cyrilzakka/clinical-trials huggingface dataset:
Analysis of Biliodigestive Anastomosis Techniques (BDA)

The aim of this prospective randomized controlled study is to determine the benefit-risk ratio (success rate, complication rate, tolerance) for patients with biliodigestive anastomosis by either continuous or interrupted suture.

The aim of this prospective randomized controlled study is to determine the benefit-risk ratio (success rate, complication rate, tolerance) for patients with biliodigestive anastomosis by either continuous or interrupted suture. A biliodigestive anastomosis is a surgical connection between the common bile duct (ductus choledochus) and the digestive tract to prevent interference of bile flow. Indications for a biliodigestive anastomosis include total or partial resection of the pancreas and duodenum (PPPD, Whipple procedure) for pancreatic tumors, tumors of the biliary tract or duodenum, and biliary tract reconstructions during liver transplantation or advanced liver resections. Furthermore a biliodigestive anastomosis can be required to manage the injury of the biliary tract and infectious and traumatic structures of the biliary tract. Biliodigestive anastomoses can be performed by continuous or interrupted suture. The aim of this study is to determine the difference between continuous and interrupted suture for biliodigestive anastomoses, as advantages and disadvantages of each technique have not been determined. Only patients receiving their first biliodigestive anastomosis will be included.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Scheduled for elective BDA procedure
* Primary BDA procedure
* Diameter of DHC \> 7mm
* Written consent

Exclusion Criteria:

* Previous BDA procedure
* Impaired mental state or language problems
* Lacking compliance
* Emergency procedure
Effects of Lidocaine Infusion on Quality of Recovery and Agitation After Functional Endoscopic Sinus Surgery

The essential anesthesia requirements for FESS include airway management, considerations for facilitating surgical access, provision of a clear and still surgical field for precision surgery, assuring quick and non-stimulating emergence from anesthesia, and fast-tracking patients for discharge. Postoperative agitation, although short-lived, is potentially harmful to both patients and recovery room staff, it has a potential for self-injury by removing intravenous catheters, tubing, oxygen masks and nasal packs. Furthermore, very agitated patients can pose an immediate danger to operating theatre staff.

Lidocaine is an amino amide-type short-acting local anesthetic (LA). It has a short half-life, and a favorable safety profile, and is therefore the LA of choice for continuous IV administration, it has analgesic, and anti-inflammatory effects that are induced by reduction of cytokines production through inhibition of neutrophil activation, and the analgesia may persist even after plasma concentration reduction. It can blunt the pressor response to endotracheal intubation also systemic lidocaine was effective in producing controlled hypotension.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective functional endoscopic sinus surgery;
* ASA class I-II,
* aged (20-60 years).

Exclusion Criteria:

* Body mass index \>35 kg/m2
* History of allergic reaction to local anesthetic agents especially lignocaine.
* History of preoperative use of opioids.
* Patients with history of uncontrolled hypertension, A-V conduction block.
* History of sleep apnea.
Effect of Nasal Spray Dexmedetomidine on Emergence Delirium Prevention in Total Hip Replacement

Emergence Delirium (ED) is a common postoperative complication refers to an acute brain dysfunction that occurs during the recovery from general anesthesia, which is mainly characterized by sudden attention and consciousness disorders. The occurrence of ED increases the risk of self-injury, wound dehiscence, accidental catheter dislocation, and postoperative delirium, and is also associated with postoperative cognitive deterioration and increased utilization of medical resources after discharge.

The incidence of hip fracture after surgery in patients over 55 years old is about 45%, and ED is highly predictive of delirium during postoperative hospitalization, which occurs in about 1/3 of ED patients during postoperative hospitalization.

It has been suggested that if delirium is monitored only on the first postoperative day and not at the PACU stage, up to 53% of delirium cases may be missed.

Studies have shown that perioperative application of dexmedetomidine can reduce the risk of postoperative delirium to a certain extent. However, intravenous dexmedetomidine usually leads to problems with delayed extubation, residual sedation, and prolonged PACU stay.

