cyrilzakka/clinical-trials huggingface dataset:
Bolus Administration of Intravenous Lidocaine at the Time of Abdominal Hysterectomy

The objective of the study to evaluate whether a bolus administration of intravenous lidocaine decreases postoperative pain and represents an opioid-minimizing strategy after abdominal hysterectomy compared with placebo.

Total abdominal hysterectomy (TAH) is the most common gynecological operation worldwide. Some studies noticed about abused of opioids in postoperative care, led to a more adverse effect of opioids, slow recovery, prolong the length of hospitalized stay and consequently increase the unnecessary cost of treatment.

Guidelines have considered using preoperative analgesics for reducing post-operative opioids consumption, including lidocaine infusion. With its anti-inflammatory, anti-hyperalgesia and analgesic properties, intravenous perioperative lidocaine infusion (IVLI) has been used for optimal postoperative care in different surgeries and in various procedures involving hysterectomy.

Therefore, the aim of this study is to assess the efficacy of bolus administration of intravenous lidocaine at the time of abdominal hysterectomy to decrease postoperative pain and reducing morphine requirements, after TAH.

Eligibility Criteria:
Inclusion Criteria:

* Women ranging age between 35-60 years a who undergoing elective total abdominal hysterectomy

Exclusion Criteria:

* Participants had known sensitivity to lidocaine
* Participants had difficulty in intubation
* Participants were on chronic pain medication or already on long-term opioids
* Participants smokers
* Participants with disabilities who were unable to communicate pain levels
* refuse to consent
Pathophysiological Subtyping of Abnormalities in Cocaine Dependence - 9

The purpose of this study is to define pathophysiological subtypes of abnormalities in subjects with cocaine dependence.

The objective of this study is to define subgroups of patients with differential treatment outcome on the basis of differential baseline electrophysiological clusters.

Eligibility Criteria:
Inclusion Criteria:

Cocaine dependence. Seeking residential treatment.
A Study of Intraperitoneal and Intravenous Paclitaxel Plus Apatinib and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells

The purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous paclitaxel plus apatinib and S-1 in the conversion therapy of gastric cancer with positive exfoliative cancer cells


Eligibility Criteria:
Inclusion Criteria:

1. Untreated (e.g. chemotherapy, radiotherapy and other antitumor therapy);
2. Age:18 to 70 years old;
3. Man or female (except pregnant and lactating women);
4. Confirmed to gastric adenocarcinoma;
5. Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive;
6. Blood cell count has to meet the following criteria:

   WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L;
7. Liver/kidney function has to meet the following criteria:

   ALT and AST≤2.5\*ULN TBIL\<1.5\*ULN； Serum creatinine ≤1.5\*ULN;
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
9. Participants were willing to join in this study, good adherence and written informed consent.

Exclusion Criteria:

1. Patients with other malignant tumors within 5 years;
2. Metastasis was found to be visible to the naked eye;
3. It has serious or uncontrolled heart diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on);
4. History of psychiatric drugs abuse and can't quit or patients with mental disorders;
5. Patients with severe or uncontrollable mental illness;
6. Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +).Has melena and hematemesis in two months;
7. Pregnant or lactating women;
8. It have serious harm to the patient's safety or affect the patients who have completed the research.
9. The researchers think inappropriate.
ExosoMe as Integrative Tool for pRognostic Stratification of Adverse Cardiac remodeLing in stEmi Patients: the MIRACLE Study

This is a multicenter observational prospective study aimed to assess whether plasma exosomes can help identify, at an early stage, patients at high risk of adverse remodeling after STEMI (ST-elevation myocardial infarction) , thus accelerating proper patient management in order to reduce the risk of future cardiovascular events. In order to study the correlation between exosome profile and severity of myocardial infarction, consecutive STEMI patients will be enrolled 3 days after Percutaneous Coronary Intervention (PCI).

