cyrilzakka/clinical-trials huggingface dataset:
Fiberoptic Evaluation of the LMA(Laryngel Mask Airway) Position During Anesthesia With Spontaneous Respiration or Controlled Ventilation in Children

LMA(Laryngel Mask Airway) is useful for pediatrics surgery, and there are various methods of LMA insertion. When the investigators evaluate the LMA position, the investigators can use fiberoptic bronchoscope (Grade 1 to 4). For pediatric patients, clinical signs(airway pressure\<20cmH2O, expiratory CO2 level)are seen normal but the grade is 3 or 4. And this will bring high risk of aspiration. Recent studies reported the LMA position after general anesthesia induction not after operation. Therefore, the investigators will observe the LMA position three times; after general anesthesia induction, after caudal block, and after operation as well as the difference regarding to spontaneous and controlled ventilation.


Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status 1 or 2,
2. pediatric patients from 1month to 7 years old
3. under general anesthesia using LMA
4. getting informed consent from the guardian

Exclusion Criteria:

1. difficult airway
2. airway diseases ; URI, asthma, pneumonia
3. not getting informed consent from the guardian
Menopause and Oral Health

Menopause is characterized by major physiological and concomitant psychological changes. The study aimed to evaluate the association between oral health parameters, bone mineral density (BMD) and physiological or psychological symptoms in post-menopausal women (PMW), compared with regularly menstruating women (RMW). Inflammatory biomarker levels in gingival crevicular fluid, saliva, serum and determination of microbial niches in subgingival plaque samples were further aimed. The participants were asked to complete the Women's Health Questionnaire to measure emotional and physical well-being.

A total of 148 women (PMW, n=76,RMW, n=72) received a comprehensive medical assessment and a full-mouth oral examination. The corresponding bone mineral density (BMD) and body mass indices (BMI) were obtained from their medical records.


Eligibility Criteria:
Inclusion Criteria:

* Being 35-65 years of age
* Having history of spontaneous amenorrhea for the last 12 months for PMW.
* Lack of irregularity in menstrual cycles during the past 12 months for RMPW.
* Possessing at least 10 natural teeth without any prosthetic restoration

Exclusion Criteria:

* History of antibiotics use in last 3 months
* Ongoing cancer therapy
* Presence of oral ulcers or acute infectious disease
* Presence of diabetes mellitus
Awareness, Care & Treatment In Obesity Management - An Observation in Mainland China

ACTION China is a cross-sectional, observational, descriptive, and exploratory survey-based study without collection of laboratory data. The study is not related to any specific treatment options or pharmaceutical product. Collection of data will be performed via quantitative online survey by a third-party vendor.

The goal of this study is to provide insights to drive awareness around the needs of People Living with Obesity (PLwO) and Health Care Professionals (HCPs) involved in obesity treatment and management.


Eligibility Criteria:
Inclusion criteria:

PLwO:

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, aged above or equal to 18 years at the time of signing informed consent
3. Lives in mainland China and is native Chinese
4. Current BMI based on self-reported height and weight of at least 28 kg/m\^2 as per mainland China definition of obesity(16) (calculated using an algorithm within the survey instrument)

HCPs:

1. Informed consent obtained before any study related activities (study-related activities are any procedure related to recording/collection of data according to the protocol)
2. Male or female, aged greather than or equal to18 years at the time of signing informed consent.
3. Physician with a license to practice
4. Specialty is not surgeon (including general, bariatric or plastic surgeon)
5. Practices in mainland China with at least 5 years in clinical practice
6. Spends at least 50% of time in direct patient care (as opposed to surgical procedures, office procedures or research/administrative tasks)
7. Has seen at least 100 patients in the past month
8. Has seen at least 10 patients needing weight management (defined as a patient with a BMI greather than or equal to28 kg/m\^2 with or without comorbidities) in the past month

Exclusion criteria:

PLwO

1. Previous participation in this study. Participation is defined as having given online consent in this study 2. Currently pregnant 3. Participates in intense fitness or body building programs 4. Has had significant, unintentional weight loss (due to major injury, illness, etc) in the past 6 months 5. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation HCPs

1. Previous participation in this study. Participation is defined as having given informed consent in this study.
2. Unwillingness, inability, or language barriers precluding adequate understanding or cooperation
Substance Use Disorder, Brain and Behavioral Regulation

The proposed project seeks to explore the effects of a neuroregulation paradigm named Z-Score Quantitative Electroencephalogram (QEEG) guided sLORETA neurofeedback (ZQLN) on optimizing brain electrophysiological activity and behavioral performance in a substance use disorder (SUD) population whose primary drug of use is cocaine.