Previous studies have shown that intranasal dexmedetomidine improves perioperative sleep quality and neurocognitive deficits in elderly patients undergoing laparoscopic gynecologic surgery. Compared with intravenous administration, intranasal administration of dexmedetomidine resulted in milder hemodynamic fluctuations. However, stable nasal spray bioavailability is superior to intravenous dosage forms for nasal use.

Based on the above background, this study aims to investigate the effect of nasal spray of dexmedetomidine on the prevention of emergence delirium after total hip replacement in elderly patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥60 years old
2. Total hip arthroplasty under general anesthesia
3. ASA II-III
4. Informed consent was obtained from patients or their guardians

Exclusion Criteria:

1. Allergy or contraindication to dexmedetomidine
2. Severe rhinitis and nasal deformity
3. Severe bradycardia (heart rate \<50 beats/minute) or atrioventricular block of grade 2 or higher, permanent pacemaker implantation, severe heart failure or ejection fraction \<30%
4. Patients with previous myocardial infarction, unstable angina pectoris, severe arrhythmia, and cardiac insufficiency
5. Emergency surgery
6. Severe hepatic and renal dysfunction (Child-Pugh class B and C, CKD3-5)
7. Preoperative mental illness, cognitive impairment, and communication difficulties could not be evaluated in the study
8. Preoperative delirium was present
Enhancing Family Based Treatment of Childhood Obesity Through Social Networks

The purpose of this study is to develop a Social Network Engagement (SNE) Intervention that will be integrated into a standard treatment program for childhood overweight. The investigators will conduct a pilot trial of SNE to assess feasibility and to estimate its effectiveness compared with historical controls who received standard treatment. The historical controls will be participants in the FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629).


Eligibility Criteria:
Inclusion Criteria Children

* Age 7-13 years
* At or above the 85th percentile for age- and gender-specific BMI

Parents

• At least one overweight parent (BMI\>25.0)

Parents and children

* English-speaking and at least at a second-grade reading level
* Live \<50 miles from the treatment site.

Exclusion Children

* Conditions known to promote obesity (e.g., Prader-Willi),
* Participation in another weight control program
* Recently started taking weight-affecting medications (e.g., stimulants).

Parents and children

* Disability or illness that would preclude them from engaging in at least moderate-intensity physical activity,
* Current or prior diagnosed eating disturbance
* Thought disorder, suicidality, or substance abuse disorder
Color Doppler to Confirm Epidural Catheter Positioning in Parturient

The aim of this study is to calculate the sensitivity and specificity of using color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter

patients will be divided into two groups Group (C) control these are the patients with BMI less than 35 and Group (O) for patients with BMI more than 35.All patients will be sitting to receive their epidural analgesia for labor pain.

A 2.5 to 5 MHz curvilinear probe (Sonosite X-porte, Fujifilm industries) will be used to detect the desired level usually between L3-4 or L4-5. patients will be divided into two groups Group (C) control these are the patients with BMI less than 35 and Group (O) for patients with BMI more than 35. All patients will be sitting to receive their epidural analgesia for labor pain.

A 2.5 to 5 MHz curvilinear probe (Sonosite X-porte, Fujifilm industries) will be used to detect the desired level usually between L3-4 or L4-5. Initially a parasagittal oblique interlaminar view will be obtained and by tilting it medially to visualize the laminae and interlaminar spaces. Starting by the sacral image, counting will start detecting the L5-S1, L4-L5 and L3-L4 levels. After marking the level another imaging in the transverse view will be attempted at the previous levels then the anesthetist will detect the posterior complex (ligamentum flavum, epidural space and dura) and anterior epidural complexes and according to the anesthetist preference a level will be This is followed by a test dose of 10 ml 0.125% bupivacaine and patient controlled epidural analgesia will be started by the following protocol (0.0625% bupivacaine) Smith Medical ASD,Inc. in intermittent dose (10 ml will be injected by the machine every 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* obstetric patients admitted for epidural analgesia in the labor department suite (LDS)

