cyrilzakka/clinical-trials huggingface dataset:
Systemic Inflammatory Response Evaluation With the Use of Inhaled Anesthetic Sevoflurane During CPB

Cardiac surgery has evolved considerably after the advent of cardiopulmonary bypass (CPB), a feature that allowed more precision and tranquility to the heart surgeon. But their influence on exacerbation of inflammatory response can unbalance the whole homeostasis so happens surgical trauma. The attenuation of the systemic inflammatory response in major surgeries like cardiac surgery for aortic aneurysm appears to represent an important advance in reducing morbidity and mortality of these patients. Some studies suggest that inhaled anesthetics such as sevoflurane appear to play an important role in this control, but the mechanism by which this happens is still unclear. This study has the primary purpose of analyzing from a clinical study sevoflurane inhalation anesthetic can change the inflammatory response induced by CPB, significantly reducing the release of inflammatory markers, especially elastase PMN.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Cardiac Surgery elective of coronary artery bypass graft with cardiopulmonary bypass (CPB)
* The informed consent signature savvy

Exclusion Criteria:

* Use of steroids or anti-inflammatory drugs routine
* Presence of asthma, COPD, autoimmune diseases
* Participation in other clinical studies
* Presence of decompensated heart failures, liver or kidney
* Combined elective surgery (ex .: aneurysm correction + CABG)
* Acute myocardial infarction in the last 30 days
* Unstable angina
* And obesity (BMI\> 50kg / m2)
Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients

This study aims to investigate the possible efficacy of duloxetine, gabapentin and lacosamide on oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer.

This is a randomized, double-blind,controlled, parallel study that will be conducted on patients with oxaliplatin induced peripheral neuropathy with gastrointestinal cancer.

This study will be done on 93 patients with gastrointestinal cancer (colon or gastric or pancreatic) cancer on standard FOLFOX-4 regimen who will divided into 3 groups:

Group 1: 31 Patients who will receive standard chemotherapy plus duloxetine 30 mg/day for 12 cycles (up to 6 months).

Group 2: 31 Patients who will receive standard chemotherapy plus gabapentin 300 mg/day for 12 cycles (up to 6 months).

Group 3: 31 Patients who will receive standard chemotherapy plus lacosamide 50 mg/day for 12 cycles (up to 6 months).

Eligibility Criteria:
Inclusion Criteria:

* A) Adults ≥ 18 years old male and female patients. B) Patients with gastrointestinal cancer receiving oxaliplatin chemotherapy

Exclusion Criteria:

* A) Preexisting neuropathic or brain disorders. B) Previous use of chemotherapeutic agents including taxanes, platinum, vinca alkaloids, and bortezomib.

C) Concomitant use of drugs reported to have neuroprotective role and analgesics.

D) Patients with diabetes, uncontrolled hypertension, congestive heart failure, drug addiction and patients who were receiving tamoxifen.

E) Patients with abnormal renal function tests (serum creatinine ≤ 30 ml/min) or liver function tests (≥ 3 times the upper normal range).

F) Participants with a documented medical history of neuropathy. G) Concomitant use of other antidepressants, anticonvulsants, high-dose vitamin supplements or drugs known to influence serotonin levels.

H) Pregnancy and lactating women. I) Uncooperative patients and patients who have psychological problems or on antipsychotic medications.
Cohort Study in South China

Healthy Chinese residents from South China will be recruited and followed up for at least 4 years to evaluate the association between climate, diet and lifestyle and risks for the development of chronic diseases. Physical examination, questionnaire survey and biological sample collection will be conducted at baseline and the incidence of chronic diseases will be investigated during follow-up.

110,000 adult Chinese (35 to 74 years old) without chronic diseases and major disability who have been living in South China including Guangdong, Fujian, Guangxi and Hainan for more than 5 years will be recruited. All participants will be prospectively followed up for the incidence of chronic diseases (stroke, coronary heart disease, malignant neoplasms, chronic obstructive pulmonary diseases, diabetes and hypertension) and their risk factors (impaired glucose tolerance and obesity). Information about socio-demographic, diet, lifestyle, psychological status, medical history and current medication will be collected by questionnaires. Physical examinations including height, weight, waist and hip circumferences, blood pressure, fat mass and vital capacity will be conducted. Besides, blood, urine and fecal samples will be collected for further analysis. Annual meteorological data throughout the study period will also be collected. The associations between climate, diet and lifestyle and risks for chronic diseases will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* adult Chinese (35-74 years old) who have been living in South China including Guangdong, Fujian, Guangxi and Hainan provinces for more than 5 years.

