cyrilzakka/clinical-trials huggingface dataset:
Effect of Photobiomodulation on ph and Salivary Flow

Changes in salivary parameters, such as decreased flow, changes in pH and composition, can lead to changes in oral health. Saliva is responsible for the homeostasis of the oral cavity and is therefore directly related to the occurrence of caries, periodontitis, fungal and bacterial infections. These situations compromise the quality of life of the population and for this reason prevention and treatment strategies need to be studied and developed. Photobiomodulation is an alternative that has been increasingly practiced by health professionals. It consists of the application of light to a biological system that is capable of inducing a photochemical process, mainly in the mitochondria, thus stimulating the production of energy in the form of adenosine triphosphate (ATP), which can increase cellular metabolism and produce effects. as analgesia and tissue regeneration. In dentistry, studies using photobiomodulation have shown promise in improving some salivary parameters. This study aimed to compare the action of infrared light on salivary flow and pH, using two application techniques: extraoral (G1) and intra and extraoral (G2), with the application interval between the two techniques being 7 days

This is a quasi-experimental clinical study evaluating the flow and salivary pH of healthy adults. The study was carried out with 20 adult patients at the Nove de Julho University. This study aimed to compare the action of infrared light on salivary flow and pH, using two application techniques: extraoral (G1) and intra and extraoral (G2), with the application interval between the two techniques being 7 days. The sample consisted of 20 healthy adults, who participated in both groups, thus being the actual control in the evaluations. Stimulated saliva was collected in both groups before and immediately after light application. In G1, a cluster with 3 spots was used, at a wavelength of 808 nanometers, power of 120 mW, with 24J of energy on the extraoral surface, for 67 seconds, in the region of the parotid gland, region of the submandibular and sublingual glands bilaterally, totaling 4 application regions, with total deposited energy of 96 joules. In G2, the laser was applied for 60 seconds, in 2 intraoral and 2 extraoral points in the region of the parotid glands bilaterally, as well as 1 intraoral and 1 extraoral point in the regions of the submandibular and sublingual glands (totaling 16 points), with a central wavelength of 808 nm; continuous operating mode; power of 100mW; with an aperture diameter of 0.354 cm (with spacer); radiant energy of 6J per point, totaling 96 joules of energy.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults over 18 years of age
* healthy dentition.

Exclusion Criteria:

* dental caries
* gingivitis or other alterations in the oral cavity
* who use medication that has the side effect of decreasing the salivary flow,
* who have used an antibiotic or anti-inflammatory within the last 30 days,
* diabetes.
Neurophysiological Mechanisms Involved in Knee Osteoarthritis

Introduction: Total knee arthroplasty (TKA) is an effective intervention to relieve people with osteoarthritis (OA). Nevertheless, 15 to 30% of patients continue to experience severe pain following surgery. Recent data suggest that central nervous system (CNS) changes may play a role in OA pain and possibly explain why some patients have poorer clinical outcomes following TKA. Objectives: Our main objectives are to explore the relationship between OA pain and (1) the integrity of corticospinal system, (2) the efficacy of descending pain inhibition circuits. Methods: Fifty-two patients waiting for TKA will be recruited. The integrity of the corticospinal projections will be measured using transcranial magnetic stimulation (recruitment curve of the affected quadriceps femoris muscle) and the descending pain inhibition circuits (bulbospinal projections) will be assessed by a counter-irritation paradigm (i.e., conditioned pain modulation with immersion of the arm in painfully cold water). Diffuse tension imaging (DTI) will also be used to quantify the strength of these corticospinal and bulbospinal projections. Clinical outcomes will be evaluated before and after arthroplasty with a series of validated questionnaires such as the WOMAC Scale, the McGill Pain Questionnaire and the Brief Pain Inventory. These different neurophysiological and clinical measures will be taken before surgery, 6 months after surgery and 1 year post-surgery. Anticipated results: The investigators expect a moderate association between pain and the strength of the corticospinal and bulbospinal projections. Moreover, it is expected that there will be a moderate association between the strength of the corticospinal/bulbospinal projections and the clinical evolution of patients.

See outcome measures

Eligibility Criteria:
Inclusion Criteria:

* Being an adults aged 50-79 years old with a diagnosis of knee OA and waiting for a primary arthroplasty
* Refrain from consuming cigarettes and caffeine 2 hours and 6 hours before testing, respectively
* Refrain from taking short-acting analgesics (e.g., acetaminophen) 6 hours before testing

Exclusion Criteria:

* Having difficulty understanding french language
* Having a diagnosis of neurological disorder or diagnosis of chronic pain (other knee OA)
* Having metal implants in the skull
* Having pacemaker or neurostimulator
* Being pregnant
* Being epileptic
Study of PYX-201 in Solid Tumors

The primary objectives of this study are to determine the recommended dose(s) of PYX-201 for participants with relapsed/refractory (R/R) solid tumors, and to determine the objective response rate (ORR) in participants treated with PYX-201 as a single agent.