Aim 1. Measure the effects of ZQLN training on brain electrophysiological activation changes in SUD patients. QEEG and Event-Related Potentials procedures, recorded with a 19-channel digital EEG, will be conducted before and after 12-15 sessions of ZQLN to examine changes on dysregulated brain sites by inspection of the brain maps deviating brain areas sLORETA Brodmann Areas Voxels Z-Scores inside and outside the target window of -/+2 standard deviations. Observation of P300 component latencies and amplitudes will be measured during a Drug-cue GoNoGo paradigm.

Aim 2. Measure the effects of ZQLN training on behavioral performance changes in SUD patients. In the same participants of Aim 1, Pre and Post behavioral performance (before and after 12-15 sessions of ZQLN) includes the assessment of attention and executive function, episodic memory, working memory language, and processing speed as measured by the NIH Toolbox Cognitive Domains battery scales. Other behavioral variables include reaction times, omission, and commission errors in the Drug-cue GoNoGo task.

Eligibility Criteria:
Inclusion criteria

* Age limit: 21 to 51
* Cocaine as a primary drug of selection
* Be stable (such as not having reading or movement problems preventing them from using a computer keyboard or iPad).
* Have completed the first stage of treatment in the program (this first phase consists of the stabilization and detoxification period of the program participants)

Exclusion criteria

* History of brain injury.
* Previous experience with neurofeedback training.
* Being unavailable to complete assessments.
Clinical Study of BDB018: Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

A Phase 1 Open-label Dose Escalation Trial of BDB018 in Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

This clinical trial is a study of an experimental drug called BDB018. BDB018 is a next-generation Toll-like receptor (TLR) 7/8 agonist that activates the immune system.

The primary objectives of this study are to evaluate the safety and tolerability of BDB018 in monotherapy and in combination with pembrolizumab (Keytruda) in subjects with unresectable or metastatic solid tumors that have relapsed or are refractory to standard treatment or for which there is no approved therapy.

This is a multi-center, open-label, dose escalation/dose expansion Phase 1 study of BDB018 in monotherapy and in combination with pembrolizumab.

The study will be conducted in two separate but independent parts: a dose escalation part with BDB018 in monotherapy and in combination with pembrolizumab and a dose expansion part of BDB018 in combination with pembrolizumab.

Eligibility Criteria:
Inclusion Criteria

1. Histologically or cytologically confirmed advanced or metastatic solid tumors that have disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment. Note: there is no limit to the number of prior treatment regimens
2. Evidence of progressive disease (PD) within 3 months of signing the informed consent form.
3. Have measurable disease

Exclusion Criteria:

1. Has disease that is suitable for local therapy administered with curative intent.
2. Prior exposure to TLR7 agonists, TLR8 agonists, TLR 7/8 dual agonists, and TLR9 agonists.

Other protocol defined inclusion/exclusion criteria could apply
End-stage Renal Disease (ESRD) Pilot Study

The purpose of this study is to investigate the safety of two different doses of a drug called BAY1213790 and how well it is tolerated in patients with end-stage renal disease (ESRD) undergoing hemodialysis (HD). Approximately 40, with up to 60 study patients will take part in the study.


Eligibility Criteria:
Inclusion Criteria

* Male and female patients between 18 and 80 years of age.
* ESRD on hemodialysis (including hemodiafiltration) for at least 3 months
* Life expectancy of \> 6 months
* Women of non-childbearing potential

Exclusion Criteria:

* High risk for clinically significant bleeding
* Acute renal failure
* Planned major surgery in the next 7 months from randomization
* Concomitant use of oral anticoagulant therapy or antiplatelet therapy
* Documented thrombotic event in the past 6 months
A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery

The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who are not planned for potential curative surgical resection are eligible.
* Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease

Exclusion Criteria:

* Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation
* Active infection requiring systemic therapy within 14 days prior to randomization
* History of organ or tissue transplant that requires systemic use of immune suppressive agents
* Prior thoracic radiotherapy

Other protocol-defined inclusion/exclusion criteria apply
The Interest of the Xylocaine® and Ketamine on the Management of Acute and Chronic Ain After Colectomy by Laparoscopy

Recent clinical studies in abdominal surgery have shown that the use of Xylocaine® parenterally intraoperative at plasma concentrations below the toxic threshold of 5 .mu.g / ml, had an analgesic effect and decreased postoperative morphine consumption.