Exclusion Criteria:

* any subject diagnosed with stroke, coronary heart disease, malignancy, chronic obstructive pulmonary disease, diabetes and hypertension.
* any subject who suffer from major disability and cannot participate in the study.
Coronavirus Disease 2019 (COVID-19) Study of Hospitalized Patients in Hong Kong

COVID-19 may cause another world-wide epidemic. This study is divided into 2 arms: (1) Prospective longitudinal observational study involving patients with laboratory-confirmed COVID-19 and (2) Retrospective study on patients with laboratory-confirmed COVID-19.

Arm 1:

We will collect EDTA blood, stool samples, rectal swab, urine, saliva, and specimens from upper respiratory tract (nasopharyngeal aspirate or flocked swab), and lower respiratory tract (sputum or tracheal aspirate) on daily, alternate day, or weekly basis as appropriate.

Arm 2:

The remainder of specimens that were submitted for laboratory investigation as part of clinical management will be retrieved. Those specimens will only be used after all clinically indicated testing and confirmation procedures have been completed. Assistance from the Public Health Laboratory Service, Department of Health, will be invited to retrieve samples as well as participate in this study.

Patients hospitalized for pneumonia in medical wards and ICU at the Prince of Wales Hospital tested negative for COVID-19 will be recruited as controls.

Understanding the clinical, virological, microbiological and immunological profiles of this infection is urgently needed to facilitate its management and control.


Eligibility Criteria:
Inclusion Criteria:

* Case are adults age ≥ 18 years old admitted to hospital with laboratory confirmed COVID-19
* Controls are patients admitted for community-acquired pneumonia

Exclusion Criteria:

* Patients who refuse to consent for study
Optimization of Fluid Therapy in Sepsis by a Passive Leg Raising Test

A randomized controlled clinical trial to evaluate whether a passive leg raising test to guide fluid therapy of patients with septic shock can reduce fluid balance and weight gain. Patients will be treated according to an algorithm in which the indexed stroke volume (stroke volume related to body surface area) and mean arterial pressure will guide the timing and amount of fluid and the use of inotropic and vasoactive support. Patients will be randomized to either an intervention group in which a passive leg raising test will be made prior to any decision for fluid administration or to a control group where this test is not performed and fluid administration is carried out according to standard of care at the department.

Hypothesis: A passive leg raising test, will reduce weight gain by day 3 by 30%.


Eligibility Criteria:
Inclusion Criteria:

All patients \>18 years admitted to the ICU diagnosed with circulatory shock due to suspected sepsis or pancreatitis. Circulatory shock is defined as MAP\<70 mm Hg or need for norepinephrine despite resuscitation with ≥30 ml/kg of crystalloid fluids.

Exclusion Criteria:

\> 12 hours have passed after onset of shock. The patient has contraindications for an arterial femoral/axillary line. Elevated ICP. Patients who have had a femoral amputation. Elevated intraabdominal pressure\>20 cm H2O.

Suspension criteria: The patient has developed pulmonary oedema during PLR test. Life threatening bleeding.

Serious adverse events:

Trombosis in arteria femoralis. Death during the study period.
Cadonilimab in Locally Advanced MSI-H/dMMR Colorectal Cancer

This is a two-arm phase II clinical study to evaluate the efficacy and safety of Cadonilimab (a PD-1/CTLA-4 bispecific antibody) in MSI-H/dMMR locally advanced colorectal cancer as the regimen of neoadjuvant treatment. Eligible patients will receive Cadonilimab monotherapy for eight cycles before surgery and part of patients may exempt from surgery.


Eligibility Criteria:
Inclusion Criteria:

* Arm 1: Histologically or pathologically confirmed colon adenocarcinoma with a stage of T3-4 or N+ according to the CT or endoscope; Arm 2: Histologically or pathologically confirmed rectal adenocarcinoma located within 12cm from the anus with a stage of T2-4 or N+ according to the CT or endoscope
* Sign the informed consent form
* 18 years and older
* Mismatch repair deficient determined by immunohistochemistry or microsatellite instable by PCR
* No prior treatment
* Performance status: ECOG 0-1
* Good organ function:

Blood routine: hemoglobin ≥90g/L, neutrophil ≥1.5×10\^9/L, platelet ≥80×10\^9/L; Renal function: creatinine≤1.5×upper limit of normal (UNL) or creatinine clearance ≥50ml/min; Liver function: total bilirubin (TBIL)≤1.5×upper limit of normal (UNL); ALT≤2.5×UNL, AST≤2.5×UNL; Ejection fraction at least 50% (or lower limit of normal) by echocardiogram

Exclusion Criteria:

* Other pathological category, such as squamous cancer
* Distant metastasis or peritoneum implantation
* Have received chemotherapy or radiotherapy in the past
* Known to have allergic reactions to any ingredients or excipients of experimental drugs
* Other active malignant tumors, excluding those who have been disease free for more than 5 years or in situ cancer considered to have been cured by adequate treatment
* Have received colorectal cancer surgery
* Diabetes was not controlled, defined as HbA1c \> 7.5% after anti-diabetic drugs or hypertension was not controlled, defined as systolic / diastolic blood pressure \> 140 / 90 mmHg after antihypertensive drug
* Myocardial infarction, severe/unstable angina, New York Heart Association (NYHA) class III or IV congestive heart failure in the past 12 months
* Known to be infected with human immunodeficiency virus (HIV), have acquired immunodeficiency syndrome (AIDS) related diseases, have active hepatitis B or hepatitis C
* Pregnant or nursing
* May increase the risk associated with participation in the study or administration of the study drug or mental illness that may interfere with the interpretation of research results
* There are other serious diseases that the researchers believe patients cannot be included in the study
MOBile Instruction for Low Back Pain (MOBIL)

The purpose of this project is to measure the impact of a short educational session on outcomes for patients consulting in primary care for low back pain. Subjects will be patients consulting to their primary care provider for a primary complaint and new episode of low back pain. Subjects will be randomized to receiving the educational tool versus usual care (information only without an educational component) in the clinic immediately prior to seeing their PCP. Patients will be followed for a 6-month period, and outcome measures will be collected and compared across both groups.

Patients that arrive for an initial evaluation for low back pain will be randomized to either receive the video education via an application (app) on a tablet computer, or usual care (which consists of information in the form of a handout but no further education prior to seeing the Primary Care Provider - PCP). To control for exposure to the tablet computer, subjects in both groups will use the tablet computer to fill out the self-reported outcome measures.

This will all take place while the patient is waiting to see their PCP, who will be blinded to the educational intervention that the patient received. After enrollment and completion of baseline outcome measures and surveys, the subject will be randomized to one of the 2 arms, receive the intervention, and then proceed to have their appointment with their PCP. The appointment with the PCP will proceed per usual care standards, with no additional research interventions. The subjects will be contacted for a follow-up at 1 and 6 months for assessment of self-reported outcomes measuring pain, function, and disability. The investigators will also abstract healthcare utilization from claims data and compare variables of healthcare use between both groups over the 6-month period following enrollment (radiographs, MRIs, prescription opioids, and specialty referrals).

Eligibility Criteria:
Inclusion Criteria:

1. A Tricare beneficiary with a primary complaint of low back pain consulting in a primary care clinic
2. Between the age of 18 - 50 years
3. Read and speak English well enough to interact with the mobile education technology, provide informed consent and follow study instructions

Exclusion Criteria:

1. History of prior surgery to the lumbosacral spine
2. Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease
3. Known current pregnancy or history of pregnancy in the last 6 months
4. Already seen in primary care for an episode of low back pain within the last 3 months
The Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson's Disease Patients With Dementia

A randomised, double-blind, 3-arm parallel group study comparing Aricept® with placebo.


Eligibility Criteria:
Patients with an established diagnosis of PD and dementia, who fulfill all of the inclusion criteria and none of the exclusion criteria listed below, will be eligible for enrolment into this study.

Best efforts must be made on clinical grounds to exclude patients with DLB and AD. The key inclusion criteria in this respect is the onset of dementia documented to have occurred at least 1 year after the diagnosis of PD.
LHC-CIDI-5 in Hong Kong

The World Health Organization Composite International Diagnostic Interview-5th (CIDI-5) is a standardized diagnostic tool used to assess the prevalence of mental and substance use disorders over varying time frames (30 days, 12 months, and lifetime) based on the diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) and International Classification of Diseases 10th edition (ICD-10). However, retrospective measurements like the CIDI-5 are susceptible to recall bias, especially for the lifetime experience, which can hinder the reporting accuracy with mental disorders.

To mitigate this issue, the life history calendar (LHC) was introduced as an aid to assist respondents in recalling the timing of life events, enhancing the ability of the CIDI-5 to measure the lifetime prevalence of mental disorders. The LHC is a grid structure with columns representing time units and rows representing life domains under study.

In a study conducted in Nepal, combining the CIDI-5 with the LHC resulted in a significant increase in the detection of mental disorders compared to using the CIDI-5 alone. This approach did not lead to an increase in false positives after clinical validation.

This experiment aims to adapt a Hong Kong version of the LHC based on the Nepalese model and evaluate the effectiveness of the LHC-assisted CIDI-5 (LHC-CIDI-5) compared to the CIDI-5 alone in assessing mental disorders.