Eligibility Criteria:
Inclusion

1. Histologically or cytologically confirmed solid tumors including locally advanced/metastatic NSCLC, HR+ and HER2- breast cancer, HR- and HER2-positive breast cancer, TNBC, HNSCC, ovarian cancer, thyroid cancer, pancreatic ductal adenocarcinoma (PDAC), sarcomas, hepatocellular carcinoma (HCC), kidney cancer, cervical cancer and endometrial cancer.
2. Male or non-pregnant, non-lactating female participants age ≥18 years.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1.
4. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
5. Life expectancy of \>3 months, in the opinion of the Investigator.
6. Corrected QTcF \<470 msec.
7. Adequate hematologic function.
8. Adequate hepatic function.
9. Adequate renal function.
10. Adequate coagulation profile.
11. Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample.

Exclusion

1. History of another malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical carcinoma; adequately treated, noninvasive bladder cancer.
2. Known symptomatic brain metastases.
3. Significant cardiovascular disease within 6 months prior to start of study drug.
4. Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug.
5. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
6. Failure to recover to baseline severity or Grade ≤1 NCI-CTCAE v5.0 from acute non-hematologic toxicity.
7. Participants with NCI-CTCAE v5.0 Grade \>1 neuropathy of any etiology.
8. Prior solid organ or bone marrow progenitor cell transplantation.
9. Prior high-dose chemotherapy requiring stem cell rescue.
10. Received systemic anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to the start of study drug.
11. Palliative radiation therapy within 14 days prior to the start of study drug.
12. Previously received extra domain B splice variant of fibronectin (EDB+FN) targeting treatments at any time prior to the start of PYX-201 treatment.
13. History of uncontrolled diabetes mellitus.
14. History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
15. Participants with corneal epithelial disease, with the exception of mild punctate keratopathy
16. Participants with the best-corrected visual acuity in the worst-seeing eye worse than 20/100 (Snellen equivalent).
The Evaluation of Training an Emergency Reflex Action Drill in the Emergency Surgical Airway in Dutch Paramedics

The goal of this observational study is to learn about the effects of training an Emergency Reflex Action Drill (ERAD) for Emergency Surgical Airway (ESA) in Dutch paramedics. The main question it aims to answer is:

- Does training an ERAD improves self-confidence in performing an ESA in Dutch paramedics Participants will fill out a questionnaire directly before and after the training. To investigate long-term effects, they will be asked to fill out a questionnaire after 2 till 3 months and after one year.


Eligibility Criteria:
Inclusion Criteria:

* Registered Dutch paramedic
* Ambulance driver on Advanced Life Support Ambulance
* Participant in the two-day trauma course.

Exclusion Criteria:

* Medium care ambulance paramedic
Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China

This study is aimed to understand the clinical characteristics, etiology and resistance phenotype of major pathogens of SCAP in China through multicenter and prospective investigation. Thus to provide epidemiological basis for improving the SCAP diagnosis and treatment protocol suitable for China.

During the study period, all patients who are diagnosed with SCAP and meet the inclusion criteria in the participating unit should be enrolled in the study . At the end of the trial, each participating unit should complete at least 20 qualified cases, and all participating units should have a total of more than 300 qualified cases.

1. Learn about the etiology of SCAP in China.
2. Grasp the resistance phenotype and molecular epidemiology of major pathogens of SCAP in China.
3. Know the important clinical characteristics of SCAP in China, including age, basic diseases, length of hospital stay, length of stay in ICU, duration of mechanical ventilation, clinical manifestations, imaging findings, complications, mortality, etc.
4. Analyze and clarify the clinical risk factors of affecting SCAP mortality.
5. Understand the current situation of antibiotic treatment of SCAP in China.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 yeas;
* Diagnosis of CAP according to the diagnosis and treatment of community-acquired pneumonia in adults: 2016 clinical practice guidelines by the Chinese Thoracic Society, Chinese Medical Association.

Exclusion Criteria:

* Bronchiectasis;
* Active tuberculosis;
* Aspiration pneumonia or obstructive pneumonia;
* Hospitalized in 2 weeks;
* Hospitalized or ventilated ≥5 days;
* Severe immunosuppression patients;
* Irregular follow-up and lost follow-up;
* Withdraw from the study for any reason.
The Association Between the Intraoperative Blood Pressure Changes and Whole Exome Genome

The intraoperative blood pressure changes have been important for postoperative morbidity and mortality. However, some patients did not occur intraoperative hypotension but some patients would have severe intraoperative hypotension. It may be associated with genome related. In this hypothesis, we aim to elucidate the association between the whole exome genome and intraoperaive blood pressure changes.

