-kinase-mediated vasoconstriction, which is a predominant mediator of the physiologic induction and maintenance of erections.

Evidences show that functional polymorphisms within endothelial NO synthase (eNOS) gene interfere with normal erectile function.

In humans, the eNOS gene is located on chromosome 7q35-36 and consists of 26 exons spanning 21 kilobases (kb). Several polymorphisms of eNOS have been investigated. More frequently, investigated regions of this gene include a variable number of 27 bp tandem repeats in intron 4 (VNTR), G894T (rs1799983) polymorphism in exon 7 and a T-786C (rs2070744) polymorphism in the promoter region

Eligibility Criteria:
Inclusion Criteria:

1. Diabetic patients with ED.
2. Using tadalafil 5mg

Exclusion Criteria:

1. Patients with history of pelvic trauma or major pelvic surgical intervention.
2. Patients with hypogonadism and hyperprolactinemia.
3. Patients with chronic liver disease or cardio vascular system diseases.
4. History of chronic intake of central nervous system, anti-androgen drugs or other drugs as Tramadol.
5. Smokers.
6. Patients with non-vasculogenic Erectile dysfunction
Immediate Unselected Coronary Angiography Versus Delayed Triage in Survivors of Out-of-hospital Cardiac Arrest Without ST-segment Elevation

The aim of the trial is to compare immediate angiography in survivors of out of hospital cardiac arrest (OHCA) without ST-segment elevation versus delayed/selective catheterization with respect to 30 day mortality.

The TOMAHAWK trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).

After inclusion and exclusion criteria have been checked patients will be randomized:

Group 1: Immediate angiography Patients randomized to group 1 will be transported to the catheterization laboratory as soon as possible after hospital admission for evaluation of coronary anatomy.

Group 2: Delayed/selective angiography Upon hospital admission, patients assigned to group 2 will first be transported to the ICU for further evaluation and stratification of OHCA etiology. Further triage will depend on the results of clinical examination and objective testing and will be left to the individual physician according to clinical judgment. Depending on clinical circumstances, further management may comprise medical therapy, laboratory testing, imaging such as echocardiography and/or computed tomography, hemodynamic or neurological monitoring, the initiation of therapeutic hypothermia or other measures of intensive care. If a high likelihood of an acute coronary trigger for OHCA persists (i.e. inconclusive results from clinical evaluation with ongoing suspicion of an acute coronary event, etc.), the treating physician may proceed to coronary angiography after a delay of 24h after the onset of cardiac arrest.

Vital status will be assessed at 30 days, 6 and 12 months after randomization by direct questioning if the patient is still hospitalized or structured telephone interview. Clinical events will be verified by original source data. At 6 and 12 months, quality of life will be assessed by the the Euroqol 5D questionnaire.

The TOMAHAWK trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).

Eligibility Criteria:
Inclusion Criteria:

* Documented resuscitated OHCA of possible cardiac origin and return of spontaneous circulation
* Age ≥30 years
* Informed consent

Exclusion Criteria:

* ST-segment elevation or new left bundle branch block
* No return of spontaneous circulation upon hospital admission
* Severe hemodynamic or electrical instability requiring immediate coronary angiography/intervention (delay clinically not acceptable)
* Obvious extra-cardiac etiology such as traumatic brain injury, primary metabolic or electrolyte disorders, intoxication, overt hemorrhage, respiratory failure due to known lung disease, suffocation, drowning
* In-hospital cardiac arrest
* Known or likely pregnancy
* Participation in another intervention study
Reduction of Staph Aureus Carriage by Non-Antibiotic NOZIN® Nasal Sanitizer® Antiseptic

The purpose of this study is to determine the extent to which bacterial growth in the nostrils by S. aureus, a common bacteria that is found in hospital environment, can be reduced by NOZIN® Nasal Sanitizer® antiseptic nasal swabs during the course of a typical 10-hour work period in participants known to have S. aureus in their nose passages.

The purpose of the proposed pilot study is to employ a repeated sampling protocol to test the effectiveness of a currently marketed, over-the-counter topical preparation to reduce carriage of Staphylococcus aureus (S. aureus) in the nasal vestibules of health professionals working in an outpatient clinical setting. The product to be tested is the NOZIN® Nasal Sanitizer® antiseptic produced by Global Life Technologies Corp. It is an alcohol-based, non-antibiotic antiseptic preparationl

The study has one primary Specific Aim:

To determine the extent to which colonization of the vestibular region of the nares by S. aureus can be reduced by a regimen of nasal topical applications of the alcohol-based antiseptic during the course of typical 10-hour work day in subjects known to exhibit S. aureus nasal carriage.

A secondary aim of the study will be to evaluate the concurrent effectiveness of the antiseptic applications on a measure of general bacterial colonization within the vestibules of each subject.

Eligibility Criteria:
Inclusion Criteria:

* All healthy health care professionals between the ages of 18 and 60 years of age who are regular full-time employees of the MUSC Hospital, work a 10 or 12 hour work shift, and test positive for nasal vestibular S. aureus carriage within 10 days prior to their scheduled study day will be eligible to participate in the study.

Exclusion Criteria:

* Excluded from the study will be individuals exhibiting symptoms of upper respiratory disease, including chronic rhinitis/sinusitis, seasonal allergies, upper respiratory infection during the previous four weeks, have known allergy to citrus or soy oil, or are "smokers". "Non-smokers" will be defined as those individuals who have abstained from smoking for at least one year prior to the study. Subjects must be able and agree to refrain from using prescription and non-prescription nasal spray or other nasal preparations or washes from the time of their screening up to and during their scheduled study day.