Adverse cardiac remodeling is a process of structural and functional changes associated with worse clinical outcomes and increased mortality, which occurs in response to sustained pathophysiological stimuli, such as ST-elevation myocardial infarction (STEMI). Despite the progresses achieved with reperfusion therapy in STEMI, a significant portion of patients still develops adverse remodeling. Cardiovascular Magnetic Resonance (CMR) is the gold standard for clinical diagnosis of adverse remodeling, as it provides reliable and reproducible information on ventricular size, function and tissue damage. However, CMR is not always applicable, due to resources and availability reasons and to patients' contraindications. Therefore, additional markers for the early detection of patients at risk for adverse remodeling after STEMI are needed. Exosomes are small extracellular vesicles released by cells and detectable in all body fluids, including plasma. Their release and cargo are influenced by cellular microenvironment, thus mirroring cell/organ status. Previous study demonstrated that concentration and cargo of plasma exosomes released during STEMI well reflect the pathophysiology of the disease, suggesting their potential as biomarkers. Whether exosome profile analysis could predict adverse remodeling after STEMI remains to be investigated.

The relevant hypothesis to be tested is whether plasma exosomes may help to identify, in an early phase, patients at high risk of adverse remodeling after STEMI, accelerating proper patient management in order to reduce risk of further cardiovascular events and improve outcomes. Overall, this new knowledge will pave the way toward a new strategy to predict adverse remodeling in STEMI patients and to develop patient-tailored therapy.

Eligibility Criteria:
Inclusion Criteria:

* chest pain suggestive of myocardial ischemia lasting \>30 min
* electrocardiogram (ECG) showing ST-segment elevation \>0.1 mV in more or equal to 2 limb leads or \>0.2 mV in more or equal to 2 contiguous precordial leads, or presumed new left bundle-branch block
* successful treatment with pPCI within 12 h from the onset of symptoms

Exclusion Criteria:

* previous myocardial infarction (MI)
* time to pPCI \>12 h
* atrial fibrillation
* renal failure with glomerular filtration \<30 ml/min
* claustrophobia
* other contraindications to CMR.
Effect of Informing Family Members of Patients During Surgery

Psychological and physiological issues encountered by family members due to the intraoperative process are factors that complicate the support and care systems of the patient. It is stated that family members of patients undergoing surgery, especially those who do not have sufficient information about the surgical process, experience stress, anxiety, and concern. The need for nursing interventions aimed at providing information about the surgical process, reducing the anxiety levels of family members during the surgery, and supporting them is emphasized. In this context, the study aims to evaluate the effect of periodically informing family members of patients undergoing abdominal cancer surgery via phone during the surgery on their anxiety levels.

Once the patient scheduled for surgery is taken to the operating room, communication between the family members and the surgical team, as well as the patient, is cut off. Family members who do not have any information about the progress of the surgery experience anxiety during the waiting period. High levels of anxiety can limit the family members' ability to understand and process information, affecting their ability to cope with the situation. The high anxiety experienced by family members during the surgery can reflect onto the patient postoperatively, potentially negatively impacting the patient's adaptation, recovery process, and family relations. It is known that family members of patients undergoing cancer surgery experience a higher level of anxiety. The anxiety emerging during this process leads to various physiological and psychological negative consequences for the family members. It is known that informing family members by nurses during surgery helps reduce their anxiety. In this direction, the primary aim of the study is to determine the effect of periodically informing family members of patients undergoing abdominal cancer surgery via phone during the surgery on their anxiety levels. Additionally, the study will evaluate the satisfaction levels of the participants.

Eligibility Criteria:
Inclusion Criteria:

* Being a first-degree relative who has given consent,
* Being able to understand and speak Turkish,
* Being literate,
* Willing to participate in the study,
* Using a phone,
* Being present in the hospital before, during, and after the surgery.

Exclusion Criteria:

* Having a hearing or speech impairment,
* Having a psychiatric disorder or using psychiatric medication.