Exclusion Criteria:

1. Patients suffering from coagulopathy.
2. Patients on recent anticoagulant therapy.
3. Patients suffering from sepsis or with local sepsis at the insertion site.
4. Patients with platelet count less than 100,000/dl.
5. Patient refusal.
6. Patient with known allergy to local anesthetic drugs
7. Patients delivered by forceps.
8. Patients who have undergone a cesarean section delivery.
Brightline: Advancing Mental Health on Campus

This observational study will employ a multi-modal observation methodology, integrating data from wearable devices and smartphones to establish comprehensive digital biomarkers for identifying symptoms of mental health conditions in university students. The study aims to identify the digital behavioural markers associated with mental health conditions, develop predictive algorithms for mental health states from digital markers, and identify university students at risk for mental health conditions.

In this study, participants will be monitored over a six-month period to determine the association between digital behavioural markers and mental health symptoms among university students. Participants will be passively monitored to collect digital phenotyping data (e.g., physical activity, sleep activity, heart rate, physiological patterns, sociability indices, finger taps, ambient light, phone states, etc.), using a wearable device and sensors from the smartphone. Participants will also complete self-report questionnaires at Months 0, 1, 3, and 6, to track changes in mental health symptoms and behavioural data. The collected data will be analysed to examine the longitudinal changes in depression, anxiety, and other mental health issues among university students and explore the feasibility of data collection procedures.

Eligibility Criteria:
Inclusion Criteria:

* Be aged 18 years or older.
* Be a current full-time undergraduate student.
* Own a smartphone with Wi-Fi, 4G, and Bluetooth capabilities.
* Possess adequate English language proficiency.
* Be able to download the study apps.
* Provide informed consent.

Exclusion Criteria:

* Are part-time students.
* Have a current diagnosis of any mental health disorder or a past diagnosis with any bipolar disorder, substance use disorder, or any psychotic disorder.
* Are currently undergoing mental health treatment.
* Lack sufficient English proficiency.
* Report suicidal ideation as indicated by Patient Health Questionnaire (PHQ-9) Item-9, "Thoughts you would be better off dead or of hurting yourself in some way".
* Cannot commit to wearing a wearable device for the six-month monitoring period.
* Receive special education accommodations or support from the university.
Single Rotary File Pulpectomy in Primary Molars

The aim of this study is to compare the clinical effectiveness of a single rotary file system versus a multiple rotary files system in pulpectomy of primary molars

In pediatric dentistry, premature loss of necrotic primary molars has been a matter of great concern over the years.

In modern pedodontic practice, Pulpectomy is regarded as the choice modality of treatment for pulpally involved necrotic teeth.

Hand files are used for mechanical preparation of primary tooth during pulpectomy but it has been found to be time consuming and may negatively influence the child's behavior . Much attention has been directed toward making pulpectomy a less time-consuming and a more-efficient procedure.

These challenges lead to the introduction of rotary endodontics in pediatric dentistry. However, the bizarre root canal morphology and thinner root dentin limited the use of rotary endodontics in primary teeth. Various modified protocols have been introduced to overcome such barriers to prevent undesirable complications.

Up to our knowledge, no clinical trials in the literature have been done to compare the clinical and radiographic success of single rotary file systems versus multiple rotary files systems when used in pulpectomy of primary molars. Thus, the present study aims to investigate the clinical effectiveness of those two techniques

Eligibility Criteria:
Inclusion Criteria:

* Children Criteria:

  * Medically free .
  * Cooperative patient.

Molar criteria :

• Mandibular second primary molar with clinical signs or symptoms of irreversible pulpitis

Radiographic criteria:

* No evidence of internal/external pathologic root resorption.
* With or without periapical or furcal lesion .

Exclusion Criteria:

* • Uncooperative children.