This study aims to evaluate the activity of Xylocaine® and ketamine separately administered parenterally, in terms of postoperative morphine consumption and decrease incidences of postoperative chronic pain at 3 and 6 months after laparoscopic colectomy compared the placebo group.

The evaluation of the intensity of postoperative pain, hyperalgesia perished skin surface scarring) and pain perception threshold by Pain Matcher® confirm or not the predictive nature of these criteria in the occurrence of chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Surgery: segmental or total colectomy performed by laparoscopy
* Anesthesia state 1 and 3

Exclusion Criteria:

* Patients classified Anesthesia state 4 or 5
* Allergy or intolerance to any of the products used in the protocol
* Creatinine clearance calculated by the Cockcroft formula below 50 ml / min
* Hepatocellular insufficiency
* Severe heart failure
* Peptic ulcer
* Chronic inflammatory bowel disease (IBD)
* Previous history of epilepsy or seizures
* Surgery emergency, palliative surgery, revision surgery
* Chronic pain requiring regular intake of analgesics include opioids
* Patients treated with lidocaine patch
* Psychic Disorder
* Additive Conduct vis-à-vis alcohol or mind-altering substances
* Pregnant or breastfeeding women
Evaluation of Success Rate of Partial Pulpotomy Versus Complete Pulpotomy in Primary Molars Using NeoPUTTY MTA

Evaluating the clinical and radiographic success of partial pulpotomy compared to complete pulpotomy in vital primary second molars with reversible pulpitis using NeoPUTTY™ (MTA).

Children with symptoms of reversible pulpitis in their second primary molar will be chosen to be enrolled in the study, and then randomly allocated into two groups. One group will undergo partial pulpotomy and the other group complete pulpotomy and followed up for 12 months. The blinding of the operator is not possible due to the nature of the technique used. Trial participants, outcome assessors and statistician will be blinded.

1. Informed consent from participating children's parents.
2. Baseline records photographs, percussion test, periapical radiograph and personal data collection.
3. Diagnostic chart with personal, medical and dental history will be filled.
4. Allocation (concealed by withdrawing a sealed opaque envelope containing Four-folded numbered papers containing the type of vital pulp therapy technique that will be used then writing the patient's name and I.D. on it and will be opened after removing the carious lesion).
5. Clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnoses are established after clinical examination).
6. Preoperative and Postoperative photographs will be taken.

Eligibility Criteria:
Inclusion Criteria:

* Patients:

  * Aged 4-7 years, in good general health and medically within normal.

Teeth:

* Restorable mandibular second primary molars.
* History of reversible pulpitis.

Preoperative radiograph:

* Absence of periapical or inter-radicular radiolucency.
* Absence of widening of periodontal ligaments (PDL) space.
* Absence of internal or external root resorption.

Exclusion Criteria:

* Patients:

  * With systemic disorders.
  * Physical or mental disabilities.
  * Unable to attend follow-up visits.
  * Refusal of Participation.
  * Refusal to sign the informed consent.

Teeth:

* Previously accessed teeth.
* Mobile mandibular second primary molar.
* Swelling in the vestibule or on palpation.
* Pain on percussion.
Effects of an Educational Program on Depression Literacy and Stigma Among Secondary School Students in Jazan City

Depression is a serious mental health disease. It is generally characterized by sadness, loss of interest in activities, and decreased energy. Globally, it is estimated that almost 350 million people suffer from depression. In Saudi Arabia, literature suggested that prevalence of depression among boy's secondary school students in Abha city was 38.2%. Another study found that the prevalence of depression was 22.4 % as moderate, 7.3 % as severe and 3.7% as very severe, with a clear predominance prevalence of depression in girls as in boys (1.5 times). It is important to assess depression literacy including knowledge and beliefs about mental disorders among adolescent. A high level of mental health literacy on depression leads to a better understanding and outcomes of depressive disorders. Schools are a typical venue in which to embed mental health literacy because the school students are more familiar with educational activities. Studies concluded that educational intervention about depression literacy and destigmatization improves knowledge and may decrease stigma. Further research, intervention and activism are needed in the field of mental health in Arab countries to improve awareness of mental health problems.

Objectives: This study is aimed to measure the effect of educational intervention program about depression among secondary schools in Jazan city on depression literacy and stigma during the academic year 2015-2016.