Endpoint Criteria:

* Inability to reach the participant when called during the surgery,
* The patient's death during the surgery.
Cognitive, Psychological and Electrophysiological Attributes to Suicide Among Depressed Patients

This study will try to provide a better understanding of the psychological, cognitive and electrophysiological factors that contribute to suicide in depressed patients.

Objectives:

1. To investigate the ability of qEEG to suspect suicidal potential in patients diagnosed with major depression.
2. To test the ability of some psychological and cognitive elements in determining the likelihood of suicide in such patients.
3. To give an objective and more reliable method than traditional questionnaires to assess the seriousness of suicidal ideations in patients suffering from depression who usually don't reveal their actual intentions.

Eligibility Criteria:
Inclusion Criteria:

* Age between 16 and 65 years
* Both males and females will be enrolled
* Patients present with the clinical picture of Major depression according to DSM 5 criteria.

Exclusion Criteria:

* Psychotic features associating depressive episode
* Bipolar depression
* The condition is due to another medical condition
* The condition is substance or medication-induced
* Intellectual disability
* Comorbid epilepsy
Mentored Clinical Career Award in Adolescent Substance Abuse

The goal of this project is to determine the barriers to, and risks and benefits of random laboratory drug testing for adolescents with identified drug or alcohol problems.

Use of drugs and alcohol is associated with a variety of health care problems, making settings where adolescents receive routine medical care ideal for implementation of routine screening and early intervention. However, little research has been conducted on the efficacy of interventions for adolescent primary care patients who are using drugs or alcohol. Urine drug testing can be used for a variety of indications, including school or work based population surveillance, verification of history, or monitoring of individuals who are in treatment for a drug-use disorder. This study will focus exclusively on the therapeutic use of urine drug testing. Drug testing can be a useful therapeutic adjuvant for patients with drug-use disorders in a variety of settings.

This study will investigate the use of random laboratory drug testing as a therapeutic intervention for teens with drug problem use, abuse or dependence. We have 5 objectives:

1. To develop a standardized protocol for random urine drug testing, produce a manual and training protocol, and refine the protocol in preparation for a future efficacy trial.
2. To estimate the cost of a random drug-testing program.
3. To determine the factors that are associated with willingness to be tested, and barriers to enrolling adolescents in laboratory drug testing programs.
4. To perform an initial, small-scale experimental trial of the random drug testing protocol. The purpose of this trial is to estimate the effect size of the intervention and will be used in calculating the sample size for a future stage 1b trial.
5. To determine the potential risks to adolescents who participate in a random drug testing program, including possible breach of confidentiality, greater conflict between the parent and child, more difficulty with communication between clinician and patient, increased use of drugs not detected by routine urine screens (i.e. inhalants), and increased use of strategies and products known to defeat drug tests.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents ages 12-21
* Participants must have use of alcohol, cannabis, or another substance on at least 2 occasions in the 30 days preceding their initial assessment or 6 or more times in the past 90 days
* Participants must have health insurance or be willing to pay for the laboratory costs associated with drug testing.
* Participants must provide informed assent and, for those under 18, parental consent.

Exclusion Criteria:

* Participants who require immediate hospitalization or immediate referral to residential substance abuse treatment
* Participants who cannot understand or read English at a 6th grade reading level
* Participants who are enrolled in the ASAP buprenorphine program
* Participants who report previous use of inhalants or any other substance that is not easily detected with urine drug testing
Esophageal Safety of High and Very High Power Short Duration Pulmonary Vein Isolation: a Randomized Comparison of the 50W and 90W Power Settings