  * Children with systemic disease.
  * Lack of informed consent by the child patient's parent.
  * Refusal of participation.
RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer

To explore the safety and clinical efficacy of cisplatin combined with RC48 and anti-PD-1 antibodies AK105 in Her-2 positive advanced gastric cancer.

Although anti-PD-1 antibody could prolong the survival of patients with adanced gastic cancer, there are relatively few reports on anti-PD-1 antibody therapy in Her2-positive gastric cancer. RC48 is a primary anti-HER2 antibody-drug conjugate, which has been approved by the Chinese NMPA for the later-line treatment of Her2-positive gastric cancer. This study was to explore the safety and clinical efficacy of RC48 combined with cisplatin and AK105 in previously untreated patients with HER2-positive gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old, ≤75 years old, regardless gender
* Pathologically confirmed gastric adenocarcinoma, Her2 immunohistochemical examination of 2+ or 3+
* ECOG PS scores 0-1
* Stage IV according to AJCC 8.0 and no systemic therapy previously
* Expected lifespan ≥ 3 months
* Adequate organ function
* At least one measurable lesion according to RECIST 1.1
* Asymptomatic intracranial metastasis
* No history of other malignancies
* Women of childbearing age must have a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during the trial and for 6 months after the trial
* Agreed to participate in this clinical study and signed the Informed Consent

Exclusion Criteria:

* Currently participating in an interventional clinical investigational treatment, or have received other investigational drugs or treatment with an investigational device within 4 weeks prior to the first dose
* Received anti-PD-1, anti-PD-L1, anti-CTLA-4, and other checkpoint inhibitor
* Received traditional Chinese medicines or immunomodulatory drugs with anti-gastric cancer indications within 2 weeks before the first administration
* Active autoimmune diseases or immunodeficiency diseases
* Allergy to any test drug and its excipients, or a history of severe allergy, or contraindication to the test drug
* Severe mental disorder
* Receiving systemic corticosteroids within 7 days prior to the first dose of the study
* Clinically apparent cardiovascular and cerebrovascular disease
* Others investigators evaluated not meet the inclusion criteria
The Acute Effects of Oleic Acid Enriched-diets on Lipids, Insulin Sensitivity and Serum Inflammatory Markers

Objectives: To investigate the acute effects of olive oil, palm olein and lard on lipid profile, insulin sensitivity and inflammatory markers.

Hypothesis: Different dietary fats will alter lipid profile, insulin sensitivity and inflammatory markers postprandially.

A randomized, single blind, crossover design was undertaken to test meals enriched with palm olein vs olive oil vs lard. Volunteers were asked to participate in three postprandial challenges, separated by at least 3-days. Subjects were provided a low fat meal(\<10g fat) the day before the intervention. Fasting blood was collected the next day and the subjects were instructed to consume test meals (50g high fat meal). Further venous blood was collected at 30 min, 1h, 2h, 3h and 4h postprandially.

Primary outcome variable: Triacylglycerol (TAG) Secondary outcome variables: Insulin sensitivity (glucose, insulin), non esterified fatty acids (NEFA), inflammatory markers

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-45 years
* BMI : 18.5-30 kg/m\^2
* Healthy, men

Exclusion Criteria:

* medical history of cardiovascular disease, cancer, diabetes or chronic diseases
* BMI \< 18.5 OR \> 30 kg/m\^2
* waist hip ratio \> 0.9
* total cholesterol \> 5.2 mmol/L
* triacylglycerol (TAG) \> 2.2 mmol/L
* current use of antihypertensive or lipid lowering medication
A Comparison of Long-acting Injectable Medications for Schizophrenia

The purpose of this research study is to compare the "real-world" effectiveness of two FDA-approved and widely used long-acting injectable antipsychotic medications (paliperidone palmitate and haloperidol decanoate) in patients with schizophrenia or schizoaffective disorder who are expected to benefit from the improved medication compliance associated with injectable medications. The goal is to evaluate the effects of the medications on outcomes of importance to patients (relapse, symptoms, adverse effects, functioning) as well as policy makers (all of the above plus costs).