We aim to elucidate the association between the whole exome genome and intraoperative blood pressure changes.

We will enroll patients older than 20 years old and undergo elective general anesthesia.

Before anesthesia, we will obtain blood sample for whole exome genome test and give arterial line for intraoperative monitor.

After completing surgery, we will follow the patients' all postoperative major organ function.

We hope this study to be able to give us the more information about the specific genetic effect on the arterial stiffness and intraoperative blood pressure changes.

Eligibility Criteria:
Inclusion Criteria:

* elective general surgery

Exclusion Criteria:

* coagulopathy
Efficacy and Safety of Multimode Thermal Therapy in the Treatment of Early Peripheral Lung Cancer

The purpose of the study is to evaluate the efficacy and safety of multimode thermal therapy for early peripheral lung cancer, and to explore the changes of systemic immune microenvironment after multimode thermal therapy.

This is a single-center, single-arm, exploratory study, and is expected to enroll a total of 10 patients. The enrolled patients were stage IA lung cancer patients with lung lesions found on chest CT, pathologically diagnosed as non-small cell lung cancer, negative for driver gene mutations, and who were considered high-risk or refused surgery by multidisciplinary evaluation. Follow-ups are performed after the multimode thermal therapy. The primary endpoint is complete ablation rate at 6 months after multimode thermal therapy. The secondary endpoints are complete ablation rate at 12 months after multimode thermal therapy, local control rate at 1, 2, 3 years post-procedure, progression-free survival and mmune effects after multimodal thermal therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old;
2. Pathologically diagnosed as primary peripheral non-small cell lung cancer, preoperative staging suggested clinical staging as T1N0M0, stage IA (including new-onset lung cancer after surgery and multiple primary lung cancer);
3. The ECOG PS score is 0-2;
4. Expected survival ≥6 months;
5. Negative driver gene mutation: driver genes were defined as EGFR, ALK, ROS1, RET;
6. Agree to undergo multimode thermal therapy as initial treatment after being assessed unsuitable for surgery or refusing surgery, and sign informed consent.

Exclusion Criteria:

1. Patients with poor cardiopulmonary function or other comorbidities who cannot tolerate multimode thermal therapy;
2. Patients whose chest CT indicated that the lung lesions could not be reached through the chest wall through multimode thermal therapy;
3. Severe liver and kidney function and coagulation function abnormalities, platelet count \<70×109/L;
4. Poor control of malignant pleural effusion;
5. Patients who have received other anti-tumor drugs or have used immune checkpoint inhibitors in the past 6 months;
6. The patient has an uncontrolled disease (including but not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia, mental illness, etc.);
7. Those who have undergone surgical operations or had allogeneic organ transplants within 1 month;
8. Primary immune deficiency or autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.);
9. Pregnant and lactating women;
10. Long-term use of steroid;
11. Other circumstances considered inappropriate for participation in this study.
A Study Comparing the Influence of a Mindfulness-based Stress Reduction Program vs. Routine Management on Psychological Variables and Biological Markers Related to Immuno-inflammation Associated With Psychological Stress in Caregivers of Patients With Severe Psychiatric Disorders

The objective of this project is to study the influence of mindfulness meditation on psychological health (stress level, affects, emotions) and physical health parameters (rate of inflammatory markers in the blood, activity of white blood cells involved in immuno-inflammation) in caregivers of people with psychiatric disorders. This study will provide the objective scientific data required for the development of mindfulness meditation programs for psychiatric caregivers.

80 participants will be randomly assigned to one of the following two groups:

* 40 participants in the "Mindfulness" group who will attend mindfulness meditation sessions in addition to their standard follow-up
* 40 participants in the "Control" group who will have a standard follow-up The duration of participation is 12 months and includes 3 visits and 8 mindfulness-based meditation sessions for the "Mindfulness" group.


Eligibility Criteria:
Inclusion Criteria:

* patient who has given oral consent
* adult patient
* a caregiver of a person with a severe psychiatric disorder (schizophrenia, recurrent depression, bipolar disorder, obsessive-compulsive disorder)

Exclusion Criteria:

* protected adult
* patient not affiliated to the national health insurance system
* pregnant, parturient or breastfeeding woman
* person suffering from a severe psychiatric disorder indicating a state of decompensated stress (with risk of associated biological inflammatory disturbances)
* person suffering from an inflammatory disease (autoimmune, infectious, neoplastic, cardio-vascular pathologies
Risk Factors of the Revisit of the Adult Heart Failure Patients in Emergency Department Siriraj Hospital

To identify the risk factors of the revisit of the adult HF patients in emergency department.