Pulmonary vein isolation (PVI) is the most effective means of maintaining sinus rhythm in atrial fibrillation (AF), while a widely used approach to PVI is point-by-point radiofrequency (RF) catheter ablation. High power short duration (HPSD) and very high power short duration e.g., 90W and 4 sec) are increasingly popular technologies, featuring higher power and shorter application durations compared to previous methods. vHPSD offers similar efficacy to HPSD, while further reducing procedure times. Atrioesophageal fistula (AEF) is a rare but deadly complication of PVI, while endoscopically detected esophageal lesions are surrogate markers for the risk of AEF. Furthermore, thermal complications include vagal lesions leading to gastroparesis. While there is considerable data on the thermal safety of HPSD technology, most studies of vHPSD focus on efficacy and a direct comparison in terms of esophageal safety is lacking. In this randomized, single-center study, we aim to compare the thermal safety of vHPSD to HPSD. Furthermore, we aimed to determine the anatomical and biophysical factors that predict thermal injury. Patients undergoing their first PVI for AF are randomized to either HPSD or vHPSD power setting. The primary endpoint of the study is the composite of esophageal mucosal lesion and gastroparesis, as assessed at the post-procedural endoscopy within 15 days after the PVI.


Eligibility Criteria:
Inclusion Criteria:

- Patients with paroxysmal or persistent atrial fibrillation undergoing their first pulmonary vein isolation procedure

Exclusion Criteria:

* Additional ablation performed outside PVI
* Contraindications to postoperative upper endoscopy
Multi-center Trial of SPECT Myocardial Blood Flow Quantitation for Detection of Coronary Artery Disease

Patients with suspected or known coronary artery disease who are scheduled for clinically indicated SPECT myocardial perfusion imaging (MPI) and will receive invasive coronary angiogram are recruited to receive SPECT MBF study.

Patients with suspected or known coronary artery disease who are scheduled for clinically indicated SPECT myocardial perfusion imaging (MPI) and likely will further receive invasive coronary angiogram will be recruited for a SPECT MBF study. The MBF study will be performed as an adjunct to MPI utilizing the same rest and stress injections of 99mTc-Sestamibi (MIBI) tracer, and the same infusion of dipyridamole, adenosine or adenosine triphosphate for stressing. The MBF study will be completed in single or two days depending on the imaging protocol of MPI for a site. This is an observational study with no interventions to the clinical routine whatsoever. Three models of SPECT (GE NM530c) and SPECT/CT (Siemens Symbia-T16 and -T2) cameras are included to acquire rest/stress dynamic SPECT and MPI data. A CT scan will be acquired for the purpose of attenuation correction. All dynamic images will be reconstructed with physical corrections, including attenuation, scatter, resolution recovery and noise reduction, and processed to quantify MBF with the same kinetic modeling. The imaging processing of MBF study will be conducted with a SPECT MBF dedicated software (MyoFlowQ) in a central lab. MPI images will be collected and independently read by three consensus readers. The angiographic result will be independently reviewed by an interventional cardiologist. Diagnostic performance of SPECT MBF and perfusion will be compared utilizing angiographic result as the reference standard.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 \~ 79 years old
* Any CAD risk factor
* CAD related symptoms
* Intermediate to high probability of CAD
* Suspected or known CAD on a stable medication regime
* Able and willing to comply with the study procedures
* Written informed consent

Exclusion Criteria:

* History or risk of severe bradycardia
* History of myocardial infarction, dilated cardiomyopathy, hypertrophic cardiomyopathy, valve issue or congenital heart disease
* Wheezing asthma or COPD
* Known second- or third-degree AV block
* Known hypersensitivity to dipyridamole or adenosine
* Breastfeeding or pregnancy
* Claustrophobia or inability to lie still in a supine position
* Unwillingness or inability to provide informed consent
Intra-tracheal Instillation of Budesonide to Prevent Chronic Lung Disease

Preterm infants are randomized to received either Intra-tracheal instillation of budesonide using surfactant as vehicle or a placebo. Intra-tracheal instillation of budesonide using surfactant as vehicle would facilitate its delivery to the periphery of the lung and would inhibit lung inflammation and mitigate acute lung injury.

