cyrilzakka/clinical-trials huggingface dataset:
Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy

Open nephrectomy is one of the most common surgical procedures in urologic practice. Pain after surgery remains a significant clinical problem as it impairs recovery adversely and may lead to the transition to chronic pain. The open approach represents a major physical trauma including postoperative pain and discomfort in the convalescence period. Adequate control of postoperative pain facilitates earlier mobilization and rehabilitation. Patient-controlled analgesia (PCA) is effective to treat pain at rest, but seems to be inadequate for dynamic analgesia and may also elicit side effects that may delay hospital discharge. Preventing early and late postsurgical pain is an important challenge for anesthesiologists and surgeons.

Ketamine (N-Methyl-D-Aspartate receptor antagonist) and lidocaine (sodium channel blocker) are popular analgesic adjuvants for improving perioperative pain management. The investigators designed this double-blind, placebo controlled study to test and compare the preventive effects of perioperative intravenous ketamine and lidocaine on early and chronic pain after elective open nephrectomy.

The investigators propose a double-blind placebo-controlled study of patients undergoing elective open nephrectomy. All patients will receive normal "patient-controlled analgesia morphine" in addition to study drugs or placebo. Research will be conducted at Charles Nicolle teaching hospital.

Participants will be randomized into one of three study groups: Group L: intravenous lidocaine: bolus of 1.5 mg/kg at induction of anesthesia followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively. Group K: Ketamine: bolus of 0.15 mg/kg followed by infusion of 0.1 mg/kg/h intraoperatively and for 24 h postoperatively. Control Group C: an equal volume of saline. The anesthetic technique will be standardized, and the postoperative assessments included pain scores, opioid consumption, recovery of bowel function and 6-minute walk distance (6-MWD) on the fourth postoperative morning. At 3 months, patients will be questioned for chronic postoperative pain using the Neuropathic Pain 4 questionnaire.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (\>/=18)
2. male or female
3. Undergoing elective open nephrectomy
4. General anesthesia
5. Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.

Exclusion Criteria:

1. Pregnancy and breastfeeding
2. Cognitively impaired (by history)
3. Subject with a history of psychosis
4. Subject known to have significant hepatic disease
5. History of previous cardiac arrhythmia
6. Subject for whom opioids or ketamine are contraindicated
Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control

The purpose of the study is to investigate the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren.

This study is a two-arm randomised controlled trial with a 18-month duration. Participants will be healthy Hong Kong Chinese schoolchildren with low to moderate myopia. The aim is to determine the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren. Optical defocus will be delivered by Defocus Incorporated Multiple Segments (DIMS) spectacle lenses.

A total of 112 Hong Kong Chinese children aged 7 to 12 years (56 in each group) will be recruited and randomly allocated into two groups. One group will receive low dose atropine (0.01%) plus DIMS spectacles (ATD Group); another one will receive low dose atropine (0.01%) plus single vision spectacles (AT Group).

They must have no prior or current myopia control treatment, have no ocular or systemic diseases/abnormalities that affect visual function, refractive development or spectacle lens wear, and no previous intraocular or corneal surgery. They must not have allergy to atropine.

Their cycloplegic refraction and axial length will be monitored every six months for 18 months. The changes in refractive errors and axial length between groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Age at enrollment: 7 to 12 years
* Ethnicity: Hong Kong Chinese
* Myopia: -0.75D (in spherical equivalent) or above in both eyes
* Astigmatism: -1.50D or less in both eyes
* Anisometropia: 1.50D or less (in spherical equivalent) between two eyes
* Best corrected monocular visual acuity (VA): 0.04 logMAR or better
* Ocular health: No abnormalities in both internal and external ocular health
* Systemic health: No abnormalities such as cardiac and respiratory diseases
* Binocular vision: No strabismus, diplopia, suppression and other binocular abnormalities
* Normal colour vision
* No previous refractive surgery or use of myopic control interventions, such as atropine, orthokeratology, and specialized spectacle lenses and contact lenses for myopic control
* Able to wear the prescribed spectacles
* No known allergy to atropine

Exclusion Criteria:

* Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.)
* Previous intraocular or corneal surgery
* Colour vision deficiencies
* Systemic disease that may affect vision, vision development (e.g. diabetes mellitus, hypertension, Down syndrome, etc.)
* Systemic disease that are contradictory to atropine (e.g. asthma, cardiac diseases, etc.)
* Previous gas permeable, soft bifocal, or orthokeratology contact lenses wear or bifocal / progressive addition lens spectacles wear or use of atropine or pirenzepine (longer than one month of usage)
* Previous or current participation in myopia control studies
* Allergy to cyclopentolate hydrochloride or atropine
Myocardial Protection With Adenosine Preconditioning

Adenosine has been proved to be an important mediator of myocardial protection induced by ischemic preconditioning. The hypothesis of this study is that adenosine preconditioning can provide additional myocardial protection in the setting of pediatric open heart surgery with cardioplegia and cardiopulmonary bypass.