The purpose of this comparative effectiveness research study is to learn more about different medications called antipsychotics that are used to treat schizophrenia or schizoaffective disorder. Specifically, we are looking at long-acting medications that are given by injection every month, instead of being taken by mouth every day. In this multi-site study, we are comparing the risk and benefits of two FDA-approved long-acting injectable medications (paliperidone palmitate and haloperidol decanoate). Study participants with schizophrenia or schizoaffective disorder are expected to benefit from the improved medication schedule.

This study aims to enroll 360 individuals with schizophrenia or schizoaffective disorder for whom treatment with a long-acting injectable antipsychotic medication is likely to be helpful. Study participants will be randomly assigned to treatment with either paliperidone palmitate and haloperidol decanoate for up to 24 months. Participants will have an equal chance of being assigned to each medication, however participants will not know which medication they are taking.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR criteria
* Age 18-65 years
* Capacity to provide informed consent
* Patients who are likely to benefit from treatment with long-acting injectable paliperidone palmitate or haloperidol decanoate
* Women of child bearing potential must have a negative serum pregnancy test at the Screening Visit.

Exclusion Criteria:

* Patients who are currently stable and doing well on an antipsychotic regimen
* Patients not expected to benefit from the study medications due to past experience with risperidone, paliperidone or haloperidol
* Patients with tardive dyskinesia that is moderate or severe
* Patients with any medical condition that, in the judgment of the investigator, might preclude safe completion of the study
* Women who are pregnant or breastfeeding
* Patients with mental retardation
Exploring the Modulatory Role of Brain State on the Prefrontal Response to Excitatory Stimulation

Therapeutic repetitive transcranial magnetic stimulation (rTMS) for depression is well-supported, with multiple protocols approved by the United States Food and Drug Administration and global efforts aimed at boosting its antidepressant effects underway. However, there exists an under-reported aspect of clinical trials using rTMS: what are patients doing during each stimulation session? Here, the investigators begin this investigation with individuals without a history of depression nor other psychiatric diagnosis. The investigators focus on the underlying brain activity. The investigators will systematically assess the modulatory role of brain state on the brain's response to a session of rTMS by using a concurrent, non-invasive brain imaging setting: functional near-infrared spectroscopy (fNIRS), marking the first effort of its kind in this field.

The scientific literature on rTMS rehabilitation is steadily growing and new treatment protocols that aim to optimize rehabilitation efficacy as well as efficiency are emerging. However, no consideration to what patients should be doing during rTMS treatment sessions is given. These details are typically omitted in the literature, and advice is not given in recent guidelines. When details are reported, patients are assumed to enter a relaxed state during treatment. This assumption is highly problematic, especially for MDD because depression is an internalizing disorder, wherein emotional and cognitive dyscontrol are major features linked with abnormal activity of the dorsolateral prefrontal cortex (DLPFC), the region being stimulated. Indeed, instructing patients to concentrate on thoughts that exacerbate their depressive symptoms during stimulation diminishes the antidepressant treatment effect, and cognitive neuroscience research suggests the importance of considering the initial brain state when conducting behavioral and neuroimaging experiments with TMS. Attention to what occurs during stimulation is highly relevant but usually omitted in neuropsychiatric rehabilitation research. This proposal is a systematic assessment of the modulatory role of brain state on the prefrontal response to rTMS in healthy participants. Results from this study will inform whether the clinical literature on therapeutic rTMS is mistaken for not controlling for brain state, and provide proof-of-concept for future clinical trials and collaborative research proposals (CRF) for the treatment of neuropsychiatric disorders.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65
* Biological and mental health, based on a clinical interview
* Able to understand and follow instructions

Exclusion Criteria:

* Major internal diseases, neurological disorders, or mental disorders
* Having a metal implant
* Hearing problems or in-ear ringing
* Pregnancy or breastfeeding
* Any conditions that will contraindicate to iTBS or fNIRS