In extremely premature infants who are ventilated there is ongoing lung injury \& lung inflammation. This can perpetuate the need for ongoing ventilation and these infants spend much longer in the hospital. The likelihood of chronic lung disease in this susceptible group is very high and they would need oxygen at home. Surfactant instillation has reduced the need for prolonged mechanical ventilation and to an extent the incidence of chronic lung disease (CLD). But many infants develop CLD and need prolonged oxygen treatment, diuretics and inhaled steroids to suppress the inflammation and obstruction of the airways. Some of the severely affected infants need orally administered steroids. The Inestigators propose to provide a dose of steroids instilled along with the surfactant in the very first day of life so as to prevent the vicious and ongoing cascade of lung injury and inflammation. As it is a poorly absorbed steroid and as only one or two doses is proposed to be used there is no effects within the body and it works locally within the lung. This is hoped to reduce CLD and improve long term outcomes. The population most susceptible to CLD is the extreme preterm infant with RDS who needs mechanical ventilation soon after birth. One of the groups will receive the surfactant with saline and the other group will receive the surfactant along with topical steroid. The groups will be followed during the hospital stay. survival along with duration of ventilation, duration of hospital stay and oxygen needs are noted. To study the hoped for long term benefits the investigators would note the long term neuro-development - if they were followed as per hospital policy between 18 months and 26 months. Intra-tracheal instillation of budesonide using surfactant as vehicle would facilitate its delivery to the periphery of the lung and would inhibit lung inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Infants born at \< 30+0/7 weeks (23+0 - 29+6/7) gestational age (GA) OR with preterm infants with a birth weight (BW) which is \< 1500 gm AND if they have severe respiratory distress syndrome (RDS) (Clinical diagnosis based on the need for mechanical ventilation in preterm infant or if they have radiologic features of RDS along with need for positive distending airway pressure and fractional inspired oxygen (FiO2) \> 0.3)

Exclusion Criteria:

1. major congenital defects
2. chromosomal abnormality
3. pneumothorax
4. Known surgical disease
5. Known or suspected congenital heart disease
6. Infant not considered viable by physician
7. Severe sepsis / infections
8. Likely to be extubated within the next 24 hours
Effects of Mediterranean Diet Based Intervention in Breast Cancer Patients

The purpose of this randomized clinical trial is to examine the effects of Mediterranean diet based intervention on inflammation and metabolic risk factors in overweight or obese postmenopausal women with breast cancer receiving adjuvant hormone therapy.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients who are receiving adjuvant hormone therapy after diagnosed with breast cancer stage Ⅰ-Ⅲ and have completed cancer treatment including breast surgery and/or adjuvant chemotherapy, radiotherapy
* Postmenopausal women
* Body mass index (BMI) ≥23 kg/m2
* Able to speak and read Korean
* Able to comply with all required study procedures and schedule
* Willing and able to give written informed consent

Exclusion Criteria:

* Participants with cancer recurrence or metastasis
* Participants with weight change more than 5kg in the previous 3 months
* Participants with secondary causes of obesity, such as hypothyroidism
* Participants with hepatic disease (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \>3 x institutional upper limit of normal) or renal disease (serum creatinine \>2.0 mg/dL)
* Participants with serious psychiatric illness, including bipolar disorder, schizophrenia, or other psychosis, bulimia, anorexia nervosa, or suicidal ideation
* Participants who are taking weight loss medications
* Participants who are receiving systemic corticosteroid therapy
* Participants with alcohol abuse or dependence
* Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
Corneal Asphericity Adjustment (Q Adjustment) in Myopic and Hyperopic Patients Undergoing Refractive Correction With Excimer Laser

To study the postoperative results in myopic and hyperopic eyes treated with two different laser ablation algorithms (STD and F-CAT), both FDA approved.


Eligibility Criteria:
Inclusion Criteria:

* Myopic and hyperopic eyes eligible for LASIK or PRK refractive correction
* Central corneal thickness more than 500 micrometers

Exclusion Criteria:

* Topographies of less than 55% of successful total sampled area and eyes exhibiting asphericity variations, in either the horizontal or the vertical axis, greater than 0.2
* Corneal scarring
* Cataract surgery
* Corneal ulceration
* Topographical abnormalities