Adenosine has been used for diagnosis and treatment of cardiovascular diseases for many years. New progresses in myocardial protection in the settings of acute myocardial infarction treatment put forward the its clinical use to a broader field. But the safety and effectiveness of its use in myocardial protection in the setting of open heart surgery has not been investigated intensively. Our primary results suggested that adenosine preconditioning could decrease the release of myocardial serum markers, such as cTnI. This study will focus on the safety and effectiveness of adenosine in the field of pediatric myocardial protection during surgery repair of congenital heart defects with CPB and cardioplegia.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of congenital heart defects eligible for surgery treatment under cardiopulmonary bypass and cardioplegia
* Body weight less than or equals to 10kg

Exclusion Criteria:

* Cardiac surgery is performed without cardiopulmonary or cardioplegia
* Body weight more than 10Kg
Effects of a 12-week Strength Training Program in Women With Myotonic Dystrophy Type 1

20 women with myotonic dystrophy type 1 (DM1) will complete a 12-week lower-limb strength training program. The training program consist of 3 series of 6 to 8 maximal repetitions of 5 different exercises: Leg extension, leg press, hip abduction, squat and plantar flexion. Training sessions will be closely supervise and take place twice a week. It is hypothesize that the training program will induce muscular hypertrophy despite the genetic defect. The training program should also have positive effects on function. The participants will be evaluated at baseline, week 6, week 12, month 6 and month 9 to quantify the effects of the training program and if these effects will be maintained over time.


Eligibility Criteria:
Inclusion Criteria:

* DM1 diagnosis must be confirmed by genetic analysis;
* Women sex, aged between 30 and 65 years old;
* Be able to walk without assistance;
* Consent of the neurologist must be given to participate in this study;
* Must reside in the Saguenay-Lac-St-Jean region;
* Subjects must be able to give their consent freely and voluntarily.

Exclusion Criteria:

* Patients with any other form of muscular dystrophy are excluded;
* Any contraindication for strenuous exercise or muscle biopsy.
Correlation Between Serum Vitamin D3 and Incidence of Uterine Leiomyoma

The aim of the current study is to evaluate the association between low serum vitamin D level and incidence of uterine leiomyoma in Egyptian women as the research hypothesis that low serum vitamin D is considered a risk factor for uterine leiomyoma


Eligibility Criteria:
Inclusion Criteria:

1. Age ranging from 20 to 45 years.
2. Postmenstrual patients to exclude current pregnancy.
3. Parity up to para 3 by either normal vaginal delivery or cesarean section.
4. Body mass index (BMI) ranging from 18 to 30 kg/m2.
5. One or more uterine fibroid with a diameter ranging from 3-10 cm.
6. Fibroids either subserous, intramural or submucous uterine fibroids

Exclusion Criteria:

1. Women aged less than 20 years have a very low incidence of fibroids or more than 45 years as there is an increased incidence of vitamin D deficiency after this age.
2. Patients known to be currently pregnant due to change in fibroids volume during pregnancy in addition to vitamin D levels may be lower than baseline for nonpregnant ones.
3. Grand multipara \>3 times frequently associated with vitamin D deficiency.
4. Cardiac( e.g rheumatic heart diseases), pulmonary( e.g asthma, bronchiectasis ), or hematological disease (including anemia; hemoglobin level below 10gm/dl , thalassemia, sickle cell anemia, and spherocytosis) because of high association between chronic illnesses and multivitamin deficiency.
5. Patients who receive pre-operative hormonal therapy (such as GnRH analogue) which may increase vitamin D levels and interfere with the study objectives.
6. Patients who will present with a suspected malignant gynecological disease which is usually associated with multiple vitamin deficiencies including vitamin D.
7. Patients who will be diagnosed as having cervical or supracervical fibroids and pedunculated fibroids (study will be limited on corporeal fibroid).
8. Small fibroid less than 3cm diameter may not be enough size to cause changes in lab results or large ones more than 10 cm diameter.
9. Previous myomectomy or hysterectomy.
10. Using vitamin supplements or hormonal therapy during or within 6 months of enrolment which may interfere with the accurate results of the study.
11. Current lactating or lactating within 6 months prior to enrollment as breastfeeding women have a significantly higher prevalence of vitamin D deficiency.
12. Current smokers or history of smoking as it decreases the production of the active form of vitamin D.
13. Steroids intake as it increases the 24-hydroxylase level causing vitamin D deficiency.
14. Cases diagnosed with any form of malignancy that may be associated with vitamin D deficiency.
15. Current treatment with heparin as it interferes with vitamin D activation.
16. Patients currently on depo-medroxyprogesterone-acetate (DMPA) contraceptives as it proved benefits in shrinking fibroid size.
Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer

The objectives of this clinical study are threefold:

1. To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation.
2. To test whether replacing fluorouracil with Xeloda in combining with cisplatin (PF or PX, respectively) in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay.
3. To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven nasopharyngeal carcinoma
* Non-keratinizing or undifferentiated type Stage III-IVB (by AJCC/UICC 6th edition)
* Essential staging investigations: CT or MRI of nasopharyngeal region Chest x-ray (or CT thorax)
* Liver function test, alkaline phosphatase Liver and bone scan if alkaline phosphatase exceeds the institutional upper limit of normal, or if clinically indicated.
* Liver scan if SGOT exceeds the institutional upper limit of normal
* Adequate marrow: WBC \> 4 and platelet \> 100
* Adequate renal function: creatinine clearance \> 60 ml/min.
* Satisfactory performance status: \> 2 by ECOG System.

Exclusion Criteria:

* WHO Type I squamous cell carcinoma or adenocarcinoma
* Age \> 70
* Treatment with palliative intent (including those with tumor extent mandating the use of AP opposing facio-cervical field technique)
* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer for which the patient has been disease-free for five years.
* Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
* History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
* Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients

This study is an open-label, multiple-dose pharmacokinetic study of imipenem-relebactam conducted in 12 non-infected, obese ICU patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years of age
2. Admitted to the ICU
3. BMI ≥40 kg/m2 and/or total body weight ≥120 kg
4. Provide a signed and dated written informed consent prior to study participation

Exclusion Criteria:

1. History of significant hypersensitivity reaction or intolerance to imipenem/cilastatin or carbapenem-based agents (doripenem, ertapenem, or meropenem +/- vaborbactam)
2. History of seizures and/or receiving 1 or more anti-epileptic agent
3. Serum creatinine ≥1.5 mg/dL
4. Estimated creatinine clearance (CLCR) \<60 mL/minute as determined by Cockcroft-Gault equation:
5. Actively receiving antimicrobial therapy for treatment of a confirmed or suspected infection
6. The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days prior to the first dose of study medication
7. Positive serum pregnancy test (for women of childbearing potential)
8. Currently breast feeding
9. Has previously participated in this study
10. Concomitant use of valproic acid or divalproex sodium
11. Any other condition that may make the patient unsuitable for the study in the judgement of the investigator
Study of Betatrophin Levels in Patients With Type 2 Diabetes and Gestational Diabetes and Healthy Subjects

Betatrophin is a newly identified hormone that promotes pancreatic beta cell proliferation, improves glucose tolerance and regulates lipids metabolism. A recent study showed that circulating concentrations of betatrophin doubled in type 1 diabetes. The objective of this study is to investigate the association of serum betatrophin levels with the progression of diabetic retinopathy in patients with type 2 diabetes and the level of betatrophin in gestational diabetes patients and pregnant women.

200 subjects were recruited in this study and divided into six groups for comparison of the serum betatrophin. 70 healthy subjects and 20 healthy young volunteers were enrolled for investigating the role of betatrophin in energy homeostasis and the circadian rhythm. 50 patients with type 2 diabetes were classified into three groups by the stage of diabetic retinopathy. Rank test was used to analyze the correlation between the progression of diabetic retinopathy and circulating betatrophin. Betatrophin were measured by a commercially available enzyme-linked immunosorbent assay and confirmed via Western Blot.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus patients
* Patients with HbA1c \>or= 7.0%

Exclusion Criteria:

* Participation in other investigational Clinical Trial
* Type 1 diabetes mellitus patients
* Patients with history of severe hepatic dysfunction
* Treatment with antifungal agent especially Miconazole
* Patients with active smoking or history of smoking cessation less than 2 months
Validation of a High-risk Versus Low-risk Referral Model in Suspected Acute Coronary Syndrome

In Emergency Departments patients admitted with chest pain may suffer from non-significant to lifethreatening conditions.

The aim of the present study is to develop and validate a referral model in chest pain patients which divide the patients with non- significant ECG changes into high risk and low risk groups for acute coronary syndrome.