Eligibility Criteria:
Inclusion Criteria:

* All household members aged 25 years old and over are randomly sampled from the Census and Statistics Department List of Quarters
* Live in the address sampled from the Census and Statistics Department List of Quarters
* Reside in Hong Kong for at least six months in the past year
* Able to read and communicate in Chinese or English
* Without linguistic or cognitive difficulties

Exclusion Criteria:

* Domestic workers
104RA204 Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Participants

To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.


Eligibility Criteria:
Inclusion Criteria:

* Must be a participant from Study 104RA202 (NCT 00664716)
* Stable dose of Methotrexate for the duration of the study

Exclusion Criteria:

* Participants with a significant change in their medical history from their previous BG9924 study
* Any clinically significant infectious illness or serious local infection

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Gratitude Interventions for Academic Stress Among Pakistani Adolescents

The experimental nature of this study will provide the empirical data in analyzing the effectiveness of gratitude exercises which later can be adapted in stress reduction programs at school level. This research will focus on the school related positive life experiences for example thinking about a teacher/mentor kindness and contribution in their lives, then write a letter that describes their gratitude \& letter will be delivered to that person indirectly. This may help in focusing on the positive aspects of school life. This modification will serve as testing this new model for assessing the combined effect of gratitude interventions.

Academic stress is an inevitable part of students' lives with long-term negative consequences on physical health, mental well-being, and social relations. In Asian cultures, expectations of parents and teachers are additional components of academic stress which have not been addressed in different stress management programs. Therefore, the present research addresses these contributory stress factors by using gratitude interventions in Pakistani high schools.

The study employs Broaden and Build Theory and Cognitive Appraisal Theory in formulating the intervention model and variables being tested through pretest-posttest experimental research design with a control group. A total of 102 high school students from two genders segregated schools of Rawalpindi city, Pakistan, served as the participants. They were randomly assigned into experimental and control groups, with 51 participants in each group. There were 41 boys and 61 girls with a mean age of 15.71+ 0.92 years. The measures included Academic Expectations Stress Inventory (AESI), Inventory of High-School Students' Recent Life Experiences (IHSSRLE), Modified Differential Emotions Scale (mDES), Gratitude Questionnaire-6 (GQ-6) and Gratitude Adjective Checklist (GAC). Three gratitude interventions, including Count your Blessings, Gratitude Letters and Loving-Kindness Meditation, were modified to focus on school-related experiences. The model consisted of nine sessions applied in schools for four weeks with 30-40 minutes each day. The research protocol and intervention model were adapted into Urdu for better understanding among participants. The data were analyzed through descriptive and inferential statistics (frequency, percentage, mean, SD, paired sample t-test, independent sample t-test, multivariate analysis of variance and effect size).

Eligibility Criteria:
Inclusion Criteria:

* High School Students
* Studying in same school for at least last six months
* within 14-17 years of age
* not having severe physical health issue or going under treatment for chronic illness

Exclusion Criteria:

* not able to understand Urdu language
* above 17 years of age or below 14 years
* recently enrolled in the particular school
Hypothermia With Intrajugular Cooling in Acute Ischemic Stroke Thrombectomy

Hypothermia with intrajugular cooling is a neuroprotective strategy that has been proven to minimize brain damage and maximize functional preservation in animal models of stroke. The purpose of this proof-of-concept study is to determine the safety and tolerability of intrajugular cooling in patients with acute ischemic stroke who are treated with mechanical thrombectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years;
2. Acute ischemic stroke caused by unilateral internal carotid artery terminal segment/middle cerebral artery M1 segment occlusion;
3. In line with the indications for mechanical thrombectomy without contraindications;
4. Successful recanalization (mTICI 2b/3) after mechanical thrombectomy that confirmed by digital subtraction angiography;
5. Written informed consent provided by the patients or their legal relatives.

Exclusion Criteria:

1. Suffering from cerebral venous system diseases such as cerebral venous thrombosis/stenosis/dysplasia;
2. Suffering from heart diseases such as ventricular arrhythmia/myocardial infarction/congestive heart failure;
3. Imaging examination after mechanical thrombectomy shows intracranial hemorrhage/contrast extravasation;
4. Difficulty in reaching the designated position of the device used for intrajugular cooling;
5. Difficulty in complying with intrajugular cooling or other conditions that the investigator considered inappropriate for inclusion.
ReActiv8 Post Market Surveillance Registry

To gather data on the long-term safety of ReActiv8 and identify any residual risks by reporting all Serious Adverse Device Effects as well as performance and health care utilization through two years post-implant.


Eligibility Criteria:
Inclusion Criteria:

1. Meet the Indications for ReActiv8
2. Willing to sign the Informed Consent for the Registry
3. Age ≥ 18 years

Exclusion Criteria:

1. Subjects will be excluded from the Registry if they are contraindicated for ReActiv8.