The intervention: the intervention will held at each selected intervention school separately. The program will be over 2 weeks intervention as the following:

* Educational strategies: 2 Lecture about depression 30 minutes supported by group discussion, brochures and display of posters with mental-health slogans on depression in the schools.
* Contact strategies: the investigators will show a video of a young male who had been diagnosed (i.e., not an actor) with depression.

Benefits:

\* The intervention group will join educational intervention program they expected to benefit from the program through increase their depression literacy and improve depression stigma, and control group will not join any form of intervention.

Risk: There is no expected risk for participating in the study.

Consent: Three Informed Consents forms will be signed from students, guardians and school manager.


Eligibility Criteria:
Inclusion Criteria:

* Students needed to be enrolled in one of the selected schools during the academic year 2015-2016.
* Must be in the age group 10-19 years.
* Must agree to participate in the study (consent was obtained from the students,and proxy consent was obtained from guardians).

Exclusion Criteria There were no exclusion criteria for participation in this study.
A Multilevel Intervention to Improve Uptake of Gastrointestinal Cancer Screening: a Cluster Randomized Clinical Trial

This study is a cluster randomized controlled trial aimed at evaluating the effectiveness of a multi-level intervention strategy in improving adherence to gastrointestinal cancer screening. Communities will be randomly assigned as the unit of randomization to either intervention or control group. The study population includes community residents aged 50-74 years. Communities in the intervention group will receive multi-level interventions including health education, patient navigation services, and appointment assistance, while communities in the control group will maintain routine screening management. All participants will be followed up for 90 days to track their endoscopy appointment and completion rates. The main research question is:

Can community-based multi-level intervention effectively improve adherence to gastrointestinal cancer screening among community residents?


Eligibility Criteria:
Inclusion Criteria:

* high-risk individuals of gastrointestinal cancer in 45-74 years old

Exclusion Criteria:

* Unable to give consent
* history of cancer
* severe cardiac, pulmonary, brain, or renal dysfunction or any other serious disease
* psychiatric illness
* pregnancy
The Observational Study of Growth Hormone-secreting Pituitary Tumors

The major purpose of this study is to evaluate the changes of multiple organs in patients with growth hormone-secreting pituitary tumors before and after surgery. Plasma, DNA samples and pituitary tumor tissues will be kept for further analysis.

Multiple organs or systems will be affected by excessive growth hormones in patients with acromegaly. The major purpose of this study is to evaluate the changes before and after the pituitary surgery.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acromegaly
* \> 18 years old
Transcutaneous Vagus Nerve Stimulation (tVNS) and Robotic Training to Improve Arm Function After Stroke

The purpose of this study is to evaluate if multiple therapy sessions of Transcutaneous Vagus Nerve Stimulation (tVNS) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy in a sham stimulation condition.

Promising new animal research suggests that vagus nerve stimulation paired with motor intervention induces movement-specific plasticity in the motor cortex and improves limb function after stroke. These results were recently extended to the first clinical trial, in which patients with stroke demonstrated significant improvements in upper limb function following rehabilitation paired with implanted VNS. Currently, vagus nerve stimulation is being used clinically to treat a number of human diseases including migraine headaches, epilepsy, and depression, and these investigations are expanding to deliver stimulation via a transcutaneous route to potentially improve intervention efficacy and decrease side effects. This pilot study will combine non-invasive transcutaneous stimulation of the vagus nerve with upper limb robotic therapy to investigate the potential of tVNS to augment improvements gained with robotic therapy in patients with chronic hemiparesis after stroke.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between 18 and 85 years of age
* First single focal unilateral supratentorial ischemic stroke with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
* Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist or PI)
* Fugl-Meyer assessment 12 to 44 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist).

Exclusion Criteria:

* Botox treatment within 3 months of enrollment
* Fixed contraction deformity in the affected limb
* Complete and total flaccid paralysis of all shoulder and elbow motor performance
* Prior injury to the vagus nerve
* Severe dysphagia
* Introduction of any new rehabilitation interventions during study
* Individuals with scar tissue, broken skin, or irremovable metal piercings that may interfere with the stimulation or the stimulation device
* Highly conductive metal in any part of the body, including metal injury to the eye; this will be reviewed on a case by case basis for PI to make a determination
* Pregnant or plan on becoming pregnant or breastfeeding during the study period
* Significant arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, sick sinus syndrome, and A-V blocks (enrollment to be determined by PI review)
* Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system; Loop recorders will be reviewed on a case by case basis by PI and the treating Cardiologist to make a determination