Eligibility Criteria:
Inclusion Criteria:

* more than 15 years old

Exclusion Criteria:

* Patients with ST-elevations in ECG
Influence of Nutritional Indices on the Prognosis of Patients With SARS-CoV-2 Infection

With the decline of virulence after the mutation of the SARS-CoV-2 , based on the national life and health and national development needs, the domestic SARS-CoV-2 infection epidemic prevention policy has changed, and the number of people infected by the SARS-CoV-2 has increased. Nutritional status is an indicator of human health and plays an important role in fighting disease. Malnutrition has been found to correlate with prognosis in patients infected with the SARS-CoV-2 infection . Timely identification and assessment of the patient's nutritional status and early implementation of relevant nutritional intervention are conducive to the recovery of the patient's condition.

In clinical practice, it is necessary to improve nutrition as an aspect of the comprehensive diagnosis and treatment of patients with SARS-CoV-2 infection, but there is still a lack of relevant nutritional indicators or models to simply and accurately assess the nutritional status of patients.The purpose of this study was to evaluate the effects of PNI, NRI, GNRI, albumin level, vitamin D, chest muscle area and density on the clinical characteristics and prognosis of patients with SARS-CoV-2 infection, to find the nutritional predictors of severe disease in patients with SARS-CoV-2 infection, and to establish a simpler and more accurate nutritional evaluation model. To provide evidence for targeted nutritional interventions in patients with SARS-CoV-2 infection.

Patients with SARS-CoV-2 infection attending the Second Affiliated Hospital of Chongqing Medical University were included in the retrospective study. Participants met the inclusion and exclusion criteria. Data to be collected include age, sex, height, and weight at initial treatment; Blood routine, liver function, kidney function, coagulation function, electrolytes, vitamin D, C-reactive protein, ferritin; CT and MRI information; Underlying diseases, complications, treatment options, etc. Follow up patients until discharge or death. After the data collection, statistical methods such as chi-square test and logistic regression analysis were used to evaluate the impact of nutritional factors on the prognosis of patients infected with SARS-CoV-2 infection.

Eligibility Criteria:
Inclusion Criteria:

Patients with a positive SARS-CoV-2 nucleic acid test or a positive SARS-CoV-2 antigen test.

Exclusion Criteria:

1. People with end-stage malignant tumors;
2. Nutritional intake disorders, mainly dependent on enteral and parenteral nutrition supporters;
3. paralyzed;
4. Intravenous drug addicts.
The Reliability and Validity of the Ankylosing Spondylitis Performance Index (ASPI) in Enthesitis-Related Arthritis

This study assesses the test-retest reliability, construct validity, and minimal detectable change of the Ankylosing Spondylitis Performance Index (ASPI) in assessing the physical function of patients with Enthesitis-related arthritis (ERA).

Enthesitis-related arthritis (ERA), which is considered the counterpart of adult spondyloarthropathies, is a human leukocyte antigen (HLA) B27-related subtype of juvenile idiopathic arthritis (JIA) characterized by enthesitis and arthritis, which can also affect the sacroiliac joints and axial spine. Compared to other JIA categories, ERA patients tend to have higher pain intensity, lower physical functionality, and poorer health status. Maintaining or improving physical functionality is one of the primary treatment goals for ERA patients. Physical functionality is also considered an important outcome measure for assessing disease course and effectiveness of treatment. When the literature is examined, it is seen that self-report-based questionnaires are used more frequently, and performance-based measurements are used less in the evaluation of ERA patients.

The Ankylosing Spondylitis Performance Index (ASPI) is a physical performance test that consists of a combination of three reliable tests (bending, putting on socks, and standing up from the floor) developed from the Bath Ankylosing Spondylitis Functional Index (BASFI). It is reported that applying ASPI can provide more objective information about the improvement in physical functionality and a better estimate of the patients' abilities.

ASPI has significant potential in this disease group, considering factors such as the fact that it was developed in adult spondyloarthropathy patients, which is the equivalent of ERA. However, its psychometric properties must be appropriate for the ASPI to be used in clinical settings and research. To our knowledge, no studies have been conducted in the current literature on the validity and reliability of the ASPI in ERA patients. Therefore, this study aimed to evaluate the test-retest reliability, construct validity, and minimal detectable change of the ASPI in assessing the physical function of patients with ERA.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with Enthesitis-Related Arthritis (ERA) according to The International League of Associations for Rheumatology (ILAR) classification
* Being between the ages of 7-18
* Volunteering to participate in research

Exclusion Criteria:

* Advanced heart/lung/liver/kidney disease, neurological disease and malignancies
* Having undergone major orthopedic surgery
* The presence of moderate to severe mental problems that will negatively affect participation
* Not volunteering to participate in the study