Because heart failure (HF) is the leading cause of hospitalization and readmission in many hospitals worldwide.

Identifying the risk factors of these HF patients in emergency department is the important reason for the proper management of the HF patients in the future. And can reduce number of hospitalization and readmission in our hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients age from 18 years old
* Patients who were diagnosed HF by the Framingham's criteria10
* Patients who were discharged home from emergency department

Exclusion Criteria:

* Patients age less than 18 years old
* Patients who not met Framingham's criteria, needed hospital admission, were referred to other hospital, and death
Behavioral Couples Therapy for Female Drug-Abusing Patients

In treating drug addiction, many studies of male patients show Behavioral Couples Therapy (BCT) helps the whole family (the drug abuser, the relationship partner, and their children) and is more effective than typical individual and group counseling. Only one study of BCT has been done with female drug-abusing patients, and results were promising but not definitive. The proposed study will test with married or cohabiting female drug-abusing patients whether BCT will produce more positive outcomes for the women, their male partners, and their children than standard individual counseling for the patient alone.


Eligibility Criteria:
Inclusion Criteria:

* female patients with primary drug abuse diagnosis \& their relationship partners
* patient married or cohabiting with relationship partner
* partner without current alcohol or drug problem

Exclusion Criteria:

* both patient and partner without severe mental health disorders
Comparison of Two Pen Systems in Patients With Diabetes Treated With Insulin

This trial is conducted in Europe. The aim of this trial is to compare two insulin delivery pens in the everyday life setting of patients with diabetes treated with insulin.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes mellitus for at least 12 months
* Adults at least 18 years
* Children/adolescents between 9-18 years
* HbA1c lesser than or equal to 11.0%

Exclusion Criteria:

* Known or suspected alcohol or drug abuse
* Patients who are not able to read the user manual (may wear glasses if needed)
* Hypoglycaemic unawareness as judged by the investigator
* Visual and/or dexterity impairments as judged by the investigator
Study of Airflow in the Lungs Using Helium MRI

Computer simulations are being developed to predict air flow abnormalities in the airways of patients with lung disease. The purpose of this study is to obtain actual gas flow measurements in the lungs of healthy patients and patients with lung disease and use these measurements to validate the computer models.

The Biotechnology High Performance Computing Software Applications Institute (BHSAI) of the Department of Defense (DoD) is studying airflow in the lungs using computational fluid dynamics in order to characterize disease-specific airflow patterns and provide useful information for medical applications. To validate these models, they are seeking to obtain experimental data of airflow in human lungs, both healthy and diseased. An assessment of airflow can be obtained by using hyperpolarized noble gas (HNG) magnetic resonance imaging (MRI) or, more specifically, hyperpolarized helium-3 (HHe) MRI in conjunction with flow-encoding schemes that are well-established in conventional proton MRI

Four chronic obstructive pulmonary disease (COPD) patients and four healthy subjects will undergo pulmonary function tests (PFTs), computed tomography (CT) scan covering the mouth, neck, and chest, and hyperpolarized helium 3 MRI. Before and after the MRI scans, three spirometry readings will be taken while the subject is lying in the same position as in the MR scanners. Data will be analyzed by the BHSAI. UVa will provide the de-identified raw image data and the de-identified results of the spirometry and other tests to BHSAI

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects:

  * Normal PFT values: FEV1 \> 90% predicted; and Forced vital capacity (FVC) \> 90% predicted
  * Normal chest x-ray (CXR)
  * Medical history: No active pulmonary symptoms (cough, shortness of breath, sputum); Negative history of pulmonary disease; Negative smoking history (never smoked)
* Pulmonary Disease Subjects:

  * PFT values: FEV1/FVC \< 70% (indicative of obstruction); and 30% \< FEV1 \< 50% predicted
  * CXR normal except hyperinflation
  * Symptoms - chronic shortness of breath
* All test subjects, healthy and with COPD should have similar physical anthropometric characteristics:

  * Similar age with age difference less than 3 years
  * Similar height (within 3-4 inches)

Exclusion Criteria:

* Any condition for which a MRI procedure is contraindicated.
* Presence of any non-MRI compatible metallic material in the body, such as pacemakers, metallic clips, etc.
* Likelihood of claustrophobia
* Chest circumference greater than that of the helium MR coil.
* Pregnancy, by report of subject. Clinically in the Department of radiology at UVA, self report is used when screening patients for MR scans as well as CT scans and fluoroscopy studies. If the subject reports there is any chance of their being pregnant a urine pregnancy test will be performed prior to any imaging.